Boehringer Ingelheim has received a second US approval for its anti-inflammatory drug Cyltezo (adalimumab-adbm), a biosimilar version of Humira, one of the most widely sold drugs in the developed world. Humira is still protected by patents which means that Cyltezo will not become commercially available in the US until 1 July 2023.
UK-based STORM Therapeutics Ltd has entered into an exclusive collaboration and licensing agreement with Exelixis Inc to discover potential treatments for cancer by inhibiting enzymes that modify RNA. The initial focus of the partnership will be on ADAR1 (adenosine deaminases acting on RNA), an enzyme that edits double-stranded RNA molecules. In so doing, the enzyme reduces their ability to activate the innate immune system.
The European Medicines Agency has recommended approval of an antibody-drug conjugate (ADC) for the treatment of metastatic triple-negative breast cancer, an aggressive cancer that does not respond to hormonal therapy medicines or medicines that target HER2 protein receptors. The positive opinion was based on data from a Phase 3 trial which showed that the therapy, Trodelvy (sacituzumab govitecan), produced an overall survival figure of 11.8 months and progression-free survival of 4.8 months, compared with 6.9 months and 1.7 months respectively, for chemotherapy.
The US Food and Drug Administration has approved the first allogeneic tissue product for the treatment of children born without a thymus, a condition known as congenital athymia. The product, Rethymic, is a donor derived product that is processed and cultured and implanted into patients to help reconstitute immunity in the absence of a thymus gland. The thymus is located behind the sternum and between the lungs, and is active until puberty. The gland secretes thymosin, a hormone necessary for T cell development and production.
A new biotech company with plans to target ABC transporters, one of the oldest families of proteins, has been launched with $100 million in Series A financing by US-based Atlas Venture and three other groups. Rectify Pharmaceuticals Inc will develop small molecule drugs aimed at restoring dysfunctional ABC transporters to a normal state. These transporters play an essential role in ferrying organic and inorganic molecules across cellular membranes.
A new collaboration between Intellia Therapeutics Inc and the French ophthalmology company SparingVision SAS will seek to apply genome editing technology to the treatment of diseases of the eye. Announced on 13 October, the partnership will use Intellia’s in vivo Crispr/Cas9-based platform to investigate up to three ocular targets.
ReNeuron Group Plc has reported that exosomes were able to deliver a therapeutic protein to the brain of an animal and function better than the supply of the protein alone. Exosomes are intracellular vesicles that carry a variety of proteins and genetic material between cells. ReNeuron is exploring their use as possible delivery vehicles for therapies targeting neurological diseases.
An antibody combination therapy has shown a statistically significant reduction in severe Covid-19 or death among patients with mild to moderate disease, the developer AstraZeneca Plc reported on 11 October. This follows the successful trial of a small molecule antiviral agent produced by Merck & Co Inc and Ridgeback Biotherapeutics LP for a similar patient population which was announced on 1 October. Using different agents, the two trials both achieved efficacy rates of 50% compared with placebo.
CureVac NV has withdrawn its application for a marketing authorisation for its first Covid-19 vaccine from the European Medicines Agency, citing plans to focus instead on a second generation product that has shown an improved immune response in an animal study. The second generation vaccine, CV2CoV, is being developed with GlaxoSmithKline Plc. It encodes for the same protein as the company’s earlier vaccine but differs in the design of non-coding regions of the mRNA backbone.
Evotec SE has made a regulatory filing in the US in preparation for a listing of its shares on the US Nasdaq market. The size of the issue of American Depositary Shares (ADSs) had not been determined as of 11 October. But it comes at a time of strong revenue growth for the Germany-based company.