14 days ago
Busy Philipps tells PEOPLE her oncologist confirmed her latest scan was clear after she was diagnosed with a brain tumor
Doctors discovered the rare tumor during a full-body MRI in February
Philipps underwent two surgeries and did not need chemotherapy or radiation
Busy Philipps shared a positive update amid her ongoing health journey after she was diagnosed with a brain tumor earlier this year.
"I chatted with my oncologist today," the Cupertino star, 47, tells PEOPLE exclusively at the Wednesday, Sept. 30, premiere of the CBS show in New York City. The Silicon Valley-set legal drama was her doctor's preferred topic of conversation, Philipps shars.
#tumor #people
Doctors discovered the rare tumor during a full-body MRI in February
Philipps underwent two surgeries and did not need chemotherapy or radiation
Busy Philipps shared a positive update amid her ongoing health journey after she was diagnosed with a brain tumor earlier this year.
"I chatted with my oncologist today," the Cupertino star, 47, tells PEOPLE exclusively at the Wednesday, Sept. 30, premiere of the CBS show in New York City. The Silicon Valley-set legal drama was her doctor's preferred topic of conversation, Philipps shars.
#tumor #people
14 days ago
Amanda Peet's advice for protecting your health? Keep an eye out for the warning signs.
The actress and "Your Friends & Neighbors" star, who was diagnosed with breast cancer last fall, opened up about the medical ordeal in a new interview on the "Today" show Thursday, Oct. 1.
"I feel great," Peet, 54, told host Savannah Guthrie, nine months after receiving her first clear scan in January. "I think about how lucky I was in so many ways."
Peet revealed her cancer battle in a March essay for The New Yorker. The actress said that in August 2025, she went in for a "routine scan" to monitor her "'dense' and 'busy' ****** ." During the appointment, her physician discovered a small tumor on an ultrasound. A subsequent MRI showed Peet had a second tumor, later determined to be benign.
Amanda Peet health: Actress's intimate essay revealing cancer is a 'way to cope a little'
#scan #essay #friends
The actress and "Your Friends & Neighbors" star, who was diagnosed with breast cancer last fall, opened up about the medical ordeal in a new interview on the "Today" show Thursday, Oct. 1.
"I feel great," Peet, 54, told host Savannah Guthrie, nine months after receiving her first clear scan in January. "I think about how lucky I was in so many ways."
Peet revealed her cancer battle in a March essay for The New Yorker. The actress said that in August 2025, she went in for a "routine scan" to monitor her "'dense' and 'busy' ****** ." During the appointment, her physician discovered a small tumor on an ultrasound. A subsequent MRI showed Peet had a second tumor, later determined to be benign.
Amanda Peet health: Actress's intimate essay revealing cancer is a 'way to cope a little'
#scan #essay #friends
1 month ago
Stanley Druckenmiller has quite a long and distinguished career as an investor. Much of this has to do with high-risk bets that have paid off enormously, such as when he and his boss, George Soros at Quantum Fund, shorted the U.K. pound for a handsome profit of what was reported to be around $1 billion.
For that reason, the trades Druckenmiller makes with his Duquesne family office matter, and his picks are taken seriously. One of the more intriguing ones is Duquesne's largest holding currently -- and for eight quarters now. It's not a famous name; rather, it's a next-generation healthcare diagnostics company that was once something of a sleeper. Here's a bit more about it.
Missed Nvidia in 2009? This Rare Signal Is Flashing Again. In 2009, a "Double Down" signal flashed for a little-known chipmaker called Nvidia. For the first time in years, that same "Total Conviction" signal is flashing for a company 1/100th the size of Nvidia. Continue »
This huge bet on the future is Natera (NASDAQ: NTRA), a medical diagnostics company that uses unique, state-of-the-art technology to evaluate a patient's blood sample. Natera isn't the only business providing these liquid biopsies, as they're known, but its personalized, tumor-informed approach makes it a best-in-class screener in numerous use cases.
The major one is oncology, which is hardly surprising given the prevalence of cancer. Natera has a set of tests for this, led by Signatera, a highly personalized one constructed from the patient's tumor profile. With this, it detects circulating tumor DNA in the blood. To say this is useful in cancer detection is an understatement, so it's hardly surprising that Natera processed roughly 296,700 oncology tests in the company's second quarter. That was up a highly impressive 57% year over year.
#tumor
For that reason, the trades Druckenmiller makes with his Duquesne family office matter, and his picks are taken seriously. One of the more intriguing ones is Duquesne's largest holding currently -- and for eight quarters now. It's not a famous name; rather, it's a next-generation healthcare diagnostics company that was once something of a sleeper. Here's a bit more about it.
Missed Nvidia in 2009? This Rare Signal Is Flashing Again. In 2009, a "Double Down" signal flashed for a little-known chipmaker called Nvidia. For the first time in years, that same "Total Conviction" signal is flashing for a company 1/100th the size of Nvidia. Continue »
This huge bet on the future is Natera (NASDAQ: NTRA), a medical diagnostics company that uses unique, state-of-the-art technology to evaluate a patient's blood sample. Natera isn't the only business providing these liquid biopsies, as they're known, but its personalized, tumor-informed approach makes it a best-in-class screener in numerous use cases.
The major one is oncology, which is hardly surprising given the prevalence of cancer. Natera has a set of tests for this, led by Signatera, a highly personalized one constructed from the patient's tumor profile. With this, it detects circulating tumor DNA in the blood. To say this is useful in cancer detection is an understatement, so it's hardly surprising that Natera processed roughly 296,700 oncology tests in the company's second quarter. That was up a highly impressive 57% year over year.
#tumor
1 month ago
Vertex Pharmaceuticals Incorporated (NASDAQ:VRTX) could be positioning itself for its next major phase of growth following its roughly $10 billion acquisition of Crinetics Pharmaceuticals. The deal gives the company immediate exposure to the endocrinology market and provides a new commercial platform beyond its established cystic fibrosis franchise.
On September 3, Citigroup **** yst Geoff Meacham highlighted the strategic importance of the Crinetics acquisition, arguing it could diversify Vertex's business while complementing its existing cystic fibrosis franchise and newer businesses in renal disease, hematology, and pain.
Through the transaction, Vertex Pharmaceuticals Incorporated (NASDAQ:VRTX) gains access to Palsonify (paltusotine), an oral treatment for acromegaly that has already received regulatory approval in Europe. Paltusotine is also in Phase 3 development for carcinoid syndrome **** ociated with neuroendocrine tumors.
Palsonify is particularly important because it provides an immediate commercial revenue opportunity, rather than requiring the company to wait several years for an entirely new drug to reach the market.
Early uptake of Palsonify has been encouraging, supported by expanding physician adoption and improving reimbursement coverage. If that momentum continues, the drug could become an important contributor to Vertex's revenue growth.
#palsonify
On September 3, Citigroup **** yst Geoff Meacham highlighted the strategic importance of the Crinetics acquisition, arguing it could diversify Vertex's business while complementing its existing cystic fibrosis franchise and newer businesses in renal disease, hematology, and pain.
Through the transaction, Vertex Pharmaceuticals Incorporated (NASDAQ:VRTX) gains access to Palsonify (paltusotine), an oral treatment for acromegaly that has already received regulatory approval in Europe. Paltusotine is also in Phase 3 development for carcinoid syndrome **** ociated with neuroendocrine tumors.
Palsonify is particularly important because it provides an immediate commercial revenue opportunity, rather than requiring the company to wait several years for an entirely new drug to reach the market.
Early uptake of Palsonify has been encouraging, supported by expanding physician adoption and improving reimbursement coverage. If that momentum continues, the drug could become an important contributor to Vertex's revenue growth.
#palsonify
1 month ago
Mike McFarland, who lent his voice to many classic anime, died Wednesday after a battle with brain cancer. He was 56.
McFarland is known to anime fans as the voice actor for "Dragon Ball Z" characters like Master Roshi and Yajirobe and the "One Piece"character Buggy the Clown. His work was impressively robust. He also famously voiced a pair of Jeans – Jean Kirstein in "Attack on ****** an" and Jean Havoc in "Fullmetal Alchemist" – along with Teppei Sugo in "Psycho-Pass" and Tecchin Tecchikawahara in "Demon Slayer."
