Despite what University of Pennsylvania (Penn) immunologist Carl June referred to as a “cold slap last November” – a launched investigation by the U.S. FDA into a possible link between CAR T-cell immunotherapies and secondary cancers – new unpublished studies by Penn and the University of Stanford highlight the rarity of such cases. “Between Stanford and Penn and these unpublished studies, with 1,500 patients analyzed, there’s not a single case where the integrated vector transgene has been observed,” June said May 6 at a public meeting arranged by Friends of Cancer Research and the Parker Institute for Cancer Immunotherapy. The FDA launched an investigation in late November 2023 into the risk of T-cell malignancies, including lymphoma, that occurred following administration of BCMA-directed and CD19-directed genetically modified autologous CAR T-cell immunotherapies. The concern spread across the globe, with South Korea issuing warnings in December and the EMA starting its own review of the risk in January. In April, the FDA required a black box warning on the six approved CAR T products on the U.S. market.

Jacobio seeks China approval of second-line KRAS lung cancer drug

China and U.S. biotech Jacobio Pharmaceuticals Group Co. Ltd.’s shares (HKEX:1167) rose nearly 20% after it filed an NDA in China on May 6 for its independently developed KRAS G12C inhibitor, glecirasib (JAB-21822), to treat lung cancer. Beijing, Shanghai and Boston-based Jacobio filed the NDA to China’s Center for Drug Evaluation of the NMPA for glecirasib as a second-line therapy to treat patients with advanced or metastatic non-small-cell lung cancer with KRAS G12C mutation. By market close of May 7, Jacobio stock was trading at HK$2.17 (US28 cents), a 16.67% increase from the previous trading day.

$200M series C to back Zenas’ bifunctional antibody

Zenas Biopharma Inc. pulled down an upsized $200 million series C preferred stock financing led by SR One along with NEA, Norwest Venture Partners and Delos Capital. Enavate Sciences and Longitude Capital participated significantly as well. Proceeds will fund the ongoing mid- to late-stage programs for the Waltham, Mass.-based company’s lead candidate, obexelimab, a high-affinity bifunctional antibody that inhibits B-cell lineages by simultaneously binding to CD19 and FcƳRIIB.

Memo boosts series C to CHF45M as BKV infection trial expands

Memo Therapeutics AG has added a further CHF20 million (US$22 million) to its series C, bringing the total for the round to CHF45 million and enabling the company to expand the phase II trial of its lead program, AntiBKV, in neutralizing BK virus infection in immune compromised kidney transplant recipients. The prompt to review the development plan for the AntiBKV monoclonal antibody was the appointment of Erik van den Berg as CEO in November 2023. “We thought it was good to attach a dose-finding extension study, so that we address all the questions we need to ask in phase II and can have a seamless progression to phase III, instead of maybe doing another study in between,” van den Berg said.

The present is Prologue: New Flagship company starts with $50M

Prologue Medicines Inc. has launched to develop therapeutics created from the viral proteome, which are proteins produced across all viruses. Flagship Pioneering has committed $50 million to advance the company platform. The goal is to develop a pipeline of therapeutic proteins to treat a range of diseases. The initial focus is to create drugs to treat immunological, oncology and metabolic indications. The company’s platform, Delve, uses artificial intelligence and machine learning to help find viral proteins to find out if and how they can help regulate human physiology.

Mindbio explores psychedelic potential of LSD for depression, PMS

The use of psychedelics is seeing impressive results in treating psychiatric disorders like treatment-resistant depression and post-traumatic stress disorder, and Mindbio Therapeutics Ltd. is expanding the field to include microdoses of lysergic acid diethylamide (LSD) to treat depression and premenstrual syndrome. “We’re the only organization in the world that has approval for the take-home use of a psychedelic medicine. All the other models exist around a therapist and a clinic setting,” Mindbio CEO Justin Hanka told BioWorld.

Missing Schedule III study drug leads to US FDA warning letter

The theft of 110 units of a study drug containing a Schedule III controlled substance resulted in a warning letter from the U.S. FDA. Addressed to the clinical investigator, Kevin Bender, of the Tamarac, Fla.-based DBC Research Corp., the letter should serve as a word of caution to all trial investigators handling controlled substances. In this case, the study drug, provided in a metered dose pump, was stored outside the designated locked cabinet in a locked room, according to the warning letter posted on the FDA website today. However, that room was apparently accessible at times to unauthorized individuals.

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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