The FDA has postponed its decision on Legend Biotech and Johnson & Johnson’s BCMA-targeting CAR-T therapy. BeiGene details Brukinsa’s win in all-important newly diagnosed chronic lymphocytic leukemia ahead of a possible BTK showdown. Samsung Biologics’ newly minted CEO talks about the CDMO’s rapid expansion and lessons learned from the COVID-19 pandemic. And more.
1. Legend’s status put on hold as FDA delays Janssen-partnered CAR-T decision
Thanks to an FDA priority review, Legend Biotech and Johnson & Johnson were expecting a decision on their CAR-T therapy cilta-cel in relapsed or refractory multiple myeloma by late November. But the agency has now pushed back that deadline by three months to give it more time to review “information recently submitted pertaining to an updated analytical method following an FDA information request,” the pair said.
BeiGene is detailing a phase 3 win for Brukinsa in newly diagnosed chronic lymphocytic leukemia, showing its BTK inhibitor pared down the risk of disease progression or death by 58% over a combo of bendamustine and Roche’s Rituxan. Results from the SEQUOIA trial look at least on par with data from AbbVie and Johnson & Johnson’s first-to-market Imbruvica and are even better on some markers.
Samsung Biologics’ newly minted CEO John Rim recently spoke with Fierce Pharma Manufacturing to discuss the South Korean CDMO’s rapid expansion at home and abroad. “We scale up very quickly,” Rim said. “Speed, in terms of our expertise, in terms of delivering quality to our clients and regulatory authority, it’s second to none.”
4. Daiichi jettisons ADC after flunking early solid tumor test
Antibody-drug conjugate leader Daiichi Sankyo has hit a setback. The Japanese company dumped a gastrointestinal stromal tumor candidate, dubbed DS-6157, after seeing “no clear responses” in a phase 1 trial. The drug targets GPR20 to deliver a toxic payload.
5. Bayer poaches Otsuka’s chief medical officer Koenen to head up its clinical operations
Otsuka Pharmaceutical’s chief medical officer Christoph Koenen is jumping ship to Bayer as its pharma unit’s new global head of clinical development and operations. He will work alongside former Roche exec Christian Rommel, who in February succeeded Joerg Moeller to become Bayer pharma’s head of R&D.
Is there still a place for Seagen’s disitamab vedotin, licensed from Chinese company RemeGen, in the HER2 market after AstraZeneca and Daiichi Sankyo’s Enhertu? During a conference call, Seagen CEO Clay Siegall touted the antibody-drug conjugate’s “incredibly rapid internalization,” namely strong tumor-binding ability and tumor uptake.
7. LianBio snags $325M IPO, slightly bigger than the multi-partnered biotech’s 2020 series A
LainBio has raised $325 million in its Nasdaq IPO. The company’s business model focuses on in-licensing novel drugs from Western partners for the Chinese market. That means the majority of the firm’s operations happen in China, which poses some regulatory risks given the tension between the U.S. and China.
8. Aptose inks $408M biobucks deal with Hanmi for access to myeloid inhibitor
Aptose shelled out $12.5 million and committed up to $407.5 million in biobucks for worldwide rights to Hanmi Pharmaceutical’s HM43239. The drug is designed to target several kinases involved in multiple myeloid malignancies. Early data from a phase 1/2 trial have shown complete responses in various disease types.
9. Pfizer drones light up night sky in China’s remote area with health tips
An award-winning team between Pfizer China and Shanghai-based creative agency F5 recently put on a drone light show in the remote mountain area of southwestern China. The show was meant to educate local people of the Yi ethnic group of some health tips. It was also part of Pfizer China’s annual employer campaign for attracting new talent.
10. GenScript embraces automation at its first cell, gene therapy manufacturing US site
Chinese CDMO GenScript’s first cell and gene therapy manufacturing facility, to be located near the firms’ U.S. headquarters in New Jersey, will feature automated technologies to speed up production. The 50,000-square-foot facility will create around 100 to 200 new jobs over the next two years.