"Mike brought so much to all of us who knew him, and to all of the anime fans that knew his work," anime streaming service Crunchyroll said in a statement regarding McFarland's death. "He was an incredible talent, a good friend to so many of us and will be sorely, sorely missed."
McFarland had diagnosed with a brain tumor several years ago. Fellow voice actors J. Michael Tatum and Brandon McInnis started a GoFundMe back in August 2025 to help McFarland pay for a live-in medical ****** istant after he underwent surgery for aggressive glioblastoma.
"Mike McFarland, my dear friend and mentor of over 20 years, is gone," Tatum posted. "A rarer, more beautiful soul this world will never know. Rest in peace, Salt. The love you created endures, but ****** ed if I know how we'll get on without you around to share it back with."
#jean #brain
McFarland is known to anime fans as the voice actor for "Dragon Ball Z" characters like Master Roshi and Yajirobe and the "One Piece"character Buggy the Clown. His work was impressively robust. He also famously voiced a pair of Jeans – Jean Kirstein in "Attack on ****** an" and Jean Havoc in "Fullmetal Alchemist" – along with Teppei Sugo in "Psycho-Pass" and Tecchin Tecchikawahara in "Demon Slayer."
"Mike brought so much to all of us who knew him, and to all of the anime fans that knew his work," anime streaming service Crunchyroll said in a statement regarding McFarland's death. "He was an incredible talent, a good friend to so many of us and will be sorely, sorely missed."
McFarland had diagnosed with a brain tumor several years ago. Fellow voice actors J. Michael Tatum and Brandon McInnis started a GoFundMe back in August 2025 to help McFarland pay for a live-in medical ****** istant after he underwent surgery for aggressive glioblastoma.
"Mike McFarland, my dear friend and mentor of over 20 years, is gone," Tatum posted. "A rarer, more beautiful soul this world will never know. Rest in peace, Salt. The love you created endures, but ****** ed if I know how we'll get on without you around to share it back with."
#jean #brain
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1 month ago
Brandi Glanville shares the treatment she is using amid her ongoing battle with a facial parasite.
The Real Housewives alum detailed her 18-hour IV treatment in a two-part video.
"I feel like death. I look like death," she told followers.
Brandi Glanville is taking fans behind the scenes with her latest health update.
The former Bravo star, who has been candid about her battle with a facial parasite and a face tumor, is undergoing IV treatments to address the issues. On Sunday, Glanville shared a video talking fans through the 18-hour regimen that she said has made her "so skinny right now."
#glanville #treatment #fans
The Real Housewives alum detailed her 18-hour IV treatment in a two-part video.
"I feel like death. I look like death," she told followers.
Brandi Glanville is taking fans behind the scenes with her latest health update.
The former Bravo star, who has been candid about her battle with a facial parasite and a face tumor, is undergoing IV treatments to address the issues. On Sunday, Glanville shared a video talking fans through the 18-hour regimen that she said has made her "so skinny right now."
#glanville #treatment #fans
1 month ago
Revolution Medicines, Inc. (NASDAQ:RVMD) received FDA approval for Rasonque, or daraxonrasib, following an expedited review. The once-daily oral RAS inhibitor is approved for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or are not candidates for multiagent systemic therapy.
Revolution Medicines, Inc. (NASDAQ:RVMD) set a wholesale acquisition cost (WAC) of $39,800 for a 30-day supply. Twelve 30-day supplies would total $477,600 at WAC before discounts, rebates, or ******* istance. Rasonque is available in the United States, with (ON)Path offering insurance navigation and financial-assistance resources, including copay support for eligible commercially insured patients.
The approval was based on RASolute 302, a randomized Phase 3 trial involving 500 patients with previously treated metastatic pancreatic adenocarcinoma. In the overall population, median overall survival reached 13.2 months with Rasonque versus 6.7 months with chemotherapy. The hazard ratio of 0.40 represented a 60% lower hazard of death during trial follow-up. Median progression-free survival was 7.2 months versus 3.6 months, while objective response rates were 30% and 11%, respectively.
The survival benefit gives Rasonque a strong clinical argument for reimbursement. Pancreatic cancer is aggressive, treatment options after progression are limited, and Rasonque improved overall survival, progression-free survival, and response rates in a randomized comparison. Oral dosing may also reduce the burden of intravenous chemotherapy.
The approved population is broader than a single mutation-defined subgroup. Rasonque can be prescribed with or without an identified RAS tumor mutation and does not require a companion diagnostic. That reduces testing friction within the approved treatment setting.
#months #pancreatic #progression #medicines
Revolution Medicines, Inc. (NASDAQ:RVMD) set a wholesale acquisition cost (WAC) of $39,800 for a 30-day supply. Twelve 30-day supplies would total $477,600 at WAC before discounts, rebates, or ******* istance. Rasonque is available in the United States, with (ON)Path offering insurance navigation and financial-assistance resources, including copay support for eligible commercially insured patients.
The approval was based on RASolute 302, a randomized Phase 3 trial involving 500 patients with previously treated metastatic pancreatic adenocarcinoma. In the overall population, median overall survival reached 13.2 months with Rasonque versus 6.7 months with chemotherapy. The hazard ratio of 0.40 represented a 60% lower hazard of death during trial follow-up. Median progression-free survival was 7.2 months versus 3.6 months, while objective response rates were 30% and 11%, respectively.
The survival benefit gives Rasonque a strong clinical argument for reimbursement. Pancreatic cancer is aggressive, treatment options after progression are limited, and Rasonque improved overall survival, progression-free survival, and response rates in a randomized comparison. Oral dosing may also reduce the burden of intravenous chemotherapy.
The approved population is broader than a single mutation-defined subgroup. Rasonque can be prescribed with or without an identified RAS tumor mutation and does not require a companion diagnostic. That reduces testing friction within the approved treatment setting.
#months #pancreatic #progression #medicines
1 month ago
By Sahil Pandey
Sept 2 (Reuters) - AI company Owkin said on Wednesday it has signed a licensing deal with Germany's Boehringer Ingelheim, giving the drugmaker access to its AI research platform and patient data to speed up discovery of drugs for cancer and immunity-related diseases.
The deal adds Boehringer to a growing list of drugmakers using Owkin's AI technology, "K Pro". AstraZeneca licensed it in May, while Sanofi expanded its partnership with a five-year agreement in June.
Here are some more details:
• The deal builds on the companies' pilot project in 2025, in which Owkin used its patient tumor samples and related biological datasets to help Boehringer prioritize potential drug targets, the AI company's CEO, Thomas Clozel, told Reuters.
#deal #patient
Sept 2 (Reuters) - AI company Owkin said on Wednesday it has signed a licensing deal with Germany's Boehringer Ingelheim, giving the drugmaker access to its AI research platform and patient data to speed up discovery of drugs for cancer and immunity-related diseases.
The deal adds Boehringer to a growing list of drugmakers using Owkin's AI technology, "K Pro". AstraZeneca licensed it in May, while Sanofi expanded its partnership with a five-year agreement in June.
Here are some more details:
• The deal builds on the companies' pilot project in 2025, in which Owkin used its patient tumor samples and related biological datasets to help Boehringer prioritize potential drug targets, the AI company's CEO, Thomas Clozel, told Reuters.
#deal #patient
1 month ago
Joe Amabile paid a heartfelt tribute to his wife, Serena Pitt, on their anniversary as he continues to recover from brain tumor surgery. The former Bachelor in Paradise star praised his wife for supporting him through both the good and the difficult moments.
Joe, who became known as Grocery Store Joe during Season 14 of The Bachelorette, marked their three-year anniversary with a special post on September 2. The 40-year-old wrote on Instagram that Pitt is "the most beautiful, caring, perfect" person. "These past few months have been pretty tough, to say the least. You have been there with me every single step of the way, taking in all the good and the bad news. You cried alone in our bedroom because you didn't want to bring me down," the Dancing With the Stars alum expressed.
