Fierce Pharma Asia—BIO-WuXi break-off; Takeda's site closure; FDA's concern over Carvykti

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来源: FiercePharma

The latest around the BIOSECURE Act, Takeda's plan to shut down a gene therapy facility, and an early death issue in Carvykti's clinical trial made our news this week.

WuXi AppTec left the Biotechnology Industry Organization amid increasing pressure on the trade group stemming from a draft U.S. bill targeting certain Chinese biotechs. Takeda will shut down a facility in Austria as the Japanese pharma pivots away from research in adeno-associated virus gene therapies. The FDA questioned whether Carvykti should be approved in earlier multiple myeloma after noticing an early detriment to patients' survival in a clinical trial. And more.

1. Biotech trade group pledges support for BIOSECURE Act, plans to boot member WuXi AppTec

The Biotechnology Industry Organization (BIO) is severing ties with WuXi AppTec as one of the “important steps” that the trade group is taking to support U.S. national security. In a revised statement, BIO said WuXi “proactively ended its membership.” BIO said it supports the BIOSECURE Act, which looks to block “adversary biotech companies,” including WuXi, from getting U.S. government contracts. BIO’s move came after its lobbying activity against the draft bill drew the ire of a lawmaker.

2. Takeda winds down manufacturing and R&D operations in Austria after gene therapy pivot, plots 190 layoffs

Takeda is shutting down operations at its adeno-associated virus gene therapy plant in Orth, Austria, and nearly 200 employees will lose their jobs. Takeda said it would divest the site about a year ago as part of its decision to end early R&D activities around AAV gene therapies. But after a “thorough and lengthy effort,” the company couldn’t find a buyer, a Takeda spokesperson said.

3. FDA flags early deaths in CAR-T myeloma trials for J&J and Legend’s Carvykti, Bristol Myers’ Abecma

The FDA has raised concerns about an increased risk of death for Johnson & Johnson and Legend Biotech’s Carvykti compared with standard combinations in the first few months of its phase 3 trial in earlier lines of treatment for multiple myeloma. More patients in the Carvykti arm died than those in the control arm in the first 10 months of the CARTITUDE-4 trial. That overall survival data set is up for discussion during an FDA advisory committee meeting.

4. Astellas puts the cork back in $350M Xork deal after Cartesian-Selecta merger

Astellas has decided to end a licensing deal with Cartesian Therapeutics about a year after signing it originally with Selecta Biosciences. Under the deal, Astellas paid $10 million upfront to use Cartesian’s Xork, an immunoglobulin protease, with its gene therapy candidate AT845. The hope was that the asset would help more patients become eligible for adeno-associated virus-based gene therapies.

5. Insilico 'pulls back the curtain' on AI drug discovery process in hope of convincing skeptics

In a Nature Biotechnology paper, Insilico Medicine described how it used artificial intelligence to discover, develop and test its lead candidate, INS018_055, a TNIK inhibitorTNIK inhibitor that’s in phase 2 development for the lung disease idiopathic pulmonary fibrosis. The company’s AI platform, PandaOmics, was used to both identify a therapeutic target and to design a drug candidate.

6. Biocon continues to divest with $150M sale of insulin and other brands to Eris

Biocon has agreed to sell its Indian branded formulations business to Eris for about $150 million. The deal includes a portfolio of metabolic, oncology and critical care products, including Insugen, which was the first recombinant human insulin product developed domestically in India. The divested franchise accounted for 3.7% of Biocon’s revenue in its fiscal year 2023.

7. Innovent shutters ADC-focused Maryland R&D site, moves lab to California (BioSpace, Yicai)

Innovent Biologics will shut down its Rockville, Maryland, site, which serves as the Chinese firm’s U.S. headquarters and is conducting research in antibody-drug conjugates. A BioSpace article, citing former employees, reported that the R&D work will move to Chin and that the company has axed the entire research team at the Maryland location. But Innovent told Yicai that the lab will be relocated to California.

Other News of Note:

8. Chinese authorities rumored to be working on policies to support innovative drugs (Bloomberg)

9. Aurobindo unit begins shipping drugs from India plant after FDA inspection triggered production halt

10. BeiGene bumps AbbVie, J&J from top lymphoma event sponsor spot

11. Sun Pharma issues recall of gout drug due to microbial contamination

12. AstraZeneca taps Mankind to distribute Symbicort in India (The Economic Times)

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