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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):
May 23, 2024
IOVANCE BIOTHERAPEUTICS, INC.
(Exact Name of Registrant as Specified inCharter)
Delaware
(State of Incorporation)
001-36860 75-3254381
Commission File Number (I.R.S. Employer Identification No.)
825 Industrial Road
,
Suite 400
San Carlos 94070
,
CA
(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 intendedto
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)).
Indicateby check mark whether the registrant is an emerging growth company as
defined in as defined in Rule 405 of the Securities Actof 1933 ((s)230.405 of
this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934
((s)240.12b-2 of this chapter).Emerging growth company
..
Ifan emerging growth company, indicate by check mark if the registrant has
elected not to use the extended transition period forcomplying 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 Name of each exchange on which
Symbol(s) registered
Common stock, par value $0.000041666 per value IOVA The Nasdaq Stock Market, LLC
Item 8.01. Other Events.
On May 23, 2024, IovanceBiotherapeutics, Inc. issued a press release
announcing updated clinical data for lifileucel in combination with
pembrolizumab in frontlineadvanced melanoma, as well as translational data,
for the upcoming 2024 American Society of Clinical Oncology Annual Meeting to
be heldMay 31 - June 4, 2024 at McCormick Place in Chicago, IL and online.
A copy of the press releaseis attached hereto as Exhibit 99.1 and is
incorporated by reference herein.
Item 9.01. FinancialStatements and Exhibits.
(d) Exhibits.
Exhibit Description
Number
99.1 Press Release dated May 23, 2024.
104 Cover Page Interactive Data File, formatted in Inline XBRL and included as Exhibit 101
SIGNATURES
Pursuant to therequirements of the Securities Exchange Act of 1934, as
amended, the registrant has duly caused this report to be signed on itsbehalf
by the undersigned hereunto duly authorized.
Iovance Biotherapeutics, Inc.
Dated: May 23, 2024 By: /s/ Frederick G. Vogt
Name: Frederick G. Vogt, Ph.D., J.D.
Title: Interim CEO and President, and General Counsel
Exhibit 99.1
Iovance Biotherapeutics Announces ClinicalData in
Frontline Advanced Melanoma at ASCO 2024 AnnualMeeting
Lifileucel TIL Cell Therapy in Combination withPembrolizumab Demonstrates
Deep, Durable Responses in Frontline AdvancedMelanoma Patients
in IOV-COM-202 Clinical Study
ASCO Oral Presentation to Highlight 65% ObjectiveResponse Rate (ORR)
and 30% Complete Response Rate
Nearly All Responses Remain Ongoing at a
Median Follow-up of 21.7 Months in the OralPresentation
Data in Published Abstract and Upcoming OralPresentation
StronglySupport Ongoing TILVANCE-301 Phase 3 Trial
SAN CARLOS, Calif., May 23, 2024 --
Iovance Biotherapeutics,Inc. (NASDAQ: IOVA), a commercial biotechnology
company focused on innovating, developing, and delivering novel polyclonal
tumor infiltratinglymphocyte (TIL) therapies for patients with cancer, today
announced updated clinical data for lifileucel in combination with
pembrolizumabin frontline advanced melanoma, as well as translational data,
for the upcoming 2024 ASCO Annual Meeting to be held May 31 - June4, 2024, at
McCormick Place in Chicago, IL and online.
Clinical Data in Frontline Advanced Melanoma (Cohort 1A in IOV-COM-202Trial)
Positive results from Cohort 1A in the IOV-COM-202 trial were publishedin an
abstract
1
and will be highlighted in an upcoming oral presentation at ASCO.
Unprecedented response rates, aswell as deep and durable responses, were
observed in patients with frontline advanced melanoma who were naive to immune
checkpointinhibitor (ICI) therapy. These results strongly support the ongoing
Phase 3 TILVANCE-301 clinical trial.
ASCO Oral Presentation Highlights
. A recent data cut included 23 patients with a median follow up of 21.7 months.
2
. Confirmed ORR was 65.2%, including 7 (30.4%) complete responses and 8 (34.8%)partial responses by RECIST v1.1.
