This week we look at a cancer immunotherapy breakthrough that could strengthen chimeric antigen receptor T cells in their fight against liquid or solid tumors. We also highlight an unexpected special purpose acquisition company transaction revival, continued efforts to improve clinical trial diversity, the Food and Drug Administration’s authorization of bivalent COVID-19 boosters, and a noninvasive neurostimulator to treat depression.
Each week we highlight five things affecting the life sciences industry. Here’s the latest.
Strengthening CAR T cells through gene deactivation
A research team led by scientists at the University of California, San Francisco, has discovered that the protein-coding RASA2 gene is important to T cell regulation. Through deactivating the gene, T cells become much stronger in their fight against liquid or solid tumors. This could lead to promising new immunotherapies for cancer patients.
Ocean Biomedical announces SPAC merger
Ocean Biomedical, a Rhode Island-based biotech company focused on cancer, infectious disease and fibrosis, announced plans to merge with Aesther Healthcare Acquisition Corp, a SPAC. The new company is expected to be valued at approximately $345 million. SPAC transactions gained popularity, particularly in the biotech industry, during 2020; however, this year there has been minimal SPAC activity across all industries.
Leading CRO professional organization releases updated guidelines to improve clinical trial diversity
Following the FDA’s April guidance surrounding improving patient diversity in clinical trials, the Association of Clinical Research Organizations has released its principles statement for all of its members. ACRO’s diversity and inclusion principles include: improving health equity through access to trials, empowering research partners, partnering with stakeholders and policymakers, and driving workforce diversity, equity and inclusion.
FDA authorizes Moderna, Pfizer-BioNTech bivalent COVID-19 vaccine boosters
The FDA has authorized bivalent formulations of the Moderna and Pfizer-BioNTech COVID-19 vaccines for use as booster doses under the existing emergency use authorizations. The Moderna bivalent vaccine is authorized for use as a single booster dose in people 18 or older. The Pfizer-BioNTech bivalent vaccine is authorized for use as a single booster dose in people 12 or older. The term “bivalent” refers to how the vaccines will target two different strains of the coronavirus, including the original strain and the BA.4/BA.5 omicron subvariants.
FDA authorizes noninvasive neurostimulation device to treat depression
BrainsWay received FDA approval for their Deep TMS H7 Coil device to treat adults suffering from severe depression. The non-invasive device uses magnetic stimulation to target specific regions of the brain. The device is already approved to treat obsessive-compulsive disorder and does not require any major upgrade or software installation to begin treatment for depression.
Note: We will pause publication next week for the Labor Day holiday. Look for our next “5 things” the week of Sept. 12.
