NEW YORK – Syndax Pharmaceuticals said this week that the US Food and Drug Administration has granted fast-track designation to its investigational menin inhibitor SNDX-5613 for patients with relapsed or refractory acute leukemias whose cancers harbor either MLL rearrangements or NPM1 mutations. The Waltham, Massachusetts-based firm announced positive results from a Phase I study of the drug in April and plans to initiate a pivotal Phase II study this year.
Transgene this week enrolled the first patient in the UK in the Phase I trial of its immunotherapy TG4050 in patients with HPV-negative head and neck cancer. TG4050 is a cancer vaccine that is based on Transgene's Myvac viral vector-based immunotherapy platform and NEC's artificial intelligence-based Neoantigen Prediction System. The drug targets antigens specific to each patient and can target up to 30 patient-specific neoantigens. Transgene expects to report initial data from the study in Q4 of 2021.
Sermonix Pharmaceuticals said this week that it has completed enrollment of a Phase II clinical trial evaluating its investigational selective estrogen receptor modulator lasofoxifene combined with abemaciclib (Eli Lilly's Verzenio) as treatment for ESR1-mutated, metastatic, estrogen receptor-positive breast cancer. To identify eligible patients and complete trial enrollment in a timely manner, Sermonix partnered with the molecular diagnostics firm Tempus. The trial, dubbed ELAINE-2, is designed to assess the safety and tolerability of the combination as primary endpoints, and progression-free survival, objective response rate, and duration of response, among other outcomes, as secondary endpoints. According to Sermonix, an initial data readout is expected in the first half of 2022.
AccessHope, a City of Hope subsidiary, said this week that it has partnered with the Dana-Farber Cancer Institute to bring the latest cancer care expertise to patients and oncologists in the community. By partnering with AccessHope, Dana-Farber's experts will support oncologists with the latest advances in oncology, including personalized treatments, clinical trials, promising investigational medications, and molecular testing. Patients in Massachusetts, Maine, New Hampshire, Vermont, Connecticut, Rhode Island, New York, and New Jersey, as well as those in other parts of the country, can access these services through their employee benefits programs. City of Hope and Northwestern University's Robert H. Lurie Comprehensive Cancer Center are also foundational members of AccessHope.
London-based Achilles Therapeutics this week said that the CHIRON trial, which it launched in the UK last year to evaluate the activity of its clonal neoantigen T-cell therapy in metastatic non-small cell lung cancer, is now open at 10 sites in the UK, EU, and US, and has enrolled the first US patient at the Moffitt Cancer Center in Florida. In the Phase I/IIa study, ultimately involving around 40 patients, researchers will evaluate the safety, tolerability, and activity of a single dose of Achilles' tumor-infiltrating lymphocyte treatment that targets clonal neoantigens, which are proteins expressed on the cancer cell surface and unique to each patient. The company will provide an update on the 10 NSCLC and melanoma patients who have been treated so far using its clonal T-cell neoantigen therapy platform within the CHIRON and THETIS trials and provide data on its proposed potency assay in the fourth quarter of this year. After reviewing interim data from these studies earlier this year, an independent data and safety monitoring committee recommended that both trials continue as planned.
Foundation Medicine and Flatiron Health announced this week that Foundation's comprehensive genomic profiling tests will be available to order through Flatiron's OncoEMR platform. The integration will allow clinicians to electronically order, track, and receive Foundation's test through OncoEMR, the companies said. Both Flatiron and Foundation are planning further integrations with other comprehensive genomic profiling tests and electronic medical record systems.
Immunovia said this week that its American subsidiary has received a CLIA Certificate of Registration, which is an important step in the accreditation of its laboratory in Marlborough, Massachusetts, and a prerequisite to receiving clinical laboratory licensure from the Massachusetts Department of Public Health. State licensure is required before Immunovia can begin testing patients with its Immray PanCan-d test, the firm said. According to the Centers for Medicare and Medicaid Services, a Certificate of Registration allows a laboratory to conduct moderate and high complexity testing until it is inspected to determine its compliance with the CLIA regulations.
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 Oncology News.