Innovent Biologics Inc.’s glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR) dual agonist, mazdutide, met the primary endpoint and all key secondary endpoints in a phase III type 2 diabetes (T2D) trial in Chinese adults. “Mazdutide is the first and fastest-developed GLP-1R/GCGR dual agonist in the world, and we are actively promoting the development of mazdutide for weight loss, T2D and other indications,” Lei Qian, Innovent’s vice president of clinical development, said. The results of another phase III study involving patients with T2D inadequately controlled by oral antidiabetic drugs met the study endpoints in May 2024, he said, stressing that, “together, the two studies demonstrate mazdutide's comprehensive efficacy in improving glycemic control, promoting weight loss and enhancing metabolic outcomes in patients with T2D.”

Aveo’s kidney cancer combo flops in PIII; LG Chem soldiers on

Aveo Pharmaceuticals Inc., a LG Chem Ltd. subsidiary, said that Fotivda (tivozanib) in combination with Bristol Myers Squibb Co.’s Opdivo (nivolumab) failed to increase progression-free survival (PFS) in advanced kidney cancer patients in a phase III Tinivo-2 study. Despite the primary endpoint miss, Aveo noted that Fotivda alone, or as a monotherapy, in the control arm meaningfully extended median PFS, helping “further support the approved use of Fotivda as a safe and effective treatment option in relapsed or refractory advanced [renal cell carcinoma] RCC following two or more prior systemic therapies.”

Muscle-weakening diseases in developer crosshairs on several fronts

Developers’ interest in muscle diseases continues apace after the U.S. FDA approval in June for Argenx SE with subcutaneously given Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase) for adults with chronic inflammatory demyelinating polyneuropathy (CIDP). Drugs are in the works not only for CIDP. Some – including Argenx – are going after such conditions as generalized myasthenia gravis and multifocal motor neuropathy.

Biopharma M&A values double from last year, reaching $67.44B in first half of 2024

In the first half of 2024, values of deals and M&As in the biopharma space are pacing higher than last year. The first half of 2024 saw deal values reach $97.59 billion, an increase of 11% from 1H23 and the highest amount raised via deals in the first half of any year in BioWorld’s records. Biopharma M&As in H1, more than doubled, from $29.59 billion in the first half of 2023 to $67.44 billion in the same period this year.

IAS 2024: Seventh HIV cure reported, but broad reach will take other approaches

The 2024 meeting of the International AIDS Society (IAS), which is being held in Munich this week, began with the announcement of another curative bone marrow transplant. The new case brings the total number of patients cured of HIV via a bone marrow transplant up to 7 since “Berlin patient” Timothy Ray Brown became the first such person in 2007. The new patient has chosen to remain anonymous. Like Timothy Ray Brown, he was transplanted at the Charité University Hospital Berlin. In 2018, 3 years after his bone marrow transplant and 10 years after first being diagnosed with HIV, he discontinued antiretroviral therapy. His virus has not rebounded since.

BioWorld Insider Podcast – The cost of delays in development and sales: It’s probably not what you think

Two costs of developing drug candidates have been upended by new research from the Tufts University School of Medicine’s Center for the Study of Drug Development. New data have produced some very different numbers than you might expect in the cost of a single day of a clinical trial and of missing a day to generate prescription drugs sales. The center’s director, Ken Getz, spoke to the BioWorld Insider podcast about updating the outdated numbers and what it means for companies and investors.

Also in the news

Abliva, Acadia, Actuate, Alkeus, Ardelyx, Biodexa, Bristol Myers Squibb, C4X, Deciphera, Eli Lilly, Gro, GSK, Hookipa, Latigo, Leo, Meitheal, Nabriva, Nervgen, Nika, Paratek, Phathom, Rakovina, Siga, Silo, Tonix, Unity, Vericel