. All evaluable patients demonstrated regression of their target lesions.
. Nearly all responses remained ongoing. The duration of response was 12+
monthsfor 8 responders (53.3%) and 6+ months for 11 responders (73.3%).
. As a one-time treatment, lifileucel's safety profile was differentiatedfrom continuous ICI combination regimens.
. Treatment-emergent adverse events were consistent with the underlying diseaseand known safety
profiles of pembrolizumab monotherapy, nonmyeloablative lymphodepletion, and interleukin-2.
Friedrich Graf Finckenstein, M.D., Chief Medical Officer of Iovance,stated,
"The compelling response rates, including a 30.4% complete response rate, and
depth and durability of responses for lifileucelin combination with
pembrolizumab strongly support our strategy in frontline advanced melanoma.
Expanding TIL cell therapy into earliertreatment settings is a top priority
for Iovance. The positive data are highly encouraging for the anticipated ORR
results in our ongoingTILVANCE-301 trial. A planned early interim analysis of
ORR, a dual primary endpoint in TILVANCE-301, may support an accelerated
approvalin the frontline setting, with full approval supported by progression
free survival."
The clinical and safety data from Cohort 1A continue to reinforcethe rationale
for the TILVANCE-301 trial.
TILVANCE-301
is a global, randomized, registrational Phase 3 trial to support acceleratedand
full U.S. approvals of lifileucel in combination with pembrolizumab in
frontline advanced melanoma. In addition, the ORR endpointin TILVANCE-301
supports full approval of lifileucel monotherapy (AmtagviTM) in post-anti-PD-1
melanoma. The U.S. Food and DrugAdministration (FDA) has agreed to the design
of the TILVANCE-301 trial, including dual-primary endpoints of ORR and
progression freesurvival. Iovance plans to conduct an early interim analysis
of ORR as the potential basis for regulatory submission and approvals.
Iovance Presentation and Posters at ASCO Annual Meeting
. Oral Presentation: Efficacy and safety of lifileucel, an autologous
tumor-infiltrating lymphocyte cell therapy, and pembrolizumab in
patients with immune checkpoint inhibitor-naive unresectable or
metastatic melanoma: updated results from IOV-COM-202 Cohort 1A (
Abstract 9505
)
o Session: Melanoma/Skin Cancers
Friday, May 31, 2024, 2:45 - 5:45p.m. CDT
. Poster: IOV-3001, a modified interleukin-2 fusion protein, for
potential use in tumor-infiltrating lymphocyte cell therapy regimens (
Abstract 2552
)
o Session: Developmental Therapeutics-Immunotherapy
Saturday, June 1, 2024, 9:00 a.m. -12:00 p.m. CDT
. Poster: Dynamics of circulating cytokines and chemokines during and aftertumor-infiltrating
lymphocyte cell therapy with lifileucel in advanced melanoma patients
o Session: Melanoma/Skin Cancers (
Abstract 9594
)
Saturday, June 1, 2024, 1:30 -4:30 p.m. CDT
ASCO 2024 Webcast
Iovance executives and key opinion leaders (KOLs) will discuss ASCO data
highlights and perspectives on the Amtagvi commercial launchduring an audio
webcast on Friday, May 31, 2024 at 6:15 p.m. CDT (7:15 p.m. EDT). To listen to
the live or archived audio webcast, pleaseregister at
https://edge.media-server.com/mmc/p/x4v33mwt/
. The live and archived webcast can be accessed in the Investors sectionof the
Company's website, IR.Iovance.com for one year.
About/Iovance Biotherapeutics, Inc.
Iovance Biotherapeutics, Inc.
aims to be the global leaderin innovating, developing, and delivering tumor
infiltrating lymphocyte (TIL) therapies for patients with cancer. We are
pioneering atransformational approach to cure cancer by harnessing the human
immune system's ability to recognize and destroy diverse cancercells in each
patient. The
Iovance TIL platform
has demonstrated promising clinical data across multiple solid tumors.
Iovance'sAmtagviTM is the first FDA-approved T cell therapy for a solid tumor
indication. We are committed to continuous innovation in celltherapy,
including gene-edited cell therapy, that may extend and improve life for
patients with cancer. For more information, pleasevisit
www.iovance.com
.
