Iovance Biotherapeutics Announces FDA has Lifted Clinical Hold on the IOV-LUN-202 Registrational Trial in Non-Small Cell Lung Cancer

Iovance Biotherapeutics Announces FDA has Lifted

Clinical Hold on the IOV-LUN-202 Registrational Trial in Non-Small Cell Lung Cancer

SAN CARLOS, Calif., March 4, 2024 -- 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 the U.S. Food and Drug Administration (FDA) lifted a partial

clinical hold placed on the registrational IOV-LUN-202 trial investigating LN-145 TIL cell therapy in non-small cell lung cancer (NSCLC).

In collaboration with the FDA and an independent data monitoring committee, Iovance developed additional safety and monitoring measures.

Upon reviewing this proposal, the FDA has cleared Iovance to resume patient enrollment in IOV-LUN-202.

The IOV-LUN-202 trial is investigating LN-145 in patients with advanced

(unresectable or metastatic) NSCLC without EGFR, ROS or ALK genomic mutations who were previously treated with chemotherapy and anti-PD-1

therapy and at least one line of an approved targeted therapy if indicated by other actionable tumor mutations. Iovance expects to complete

enrollment of approximately 120 patients in the IOV-LUN-202 registrational cohorts in 2025.

Preliminary data from the IOV-LUN-202 trial support the potential

benefit of one-time TIL therapy, including the opportunity for more durable responses than available second line chemotherapies. Initial

preliminary data were reported in July of 2023. An updated analysis in November of 2023 showed additional ongoing responses and

duration of response greater than six months for 71% of the confirmed responders in the trial.

For more information about the IOV-LUN-202 trial please visit www.lungcelltherapy.com.

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," "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 and Proleukin, for which we obtain U.S. Food and Drug Administration

("FDA"), European Medicines Agency ("EMA"), or other regulatory authority approval; the risk that the EMA or other

regulatory authorities may not approve or may delay approval for our biologics license application ("BLA") 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; our ability or inability to manufacture our therapies using third party manufacturers

or at 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 risk that future competitive or other market

factors may adversely affect the commercial potential for Amtagvi or Proleukin; 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 effects of the COVID-19 pandemic; and other factors, including general economic conditions and regulatory developments, not within

Iovance Biotherapeutics,

Sara Pellegrino, IRC

Senior Vice President, Investor Relations & Corporate Communications

650-260-7120 ext. 264

Director, Investor Relations & Public Relations