Acura Pharmaceuticals Inc., of Palatine, Ill., said in conjunction with a third-party developer, the formulation and manufacturing process for LTX-03 (hydrocodone bitartrate and acetaminophen) tablets has been optimized for commercial scale. The product is intended to mitigate risks associated with overdose of hydrocodone. Acura’s partnered commercial manufacturer has received hydrocodone quota from the Drug Enforcement Administration and is in the process of acquiring specific auxiliary equipment for the identified manufacturing process. The company has also completed a nonclinical small animal study to identify the benefits of a reduction in peak plasma drug concentrations on opioid induced respiratory depression. The firm’s LIMITx technology is designed to retard the release of active drug ingredients when too many tablets are accidentally or purposefully ingested by neutralizing stomach acid with buffer ingredients, and also deliver efficacious amounts of drug when taken as a single tablet with a nominal buffer dose.  

Biontech SE, of Mainz, Germany, said a report published in Science, titled “An RNA vaccine drives expansion and efficacy of claudin-CAR T cells against solid tumors,” provides preclinical proof-of-concept data for the company’s first CAR T product candidate, BNT-211, an autologous CAR T-cell therapy targeting the oncofetal antigen Claudin 6 (CLDN6). It also outlines CAR T-cell amplifying RNA vaccine (CARVac) as a broadly applicable RNA vaccine approach to improve therapeutic efficacy of CAR T-cell therapies. In the study, a second-generation CLDN6-CAR T therapy with a 4-1BB costimulatory domain (BNT-211) was evaluated both in vitro in tumor cell lines and in vivo in mice with human ovarian cancer transplants. In mice, CLDN6-CAR T-cell therapy demonstrated complete tumor regression of transplanted large human tumors within two weeks after treatment initiation. Furthermore, the combination with CARVac achieved an improved engraftment, proliferation and expansion of CAR T cells in vivo resulting in tumor regression even at subtherapeutic CAR T doses. CARVac was also successfully applied for CA -T cells targeting the pancancer antigen CLDN18.2 and CD19, the target of approved CAR T-cell therapies. The company plans to initiate a first-in-human phase I/II trial for BNT-211 this year in solid tumors, including ovarian, testicular, uterine and lung cancers.  

Can-Fite Biopharma Ltd., of Petach Tikva, Israel, said preclinical data generated at the Hadassah Medical Center demonstrate that namodenoson induced a significant decrease in weight in both high-fat diet mouse models and in diabetic rat models, and normalized glucose levels in a glucose tolerance test. Based on those findings, a patent application has been filed for the utilization of namodenoson as an obesity drug. 

Leap Therapeutics Inc., of Cambridge, Mass., and Beijing-based Beigene Ltd. said they entered an exclusive option and license agreement for the clinical development and commercialization of DKN-01, Leap's anti-Dickkopf-1 (DKK1) antibody, in Asia (excluding Japan), Australia and New Zealand. Leap will retain exclusive rights for the rest of the world. It will receive an up-front cash payment of $3 million and will be eligible to receive an additional payment upon Beigene's exercise of the option following initial proof-of-concept studies. Additionally, Leap is eligible to receive potential downstream milestone payments for a total deal value of up to $132 million, together with tiered royalties on any product sales of DKN-01 in the licensed territory. During the option period, Leap has agreed to study the combination of DKN-01 and tislelizumab in approximately 40 patients with second-line gastric cancer/gastroesophageal junction cancer (GC/GEJ) whose tumors express high levels of DKK1 to build upon the positive clinical experience of DKN-01 in combination with PD-1 inhibitors in those patients. In addition, it plans to evaluate the combination of DKN-01 with tislelizumab and chemotherapy in approximately 20 patients with first-line GC/GEJ. Related to the agreement with Beigene, Leap has also entered a securities purchase agreement to issue and sell in a private placement 1.42 million shares of newly designated series A mandatorily convertible preferred stock to a lead institutional investor and 1.13 million shares of newly designated series B mandatorily convertible preferred stock to Beigene and Perceptive Advisors, at $10.55 per share. The aggregate gross proceeds are approximately $27 million. 

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