Continuing his post, Joe praised Serena for standing by him throughout his recovery. He said she took care of everything from cooking and cleaning to attending his doctor's appointments. She also managed his medications and woke up with him in the middle of the night. Joe said he felt incredibly lucky to have Serena as his wife, partner, and best friend. He ended the heartfelt message by telling her he loved her "forever and always."
Joe and Serena got engaged on Bachelor in Paradise season 7 in 2021. They first tied the knot at a New York City courthouse on October 27, 2022. They held a second, larger wedding celebration with loved ones in Charleston on September 2, 2023.
The former reality star first revealed the diagnosis on July 13 in an Instagram video. He said a full-body MRI scan through Prenuvo led doctors to discover an early-stage glioma. He explained that he later underwent a brain MRI. The scan showed a blueberry-sized lesion in his brain that appeared to be a glioma, which is a type of tumor.
#wife #brain #season #heartfelt
Joe, who became known as Grocery Store Joe during Season 14 of The Bachelorette, marked their three-year anniversary with a special post on September 2. The 40-year-old wrote on Instagram that Pitt is "the most beautiful, caring, perfect" person. "These past few months have been pretty tough, to say the least. You have been there with me every single step of the way, taking in all the good and the bad news. You cried alone in our bedroom because you didn't want to bring me down," the Dancing With the Stars alum expressed.
Continuing his post, Joe praised Serena for standing by him throughout his recovery. He said she took care of everything from cooking and cleaning to attending his doctor's appointments. She also managed his medications and woke up with him in the middle of the night. Joe said he felt incredibly lucky to have Serena as his wife, partner, and best friend. He ended the heartfelt message by telling her he loved her "forever and always."
Joe and Serena got engaged on Bachelor in Paradise season 7 in 2021. They first tied the knot at a New York City courthouse on October 27, 2022. They held a second, larger wedding celebration with loved ones in Charleston on September 2, 2023.
The former reality star first revealed the diagnosis on July 13 in an Instagram video. He said a full-body MRI scan through Prenuvo led doctors to discover an early-stage glioma. He explained that he later underwent a brain MRI. The scan showed a blueberry-sized lesion in his brain that appeared to be a glioma, which is a type of tumor.
#wife #brain #season #heartfelt
1 month ago
By Sahil Pandey
Sept 2 (Reuters) - AI company Owkin said on Wednesday it has signed a licensing deal with Germany's Boehringer Ingelheim, giving the drugmaker access to its AI research platform and patient data to speed up discovery of drugs for cancer and immunity-related diseases.
The deal adds Boehringer to a growing list of drugmakers using Owkin's AI technology, "K Pro". AstraZeneca licensed it in May, while Sanofi expanded its partnership with a five-year agreement in June.
Here are some more details:
• The deal builds on the companies' pilot project in 2025, in which Owkin used its patient tumor samples and related biological datasets to help Boehringer prioritize potential drug targets, the AI company's CEO, Thomas Clozel, told Reuters.
#patient
Sept 2 (Reuters) - AI company Owkin said on Wednesday it has signed a licensing deal with Germany's Boehringer Ingelheim, giving the drugmaker access to its AI research platform and patient data to speed up discovery of drugs for cancer and immunity-related diseases.
The deal adds Boehringer to a growing list of drugmakers using Owkin's AI technology, "K Pro". AstraZeneca licensed it in May, while Sanofi expanded its partnership with a five-year agreement in June.
Here are some more details:
• The deal builds on the companies' pilot project in 2025, in which Owkin used its patient tumor samples and related biological datasets to help Boehringer prioritize potential drug targets, the AI company's CEO, Thomas Clozel, told Reuters.
#patient
2 months ago
Tempus AI, Inc. (NASDAQ:TEM) rallied following a melanoma breakthrough reported by Moderna and Merck. The companies said their Phase 3 INTerpath-001 trial met its recurrence-free survival endpoint for the personalized cancer therapy intismeran autogene, also known as V940, combined with Keytruda. Detailed trial data remain pending. The read-through came from Personalis, which has supported the V940 clinical-development program since its inception. Tempus agreed in July to a pending acquisition of Personalis at a $1.5 billion enterprise value, net of Tempus's existing stake. The question for Tempus AI, Inc. (NASDAQ:TEM) is whether the result validates the acquisition or merely confirms that one Personalis platform is strategically relevant to personalized cancer therapy.
Personalis uses ImmunoID NeXT to sequence tumor information for personalized vaccine development. That technology is distinct from NeXT Personal, the company's tumor-informed molecular residual disease test and the central strategic target of the acquisition. For Tempus AI, Inc. (NASDAQ:TEM), the clinical result validates Personalis's sequencing capabilities without establishing the economics of either product.
Tempus AI, Inc. (NASDAQ:TEM) is acquiring a company that has supported the V940 program from its beginning. A successful Phase 3 endpoint could strengthen Personalis's credibility with biopharma customers and create additional sequencing opportunities as drugmakers pursue individualized therapies across more tumor types.
The acquisition also reaches beyond vaccine sequencing. Tempus AI, Inc. (NASDAQ:TEM) has commercialized NeXT Personal since 2023. The MRD test searches for small traces of circulating tumor DNA after treatment, helping clinicians monitor response and identify possible recurrence before it becomes visible through conventional imaging.
Tempus AI, Inc. (NASDAQ:TEM) reported 9,000 total MRD tests in the second quarter, up from 6,500 sequentially. Personalis generated finalized quarterly revenue of $22.357 million and delivered 10,384 clinical tests, with volume rising 33% sequentially. NeXT Personal also has Medicare coverage in three indications, giving the pending transaction a commercial foundation independent of V940.
#v940 #acquisition #tumor
Personalis uses ImmunoID NeXT to sequence tumor information for personalized vaccine development. That technology is distinct from NeXT Personal, the company's tumor-informed molecular residual disease test and the central strategic target of the acquisition. For Tempus AI, Inc. (NASDAQ:TEM), the clinical result validates Personalis's sequencing capabilities without establishing the economics of either product.
Tempus AI, Inc. (NASDAQ:TEM) is acquiring a company that has supported the V940 program from its beginning. A successful Phase 3 endpoint could strengthen Personalis's credibility with biopharma customers and create additional sequencing opportunities as drugmakers pursue individualized therapies across more tumor types.
The acquisition also reaches beyond vaccine sequencing. Tempus AI, Inc. (NASDAQ:TEM) has commercialized NeXT Personal since 2023. The MRD test searches for small traces of circulating tumor DNA after treatment, helping clinicians monitor response and identify possible recurrence before it becomes visible through conventional imaging.
Tempus AI, Inc. (NASDAQ:TEM) reported 9,000 total MRD tests in the second quarter, up from 6,500 sequentially. Personalis generated finalized quarterly revenue of $22.357 million and delivered 10,384 clinical tests, with volume rising 33% sequentially. NeXT Personal also has Medicare coverage in three indications, giving the pending transaction a commercial foundation independent of V940.
#v940 #acquisition #tumor
2 months ago
BioNTech SE (NASDAQ:BNTX) rallied following the first positive interim Phase 3 topline result for a personalized mRNA cancer therapy. Moderna and Merck said intismeran, combined with Keytruda, significantly improved recurrence-free and distant metastasis-free survival in patients with surgically removed high-risk melanoma. The result lifted other mRNA developers because it provided the strongest evidence yet that the technology can work against cancer in a large late-stage trial. For BioNTech SE (NASDAQ:BNTX), however, the rally raises a harder question: does validation of the therapeutic class meaningfully improve the odds for its own candidates, or has the market moved ahead of company-specific evidence?
The distinction matters. Moderna's intismeran is individually designed around mutations found in each patient's tumor. BioNTech SE (NASDAQ:BNTX) is awaiting an interim ******* ysis from the Phase 3 portion of AHEAD-MERIT, which tests BNT113 with pembrolizumab in first-line unresectable recurrent or metastatic HPV16-positive, PD-L1-positive head-and-neck squamous cell carcinoma. BNT113 is an off-the-shelf FixVac therapy encoding the HPV16 E6 and E7 oncoproteins. Different antigens, manufacturing approaches, cancer types and treatment settings prevent Moderna's result from functioning as a direct clinical read-through.
