Iovance Biotherapeutics Obtains License to Develop and Commercialize a Novel IL-2 Analog
January 12 2020 - 4:30PM
Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage
biotechnology company developing novel T cell-based cancer
immunotherapies, today announced that the company has obtained a
license from Novartis to develop and commercialize an antibody
cytokine engrafted protein, referred to as IOV-3001. Under the
agreement, Iovance will pay an upfront payment to Novartis as well
as low single digit milestones involved in initiation of patient
dosing in various phases of clinical development for IOV-3001 and
approval of the product in the U.S., EU and Japan. Novartis is also
entitled to low-to-mid single digit royalties from commercial sales
of the product.
“As we progress our development efforts to commercialize TIL, we
continue exploring ways to optimize the TIL treatment regimen which
includes administration of IL-2,” said Maria Fardis, Ph.D., MBA,
Iovance’s President and Chief Executive Officer. “We therefore
see a great strategic and long-term fit for Iovance to pursue
development of a targeted and selective IL-2 analog with better
pharmacokinetic properties. This product further adds to our
research efforts in making safe and more potent TIL products with
the potential opportunity for chronic administration.”
IOV-3001 is an engineered IL-2 CDR graft which targets IL2R
beta-gamma-expressing cells and limits IL2R
alpha-beta-gamma-dependent Treg activation. The protein has an
improved half-life leading to a better exposure while minimizing
Cmax possibly reducing the side effects associated with IL-2
protein. Iovance will focus on GMP manufacturing of IOV-3001 during
2020 and may initiate IND-enabling activities as early as
2021.
About Iovance Biotherapeutics, Inc.
Iovance Biotherapeutics aims to improve patient care by making T
cell-based immunotherapies broadly accessible for the treatment of
patients with solid tumors and blood cancers. Tumor infiltrating
lymphocyte (TIL) therapy uses a patient’s own immune cells to
attack cancer. TIL cells are extracted from a patient’s own tumor
tissue, expanded through a proprietary process, and infused back
into the patient. After infusion, TIL reach tumor tissue, where
they attack tumor cells. The company is currently conducting
pivotal studies in patients with metastatic melanoma and advanced
cervical cancer. In addition, the company’s TIL therapies are being
investigated for the treatment of patients with locally advanced,
recurrent or metastatic cancers including head and neck and
non-small cell lung cancer. A clinical study to investigate
Iovance’s T cell therapy for blood cancers called peripheral blood
lymphocyte (PBL) therapy is being initiated. 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”).
We may, in some cases, use terms such as “predicts,” “believes,”
“potential,” “continue,” “estimates,” “anticipates,” “expects,”
“plans,” “intends,” “may,” “could,” “might,” “will,” “should” or
other words that convey uncertainty of future events or outcomes to
identify these forward-looking statements. The forward-looking
statements include, but are not limited to, risks and uncertainties
relating to the success, timing, projected enrollment,
manufacturing and production capabilities, and cost of our ongoing
clinical trials and anticipated clinical trials for our current
product candidates (including both Company-sponsored and
collaborator-sponsored trials in both the U.S. and Europe), such as
statements regarding the timing of initiation and completion of
these trials; the timing of and our ability to successfully submit,
obtain and maintain FDA or other regulatory authority approval of,
or other action with respect to, our product candidates, including
those product candidates that have been granted breakthrough
therapy designation (“BTD”) or regenerative medicine advanced
therapy designation (“RMAT”) by the FDA and new product candidates
in both solid tumor and blood cancers; the strength of the
Company’s product pipeline; the successful implementation of the
Company’s research and development programs and collaborations; the
Company’s ability to obtain tax incentives and credits; the
guidance provided for the Company’s future cash, cash equivalent,
and short term investment positions; the success of the Company’s
manufacturing, license or development agreements; the acceptance by
the market of the Company’s product candidates, if approved; and
other factors, including general economic conditions and regulatory
developments, not within the Company’s control. The factors
discussed herein could cause actual results and developments to be
materially different from those expressed in or implied by such
statements. Actual results may differ from those set forth in this
press release due to the risks and uncertainties inherent in the
Company’s business, including, without limitation: the preliminary
clinical results, which may include efficacy and safety results,
from ongoing Phase 2 studies may not be reflected in the final
analyses of these trials or subgroups within these trials; a slower
rate of enrollment may impact the Company’s clinical trial
timelines; enrollment may need to be adjusted for the Company’s
trials and cohorts within those trials based on FDA and other
regulatory agency input; the new version of the protocol which
further defines the patient population to include more advanced
patients in the Company’s cervical cancer trial may have an adverse
effect on the results reported to date; the data within these
trials may not be supportive of product approval; changes in
patient populations may result in changes in preliminary clinical
results; the Company’s ability or inability to address FDA or other
regulatory authority requirements relating to its clinical programs
and registrational plans, such requirements including, but not
limited to, clinical, safety, manufacturing and control
requirements; the Company’s interpretation of communications with
the FDA may differ from the interpretation of such communications
by the FDA; risks related to the Company’s ability to maintain and
benefit from accelerated FDA review designations, including BTD and
RMAT, which may not result in a faster development process or
review of the Company’s product candidates (and which may later be
rescinded by the FDA), and does not assure approval of such product
candidates by the FDA or the ability of the Company to obtain FDA
approval in time to benefit from commercial opportunities; the
ability or inability of the Company to manufacture its therapies
using third party manufacturers or its own facility may adversely
affect the Company’s potential commercial launch; and additional
expenses may decrease our estimated cash balances and increase our
estimated capital requirements. A further list and description of
the Company’s risks, uncertainties and other factors can be found
in the Company’s most recent Annual Report on Form 10-K and the
Company’s subsequent filings with the Securities and Exchange
Commission. Copies of these filings are available online at
www.sec.gov or www.iovance.com. The forward-looking statements are
made only as of the date of this press release and the Company
undertakes no obligation to publicly update such forward-looking
statements to reflect subsequent events or circumstances.
Investor Relations Contacts: Annie
ChangSolebury Trout646-378-2972achang@troutgroup.com
Chad RubinSolebury Trout646-378-2947crubin@troutgroup.com
Media Relations Contact: Rich AllanSolebury
Trout646-378-2958rallan@troutgroup.com
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