This week's life sciences industry news includes a Penn spinout developing cell therapies, a company from India setting up a plant in New Jersey, a loan deal for a Swiss biopharmaceutical company that has its U.S. headquarters on the Main Line, and more.
Here’s the roundup:
Verismo Therapeutics
The Philadelphia cell therapy company spun out of the University of Pennsylvania has expanded its partnership with Penn to include clinical cell manufacturing.
Under the expanded partnership, Verismo's SynKIR-110 experimental KIR-CAR T-cell therapy will be produced by the Clinical Cell and Vaccine Production Facility at Penn's Perelman School of Medicine for clinical testing and potential use in a Phase I clinical trial.
Financial terms of the expanded deal were not disclosed.
Dr. Bryan Kim, CEO of Verismo, noted Penn’s Clinical Cell and Vaccine Production Facility has a long history of producing “cutting-edge” cell therapies including the first Food and Drug Administration-approved genetically engineered cell therapy product and the first use of CRISPR-edited cells used in human clinical trials.
“Together, we will be well-positioned to manufacture SynKIR-110 for Phase I clinical testing," he said.
SynKIR-110 is being studied as a potential treatment for mesothelioma, ovarian cancer and cholangiocarcinoma.
Verisimo’s SynKIR platform is a type of CAR T-cell therapy. In therapy using CAR T cells, an acronym for chimeric antigen receptors, a patient's T cells are removed and genetically modified in the laboratory. After the re-engineered cells are injected back into a patient, their immune system is better able to attack cancer cells.
Kim, along with his Verismo co-founders and Penn professors Dr. Michael C. Milone and Dr. Donald L. Siegel, re-invented the technology to create its KIR-CAR platform to potentially treat solid tumors. KIR is an acronym for killer immunoglobulin-like receptors.
Verismo's KIR-CAR platform, according to the company, is being used to create the first "multi-chain" CAR capable of maintaining the T-cell activity even in harsh solid tumor environments. KIR-CAR is being designed to provide a "natural stimulation" to the cell without triggering T-cell exhaustion. The therapy will continue to destroy solid tumors from the inside until they disappear, the company said.
Enzene Biosciences
The global biotech company based in Pune, India, is opening its first location outside of India this month with the debut of a biopharmaceutical manufacturing plant on the Princeton West Innovation Campus in Hopewell, New Jersey.
The $50 million, 55,000-square-foot plant is expected to open with a staff of 50 and eventually bring 300 jobs to Mercer County.
Dr. Himanshu Gadgil, CEO of Enzene Biosciences, said the contract development and manufacturing organization selected New Jersey as the site for the plant because of the state's "highly skilled workforce, infrastructure, and academic institutions."
New Jersey Gov. Phil Murphy, in a statement, said, “The strong relationship between New Jersey and India has gained increasing momentum since we opened the New Jersey India Center to cultivate economic opportunities during our trip to the country in 2019."
Debbie Hart, BioNJ president and CEO, said she believes Enzene will be a valuable addition to New Jersey’s "robust life sciences ecosystem."
Idorsia
The Swiss biopharmaceutical company that has its U.S. headquarters in Radnor said it secured an $83.4 million bridge financing.
The financing, according to the company, will extend the company’s cash runway until the end of July and allow for the completion of its "recently announced prospective strategic transaction" for its Asia Pacific operations, which Idorsia said is subject to completion of satisfactory due diligence and legal documentation.
The financing was provided by Jean-Paul Clozel, Idorsia's CEO and the company's largest shareholder.
Idorsia, founded in 2017 and based in Basel, Switzerland, has commercial operations in Europe, Japan, and the United States. The company generated revenue of $106.7 million in 2022, up from $38.5 million the previous year.
Its lead product, Quviviq, received FDA approval as a treatment for insomnia in January 2022. The company has promoted the drug through endorsements from actress Jennifer Aniston and Olympic skier Lindsey Vonn. Quviviq generated sales of $7.2 million for the company last year.
Quick Hits
London-based GSK, which has major operations in Philadelphia and Montgomery County, said the FDA has extended the review period of its new drug application for momelotinib, an experimental treatment for myelofibrosis patients with anemia, by three months so the agency has time to review recently submitted data. The FDA is now expected to make a decision on the application by Sept. 16. … Vesteck received a U.S. patent for its remote surgical suture system. The West Chester medical device company is focused on bringing a proprietary technology to the aortic repair and structural heart markets. Its flagship product, the "suture-tight" catheter, comes preloaded with four pairs of nitinol sutures that secure endovascular grafts to the aorta on initial implant or during repair procedures. … Berwyn-based Annovis Bio (NYSE: ANVS) said it received a positive safety review by the Data and Safety Monitoring Board for its Phase 3 clinical trial of buntanetap, a once-a-day pill being developed as a treatment for early Parkinson’s disease patients. The board recommended that Annovis Bio continue the trial as originally designed. Annovis initiated the patient trial of buntanetap in late August 2022. Study results are expected by the end of the year.