Still, BioNTech SE (NASDAQ:BNTX) has more than one attempt at building an oncology franchise. The company has 14 ongoing pivotal trials across mRNA immunotherapies, immunomodulators and antibody-drug conjugates. It expects three late-stage readouts during 2026, including the BNT113 interim ******* ysis, and ended June with €16.6 billion in cash, cash equivalents and security investments.
The bull case for BioNTech SE (NASDAQ:BNTX) is that Moderna and Merck have reduced skepticism around the broader platform. Their trial enrolled 1,137 patients and met its primary endpoint of recurrence-free survival and a secondary endpoint of distant metastasis-free survival, with no new safety concerns reported. The result shows that an mRNA therapy can add meaningful benefit to a checkpoint inhibitor in Phase 3.
BioNTech also has a personalized program that more closely resembles intismeran. Autogene cevumeran, partnered with Genentech, is being studied in randomized Phase 2 trials in pancreatic and colorectal cancer. Meanwhile, BNT113 has FDA Fast Track designation and could provide BioNTech's own pivotal mRNA evidence. The company's cash position gives it room to fund these programs and absorb failures elsewhere in the portfolio.
#biontech
The distinction matters. Moderna's intismeran is individually designed around mutations found in each patient's tumor. BioNTech SE (NASDAQ:BNTX) is awaiting an interim ******* ysis from the Phase 3 portion of AHEAD-MERIT, which tests BNT113 with pembrolizumab in first-line unresectable recurrent or metastatic HPV16-positive, PD-L1-positive head-and-neck squamous cell carcinoma. BNT113 is an off-the-shelf FixVac therapy encoding the HPV16 E6 and E7 oncoproteins. Different antigens, manufacturing approaches, cancer types and treatment settings prevent Moderna's result from functioning as a direct clinical read-through.
Still, BioNTech SE (NASDAQ:BNTX) has more than one attempt at building an oncology franchise. The company has 14 ongoing pivotal trials across mRNA immunotherapies, immunomodulators and antibody-drug conjugates. It expects three late-stage readouts during 2026, including the BNT113 interim ******* ysis, and ended June with €16.6 billion in cash, cash equivalents and security investments.
The bull case for BioNTech SE (NASDAQ:BNTX) is that Moderna and Merck have reduced skepticism around the broader platform. Their trial enrolled 1,137 patients and met its primary endpoint of recurrence-free survival and a secondary endpoint of distant metastasis-free survival, with no new safety concerns reported. The result shows that an mRNA therapy can add meaningful benefit to a checkpoint inhibitor in Phase 3.
BioNTech also has a personalized program that more closely resembles intismeran. Autogene cevumeran, partnered with Genentech, is being studied in randomized Phase 2 trials in pancreatic and colorectal cancer. Meanwhile, BNT113 has FDA Fast Track designation and could provide BioNTech's own pivotal mRNA evidence. The company's cash position gives it room to fund these programs and absorb failures elsewhere in the portfolio.
#biontech
2 months ago
Aug 28 (Reuters) - BioNTech SE said on Friday it has decided to terminate the mid-stage trial of its experimental mRNA-based cancer vaccine for patients with a type of colorectal cancer, sending the German firm's U.S.-listed shares down nearly 9%.
An independent data safety monitoring board, responsible for overseeing the safety and integrity of the trial, recommended discontinuing treatment of patients and terminating the study.
The immunotherapy, autogene cevumeran, is being jointly developed by BioNTech and Roche's Genentech. The trial was evaluating it as an adjuvant monotherapy in patients with high-risk stage II or stage III colorectal cancer whose tumors had been surgically removed but who remained ctDNA-positive.
In its most recent review of the available data of this trial, the board identified a numerical imbalance in overall survival between treatment arms in this specific patient population and noted that further trial continuation was unlikely to change the efficacy outcome.
(Reporting by Sriparna Roy in Bengaluru; Editing by Shilpi Majumdar)
#patients #colorectal
An independent data safety monitoring board, responsible for overseeing the safety and integrity of the trial, recommended discontinuing treatment of patients and terminating the study.
The immunotherapy, autogene cevumeran, is being jointly developed by BioNTech and Roche's Genentech. The trial was evaluating it as an adjuvant monotherapy in patients with high-risk stage II or stage III colorectal cancer whose tumors had been surgically removed but who remained ctDNA-positive.
In its most recent review of the available data of this trial, the board identified a numerical imbalance in overall survival between treatment arms in this specific patient population and noted that further trial continuation was unlikely to change the efficacy outcome.
(Reporting by Sriparna Roy in Bengaluru; Editing by Shilpi Majumdar)
#patients #colorectal
2 months ago
Michael Strahan is reportedly a father of five!
The "Good Morning America" host, 54, and girlfriend Kayla Quick quietly welcomed their first child together, a daughter, earlier this year, according to TMZ. Strahan is also dad to daughter Tanita, 34, and son Michael Jr., 31, whom he shares with ex-wife Wanda Hutchins, and twins Sophia and Isabella, 21, with ex-wife Jean Muggli.
The former New York Giants player and Quick, who founded wellness supplement brand FIZZNESS, were first romantically linked in 2015. In the years since, they have largely kept their relationship under wraps.
In 2023, they made a rare public appearance together when Quick attended a ceremony honoring Strahan as he received a star on the Hollywood Walk of Fame.
Strahan has been outspoken about his kids in the past, sharing in 2025 that his daughter Isabella Strahan had been diagnosed with medulloblastoma, a cancerous brain tumor, two years prior. She appeared alongside her dad on "GMA" at the time, explaining how she had to have emergency surgery to remove the golf ball-sized mass.
#first
The "Good Morning America" host, 54, and girlfriend Kayla Quick quietly welcomed their first child together, a daughter, earlier this year, according to TMZ. Strahan is also dad to daughter Tanita, 34, and son Michael Jr., 31, whom he shares with ex-wife Wanda Hutchins, and twins Sophia and Isabella, 21, with ex-wife Jean Muggli.
The former New York Giants player and Quick, who founded wellness supplement brand FIZZNESS, were first romantically linked in 2015. In the years since, they have largely kept their relationship under wraps.
In 2023, they made a rare public appearance together when Quick attended a ceremony honoring Strahan as he received a star on the Hollywood Walk of Fame.
Strahan has been outspoken about his kids in the past, sharing in 2025 that his daughter Isabella Strahan had been diagnosed with medulloblastoma, a cancerous brain tumor, two years prior. She appeared alongside her dad on "GMA" at the time, explaining how she had to have emergency surgery to remove the golf ball-sized mass.
#first
2 months ago
Michelle Williams dedicated part of her Actors Awards speech to Busy Philipps the night before her brain tumor surgery
Philipps revealed to PEOPLE that she discovered the tumor early and had it fully removed: "I'm kinda like good to go," she says
Williams supported Philipps before and after the surgery, providing meals and emotional support
Michelle Williams gave her dear friend Busy Philipps a sweet and meaningful shout-out in her Actor Awards acceptance speech on March 1.
When Williams accepted the Actor Awards trophy for Outstanding Performance by a Female Actor in a Television Movie or Limited Series for her performance in Dying for ******* , an FX/Hulu dramedy about a woman with cancer living out her ******* ual fantasies, she noted the friendship between her character and best friend Nikki, played by Jenny Slate.
#awards
Philipps revealed to PEOPLE that she discovered the tumor early and had it fully removed: "I'm kinda like good to go," she says
Williams supported Philipps before and after the surgery, providing meals and emotional support
Michelle Williams gave her dear friend Busy Philipps a sweet and meaningful shout-out in her Actor Awards acceptance speech on March 1.
When Williams accepted the Actor Awards trophy for Outstanding Performance by a Female Actor in a Television Movie or Limited Series for her performance in Dying for ******* , an FX/Hulu dramedy about a woman with cancer living out her ******* ual fantasies, she noted the friendship between her character and best friend Nikki, played by Jenny Slate.
