Aurigene, a Wholly Owned Subsidiary of Dr. Reddy’s, & Curis Announce CA-170 Program Update Following Data Presented at ESMO...
12 September 2017 - 11:22PM
Business Wire
-- Results from 34 patients demonstrate
positive safety profile and support decision to expand Development
--
-- Aurigene and Curis Plan Clinical Trial of
CA-170 in India --
Aurigene Discovery Technologies Limited, a wholly owned
subsidiary of Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE:
DRREDDY, NYSE: RDY) and a specialized biotechnology company engaged
in discovery and early clinical development of novel and
best-in-class therapies to treat cancer and inflammatory diseases,
today announced plans to initiate a Phase 2 trial of CA-170, a
PDL1-VISTA inhibitor to be conducted at sites in India. This was
announced following the presentation of preliminary data from the
initial 34 patients with cancer treated in the dose escalation
stage of the Phase 1 trial of CA-170 at the European Society for
Medical Oncology (ESMO) 2017 Congress by Aurigene’s collaborator
and licensee of CA-170, Curis, Inc. (NASDAQ: CRIS), a biotechnology
company focused on the development and commercialization of
innovative and effective therapeutics for the treatment of cancer.
The trial has been conducted in the U.S., South Korea and Spain.
The Phase 2 trial is the result of the initial safety data and
preliminary evidence of clinical benefit observed in the trial.
CA-170 is an oral small molecule targeting the immune
checkpoints PDL1 and VISTA. Data presented at the ESMO 2017
conference represent the initial 34 patients treated to date in the
dose escalation Phase 1 trial. 30 patients were naïve to prior
immunotherapy treatment, while four patients had experienced prior
treatment with approved anti-checkpoint antibodies. No dose
limiting toxicities were observed at doses ranging from 50 mg to
800 mg once daily dosing examined thus far. CA-170 demonstrated
good oral bioavailability and plasma drug levels were shown to
increase in a near-linear manner with increasing doses. Evidence of
immune modulation, including an increase in activated CD8+ T cells,
was observed in patient blood and tumor biopsy samples examined
following treatment. Of the 21 patients evaluable for disease
assessment, 13 patients experienced disease stabilization. Four
immunotherapy treatment-naïve patients treated with CA-170
experienced shrinkage of their tumors. Six patients remained on
drug treatment beyond three months, including all four patients
with tumor shrinkages. In addition, seven of the 34 patients remain
on study and are continuing with treatment.
“These results are consistent with the observations made in the
preclinical setting and further affirm CA-170’s mechanism of action
as an oral small molecule checkpoint inhibitor. Based on these
initial clinical results, we are excited for the opportunity to
expand testing of CA-170, possibly in earlier lines of treatment
and in a greater number of immunotherapy treatment-naïve cancer
patients,” commented Mr. CSN Murthy, Chief Executive Officer of
Aurigene. “Together with Curis, we have designed a Phase 2 trial,
treating selected populations of patients of interest in the CA-170
program to be treated at major cancer centers in India. Aurigene’s
decision to sponsor and fund this trial is further affirmation of
our commitment to CA-170 and a reflection of the successful
collaboration we have with Curis in multiple development programs.
Aurigene has the commercial rights to the program in India and
Russia in addition to milestones, royalties other commercial supply
rights globally.”
“We are pleased with these early results. Evidence of tumor
shrinkage and multiple patients remaining on drug treatment for
extended periods, along with signals for biomarkers of immune
modulation in patient blood and tumor samples, tells us the program
continues to move in the right direction. We plan to continue with
the dose escalation and continued analysis of patient biopsy
samples in the Phase 1 trial,” said Ali Fattaey, Ph.D., President
and Chief Executive Officer of Curis. “We expect to provide
additional updates at upcoming conferences including the Society
for Immunotherapy of Cancer (SITC) annual meeting in November.”
“The ability for cancer patients to administer a potential
checkpoint inhibitor on their own as a once daily oral drug is a
significant and unique opportunity in our field,” added Adil Daud,
M.D., investigator in the CA-170 Phase 1 trial and director of
Melanoma Clinical Research at the UCSF Helen Diller Family
Comprehensive Cancer Center. “These initial clinical results are
encouraging and merit continued development.”
About Aurigene: Aurigene, a wholly owned subsidiary of
Dr. Reddy’s Laboratories Ltd., is a specialized biotechnology
company, engaged in discovery and early clinical development of
novel and best-in-class therapies to treat cancer and inflammatory
diseases. Aurigene is focused on oral check-point inhibitors,
precision-oncology and the Th-17 pathway. Aurigene’s oral PD-L1/
VISTA antagonist program is currently entering Phase 2 clinical
development; in addition, two other assets licensed to Curis, are
in IND-enabling studies. Aurigene has partnered with several large-
and mid-pharma companies in the United States and Europe and has
delivered over 15 compounds which are in clinical development. For
more information, please visit Aurigene’s website at
http://www.aurigene.com.
About Dr. Reddy’s: Dr. Reddy’s Laboratories Ltd. (BSE:
500124, NSE: DRREDDY, NYSE: RDY) is an integrated pharmaceutical
company, committed to providing affordable and innovative medicines
for healthier lives. Through its three businesses - Pharmaceutical
Services & Active Ingredients, Global Generics and Proprietary
Products – Dr. Reddy’s offers a portfolio of products and services
including APIs, custom pharmaceutical services, generics,
biosimilars and differentiated formulations. Our major therapeutic
areas of focus are gastrointestinal, cardiovascular, diabetology,
oncology, pain management and dermatology. Dr. Reddy’s operates in
markets across the globe. Our major markets include – USA, India,
Russia & CIS countries, and Europe. For more information, log
on to: www.drreddys.com
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Aurigene Discovery Technologies LimitedCSN
MurthyCEOmurthy_csn@aurigene.comorDr. Reddy’s Laboratories
LimitedCalvin PrinterMedia Relationscalvinprinter@drreddys.com
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