Aurigene, a wholly owned subsidiary of Dr Reddy’s, and Curis announce CA-170 program update following data presented at ESMO 2017
— 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 —
Bangalore, September 12, 2017 — 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
Disclaimer: This press release may include statements of future expectations and other forward-looking statements that are based on the management’s current views and assumptions and involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. In addition to statements which are forward looking by reason of context, the words “may”, “will”, “should”, “expects”, “plans”, “intends”, “anticipates”, “believes”, “estimates”, “predicts”, “potential”, or “continue” and similar expressions identify forward-looking statements. Actual results, performance or events may differ materially from those in such statements due to without limitation, (i) general economic conditions such as performance of financial markets, credit defaults, currency exchange rates , interest rates , persistency levels and frequency / severity of insured loss events (ii) mortality and morbidity levels and trends, (iii) changing levels of competition and general competitive factors, (iv) changes in laws and regulations and in the policies of central banks and/or governments, (v) the impact of acquisitions or reorganization , including related integration issues. The company assumes no obligation to update any information contained herein.
CAMBRIDGE, Mass., April 27, 2017 (GLOBE NEWSWIRE) — Agios Pharmaceuticals, Inc. (NASDAQ:AGIO) and Aurigene Discovery Technologies Limited today announced a global license agreement to research, develop and commercialize small molecule inhibitors of an undisclosed cancer metabolism target.
Under the terms of the agreement, Aurigene will provide Agios exclusive rights to its portfolio of novel small molecules for the undisclosed target. Financial terms of the agreement include a $3 million upfront payment and potential future milestone payments of up to $17 million per licensed product if certain development and regulatory milestones are achieved by Agios. Aurigene is also eligible to receive low single-digit royalties on product sales. Agios will conduct preclinical studies and, if successful, fund further global research and development, as well as regulatory and commercial activities.
Agios is focused on discovering and developing novel investigational medicines to treat cancer and rare genetic diseases through scientific leadership in the field of cellular metabolism. In addition to an active research and discovery pipeline across both therapeutic areas, Agios has multiple first-in-class investigational medicines in clinical and/or preclinical development. All Agios programs focus on genetically identified patient populations, leveraging our knowledge of metabolism, biology and genomics. For more information, please visit the company’s website at www.agios.com.
Aurigene 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 in Phase 1 clinical development with its partner. 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. Aurigene is an independent, wholly owned subsidiary of Dr. Reddy’s Laboratories Ltd. (NYSE:RDY).
Aurigene a discovery stage biotechnology company, developing novel and best-in-class therapies to treat cancer and inflammatory diseases, announced today the nomination of the development candidate and exercising of the option for CA-327, an oral, small molecule immune checkpoint antagonist targeting programmed death ligand-1 (PD-L1) and T-cell immunoglobulin and mucin domain containing protein-3 (TIM-3) by Curis, Inc.
CA-327 is the third program in the Aurigene – Curis collaboration signed in January 2015. The first two programs under the collaboration are an orally available small molecule antagonist of programmed death ligand-1 (PD-L1) and V-domain Ig suppressor of T cell activation (VISTA) in the immuno-oncology field, and an orally available, small molecule inhibitor of Interleukin-1 receptor-associated kinase 4 (IRAK4) in the precision oncology field.
In September 2016 the agreement was amended allowing Aurigene to invest upto to 10.2 million shares of Curis’s common stock in lieu of $24.5 million of milestone and other payments.
“We are pleased with the progress of our collaboration,” said Dr. Ali Fattaey, Curis’s CEO, “and look forward to working with our partner, Aurigene, to complete IND-enabling studies for CA-327 in the coming months and expect to file an IND in 2017.”
“We are delighted that our collaboration is advancing its third small molecule program in less than two years,” said CSN Murthy, Aurigene’s CEO. “We continue to work closely with Curis to focus our collective resources, creating and developing innovative drug candidates in the field of oncology, including multiple first-in-class oral small molecule checkpoint antagonists within immuno-oncology. For Aurigene, this demonstrates the validation of its platform technology in the development of oral checkpoint inhibitors, with the second program (PD-L1/ TIM3) rapidly advancing to candidate nomination status after the PD-L1/ VISTA program. This allows us to confidently make progress on other checkpoint targets in the I/O space in the coming months and years”.
