Iovance Biotherapeutics Announces First Patient Dosed with

First Genetically Modified (TALEN^®-edited) Iovance TIL Therapy with Inactivated PD-1 Expression

SAN CARLOS, Calif., Oct. 10, 2022 (GLOBE NEWSWIRE) — Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology firm growing novel T cell-based most cancers immunotherapies, introduced that the primary affected person was dosed, and accomplished the security remark interval, within the IOV-GM1-201 trial of Iovance’s genetically modified, PD-1 inactivated TIL remedy, IOV-4001. IOV-GM1-201 is a Phase 1/2, first-in-human research investigating the security and efficacy of IOV-4001 in sufferers with beforehand handled metastatic non-small cell lung most cancers (NSCLC) or superior melanoma.

Friedrich Graf Finckenstein, M.D., Chief Medical Officer of Iovance, said, “Dosing the first patient with IOV-4001 is an important first step in providing proof-of-concept for delivering genetically modified TIL therapy to solid tumor patients with significant unmet needs and few treatment options. We look forward to dosing the next patient. This trial may also support our broader platform of genetically modified Iovance TIL therapies to potentially address difficult-to-treat solid tumor cancers.”

To inactivate the gene coding for the PD-1 protein, IOV-4001 makes use of the gene-editing TALEN^® expertise licensed from Cellectis (Euronext Growth: ALCLS – NASDAQ: CLLS), a clinical-stage biotechnology firm utilizing its pioneering gene-editing platform to develop probably life-saving cell and gene therapies. This single genetic modification in IOV-4001 might improve the antitumor exercise of the TIL mechanism to instantly goal and kill tumor cells.

Jason Chesney, M.D., Ph.D., Director and Endowed Professor, UofL Health – Brown Cancer Center, University of Louisville, and an IOV-GM1-201 principal investigator, said, “I am excited about the potential for gene-editing to open new doors for TIL therapy in patients with solid tumor cancers that do not respond well to current treatment options. As the first multicenter clinical trial to investigate a genetically modified TIL therapy, the IOV-GM1-201 trial may pave the way for a promising new treatment approach to cancer.”

PD-1 is a checkpoint protein discovered on T cells that usually acts as an “off switch” to assist to stop T cells from attacking different cells within the physique. It works by binding to PD-L1, a protein discovered on each regular and cancerous cells, thereby shutting down an assault by a T cell. As a TIL remedy that’s genetically modified to take away this necessary barrier for T cells to assault most cancers, IOV-4001 has the potential to turn into an optimized, subsequent technology TIL remedy for a number of strong tumor cancers. A poster on preclinical knowledge was offered on the American Association for Cancer Research (AACR) 2022 Annual Meeting.

IOV-GM1-201 is actively enrolling grownup individuals with superior NSCLC or unresectable or metastatic melanoma. For extra data, eligibility standards, and trial places, please go to www.clinicaltrials.gov (NCT05361174) or contact [email protected].

About Iovance Biotherapeutics, Inc.
Iovance Biotherapeutics goals to be the worldwide chief in innovating, growing and delivering tumor infiltrating lymphocyte (TIL) cell therapies for sufferers with most cancers. We are pioneering a transformational method to remedy most cancers by harnessing the human immune system’s means to acknowledge and destroy various most cancers cells in every affected person. Our lead late-stage TIL product candidate, lifileucel for metastatic melanoma, has the potential to turn into the primary accredited one-time cell remedy for a strong tumor most cancers. The Iovance TIL platform has demonstrated promising scientific knowledge throughout a number of strong tumors. We are dedicated to steady innovation in cell remedy, together with gene-edited cell remedy, that will lengthen and enhance life for sufferers with most cancers. For extra data, please go to www.iovance.com.

Forward-Looking Statements
Certain issues mentioned on this press launch are “forward-looking statements” of Iovance Biotherapeutics, Inc. (hereinafter known as the “Company,” “we,” “us,” or “our”) throughout the which means of the Private Securities Litigation Reform Act of 1995 (the “PSLRA”). All such written or oral statements made on this press launch, apart from statements of historic reality, are forward-looking statements and are supposed to be lined by the protected harbor for forward-looking statements supplied by the PSLRA. Without limiting the foregoing, we might, in some circumstances, use phrases corresponding to “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “forecast,” “guidance,” “outlook,” “may,” “could,” “might,” “will,” “should” or different phrases that convey uncertainty of future occasions or outcomes and are supposed to determine forward-looking statements. Forward-looking statements are based mostly on assumptions and assessments made in mild of administration’s expertise and notion of historic developments, present circumstances, anticipated future developments and different elements believed to be acceptable. Forward-looking statements on this press launch are made as of the date of this press launch, and we undertake no responsibility to replace or revise any such statements, whether or not on account of new data, future occasions or in any other case. Forward-looking statements are usually not ensures of future efficiency and are topic to dangers, uncertainties and different elements, a lot of that are exterior of our management, that will trigger precise outcomes, ranges of exercise, efficiency, achievements and developments to be materially totally different from these expressed in or implied by these forward-looking statements. Important elements that might trigger precise outcomes, developments and business choices to vary materially from forward-looking statements are described within the sections titled “Risk Factors” in our filings with the Securities and Exchange Commission, together with our most up-to-date Annual Report on Form 10-Okay and Quarterly Reports on Form 10-Q, and embrace, however are usually not restricted to, the next substantial identified and unknown dangers and uncertainties inherent in our business: the results of the COVID-19 pandemic; dangers associated to the timing of and our means to efficiently develop, submit, acquire and keep U.S. Food and Drug Administration (“FDA”) or different regulatory authority approval of, or different motion with respect to, our product candidates, and our means to efficiently commercialize any product candidates for which we acquire FDA approval; whether or not scientific trial outcomes from our pivotal research and cohorts might help registration and approval by the FDA; preliminary and interim scientific outcomes, which can embrace efficacy and security outcomes, from ongoing scientific trials or cohorts will not be mirrored within the remaining analyses of our ongoing scientific trials or subgroups inside these trials or in different prior trials or cohorts; the chance that enrollment might must be adjusted for our trials and cohorts inside these trials based mostly on FDA and different regulatory company enter; the altering panorama of take care of cervical most cancers sufferers might impression our scientific trials on this indication; the chance that we could also be required to conduct extra scientific trials or modify ongoing or future scientific trials based mostly on suggestions from the FDA or different regulatory authorities; the chance that our interpretation of the outcomes of our scientific trials or communications with the FDA might differ from the interpretation of such outcomes or communications by the FDA (together with from the latest pre-BLA assembly with the FDA); the chance that the rolling BLA submission for lifileucel in metastatic melanoma might take longer than anticipated; the acceptance by the market of our product candidates and their potential reimbursement by payors, if accredited; our means or incapability to fabricate our therapies utilizing third social gathering producers or our personal facility might adversely have an effect on our potential business launch; the outcomes of scientific trials with collaborators utilizing totally different manufacturing processes will not be mirrored in our sponsored trials; the chance that unanticipated bills might lower our estimated money balances and forecasts and enhance our estimated capital necessities; and different elements, together with normal financial circumstances and regulatory developments, not inside our management.

CONTACTS

Iovance Biotherapeutics, Inc:
Sara Pellegrino, IRC
Senior Vice President, Investor Relations & Corporate Communications
650-260-7120 ext. 264
[email protected]

Jen Saunders
Director, Investor Relations & Public Relations
267-485-3119
[email protected]

TALEN^® is a trademark owned by Cellectis