NEW YORK – Helio Genomics last week announced that it completed its separation from its parent company Laboratory for Advanced Medicine on June 19. LAM is a Chinese cancer diagnostic firm, and Irvine, California-based Helio Genomics is an American independent entity. Helio offers a blood-based liver cancer test that uses cell-free DNA methylation patterns and serum protein biomarkers to detect hepatocellular carcinoma. Helio Chief Growth Officer Gary Frazier said in a statement that "the separation from LAM marks the beginning of a new chapter for Helio, one that reflects our growth as a company as we transition from R&D to commercialization with the HelioLiver Dx diagnostics test."
VolitionRx has appointed transaction advisory firm PharmaVentures to provide strategic advice and transactional support on the out-licensing of Volition's oncology portfolio. PharmaVentures will advise Volition as it attempts to secure licensing deals for its Nu.Q Cancer blood-based epigenetic assays to help detect, guide treatment of, and monitor cancer, as well as its Capture-PCR detection method for liquid biopsy.
Mainz Biomed this week submitted its next-generation colorectal cancer screening test to the US Food and Drug Administration for breakthrough device designation. Mainz has defined the final configuration of its test, which integrates its fecal immunochemical test with proprietary mRNA biomarkers and an artificial intelligence-based algorithm, after readouts from its ColoFuture and eAArly Detect studies. In a clinical study of the next-generation test, the assay had sensitivity of 97 percent for colorectal cancer, sensitivity for advanced precancerous lesions of 88 percent, and specificity of 93 percent.
Cleveland-based Abeona Therapeutics this week announced a nonexclusive agreement giving Beacon Therapeutics 12 months to evaluate the therapeutic potential of its AAV204 capsid within select ophthalmology indications, under which the London-based firm may develop and commercialize gene therapies using the novel adeno-associated virus (AAV) capsid to target therapeutics in the eye. Beacon will have an option for a worldwide, nonexclusive license to use AAV204 with up to five gene or disease targets and the right to use the capsid in up to four additional gene or disease targets subject to certain conditions. Financial details of the transaction were not disclosed, but under the agreement, Abeona will receive an upfront payment upon Beacon's decision to license AAV204, with additional payments tied to development, regulatory, and sales milestones and tiered royalties on worldwide net sales.
The US Food and Drug Administration this week granted fast-track designation to Obsidian Therapeutics' tumor-infiltrating lymphocyte therapy OBX-115 in advanced melanoma patients who've previously received PD-1/PD-L1 immune checkpoint inhibitors. The autologous TIL therapy is engineered to produce membrane-bound IL-5, which eliminates the need for patients to receive IL-2 infusions with their infused TIL cells. With FDA fast-track status, a sponsor can meet with regulators more frequently for advice on developing agents, submit data on a rolling basis, and apply for accelerated approval or priority review.
Tokyo-based Eisai and Cambridge, Massachusetts-based Biogen this week said that Hong Kong's department of health has approved their Alzheimer's disease drug Leqembi (lecanemab) for use in the country. Also this week, the companies said that the drug has been approved in Israel. Hong Kong and Israel are the fifth and sixth countries, respectively, to approve the beta-amyloid-targeting monoclonal antibody as a treatment to slow disease progression in patients with early-stage Alzheimer's after approvals in the US, Japan, China, and South Korea.
Bayer subsidiary Asklepios BioPharmaceutical this week said that the US Food and Drug Administration has granted fast-track designation to AB-1005, a gene therapy candidate the company is developing as a treatment for moderate-stage Parkinson's disease. Also this week, Research Triangle Park, North Carolina-based AskBio said AB-1005 has been granted the innovation passport from the UK Medicines and Healthcare Products Regulatory Agency. AskBio is currently enrolling patients in the Phase II REGENERATE-PD clinical trial to test the gene therapy in the US, with plans to open sites in the EU and UK later this year.
In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on Precision Medicine Online.