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In Brief This Week: Biogen, Eisai, Regeneron, Ideaya Biosciences, Uppi, Evergreen Theragnostics

NEW YORK – Biogen and Eisai this week said Leqembi (lecanemab), a monoclonal antibody that targets beta-amyloid plaque in the brain, has been granted approval in Japan as a treatment for slowing progression of mild cognitive impairment and mild dementia due to Alzheimer's disease. Eisai, which is leading Leqembi's development and regulatory submissions globally, will conduct post-marketing surveillance in patients who are administered the drug in Japan. This is the second country to approve Leqembi after the US granted accelerated approval in January, followed by traditional approval in July. 

Regeneron Pharmaceuticals this week said it completed its previously announced acquisition of Decibel Therapeutics, a biotech firm developing gene therapies to restore hearing. Regeneron and Decibel started collaborating in 2017 and are currently codeveloping three gene therapy programs, including Decibel's lead investigational candidate, DB-OTO, which is designed to restore hearing for pediatric patients who have a rare form of congenital hearing loss due to mutations in the OTOF gene. 

Ideaya Biosciences this week said that the US Food and Drug Administration granted fast-track designation to two indications of its PARG inhibitor IDE161: as a treatment for patients with advanced or metastatic ovarian cancer bearing BRCA1/2 mutations who are platinum resistant and after receiving antiangiogenic and PARP inhibitor therapies; and as a treatment for patients with advanced hormone receptor-positive, HER2-negative breast cancer with BRCA1/2 mutations who have progressed following at least one line of hormonal therapy, a CDK4/6 inhibitor, and a PARP inhibitor. Ideaya is evaluating safety, tolerability, pharmacokinetics, and pharmacodynamics of IDE161 in a Phase I trial involving patients with solid tumors that have homologous recombination deficiency mutations. Fast-track designation allows a sponsor to meet with the FDA more frequently, to get advice on developing agents, submit data on a rolling basis, and apply for accelerated approval or priority review. 

Uppi and Evergreen Theragnostics said this week that they have inked a deal, in which Uppi pharmacies will prepare, sell, and distribute Evergreen's gallium-based diagnostic PET imaging agent Octevy (Kit for Preparation of Ga 68 DOTATOC Injection) in the event it nets US Food and Drug Administration approval for somatostatin receptor-positive neuroendocrine tumors. If Octevy is approved, Uppi will reconstitute, radiolabel, and deliver the radiopharmaceutical to hospitals and PET imaging centers in the US. 

The US Food and Drug Administration this week granted Mythic Therapeutics fast-track designation for its cMET-targeting antibody-drug conjugate MYTX-011 as a potential treatment for patients with non-small cell lung cancer overexpressing cMET.  

Cue Biopharma said this week that it has finished enrolling patients onto its Phase Ib clinical trial of CUE-101 plus Merck's Keytruda (pembrolizumab). In the study, Cue and Merck are evaluating the combination as first-line treatment for certain patients with human papilloma virus (HPV)-positive head and neck cancer. The firm plans to discuss potential registrational paths for its interleukin 2-based biologic both as a monotherapy and in combination with Keytruda. 

ClearNote Health said this week that its Avantect Pancreatic Cancer test has received a new Current Procedural Terminology Proprietary Laboratory Analyses code from the American Medical Association. The Centers for Medicare and Medicaid Services also released preliminary reimbursement rate determinations for new and revised CPT codes, including code 0410U for Avantect, ClearNote said in a statement. The recommended reimbursement rate for the test is $1,160, and CMS is expected to issue its final determination on the reimbursement rate later this year. The code goes into effect on Oct. 1, and final rates will go into effect on Jan. 1. ClearNote’s test is intended for patients at high risk for pancreatic cancer and uses epigenomic methods to measure levels of 5-hydroxymethylcytosine in cell-free DNA to detect pancreatic cancer signals at an early stage. 

Point32Health and Grail this week announced they have expanded a previously announced pilot to offer Grail's Galleri multi-cancer early detection screening test. The initial pilot program, announced in February 2022, enabled access to Galleri at no cost for eligible Point32Health employees and Harvard Pilgrim Health Care members who purchase their insurance on the Maine health insurance marketplace. The expansion of the pilot will now enable access for Point32Health's Commercial Tufts Health Plan or Harvard Pilgrim Health Care members who meet eligibility requirements for the test and whose primary care provider is a Mass General Brigham-affiliated provider. Point32Health is the parent company of Harvard Pilgrim Health Care and Tufts Health Plan. 

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.