The deal that could bring IGM Biosciences Inc. more than $6 billion is 2022’s largest and cracks the BioWorld top 10 list as the ninth biggest ever. Sanofi SA and IGM agreed to develop, manufacture and commercialize immunoglobulin M (IgM) antibody agonists in treating cancer and immunology/inflammation targets. IGM is getting $150 million up front once the deal closes, which the company expects to happen in the second quarter of 2022.
Following another failure in amyotrophic lateral sclerosis (ALS), Biogen Inc. will discontinue its development of antisense oligonucleotide BIIB-078 with partner Ionis Pharmaceuticals Inc. The stumble is part of a mega-collaboration the two companies began 10 years ago that has also yielded a lot of success, including the blockbuster Spinraza (nusinersen).
Top-line interim phase I/II data from Icosavax Inc.’s virus-like particle COVID-19 vaccine fell short of company and market expectations. IVX-411, which displays the SARS-CoV-2 receptor binding domain, was found to be immunogenic and well-tolerated, but the level of immune response was lower than anticipated and inconsistent with data on Icosavax’s platform and its preclinical results.
The U.S. FDA has approved Novartis AG’s Pluvicto (lutetium Lu 177 vipivotide tetraxetan, formerly referred to as 177Lu-PSMA-617) for treating adults with metastatic prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer. The treatment is the indication’s first FDA-approved targeted radioligand therapy that contains a radioisotope.
Fungal biosphere specialist Lifemine Therapeutics Inc. has struck a goldmine through a $175 million series C financing and an R&D collaboration allowing Glaxosmithkline plc (GSK) to use the company's platform to identify small-molecule leads.
In its drive to rewrite the rules of the tumor microenvironment so it can capture of the holy grail of successfully battling solid tumors by using T cells, Affini-T Therapeutics Inc. has completed an oversubscribed $175 million. The focus is to develop multiple oncogene driver programs for treating solid tumors such as those with mutated KRAS variants into the clinic, pursue complementary technology licenses to strengthen its cell therapy platform and to optimize its discovery engine.
Marinus Pharmaceuticals Inc.’s GABAA receptor agonist Ztalmy (ganaxolone), has won U.S. FDA approval for treating seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder.
Marinus Pharmaceuticals Inc.’s GABAA receptor agonist Ztalmy (ganaxolone), has won U.S. FDA approval for treating seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder. It is the first therapy indicated specifically for the rare genetic condition and is now approved for patients ages 2 and older, earning Marinus a rare pediatric disease priority review voucher.
Despite global drops in COVID-19 infections and because variants never rest, Eiger Biopharmaceuticals Inc. is taking its strong top-line phase III data of pegylated interferon lambda to global regulatory agencies for approval. The type III interferon that stimulates immune responses significantly reduced the risk of COVID-19-related hospitalizations or emergency room visits longer than six hours by 50% and death by 60%. The results prompted Eiger to say it would submit the data to the FDA for an emergency use authorization – and also to the EMA and Asian agencies – as soon as it could.
New data from two phase II studies from two companies showed progress in their respective Parkinson’s disease programs. The data for both therapies, from Anavex Life Sciences Corp. and Sage Therapeutics Inc., were presented on opening day, March 15, at the AD/PD 2022 Advances in Science & Therapy International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological Disorders, being held in Barcelona until March 20.
