Investor Conference Call and Webcast on June 26 at 5:00 p.m. ET
SAN CARLOS, Calif., June 20, 2023 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, will host an investor conference call and webcast to discuss lifileucel TIL therapy and the emerging melanoma treatment landscape on June 26, 2023, at 5:00 p.m. ET.
During the one-hour event, the Iovance leadership team will provide a brief recap of the C-144-01 trial and clinical data, defined regulatory pathway, and pre-commercial activities for lifileucel in advanced post-anti-PD-1 melanoma. A multidisciplinary panel of key opinion leaders (KOLs) will discuss the disease burden and unmet needs for advanced melanoma patients within current treatment practices, perspectives on TIL therapy and the emerging landscape, and preparations for broad adoption of lifileucel and cell therapies within their treatment centers.
The KOL roundtable will be moderated by Dr. Brian Gastman, Executive Vice President, Medical Affairs at Iovance and a practicing surgeon who consults and operates on cancer patients at the Cleveland Clinic. Prior to his recent arrival at Iovance, Dr. Gastman led the melanoma clinical trials team, including as lead investigator on numerous trials of TIL and other cell therapies, as Co-Medical and Surgical Director of Cleveland Clinic and Taussig Cancer Center’s melanoma and high-risk skin cancer program.
Virtual KOL Event Agenda Introduction: Recap of Lifileucel TIL Therapy Development & Regulatory Pathway
Multidisciplinary KOL Roundtable: Perspectives on Lifileucel and Advanced Melanoma Treatment Landscape
Participant
Title
TIL Experience
Brian Gastman, M.D. (moderator)
EVP, Medical Affairs at Iovance Biotherapeutics and practicing surgeon at the Cleveland Clinic
Lead investigator of TIL trials at Cleveland Clinic
Krishna Komanduri, M.D.
Professor and Chief, Division of Hematology and Oncology, Dept. of Medicine; Physician-in-Chief, Helen Diller Family Comprehensive Cancer Center; Clinical Director, Living Therapeutics Initiative, University of California San Francisco (UCSF)
Chair of TIL Working Group (TIL-WG), dedicated to educating healthcare practitioners about TIL therapy
Past President, American Society for Transplantation and Cellular Therapy (ASTCT)
Mario Sznol, M.D.
Medical oncologist at Yale Medicine; co-director of the Cancer Immunology Program at Yale Cancer Center
Iovance Scientific Advisory Board member
Live Audience Q&A Session
About Iovance Biotherapeutics, Inc. Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) cell 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. Our lead late-stage TIL product candidate, lifileucel for metastatic melanoma, has the potential to become the first approved one-time cell therapy for a solid tumor cancer. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may extend and improve life for patients with cancer. For more information, please visit www.iovance.com.
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”). All such written or oral statements made in this press release, other than statements of historical fact, are forward-looking statements and are intended to be covered by the safe harbor for forward-looking statements provided by 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,” “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 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 effects of the COVID-19 pandemic; risks related to the timing of and our ability to successfully develop, submit, obtain and maintain U.S. Food and Drug Administration (“FDA”) or other regulatory authority approval of, or other action with respect to, our product candidates, and our ability to successfully commercialize any product candidates for which we obtain FDA approval; whether clinical trial results from our pivotal studies and cohorts, and meetings with the FDA, may support registrational studies and subsequent approvals by the FDA; 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 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 or other regulatory authorities; the risk that our interpretation of the results of our clinical trials or communications with the FDA may differ from the interpretation of such results or communications by the FDA (including from the prior pre-BLA meeting with the FDA); the risk that the FDA may not approve our BLA submission for lifileucel in metastatic melanoma; the acceptance by the market of our product candidates and their potential reimbursement by payors, if approved; our ability or inability to manufacture our therapies using third party manufacturers or our own facility may adversely affect our potential commercial launch; the results of clinical trials with collaborators using different manufacturing processes may not be reflected in our sponsored trials; the risk that unanticipated expenses may decrease our estimated cash balances and forecasts and increase our estimated capital requirements; and other factors, including general economic conditions and regulatory developments, not within our control.
