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Iovance Biotherapeutics Provides Corporate, Clinical, and Regulatory Updates Acquisition of Worldwide Rights to Proleukin Provides Immediate and Ongoing Revenue and Secures IL-2 Supply for Clinical and Future Commercial

Key Takeaway: Iovance Biotherapeutics has announced significant updates including the acquisition of worldwide rights to Proleukin, which is expected to enhance TIL therapy by providing immediate revenue and securing IL-2 supply. The company received positive FDA feedback regarding its Phase 3 TILVANCE-301 confirmatory trial for advanced melanoma, which seeks to support both accelerated and full approval of lifileucel. Additionally, promising clinical data from combination therapies in metastatic non-small cell lung cancer were reported. Iovance's strong cash position indicates financial stability to support ongoing operations and future growth.

Market Sentiment Analysis

POSITIVE FACTORS

  • Acquisition of Proleukin provides immediate and ongoing revenue.
  • Positive feedback from the FDA on the Phase 3 study in melanoma.
  • Strong cash position estimated at $477 million supports future operations.
  • Encouraging clinical data in treating metastatic non-small cell lung cancer.

Full Press Release Details

Iovance Biotherapeutics Provides Corporate,
Clinical, and Regulatory Updates
Acquisition of Worldwide Rights to Proleukin
Provides Immediate and Ongoing Revenue and Secures IL-2 Supply for Clinical and Future Commercial TIL Therapy
Positive FDA Feedback on Phase 3 Confirmatory
Study in Frontline Advanced (Metastatic or Unresectable) Melanoma
Positive Clinical Data in Anti-PD-1 Na ve
Metastatic Non-Small Cell Lung Cancer (NSCLC)
Biologics License Application (BLA) Submission
in Post-Anti-PD-1 Advanced Melanoma on Track to Complete in Q1 2023
Strengthened Cash Position to Fund Operating
SAN CARLOS, Calif., January 23, 2023 - Iovance
Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies (tumor infiltrating
lymphocyte, TIL, and peripheral-blood lymphocyte, PBL), today provided corporate, clinical, and regulatory updates.
Acquisition of Proleukin
Under a definitive agreement between Iovance and Clinigen Limited,
Iovance will acquire worldwide rights to Proleukin (aldesleukin), an interleukin-2 (IL-2) product used to promote T-cell activity
following TIL infusion. Iovance expects the benefits of this transaction to include immediate and future revenue, securing the IL-2 supply
chain and logistics surrounding TIL therapy administration, and lower cost of goods and clinical trial expenses for Proleukin used
Terms of the agreement include an upfront payment of 166.7 million,
a 41.7 million milestone payment upon first approval of lifileucel in advanced melanoma, and double-digit Proleukin global
sales royalties from Iovance to Clinigen. The transaction is expected to close in the first quarter of 2023, subject to required regulatory
approvals and clearances and other customary closing conditions.
Iovance is financing the acquisition with existing cash. As of January
20, 2023, Iovance's unaudited cash position is approximately $477.0 million, which includes net proceeds from an at-the market (ATM)
equity financing facility of approximately $227.1 million raised during the fourth quarter of 2022 and early 2023. In addition, Iovance
has agreed to terms for a secured line of credit of up to $100 million from Quogue Capital. These proceeds are expected to fund the acquisition
of Proleukin and Iovance's operating plan well into 2024.
CLINICAL AND REGULATORY UPDATES
Lifileucel in Advanced Melanoma
TILVANCE-301 Phase 3 Confirmatory Trial: During the fourth quarter
of 2022, Iovance reached agreement with the U.S. Food and Drug Administration (FDA) regarding the Phase 3 TILVANCE-301 trial of lifileucel
in combination with pembrolizumab in frontline advanced melanoma. The TILVANCE-301 trial will randomize 670 patients and will investigate
lifileucel in combination with pembrolizumab (experimental arm) compared with pembrolizumab monotherapy (control arm).
The FDA agreed to dual primary endpoints of objective response rate
