Iovance Biotherapeutics Expands Pipeline of TIL Therapies into Lung Cancer
December 13 2017 - 7:00AM
Moffitt Cancer Center Phase 1 Study Combining TIL and
Nivolumab Initiated in NSCLC Patients
Iovance Biotherapeutics, Inc. (NASDAQ:IOVA), a biotechnology
company developing novel cancer immunotherapies based on
tumor-infiltrating lymphocyte (TIL) technology, today announced
that patient enrollment has begun in a study combining TIL and
nivolumab in advanced non-small cell lung cancer (NSCLC) patients
in collaboration with researchers at H. Lee Moffitt Cancer Center
and Research Institute (Moffitt), Stand Up to Cancer and other
partners. The company also announced that a Phase 2 study in
PD-1/PDL-1 naïve NSCLC patients, sponsored by Iovance, in
collaboration with MedImmune, the global biologics research and
development arm of AstraZeneca, will initiate in the first half of
2018. The study with MedImmune will allow for enrollment of NSCLC
patients for treatment with LN-145 alone or in combination with
durvalumab.
“Lung cancer is the leading cause of death in cancer and the
second most common cancer in the United States. Five-year survival
for NSCLC remain under 20% despite recent advances in the field,”
said Dr. Maria Fardis, PhD, MBA, President and Chief Executive
Officer of Iovance Biotherapeutics. “The Phase 1 TIL and
nivolumab combination study is being conducted in collaboration
with the Moffitt Cancer Center, Stand Up To Cancer, as well as
support from Bristol-Myers Squibb and Prometheus Laboratories,1 and
speaks to the potential application of TIL technology in lung
cancer. MedImmune is a leader in development of immuno-oncology
therapy and we look forward to initiating our clinical
collaboration with them for this unique combination therapy in the
first half of next year.”
The initiated Phase 1 study (NCT03215810) is designed to enroll
up to 18 patients with advanced NSCLC.
NSCLC is associated with high mutational load in the tumor.
Results of TIL growth from this tumor type has been reported by
Iovance at the SITC 31st Annual Meeting in 2016. Impact of
treatment of NSCLC with TIL alone, as well as in combination with
durvalumab, will be explored in PD-1/PDL-1 naïve patients in the
Iovance Phase 2 study to be conducted in collaboration with
MedImmune. The Phase 2 multicenter study will enroll up to 24
patients and be composed of two cohorts to assess the efficacy and
safety of LN-145 alone and in combination with anti-PD-L1 inhibitor
durvalumab in patients with locally advanced or metastatic
NSCLC.
About Lung CancerLung cancer is the leading
cause of human cancer deaths worldwide, with approximately 1.7
million deaths reported in 2015, of which 80% to 85% were
attributed to non-small cell lung cancer (NSCLC). In 2017, there
were an estimated 222,500 new cases and 155,870 deaths due to lung
and bronchus cancer in the United States. In men and women, the
lifetime risk of developing lung cancer is about 1 in 14 and 1 in
17, respectively, including both smokers and nonsmokers.
Forward-Looking Statements Certain matters
discussed in this press release are “forward-looking statements”.
The Company 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. In
particular, the Company’s statements regarding trends and potential
future results are examples of such forward-looking statements. The
forward-looking statements include risks and uncertainties,
including, but not limited to, the success, timing and cost of the
Company’s ongoing clinical trials and anticipated clinical trials
for its current product candidates, including statements regarding
the timing of initiation and completion of the trials; the timing
of and its ability to obtain and maintain U.S. Food and Drug
Administration or other regulatory authority approval of, or other
action with respect to, its 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 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. 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 circumstance.
About Iovance Biotherapeutics, Inc. Iovance
Biotherapeutics, Inc. is a clinical-stage biotechnology
company focused on the development of cancer immunotherapy products
for the treatment of various cancers. The Company's lead product
candidate is an adoptive cell therapy using tumor-infiltrating
lymphocyte (TIL) technology being investigated for the treatment of
patients with metastatic melanoma, recurrent and/or metastatic
squamous cell carcinoma of the head and neck and recurrent and
metastatic or persistent cervical cancer. For more information,
please visit http://www.iovance.com.
1 More details about the collaboration can be found at:
https://www.moffitt.org/newsroom/press-release-archive/2017/stand-up-to-cancer-awards-moffitt-267-million-to-study-new-lung-cancer-immunotherapy/
Investor Relations Contact: Sarah McCabe Stern
Investor Relations, Inc. 212-362-1200 sarah@sternir.com
Media Contact: Evan Smith FTI Consulting
212-850-5622 evan.smith@fticonsulting.com
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