Fierce Pharma Asia—BioNTech's ADC clinical hold; Takeda's leukemia bet; China NMPA's meeting with FDA

2024-06-21

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并购抗体药物偶联物临床结果临床3期临床1期

Fierce Pharma Asia—BioNTech's ADC clinical hold; Takeda's leukemia bet; China NMPA's meeting with FDA

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来源: FiercePharma

A partial clinical hold on BioNTech's ADC candidate, Takeda's option deal with Ascentage, and a senior leadership meeting between Chinese and U.S. drug regulators made our news this week.

BioNTech and MediLink's HER3 ADC has been put on a partial clinical hold by the FDA. Takeda has identified a potential challenger to Novartis' Scemblix. Senior officials from China and U.S. drug authorities met at the FDA's headquarters for the first time since 2017. And more.

1. FDA halts trial of BioNTech-MediLink ADC over 'significant risk of illness'

The FDA has put a partial hold on a phase 1 trial of MediLink Therapeutics’ BioNTech-partnered HER3-targeted antibody-drug conjugate. A BioNTech presentation recently showed that as of Feb. 4, two patients from the fifth dose cohort and one in the seventh dose group had died in the study. In the slides, BioNTech said it will focus further clinical development on lower dose levels.

2. Takeda circles leukemia rival to Novartis' Scemblix in up to $1.3B deal with Ascentage

Takeda is paying $100 million for an option to license a third-generation BCR-ABL tyrosine kinase inhibitor BCR-ABL tyrosine kinase inhibitor from China’s Ascentage Pharma. The drug, called olverembatinib and already approved in China, is a competitor to Novartis’ Scemblix in chronic myeloid leukemia. Takeda is also making a $75 million investment in Ascentage, which is in line for up to about $1.2 billion in milestones if everything plays out positively.

3. China’s NMPA visits US in first senior-level meeting at FDA HQ since 2017 (tweets)

Deputy Commissioner Zhao Junning of China’s National Medical Products Administration met with FDA Deputy Commissioner Kim Trzeciak Tuesday in the first senior-level meeting between the two agencies at FDA’s headquarters since 2017. The two agencies discussed the 2007 FDA-SFDA China Agreement on the Safety of Drugs and Medical Devices, including their 2024 work plan, according to the FDA.

4. Day One inks $1.2B biobucks pact for MabCare’s solid tumor ADC

Day One Biopharmaceuticals paid $55 million up front to get its hands on ex-China rights to MabCare Therapeutics’ antibody-drug conjugate targeting PTK7, which is overexpressed in esophageal, ovarian, lung and endometrial cancers among adults, as well as in neuroblastoma, rhabdomyosarcoma and osteosarcoma in children. The Chinese biotech may get up to $1.15 billion in potential milestones.

5. Takeda flunks pivotal epilepsy tests but mulls path to market for Ovid-partnered prospect

Takeda’s soticlestat, for which it paid Ovid Therapeutics $196 million to partner on, missed the primary endpoints in two phase 3 trials in two forms of epilepsy, refractory Lennox-Gastaut syndrome and Dravet syndrome, respectively. Still, arguing that the cholesterol 24 hydroxylase inhibitor showed some treatment effects, Takeda said it will discuss the totality of the data with the FDA.

6. India's Lupin announces CEO pick for new subsidiary as it moves into the CDMO arena

Lupin is venturing into the CDMO space with its new subsidiary Lupin Manufacturing Solutions, which will work on the development, production and sale of active pharmaceutical ingredients. The unit will be led by Abdelaziz Toumi, who previously worked at Bayer, Catalent, Lonza and other companies. Lupin has in the past dealt with drug recalls and FDA citations.

7. Emergent, pivoting away from CDMO business, sells Baltimore plant to acquisitive Bora for $30M

Emergent BioSolutions has agreed to sell its fill-finish drug product facility in Baltimore-Camden to Taiwanese CDMO Bora Pharmaceuticals for $30 million. Bora intends to keep about 350 Emergent employees currently stationed at the 87,000-square-foot facility. The deal follows Bora’s $210 million acquisition of Minnesota generic manufacturer Upsher-Smith Laboratories earlier this year.

Other News of Note:

8. Innovent braves bruising cytokine space, linking fusion protein to tumor responses in small study