In a research collaboration that could bring in up to $600 million, Metaphore Biotechnologies Inc. has become the third Flagship Pioneering company this year to cut a development deal with Novo Nordisk A/S. Metaphore and Novo agreed to develop a portfolio of treatments for cardiometabolic and rare diseases, including up to two multitarget therapeutics leveraging GLP-1R and related biology for obesity management. Metaphore will handle R&D with Pioneering Medicines, Flagship’s drug development group. Novo will shepherd the foundational and preclinical development work. The other two 2024 Flagship-Novo deals were with Omega Therapeutics and Cellarity Inc.

Flying high with $182M, Bluejay Therapeutics advances BJT-778

Three years ago when Keting Chu pondered the name for a new biopharma company that would fold in infectious disease assets from Novartis AG, she looked out over her West Coast backyard. “I was looking for a name that made you think of California,” she told BioWorld. She nixed the idea of incorporating redwood trees into the name, but then she saw the blue jays flying around those trees and thought, “that’s a beautiful bird.” Hence, Chu founded and became CEO of Bluejay Therapeutics Inc., first raising $20 million through a series A in June 2021 and a $41 million series B in August 2022. On May 9, the San Mateo, Calif.-based company closed a $182 million series C round, with plans to accelerate development of lead compound BJT-778 to treat chronic hepatitis D virus, a condition for which there are no approved therapeutics in the U.S.

Bio Korea 2024: AI teeters toward ‘necessity’ in new drug R&D

As the average cost of new drug R&D continues to skyrocket, the perception around using artificial intelligence (AI) as a tool to boost drug discovery is changing. “Developing new AI-based drugs is a difficult task, not only for Korea but also for countries with leading AI technology,” Hyeyun Jung, principal researcher of Korea Health Industry Development Institute’s Center for Health Industry Policy, told the audience at the Bio Korea meeting on May 9. “But there is a change in perception; [namely that] applying AI to new drug development is not an option but a necessity.”

Cytomx sinks on phase I data with T-cell engager

Shares of South San Francisco-based Cytomx Therapeutics Inc. (NASDAQ:CTMX) fell $2.28, down $1.91, or 45%, as the company made known first data from the ongoing CX-904 phase Ia dose-escalation study that showed a favorable safety profile and confirmed anticancer activity. CX-904 is an investigational, masked, conditionally activated Probody T-cell engager designed to target EGFR on cancer cells and the CD3 receptor on T cells in the tumor microenvironment. Results proved especially promising in pancreatic tumors, the company said.

Newco news: Aiming for complement activation, Commit launches with €16M

Newco Commit Biologics ApS has arrived on the scene after raising €16 million (US$17.2 million) in a seed round to advance bispecific antibodies that are designed to activate the complement system and direct it to selectively kill cancer cells. The company’s bispecific complement engaging platform combines a single-domain antibody which binds to the C1q protein – the starting point for activating the complement cascade – with an antibody targeted at a tumor-associated antigen.

FDA’s Califf downplays utility of advisory committee voting process

In a May 8 Senate hearing, U.S. FDA commissioner Bob Califf described the agency’s advisory committee process as a useful source of information, but Califf reassured members of the Senate that the FDA is not intent in doing away with advisory hearing votes altogether. Nonetheless, he characterized advisory hearings primarily as a source of background information, adding that there would be no need for an FDA if the agency acted in concordance with every advisory committee vote.

ASGCT: In utero interventions can prevent organ damage after birth

“Prenatal therapies are the next disruptive technologies in health care, which will advance and shape the future of patient care in the 21st century,” said Graça Almeida-Porada, a professor at the Fetal Research and Therapy Center of the Wake Forest Institute for Regenerative Medicine in Winston-Salem, N.C. At the American Society of Gene & Cell Therapy (ASGCT) annual meeting in Baltimore on May 5, 2024, Almeida-Porada introduced the first presentation of the scientific symposium “Prospects for Prenatal Gene and Cell Therapy.”

Tiumbio’s Merigolix hits phase II endpoint for endometriosis pain

Tiumbio Co. Ltd., of Seongnam-si, Gyeonggi-do, reported positive phase IIa top-line data on May 8 for Merigolix, its lead asset to reduce pain in female patients with moderate to severe endometriosis. "Despite the small size of each group, with around 20 patients per group, Merigolix showed statistically significant efficacy compared to placebo at all doses in the phase IIa clinical trial,” Tiumbio CEO Hun-Taek Kim said. As previously reported by BioWorld, Merigolix is an oral gonadotropin-releasing hormone receptor antagonist to treat endometriosis-related pain.

BioWorld Insider Podcast – Back to fundamentals: The latest numbers point to better times

BioWorld Managing Editor Karen Carey joins the podcast to talk about the numbers from the first quarter of 2024, along with a look back at some 2023 deals and indicators that signal better times are on the way. Financings for the quarter were better than expected, sporting some of the best numbers of the past 13 years. It’s part of a larger trend, Carey says, of investors being a lot pickier about where they put their money and demanding better data. The result is a strengthened market and a better outlook.

BioWorld reader feedback needed: Cyberattack impact survey

The recent cyberattack on Change Healthcare, a part of the Unitedhealth Group, crippled reimbursement claims processing for thousands of providers for several weeks and potentially exposed troves of patient data. Congressional committees are investigating the attack, its scope, and Unitedhealth’s response. Are there downstream impacts that are being overlooked in the biopharmaceutical and/or medical technology sectors? Please take a few minutes to fill out this short survey to help BioWorld understand how your company is responding to these threats. You can click through to the questions here.

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Aardvark, Acepodia, Acumen, Aldeyra, Alkeus, Alterity, Alzamend Neuro, Annexon, Apollomics, Avidity, Cassava, Cel-Sci, Compass Pathways, Cytokinetics, Eisai, Eyecro, Fulcrum, Karolinska, Leo, Mabwell, Medigene, Medincell, Merakris, Merrimack, Mitsubishi Tanabe, Neurocrine, Neushen, Optinose, Organovo, Pacira, Pfizer, Regeneron, Renova, Rion, Shionogi, Sobi, Stealth, Tersera, Teva, Tiumbio, Verona, X4, Xinnate