Endocyte Presents Data at AACR Identifying Multiple Methods for Managing Severe Side Effects Resulting from CAR T-Cell Treatm...
April 05 2017 - 8:00AM
- Late-breaking poster demonstrates that
Endocyte’s bi-specific adaptor molecules can mitigate or eliminate
cytokine storms -
Endocyte, Inc. (NASDAQ:ECYT), a leader in developing targeted small
molecule drug conjugates (SMDCs) and companion imaging agents for
personalized therapy, today announced in a late-breaking poster
session the presentation of new research from investigators and
faculty at the Purdue University Center for Drug Discovery on the
application of Endocyte’s SMDC technology in a chimeric antigen
receptor (CAR) therapy setting (Poster #LB-187 – New Methods for
Controlling CAR T Cell-mediated Cytokine Storms) at the American
Association for Cancer Research (AACR) Annual Meeting 2017 in
Washington D.C.
“The significant potential of CAR T-cell therapies has been
limited by an inability to control the rate and degree of cytokine
release, which can cause severe safety issues in patients. The data
presented demonstrate approaches that may successfully mitigate
these cytokine storms and highlight how Endocyte’s bi-specific SMDC
adaptors can potentially improve the safety and tolerability
profiles of current CAR T-cell therapies,” said Mike Sherman,
president and CEO at Endocyte. “This is just one example of how we
are continuing to advance our next-generation CAR T-cell
therapeutic platform, now also in collaboration with leading
experts in the field at Seattle Children’s Research Institute.”
This presentation discusses methods in which Endocyte’s
bi-specific SMDC adaptors can control the rate and extent of CAR
T-cell activation, by using a bispecific adaptor molecule to
mediate engagement of the CAR T-cell with the cancer cell.
Endocyte’s unique bispecific adaptors are constructed with a
fluorescein isothiocyanate (FITC) molecule and a tumor-homing
molecule to precisely bridge a universal CAR T-cell with the cancer
cells, which causes localized T-cell activation. This approach
enables a universal CAR T-cell to bind and kill a cancer cell only
when the bispecific adaptor establishes a bridge between the two.
The poster explores several novel strategies for regulating
cytokine storms, including: 1) interruption of bi-specific adaptor
administration, 2) injection of excess folate to block/compete
bi-specific adaptor bridging of the CAR T-cell to the cancer cell,
3) use of a very low or very high dose of the bi-specific adaptor
and 4) gradual escalation of bi-specific adaptor dose. Since the
circulation half-life of most bi-specific adaptors is approximately
30 minutes, unwanted toxicity from CAR T-cell induced cytokine
storms can be either pre-emptively prevented or rapidly suppressed
following their emergence. Data in this poster demonstrate in
pre-clinical models that all of the above strategies mitigate or
eliminate cytokine storms.
“We are very pleased with the results of these studies, as they
confirm our hypothesis that the use of bi-specific SMDC adaptors
can offer a next-generation approach to CAR T-cell therapy. We look
forward to continuing our research, including exploring the ability
of this approach to more completely target cells in heterogeneous
solid tumors,” said Phil Low, Ph.D., professor of chemistry and
director of the Center for Drug Discovery at Purdue University. Dr.
Low is the chief scientific officer, a board member and founder of
Endocyte.
Endocyte and Purdue University have exclusive agreements to
research, develop and commercialize SMDC therapeutics and companion
imaging agents for the treatment of disease through a long-standing
partnership with Dr. Low and Purdue University. Those agreements
grant Endocyte exclusive rights to the CAR T-cell and SMDC adaptors
for all indications. This technology is jointly-owned by Endocyte
and Purdue, and covered by pending patent applications.
About Endocyte's SMDC Bi-Specific
Adaptors
Endocyte's SMDC bi-specific adaptors represent a novel
approach that makes possible the engineering of a single universal
CAR T-cell, designed to bind with high affinity to FITC. This
universal CAR T-cell can be specifically directed to cancer cells
through the administration of a tumor targeted FITC-containing
SMDC, known as a bi-specific adaptor that acts to bridge the
universal CAR T-cell with the cancer cells to cause localized
T-cell activation. This approach has been shown
pre-clinically to address three key CAR T-cell issues by: (i)
avoiding hyper-activation of CAR T-cells leading to a cytokine
storm, (ii) enabling termination of CAR T-cell activity upon
eradication of the tumor, and (iii) potentially enabling
elimination of all cancer cells in heterogeneous solid tumors.
In March 2017, Endocyte entered into a
research collaboration with Seattle Children's Research
Institute and Dr. Michael Jensen for the development
of Endocyte's SMDC platform in CAR T-cell immunotherapy
setting through the use of Endocyte's proprietary SMDC
bi-specific adaptor molecules.
About Endocyte
Endocyte is a biopharmaceutical company and leader in developing
targeted therapies for the treatment of cancer and other serious
diseases. Endocyte uses its proprietary drug conjugation
technology to create novel SMDCs and companion imaging agents for
personalized targeted therapies. The company's SMDCs actively
target receptors that are over-expressed on diseased cells,
relative to healthy cells. This targeted approach is designed
to enable the treatment of patients with highly active drugs at
greater doses, delivered more frequently and over longer periods of
time than would be possible with the untargeted drug alone.
The companion imaging agents are designed to identify patients
whose disease over-expresses the target of the therapy and who are
therefore more likely to benefit from treatment. For additional
information, please visit Endocyte's website at
www.endocyte.com.
Endocyte Forward-Looking Statement
Certain of the statements made in this press release are forward
looking, such as those relating to the company’s development
programs and upcoming milestones. Actual results or developments
may differ materially from those projected or implied in these
forward-looking statements. Factors that may cause such a
difference include risks that the company may experience delays in
the completion of its clinical trials (whether caused by
competition, adverse events, patient enrollment rates, shortage of
clinical trial materials, regulatory issues or other factors);
risks that data from its clinical trials may not be indicative of
subsequent clinical trial results; risks related to the safety and
efficacy of the company’s product candidates; risks that early
stage preclinical data may not be indicative of subsequent data
when expanded to additional preclinical models or to subsequent
clinical data; risks that evolving competitive activity and
intellectual property landscape may impair the company's ability to
capture value for the technology; estimates of the potential
markets for its product candidates; estimates of the capacity of
manufacturing and other facilities required to support its product
candidates; projected cash needs; and expected future revenues,
operations, expenditures and cash position. More information about
the risks and uncertainties faced by Endocyte, Inc. is contained in
the company’s periodic reports filed with the Securities and
Exchange Commission. Endocyte, Inc. disclaims any intention or
obligation to update or revise any forward-looking statements,
whether as a result of new information, future events or
otherwise.
CONTACT:
Stephanie Ascher, Stern Investor Relations, Inc., (212) 362-1200, stephanie@sternir.com
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