Adagene Inc. has announced a research collaboration with Sanofi SA, to find “masked” monoclonal and bispecific antibodies that are safer than marketed drugs in oncology, in a deal worth up to $2.5 billion plus royalties. San Diego and Suzhou, China-based Adagene will generate masked versions of Sanofi antibodies, taking responsibility for early stage research activities using its Safebody technology.
Adagene Inc. has announced a research collaboration with Sanofi SA, to find “masked” monoclonal and bispecific antibodies that are safer than marketed drugs in oncology, in a deal worth up to $2.5 billion plus royalties. San Diego and Suzhou, China-based Adagene will generate masked versions of Sanofi antibodies, taking responsibility for early stage research activities using its Safebody technology. Sanofi will be responsible for later-stage research and all clinical, product development and marketing activities.
Chinese company Seekin Inc. is preparing to launch its cancer detection technology in Europe after securing CE marking for the Seekincare pan-cancer test. The artificial intelligence, blood-based platform uses insights from public and private data to identify cancer DNA and protein signals in the blood. The test has been available in Chinese labs since 2018.
Remix Therapeutics Inc., a company developing small molecules to manipulate RNA processing, stands to earn upward of $1 billion through a new strategic collaboration with Janssen Pharmaceutica NV. A Cambridge, Mass.-based startup, Remix last year patented new RNA splicing modulators. It will receive an initial payment of $45 million for research funding plus potential preclinical, clinical, commercial and sales milestone payments, and royalties. Janssen gains exclusive rights to three targets with applications in immunology and oncology.
Although diversity was front and center, it wasn’t the only reason the U.S. FDA’s Oncologic Drugs Advisory Committee voted 14-1 on Feb. 10 that additional clinical trials demonstrating applicability to the U.S. non-small-cell lung cancer population are needed before sintilimab, a PD-1 inhibitor partnered in the U.S. by Innovent Biologics Co. Ltd. and Eli Lilly and Co., is ready for approval.
Although diversity was front and center, it wasn’t the only reason the U.S. FDA’s Oncologic Drugs Advisory Committee voted 14-1 that additional clinical trials demonstrating applicability to the U.S. non-small-cell lung cancer population are needed before sintilimab, a PD-1 inhibitor partnered in the U.S. by Innovent Biologics Co. Ltd. and Eli Lilly and Co., is ready for approval.
The Feb. 10 meeting of the U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) is about far more than one biologic license application (BLA), as the single question the agency will put to the committee is whether data from a trial in one foreign country are sufficient to support approval in the U.S.
Since COVID-19 hit the U.S. in 2020, the pandemic has taken more than 800,000 American lives. In that same time, cancer has claimed 1.2 million lives, President Joe Biden said Feb. 2 as he “reignited” the cancer moonshot he first launched in 2016 when he was serving as vice president.
When Glaxosmithkline plc’s new CEO, Emma Walmsley, was hiring a “dream team” of executives to lead the company in 2017, former Genentech whizz Hal Barron was the star signing as chief scientific officer. Lured away from Alphabet Inc.’s biotech subsidiary, Calico LLC, by a bumper pay deal, Barron was arguably Walmsley’s most important appointment. Walmsley badly needed a strong leader with credible expertise in science to lead the company’s R&D efforts, as her expertise and experience came from the company’s consumer operation. But as GSK plans to split later this year, Barron is heading for the exit to become CEO of California’s ambitious and enormously well-funded startup Altos Labs Inc.
The U.S. Drug Enforcement Administration (DEA) needs to stop ignoring the 2018 Right to Try Act and stop blocking terminally ill patients’ access to psilocybin, an investigational drug that may provide relief from debilitating anxiety and depression, a bipartisan group of House members said.
