Iovance Biotherapeutics Announces First Patient Dosed in Cohort 4 of Pivotal InnovaTIL-01 Study of Lifileucel in Metastatic M...
April 02 2019 - 7:00AM
- Patient dosing commenced in pivotal metastatic
melanoma cohort -
Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage
biotechnology company developing novel cancer immunotherapies based
on tumor-infiltrating lymphocyte (TIL) technology, today announced
that first patient has been dosed in Cohort 4, the pivotal cohort
of the innovaTIL-01 (C-144-01) study of lifileucel. Cohort 4 is
designed to enroll 75 patients with advanced melanoma.
“Dosing of the first patient in Cohort 4, the pivotal arm of our
melanoma program, is a significant step toward registration of TIL
therapy,” commented Maria Fardis, Ph.D., president and chief
executive officer of Iovance. “Complete enrollment of this cohort
is expected in early 2020 and we remain on track to file a
Biologics License Application for regulatory approval of lifileucel
in late 2020.”
InnovaTIL-01 (NCT02360579) is a pivotal phase 2 global
multicenter study evaluating the safety and efficacy of Iovance’s
autologous lifileucel TIL therapy for treatment of patients with
metastatic melanoma. The study is currently enrolling in the United
States and Europe. To date, Iovance has activated 39 clinical sites
in the United States and Europe. Additional information on this
study is available at
https://clinicaltrials.gov/ct2/show/NCT02360579.
About Iovance Biotherapeutics, Inc.
Iovance Biotherapeutics intends to commercialize lifileucel, an
autologous cell therapy product using TIL technology that amplifies
the body’s own immune response to eradicate solid tumors or attack
blood cancers. The company is currently conducting the pivotal
study innovaTIL-01 in patients with metastatic melanoma. In
addition, the company’s TIL therapies are being investigated for
the treatment of patients with locally advanced, recurrent or
metastatic cancers including cervical, head and neck, and non-small
cell lung 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”).
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 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 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; the
strength of Company’s product pipeline; the successful
implementation of the Company’s research and development programs
and collaborations; 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, including efficacy and safety results, from
ongoing Phase 2 studies may not be reflected in the final analyses
of these trials, including new cohorts within these trials, and may
not be supportive of product approval; the FDA or other regulatory
authorities may potentially delay the timing of their approval of,
or other action with respect to, the Company’s product candidates;
the Company’s ability to address FDA or other regulatory authority
requirements relating to its clinical programs and registrational
plans, such requirements including, but not limited to, clinical
and safety requirements as well as manufacturing and control
requirements; risks related to the Company’s accelerated FDA review
designations; and the ability of the Company to manufacture its
therapies using third party manufacturers. 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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