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In Brief This Week: Avenge Bio, Mainz Biomed, NKGen Biotech, Oxford Biodynamics, Actinium

NEW YORK – Avenge Bio this week said the US Food and Drug Administration granted fast-track designation to its allogenic cell-based immunotherapy product AVB-001 for platinum-resistant, refractory ovarian cancer. The cell-based drug production technology used to develop AVB-001 is also being used in the THOR implantable oncotherapeutic device, which was awarded a grant of up to $45 million by the National Institutes of Health's Advanced Research Projects Agency for Health for development as a personalized ovarian cancer treatment. Under fast-track designation, a sponsor can meet with the FDA more frequently to get advice on developing fast-track designated agents, submit data on a rolling basis, and apply for accelerated approval or priority review. 


Mainz Biomed has partnered with Romanian lab firm Bioclinica to make its at-home colorectal cancer test ColoAlert available throughout Romania, the company said this week. The deal includes comarketing activities for the test, which is a PCR-based assay that analyzes tumor DNA in stool samples.  


Santa Ana, California-based NKGen Biotech went public this week through a merger with Graf Acquisition Corp. IV, a special purpose acquisition company. After completing the merger, which was first announced in April, the company's common stock began trading Monday on the Nasdaq under the ticker symbol "NKGN." Going public will allow the firm to accelerate its clinical programs in autologous cell therapies for neurodegenerative diseases and allogenic cell therapies for cancer, company officials said.  


Oxford Biodynamics said this week that it has received a Proprietary Laboratory Analysis code from the American Medical Association for the firm's recently launched prostate cancer screening test. The code will be used to secure reimbursement for the EpiSwitch Prostate Screening test, a blood-based laboratory-developed test (LDT) that is designed to be used alongside a prostate-specific antigen test and increases the accuracy of those results to 94 percent compared to 55 percent without the EpiSwitch test, the company said. Oxford Biodynamics' test uses five proprietary epigenic biomarkers to predict whether prostate cancer is present. 


The National Institutes of Health this week awarded Actinium Pharmaceuticals a Small Business Technology Transfer grant extension to support a clinical study of its CD45-targeting radiotherapeutic prior to treatment with Memorial Sloan Kettering Cancer Center's CD19-targeted autologous CAR T-cell therapy in patients with relapsed or refractory B-cell acute lymphoblastic leukemia and diffuse large B-cell lymphoma. Iomab-ACT is designed to enable lymphodepletion or reduced intensity conditioning in preparation for CAR-T and gene therapies.  


New York Blood Center Enterprises this week said it will acquire commercial-scale cell and gene therapy development and manufacturing facilities and certain other technologies and equipment from Talaris Therapeutics in Houston and Louisville, Kentucky. The acquisition will enable NYBCE to have fully integrated start-to-finish cell and gene therapy production capabilities.  


Novartis said this week that it has completed the spin-off of its generics and biosimilars drug business, Sandoz. Sandoz is now its own company, traded on the SIX Swiss Exchange under the symbol SDZ. With the spinoff, Novartis has sharpened its focus on innovative medicines including precision oncology.   


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.