We have summarised three articles to help keep you informed of the latest developments in the industry. This week, our Healthcare Industry Insight looks at positive pre-clinical results for THIO, an investigational telomere targeting agent, in small-cell lung cancer. We also take a look at new FDA drug approvals for advanced melanoma and food allergens.
THIO, 6-Thoo-2’-deoxyguanosine, is an investigational telomere targeting agent that is preferentially incorporated by telomerase into telomeres, leading to telomere dysfunction. It was previously awarded orphan drug designation by the U.S. Food and Drug Administration (FDA) for small cell lung cancer. This preclinical mouse and human-derived model has found that intermittent low-dose THIO can inhibit tumour growth and reduce metastatic burden. Following the positive preclinical results, they have now entered the Phase 2 planning stage for a clinical trial of THIO in SCLC.
AMTAGVI, or lifileucel, is the first individualised tumour-infiltrating lymphocyte therapy to get to market. Ivoance Biotherapeutics announced on February 16 that the FDA had approved AMTAGVI for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF v600 mutation-positive, a BRAF inhibitor with or without a MEK inhibitor. This approval is based on safety and efficacy results from the C-144-01 clinical trial. Among 73 patients, 31.5% achieved an objective response by Response Evaluation Criteria in Solid Tumour (RECIST). After 18.6 months of follow-up, 43.5% of responders had been in remission for more than one year. It does come at a high cost, with the one-time treatment priced at a wholesale acquisition cost of $515,000 per patient.
Xolair becomes the first medicine approved in the U.S. for food allergy
Genetech has announced that the FDA has approved Xolair, omazlizumab, for the reduction of allergic reactions that may occur with accidental exposure to one or more foods in adults and children older than one year. This is the only FDA-approved medicine to reduce allergic reactions in people with one or more food allergies. FDA approval was based on the Phase III OUtMATCH study, which showed that a significantly higher proportion of people with food allergy treated with Xolair could tolerate small amounts of common allergens without an allergic reaction versus those treated with placebo. However, the authors highlight that caution is still required, with ongoing avoidance of food allergens.
