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In Brief This Week: Orgenesis, Merck, 23andMe, AstraZeneca, Genenta Science, GenScript

NEW YORK – Orgenesis said this week that it has closed a registered direct offering of 1,947,368 common stock and warrants to purchase up to 973,684 shares of common stock at $1.90 per share. The firm brought in roughly $3.7 million through the transaction less placement fees and offering expenses. The exercise price of the warrants is $1.90 per share, and are exercisable immediately. They will expire five years after they're issued. The transaction's pricing was first announced on Feb. 23. The point-of-care cell therapy company said it plans to use the proceeds to fund general corporate purposes, working capital, and general and administrative costs. 

Merck said this week that its checkpoint inhibitor Keytruda (pembrolizumab) plus chemotherapy did not significantly improve overall survival versus chemotherapy alone among previously treated patients with metastatic non-squamous non-small cell lung cancer whose tumors harbor EGFR mutations in the Phase III KEYNOTE-789 clinical trial. The addition of Keytruda did improve both progression-free survival and overall survival, Merck said, but not to the extent of statistical significance. 

23andMe this week began dosing patients in the Phase IIa study of its CD200R1-targeted drug 23ME-00610 in patients with advanced solid malignancies. In this portion of the trial, the firm will enroll cohorts of patients with previously treated microsatellite instability-high cancers or tumor mutational burden-high (TMB-H) cancers, along with clear cell renal cell carcinoma, epithelial ovarian, fallopian tube, primary peritoneal carcinoma, neuroendocrine cancers, and small cell lung cancer. 23andMe began the Phase I/II trial of 23ME-00610 in January 2022. 

Merck and AstraZeneca said this week that the US Food and Drug Administration plans to convene an Oncologic Drugs Advisory Committee (ODAC) meeting on April 28 to discuss the drugmakers' supplementary new drug application seeking approval for the PARP inhibitor Lynparza (olaparib) plus Janssen's Zytiga (abiraterone) and the steroid prednisone as upfront treatment for patients with metastatic castration resistant prostate cancer (mCRPC). The ODAC members will provide the FDA with independent advice on whether to approve the treatment combination based on the results of the Phase III PROpel trial, though the FDA is not obligated to follow the committee's guidance. News of the meeting follows in the wake of recent debate regarding the PARP inhibitor's benefit in the all-comers population versus a biomarker-defined subset of mCRPC patients. 

The US Food and Drug Administration this week granted orphan drug designation to Genenta Science's investigational cell therapy Temferon as treatment for glioblastoma multiforme patients whose tumors have an unmethylated MGMT gene promoter. The FDA grants orphan designation to drugs for rare diseases, which provides sponsors tax credits for clinical trials, exemption from user fees, and seven years of market exclusivity for the drug after regulatory approval. 

GenScript said this week that it is expanding its Singapore facility to provide gene synthesis services. The move adds nearly 1,000 square meters to the facility's production footprint, bringing it to 3,500 square meters, and will raise the headcount to 150. The capacity of the new facility will support cell and gene therapy research and vaccine development programs, the firm said in a statement. 

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.