VET2-L2

Phase 1/1b study of VET3-TGI, alone and in combination with checkpoint inhibitor therapy, for advanced solid tumors PITTSBURGH--(BUSINESS WIRE)-- KaliVir Immunotherapeutics, Inc., a biotech company developing cutting-edge, multi-mechanistic oncolytic viral immunotherapy programs, today announced that the FDA has cleared the Investigational New Drug (IND) application for the STEALTH-001 study of VET3-TGI in patients with incurable, advanced solid tumors. VET3-TGI is a novel oncolytic immunotherapy which in nonclinical studies specifically targets and preferentially kills tumor cells directly while stimulating anti-cancer immunity by expressing its therapeutic payload consisting of the transgenes for interleukin-12 and a TGFbeta inhibitor. The Phase 1/1b study (ClinicalTrials.gov ID NCT06444815) will evaluate the safety pro efficacy of VET3-TGI when administered through intravenous infusion or intratumoral injection in patients with advanced, incurable solid tumors. The trial will assess VET3-TGI both as a monotherapy and in combination with checkpoint inhibitor therapy. “The initiation of this Phase 1/1b clinical study marks a pivotal moment in our continued journey to redefine cancer treatment with oncolytic virus therapy and combat advanced, unresectable or metastatic solid tumors,” said Helena Chaye, Ph.D., CEO of KaliVir Immunotherapeutics. “This marks our second initiation of a clinical trial from the VET platform, having announced in 2023 the progress with ASP1012 exclusively licensed to Astellas. We remain fully committed to pushing the boundaries on what is possible with cancer therapies and develop safer, more effective options that have the potential to transform the treatment landscape of oncology.” About KaliVir Immunotherapeutics, Inc. KaliVir Immunotherapeutics is a privately held biotech company developing cutting-edge, multi-mechanistic oncolytic viral immunotherapy programs. The company has developed a unique vaccinia virus-based platform, Vaccinia Enhanced Template “VET” Platform, that can generate potent novel oncolytic vaccinia viruses with modifications to maximize viral replication and to enhance intravenous delivery and spread. VET™ platform utilizes the large transgene capacity of the vaccinia virus to deliver therapeutics matched to tumor immunophenotypes to stimulate patients’ immune systems and modify the tumor microenvironment. KaliVir’s oncolytic virus candidates are designed to be safe, potent and systemically deliverable to treat cancer patients across multiple tumor types. KaliVir has separate collaborations with Roche and Astellas Pharma to design and generate novel oncolytic vaccinia viruses derived from the VET™ platform. In addition, Astellas entered into a world-wide exclusive license to develop and commercialize KaliVir’s initial lead clinical candidate VET2-L2 oncolytic vaccinia virus. KaliVir is currently advancing multiple therapeutic candidates toward the clinic. For more information, please visit kalivir.com.

Pictured: A red illustration of a businessman walking through a door/iStock, lerbank Welcome to the first in a regular series of rundowns of people coming and going from the executive positions in the biopharma companies that BioSpace covers. This column will highlight the hired, fired, retired, promoted or resigning, and even those personally named in lawsuits. The big news of last week is that Richard Gonzalez will retire in July after 11 years as CEO of AbbVie, after helping AbbVie navigate the U.S. patent cliff for its blockbuster anti-inflammatory drug Humira. And just yesterday, we learned that ReNAgade Therapeutics, featured in this year’s NextGen list, is hiring its first-ever chief science innovation officer just under a year after the company’s launch. The fact that ReNAgade did not hire for this position sooner highlights a trend we’ve noticed in the industry toward leaner C-suites. It will be interesting to track whether this continues. Feb. 27 ReNAgade Therapeutics, which placed 6th in BioSpace’s 2024 NextGen class, hired former Moderna Therapeutics R&D boss Joe Bolen as its first chief science innovation officer. The company launched in May 2023 with the goal of building an integrated therapeutic platform that can provide all elements needed to produce RNA therapeutics. Feb. 27 Adaptimmune is bringing back Cintia Piccina as chief commercial officer, effective March 18. Piccina, who served in this role from January 2022 to March 2023, will lead the commercialization of afami-cel, an engineered TCR T cell therapy targeting solid tumors in advanced synovial sarcoma. The American-British firm has an Aug. 4 PDUFA date for afami-cel, formerly called ADP-A2M4CD8. Feb. 27 Vittoria Biotherapeutics has brought in Rosemary Mazanet to serve as chief medical officer. Mazanet will lead clinical development strategy and operations for the startup CAR T therapies developer, which recently received FDA clearance to initiate a Phase I clinical trial for its lead candidate, VIPER-101, a