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In Brief This Week: Scripps Research Translational Institute, DermTech, Sensorion, Abeona, HutchMed

NEW YORK –  The Scripps Research Translational Institute has received $54 million in renewed funding from the National Institutes of Health for enrolling and engaging participants in the All of Us Research Program, Scripps Research said last week. Under the five-year project, SRTI will oversee the Participant Center for the program and anticipates receiving $282 million in total funding, depending on annual approvals and the availability of funds. Scripps Research was originally awarded $207 million over five years in 2016 to lead the Participant Technologies Center for what was then called the Precision Medicine Initiative, now All of Us. 

DermTech said this week that it has received a favorable coverage policy for its molecular melanoma test from a Blues plan in Michigan. The policy, which adds to a contract that became effective last August, enhances access to the Pigmented Lesion Assay (PLA), the foundational assay for the company's DermTech Melanoma Test (DMT), which includes another gene, for the approximately 4.5 million members of the plan. DermTech's total of covered lives in the US is now approximately 133 million, including 68 million for Medicare/Medicare Advantage and 65 million for commercial and governmental payors. 

French biotech firm Sensorion this week said it submitted a clinical trial application in Europe for its lead candidate, a hearing loss gene therapy called OTOF-GT, in the hopes of starting a Phase I/II trial of the drug in France, Italy, and Germany. OTOF-GT is a dual adeno-associated virus vector-based gene therapy designed to restore hearing in pediatric patients up to 31 months old and suffering from severe, sensorineural, prelingual non-syndromic hearing loss caused by mutations in the OTOF gene. 

Sensorion earlier in July submitted its first clinical trial application for the gene therapy to the UK Medicines and Healthcare Products Regulatory Agency. 

Abeona Therapeutics this week said it has joined the Rare Disease Company Coalition (RDCC), an alliance of life sciences firms that advocates for policies to enable innovation and equitable access to rare disease treatments. Cleveland-based Abeona is studying the autologous cell therapy EB-101 in a Phase III trial in recessive dystrophic epidermolysis bullosa, a condition caused by mutations in the COL7A1 gene that results in easily blistered skin and open wounds, often all over the body. There are between 3.05 and 1.35 cases of recessive dystrophic epidermolysis bullosa per 1 million live births, according to one estimate. 

"We understand the unique challenges and opportunities that come with developing treatments for small and differentiated patient populations," Abeona CEO Vish Seshadri said in a statement. "By working together with the RDCC, we can advocate for policies and regulations that support continued innovation and patient access to life-changing therapies." 

HutchMed this week received breakthrough therapy designation from China's National Medical Products Administration (NMPA) for the combination of VEGFR inhibitor fruquintinib and anti-PD-1 antibody sintilimab for the treatment of patients with advanced endometrial cancer with mismatch repair proficient (pMMR) tumors. The fruquintinib-sintilimab combination is currently being studied in a Phase Ib/II trial in solid tumors, including a pMMR cohort of endometrial cancer patients. Drug candidates granted breakthrough therapy designation by NMPA may be considered for conditional approval and priority review when submitting for approval. 


In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared in Precision Medicine Online.