BioNTech

Bavarian Nordic A/S faces pressure to lower its mpox vaccine price for Africa, currently at $100-$141 per dose, as talks with agencies like Unicef aim to secure 12 million doses by 2025. Critics argue the high cost is prohibitive for African nations dealing with multiple health crises, urging discounts or generic production. Bavarian Nordic acknowledges pricing challenges but seeks a balance to ensure vaccine availability.

Autolus Therapeutics' obe-cel, an autologous CAR-T cell therapy for relapsed/refractory adult B-cell Acute Lymphoblastic Leukemia, awaits FDA approval on November 16, 2024. The therapy targets CD-19 and has shown a 78% ORR in the FELIX study, with potential peak revenues of ~$300m. Despite a 25% share price drop, Autolus holds $700m in cash and has partnerships with BioNTech, Moderna, and Bristol Myers Squibb, positioning it for future growth.

Mpox, caused by monkeypox virus (MPXV), re-emerged in 2024 with clade I strains spreading faster and being deadlier. A new study led by researchers from the United States Army Medical Research Institute of Infectious Diseases, the National Institutes of Health, Boston University, and Moderna, published in *Cell*, demonstrated that mRNA-based vaccines, like mRNA-1769, could be more effective than the modified vaccinia Ankara (MVA) vaccine in protecting against severe mpox disease in macaques. The mRNA-1769 vaccine, targeting four MPXV antigens, showed tenfold fewer lesions and reduced viral load compared to MVA, highlighting the potential of mRNA technology to combat MPXV-like viruses.

Moderna's mRNA vaccine for mpox shows higher efficacy than Bavarian Nordic's Jynneos in preventing severe disease and reducing virus levels in monkeys, according to a study published in Cell. The vaccine also reduced viral replication and lesion formation, potentially limiting spread. Moderna is currently conducting a Phase I/II trial in the UK, with data expected in mid-2025.

Moderna's updated COVID-19 vaccine targeting the JN.1 strain of Omicron receives a positive opinion from the EMA's CHMP, paving the way for marketing authorization in the EU for the 2024-2025 respiratory season.

A vaccine, BNT116 by BioNTech, targeting non-small cell lung cancer (NSCLC) is being tested in Maryland and Virginia, aiming to eliminate cancer cells and prevent recurrence through a global clinical trial. Using mRNA technology, it trains the immune system to recognize and attack NSCLC-specific tumor markers. The trial, recruiting participants in the D.C. region, will test BNT116's efficacy alone and with chemotherapy/immunotherapy, aiming to prevent lung cancer recurrence.

Pfizer and BioNTech receive FDA approval for Omicron KP.2-adapted COVID-19 vaccine for individuals 12 years and older, with emergency use authorization for those 6 months through 11 years. The vaccine is based on mRNA technology and will be available in pharmacies, hospitals, and clinics across the U.S.

Pfizer and BioNTech announce Phase 3 trial results for their mRNA-based combination vaccine against influenza and COVID-19 in adults 18-64, with one immunogenicity objective met. A separate Phase 2 trial showed robust immunogenicity for standalone influenza mRNA vaccines. The companies are evaluating adjustments to improve immune responses against influenza B and will discuss next steps with health authorities.