NEW YORK – AstraZeneca, Loxo Oncology, and Invitae this week joined the Access to Comprehensive Genomic Profiling Coalition, a group that advocates for US health insurers to cover comprehensive genomic profiling for cancer patients. The coalition also educates health insurers and other healthcare stakeholders about the clinical utility and value of comprehensive genomic profiling for all tumor types. The coalition's full members comprise diagnostics companies and laboratories including Exact Sciences, Foundation Medicine, Illumina, Laboratory Corporation of America, NeoGenomics, Qiagen, Roche, Tempus, and Thermo Fisher Scientific. Invitae joined the coalition as a full member, and AstraZeneca and Loxo joined as associate members.
Amgen said this week that the US Food and Drug Administration has granted breakthrough therapy designation to bemarituzumab combined with chemotherapy for patients with advanced, FGFR2b-overexpressing, HER2-negative gastric or gastroesophageal cancer. The agency based the designation on the results of the Phase II FIGHT trial, which evaluated bemarituzumab plus chemotherapy (mFOLFOX6) versus chemotherapy alone as frontline treatment for patients with at least 10 percent of tumor cells overexpressing FGFR2b, as assessed by an FDA-approved companion diagnostic assay. In the study, bemarituzumab improved progression-free survival, overall survival, and overall response rate versus the control arm. Amgen recently brought bemarituzumab into its oncology portfolio with the acquisition of Five Prime Therapeutics.
Oncocyte said this week that it has closed its acquisition of Chronix Biomedical. The deal brings Oncocyte a new commercial test candidate that it has dubbed DetermaCNI. The assay quantitatively measures copy number variation present in a cancer patient's blood as a measure of response, or lack thereof, to cancer immunotherapy. The terms of the acquisition include Oncocyte delivering $2.675 million in cash and $1.5 million of its common stock (or approximately 295,000 shares) at closing of the transaction.
Rain Therapeutics this week announced the pricing of its initial public offering of 7,352,941 shares of common stock at $17 per share. The firm expects gross proceeds of around $125 million from the offering. The firm's shares will begin trading on the Nasdaq on Friday under the ticker symbol RAIN, and the offering is expected to close on April 27. Goldman Sachs, Citigroup, Piper Sandler, and Guggenheim Securities are acting as joint book-running managers for the offering. Rain's pipeline includes the HER2 inhibitor tarloxotinib, a RAD52 inhibitor being studied in tumors with BRCA1/2 mutations, and an MDM2 inhibitor.
Translational Research In Oncology said this week that enrollment is now complete for a Phase III trial evaluating the CDK 4/6 inhibitor ribociclib (Novartis' Kisqali) combined with endocrine therapy as adjuvant treatment for hormone receptor-positive, HER2-negative early-stage breast cancer patients. The study, dubbed NATALEE, has enrolled 5,101 patients globally and has a primary endpoint of invasive disease-free survival.
NorthShore University HealthSystem and Sema4 said this week that they have partnered to launch a genomics program that will use predictive analytics to help prevent, detect, and treat diseases at an early stage. As part of the program, NorthShore clinicians and patients will have access to Sema4's genomic products for hereditary cancer, cardiovascular diseases, pharmacogenomics, and rare diseases. Sema4's technology combines clinical information with genomic analysis to understand how genetic variants will influence a patient's risk of developing disease. Patients can also consent to share their data with researchers. NorthShore will subsidize genetic testing for patients who cannot pay for it through a gift from the Swedish Hospital Foundation. Earlier this month, NorthShore started offering the program to patients of Swedish Hospital, a safety net hospital in Illinois that is in a medically underserved area.
Reven Holdings this week launched a translational oncology program focused on the tumor microenvironment. The company will use its lead compound Rejuveinix (RJX), a microenvironment modulator also used as a treatment for patients with HIV and cardiovascular issues, to target TGF-beta signaling in cancer patients. TGF-beta can limit T-cell infiltration in the tumor microenvironment, which can diminish the effects of other anti-cancer treatments. Reven also plans to explore SYK-PI3K-AKT signaling pathway inhibitors and the use of RJX to target and limit lactate production in the tumor microenvironment, which can also be immunosuppressive.
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.