BeiGene's R&D chief talked to Fierce Biotech about the company's PD-1 plans and how its TIGIT plans are still alive despite Roche's recent trial failures. Expanding on novel technologies, BeiGene also signed a research pact for mRNA therapies. Legend Biotech has terminated an early CAR-T program weeks after coming off an FDA clinical hold. Eisai and Biogen scored an FDA priority review for their Alzheimer's follow-up drug. And more.
Doubling down on mRNA, BeiGene taps rising Hong Kong star to create targeted therapies
BeiGene’s R&D chief, Lai Wang, Ph.D., acknowledged its Novartis-partnered tislelizumab is late to the PD-1 game. In an interview, Wang laid out where he thinks the latecomer’s strength lies. Among the potential combination therapies in development, he argued the TIGIT story isn’t over despite recent high-profile flops by Roche. BeiGene is also investing heavily in novel technologies, having this week signed on InnoRNA in an mRNA therapy research collaboration.
2. Legend scraps early stage CAR-T for lymphoma 6 weeks after clinical hold lifted
Six weeks after Legend’s early-stage autologous CAR-T candidate, LB1901, was freed from an FDA clinical hold, the company has decided to scrap the program. The company said it decided to end the phase 1 study because another similar candidate failed to show a benefit in a Chinese trial. The cell therapy specialist also wants to spend money elsewhere in its pipeline.
Eisai and Biogen’s second anti-amyloid beta drug lecanemab scored priority review, with a decision set for Jan. 6. The pair is targeting an accelerated approval for early Alzheimer’s disease, and Eisai confirmed that the FDA doesn’t intend to host an advisory committee meeting for the application.
4. Insilico Medicine's AI uncovers 28 new potential drug targets for ALS
Insilico Medicines, working alongside scientists from several prestigious research institutions, has used its artificial intelligence platform to identify 28 potential new targets for amyotrophic lateral sclerosis. Among them, blocking 18 of those targets showed moderate to strong effects on neurodegeneration in fruit fly models, according to findings published in the journal Frontiers in Aging Neuroscience.
5. Otsuka pays Akebia $55M to exit anemia pill pacts amid dispute and FDA rejection
After a short dispute over whether Akebia Therapeutics breached contract, Otsuka has decided to shell out $55 million to end their partnership on oral anemia drug vadadustat in the wake of a recent FDA rejection. The drug has ongoing applications in Europe, and Akebia said it’ll decide the next step in the U.S. after a scheduled meeting with the FDA.
6. Junshi, Coherus get year-end FDA target for refiled China-developed PD-1 (release)
Another Asia-U.S. partnership hopes for better luck with their once FDA-rejected drug. Junshi Biosciences and partner Coherus BioSciences said their resubmission for China-approved PD-1 inhibitor toripalimab for nasopharyngeal carcinoma has been accepted by the FDA. The agency has set a target action date for Dec. 23, but travel restrictions in China remain an uncertainty for a required inspection.
7. Lotte Biologics plots $77M investment at former BMS plant, where it aims to add 70 jobs
Lotte taps MilliporeSigma to chip in on build-out of former Bristol Myers plant
Lotte is tapping Merck KGaA to help build its U.S. biologics CDMO business. The MilliporeSigma subsidiary will help Lotte with facility design, workforce training and equipment supply. At a former Bristol Myers Squibb manufacturing plant in East Syracuse, New York, Lotte Biologics will add 70 jobs to its existing workforce of 450 and will invest $77 million to boost capacity.
8. ClinChoice raises $150M in series E round as CRO outlines growth plan and potential IPO
CRO outfit ClinChoice has raised $150 million in series E from Asian investors, including Lilly Asia Ventures, Legend Capital, Taikang Life Insurance, among others. The money will fund the company’s further expansion through internal growth and M&A, and it lays the foundation for a public listing in the near future, the company said.
Other News of Note
9. Japan's Mitsubishi Tanabe and EditForce sign $146M deal to discover CNS gene therapies
10. Novo Nordisk union protests breakdown of wage and incentive talks in South Korea: report
11. WuXi unveils new production capabilities at Changzhou campus amid expansion push