AmtagviTM and its accompanying design marks, Proleukin
(R)
,Iovance
(R)
, and IovanceCaresTM are trademarks and registered trademarks of Iovance
Biotherapeutics, Inc. orits subsidiaries. All other trademarks and registered
trademarks are the property of their respective owners.
Forward-Looking Statements
Certain matters discussed in this press releaseare "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-lookingstatements. Forward-looking statements are
based on assumptions and assessments made in light of management's experience
and perceptionof historical trends, current conditions, expected future
developments, and other factors believed to be appropriate. Forward-lookingstate
ments in this press release are made as of the date of this press release, and
we undertake no duty to update or revise any suchstatements, whether as a
result of new information, future events, or otherwise. Forward-looking
statements are not guarantees of futureperformance and are subject to risks,
uncertainties, and other factors, many of which are outside of our control,
that may cause actualresults, levels of activity, performance, achievements,
and developments to be materially different from those expressed in or
impliedby these forward-looking statements. Important factors that could cause
actual results, developments, and business decisions to differmaterially 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 relatedto our
ability to successfully commercialize our products, including Amtagvi, for
which we have obtained U.S. Food and Drug Administration("FDA") approval, and
Proleukin, for which we have obtained FDA and European Medicines Agency
("EMA") approval;the risk that the EMA or other ex-U.S. regulatory authorities
may not approve or may delay approval for our marketing authorization
applicationsubmission for lifileucel in metastatic melanoma; the acceptance by
the market of our products, including Amtagvi and Proleukin, and theirpotential
pricing and/or reimbursement by payors, if approved (in the case of our
product candidates), in the U.S. and other internationalmarkets and whether
such acceptance is sufficient to support continued commercialization or
development of our products, including Amtagviand Proleukin, or product
candidates, respectively; the risk whether the number of patients treated
and/or ATCs is an appropriate measureof commercial success and/or recognized
revenue; future competitive or other market factors may adversely affect the
commercial potentialfor Amtagvi or Proleukin; the risk regarding our ability
or inability to manufacture our therapies using third party manufacturers orat
our own facility, including our ability to increase manufacturing capacity at
such third party manufacturers and our own facility,may adversely affect our
commercial launch; the results of clinical trials with collaborators using
different manufacturing processesmay not be reflected in our sponsored trials;
the risk regarding the successful integration of the recent Proleukin
acquisition; the riskthat the successful development or commercialization of
our products, including Amtagvi and Proleukin, may not generate sufficient
revenuefrom product sales, and we may not become profitable in the near term,
or at all; the risks related to the timing of and our ability tosuccessfully
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 otherregulatory authorities may support registrational
studies and subsequent approvals by the FDA, EMA, or other regulatory
authorities, includingthe 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 ourongoing
clinical trials or subgroups within these trials or in other prior trials or
cohorts; the risk that enrollment may need to beadjusted for our trials and
cohorts within those trials based on FDA and other regulatory agency input;
the risk that the changing landscapeof care for cervical cancer patients may
impact our clinical trials in this indication; the risk that we may be
required to conduct additionalclinical trials or modify ongoing or future
clinical trials based on feedback from the FDA, EMA, or other regulatory
authorities; therisk that our interpretation of the results of our clinical
trials or communications with the FDA, EMA, or other regulatory authoritiesmay
differ from the interpretation of such results or communications by such
regulatory authorities (including from our prior meetingswith the FDA
regarding our non-small cell lung cancer clinical trials); the risk that
clinical data from ongoing clinical trials of Amtagviwill 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
withinour control.
1
Abstract data cut off: December22, 2023
2
Oral presentation data cut off:April 17, 2024
CONTACTS
Iovance Biotherapeutics, Inc.
:
Sara Pellegrino, IRC
SVP, Investor Relations & Corporate Communications
650-260-7120 ext. 264
Sara.Pellegrino@iovance.com
Jen Saunders
Senior Director, Investor Relations & Corporate Communications
267-485-3119
Jen.Saunders@iovance.com
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