News

A small molecule inhibitor of the mutated RAS protein, a high priority cancer target, has successfully delivered a significant overall survival benefit for patients with metastatic pancreatic cancer. The results were obtained in a Phase 3 trial of the RAS inhibitor daraxonrasib and reported on 13 April. The developer is Revolution Medicines Inc, a clinical-stage US biopharmaceutical company with a portfolio of RAS-addicted cancers. These are cancers that are dependent on mutant RAS activity for their survival.

China’s regulatory authority, the National Medical Products Administration, has approved Blenrep (belantamab mafodotin), a treatment for multiple myeloma which is a relatively rare blood cancer but with a global prevalence. In China, it is now the only B-cell maturation antigen (BMCA) targeting second-line therapy for the disease. “Blenrep provides a new and needed mechanism of action in therapy,” the developer GSK Plc said in a statement on 20 April. Blenrep is an antibody-drug conjugate consisting of a humanised antibody conjugated to a cytotoxic agent via a non-cleavable linker.

Marty Makary, commissioner of the US Food and Drug Administration, has invited developers of testosterone replacement therapies for men to approach the agency to discuss a possible augmentation for their products. Specifically, this means pursuing a potential new indication for low libido in men with idiopathic hypogonadism, or sexual disfunction without a known cause. “New and emerging data suggest there may be an opportunity to help men suffering from symptoms that significantly affect quality of life,” he said in a statement issued on 16 April.

A new observational study led by researchers at University College London suggests that changes in the gut microbiome may provide an early indication of Parkinson’s disease risk, potentially years before clinical symptoms appear. Published in Nature Medicine on 20 April, the peer-reviewed study analysed microbial patterns in the digestive systems of individuals with Parkinson’s disease, those genetically predisposed to the condition, and healthy controls.

A veterinary vaccine using RNA technology and originally developed by Merck & Co has received a positive opinion from the European Medicines Agency on the basis of multiple, positive studies in cats. The vaccine, Nobivac NXT HCPChFeLV, contains live attenuated strains of five feline viruses, one of which is a strain of the feline leukaemia virus. This virus strain suppresses the immune system and is a common cause of cancer in cats. It is species specific and does not affect humans.

A small peptide drug in development at Oculis Holding AG of Switzerland has received regulatory designations from agencies in both Europe and the US for its promise as a treatment for optic neuritis, a disease that can seriously impair vision. Called privosegtor, the candidate drug activates pathways in the brain in order to promote the survival of neurons after an inflammatory attack. Optic neuritis can be caused by autoimmune diseases such as multiple sclerosis, or viral infections such as mumps, measles or the flu, according to the American Academy of Ophthalmology. 

Kailera Therapeutics Inc, a venture capital-backed enterprise with obesity assets in-licensed from China, has raised $625 million from an initial public offering on Nasdaq, one of the largest biotech IPOs in recent years. The funds will be used to advance the company’s lead product ribupatide, currently in global Phase 3 trials, as well as three other candidate obesity treatments that cover several mechanisms of action and methods of delivery.

Tubulis GmbH, a 2019 German university spin-out, is to be acquired by Gilead Sciences Inc for up to $5 billion – one of the larger biopharma transactions in Europe this year. Announced on 7 April, the deal involves an upfront payment of $3.15 billion and potential milestones of $1.85 billion for ownership of an early clinical-stage portfolio of antibody-drug conjugates (ADCs) for cancer. As part of the agreement, Tubulis’ scientists and other staff will remain at their current location in Munich which will serve as a hub for ADC innovation for Gilead as a whole.

Eli Lilly and Company signalled its intention to broaden its neuroscience portfolio on 31 March with the planned acquisition of Centessa Pharmaceuticals Plc, a Nasdaq-listed developer of treatments for sleep-wake disorders. Centessa is developing a pipeline of orexin receptor 2 (OX2R) agonists. The lead product, cleminorexton, is in Phase 2a clinical studies for the treatment of two types of narcolepsy and idiopathic hypersomnia, all chronic neurological disorders affecting sleep.

The Belgian biotech Galapagos NV has signed a binding agreement with Gilead Sciences Inc giving it rights to a prospective T cell therapy programme targeting autoimmune diseases. Concluded on 31 March, the deal centres on an early clinical-stage bispecific antibody designed to link a patient’s T cells to the B cell maturation antigen (BCMA) on plasma cells. In this way, it would eliminate pathogenic B cells and plasma cells in order to reduce inflammation and treat autoimmune diseases.