Iovance Biotherapeutics Announces the Promotion of Raj Puri, M.D., Ph.D. to Chief Regulatory Officer

Rhea-AI Summary

Iovance Biotherapeutics (NASDAQ: IOVA) has promoted Dr. Raj Puri to the newly created position of Chief Regulatory Officer. Dr. Puri, who joined Iovance in March 2022 as Executive Vice President of Regulatory Strategy and Translational Medicine, played a key role in securing regulatory approval for Amtagvi™ in the United States and advancing submissions in multiple international markets. The company aims to address more than 20,000 patients annually with previously treated advanced melanoma starting in 2025. Dr. Puri brings over 33 years of FDA experience, including 19 years as director of the Division of Cellular and Gene Therapies in the FDA's Center for Biologics Evaluation and Research.

Positive

• Successfully obtained regulatory approval for Amtagvi™ in the United States
• Advancing regulatory submissions in multiple international markets (EU, UK, Canada, Australia, Switzerland)
• Potential to address 20,000+ patients annually with advanced melanoma by 2025

Negative

• None.

SAN CARLOS, Calif., Nov. 26, 2024 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, today announced that Raj Puri, M.D., Ph.D. has been promoted to the newly created role of Chief Regulatory Officer. Dr. Puri joined Iovance in March 2022 as Executive Vice President, Regulatory Strategy and Translational Medicine.

Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive Officer of Iovance, stated, “Raj was instrumental in our successfully obtaining regulatory approval of Amtagvi™ in the United States, and in advancing regulatory submissions in the European Union, United Kingdom, Canada, Australia, and Switzerland, with the potential to address more than 20,000 patients annually with previously treated advanced melanoma beginning in 2025. Raj has also played a crucial role in advancing our product pipeline, including lifileucel in non-small-cell lung cancer and endometrial cancer and our novel genetically-engineered TIL candidates, with many more regulatory milestones and designations expected in 2025.”

Prior to joining Iovance, Dr. Puri served as the director of the Division of Cellular and Gene Therapies (DCGT) in the Office of Tissues and Advanced Therapies at the U.S. Food and Drug Administration (FDA) in its Center for Biologics Evaluation and Research for more than 19 years. He was also a Chief of Tumor Vaccines and Biotechnology Branch within DCGT. During his more than 33-year tenure at the FDA, Dr. Puri held various positions as a reviewer and laboratory/branch chief prior to his service as a division director. Dr. Puri has decades of experience with the evaluation and regulation of advanced therapies including cell and gene therapy, cancer vaccines, and cellular immunotherapy. As a principal investigator and throughout his career, Dr. Puri has led research in the field of cancer therapies, including agents such as immunotoxins, cancer vaccines, and T cells including chimeric antigen receptor-modified T cells and TILs.

Dr. Puri trained at the National Cancer Institute’s Surgery Branch, where he worked in the laboratory of Dr. Steven Rosenberg on adoptive immunotherapy approaches for cancer, and at the Mayo Clinic, Rochester, Minnesota where he worked on progesterone hormone receptors. He received his M.D. from the University of Juarez Medical School Institute of Biosciences and his Ph.D. in Medical Sciences from the Central Drug Research Institute, Lucknow, India.

About Iovance Biotherapeutics, Inc. 

Iovance Biotherapeutics, Inc. aims to be the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) therapies for patients with cancer. We are pioneering a transformational approach to cure cancer by harnessing the human immune system’s ability to recognize and destroy diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. Iovance’s Amtagvi™ is the first FDA-approved T cell therapy for a solid tumor indication. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, that may extend and improve life for patients with cancer. For more information, please visit www.iovance.com.

Amtagvi™ and its accompanying design marks, Proleukin^®, Iovance^®, and IovanceCares™ are trademarks and registered trademarks of Iovance Biotherapeutics, Inc. or its subsidiaries. All other trademarks and registered trademarks are the property of their respective owners.