#awards
2 months ago
Merck & Co., Inc. (NYSE:MRK) jumped 12.6% to a record $152.20 on August 19 after a pivotal melanoma trial validated intismeran autogene, the individualized mRNA cancer therapy developed with Moderna. In the 1,137-patient Phase 3 INTerpath-001 study, intismeran plus Keytruda produced statistically significant and clinically meaningful improvements in recurrence-free survival and distant-metastasis-free survival compared with Keytruda alone. No new safety concerns emerged. Investors are now asking whether intismeran can turn Keytruda from a drug approaching a patent cliff into the foundation of a personalized-cancer platform.
That distinction matters because Merck & Co., Inc. (NYSE:MRK) generated $31.68 billion from Keytruda and Keytruda Qlex in 2025, nearly half of the company's sales. In the U.S., biosimilar competition could begin after Keytruda's primary compound patent expires in December 2028, although biosimilars have already entered some smaller international markets. A successful combination could support continued use of the franchise without removing the need for other growth engines.
The bullish case for Merck & Co., Inc. (NYSE:MRK) is that intismeran adds a personalized immune response to a checkpoint inhibitor already embedded across oncology. The treatment is designed from the unique mutations in each patient's tumor and encodes as many as 34 neoantigens, training the immune system to recognize tumor cells while Keytruda removes a brake on the immune response.
Earlier Phase 2b data showed a 49% reduction in the risk of recurrence or death and a 59% reduction in distant metastasis or death at five years. Phase 3 confirmation makes the approach more credible for Merck & Co., Inc. (NYSE:MRK) beyond melanoma. The company is also studying intismeran combinations in non-small cell lung, bladder and renal-cell cancers. Success across several tumor types could create a portfolio of Keytruda combinations rather than a single indication.
That would give Merck & Co., Inc. (NYSE:MRK) another lifecycle-management tool alongside Keytruda Qlex and newer oncology ***** ets. It also strengthens the argument that Keytruda can remain commercially relevant after standalone pembrolizumab faces lower-priced competition.
#NYSE #tumor #cancer
That distinction matters because Merck & Co., Inc. (NYSE:MRK) generated $31.68 billion from Keytruda and Keytruda Qlex in 2025, nearly half of the company's sales. In the U.S., biosimilar competition could begin after Keytruda's primary compound patent expires in December 2028, although biosimilars have already entered some smaller international markets. A successful combination could support continued use of the franchise without removing the need for other growth engines.
The bullish case for Merck & Co., Inc. (NYSE:MRK) is that intismeran adds a personalized immune response to a checkpoint inhibitor already embedded across oncology. The treatment is designed from the unique mutations in each patient's tumor and encodes as many as 34 neoantigens, training the immune system to recognize tumor cells while Keytruda removes a brake on the immune response.
Earlier Phase 2b data showed a 49% reduction in the risk of recurrence or death and a 59% reduction in distant metastasis or death at five years. Phase 3 confirmation makes the approach more credible for Merck & Co., Inc. (NYSE:MRK) beyond melanoma. The company is also studying intismeran combinations in non-small cell lung, bladder and renal-cell cancers. Success across several tumor types could create a portfolio of Keytruda combinations rather than a single indication.
That would give Merck & Co., Inc. (NYSE:MRK) another lifecycle-management tool alongside Keytruda Qlex and newer oncology ***** ets. It also strengthens the argument that Keytruda can remain commercially relevant after standalone pembrolizumab faces lower-priced competition.
#NYSE #tumor #cancer
2 months ago
Busy Philipps has ex-husband Marc Silverstein and late friend James Van Der Beek to thank for the discovery of her rare brain tumor.
Philipps, 47, is "grateful" to be alive after doctors found a grade 2 oligodendroglioma, a rare type of brain cancer, during the actress' voluntary full-body scan in February.
Mega
The White Chicks star told People in a Wednesday, August 26, interview that she had originally scheduled the procedure for January, but was forced to postpone due to a blizzard in New York City. Her rescheduled appointment, however, was set for February 12 — just one day after her beloved Dawson's Creek costar Van Der Beek died after a battle with stage 3 colorectal cancer.
"Should I just cancel it?" she recalled asking Silverstein, 55, with whom she shares daughters Birdie, 18, and Cricket, 13. "He's like, 'Maybe it's the best thing you could do for your friend this morning. Go get that scan.'"
#silverstein #beek #february
Philipps, 47, is "grateful" to be alive after doctors found a grade 2 oligodendroglioma, a rare type of brain cancer, during the actress' voluntary full-body scan in February.
Mega
The White Chicks star told People in a Wednesday, August 26, interview that she had originally scheduled the procedure for January, but was forced to postpone due to a blizzard in New York City. Her rescheduled appointment, however, was set for February 12 — just one day after her beloved Dawson's Creek costar Van Der Beek died after a battle with stage 3 colorectal cancer.
"Should I just cancel it?" she recalled asking Silverstein, 55, with whom she shares daughters Birdie, 18, and Cricket, 13. "He's like, 'Maybe it's the best thing you could do for your friend this morning. Go get that scan.'"
#silverstein #beek #february
2 months ago
Busy Philipps and Joe Amabile connected after both were diagnosed with brain tumors found through Prenuvo scans
Philipps introduced Amabile to her surgeon, who performed his successful surgery in August
Both stars hope sharing their experiences inspires others to prioritize their health
Busy Philipps has been helping Joe Amabile through his brain tumor diagnosis just months after going through the same journey herself.
In a new PEOPLE cover story, Philipps, 47, revealed that a Prenuvo scan led to her being diagnosed with a grade 2 oligodendroglioma, a malignant but highly treatable brain tumor. She underwent surgery to have it removed in March.
#tumor #august #people
Philipps introduced Amabile to her surgeon, who performed his successful surgery in August
Both stars hope sharing their experiences inspires others to prioritize their health
Busy Philipps has been helping Joe Amabile through his brain tumor diagnosis just months after going through the same journey herself.
In a new PEOPLE cover story, Philipps, 47, revealed that a Prenuvo scan led to her being diagnosed with a grade 2 oligodendroglioma, a malignant but highly treatable brain tumor. She underwent surgery to have it removed in March.
#tumor #august #people
2 months ago
Busy Philipps is sharing new details about a terrifying health scare that led to the "weirdest six months" of her life.
The actress recently revealed that she underwent two surgeries earlier this year after doctors discovered a rare, slow-growing brain tumor. While she's now safely on the other side of the procedures and feels "grateful" to be alive, she admits she came very close to skipping the appointment that caught the mass.
More from SheKnows
Whitney Port Says This 'Annoying' Surgery Is the Next Step in Her IVF Journey
Philipps told People that she'd been curious about getting a full-body Prenuvo MRI scan after seeing it on Instagram, even though her primary care doctor said it wasn't necessary since she was young, healthy, and her annual labs were normal. Going with her gut instinct, Philipps booked the appointment anyway.
#port
The actress recently revealed that she underwent two surgeries earlier this year after doctors discovered a rare, slow-growing brain tumor. While she's now safely on the other side of the procedures and feels "grateful" to be alive, she admits she came very close to skipping the appointment that caught the mass.
More from SheKnows
Whitney Port Says This 'Annoying' Surgery Is the Next Step in Her IVF Journey
Philipps told People that she'd been curious about getting a full-body Prenuvo MRI scan after seeing it on Instagram, even though her primary care doctor said it wasn't necessary since she was young, healthy, and her annual labs were normal. Going with her gut instinct, Philipps booked the appointment anyway.
#port
2 months ago
Busy Philipps is grateful to be alive after spending six months battling a brain tumor.
Talking with People in an interview published Wednesday, Philipps revealed that she learned about her grade 2 oligodendroglioma – a rare and slow-moving tumor – right as she booked her upcoming role on "Cupertino." She called the experience "the weirdest six months of my life."
"I'm grateful that I'm alive," she said.
The tumor was discovered after Philipps did a Prenuvo MRI scan. She did it despite her doctors saying it wasn't needed because she was young and did not have any symptoms but she felt the need to do it anyway.
The day before the scan was scheduled, Philipps' friend and former "Dawson's Creek" co-star James Van Der Beek lost his battle with cancer and the day after the scan she was set to meet with "Cupertino" creators Michelle and Robert King. She wondered if because of all that if she should just cancel the scan but a conversation with her ex-husband Marc Silverstein convinced her to stick it out.
