Iovance Biotherapeutics, Inc. (NASDAQ:IOVA), a biotechnology
company developing novel cancer immunotherapies based on
tumor-infiltrating lymphocyte (TIL) technology, today
announced early efficacy and safety data from Cohort 2 of the
ongoing Phase 2 LN-144 metastatic melanoma trial (C-144-01). These
data, being presented as a late-breaking poster (Poster #515) on
Friday, November 10, 2017 at the Society for Immunotherapy of
Cancer (SITC) 32nd Annual Meeting in National Harbor, Maryland,
show that administration of the company’s Generation 2 (Gen 2)
manufacturing process in nine efficacy-evaluable metastatic
melanoma patients resulted in a disease control rate (DCR) of 78%,
which includes 3 confirmed partial responders (PRs) and a fourth PR
awaiting confirmation. These patients had four median prior
therapies. The Gen 2 manufacturing process reduces the process time
to 22 days and the cell product is cryopreserved for ease of
administration and handling.
“The new study findings presented at SITC indicate encouraging
preliminary efficacy from patients in Cohort 2 with advanced
metastatic melanoma disease, who were treated with our
cryopreserved TIL product LN-144,” said Maria Fardis, PhD, MBA,
Iovance Biotherapeutics President and Chief Executive Officer. “We
are excited to be able to offer patients a TIL product manufactured
with a significantly shorter process, minimizing the time a patient
has to wait to receive their TIL. The cryopreservation of the
product further offers the clinical sites flexibility of scheduling
the patient dosing. The reduction in duration of manufacturing will
reduce our manufacturing costs as well. We intend to make the
decision regarding which manufacturing process to utilize for our
ongoing and future clinical trials by year-end and in advance of
initiation of our regulatory interactions.”
In addition to the late-breaking poster, a poster will be
presented on the new Gen 2 manufacturing protocol, highlighting key
improvements around the current high throughput commercial
manufacturing method (Poster #203). A third poster will demonstrate
utility of a new reagent used for TIL expansion and effector
function (Poster #357), and a fourth poster will provide data
regarding investigation of key quality attributes of TIL product
(Poster #194). The company will also present two posters in the
Clinical Trials in Progress session that include the design of
LN-145 in head and neck and cervical cancer. The details of the
poster presentations are as follows:
Cellular Therapy Approaches Late-Breaking
Abstract
Title: Novel Cryopreserved Tumor Infiltrating
Lymphocytes (LN-144) Administered to Patients with Metastatic
Melanoma Demonstrates Efficacy and Tolerability in a Multicenter
Phase 2 Clinical Trial Authors: Sarnaik, et al.
Poster #: 515 Presentation date:
Friday, November 10, 2017
Key Takeaways:
- Preliminary efficacy data from nine patients in Cohort 2 shows
a DCR of 78% including three partial responses and a fourth
awaiting confirmation.
- Preliminary data to date show that the safety profile of Gen 2
LN-144 therapy is similar to Gen 1 LN-144 therapy previously
presented at ASCO 2017. The most common adverse events reported
were pyrexia, anaemia and nausea.
Cellular Therapy Approaches Abstracts
Title: A Cryopreserved TIL Product, LN-144,
Generated with an Abbreviated Method Suitable for High Throughput
Commercial Manufacturing Exhibits Favorable Quality Attributes for
Adoptive Cell Transfer Authors: Wardell, et al.
Poster #: 203 Presentation
date: Friday, November 10, 2017
Key Takeaways:
- The Iovance Generation 2 manufacturing process produces a
potentially potent TIL product with comparable quality attributes
to the Generation 1 manufacturing process.
- The abbreviated 22-day expansion platform allows for the rapid
generation of TIL product for patients in urgent need of therapy.
The cryopreserved product also offers flexibility of patient
dosing.
- The cryopreserved drug product introduces critical logistical
efficiencies allowing flexibility in distribution, and overcomes
traditional barriers to the wider application of TIL
therapy.
Title: Studies of Key Quality Attributes for
TIL Product, LN-144 Authors: Ritthipichai, et al.
Poster #: 194 Presentation date:
Saturday, November 11, 2017
Key Takeaways:
- Commercial manufacturing of TIL products will require a robust
analytical platform to ensure consistent delivery of products
meeting the critical quality attributes of cellular
therapeutics.
- Study shows TIL products manufactured by Iovance are composed
of greater than 99% CD45+CD3+ T cells.
- Residual melanoma cells in TIL products were below the limit of
detection using a specialized assay developed for this
assessment.
Immune Modulation, Cytokines, and Antibodies
Abstract
Title: The T-cell Growth Factor Cocktail
IL-2/IL-15/IL-21 Enhances Expansion and Effector Function of
Tumor-Infiltrating T cells in a Novel Process Developed by Iovance
Authors: Simpson-Abelson, et al.
Poster #: 357 Presentation date:
Friday, November 10, 2017
Key Takeaways:
- This study demonstrates the positive effects of adding IL-15
and IL-21 to the standard IL-2-containing cell culture in an ex
vivo TIL generation protocol.
Clinical Trials (In Progress) Abstracts
Title: A Phase 2 Study to Evaluate the Safety
and Efficacy Using Autologous Tumor Infiltrating Lymphocytes
(LN-145) in Patients with Recurrent and/or Metastatic Squamous Cell
Carcinoma of the Head and Neck Authors: Leidner,
et al. Poster #: 221 Presentation
date: Friday, November 10, 2017
Title: A Phase 2, Multicenter Study to Evaluate
the Efficacy and Safety Using Autologous Tumor Infiltrating
Lymphocytes (LN-145) in Patients with Recurrent, Metastatic, or
Persistent Cervical Carcinoma Authors: Jazaeri, et
al. Poster #: 220 Presentation
date: Saturday, November 11, 2017
Additional information including the presentation schedule and
full abstracts can be found on the conference website:
http://www.sitcancer.org/2017/attendees/annual-meeting/schedule.
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 efficacy, safety, tolerability
and cost of the Gen 2 manufacturing process, 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.
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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