News

On the back of a €18.5 million fundraising, Kither Biotech Srl plans to accelerate development of a candidate product for cystic fibrosis. The product, KIT2014, is currently in preclinical studies which are expected to complete in 2022. Soon thereafter, it will move on to a Phase 1/2A trial. KIT2014 is being developed as an add-on to the current standard of care. It is delivered directly to the lungs as an inhaled therapy. It works by modulating cyclic adenosine monophosphate levels inside cells.

The US Food and Drug Administration has approved the first monoclonal antibody targeting the LAG-3 protein on T cells – one of several proteins that prevent the immune system from fighting cancer. The antibody, relatlimab, has been developed in combination with nivolumab to treat metastatic melanoma. The combination is being commercialised by Bristol Myers Squibb Co under the name Opdualag.

Novartis is to explore new ways of delivering gene therapies to the brain under a licence option agreement with Voyager Therapeutics Inc, a US company with adeno-associated virus (AAV) capsid technology. Under the agreement, the Swiss multinational may elect to license novel capsids for use in directing therapies against three undisclosed central nervous system (CNS) targets. Further out, it may exercise options for two additional targets. The goal is to develop gene therapies for neurological diseases that manifest in deep regions of the brain.

An allogeneic cell therapy has been successfully used to treat patients 10 years and older with Duchenne muscular dystrophy, a rare genetic disease that affects both skeletal and cardiac muscle. The therapy, CAP-1002, was tested in a Phase 2, placebo-controlled trial and effectively reduced the deterioration of upper limb function in the patients as well as improved cardiac function. The results of the study, called HOPE-2, were published in The Lancet on 12 March 2022.

AbbVie Inc has acquired a Belgian neurology company for up to $1 billion in order to enrich its portfolio with assets designed to treat cognitive impairment. The company, Syndesi Therapeutics SA, was founded in 2017 through a partnership between UCB Pharma and Novo Seeds and supported by a syndicate of Belgian and international investors.

Valneva SE is preparing a regulatory submission in the US for its candidate vaccine, VLA1553, to prevent chikungunya virus infection. This follows positive clinical data from a six-month study which confirmed the results of a large Phase 3 trial of 4,115 adults.

The European Medicines Agency is studying the T cell immune response generated by the currently approved Covid-19 vaccines to find out whether anything can be learned for the future. In a briefing with journalists on 3 March, Marco Cavaleri, head of biological health threats and vaccines strategy, said the review covers all platforms represented by the currently approved vaccines. One of the objectives is to find out if the T cell component of immunity can offer protection against new variants of the virus.

The diabetes and cardiovascular medicine Jardiance (empagliflozin) has been approved in the US to treat a wider range of patients with heart failure, giving it a new role in reducing the risk of cardiovascular death and hospitalisation in adults. Jardiance is already approved as a supplement to diet and exercise to improve glucose control in adults with Type 2 diabetes, and to reduce the risk of cardiovascular death in adults with diabetes and cardiovascular disease.

A new medicine for uveal melanoma, a rare cancer of the eye, has received a positive opinion from the European Medicines Agency, putting it on course to be the first T cell receptor (TCR) therapy on the market in Europe. Kimmtrak (tebentafusp) is a bispecific protein comprised of a T cell receptor fused to an effector molecule that redirects T cells to cancer cells. The sponsor is Immunocore Holdings Plc which is developing TCR bispecific therapies for cancer as well as for autoimmune and infectious diseases.

The European Medicines Agency has proposed to extend the use of two messenger RNA (mRNA) vaccines for Covid-19 in order to give protection against the SARS-CoV-2 virus to younger people. In separate decisions, the agency is recommending that primary vaccination with Spikevax be approved for use in children from the ages of six to 11 years. Spikevax was developed by Moderna Inc. The agency is also proposing that Comirnaty, developed by BioNTech SE and Pfizer Inc, be authorised as a booster dose for adolescents from 12 years of age.