#months
Talking with People in an interview published Wednesday, Philipps revealed that she learned about her grade 2 oligodendroglioma – a rare and slow-moving tumor – right as she booked her upcoming role on "Cupertino." She called the experience "the weirdest six months of my life."
"I'm grateful that I'm alive," she said.
The tumor was discovered after Philipps did a Prenuvo MRI scan. She did it despite her doctors saying it wasn't needed because she was young and did not have any symptoms but she felt the need to do it anyway.
The day before the scan was scheduled, Philipps' friend and former "Dawson's Creek" co-star James Van Der Beek lost his battle with cancer and the day after the scan she was set to meet with "Cupertino" creators Michelle and Robert King. She wondered if because of all that if she should just cancel the scan but a conversation with her ex-husband Marc Silverstein convinced her to stick it out.
#months
2 months ago
Busy Phillips, 47, revealed she was diagnosed with a rare brain tumor in February, telling People that she's experienced "the weirdest six months of my life" after undergoing two surgeries.
"I'm grateful that I'm alive," Phillips shared as she recovers from a grade 2 oligodendroglioma, which is found in only 1,100 to 1,300 people per year in the U.S., according to her neuro-oncologist, Dr. Alexandra Miller.
Phillips noted that after one of her trusted sources, Dr. Orrin Devinsky, a neurologist at NYU Langone, reviewed her MRI, the reality of her condition set in.
"'This is a real tumor, and it's inside your brain. And, Busy, it's got to come out,'" Philipps recalled Devinsky telling her on the phone. "I was hyperventilating and trying to breathe."
After her surgery on March 2, a mass in her brain measuring 2.6 centimeters was removed and biopsied.
#brain #devinsky #telling
"I'm grateful that I'm alive," Phillips shared as she recovers from a grade 2 oligodendroglioma, which is found in only 1,100 to 1,300 people per year in the U.S., according to her neuro-oncologist, Dr. Alexandra Miller.
Phillips noted that after one of her trusted sources, Dr. Orrin Devinsky, a neurologist at NYU Langone, reviewed her MRI, the reality of her condition set in.
"'This is a real tumor, and it's inside your brain. And, Busy, it's got to come out,'" Philipps recalled Devinsky telling her on the phone. "I was hyperventilating and trying to breathe."
After her surgery on March 2, a mass in her brain measuring 2.6 centimeters was removed and biopsied.
#brain #devinsky #telling
2 months ago
Busy Philipps learned she had a brain tumor after getting a full-body scan in February
The tumor, which was removed and biopsied during a surgery in March was identified as a rare grade 2 oligodendroglioma
Philipps recalls the moment the doctor who reviewed her MRI called her with news she needed to have the surgery: "The wind sort of knocked out of me," she tells PEOPLE
Busy Philipps recalls the exact moment she learned she needed surgery to remove a brain tumor.
In a new interview with PEOPLE, the Cougar Town alum, 47, details how she got a full-body Prenuvo scan in February, which showed she had a lesion on her brain. She needed a follow-up MRI to get a closer look, and Dr. Orrin Devinsky of NYU Langone reviewed the scan.
#brain
The tumor, which was removed and biopsied during a surgery in March was identified as a rare grade 2 oligodendroglioma
Philipps recalls the moment the doctor who reviewed her MRI called her with news she needed to have the surgery: "The wind sort of knocked out of me," she tells PEOPLE
Busy Philipps recalls the exact moment she learned she needed surgery to remove a brain tumor.
In a new interview with PEOPLE, the Cougar Town alum, 47, details how she got a full-body Prenuvo scan in February, which showed she had a lesion on her brain. She needed a follow-up MRI to get a closer look, and Dr. Orrin Devinsky of NYU Langone reviewed the scan.
#brain
2 months ago
Tempus AI (NASDAQ: TEM) stock posted massive gains this week despite valuation pressures across the broader market. The healthcare artificial intelligence (AI) specialist's share price climbed 39.5% over its close at the end of the previous week's trading. Meanwhile, the S&P 500's level declined 1.9%, and the Nasdaq Composite's level declined 2.8%.
Tempus's big gains this week stemmed from a press release published by Merck and Moderna that provided an update on a trial for their cancer vaccine. Despite the big valuation pop, Tempus stock is still down roughly 10% over the last year.
Missed Nvidia in 2009? This Rare Signal Is Flashing Again. In 2009, a "Double Down" signal flashed for a little-known chipmaker called Nvidia. For the first time in years, that same "Total Conviction" signal is flashing for a company 1/100th the size of Nvidia. Continue »
On Wednesday, Merck and Moderna published a press release detailing Phase 3 trial data for the use of a jointly developed messenger ribonucleic acid (mRNA) vaccine along with Merck's Keytruda immunotherapy as a cancer treatment. The results showed that patients who took the combined treatment saw significant benefits compared to those who just took Keytruda, with the return and spread of cancer both being diminished among the cohort.
Tempus stock soared following the announcement, largely due to its pending acquisition of Personalis -- the company that developed the genomic tumor-profiling technology that was central to the development of Merck and Moderna's cancer vaccines. Tempus's deal to acquire Personalis is a binding agreement and is expected to close late this year or early in 2027.
#tempus #NASDAQ #keytruda
Tempus's big gains this week stemmed from a press release published by Merck and Moderna that provided an update on a trial for their cancer vaccine. Despite the big valuation pop, Tempus stock is still down roughly 10% over the last year.
Missed Nvidia in 2009? This Rare Signal Is Flashing Again. In 2009, a "Double Down" signal flashed for a little-known chipmaker called Nvidia. For the first time in years, that same "Total Conviction" signal is flashing for a company 1/100th the size of Nvidia. Continue »
On Wednesday, Merck and Moderna published a press release detailing Phase 3 trial data for the use of a jointly developed messenger ribonucleic acid (mRNA) vaccine along with Merck's Keytruda immunotherapy as a cancer treatment. The results showed that patients who took the combined treatment saw significant benefits compared to those who just took Keytruda, with the return and spread of cancer both being diminished among the cohort.
Tempus stock soared following the announcement, largely due to its pending acquisition of Personalis -- the company that developed the genomic tumor-profiling technology that was central to the development of Merck and Moderna's cancer vaccines. Tempus's deal to acquire Personalis is a binding agreement and is expected to close late this year or early in 2027.
#tempus #NASDAQ #keytruda
2 months ago
Joe Amabile went on a 3-mile run after being medically cleared just 15 days after undergoing brain surgery
He revealed he has a low-grade astrocytoma and will take daily medication to manage it
His brain tumor was discovered during a full-body MRI scan with Prenuvo
Joe Amabile is already back on his feet after undergoing brain surgery.
On Thursday, Aug. 20, the 40-year-old Bachelor alum — who is widely known to fans as "Grocery Store Joe" — posted a video on Instagram of himself gearing up for his first run as he continues to recover from having a brain tumor removed.
#amabile #surgery #tumor
He revealed he has a low-grade astrocytoma and will take daily medication to manage it
His brain tumor was discovered during a full-body MRI scan with Prenuvo
Joe Amabile is already back on his feet after undergoing brain surgery.
On Thursday, Aug. 20, the 40-year-old Bachelor alum — who is widely known to fans as "Grocery Store Joe" — posted a video on Instagram of himself gearing up for his first run as he continues to recover from having a brain tumor removed.
#amabile #surgery #tumor
2 months ago
A Reddit post asked users to name "a horrible thing that a famous person did that everyone forgot about" and has drawn a long list of controversial celebrity and political stories.
The r/AskReddit post had more than 2,100 upvotes as of publication. Some of the most popular responses were allegations or events that have been documented in news reports, court records, or autobiographies. At the same time, several commenters also repeated claims that could use more context.
One of the top comments brought up comedian George Lopez and said he cheated on his wife after she donated a kidney to him. Lopez's ex-wife, Ann Serrano, donated a kidney to him in 2005 after he was diagnosed with a genetic condition. Later in 2010, the couple announced that they were ending their 17-year marriage, and Serrano filed for divorce in 2012. The official cause, however, was irreconcilable differences.
