Like many developers of cancer drugs, MorphoSys AG is using data from a single-arm Phase 2 trial as the basis for a regulatory submission to the US Food and Drug Administration. The company’s L-MIND trial reported positive results in May showing that the antibody tafasitamab, combined with the myeloma drug lenalidomide, met its primary endpoint of objective response in patients with lymphoma. This is the basis of a rolling submission to the FDA.
GlaxoSmithKline Plc expects to make regulatory filings for three new oncology drugs by the end of 2019, all of which reported positive data in the third quarter. The regulatory plans were highlighted by Emma Walmsley, the chief executive, in a teleconference on 30 October where she also announced an upgrade of the company’s earnings guidance.
Adjusted earnings per share, which exclude amortisations and impairments, are expected to be flat at constant exchange rates, rather than down. The dividend is expected to be unchanged at 80 pence per share.
A vaccine designed to reduce the incidence of pulmonary tuberculosis in HIV-negative adults has shown an overall efficacy rate of 50%, according to the developers GlaxoSmithKline Plc and the international AIDS vaccine initiative (IAVI). The Phase 2b study enrolled adults with latent TB infection, which is estimated to affect one-quarter of the global population. Of this number, an estimated 10% will develop active pulmonary TB disease.
The kinase inhibitor tucatinib has shown a 46% reduction in the risk of breast cancer progression in a Phase 3 trial that enrolled patients who had previously received two antibody treatments and one antibody-drug conjugate. Announcing the results on 21 October, Seattle Genetics Inc said a US regulatory filing is planned for the first quarter of 2020.
A Phase 2 trial of an experimental treatment for atopic dermatitis, MOR106, which was being jointly developed by Galapagos NV, MorphoSys AG and Novartis Pharma AG, has been stopped for futility, the companies announced on 28 October. An interim analysis showed a low probability of the compound meeting it's primary endpoint, defined as the percentage change in the eczema area and severity index score.
Kiadis Pharma NV has strengthened its scientific advisory board to guide the ongoing development of its cell therapy for patients who’ve had a stem cell transplant. This follows guidance from the European Medicines Agency that the product, ATIR101, will not be recommended for approval. ATIR101 has been under regulatory review since 2017.
Denmark’s Zealand Pharma A/S has expanded its capacity for developing peptide-based medicines with the acquisition of Encycle Therapeutics Inc, a private Canadian company with a preclinical asset for gastrointestinal diseases.
Netherlands-based Pharming Group NV continued its transition into profitability in the first nine months of 2019 with product revenue of €122.8 million, up by 26% from a year earlier, and an operating profit of €42.7 million, up by 38%. This follows the company’s first profit in 2018 on the back of strong sales of its marketed product for acute hereditary angioedemia. The product, Ruconest, is marketed in the US, the EU, South Korea and Israel.
Novartis has teamed up with a UK fund manager and the Cancer Research UK Beatson Institute in Glasgow to develop RAS inhibitors for difficult-to-treat cancers. RAS is a family of genes that make proteins involved in cell signalling pathways that control cell growth and death. It is estimated that more than 30% of all human cancers, including 95% of pancreatic cancers and 45% of colorectal cancers are driven by mutations of the RAS gene family.
Vivoryon Therapeutics AG has raised €43 million from a rights offering and private placement to finance an upcoming Phase 2b study of its lead product for Alzheimer’s disease, PQ912. The product is a small molecule drug that targets an enzyme, glutaminyl cyclase, thought to be responsible for the formation of toxic oligomers in Alzheimer’s disease. The drug has shown promising efficacy signals in an earlier Phase 2a trial – signals that the company hopes to confirm in a larger patient population.