News/Press Releases

News/Press Releases2018-11-19T08:30:46+00:00

Exelixis and Aurigene Enter Into Exclusive Collaboration, Option and License Agreement to Discover and Develop Novel Therapies for Cancer

ALAMEDA, Calif.–(BUSINESS WIRE)–Exelixis, Inc. (Nasdaq: EXEL) today announced that it has entered into an exclusive collaboration, option and license agreement with Aurigene Discovery Technologies Limited (Aurigene), the India-based discovery biotechnology company focused on oncology and inflammatory disorders. The agreement allows Exelixis to in-license as many as six programs from Aurigene, which has developed a focused approach to drug discovery that targets differentiated first-in-class and best-in-class opportunities with unique mechanisms of action. The deal is part of Exelixis’ ongoing strategy to build an innovative pipeline behind the company’s internally discovered, commercially available therapies, including its flagship product, CABOMETYX® (cabozantinib).

Under the terms of the agreement, Exelixis will make an upfront payment of $10 million for exclusive options to license three preexisting programs from Aurigene. Also, Exelixis and Aurigene will initiate three Aurigene-led drug discovery programs on mutually agreed upon targets, in exchange for additional option payments of $2.5 million per program. Exelixis will also contribute research funding to Aurigene to facilitate discovery and preclinical development work on all six programs. As the programs mature, Exelixis will have the opportunity to exercise an exclusive option for each program up until the time of Investigational New Drug (IND) acceptance. If Exelixis decides to exercise an option, it will make an option exercise payment to Aurigene and assume responsibility for that program’s future clinical development and commercialization including global manufacturing. Aurigene will be eligible for clinical development, regulatory, and sales milestones, as well as royalties on sales. Under the terms of the agreement, Aurigene retains limited development and commercial rights for India and Russia.

“Aurigene has a proven track record in discovery collaborations with 14 partnered programs currently in clinical trials, including 10 trials in the United States,” said Peter Lamb, Ph.D., Executive Vice President, Scientific Strategy and Chief Scientific Officer of Exelixis. “Our collaboration has the potential to enhance Exelixis’ early-stage pipeline with promising therapeutic candidates while mitigating financial risk for Exelixis through a success-based payment structure. Aurigene’s small molecule discovery expertise complements our internal discovery capabilities and gives us access to an expanded range of targets and mechanisms, including covalent inhibition and induced protein degradation. We’re excited to start working with Aurigene and are hopeful that our partnership will result in multiple clinical-stage compounds and, eventually, therapies that may benefit patients with cancer.”

“Aurigene has deep expertise exploring novel mechanisms of action for discovering new, effective treatments for patients with cancer,” said Murali Ramachandra, Ph.D., Chief Executive Officer of Aurigene. “Exelixis’ demonstrated success in bringing oncology therapies to market, as well as its legacy of drug discovery expertise, make it a natural partner for Aurigene. We look forward to combining these complementary skills to drive potential new therapies for the patients that need them.”

About Aurigene

Aurigene is a development-stage biotech company engaged in the discovery and clinical development of novel and best-in-class therapies to treat cancer and inflammatory diseases and a wholly-owned subsidiary of Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DR REDDY, NYSE: RDY). Aurigene is focused on precision-oncology, oral immune checkpoint inhibitors, and the Th-17 pathway. Aurigene currently has several programs from its pipeline in clinical development. Aurigene’s oral PD-L1/ VISTA antagonist CA-170 is currently in phase 2 clinical development in India. Additionally, Aurigene has multiple compounds at different stages of pre-clinical development. Aurigene has partnered with many large and mid-pharma companies in the United States and Europe and has 15 programs currently in clinical development. For more information, please visit Aurigene’s website at https://aurigene.com/.

About Exelixis

Founded in 1994, Exelixis, Inc. (Nasdaq: EXEL) is a commercially successful, oncology-focused biotechnology company that strives to accelerate the discovery, development, and commercialization of new medicines for difficult-to-treat cancers. Following early work in model system genetics, we established a broad drug discovery and development platform that has served as the foundation for our continued efforts to bring new cancer therapies to patients in need. Our discovery efforts have resulted in four commercially available products, CABOMETYX® (cabozantinib), COMETRIQ® (cabozantinib), COTELLIC® (cobimetinib) and MINNEBRO® (esaxerenone), and we have entered into partnerships with leading pharmaceutical companies to bring these important medicines to patients worldwide. Supported by revenues from our marketed products and collaborations, we are committed to prudently reinvesting in our business to maximize the potential of our pipeline. We are supplementing our existing therapeutic assets with targeted business development activities and internal drug discovery — all to deliver the next generation of Exelixis medicines and help patients recover stronger and live longer. Exelixis is a member of the Standard & Poor’s (S&P) MidCap 400 index, which measures the performance of profitable mid-sized companies. For more information about Exelixis, please visit www.exelixis.com, follow @ExelixisInc on Twitter or like Exelixis, Inc. on Facebook.

