Pembrolizumab

Today, a brief rundown of news involving Agenus and the University of Oxford, as well as updates from Apnimed, Bristol Myers Squibb and Pfizer that you may have missed.Agenus has raised $340 million in private funding as part of a plan to change its clinical development strategy. The company will no longer financially support an ongoing late-stage trial of a cancer immunotherapy combination, BOT+BAL, in a form of late-line colorectal cancer. Instead, itll use the new funding to back a study testing that regimen in the neoadjuvant, or pre-surgery setting in certain colon cancers. Agenus claimed Monday that that setting represents an annual sales opportunity of more than $7 billion and that the financing from RA Capital Management, TCGX and others will enable the company to operate through an interim readout. Company shares doubled in early Monday trading.A vaccine developed by the University of Oxford has become the first preventive shot for the Bundibugyo ebolavirus to reach Phase 1 testing. Known as ChAdOx1 BDBV, the vaccine was developed in response to the outbreak spreading through the Democratic Republic of the Congo and Uganda, and is one of a few shots currently being fast-trackedby the Coalition for Epidemic Preparedness Innovation. Study recruitment is underway, with vaccinations expected to begin “within the coming weeks,“ CEPI said Monday. The shot was invented with the same underlying technology that produced a COVID-19 vaccine once sold by AstraZeneca.Apnimed is seeking an initial public offering to help fund the expected launch of a sleep apnea pill. Apneas prospective treatment, to be sold as Oxnimbi,is a dual-acting medication thats designed to target the neuromuscular defect that causes airways to collapse during sleep in people with obstructive sleep apnea. That treatment succeeded in a pair of Phase 3 trials, but in discussions afterwards, the Food and Drug Administration indicated that additional analyses and justification may be needed to prove it provides a clinically meaningful benefit. Apnimed believes its addressed those concerns and submitted an approval application in June.The FDA will decide whether to approve an experimental Bristol Myers Squibb medication for multiple myeloma by May 13, 2027. Called mezigdomide, the drug is one of a few new protein degrading CELMoDs Bristol Myers hopes to position as successors to its lucrative Revlimid franchise. The agency could clear the first of those therapies, iberdomide, by Aug. 17. Bristol Myers presented study data supporting its application for mezigdomide at the American Society of Clinical Oncology meeting in May.The FDA on Friday also broadened use of a regimen involving Pfizer and Astellas Pharma's antibody-drug conjugate Padcev in early muscle-invasive bladder cancer, or MIBC. A combination of Padcev and Merck & Co.'s Keytruda used before and after surgical removal of a MIBC tumor was first approved in 2025. On Friday, the agency expanded that clearance to include patients who are eligible for a common chemotherapy, making Padcev-Keytruda the first chemo-free option available for all patients in that setting. '

Merck & Co.’s almighty Keytruda has become the first PD-1 inhibitor to show a benefit as a single agent for the front-line treatment of a subtype of endometrial cancer. Keytruda significantly improved progression-free survival over platinum-based chemotherapy in patients with mismatch repair deficient (dMMR) advanced or recurrent endometrial cancer. The patients had either received no systemic chemotherapy or experienced recurrence more than six months after completing prior adjuvant therapy. On its other dual primary endpoint, the Keynote-C93 trial also recorded an immature trend toward improvement in overall survival at the interim analysis. The trial is ongoing, with plans to evaluate the endpoint in the future. The positive readout sets Keytruda up to be a new chemo-free option in first-line dMMR endometrial cancer, Brian Slomovitz, M.D., from Mount Sinai Medical Center and the study’s principal investigator, noted in a July 15 release. Merck now plans to share the results with regulatory authorities. PD-1 inhibitors like Keytruda have been approved as single agents for previously treated dMMR endometrial cancer or in combinations with chemotherapy in first-line endometrial cancer. In endometrial cancer, Keytruda’s main competitor is GSK’s Jemperli, which, despite being a latecomer in the overall cancer immunotherapy market, was the first PD-1 inhibitor to win an FDA approval in first-line endometrial cancer with a 2023 go-ahead for use alongside chemo in dMMR tumors. About two years ago, the FDA approved both PD-1 drugs in quick succession as combinations with carboplatin and paclitaxel for patients with primary advanced or recurrent endometrial cancer. In its first-line endometrial cancer rivalry, GSK’s Jemperli benefits from a statistically significant overall survival improvement achieved in the phase 3 Ruby trial. By comparison, Keytruda’s Keynote-868 trial can’t yet claim a life extension benefit. During GSK’s first-quarter earnings call in April, Nina Mojas, who leads the British drugmaker’s commercial operations as president of global product strategy, cited the significant OS benefit in endometrial cancer as the main driver of Jemperli’s 40% year-over-year sales growth to 232 million pounds sterling ($313 million). Keytruda previously suffered a setback in endometrial cancer when the phase 3 Keynote-B21 study testing the PD-1 drug in combination with chemotherapy as adjuvant treatment failed to meet its primary endpoint in newly diagnosed, high-risk tumors after surgery. That study remains ongoing to analyze results in the dMMR subgroup. Both Merck and GSK are developing next-generation therapies for endometrial cancer. In May, Merck reported the first global phase 3 win for its TROP2-directed antibody-drug conjugate, sac-TMT, partnered with China’s Kelun-Biotech. The TroFuse-005 trial met its primary endpoints of PFS and OS, as sac-TMT beat chemotherapy in patients with endometrial cancer who have previously received platinum-based chemo and immunotherapy. A separate phase 3 trial, coded TroFuse-033, is evaluating sac-TMT in the first-line maintenance setting among endometrial cancers that are mismatch repair proficient. As for GSK, the company recently advanced its B7-H4 ADC, mo-rez, into phase 3 testing in advanced endometrial cancer after recording a 67% overall response rate in a phase 1 trial. The drug is licensed from China’s Hansoh Pharma.