With one program in the clinic and another not far behind, Generate Biomedicines Inc. raised $273 million in a series C financing to advance its generative biology platform. It is one of the largest venture capital rounds for a U.S. company in 2023. Funds will go toward advancing the company’s 17 pipeline programs, including its most advanced candidate for SARS-CoV-2, and by filing multiple IND applications in 2024. The company expects its artificial intelligence and machine learning platform will lead to about 10 new programs a year. While the “Generate” platform started out by creating antibodies and peptides, it has since expanded into new modalities, including bispecifics, enzymes, T-cell engagers and cell therapy. The aim is to take years off of traditional complex protein design.

Innovent to raise $306M to advance late-stage pipeline 

Innovent Biologics Inc. announced a HKD$2.37 billion (US$306 million) placement on the Hong Kong Stock Exchange (HKEX) to advance its late-stage pipeline, including mazdutide, a GLP-1R/GCGR dual agonist for diabetes and obesity. The company plans to offer 68 million new shares priced at HKD$34.92, which represents an 8.8% discount to the previous closing price of HKD$38.30 per share. Innovent said that roughly 60% of the placement would be used for expediting research and development of some of its “prioritized preclinical and clinical programs,” including multiregional clinical trials and building up its global infrastructure.

Alnylam posts an adcom win but shares slide 

A U.S. FDA advisory committee’s backing will keep Alnylam Pharmaceuticals Inc.’s Onpattro (patisiran) on the road to a supplemental in treating a rare heart disease approval, but it couldn’t stop the company stock from sliding. Shares (NASDAQ:ALNY) were down 6.5% at midday to $198 each the day after the Cardiovascular and Renal Drugs Advisory Committee voted 9-3 that patisiran’s benefits outweigh the risks in treating transthyretin-mediated amyloidosis cardiomyopathy. The adcom voiced concerns about clinical meaningfulness of the data presented. The FDA accepted the supplemental NDA to expand use to ATTM, setting a PDUFA date of Oct. 8. Patisiran already has FDA approval as Onpattro for polyneuropathy of hereditary ATTR amyloidosis in adults.

One trial, two regulators, two opinions on Oncopeptides drug

Supporting their conclusions with data from the same phase III study, the EMA’s Committee for Medicinal Products for Human Use issued a positive opinion this week for extending the use of Oncopeptides AB’ Pepaxti (melflufen) to earlier lines of multiple myeloma treatment even as the FDA dug in its heels about withdrawing the drug from the U.S. market. The FDA’s Center for Drug Evaluation and Research posted its response to Oncopeptides’ August appeal, concluding that Pepaxto, as it was marketed in the U.S. under accelerated approval, failed its confirmatory trial and is no longer shown to be safe and effective.

Alveogene launch disclosed as companies pursue AATD with varied approaches

The launch of Alveogene, developer of inhaled gene therapies, put more eyes on the alpha-1-antitrypsin deficiency (AATD) space. A number of contenders are working on AATD, including Grifols SA, which this summer completed enrollment in the phase III study called Sparta. Other developers include Santhera Pharmaceuticals Holding AG, and Mereo Biopharma Group plc.

Insilico nabs $80M up front in cancer drug out-licensing deal with Exelixis

Insilico Medicine Inc. struck an out-licensing deal with Exelixis Inc. for its small-molecule USP1-inhibitor candidate called ISM-3091, the company said on Sept. 12, standing to gain $80 million in up-front payments. Under the exclusive licensing agreement, Exelixis picks up worldwide rights to develop and commercialize ISM-3091, along with other USP-1-targeting compounds, while Insilico gains undisclosed milestone payments for development, commercial and sales of the drug, along with tiered royalties on net sales, on top of the initial payout.

US FTC vote clears way for more scrutiny of Orange Book patents

Patent listings in the U.S. FDA’s Orange Book will be subject to antitrust scrutiny in the wake of today’s unanimous FTC vote to issue a policy statement recognizing that improperly listed patents “may constitute an unfair method of competition.” By law, only patents claiming a drug’s substance, formulation or method of use may be listed in the Orange Book, but some companies have been listing and then litigating other patents, including ones pertaining to devices used to administer a drug, to protect their monopolies, FTC Chair Lina Khan said.

BioWorld Insider Podcast – AI: driving drug development from effective to remarkable

Google’s Scott Penberthy joins the podcast for a visionary discussion that scans the horizon for startling changes artificial intelligence will bring to drug development in the relatively near future. Among the gems and eyebrow raisers is talk of dramatic reductions in the time it takes to identify the right molecule for development and how digital clinical trials in the not-too-distant future will substantially shrink study times. This episode also provides a preview of the annual Biofuture conference. Each year, a group of trailblazers, disruptors and forward-thinking executives converge to evaluate and forecast the future of health care. This year, BioWorld is a gold sponsor of the Oct. 4-6 event in New York. If you attend, you'll have the chance to hear panels and join workshops and fireside chats with key opinion leaders like Penberthy.

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Abbvie, Aclipse, Alzheon, An2, Apmonia, Asieris, Astellas, Aston, Beigene, Bionomics, Bioray, Caliway, Chong Kun Dang, Clearmind, Dalcor, Eiger, Evecxia, First Wave, Gilead, Harpoon, Horizon, Hoth, Imcyse, Innocare, J Ints, Kyverna, Landos, Madrigal, Matica, Moderna, Morphosys, Nektar, Nine Square, Nona, Nurexone, Ocugen, Okyo, Pasithea, Pharmadrug, Pharmazz, Q32, Recce, Regulus, Rocket, Sun, Takeda, Thirtyfivebio, Tme, Vertex