Sanofi SA is snatching up a key asset from Inhibrx Inc. in a setup worth as much as $2.2 billion. The pharma behemoth, via subsidiary Aventis Inc., will acquire INBRX-101, an optimized, recombinant alpha-1 antitrypsin (AAT) augmentation therapy undergoing a registrational trial for AAT deficiency, an inherited genetic disorder caused by single nucleotide variants in the SERPINA1 gene. The deal is structured similarly to the 2022 agreement between Pfizer Inc. and Biohaven Pharmaceutical Holding Co. Ltd., whereby the former took over the maker of Nurtec ODT (rimegepant), a dual-acting therapy first approved by the U.S. FDA in February 2020.

Genedit gets $15M up front in Genentech collaboration

Privately held Genedit Inc. will work with Genentech to find and develop hydrophilic nanoparticles for creating nucleic acid-based drugs to treat autoimmune diseases. Genedit is getting $15 million up front could bring in up to $629 million in milestones. Genedit’s platform is focused on delivering genetic medicines into select tissue. Genentech is a unit of Roche Holding AG. South San Francisco-Genedit company also just raised $24 million in a series A1 financing. Existing investors are Eli Lilly and Co., Sequoia Capital, Korea Investment Partners, Woori Venture Partners, Dayli Partners, KB Investment, IMM Investment and Timefolio Asset Management. The funding will support continued development of Genedit’s Nanogalaxy platform and preclinical candidates.

NMPA approves China’s second homegrown SGLT2 inhibitor janagliflozin

Jilin, China-based Huisheng Biopharmaceutical Co. Ltd. gained China NMPA approval for Huiyoujing (proline janagliflozin tablets), its independently developed sodium glucose transporter 2 (SGLT2) inhibitor for type 2 diabetes. The regulatory clearance, announced on Jan. 23, makes janagliflozin the second China-made SGLT2 inhibitor after Jiangsu Hengrui Medicine Co. Ltd.’s henagliflozin (SHR-3824), which was launched domestically in May 2022.

US FDA says reorganization a tough slog in tight budgetary environment

The U.S. FDA is undergoing a significant overhaul of operations which is designed in part to make the agency’s Office of Regulatory Affairs more efficient and less obtrusive to product centers, such as the Center for Devices and Radiological Health. FDA principal deputy commissioner Janet Woodcock has advised stakeholders, however, that the agency is operating under fiscal 2023 appropriations despite the additional workload, a difficult proposition for which relief might not emerge until the start of the 2025 federal budget year.

Pharmabcine faces stock suspension on KRX just as Tirebank takes rein

South Korean regulators suspended trading of Pharmabcine Inc.’s stock on Jan. 19, citing an “unfaithful disclosure” related to a withdrawn ₩30 billion (US$22.39 million) capital increase on Dec. 1, 2023, that violated market regulations. The Korea Exchange (KRX) suspended trading of Pharmabcine’s stock on Kosdaq nearing 6 pm on Jan. 19 due to the “reversal,” or cancellation, of the third-party paid-in capital increase originally announced on June 16, 2023. The suspension will hold indefinitely until the regulator reaches a verdict on the eligibility of Pharmabcine’s listing, which could potentially result in the removal of its stock from the Korean stock exchange.

Biontech and Dualitybio progress HER2 ADC to pivotal trials in China in metastatic breast cancer

Biontech SE and Duality Biologics Co. Ltd. have progressed BNT-323/DB-1303 to pivotal phase III trials, beginning in China in patients with hormone receptor-positive (HR+) and HER2-low metastatic breast cancer. The global, multicenter, open-label, randomized phase III trial will assess the efficacy and safety of BNT-323/DB-1303 compared to standard-of-care single-agent chemotherapy in chemotherapy-naïve patients with HR-positive and HER2-low metastatic breast cancer that have progressed on hormone therapy. The study’s primary endpoint is progression-free survival. Secondary endpoints include overall survival, objective response rate, duration of response and safety.

From viral peptides, small-molecule drugs far beyond infection

Using interactions between viral peptides and human proteins as a starting point, researchers from Enyo Pharma Inc., the University of Lyon and other institutions were able to bootstrap themselves to a mitochondria-targeting small molecule that showed activity in a mouse model of nonalcoholic steatohepatitis with chronic kidney disease.

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