Iovance Biotherapeutics Completes Biologics License Application (BLA) Submission for Lifileucel in Advanced Melanoma First TIL Therapy BLA Submission to U.S. Food and Drug Administration

Iovance Biotherapeutics Completes Biologics

License Application (BLA)

Submission for Lifileucel in Advanced Melanoma

First TIL Therapy BLA Submission to U.S. Food

and Drug Administration

SAN CARLOS, Calif., March 24, 2023 -- Iovance Biotherapeutics,

Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, today announced it has completed

its rolling Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA) for lifileucel. Lifileucel is

a tumor infiltrating lymphocyte (TIL) therapy intended as a treatment for patients with advanced (unresectable or metastatic) melanoma

who progressed on or after prior anti-PD-1/L1 therapy and targeted therapy, where applicable. There are no FDA approved therapies in this

Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive

Officer of Iovance, stated, "Completing our BLA submission for lifileucel is a critical step forward in our journey to deliver the

first individualized, one-time cell therapy for a solid tumor. I would like to acknowledge the patients and physicians who participated

in the C-144-01 clinical trial and the FDA review team for their commitment and support, as well as our internal team for their tremendous

effort in completing the first BLA submission for Iovance. Our preparations for commercialization remain on track to support a launch

later this year. We look forward to continued collaboration with the FDA as they review this new class of treatment for advanced melanoma

patients with limited options."

The BLA submission for lifileucel is supported by positive clinical

data from the C-144-01 clinical trial in patients with advanced post-anti-PD1 melanoma. Following a successful pre-BLA meeting

with the FDA, Iovance is pursuing accelerated approval in this indication. Iovance also reached agreement with the FDA regarding the

registrational trial design for the Phase 3 TILVANCE-301 trial of lifileucel in combination with pembrolizumab in frontline advanced

melanoma. TILVANCE-301 is intended to support full approval of lifileucel in post-anti-PD-1 advanced melanoma and is also designed to

support registration for lifileucel in combination with pembrolizumab as therapy for advanced melanoma in the frontline setting. Startup

activities for TILVANCE-301 are ongoing and the trial is expected to be well underway at the time of potential accelerated approval for

lifileucel in advanced post-anti-PD-1 melanoma.

Marc Hurlbert, Ph.D., CEO of the Melanoma Research Alliance (MRA),

said, "MRA congratulates Iovance for completing the BLA submission and moving closer toward making TIL therapy an option for people

with advanced melanoma who have progressed following prior treatments. We hope for an FDA approval as quickly as possible for patients

with significant unmet need who have no approved treatment options."

Following receipt of the complete rolling BLA submission for lifileucel,

the FDA has 60 days to determine the acceptability of the BLA for review. The rolling BLA allowed Iovance to submit portions of the BLA

to the FDA on an ongoing basis, enabling the FDA to begin review as early as possible as documents were received. The rolling BLA submission

and eligibility for priority review are benefits available under the FDA's guidance on expedited programs for serious conditions,

which allow for an expedited six-month review from the time of BLA acceptance. In addition, the FDA previously granted a regenerative

medicine advanced therapy (RMAT) designation for lifileucel in advanced melanoma.

About Iovance Biotherapeutics, Inc.

Iovance Biotherapeutics 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.

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 accept

the BLA submission for lifileucel in metastatic melanoma, and even if the BLA submission is accepted for review, the FDA ultimately

may not approve the BLA; 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 the acquisition of Proleukin may

not be completed in a timely manner or at all; the failure to satisfy the closing conditions to the consummation of the Proleukin

acquisition, including the receipt of all required regulatory approvals; 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.

Iovance Biotherapeutics,

Sara Pellegrino, IRC

Senior Vice President, Investor Relations & Corporate Communications

650-260-7120 ext. 264

Director, Investor Relations & Public Relations