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In Brief This Week: Helio Genomics, BeiGene, Day One, Mustang Bio, Ikena Oncology, Strata Oncology

NEW YORK – AI-driven healthcare firm Helio Health said this week that it has changed its name to Helio Genomics. The Irvine, California-based firm said the new name better reflects its focus on epigenetics and its commitment to advancing technology for early cancer detection and surveillance. Helio Genomics' technology platform, Eclipse, detects methylation patterns in cell-free DNA from blood samples and uses next-generation sequencing to identify biomarkers of cancer. Its HelioLiver blood test combines cfDNA methylation patterns and serum protein markers to detect hepatocellular carcinoma. 

BeiGene said this week that it has submitted a supplemental biologics license application in China for first-line tislelizumab plus chemotherapy as a treatment for advanced PD-L1-expressing gastric or gastroesophageal junction cancers. The Center for Drug Evaluation within China's National Medical Products Administration (NMPA) has accepted the application for review, which contains data from an interim analysis of the global Phase III RATIONALE 305 trial.

If approved, the indication would be the 10th approval for tislelizumab in China. The agent has not garnered approval outside of China, but the US Food and Drug Administration and European Medicines Agency are currently reviewing applications for the agent in esophageal cancer and non-small cell lung cancer. Last year, BeiGene inked a licensing deal with Novartis to develop the drug in North America, Europe, and Japan. 

Day One Biopharmaceuticals this week closed its previously announced upsized underwritten public offering of 11.5 million shares. The firm said the underwriters also purchased an additional 1.5 million shares at $15.00 per share. The proceeds from the offering totaled $172.5 million before deducting underwriting discounts, commissions, and other offering expenses. Day One plans to use the funds to support ongoing clinical trials of its pan-RAF inhibitor tovorafenib in pediatric low-grade glioma and its MEK inhibitor pimasertib in solid tumors with activating RAF alterations. 

The US Food and Drug Administration this week granted orphan drug designation to Mustang Bio's CD20-targeted, autologous CAR T-cell therapy MB-106 for the treatment of Waldenstrom macroglobulinemia, a rare type of B-cell non-Hodgkin lymphoma. In data presented this month from a Phase I trial of MB-106, the drug demonstrated a 96 percent response rate among 24 evaluable patients. Two patients with Waldenstrom macroglobulinemia and two patients with non-Hodgkin lymphoma in the study achieved complete responses. Mustang plans to begin a Phase I/II clinical trial evaluating MB-106 for relapsed or refractory B-cell non-Hodgkin lymphoma and chronic lymphocytic leukemia. 

The US Food and Drug Administration this week granted fast track designation to Ikena Oncology's TEAD inhibitor IK-930 for patients with unresectable NF2-deficient malignant pleural mesothelioma. Ikena is currently evaluating the agent in a Phase I clinical trial for solid tumor patients with and without gene alterations in the Hippo pathway including NF2-deficient malignant pleural mesothelioma, epithelial hemangioendothelioma with documented TAZ/CAMTA1 fusion genes, and other solid cancers with either NF2 deficiencies or YAP/TAZ genetic fusions. The FDA granted IK-930 orphan drug status earlier this year. 

Strata Oncology said this week that Lehigh Valley Topper Cancer Institute and the University of Michigan Health Rogel Cancer Center have joined on as clinical trial sites for Strata Sentinel, a prospective, observational study of the StrataMRD minimal residual disease test. 

The 100,000-patient trial was launched last year to validate the company's tumor-informed, personalized MRD assay methodology, similar to technology being advanced by companies like Natera and various other recent entrants to the market. "With the Strata Sentinel trial, we aim to demonstrate the utility of detecting recurrence as soon as possible," Lehigh Physician-in-Chief Suresh Nair said in a statement. "We will also evaluate the clinical benefit of treating patients with micrometastatic disease, including with biomarker-matched therapies chosen based on the extended treatment selection data provided by the Strata Oncology platform."

Taiho Pharmaceutical this week completed the acquisition of Cullinan Oncology subsidiary Cullinan Pearl and its agreement to jointly develop in the US an irreversible EGFR inhibitor targeting EGFR exon 20 insertion mutations. Under the deal, announced in May, Taiho paid $275 million upfront to acquire Cullinan Pearl and the EGFR inhibitor, called CLN-081 by Cullinan and TAS6417 by Taiho. Cullinan is eligible to receive an additional $130 million in regulatory milestones. Taiho also obtained exclusive global rights to the EGFR inhibitor outside of the US, and the firms will jointly develop the drug in the US for EGFR exon 20-mutated non-small cell lung cancer. 

The European Medicines Agency this week granted priority medicines designation to BioNTech's cell therapy regimen BNT211 for previously treated testicular cancer. BNT211 comprises an autologous Claudin-6 (CLDN6)-targeting CAR T-cell therapy and a CLDN6-encoding CAR T-cell amplifying RNA vaccine dubbed CARVac. The EMA granted the designation after reviewing preliminary data from a Phase I/II clinical trial of BNT211 in heavily pretreated patients with relapsed or refractory solid tumors. The trial showed that the cell therapy, either alone or combined with the CARVac therapy, was safe and had preliminary anti-tumor activity in testicular cancer patients. 

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.