News

Ilixadencel, an allogeneic cell therapy developed by Immunicum AB of Sweden, has achieved complete tumour responses in five out of 45 evaluable patients with metastatic kidney cancer in a Phase 2 trial, compared with just one out of 25 patients receiving standard-of care sunitinib. Announcing the results on 29 August, the company said the data support its vision of positioning ilixadencel as a “backbone therapy” for modern cancer treatment regimens.

Celgene Corp, which is in the process of being acquired by Bristol-Myers Squibb Co, has reached an option agreement with privately-owned Immatics Biotehnologies GmbH of Germany that would give it access to prospective cell therapies for cancer. Celgene already owns clinical-stage T cell therapies for cancer arising from its 2018 acquisition of Juno Therapeutics Inc.

Amgen Inc has reached an agreement with Celgene Corp to buy its psoriasis asset Otezla (apremilast) for $13.4 billion in cash, thus enabling Celgene to proceed with its previously announced merger with Bristol-Myers Squib Company. The merger, announced in early January, will combine the oncology and inflammation franchises of BMS and Celgene. But US regulators had raised questions about the two companies’ potential dominance in the area of psoriasis. The asset disposal is expected to satisfy these concerns.

GlaxoSmithKline Plc has reported positive Phase 2 data for an antibody-drug conjugate directed against multiple myeloma and announced plans to make regulatory filings later this year. The drug, belantamab mafodotin, showed a clinically meaningful overall response rate in patients with the disease, GSK announced on 23 August.

DREAMM-2 enrolled 223 patients with relapsed multiple myeloma who had not responded to other treatments such as an immunomodulatory drug, a proteasome inhibitor and an anti-CD38 antibody. The two-arm study met its primary endpoint of overall response.

Pfizer Inc has announced a $500 million investment in a new gene therapy manufacturing facility in Sanford, North Carolina, US, not far from the headquarters of Asklepios BioPharmaceutical Inc (AskBio Inc), a developer of adeno-associated viral vector (AAV) technology. The new Pfizer plant will use AskBio’s technology.

A proposed treatment for non-small cell lung cancer combining Imfinzi (durvalumab) with tremelimumab failed to improve overall survival in patients with late-stage disease, AstraZeneca reported on 21 August. The combination therapy was being tested against standard-of-care chemotherapy.

A new antibiotic which has shown activity against pneumonia was cleared for marketing by the US Food and Drug Administration on 19 August. The safety and efficacy of Xenleta (lefamulin) were demonstrated in two clinical trials of 1,289 patients with community acquired bacterial pneumonia.

A second drug has been approved in the US for myelofibrosis, a rare bone marrow disorder that disrupts the body’s normal production of blood cells. The drug, Inrebic (fedratinib), has been authorised for primary myelofibrosis as well as secondary post-polycythemia vera or post-essential thrombocythemia disease.

The US Food and Drug Administration has approved a third cancer drug that targets a genetic driver of cancer, rather than a specific type of tumour. The drug, Rozlytrek (entrectinib), is directed at cancers with neurotrophic tyrosine receptor kinase (NTRK) gene fusions, a fault that can result in the activation of signalling pathways involved in the proliferation of a number of solid tumours. These fusions are known to occur in breast, colorectal, non-small cell lung, pancreatic and thyroid cancers, among others.

A new combination treatment for drug-resistant tuberculosis (TB) has been approved in the US and is under review at the European Medicines Agency. Developed by the Global Alliance for TB Drug Development Inc, it is only the third new drug approved for TB in more than 40 years, and the first to be produced by a not-for profit organisation.