Provides Update on Additional Antibody Programs Against TIM-3 and
LAG-3
Enumeral Biomedical Holdings, Inc. (OTCQB:ENUM), a biotechnology company
focused on discovering and developing novel antibody immunotherapies
that help the immune system fight cancer and other diseases, today
announced important progress in its anti-PD-1 antibody program. Enumeral
also provided an update on the progress of additional programs in the
Company’s R&D pipeline, including its TIM-3 and LAG-3 antibody programs.
Earlier this year, Enumeral announced the identification of antibodies
that appear to bind to the PD-1 inhibitory checkpoint protein in a
manner different from that of currently marketed anti-PD-1 antibodies,
while retaining activity in cell-based assays. Today Enumeral reported
that these novel antibodies do not appear to compete with currently
marketed antibodies for binding to PD-1, nor do they appear to compete
with PD-L1, providing further evidence of a differentiated mechanism of
action. Enumeral presented these and related findings during the recent
CRI-CIMT-EATI-AACR Inaugural International Cancer Immunotherapy
Conference and the Biopharm America Conference. The Company’s poster and
presentation from those respective conferences are available on
Enumeral’s website.
“Since these antibodies do not compete with PD-L1, yet still display
activity in relieving the immunosuppressive effects of PD-L1, they may
prove useful in treating patients who have failed prior PD-1 therapy.
Further, this potentially distinct class might be synergistic when
combined with other PD-1 pathway-directed therapies, including
anti-PD-L1 therapy, which we are planning to test in preclinical
models,” commented Arthur H. Tinkelenberg, Ph.D., President and Chief
Executive Officer of Enumeral.
Enumeral has isolated and sequenced more than 300 anti-PD-1 antibodies
from primary B cells. The Company has humanized two lead antibodies and
tested them in cell-based assays. As reported at the recent
immunotherapy meeting, Enumeral’s novel family of antibodies exhibits a
higher level of T cell activation in mixed lymphocyte reaction (MLR) and
other assays than associated with currently-marketed antibodies,
including:
-
Enumeral’s lead antibodies demonstrated increased interferon gamma
production as shown by MLR assay, which is designed to assess T cell
effector function using primary human immune cells.
-
These antibodies also demonstrated dose-dependent increases in T cell
CD25 expression.
“This activity may be partially responsible for the elevated production
of interferon gamma, perhaps through an autocrine IL-2 signaling
mechanism, in contrast to other types of antibodies, which do not appear
to have an effect on CD25 expression. Based on the evidence in the
literature, we have had a strong rationale to pursue an alternative
approach to PD-1 antagonism with the goal of improving initial response
rates in patients treated with anti-PD-1 therapy,” noted Cokey Nguyen,
Ph.D., Enumeral’s Vice President of Research and Development.
“Approved antagonists do not appear to exhibit dose-dependent
pharmacologic effects, and their reported affinities for the PD-1
protein vary widely, which suggests to us that the mechanism of action
of these agents is not fully understood. Therefore, there might be an
opportunity to identify a potential ‘best in class’ agent. Based on our
industry-leading discovery platform, we set out to find mechanistically
distinct antibodies that exhibited enhanced function in immunomodulation
assays,” Dr. Nguyen continued.
Enumeral is further investigating the mechanism of action of these
differentiated antibodies, and has initiated testing in immuno-humanized
mouse models of cancer, which enable testing of PD-1 modulatory
therapies. The Company expects data from these studies to be available
in December 2015.
“We set out to use our platform technology to identify novel potential
‘best-in-class’ antibodies that would improve immunotherapy response
rates in the initial treatment of cancer. We are excited by the
potential for these novel antibodies to broaden the effectiveness of
checkpoint therapy by providing PD-1 antibodies with an alternative
mechanism of action,” added Dr. Tinkelenberg.
In Enumeral’s TIM-3 program, the Company has isolated 124 TIM-3 binding
antibodies to date. Enumeral’s bioinformatics analysis indicates
desirable diversity, with the antibodies falling into 42 distinct clades
that bind to TIM-3. Enumeral plans to apply its unique approach to
cellular immune response profiling to further understand the utility of
these different antibodies for modulation of different tumor
infiltrating lymphocytes.
Enumeral believes antibodies that block TIM-3 may potentiate anti-cancer
immune responses, either as a monotherapy or in combination with other
therapies, including other immune checkpoint-targeted drugs. The Company
currently anticipates nominating lead clones in the fourth quarter of
2015, and beginning the humanization process by the end of this year.
In Enumeral’s LAG-3 program, the Company has isolated 102 LAG-3 binding
antibodies that fall into 40 distinct clades that bind to LAG-3. The
Company is currently in the process of selecting antibody clones for
further characterization.
About Enumeral
Enumeral is a biopharmaceutical company discovering and developing novel
antibody immunotherapies that help the immune system fight cancer and
other diseases. The Company is building a pipeline focused on
next-generation checkpoint modulators, with initial targets including
PD-1, TIM-3, LAG-3, OX40, and VISTA. In developing these agents,
Enumeral’s researchers apply a proprietary immune profiling technology
platform that measures functioning of the human immune system at the
level of individual cells, providing key insights for candidate
selection and validation. For more information on Enumeral, please visit www.enumeral.com.
Forward Looking Statements Disclosure
This press release contains certain “forward-looking statements” within
the meaning of the Private Securities Litigation Reform Act of 1995, as
amended. Such statements reflect current beliefs of Enumeral Biomedical
Holdings, Inc. (“Enumeral”) with respect to future events and involve
known and unknown risks, uncertainties, and other factors affecting
operations, market growth, Enumeral’s stock price, services, products
and licenses. No assurances can be given regarding the achievement of
future results, and although Enumeral believes that the expectations
reflected in these forward-looking statements are based on reasonable
assumptions, actual results may differ from the assumptions underlying
the statements that have been made regarding anticipated events. Factors
that may cause actual results, performance or achievements, or industry
results to differ materially from those contemplated by such
forward-looking statements include, among others, the risks that (a)
Enumeral’s expectations regarding market acceptance of the Company’s
business in general and the Company’s ability to penetrate the antibody
discovery and development fields in particular, as well as the timing of
such acceptance, (b) Enumeral’s ability to attract and retain management
with experience in biotechnology and antibody discovery and similar
emerging technologies, (c) the scope, validity and enforceability of
Enumeral’s and third party intellectual property rights, (d) Enumeral’s
ability to raise capital when needed and on acceptable terms and
conditions, (e) Enumeral’s ability to comply with governmental
regulation, (f) the intensity of competition, (g) changes in the
political and regulatory environment and in business and fiscal
conditions in the United States and overseas and (h) general economic
conditions.
More detailed information about Enumeral and risk factors that may
affect the realization of forward-looking statements, including
forward-looking statements in this press release, is set forth in
Enumeral’s filings with the Securities and Exchange Commission. Enumeral
urges investors and security holders to read those documents free of
charge at the Commission’s website at http://www.sec.gov.
Forward-looking statements speak only as to the date they are made, and
except for any obligation under the U.S. federal securities laws,
Enumeral undertakes no obligation to publicly update any forward-looking
statement as a result of new information, future events or otherwise.
View source version on businesswire.com: http://www.businesswire.com/news/home/20150924005177/en/
Copyright Business Wire 2015