(ORR) to support accelerated approval and progression free survival (PFS) to support full approval of lifileucel in frontline advanced
melanoma. The TILVANCE-301 confirmatory trial will also support full approval of lifileucel in post-anti-PD-1 advanced melanoma and is
expected to be well underway at the time of potential BLA approval for lifileucel. Further details will be shared later in 2023.
Updated results from nearly 20 patients treated in Cohort 1A of the
IOV-COM-202 trial of lifileucel in combination with pembrolizumab in frontline advanced melanoma remain consistent with previously reported
data1 demonstrating robust ORR by RECIST 1.1 and durability of response. Additional data will be shared later in 2023 and continue
to support the opportunity for lifileucel in frontline advanced melanoma.
Lifileucel in Anti-PD-1 Na ve Metastatic Non-Small Cell Lung
IOV-COM-202 Cohort 3A: Confirmed ORR by RECIST 1.1 of 47% (n=8/17)
was observed in patients treated with a combination of TIL therapy (LN-145) and pembrolizumab in Cohort 3A of the IOV-COM-202 trial. Responses
were observed regardless of PD-L1 status. Safety was consistent with other studies of Iovance TIL therapies in combination with pembrolizumab.
Study enrollment remains ongoing.
ORR by Clinical Subset: Cohort 3A comprises three distinct clinical
subsets of anti-PD-1 na ve metastatic NSCLC: 1) treatment-na ve, 2) post-chemotherapy, and 3) EGFR-mutant after prior
treatment with tyrosine kinase inhibitors (TKI). Response rates were highest in patients who were treatment-na ve (80% ORR; n=4/5)
and post-chemotherapy anti-PD-1 na ve (43% ORR, n=3/7) compared with EGFR-mutant after prior treatment with TKI (20% ORR,
n=1/5). Two patients achieved complete responses and remain on study (post-chemotherapy anti-PD-1 naive, n=1 and EGFR-mutant after
prior treatment with TKI, n=1). The observed differences in ORR between the patient subsets are informing the design of a subsequent potential
registration study. Detailed clinical results will be shared at a future medical meeting.
Regulatory Strategy: Iovance plans to meet with FDA in 2023
to discuss Cohort 3A results and a potential registration trial of lifileucel in frontline advanced NSCLC patients who are EGFR
wild-type. The proposed design will be a frontline maintenance study of standard-of-care pembrolizumab and limited duration chemotherapy
followed by treatment consisting of TIL therapy in combination with pembrolizumab compared with pembrolizumab monotherapy in responding
patients. This design takes advantage of the findings of Cohort 3A and has the potential to offer frontline advanced NSCLC patients improved
responses and PFS compared with single agent maintenance pembrolizumab.
The rolling BLA submission for lifileucel in post-anti-PD-1 advanced
melanoma commenced in August 2022 and is on track to complete during the first quarter of 2023.
Iovance will host a webcast on Monday, January 23, 2023, at 8:30 a.m.
ET to discuss these corporate, clinical and regulatory updates. To participate in the webcast, please register at https://register.vevent.com/register/BIb01d5a16742c4d99b3dfe1b02bad8147.
The live webcast and replay can be accessed in the Investors section of the company's website at ir.iovance.com.
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, that 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 registration 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

Frequently Asked Questions

What acquisition did Iovance Biotherapeutics announce?

Iovance announced the acquisition of worldwide rights to Proleukin.

What is the purpose of Proleukin in TIL therapy?

Proleukin promotes T-cell activity following tumor-infiltrating lymphocyte infusion.

What trial is Iovance conducting for lifileucel?

Iovance is conducting the Phase 3 TILVANCE-301 trial for lifileucel in melanoma.

When is the BLA submission for lifileucel expected to complete?

The BLA submission for lifileucel is on track to complete in Q1 2023.

What were the results for TIL therapy in NSCLC?

Cohort 3A showed a confirmed objective response rate of 47% in NSCLC patients.

Last updated: Jan 23, 2023