News

Finland-based Kaiku Health Oy and Novartis have expanded their partnership in digital medicine in order to use machine learning to predict symptoms of multiple diseases. The two companies have been collaborating since June 2021 on a project involving the monitoring of patients with melanoma. Using Kaiku’s digital platform, data is collected from cancer patients and then fed back to healthcare workers to help them personalise care. Patients participating in the first project had melanoma and were receiving combination therapies which inhibit the BRAF and MEK proteins.

A spin-out of the Belgian university KU Leuven (Katholieke Universiteit Leuven) has raised €30 million from a large group of venture capitalists in order to develop a new generation of vaccines. AstriVax NV will use the seed funding to bring a thermostable yellow fever vaccine into clinical development and further develop candidate vaccines for rabies and chronic hepatitis B.

Novartis is to spin off Sandoz, its generics business, into a separately incorporated Swiss company by the second half of 2023 in order to focus on proprietary medicine development. The decision, announced on 25 August, follows a year-long strategic review that included the options of retaining Sandoz as an autonomous business unit within the group, or divesting it.

A Phase 3 trial of a new monoclonal antibody for rheumatoid arthritis has been shown to be at least as effective as Humira (adalimumab) and methotrexate, the current standard of care, potentially increasing the treatment options for patients who haven’t been able to control their disease with methotrexate chemotherapy alone. The experimental drug, olokizumab, targets the interleukin-6 (IL-6) cytokine directly. This distinguishes it from Humira which targets tumour necrosis factor-alpha and three other antibody drugs that target the IL-6 receptor.

Belgium-based eTheRNA NV has changed its business strategy in order to exploit the potential of its technology platform to provide services to the RNA therapeutics industry. Previously, the company’s focus was on proprietary messenger RNA (mRNA) drug development. But with the support of a new €39 million financing round, the company has changed its model to focus on services.

Sanofi SA announced the discontinuation on 17 August of its breast cancer programme AMEERA which was investigating amcenestrant, an oral estrogen receptor degrader, in several breast cancer indications. The decision follows the failure of a Phase 3 trial of the drug in patients with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer.

Merck & Co Inc has entered into a collaboration with the Cambridge, US biotech company Orna Therapeutics Inc to discover new therapeutics using engineered RNA molecules. Simultaneously, Orna has raised $221 million in a Series B financing round to accelerate development of its technology platform which includes a proprietary lipid nanoparticle delivery system. Orna calls its engineered RNA molecules circular RNA therapeutics (oRNA) because they have been transformed from a linear format into a circular format.

The first cell-based gene therapy for the treatment of patients with beta thalassaemia, an inherited blood disorder, was approved by the US Food and Drug Administration on 17 August. Zynteglo (betibeglogene autotemcel) is a one-time treatment administered as an ex vivo lentiviral vector gene therapy. A functional beta globin gene is added into a patient’s cells outside of the body and then infused back into the patient. The treatment process is comprised of several steps and will be administered at qualified treatment centres in the US.

H. Lundbeck A/S and its Japanese partner Otsuka Pharmaceutical Co Ltd expect to make a regulatory filing for a new indication for Rexulti, an approved drug for schizophrenia and depression, before the end of the year. The proposed indication, for agitation in patients with Alzheimer’s dementia, would be supported by positive data from a Phase 3 study showing a statistically significant reduction in agitation in patients receiving the drug compared with placebo. The trial results were reported in June.

Enhertu (trastuzumab deruxtecan) has been approved by the US Food and Drug Administration to treat non-small cell lung cancer whose tumours have activating HER2 mutations. The accelerated approval comes just a week after Enhertu, an antibody-drug conjugate (ADC), was authorised by the FDA for a new breast cancer indication. The decision, announced on 12 August, brings the total number of US regulatory approvals for the drug up to five, all of which are for cancers expressing the HER2 protein.