ABC News reporting on the divorce did not support the claim that adultery was the cause of their split.
Another highly upvoted comment was in reference to former House Speaker Newt Gingrich. Reddit users claimed he filed divorce papers against his first wife while she was recovering from cancer surgery. FactCheck.org, on the other hand, reported that Gingrich and Jackie Battley were already separated and in divorce proceedings when she was hospitalized in 1980. Battley had undergone cancer surgery earlier and was recovering from surgery to remove another tumor. Gingrich has also said that the two argued during the hospital visit.
#divorce #serrano #post #donated
The r/AskReddit post had more than 2,100 upvotes as of publication. Some of the most popular responses were allegations or events that have been documented in news reports, court records, or autobiographies. At the same time, several commenters also repeated claims that could use more context.
One of the top comments brought up comedian George Lopez and said he cheated on his wife after she donated a kidney to him. Lopez's ex-wife, Ann Serrano, donated a kidney to him in 2005 after he was diagnosed with a genetic condition. Later in 2010, the couple announced that they were ending their 17-year marriage, and Serrano filed for divorce in 2012. The official cause, however, was irreconcilable differences.
ABC News reporting on the divorce did not support the claim that adultery was the cause of their split.
Another highly upvoted comment was in reference to former House Speaker Newt Gingrich. Reddit users claimed he filed divorce papers against his first wife while she was recovering from cancer surgery. FactCheck.org, on the other hand, reported that Gingrich and Jackie Battley were already separated and in divorce proceedings when she was hospitalized in 1980. Battley had undergone cancer surgery earlier and was recovering from surgery to remove another tumor. Gingrich has also said that the two argued during the hospital visit.
#divorce #serrano #post #donated
2 months ago
On August 11, Bicara Therapeutics (NASDAQ:BCAX) used its second-quarter earnings call to deliver two headlines at once. CEO Claire Mazumdar announced she will step into a Vice Chair and Strategic Adviser role at the start of next year, handing the top job to President and Chief Operating Officer Ryan Cohlhepp. That handoff arrives just as the company points to fresh survival data for ficerafusp alfa, its lead drug candidate for frontline recurrent or metastatic HPV-negative head and neck cancer, and pushes its pivotal trial toward a critical readout.
At May's ASCO meeting, Bicara presented three-year follow-up data spanning roughly 90 patients across three dose cohorts, the longest follow-up reported for any investigational agent in HPV-negative head and neck cancer. At the 1,500 milligram weekly pivotal dose, about one in three patients was still alive at three years, roughly double the survival rate seen in retrospective **** yses of standard-of-care pembrolizumab in this population. Management ties that benefit to the drug's TGF-beta inhibition, which it says drives tumor penetration and immune cell infiltration rather than blocking a single pathway. Overall survival nearly doubled against the standard of care while the safety profile stayed consistent, the company said.
Execution on the pivotal Phase III FORTIFI-HN01 study has kept pace. Bicara says it is on track for substantial enrollment by the end of 2026, with more than 200 sites now active, positioning the trial for a mid-2027 interim readout that could open the door to accelerated approval. The company also launched FORTIFI-FLEX, a study of an every-three-week maintenance dose built on encouraging results from an exploratory every-two-week cohort shown earlier this year, with data targeted for the time of any U.S. approval decision. Beyond the core indication, Bicara points to early proof of concept in cutaneous squamous cell carcinoma and **** canal cancer, backed by roughly $497 million in cash that management says funds operations through the first half of 2029.
The leadership overhaul goes well beyond the CEO chair. Jenn Larson took over as Chief Financial Officer the day after the call, succeeding Ivan Hyep, who had a hand in raising over $800 million for the company since its early days. Two more transitions take effect in January: Chief Development Officer Tanya Green moves into the Chief Operating Officer seat, and Chief Corporate Affairs Officer Jenna Cohen becomes Chief Business Officer. A new Chief Legal Officer and two new board members are joining as well, a lot of change concentrated in a single quarter right as the company approaches its most consequential trial milestone.
#bicara #three #survival #cancer
At May's ASCO meeting, Bicara presented three-year follow-up data spanning roughly 90 patients across three dose cohorts, the longest follow-up reported for any investigational agent in HPV-negative head and neck cancer. At the 1,500 milligram weekly pivotal dose, about one in three patients was still alive at three years, roughly double the survival rate seen in retrospective **** yses of standard-of-care pembrolizumab in this population. Management ties that benefit to the drug's TGF-beta inhibition, which it says drives tumor penetration and immune cell infiltration rather than blocking a single pathway. Overall survival nearly doubled against the standard of care while the safety profile stayed consistent, the company said.
Execution on the pivotal Phase III FORTIFI-HN01 study has kept pace. Bicara says it is on track for substantial enrollment by the end of 2026, with more than 200 sites now active, positioning the trial for a mid-2027 interim readout that could open the door to accelerated approval. The company also launched FORTIFI-FLEX, a study of an every-three-week maintenance dose built on encouraging results from an exploratory every-two-week cohort shown earlier this year, with data targeted for the time of any U.S. approval decision. Beyond the core indication, Bicara points to early proof of concept in cutaneous squamous cell carcinoma and **** canal cancer, backed by roughly $497 million in cash that management says funds operations through the first half of 2029.
The leadership overhaul goes well beyond the CEO chair. Jenn Larson took over as Chief Financial Officer the day after the call, succeeding Ivan Hyep, who had a hand in raising over $800 million for the company since its early days. Two more transitions take effect in January: Chief Development Officer Tanya Green moves into the Chief Operating Officer seat, and Chief Corporate Affairs Officer Jenna Cohen becomes Chief Business Officer. A new Chief Legal Officer and two new board members are joining as well, a lot of change concentrated in a single quarter right as the company approaches its most consequential trial milestone.
#bicara #three #survival #cancer
2 months ago
CHICAGO, Aug 19 (Reuters) - Merck and Moderna's success with a personalized cancer vaccine designed to keep melanoma at bay opens a new avenue of treatment that doctors hope will work against many types of tumors.
Unlike chemotherapy, which kills both healthy and cancerous cells, or immunotherapy, which revs up the immune system, personalized cancer vaccines train the immune system to specifically target mutations found only on a person's tumor.
Merck and Moderna said on Wednesday their vaccine helped prevent the return and spread of disease in a large trial involving more than 1,000 melanoma patients. They had localized tumors that were removed surgically, but had a high risk of recurrence. Moderna expects that thousands of melanoma patients could benefit within the first few years of approval.
"It is a big deal for the field in general," said Dr. Ryan Sullivan, director of the Center for Melanoma at Mass General Brigham Cancer Institute. "With this positive study, there is hope (and likely investment to follow) that these approaches may change the way we treat cancer more broadly."
The trial result is "a monumental leap forward," validating mRNA technology as a cancer treatment, said Dr. Julie Gralow, chief medical officer of the American Society of Clinical Oncology.
#cancer #merck #general
Unlike chemotherapy, which kills both healthy and cancerous cells, or immunotherapy, which revs up the immune system, personalized cancer vaccines train the immune system to specifically target mutations found only on a person's tumor.
Merck and Moderna said on Wednesday their vaccine helped prevent the return and spread of disease in a large trial involving more than 1,000 melanoma patients. They had localized tumors that were removed surgically, but had a high risk of recurrence. Moderna expects that thousands of melanoma patients could benefit within the first few years of approval.
"It is a big deal for the field in general," said Dr. Ryan Sullivan, director of the Center for Melanoma at Mass General Brigham Cancer Institute. "With this positive study, there is hope (and likely investment to follow) that these approaches may change the way we treat cancer more broadly."
The trial result is "a monumental leap forward," validating mRNA technology as a cancer treatment, said Dr. Julie Gralow, chief medical officer of the American Society of Clinical Oncology.
#cancer #merck #general
2 months ago
ST. LOUIS — Gary Woodland doesn't need any reminders about the challenges he has encountered over the last three years, the surgery he underwent in 2023 to remove a lesion from his brain and his subsequent battle with post-traumatic stress disorder that forces him to keep constant anxiety in check while competing at the highest level of professional golf.