potential treatment for relapsed or refractory T cell lymphoma. Feb. 27 Domain Therapeutics has elevated Stephan Schann to the position of chief scientific officer. Formerly vice president of research, Schann will lead R&D and pipeline development for the multinational company, which is developing a pipeline of targeted cancer immunotherapies. Feb. 22 The Pharmaceutical Research and Manufacturers of America (PhRMA) tapped Gilead Sciences CEO Daniel O’Day to be its new board chair, succeeding Novartis CEO Vas Narasimhan. Pfizer CEO Albert Bourla and Sanofi CEO Paul Hudson will serve alongside O’Day, becoming PhRMA’s board chair-elect and treasurer. The industry powerhouse is navigating a rare string of setbacks in terms of membership and executive losses while it also puts up a united front against the Medicare Drug Price Negotiation Program under the Inflation Reduction Act. Feb. 22 Ocular Therapeutix announced several executive-level appointments, notably elevating Jeffrey Heier from director and advisor to chief scientific officer. The news coincided with Ocular securing a $325 million private placement, which the company will apply to development of Axpaxli (axitinib intravitreal implant) for treatment of wet age-related macular degeneration. Feb. 21 AbbVie announced that CEO Richard Gonzalez will retire July 1. He will be succeeded by current President and COO Robert Michael. Gonzalez, who has helmed AbbVie since its 2013 spinoff from Abbott Laboratories, will become executive chairman. Gonzalez’s departure comes as AbbVie has been active in the M&A space, including its $10 billion buy of ImmunoGen in November 2023 and the $8.7 billion deal for Cerevel Therapeutics in December 2023. In an SEC filing this month, Cerevel reported that the company and AbbVie were handed a request for additional information and documentary materials (second request) from the Federal Trade Commission regarding the regulator’s review of the merger. Gonzalez also helped AbbVie navigate the U.S. patent cliff for its blockbuster anti-inflammatory drug Humira, helping the company to successfully withstand competition from low-cost biosimilars. Gonzalez said in AbbVie’s fourth quarter and full-year 2023 investor call that there was a connection between Humira’s loss of exclusivity (LOE) and his future with the company. “When we believe that we are comfortable, we’ve navigated the LOE, and the rest of the business is performing at high level, that’s the point at which we want to make the transition,” he said. Feb. 21 Narcan (naloxone) maker Emergent BioSolutions brought in Joseph Papa as president and CEO, replacing interim CEO Haywood Miller. Papa, former CEO of Bausch + Lomb, Valeant Pharmaceuticals and Perrigo, is reportedly tasked with engineering a turnaround, as he did at Bausch. Feb. 21 Saghmos Therapeutics named former FDA official Stephen Grant chief regulatory officer. The company is turning to Grant, former deputy director of the FDA Division of Cardiology and Nephrology, to help shepherd compounds including cardiorenal metabolic modulator ST-62516 (trimetazidine) through the review and approval process. Saghmos recently announced a notice of allowance for a U.S. patent on the drug, which seeks to reduce acute kidney injury and major adverse cardiac and kidney events during contrast procedures in patients with chronic kidney disease. Feb. 21 Sergio Santillana resigned as CMO of Ikena Oncology and was replaced by Caroline Germa, the company said. Ikena is currently in early-stage clinical trials with two candidate targeted cancer therapies, the IK-930 TEAD1 selective hippo pathway inhibitor and the IK-595 MEK-RAF “molecular glue.” Feb. 21 Synthekine announced several C-suite changes, including the promotion of Martin Oft to chief scientific officer and the hiring of Geoff Nosrati as chief business officer. The cytokine therapeutics startup is in a Phase I clinical trial with an orthogonal IL-2 and CD19 CAR-T combination therapy currently called STK-009 + SYNCAR-001. Last month, Synthekine formed a partnership with Sanofi US to develop and market IL-10 receptor agonists for inflammatory conditions. Feb. 21 James Burke left CG Oncology to become CMO at KaliVir Immunotherapeutics. Pittsburgh-based KaliVir recently obtained FDA IND clearance for a Phase I clinical study of ASP1012, a systemic oncolytic vaccinia virus therapy licensed to Astellas Pharma. The trial includes subjects with locally advanced or metastatic solid tumors. Feb. 20 Phil Pang, executive vice president and CMO of Vir Biotechnology, will step down at the end of March, the company said. Just last week, Vir reported that GSK decided to terminate a partnership to research, develop and commercialize Vir’s monoclonal antibodies for the prevention, treatment or prophylaxis of the influenza virus. Vir now will hold sole rights to its investigational flu therapies. Neil Versel is the business editor at BioSpace. You can reach him at neil.versel@biospace.com. Follow him on LinkedIn or X.