BioNTech's ADC Hold, Takeda's Leukemia Bet, China NMPA Meets FDA

BioNTech and MediLink's HER3 ADC has encountered a significant setback, with the FDA imposing a partial clinical hold on its phase 1 trial due to concerns about severe illness risks. This decision followed BioNTech's revelation that three patients had died during the trial—two from the fifth dose cohort and one from the seventh. Consequently, BioNTech has announced plans to concentrate future clinical development on lower dose levels.

Takeda has made a strategic move to challenge Novartis' Scemblix by securing an option to license olverembatinib, a third-generation BCR-ABL tyrosine kinase inhibitor from China’s Ascentage Pharma. This deal involves an upfront payment of $100 million and a $75 million investment in Ascentage. If the drug shows positive results and meets all milestones, the total value of the deal could reach $1.3 billion. Currently approved in China, olverembatinib is seen as a promising treatment for chronic myeloid leukemia.

In a significant development in international regulatory relations, Deputy Commissioner Zhao Junning of China’s National Medical Products Administration (NMPA) met with FDA Deputy Commissioner Kim Trzeciak. This meeting marks the first senior-level dialogue at the FDA's headquarters since 2017. The discussions centered on the 2007 FDA-SFDA China Agreement on the Safety of Drugs and Medical Devices and included plans for future collaboration, such as their 2024 work plan.

Day One Biopharmaceuticals has entered into a notable agreement with MabCare Therapeutics, securing ex-China rights to an antibody-drug conjugate targeting PTK7. This protein is notably overexpressed in a variety of adult and pediatric cancers, including esophageal, ovarian, lung, endometrial, neuroblastoma, rhabdomyosarcoma, and osteosarcoma. Day One paid $55 million upfront and potentially up to $1.15 billion in milestone payments, highlighting the high stakes and potential of this oncology drug.

Despite setbacks in pivotal epilepsy trials, Takeda is not giving up on its partnership with Ovid Therapeutics for soticlestat. The drug failed to meet primary endpoints in phase 3 trials for Lennox-Gastaut syndrome and Dravet syndrome. However, Takeda noted some treatment effects and intends to discuss the overall data with the FDA, indicating that there may still be a path forward for this cholesterol 24 hydroxylase inhibitor.

Lupin, an Indian pharmaceutical company, is expanding its operations into the CDMO (Contract Development and Manufacturing Organization) sector with a new subsidiary, Lupin Manufacturing Solutions. The subsidiary will be led by industry veteran Abdelaziz Toumi, who has experience from companies such as Bayer, Catalent, and Lonza. This move signifies Lupin's strategic shift towards diversifying its business model.

Emergent BioSolutions is pivoting away from the CDMO business by selling its fill-finish drug product facility in Baltimore-Camden to Bora Pharmaceuticals for $30 million. Bora plans to retain approximately 350 Emergent employees at the facility. This transaction follows Bora's acquisition of Minnesota-based Upsher-Smith Laboratories for $210 million earlier this year, indicating Bora’s aggressive expansion strategy.

In other notable news, Innovent Biologics is making strides in the challenging cytokine space with a fusion protein showing promising tumor responses in early studies. Samsung Biologics has enhanced its collaboration with Baxter in a $223 million agreement. Additionally, Mission Based Media has introduced an ad-free model for health podcasts, including a series on Alzheimer's disease supported by Eisai. Finally, Biocon is seeking a partner to conduct trials for a generic version of Novo Nordisk’s Wegovy and Ozempic in China.

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