Agenus Advances MSS Colorectal Cancer Trial and Secures $340 Million in Funding

Agenus has discontinued support for the late-stage clinical trial of its 'BOT+BAL' combination therapy for microsatellite stable (MSS) colorectal cancer. Instead, the company will focus resources on a Phase 3 'ROBBIN' trial targeting the neoadjuvant setting. This strategic shift, along with the successful raising of $340 million in private funding, ensures financial stability. Agenus aims to optimize its pipeline and continue research to achieve interim results, targeting a new $7 billion market.

Apnimed Submits Oxnimbi NDA and Plans IPO

Apnimed, a company developing treatments for obstructive sleep apnea (OSA), has received official FDA acceptance of its New Drug Application (NDA) for 'Oxnimbi,' an oral combination therapy. This novel drug targets the neuromuscular dysfunction that causes upper airway collapse during sleep, combining aroxibutynin and atomoxetine. The PDUFA target action date is set for February 28, 2027, and the company plans to raise commercialization funds through a Nasdaq IPO. Oxnimbi is poised to be a game-changer, potentially replacing existing CPAP therapy.

Oxford University Initiates First-in-Human Trial for Bundibugyo Ebolavirus Vaccine, BMY Awaits New Drug Approval

The 'ChAdOx1 BDBV' vaccine candidate, developed by Oxford University for Bundibugyo ebolavirus, has entered the first-in-human Phase 1 clinical trial. The Coalition for Epidemic Preparedness Innovations (CEPI) is providing $8.6 million in funding, and the Serum Institute of India (SII) has stockpiled 620,000 doses for clinical use. Meanwhile, Bristol Myers Squibb's new drug for multiple myeloma, 'mezigdomide,' has a PDUFA date of May 13, 2027, and is set to follow in the footsteps of the blockbuster drug Revlimid.

Pfizer and Astellas Expand Padcev Indication for Bladder Cancer

Pfizer and Astellas have received FDA approval for the expanded use of 'Padcev,' an antibody-drug conjugate (ADC), in combination with Keytruda for bladder cancer. This approval allows for the use of the combination therapy as neoadjuvant and adjuvant treatment for all patients with muscle-invasive bladder cancer (MIBC), regardless of their eligibility for cisplatin chemotherapy. In a Phase 3 trial, the combination therapy reduced the risk of death by 35% compared to standard chemotherapy, demonstrating significant survival benefits. As the first and only chemo-free treatment option, Padcev is expanding its market share in the treatment of bladder cancer.