San Francisco-based Xyphos Biosciences Inc. is pooling technology platforms with Boston’s Kelonia Therapeutics Inc. in an immuno-oncology drug discovery deal that could fetch more than $800 million. Xyphos, founded in 2017, is a wholly owned subsidiary of Tokyo-headquartered Astellas Pharma Inc. Under the terms, Xyphos and Kelonia will collaborate to develop a maximum of two in vivo CAR T-cell therapy programs, utilizing both Kelonia’s in vivo gene placement system called iGPS and Xyphos’ Accel technology platform. Kelonia will receive $40 million in an up-front payment for the first program, and an additional $35 million if Xyphos chooses to exercise options for the second program, along with potential milestones and contingency payments totalling about $800 million.

Inventiva pauses pivotal lanifibranor study on serious liver reaction in NASH patient

Inventiva SA has halted enrollment in its pivotal phase III Nativ3 trial with nonalcoholic steatohepatitis (NASH) candidate lanifibranor after a patient experienced raised liver enzymes indicative of autoimmune hepatitis. The resulting delays to the study could spell trouble for the firm, which estimates its cash runway will only see it through to the start of the third quarter. The adverse event has been termed by the U.S. FDA as a treatment-related suspected unexpected serious adverse reaction. Daix, France-based Inventiva has withdrawn the patient from the pan-PPAR agonist and paused screening and randomization in the study.

‘Enhancement’ or delay to Helios-B? Alnylam falls, Bridgebio rises

Alnylam Pharmaceuticals Inc.’s decision to change its analysis plan for the phase III Helios-B trial of Amvuttra (vutrisiran) to treat ATTR amyloidosis with cardiomyopathy, pushing top-line results back by three months, pressured its share price (NASDAQ:ALNY) down by 10% on Feb. 15, while also boosting shares of competitor Bridgebio Pharma Inc. (NASDAQ:BBIO) by 14%. Bridgebio presented strong phase III data of its oral, small-molecule stabilizer of transthyretin, acoramidis, in July 2023, and in early February, the U.S. FDA accepted the NDA for review, granting a PDUFA date of Nov. 29, 2024. In contrast, within its fourth-quarter and full-year financial results, Alnylam on Thursday updated its plan for Helios-B in a move that CEO Yvonne Greenstreet said would “enable the best demonstration of vutrisiran’s impact across the entirety of the patient population and supports a strong and competitive label.”

Kalvista, Pharvaris facing off in bids for on-demand HAE therapy

Recent phase III news from Kalvista Pharmaceuticals Inc. on sebetralstat, an oral on-demand kallikrein inhibitor, in hereditary angioedema (HAE), whetted appetite for a drug that patients can take as needed. Pharvaris BV has deucrictibant, a bradykinin B2 receptor antagonist, moving through the pipeline. Drugs have been approved and/or are in the works for HAE prophylaxis and treatment during attacks.

New year gets a slow start with 8 US FDA approvals in January

The U.S. FDA approved eight drugs in January, down from 10 approvals the previous January and also down from December’s 21 FDA greenlights. Approvals of new molecular entities also continued to decline, going from six in November to three in December, to one in the first month of 2024.

Holiday notice

BioWorld's offices will be closed in observance of Presidents Day in the U.S. No issue will be published Monday, Feb. 19.

Also in the news

Acelyrin, Acousia, Aiolos, Applied, Caliway, Cardiol, Cero, Chromocell, Diamyd, Dragonfly, GSK, Halia, Healthbioai, Hepion, Hyloris, Intellia, Ionis, Kinnate, wLigand, Mannkind, Mesoblast, Nervgen, Opthea, Osivax, Phoenix, Recode, Repare, Ryvu, Sanofi, Starton, T2 Biosystems, Taysha Gene Therapies, Tevogen, Theratechnologies, Viridian, Vogenx, Xoma