Shares of Rapt Therapeutics Inc. (NASDAQ:RAPT) were trading midday at $9.36, down $16.61, or almost 64%, after the South San Francisco-based firm disclosed the U.S. FDA has imposed a clinical hold on the company’s phase IIb trial of zelnecirnon (RPT-193) in atopic dermatitis (AD) and the phase IIa trial in asthma. A serious adverse event of liver failure was found in one patient in the AD trial, the cause of which is unknown, although it’s deemed “potentially related” to zelnecirnon, an orally given small-molecule CCR4 antagonist. Dosing has been halted in both studies, along with enrollment. The patient in question has received a liver transplant and is recovering, Rapt noted.

FDA clears first TIL therapy as Iovance wins accelerated nod in melanoma

Roughly 35 years after early patient data suggested the potential of tumor-infiltrating lymphocytes (TIL) in cancer, Iovance Biotherapeutics Inc. received U.S. FDA approval for lifileucel, marking both the first autologous TIL cell therapy for commercial use and the first one-time cell therapy for a solid tumor cancer. Branded Amtagvi, lifileucel is cleared for use in patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation-positive, a BRAF inhibitor with or without a MEK inhibitor. The approval, announced just after market close on Feb. 16, boosted shares of Iovance (NASDAQ:IOVA) up 39% at midday Feb. 20.

Innovent thyroid eye therapy hits phase III goal, spurs China NDA

In a crowded thyroid eye disease (TED) space, Innovent Biologics Inc. reported positive late-stage findings for its TED therapy, IBI-311, spurring the Suzhou, China-based biopharma to file for regulatory approval in China. Innovent said it would file an NDA with China’s NMPA Center for Drug Evaluation for IBI-311, based on results of a phase III Restore-1 registry study disclosed on the Hong Kong Stock Exchange on Feb. 20. If approved, IBI-311 would become the first TED therapy approved in China.

AAAS 2024: Chemo brain, other conditions provide lens for long COVID

The biological processes giving rise to the central nervous system symptoms of long COVID remain a mystery. But multiple studies suggest they do not appear to be a result of a direct viral infection of brain tissue. The latest such research, which appeared online in Nature Neuroscience on Feb. 16, 2024, demonstrated that local immune response in brain tissues persisted long after SARS-CoV-2 virus had disappeared.

Finding the good in autoantibodies could REAP broad benefits

Autoantibodies call to mind disease – autoimmune disease, to be exact. But the physiological roles of autoantibodies are, at the very least, more complex than this view accounts for. “The autoantibody reactome is extraordinary,” Aaron Ring told BioWorld. “Nearly everyone has autoantibodies, whether they know it or not.”

No consensus on broader WTO COVID-19 waiver

Unless there’s a last-minute meeting of the minds, it looks like any extension of the World Trade Organization’s (WTO) intellectual property (IP) waiver for COVID-19 vaccines will be shelved, at least for now. In preparing for next week’s 13th WTO Ministerial Conference, WTO members recently adopted a report acknowledging that they couldn’t reach the necessary consensus to expand the waiver to include COVID-19-related drugs, devices and diagnostics. In the U.S., industry and several lawmakers have opposed any expansion, saying it would be especially harmful to small companies developing COVID-19 products based on platform technologies, as the waiver would include the IP to those technologies.

FDA accepts Daiichi/Astrazeneca’s BLA for Trop2 lung cancer drug

The U.S. FDA has accepted for review Daiichi Sankyo Co. Ltd.’s and Astrazeneca plc’s BLA for datopotamab deruxtecan (dato-dxd) to treat adults with locally advanced or metastatic nonsquamous non-small-cell lung cancer (NSCLC) who have received prior systemic therapy. The PDUFA date is set for Dec. 20, 2024. Jointly developed by Daiichi Sankyo and Astrazeneca, dato-dxd could be the first trophoblast cell surface antigen 2 (TROP2)-directed antibody-drug conjugate for lung cancer, according to Clarivate’s Drugs to Watch, anticipates dato-dxd to reach $2.7 billion in sales for breast cancer and NSCLC combined in 2029.

Will promised Orange Book guidance overturn years of practice?

After more than a decade of industry pleading for guidance on Orange Book patent listings, the U.S. FDA is finally planning on answering that request this year. If the guidance that’s produced reflects the FTC’s position that device patents can’t be listed for combination products, it could overturn years of accepted practice, even though guidance, especially draft documents, are not the same as regulation. Several letters from biopharma companies responding to FTC challenges to their listed device patents insisted that their listings are consistent with the FDA’s long-held interpretation that a finished dosage form includes a drug’s device, which is approved as part of the NDA.

Holiday notice

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

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