Aurigene is a discovery stage biotechnology company, developing novel and best-in-class therapies to treat cancer and inflammatory diseases. Aurigene’s PD-L1/Vista small molecule program that is currently being investigated in a Phase 1 trial in patients, is the first of several immune checkpoint programs at different stages of discovery and preclinical development. Aurigene has signed four licensing deals for multiple programs in the last three years, covering immune-oncology and epigenetic pathway programs. Of these, one program is in Phase 1 clinical development, IND/ CTA has been filed for a second program, and two programs are currently in IND-enabling pre-clinical studies. Among others, Aurigene has advanced stage assets targeting: (a) RORg for autoimmune diseases in IND enabling studies (b) Novel NAMPT inhibitors for oncology, in preclinical development, (c) Covalent CDK7 inhibitors for oncology, in late lead optimization stage, and (d) Covalent and G12C selective KRAS small molecule inhibitors in preclinical development.
About the Curis Collaboration
On January, 2015, Aurigene entered into collaboration, license and option agreement focussed on immuno-oncology and selected precision oncology targets with Curis, Inc., a biotechnology company focused on the development and commercialization of innovative drug candidates for the treatment of human cancers.
The agreement provides Curis the option to license-in programs when a development candidate is nominated. The first two licensed programs under the collaboration are an orally available small molecule antagonist of PD-L1/ VISTA in the immuno-oncology field, and an orally available, small molecule inhibitor of IRAK4 in the precision oncology field. With the licensing of CA-327, a third licensed program has been added to the portfolio of compounds under development by Curis.
In partial consideration for the rights granted to Curis under the collaboration agreement, Curis issued about 17.1 million shares of common stock to Aurigene, and additional development and regulatory milestones of over $ 200 million, apart from commercialization rights for the programs in India and Russia, sharing of value in non-US/ EU makets with Aurigene, Drug Substance and Drug Product manufacturing rights and royalties on net sales ranging between high single digits to 10%
In September 2016, the Agreement between the partners was amended allowing Aurigene to invest upto to 10.2 million shares of Curis’s common stock in lieu of $24.5 million of milestone and other payments.
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2017-02-06T18:31:12+00:00 October 11th, 2016|
By Vikas Dandekar, ET Bureau | Jul 01, 2016, 03.44 AM IST
MUMBAI: Aurigene Discovery Technologies has moved one step closer to developing a capsule that can potentially alter the treatment paradigm from painful intravenous injections currently used to treat advanced form of cancers such as melanoma, lung cancer and advanced renal cell carcinoma. The Bengaluru-based company is an independent subsidiary of Dr Reddy’s Laboratories and its United States-based partner Curis Inc.
The two partners recently announced the dosing of the first patient as part of a phase one clinical trial for the drug coded CA-170, which has been described by industry watchers as a breakthrough and first such candidate in the world in a fiercely competed set of experimental drugs called checkpoint inhibitors.
Checkpoint inhibitors or the mechanism of blocking proteins that are expressed on cancer cells or immune cells in the human body and trigger the body’s immune system to fight cancer cells is the latest frontier in cancer research with large drug makers pumping in billions of dollars in search of effective leads.
For Curis Inc and Aurgiene Discovery Technologies, the journey is likely to be long and tedious, with associated risks of failure in clinical development cycle, and could take four to six years to reach a stage of commercialisation. But if all goes well, a bounty awaits, experts said. The two marketed intravenous drugs Keytruda (pembrolizumab) of Merck and Opdivo (nivolumab) from Bristol Myers Squibb clocked about $1.5 billion or Rs 10,000 crore in sales in 2015.
The industry expects the expanding field of immune-oncology drugs including blockers of immune checkpoints such as CTLA4, PD-1, Vista, TIM3 and others to top $35 billion in revenue in the next eight years. Aurigene Discovery Technologies CEO CSN Murthy told ET, “The success of this (CA-170) programme will pave the way for a number of other oral immune checkpoint inhibitors in the pipeline at Aurigene, including a dual PD-L1/TIM3 inhibitor also licensed to the same partner – Curis Inc. Aurigene’s platform technology will see multiple opportunities develop over the next couple of years.”
According to the company’s researchers, CA-170, a dual PD-L1/Vista inhibitor agent, has many firsts to its credit. The ability to simultaneously block two important immune checkpoints, PD-L1and Vista, can potentially address certain patients who show resistance to existing therapies, they said.
By being the only oral capsule in development, the drug adds to the convenience and compliance of patients. As a small molecule (in contrast to the existing checkpoint inhibitors that are large proteins), the potential for CA-170 to penetrate cancer tissues is much higher. Additionally, CA-170 provides added flexibility to combine with other anti-cancer agents to provide better safety profile, especially in cases of immune related adverse events.