July 31st, 2019|

Aurigene Announces First in Human Dosing with RoRγt inverse agonist AUR-101

– Phase 1 data from the study expected to be available by December 2018

 

Aurigene, a biotechnology company focused on discovering and developing drugs for oncology and inflammatory disorders, announced today that it has commenced dosing in INDUS, a Phase 1 trial of AUR-101 in healthy volunteers. The study is designed to evaluate the safety signals, pharmacodynamic modulation, and recommended dosage for Phase 2 studies (RP2D).

AUR-101 is a selective, potent inverse agonist of the receptor RoRγt, designed as an oral agent for the treatment of IL17-driven immunological conditions, including psoriasis. Aurigene expects data from the INDUS study to be available by December, 2018.

Commenting on the trial, CSN Murthy, CEO of Aurigene said “This is the first study of the planned global clinical development for AUR-101; we are excited to have started the clinical evaluation of the compound and expect to mirror the excellent results seen in established pre-clinical disease models”.

 

About AUR-101

AUR-101 is a potent, oral RORϒt inverse agonist, with high selectivity across other ROR isoforms and nuclear hormone receptors and expected to confer a superior safety profile. AUR-101, with a good ADME/PK profile and high bioavailability, has demonstrated inhibition of IL-17A in whole blood from psoriasis patients and also very significant reduction in ear swelling and histopathology scores in two separate pre-clinical psoriasis models.  In addition, AUR-101 has been found to be safe in preclinical toxicology evaluations, at several fold of anticipated efficacious doses in humans.

 

About Aurigene

Aurigene is a development stage biotech company, engaged in discovery and clinical development of novel and best-in-class therapies to treat cancer and inflammatory diseases. Aurigene is focused on oral immune checkpoint inhibitors, precision-oncology and the Th-17 pathway.  Aurigene currently has three programs from its pipeline in clinical development. Aurigene’s oral PD-L1/ VISTA antagonist CA-170 is currently in Phase 2 clinical development in India. Additionally, Aurigene’s selective CDK7, CDK12 inhibitors, CD47 immune checkpoint inhibitor, and SMARCA2/ 4 degraders are at different stages of pre-clinical development. Aurigene has partnered with several large- and mid-pharma companies in the United States and Europe and has delivered over 15 compounds currently in clinical development. For more information, please visit Aurigene’s website at https://aurigene.com/

 

July 10th, 2018|

Aurigene and its Partner Curis Announce the dosing of CA-170 in Phase II India trial

The Phase 2 trial is the result of the initial safety data and preliminary evidence of clinical benefit observed in the trial.

Aurigene Discovery Technologies Limited, a wholly owned subsidiary of Dr. Reddy’s Laboratories Ltd. 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, 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., 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.”

March 8th, 2018|

Aurigene, a wholly owned subsidiary of Dr Reddy’s, and Curis announce CA-170 program update following data presented at ESMO 2017

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.”

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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 https://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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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.

 

For more information:

CSN Murthy
CEO
Aurigene Discovery Technologies Limited
murthy_csn@aurigene.com

 

Calvin Printer

Media Relations

Dr. Reddy’s Laboratories Limited

calvinprinter@drreddys.com

 

September 12th, 2017|

Agios and Aurigene Enter into Exclusive License Agreement for Novel Small Molecules for Cancer Metabolism Target

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.

About Agios

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.

About Aurigene
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).

April 27th, 2017|

AURIGENE ANNOUNCES THE EXERCISE OF CURIS’ OPTION FOR CA-327 (PD-L1/TIM-3 small molecule antagonist), THE THIRD PROGRAM UNDER ITS COLLABORATION, LICENSE AND OPTION AGREEMENT OF JANUARY, 2015

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”.

About Aurigene

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{4373c5eac72f2e338e1c62e7ffa56ad670cebfc5c328ff71c01bff73ebc0a1df}

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.

 

Media Contact:

Rajshree KT

Director Corporate Development & Strategy

+91 – 40 – 4465 7777

October 11th, 2016|