But there he was last week at the FedEx St. Jude Championship in Memphis meeting with an 11-year-old boy from New Zealand after the youngster followed the former U.S. Open champion around TPC Southwind. The boy has an inoperable brain tumor.
Woodland shared this anecdote on Thursday after the first round of the BMW Championship. And just seeing the look in his eyes relaying that moment in Memphis said so much about how he ***** ses what his career has come to mean to others and not just himself.
"I think I got a lot of perspective over the last couple years. I know I'm fighting for a lot more than playing golf," he said. "I'm hopefully having a positive impact on a lot of people's lives just showing up and fighting. Knowing that I'm struggling every day, and hopefully … I'm having a bigger impact than just showing up and showing that I can still compete and play out here and live my dreams. That's the big deal is I'm struggling and I'm still living my dreams. I hope people see that and try to do the same thing."
Woodland's dream took a fairytale turn in late March when he won the Texas Children's Houston Open less than a month after revealing that he suffers from PTSD. That victory, his fifth career ***** le on the PGA Tour and first in almost seven years, is easily the most inspirational story of the year, one that was a triumph of the spirit more than a conquering of a golf course and a field of talented competitors.
#last #woodland #memphis #brain
But there he was last week at the FedEx St. Jude Championship in Memphis meeting with an 11-year-old boy from New Zealand after the youngster followed the former U.S. Open champion around TPC Southwind. The boy has an inoperable brain tumor.
Woodland shared this anecdote on Thursday after the first round of the BMW Championship. And just seeing the look in his eyes relaying that moment in Memphis said so much about how he ***** ses what his career has come to mean to others and not just himself.
"I think I got a lot of perspective over the last couple years. I know I'm fighting for a lot more than playing golf," he said. "I'm hopefully having a positive impact on a lot of people's lives just showing up and fighting. Knowing that I'm struggling every day, and hopefully … I'm having a bigger impact than just showing up and showing that I can still compete and play out here and live my dreams. That's the big deal is I'm struggling and I'm still living my dreams. I hope people see that and try to do the same thing."
Woodland's dream took a fairytale turn in late March when he won the Texas Children's Houston Open less than a month after revealing that he suffers from PTSD. That victory, his fifth career ***** le on the PGA Tour and first in almost seven years, is easily the most inspirational story of the year, one that was a triumph of the spirit more than a conquering of a golf course and a field of talented competitors.
#last #woodland #memphis #brain
2 months ago
On August 11, Bicara Therapeutics (NASDAQ:BCAX) used its second-quarter earnings call to deliver two headlines at once. CEO Claire Mazumdar announced she will step into a Vice Chair and Strategic Adviser role at the start of next year, handing the top job to President and Chief Operating Officer Ryan Cohlhepp. That handoff arrives just as the company points to fresh survival data for ficerafusp alfa, its lead drug candidate for frontline recurrent or metastatic HPV-negative head and neck cancer, and pushes its pivotal trial toward a critical readout.
At May's ASCO meeting, Bicara presented three-year follow-up data spanning roughly 90 patients across three dose cohorts, the longest follow-up reported for any investigational agent in HPV-negative head and neck cancer. At the 1,500 milligram weekly pivotal dose, about one in three patients was still alive at three years, roughly double the survival rate seen in retrospective ****** yses of standard-of-care pembrolizumab in this population. Management ties that benefit to the drug's TGF-beta inhibition, which it says drives tumor penetration and immune cell infiltration rather than blocking a single pathway. Overall survival nearly doubled against the standard of care while the safety profile stayed consistent, the company said.
Execution on the pivotal Phase III FORTIFI-HN01 study has kept pace. Bicara says it is on track for substantial enrollment by the end of 2026, with more than 200 sites now active, positioning the trial for a mid-2027 interim readout that could open the door to accelerated approval. The company also launched FORTIFI-FLEX, a study of an every-three-week maintenance dose built on encouraging results from an exploratory every-two-week cohort shown earlier this year, with data targeted for the time of any U.S. approval decision. Beyond the core indication, Bicara points to early proof of concept in cutaneous squamous cell carcinoma and ****** canal cancer, backed by roughly $497 million in cash that management says funds operations through the first half of 2029.
The leadership overhaul goes well beyond the CEO chair. Jenn Larson took over as Chief Financial Officer the day after the call, succeeding Ivan Hyep, who had a hand in raising over $800 million for the company since its early days. Two more transitions take effect in January: Chief Development Officer Tanya Green moves into the Chief Operating Officer seat, and Chief Corporate Affairs Officer Jenna Cohen becomes Chief Business Officer. A new Chief Legal Officer and two new board members are joining as well, a lot of change concentrated in a single quarter right as the company approaches its most consequential trial milestone.
#three
At May's ASCO meeting, Bicara presented three-year follow-up data spanning roughly 90 patients across three dose cohorts, the longest follow-up reported for any investigational agent in HPV-negative head and neck cancer. At the 1,500 milligram weekly pivotal dose, about one in three patients was still alive at three years, roughly double the survival rate seen in retrospective ****** yses of standard-of-care pembrolizumab in this population. Management ties that benefit to the drug's TGF-beta inhibition, which it says drives tumor penetration and immune cell infiltration rather than blocking a single pathway. Overall survival nearly doubled against the standard of care while the safety profile stayed consistent, the company said.
Execution on the pivotal Phase III FORTIFI-HN01 study has kept pace. Bicara says it is on track for substantial enrollment by the end of 2026, with more than 200 sites now active, positioning the trial for a mid-2027 interim readout that could open the door to accelerated approval. The company also launched FORTIFI-FLEX, a study of an every-three-week maintenance dose built on encouraging results from an exploratory every-two-week cohort shown earlier this year, with data targeted for the time of any U.S. approval decision. Beyond the core indication, Bicara points to early proof of concept in cutaneous squamous cell carcinoma and ****** canal cancer, backed by roughly $497 million in cash that management says funds operations through the first half of 2029.
The leadership overhaul goes well beyond the CEO chair. Jenn Larson took over as Chief Financial Officer the day after the call, succeeding Ivan Hyep, who had a hand in raising over $800 million for the company since its early days. Two more transitions take effect in January: Chief Development Officer Tanya Green moves into the Chief Operating Officer seat, and Chief Corporate Affairs Officer Jenna Cohen becomes Chief Business Officer. A new Chief Legal Officer and two new board members are joining as well, a lot of change concentrated in a single quarter right as the company approaches its most consequential trial milestone.
#three
2 months ago
It's the day after one of the surprise healthcare stories of 2026.
Moderna (MRNA) shares fell 20% in early trading on Thursday after a stunning 177% gain yesterday on news that the biotech and partner Merck (MRK) notched a big breakthrough in the fight against cancer.
The pair announced that their personalized mRNA cancer vaccine — called intismeran — successfully hit its primary goal in a Phase 3 late-stage trial, demonstrating a meaningful reduction in melanoma recurrence in patients who had already had their tumors surgically removed.
The trial compared using intismeran alongside Merck's well-known immunotherapy drug Keytruda against using Keytruda alone. Patients who received the combination lived meaningfully longer without their cancer returning or spreading.
"It's a home run, maybe even a grand slam," Dr. Ezekiel Emanuel said on Yahoo Finance (video above). "The results are pretty amazing."
#patients
Moderna (MRNA) shares fell 20% in early trading on Thursday after a stunning 177% gain yesterday on news that the biotech and partner Merck (MRK) notched a big breakthrough in the fight against cancer.
The pair announced that their personalized mRNA cancer vaccine — called intismeran — successfully hit its primary goal in a Phase 3 late-stage trial, demonstrating a meaningful reduction in melanoma recurrence in patients who had already had their tumors surgically removed.
The trial compared using intismeran alongside Merck's well-known immunotherapy drug Keytruda against using Keytruda alone. Patients who received the combination lived meaningfully longer without their cancer returning or spreading.
"It's a home run, maybe even a grand slam," Dr. Ezekiel Emanuel said on Yahoo Finance (video above). "The results are pretty amazing."
#patients