In a mammoth deal with a potentially huge payoff, Nurix Therapeutics Inc. and Seagen Inc. will collaborate to develop what the companies are calling a new class of medicines, Degrader-Antibody Conjugates, to create drugs with new mechanisms of action for treating cancer. The approach uses a combination of antibody-drug conjugation and targeted protein degradation therapies. Nurix will get $60 million up front and could ultimately bring in about $3.4 billion in R&D, regulatory and commercial milestone payments from several programs. Nurix stock (NASDAQ:NRIX) was trading 9.8% upward at midday, with shares going for $9.10 each.

Radiopharma firm Mariana Oncology raises $175M in series B

On track to move its lead candidate, MC-339, into the clinic for small-cell lung cancer in 2024, Mariana Oncology Inc. raised $175 million through an oversubscribed series B round co-led by Deep Track Capital and Forbion. The radiopharmaceutical company was incubated for 18 months before conducting a $75 million series A in December 2021 and has since built out its R&D division and a phase I/II manufacturing unit, with 50 employees. “Very few other radiopharmaceutical companies have all of that capability in house,” said Simon Read, founder and CEO of Mariana.

Corteria closes $70.7M series A to advance heart failure candidates

As part of its quest to advance its three first-in-class heart failure drug candidates toward the clinic, Corteria Pharmaceuticals SAS has closed an oversubscribed €65 million (US$70.7 million) series A, co-led by investors Orbimed and Jeito Capital, companies based in the U.S. and Europe, respectively. The company was founded in 2021 by former employees of Sanofi SA, Philip Janiak and Marie-Laure Ozoux, who brought with them two of Sanofi’s programs – a corticotropin-releasing hormone receptor 2 agonist and an arginine vasopressin neutralizing monoclonal antibody. Most of the series A funds will go toward Corteria’s lead, a once-daily, subcutaneous CRF2 agonist for treating worsening heart failure.

White paper delves into US regulatory aspects of AI in drug, device development

While the U.S. FDA’s preclinical and clinical trial framework is generally well-suited to adapt to the use of artificial intelligence (AI) in developing new drugs, its regulatory framework for medical devices that incorporate evolving AI leaves a lot to be desired, according to Sen. Bill Cassidy (R-La.), the ranking member of the Senate Health, Education, Labor and Pension Committee. “Congress may need to consider targeted updates to provide predictability and flexibility for AI-powered devices while ensuring that such devices are safe and effective for patients,” Cassidy said in a white paper released yesterday. “Moreover, foundational questions about AI applications remain regarding the transparency of algorithm development, ongoing effectiveness of such applications and who carries the liability if something goes wrong.”

GPKOL 2023: Amid global downturn, experts mull pharma’s growth post-pandemic

South Korean biopharmaceutical firms are facing a harsher climate and an uphill battle both domestically and abroad, amid the larger economic downturn that has slowed everything from new drug approval to dealmaking. At the Global Pharma Key Opinion Leaders (GPKOL) 2023 Symposium held at the El Tower on Sept. 9 in Seocho-gu, Seoul, officials from the industry, government and academia gathered to discuss strategies on bouncing back from the lasting effects of the COVID-19 pandemic.

China’s NMPA approves Gloria Bio’s zimberelimab as first PD-1 MAb for cervical cancer

China’s National Medical Products Administration (NMPA) has given the green light to Gloria Biosciences Co. Ltd.’s anti-PD-1 monoclonal antibody, zimberelimab (Yutuo, GLS-010), for treating second-line cervical cancer, making it the first immune checkpoint inhibitor approved in China for treating the disease. The approved indication is for monotherapy for the treatment of recurrent or metastatic cervical cancer patients with positive PD-L1 expression who progressed on or after platinum-based chemotherapy.

Corvus preps for randomized phase III for soquelitinib in PTCL

Shares of Corvus Pharmaceuticals Inc. (NASDAQ:CRVS) sank 22.5% in early trading on Sept. 7, despite news that the company confirmed a phase III plan with the U.S. FDA for its ITK inhibitor soquelitinib to treat relapsed peripheral T-cell lymphoma (PTCL). The gist of the investor disappointment is the design of the trial. It is a longer, randomized, controlled study with 150 patients with a full readout expected in two years, unlike the shorter, single-arm trials required for the accelerated approval of second-line drugs already marketed for PTCL. The phase III trial is expected to begin in the first quarter of 2024.

US FTC and DOJ draws mixed reviews of proposed framework for regulation of mergers

Two U.S. federal government departments recently issued a series of guidelines for their handling of mergers and acquisitions in a draft that has provoked both support and opposition from observers. Barry Nigro of the George Washington University School of Law said he is concerned that the presumption that a transaction is necessarily anticompetitive will prompt litigation over that presumption and thus bog down the process of reviewing these transactions.

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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