News

Adaptimmune Therapeutics Plc has entered into a collaboration with the Japanese company Noile-Immune Biotech Inc to develop new T cell therapies for cancer. The partnership will involve co-developing Adaptimmune’s T cell products with technology originated by Noile-Immune enabling the T cells to secrete interleukin 7 and the protein CCL19. This is expected to improve the proliferation and trafficking of T cells to solid tumours. Adaptimmune will make an upfront cash payment and milestone payments to Noile-Immune of up to $312 million across all programmes.

Over the past decade, the European Medicines Agency and the US Food and Drug Administration have stepped up their collaborations with the result that more than 90% of the marketing authorisation decisions made by the two organisations are aligned. This is the conclusion of an analysis conducted by the EMA and FDA, which compared outcomes on 107 new medicine applications between 2014 and 2016. While both agencies evaluate applications independently, they nevertheless are coming to many of the same conclusions.

Glasgow, UK-based MGB Biopharma Ltd has completed a new funding round, enabling it to advance an ongoing Phase 2a trial of its candidate antibiotic MGB-BP-3 and prepare for the next stage of development. The candidate drug is being developed to treat Clostridium difficile-associated disease.

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.