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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
Current Report
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (date of earliest event reported): December 27, 2023
IOVANCE BIOTHERAPEUTICS, INC.
(Exact Name of Registrant as Specified in
Charter)
Delaware |
(State of Incorporation) |
|
001-36860 |
|
75-3254381 |
Commission File Number |
|
(I.R.S. Employer Identification No.) |
|
|
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825
Industrial Road, Suite 400 |
|
|
San Carlos, CA |
|
94070 |
(Address of Principal Executive Offices) |
|
(Zip Code) |
|
|
|
(650) 260-7120 |
(Registrant’s Telephone Number, Including Area Code) |
|
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
|
¨ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425). |
|
¨ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12). |
|
¨ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)). |
|
¨ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)). |
Indicate
by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act
of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ¨
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for
complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
Trading
Symbol(s) |
Name of each exchange on which
registered |
Common stock, par value $0.000041666 per value |
IOVA |
The Nasdaq Stock Market, LLC |
Item 8.01. Other Events.
On December 27, 2023,
Iovance Biotherapeutics, Inc. issued a press release announcing a clinical program update for LN-145 in non-small cell lung cancer.
A copy of the press release
is attached hereto as Exhibit 99.1 and is incorporated by reference herein.
Item 9.01. Financial
Statements and Exhibits.
(d) Exhibits.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its
behalf by the undersigned hereunto duly authorized.
|
Iovance Biotherapeutics, Inc. |
|
|
|
|
|
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Dated: December 27, 2023 |
By: |
/s/ Frederick G. Vogt |
|
Name: |
Frederick G. Vogt, Ph.D., J.D. |
|
Title: |
Interim CEO and General Counsel |
Exhibit 99.1
Iovance Biotherapeutics Announces Clinical Program Update for LN-145
in Non-Small Cell Lung Cancer
December 27, 2023
SAN CARLOS, Calif., Dec. 27, 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, today announced a clinical program update for
LN-145 TIL therapy in non-small lung cancer (NSCLC).
The
U.S. Food and Drug Administration (FDA) placed a clinical hold on the IOV-LUN-202 trial on December 22, 2023, in response to a recently
reported Grade 5 (fatal) serious adverse event potentially related to the non-myeloablative lymphodepletion
pre-conditioning regimen. IOV-LUN-202 is investigating LN-145 in patients who have progressed on or after chemotherapy and anti-PD-1 therapy
for advanced (unresectable or metastatic) non-small cell lung cancer (NSCLC) without EGFR, ROS or ALK genomic mutations and had received
at least one line of an FDA-approved targeted therapy if indicated by other actionable tumor mutations. These patients have a poor prognosis,
limited treatment options, and a real-world overall survival of less than six months.1 The
clinical hold for IOV-LUN-202 has no impact on any other Iovance clinical trials and is independent of the FDA’s Priority Review
of the biologics license application (BLA) for lifileucel in advanced melanoma. The BLA remains on track toward the Prescription Drug
User Fee Act (PDUFA) action date of February 24, 2024.
Iovance will pause enrollment and the LN-145 TIL treatment regimen
for new patients in IOV-LUN-202 during the clinical hold. Patients previously treated with LN-145 in the IOV-LUN-202 trial will continue
to be monitored and followed according to the trial protocol. Patients who have already undergone tumor resection will continue to receive
the LN-145 TIL treatment regimen with additional precautions and risk mitigations.
Preliminary data for IOV-LUN-202
was 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. These results from IOV-LUN-202 in previously treated patients with
advanced NSCLC continue to support the potential benefit of one-time TIL therapy, including the opportunity for more durable responses
than available second line chemotherapies. Iovance is committed to bringing TIL therapy to patients with NSCLC and to continuing activities
that support regulatory approval in this indication.
Friedrich Graf Finckenstein, M.D., Chief Medical Officer of Iovance,
stated, “Iovance remains dedicated to addressing a significant unmet medical need for patients with advanced NSCLC, who have poor
prognosis following disease progression and limited treatment options. We will work with the FDA to safely resume enrollment in the IOV-LUN-202
trial as soon as possible.”
More than 700 patients have been treated with Iovance TIL therapies
across multicenter clinical trials in solid tumor cancers, including more than 100 patients treated with LN-145 for lung cancer. In clinical
trial results reported to date, treatment-emergent adverse events were consistent with the underlying disease and known adverse event
profiles of non-myeloablative lymphodepletion and interleukin-2.
1National Cancer Database,
NSCLC survival from >1 million patients assessed. Lou Y et al. Survival trends among non-small-cell lung cancer patients over a decade:
impact of initial therapy at academic centers. Cancer Med. 2018.
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, or maintain U.S. Food and Drug Administration (“FDA”), European
Medicines Agency (“EMA”), 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, EMA, or other regulatory authority approval;
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 the prior pre-BLA meeting with
the FDA and/or regarding our prior meetings with the FDA regarding our NSCLC clinical trials); the risk that the FDA, EMA, or other regulatory
authorities may not approve or may delay approval for 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, in the U.S. and other international markets;
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 regarding the successful integration of the recent Proleukin acquisition; the risk that the successful development
or commercialization of our products may not generate sufficient revenue from product sales, and we may not become profitable in the near
term, or at all; 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.
CONTACTS
Iovance Biotherapeutics,
Inc:
Sara Pellegrino, IRC
Senior Vice President, Investor Relations & Corporate Communications
650-260-7120 ext. 264
Sara.Pellegrino@iovance.com
Jen Saunders
Director, Investor Relations & Public Relations
267-485-3119
Jen.Saunders@iovance.com
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