News

Nanobiotix SA, whose lead product is a radioenhancer for cancer, has extended its cash runway into the fourth quarter of 2025 following receipt in January of a $20 million milestone payment from Janssen Pharmaceutica NV, its development partner. The lead product, NBTXR3 has been given a ‘fast track’ designation by the US Food and Drug Administration for the treatment of elderly patients with locally advanced head and neck squamous cell carcinoma who are ineligible for cisplatin chemotherapy. In an ongoing Phase 3 trial, the drug is being evaluated with or without cetuximab (Erbitux).

AstraZeneca Plc has received US approval for a new indication for Fasenra (benralizumab), an antibody therapeutic originally developed for asthma and now authorised to treat eosinophilic granulomatosis with polyangiitis (EGPA), a rare disease caused by inflammation of small to medium-sized blood vessels. Fasenra binds to a subunit of the interleukin-5 receptor which is predominantly expressed on human eosinophils, a type of white blood cell. Although affecting only an estimated 118,000 people globally, the disease can be fatal without treatment. 

The breast cancer treatment Kisqali (ribociclib), first approved in the US in 2017, has received a new indication from the Food and Drug Administration for patients with early cancer who are at a high risk of disease recurrence. The approval, announced by Novartis on 17 September, is based on data from a Phase 3 trial which showed a clinically meaningful reduction in the risk of disease recurrence in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative, including those with node-negative disease.

ImmunOs Therapeutics AG, a Swiss biotech developing candidate therapies for cancer, has raised $11 million in a Series C financing round to advance its lead clinical programme targeting solid tumours. The product, IOS-1002, is a human leukocyte antigen (HLA)-based protein that block receptors in the innate immune system. The financing follows a Series B round that raised $74 million in 2022.

The latest financing was led by the existing investors Gimv, Pfizer Ventures, Mission BioCapital and BioMed Partners and supported by the new investor Double Point Ventures.

An academic team in the US has made progress in designing an experimental gene therapy for multiple sulfatase deficiency (MSD), a lysosomal storage disorder that affects the brain, lungs, skin and skeleton and for which there are no approved treatments. The results of the preclinical study, conducted at the Children’s Hospital of Philadelphia, were published in the journal Molecular Therapy on 4 September 2024.

Asgard Therapeutics AB, a privately-held preclinical biotech based in Sweden announced on 5 September the publication in Science of preclinical data for its lead gene therapy programme AT-108. The programme is an autologous therapy that reprogrammes tumour cells into a subset of dendritic cells thereby mounting a cytotoxic T cell response in cancer. The study, co-led by Asgard and the scientists at the Pereira Lab at Lund University in Sweden, showed that it was possible to reprogramme dendritic cells in mice that were resistant to treatment with checkpoint inhibitors.

Flagship Pioneering, a Cambridge, US-based venture capital group, is to explore the potential for drug discovery of a new approach to cell biology under a collaboration with Pfizer Inc and tapping the scientific expertise of Quotient Therapeutics Ltd, a biotech it founded in 2022. Located in Cambridge, UK, Quotient is investigating somatic genomics which describes alterations in DNA among individuals, or differences in DNA between populations among the same species.

Navigator Medicines Inc, a new US biotech company with a focus on antibody therapeutics, has raised $100 million in a Series A financing round to develop a bispecific antibody for autoimmune diseases. Announced on 27 August, the funding round was co-led by Forbion of the Netherlands and RA Capital of the US. It will enable Navigator, a subsidiary of Sera Medicines LLC, to develop an in-licenced bispecific antibody targeting OX4OL, which is expressed on many antigen presenting cells such as dendritic cells, and tumour necrosis factor alpha (TNF-alpha), a regulator of immune cells. 

Novartis is to increase its investment in RNA-based medicines with the start of a new company in Vancouver, Canada called Borealis Biosciences which will focus on kidney diseases. The company is being launched through a collaboration with the venture capital group Versant Ventures and will take over research projects and staff from Chinook Therapeutics Inc, an enterprise acquired by Novartis in June 2023. The transaction involves the divestment of Chinook, the allocation of funds to the new company, and a strategic research collaboration.

More than a decade ago, the US Food and Drug Administration approved an autologous cellular therapy, Provenge (sipuleucel-T), to treat prostate cancer. At the time, it was the first therapeutic cancer vaccine to be approved in the US. Developed by Dendreon Corp, the vaccine later changed hands twice, entering the portfolio of a private Chinese conglomerate, Sanpower Group in 2017.