China’s CAR T market is expected to grow from $72 million in 2022 to $342 million over the next decade. There are currently more than 400 CAR T therapies in the pipeline in China, and most of these are being developed by specialized Chinese biotechs. Research by Clarivate plc, BioWorld’s parent company, indicates that a notable proportion of CAR T-cell therapies in late-phase development in China are being developed through strategic partnerships and joint ventures between multinational corporations and domestic companies, including Johnson & Johnson and Nanjing Legend Biotech Corp., Juno Therapeutics Inc. and Wuxi Apptec Co. Ltd., and CASI Pharmaceuticals Inc. and Juventas Cell Therapy Ltd.
MASH-up: Ochre joins a $1B+ deal with Boehringer as Hepion struggles
In a deal that could exceed $1 billion for Ochre Bio Ltd., the U.K.-based liver disease therapy developer will collaborate with Boehringer Ingelheim GmbH. The agreement is based on discovering and developing first-in-class regenerative chronic liver disease treatments, including for late-stage metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis. Privately held Ochre will receive up to $35 million up front and near-term milestone payments based on research goals. What could bring the total to more than $1 billion are the milestones for clinical, regulatory and commercial milestones, plus tiered royalties. Ochre is developing RNA-based medicines. It’s been a tougher day for Hepion Pharmaceuticals Inc., a liver disease treatment developer that began shutting down its phase IIb Ascend-NASH study while it examines alternatives. The study of rencofilstat, a cyclophilins inhibitor, was for treating MASH. Hepion’s stock (NASDAQ:HEPA) was down 32% at midday to $1.43 a share.
Synox raises $75M series B for emactuzumab phase III
Synox Therapeutics Ltd. has raised $75 million in a series B round to fund phase III development of emactuzumab, an antibody in-licensed from Roche Holdings AG. The product, a colony stimulating factor 1 receptor inhibitor, was tested by Roche in a number of indications. Synox is taking it into a phase III registrational trial in tenosynovial giant cell tumor on the basis of phase II data showing an overall objective response rate of 71%. The funding is “transformational,” allowing the company to generate the data needed to get marketing approval, said Ray Barlow, CEO.
Skyhawk, Ipsen in $1.8B deal for RNA splicing modulators
Boston-based Skyhawk Therapeutics Inc. signed on to work with Paris-based Ipsen SA in a neurological disease-focused deal worth potentially $1.8 billion to discover and develop novel small molecules that modulate RNA. The deal is an option agreement for exclusive global rights to two candidates. Once the parties have identified and validated those candidates, Ipsen will take on all further development and commercialization. While the money is not broken down, it includes development, regulatory and commercial milestones, as well as an up-front payment, plus tiered royalties.
Genfleet’s KRAS G12C inhibitor moves into phase III
Genfleet Therapeutics Inc. has entered the KRAS G12C inhibitor race in the U.S. as it gears up to begin phase III trials of GFH-925 (IBI-351) in patients with refractory metastatic colorectal cancer (CRC) following U.S. FDA clearance. GFH-925 was the first KRAS G12C inhibitor to receive breakthrough therapy designation from China's National Medical Products Administration for previously treated advanced CRC.
Kintor’s China-based phase II positive for male hair loss therapy
Suzhou, China-based Kintor Pharmaceutical Ltd. reported positive findings from a phase II study of GT-20029, a topical therapy for male androgenetic alopecia, on April 21 – boosting both the company’s stock and its chances for a late-stage clinical study in China and the U.S. News of the hair loss therapy‘s efficacy boosted Kintor’s stock (HKEX:9939) by nearly 15% on April 22, closing at HK$1.00 (US13 cents).
Lumicell shines a light on residual breast cancer with FDA approvals
Lumicell Inc. sees a brighter future now that it has secured U.S. FDA approval for both its new drug application for the Lumisight (pegulicianine) optical imaging agent and premarket approval for the Lumicell direct visualization system. The company markets the two together as the Lumisystem to detect and resect residual breast cancer. Newton, Mass.-based Lumicell expects the Lumisystem will be available in the fourth quarter of 2024, Lumicell President and Chief Operating Officer Howard Hechler told BioWorld.
BioWorld Insider Podcast: Biopharma execs seek to avoid pain points in AI integration
Because artificial intelligence is such a new technology it comes with a mountain of unknowns. Integrating it into a pharmaceutical company presents a unique series of challenges, as a new survey from Verix shows. The report is based on responses from directors, vice presidents and C-suite executives in sales, marketing and brand management at pharmaceutical companies in the U.S. that have more than $100 million in annual revenue. Doron Aspitz, the CEO of Verix, talked about the new findings with the BioWorld Insider podcast and the profound shift that executives face as the new technology takes over an entire industry.
Also in the news
Amarna, Astellas, Bio-Path, Calidi, Inmune, Kaerus, Kalvista, Mirror, Moderna, Neurolentech, Oculis, Plus, Rubedo, Salubris, Seabelife, Sernova, Snipr Biome, Sumitomo Mitsui, Takeda, Tscan