News

MorphoSys AG has drawn up a broad development plan for its newly authorised antibody therapeutic Monjuvi (tafasitamab) which, if successful, would see the drug investigated for a number of B cell malignancies. Monjuvi was approved by the US Food and Drug Administration on 31 July in combination with lenalidomide for the treatment of diffuse large B cell lymphoma (DLBCL). The approval marked an important milestone for the German company which is now a fully integrated biopharmaceutical enterprise.

H. Lundbeck A/S has stopped a Phase 2 proof of concept study of a small molecule drug for schizophrenia after an interim analysis of the data showed the trial was unlikely to achieve statistical significance on its primary endpoint. The drug Lu AF11167 is an inhibitor of the phosphodiesterase 10A enzyme.

Evotec SE is to develop antisense oligonucleotide drugs for a number of indications under a new drug discovery collaboration with Secarna Pharmaceuticals GmbH of Munich, Germany. Secarna was founded in 2015 and has more than 15 programmes in development focusing on oncology, immunology, ophthalmology as well as cardiometabolic diseases.

The financial terms of the agreement were not disclosed. The agreement was announced on 5 August, only a week after Vico Therapeutics BV of the Netherlands raised $31 million for its preclinical antisense oligonucleotide platform.

A group of international investors led by Life Sciences Partners has raised $31 million for Vico Therapeutics BV, a young Dutch company with a preclinical antisense oligonucleotide asset which is being developed for rare central nervous system (CNS) diseases. The Series A financing was co-led by Kurma Partners with participation by Polaris Partners and others.

A second rheumatoid arthritis drug has failed to improve the condition of patients with severe Covid-19 associated pneumonia. Actemra (tocilizumab) did not meet its primary endpoint in a Phase 3 trial of hospitalised Covid-19 patients, Roche announced on 29 July. This follows news earlier in the month that a trial of Kevzara (sarilumab), also for hospitalised Covid-19 patients, was stopped early on lack of efficacy and adverse events.

The chimeric antigen receptor (CAR) T cell therapy Kymriah (tisagenlecleucel) has delivered positive data in a Phase 2 study of patients with relapsed or refractory follicular lymphoma, the second most common form of non-Hodgkin lymphoma, Novartis announced on 4 August. The global ELARA trial met its primary endpoint of complete response rate as assessed by an independent review committee. No new safety signals were observed.

MorphoSys AG has secured regulatory approval from the US Food and Drug Administration for its first proprietary antibody therapeutic, Monjuvi (tafasitamab), to treat adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL). The approval was based on data from the Phase 2 L-MIND study, a multicentre, single arm trial of Monjuvi in combination with lenalidomide, a drug for multiple myeloma. DLBCL is the most common type of non-Hodgkin lymphoma that can develop in the lymph nodes or any organ of the body.

Sangamo Therapeutics Inc is to help develop genomic medicines for neurodevelopmental disorders under a new agreement with Novartis valued at up to $795 million. The two companies will use Sangamo’s zinc finger protein transcription factor technology to upregulate the expression of three undisclosed genes involved in diseases which include autism spectrum disorder and intellectual disability.

F-star Therapeutics Ltd is set to gain a listing on Nasdaq through a merger with Spring Bank Pharmaceuticals Inc of the US giving it a fresh source of capital to advance its pipeline of bispecific antibodies. The transaction is expected to complete in late 2020 and give F-star’s shareholders 61.2% of the new group to be called F-star Therapeutics Inc.

Eliot Forster, the current chief executive of F-star, will become president and chief executive of the combined group which will be co-located in Cambridge, UK and Cambridge, Massachusetts, US.

The US government is to provide up to $2.1 billion to Sanofi SA and GlaxoSmithKline Plc to help them develop and manufacture a Covid-19 vaccine. The two European companies are among eight others selected for support under the government’s Operation Warp Speed programme. The goal is to secure supplies of a variety of vaccines for the US population.

Sanofi and GSK are working on a candidate vaccine that combines the French company’s recombinant protein-based technology with adjuvant from GSK. Sanofi has used the same technology for an influenza vaccine.