Immuno-oncology company Imugene Ltd. has acquired a worldwide exclusive license to Precision Biosciences Inc.’s allogeneic CD19 CAR T-cell therapy program in a deal worth more than $227 million. The off-the-shelf CD19 CAR T-cell therapy, azercabtagene zapreleucel (azer-cel), could potentially be the first allogeneic CAR T to be approved, Imugene CEO Leslie Chong told BioWorld. “Autologous CAR Ts are the only approved CAR Ts out there, and when patients relapse, they really don't have much of anything else,” she said, noting that azer-cel is designed to address the unmet need in the post autologous CAR T setting of diffuse large B-cell lymphoma, an aggressive type of non-Hodgkin lymphoma.

Astrazeneca slapped with OPDP warning letter

Usually when the U.S. FDA’s Office of Prescription Drug Promotion (OPDP) determines that the marketing of a drug crosses the line of misbranding, it hands the sponsor an untitled letter schooling it on how the promotional materials run afoul on safety or efficacy claims. But in the case of a sales aid for Astrazeneca plc’s Breztri Aerosphere (budesonide, glycopyrrolate and formoterol fumarate), OPDP delivered a much sterner warning letter. The Aug. 4 letter, posted yesterday, takes the drugmaker to task for misrepresenting trial data to make “false or misleading claims” about the benefit of the drug in treating chronic obstructive pulmonary disease.

Newco news: Viralytics team back together again to develop new oncolytic viruses with Immvirx

The old Viralytics Ltd. team is back together again in a new company called Immvirx Pty Ltd. that is developing oncolytic viruses to tackle the four most deadly cancers, Immvirx CEO and co-founder Malcolm McColl told BioWorld. Merck & Co. Inc. acquired Viralytics for $394 million in February 2018, gaining full rights to Cavatak RNA (CVA-21), an immunotherapy candidate based on an oncolytic virus (coxsackievirus A21) formulation shown to preferentially infect and kill cancer cells. “The Viralytics crew spent 12 to 18 months working at Merck to manage the transition of Cavatak off to Merck, and then we decided there was some unfinished business, and we really wanted to tackle some of these more difficult cancers where there was a high unmet need,” McColl said.

FDA accepts Venatorx NDA for cUTI antibiotic; PDUFA early 2024

Venatorx Pharmaceuticals Inc. on Aug. 15 said the U.S. FDA accepted its NDA for an intravenous antibiotic combination, cefepime-taniborbactam, to treat complicated urinary tract infection (cUTI), including acute pyelonephritis. Cefepime-taniborbactam combines cefepime, a fourth-generation cephalosporin widely used as a beta-lactam antibiotic, with taniborbactam, a beta-lactamase inhibitor antibiotic. The latest PDUFA target action date from the FDA – Feb. 22, 2024 – now brings the privately held pharma a step closer to bringing a new I.V. antibiotic for cUTI to the antimicrobial-resistant and multidrug-resistant markets, which stagnated after big pharma largely discontinued R&D from low returns on investment.

Delcath gets FDA win for Hepzato Kit for metastatic uveal melanoma

Delcath Systems Inc. reported that the FDA approved its Hepzato Kit for the treatment of adults with unresectable hepatic-dominant metastatic uveal melanoma. The FDA nod also triggered a second tranche of financing of approximately $35 million from a private placement in March.

US FDA’s informed consent guidance long time coming

It’s been 25 years since the U.S. FDA issued a final guidance on informed consent and nine years since it asked for comments on a draft guidance to supersede that 1998 guide. A lot’s happened since then, including the release of the 2018 Common Rule, which governs the protection of human subjects involved in research conducted or supported by the Department of Health and Human Services, its agencies and other federal departments.

BioWorld Insider Podcast: The struggle is real: The first half of 2023 was an uphill climb

Guests Karen Carey, BioWorld’s managing editor, and Mike Ward, Clarivate’s global head of Life Sciences and Healthcare Thought Leadership, discuss the deals, financing and M&A landscape for the first half of 2023 and how U.K. biopharmas are faring post Brexit.

Also in the news

Alaunos, Aliada, Amicus, AN2, Arcellx, Avidity, Biocorrx, Biostax, Briacell, Calliditas, Chiesi, Compass Pathways, Core Bio, CU Innovations, Cytomed, Day One, Design, Diffusion, EIP, Eyenovia, Formosa, Immpact, Impel, Mediwound, Mimedx, Oncusp, Perspective, RVL, Sagimet, Sandoz, Sprint, Thryv, Tiziana, Venatorx, Wugen