Glucagon-like peptide 1 (GLP-1) receptor agonists have brought significant weight loss to patients, catching the attention of investors, but drug developers are continually seeking new therapies with different mechanisms to enhance the effects and improve the tolerability. A therapy that can show benefits beyond the weight loss, one that addresses co-morbidities, may not only improve outcomes for patients, but will likely be reimbursable by payers. Two companies working in the obesity space shared their efforts with BioWorld recently, addressing not only the opportunity of advancing obesity medications, but the challenges as well. The attention obesity has attracted is far overdue, said Adam Steensberg, president and CEO of Copenhagen, Denmark-based Zealand Pharma A/S. “We probably should have started a little bit earlier as a society,” he said. “I think, still, people underestimate the long-term consequence of the level of obesity in society.”

ODAC could set flexibility precedent for rare disease drugs

Today’s meeting of the U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) stems from a neuroblastoma diagnosis in a 3-month-old boy – the nephew of Kristen Gullo, vice president of development and regulatory affairs at US Worldmeds LLC. In her search for answers for her nephew, Gullo told the adcom, she connected with officials at the Beat Childhood Cancer research consortium who told her of an early trial of eflornithine (DFMO) and the need for a partner to further develop the oral drug to reduce the risk of relapse in pediatric patients with high-risk neuroblastoma. Worldmeds became that partner. If the FDA approves DFMO for the indication based on the data submitted, DFMO would be the first cancer drug approved based on an external-control trial and preclinical data. That potential precedent is why the adcom was convened.

‘Systemic bias’ potential highlighted in briefing docs for Amgen’s Lumakras

Briefing documents ahead of the U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) meeting slated for Oct. 5 bode poorly for Amgen Inc.’s Lumakras (sotorasib), the KRAS-G12C inhibitor granted accelerated approval in May 2021 for locally advanced or metastatic non-small-cell lung cancer (NSCLC) after at least one systemic therapy. A fully human monoclonal antibody that binds to EGFR, Lumakras was the subject of a phase III confirmatory trial called Codebreak 200 that will come under ODAC scrutiny during the session. Meanwhile, Wall Street was taken aback by the briefing docs, which cite potential “systemic bias” in the 345-subject experiment that tested Lumakras compared with docetaxel in NSCLC as a way of gaining full approval for the compound. Shares of Thousand Oaks, Calif.-based Amgen (NASDAQ:AMGN) were trading midday at $263.44, up $2.43.

Teva picks Sanofi in $1.5B IBD alliance

Teva Pharmaceutical Industries Ltd. is joining forces with Sanofi SA to co-develop and co-commercialize anti-TL1A candidate TEV ‘574 for inflammatory bowel disease (IBD). Under the terms, Teva will get an up-front payment of €469 million (US$500 million) and up to €940 million in development and launch milestones. The companies will share development costs globally and net profits and losses in major markets, with Teva leading commercialization in Europe, Israel and specified other countries, and Sanofi taking the lead in North America, Japan, other parts of Asia and the rest of the world. TEV ‘574, also known as TEV-48574, is in phase IIb testing in ulcerative colitis and Crohn’s disease, two types of IBD, with data expected in mid-2024.

Nobel Prize in Chemistry 2023 goes to quantum dots, which illuminated the path to nanotechnology

Quantum dots, a phenomenon in quantum physics that alters the energy of electrons and changes the properties of particles, caught the attention of the Royal Swedish Academy of Sciences (KVA) for the 2023 Nobel Prize in Chemistry. Alexei Ekimov and Louis Brus received the award for their discovery; Moungi Bawendi, for developing its applications. With their work, “in equal shares,” said the Secretary General of KVA Hans Ellegren, the three scientists have laid the foundations of nanotechnology, a tool that we see today in our homes, on televisions and LED lamps, or in laboratories and hospitals for designing new drugs or new strategies against cancer.

Adlai Nortye raises $97.5M from Nasdaq IPO, private placement

Cancer biotech Adlai Nortye Ltd. raised $57.5 million from its U.S. IPO on Nasdaq and $40 million from a concurrent private placement, ringing up $97.5 million in funding to develop its combo immunotherapy pipeline. According to the Sept. 27 SEC filing, Adlai offered 2.5 million American depositary shares (ADSs) at $23 each. Each ADS represents three class A ordinary shares. Following its public debut on Sept. 29, shares (NASDAQ:ANL) fell to $15, a drop of 34.8%. Adlai, a Cayman Islands holding company that operates through subsidiaries in North Brunswick, N.J., and Hangzhou, China, also secured $40 million in a private placement from Nippon Kayuku Co. Ltd.

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