Forward-Looking Statements

Certain matters discussed in this press release are “forward-looking statements” of Iovance Biotherapeutics, Inc. (hereinafter referred to as the “Company,” “we,” “us,” or “our”) within the meaning of the Private Securities Litigation Reform Act of 1995 (the “PSLRA”). Without limiting the foregoing, we may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “forecast,” “guidance,” “outlook,” “may,” “can,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes and are intended to identify forward-looking statements. Forward-looking statements are based on assumptions and assessments made in light of management’s experience and perception of historical trends, current conditions, expected future developments, and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and we undertake no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties, and other factors, many of which are outside of our control, that may cause actual results, levels of activity, performance, achievements, and developments to be materially different from those expressed in or implied by these forward-looking statements. Important factors that could cause actual results, developments, and business decisions to differ materially from forward-looking statements are described in the sections titled "Risk Factors" in our filings with the U.S. Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, and include, but are not limited to, the following substantial known and unknown risks and uncertainties inherent in our business: the risks related to our ability to successfully commercialize our products, including Amtagvi, for which we have obtained U.S. Food and Drug Administration (“FDA”) approval, and Proleukin, for which we have obtained FDA and European Medicines Agency (“EMA”) approval; the risk that the EMA or other ex-U.S. regulatory authorities may not approve or may delay approval for our marketing authorization application submission for lifileucel in metastatic melanoma; the acceptance by the market of our products, including Amtagvi and Proleukin, and their potential pricing and/or reimbursement by payors, if approved (in the case of our product candidates), in the U.S. and other international markets and whether such acceptance is sufficient to support continued commercialization or development of our products, including Amtagvi and Proleukin, or product candidates, respectively; future competitive or other market factors may adversely affect the commercial potential for Amtagvi or Proleukin; the risk regarding our ability or inability to manufacture our therapies using third party manufacturers or at our own facility, including our ability to increase manufacturing capacity at such third party manufacturers and our own facility, may adversely affect our commercial launch; the results of clinical trials with collaborators using different manufacturing processes may not be reflected in our sponsored trials; the risk regarding the successful integration of the recent Proleukin acquisition; the risk that the successful development or commercialization of our products, including Amtagvi and Proleukin, may not generate sufficient revenue from product sales, and we may not become profitable in the near term, or at all; the risks related to the timing of and our ability to successfully develop, submit, obtain, or maintain FDA, EMA, or other regulatory authority approval of, or other action with respect to, our product candidates; whether clinical trial results from our pivotal studies and cohorts, and meetings with the FDA, EMA, or other regulatory authorities may support registrational studies and subsequent approvals by the FDA, EMA, or other regulatory authorities, including the risk that the planned single arm Phase 2 IOV-LUN-202 trial may not support registration; preliminary and interim clinical results, which may include efficacy and safety results, from ongoing clinical trials or cohorts may not be reflected in the final analyses of our ongoing clinical trials or subgroups within these trials or in other prior trials or cohorts; the risk that enrollment may need to be adjusted for our trials and cohorts within those trials based on FDA and other regulatory agency input; the risk that the changing landscape of care for cervical cancer patients may impact our clinical trials in this indication; the risk that we may be required to conduct additional clinical trials or modify ongoing or future clinical trials based on feedback from the FDA, EMA, or other regulatory authorities; the risk that our interpretation of the results of our clinical trials or communications with the FDA, EMA, or other regulatory authorities may differ from the interpretation of such results or communications by such regulatory authorities (including from our prior meetings with the FDA regarding our non-small cell lung cancer clinical trials); the risk that clinical data from ongoing clinical trials of Amtagvi will not continue or be repeated in ongoing or planned clinical trials or may not support regulatory approval or renewal of authorization; the risk that unanticipated expenses may decrease our estimated cash balances and forecasts and increase our estimated capital requirements; the risk that we may not be able to recognize revenue for our products; the risk that Proleukin revenues may not continue to serve as a leading indicator for Amtagvi revenues; the risks regarding our anticipated operating and financial performance, including our financial guidance and projections; the effects of global pandemic; the effects of global and domestic geopolitical factors; and other factors, including general economic conditions and regulatory developments, not within our control. Any financial guidance provided in this press release assumes the following: no material change in our ability to manufacture our products; no material change in payor coverage; no material change in revenue recognition policies; no new business development transactions not completed as of the period covered by this press release; and no material fluctuation in exchange rates.

CONTACTS 

Iovance Biotherapeutics, Inc.:
Sara Pellegrino, IRC 
SVP, Investor Relations & Corporate Communications 
650-260-7120 ext. 264 
Sara.Pellegrino@iovance.com 

Jen Saunders 
Senior Director, Investor Relations & Corporate Communications 
267-485-3119 
Jen.Saunders@iovance.com

FAQ

What is Dr. Raj Puri's new role at Iovance Biotherapeutics (IOVA)?

Dr. Raj Puri has been promoted to the newly created position of Chief Regulatory Officer at Iovance Biotherapeutics.

When did Iovance Biotherapeutics (IOVA) receive FDA approval for Amtagvi?

The press release indicates that Amtagvi has received FDA approval, though the specific approval date is not mentioned in the release.

What markets is Iovance Biotherapeutics (IOVA) targeting for Amtagvi expansion?

Iovance is advancing regulatory submissions for Amtagvi in the European Union, United Kingdom, Canada, Australia, and Switzerland.

How many patients could Iovance Biotherapeutics (IOVA) potentially treat with Amtagvi by 2025?

Iovance aims to address more than 20,000 patients annually with previously treated advanced melanoma beginning in 2025.