The American Society of Clinical Oncology (ASCO) begins its 2024 annual meeting at the cavernous and labyrinthine McCormick Place convention center in Chicago Friday, May 31. It’s the one of the world’s largest cancer research conferences and can be daunting to follow. More than 400 organizations will participate this year, with about 200 sessions ready to convene. The vast majority of the 5,000 abstracts that cover all aspects of cancer treatment have already been released, and they will be scrutinized by the more than 40,000 attendees from around the world. The newest BioWorld Insider podcast is an ASCO preview with Chris Barden, a co-managing partner at MPM Bioimpact who manages the firm’s Bioimpact Equities and Oncology Impact funds. She talks with BioWorld about the major trends in oncology that will be part of the conference and the development areas she finds most interesting. Among the most important abstracts will be data from Biontech SE, Gilead Sciences Inc. Pfizer Inc., Eli Lilly and Co. and Astrazeneca plc. The conference continues through Tuesday, June 4.

Merus raising $400M; petosemtamab scores in head and neck cancer

After shares climbed 36% on May 24 following the release of an American Society of Clinical Oncology abstract detailing an impressive phase II overall response rate (ORR) in first-line head and neck cancer with bispecific antibody petosemtamab in combination with Keytruda (pembrolizumab, Merck & Co. Inc.), Merus NV is raising $400.2 million in an upsized follow-on offering. The 60% ORR noted in the abstract was sweetened on May 28 with four months of additional data bumping the rate up to 67%, stirring excitement among investors and analysts who estimated a worldwide market for the indication of up to $5 billion. “What more could you want before starting a phase III study in [first-line head and neck squamous cell carcinoma]?” asked analyst Andrew Fein, of H.C. Wainwright.

Hanall, Turn Bio partner for mRNA-based eye, ear therapies

South Korea’s Hanall Biopharma Co. Ltd., of Songpa-gu, Seoul, agreed to an exclusive licensing deal with San Francisco-based Turn Biotechnologies Inc. to develop novel ophthalmic and optic therapies using the latter’s mRNA-based technology. Under the terms announced May 28, Hanall gains rights to use Turn Bio’s Epigenetic Reprogramming of Aging technology to research, develop, manufacture and commercialize medicines for ear- and eye-related conditions. The deal, valued at more than $300 million for the first product, is structured around negotiated milestones.

Celltrion gains Korea approval of Eylea biosimilar

Celltrion Inc., of Incheon, South Korea, gained MFDS clearance of Eydenzelt (CT-P42) as a biosimilar referencing Regeneron Pharmaceuticals Inc./Bayer AG’s Eylea (aflibercept) on May 30. The news comes on the heels of the U.S. FDA approving the first Eylea interchangeable biosimilars on May 20. Eydenzelt’s approval adds to Celltrion’s recent win with Omlyclo (CT-P39) in Europe, which gained EMA clearance as a biosimilar to Genentech Inc./Novartis AG’s Xolair (omalizumab) and three of its major indications. Korea’s regulatory body approved Eydenzelt, in both injectable and prefilled syringe form, for all of Eylea’s indications.

Brain cell maps, the neurological zoom of psychiatric disorders

Understanding psychiatric disorders at a cellular and molecular level could provide a different perspective to design diagnostic and therapeutic tools searching for the origin of these disorders and the alterations they cause. Fourteen simultaneous studies from the PsychENCODE Consortium have delved into the cellular atlases of human neurodevelopment, reporting the broadest view of neuropsychiatry to date.

Many NIH-funded trials missing the mark on inclusion

Despite U.S. NIH policy and its peer-review grant process, providing for inclusive enrollment in phase III NIH-funded clinical trials seems to be a check-the-box exercise for many researchers. In a review of a sample of the trials conducted between 2016 and 2020, the Health and Human Services Office of Inspector General (OIG) found that two-thirds had the required inclusive enrollment plans, while 57% provided no rationale for their enrollment targets. “These shortfalls we saw in our review of inclusion plans raise concerns about NIH’s peer review process and the extent to which this section of the grant application is thoroughly analyzed,” the OIG said in a report released this week.

Also in the news

Achieve, Affimed, Alentis, Amgen, Anaveon, Arrowhead, Astrazeneca, Biohaven, Bluejay, Bristol Myers Squibb, CDR-Life, Genentech, Georgiamune, Harness, Heron, Iliad, Immunocore, Jazz, JJP, Johnson & Johnson, Kiromic, LIB, Lundbeck, Merck, Milestone, Mira, Onconic, Otsuka, Rege Nephro, Remedy, Rocket, Spinogenix, Splisense, Tris, Tscan, Unravel, VBI Vaccines, Vyluma