Phase 2 trial will evaluate combination of PD-1 inhibitor Libtayo® (cemiplimab-rwlc) and oncolytic virus Voyager-V1; preclinical research collaboration will explore new oncolytic virus treatments
Vyriad to receive upfront payment and equity investment from Regeneron
TARRYTOWN, NY and ROCHESTER, MN, USA I November 6, 2019 I Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Vyriad, Inc. today announced a research collaboration and option licensing agreement focused on the development of new oncolytic (cancer-killing) virus-based treatments for various forms of cancer. The agreement includes a Phase 2 clinical study, slated to begin in 2020, evaluating Regeneron’s PD-1 inhibitor Libtayo® (cemiplimab-rwlc) in combination with Vyriad’s oncolytic virus Voyager-V1 in multiple types of cancer, including melanoma, lung, liver and endometrial cancers. The companies will also enter into a five-year research effort that utilizes Regeneron’s VelociSuite® technologies to jointly design and validate novel Vesicular Stomatitis Virus (VSV)-based oncolytic virus treatments.
Libtayo is a fully-human monoclonal antibody targeting the immune checkpoint receptor PD-1 (programmed cell death protein-1) and is being jointly developed and commercialized by Regeneron and Sanofi under a global collaboration agreement. Libtayo was invented by Regeneron using the company’s proprietary VelocImmune® technology which uses a unique genetically-humanized mouse to produce optimized fully-human antibodies.
Vyriad’s investigational drug candidate Voyager-V1 is a potent VSV programmed to attack cancer cells selectively, while also activating the immune system to kill local and distant cancer cells. Further, it amplifies inflammatory and antitumor immune system responses that help turn “cold” tumors “hot,” which potentially enhances anti-PD-1 activity. Voyager-V1 is deliverable by intravenous infusion.
“Vyriad’s differentiated oncolytic virotherapy platform helps Regeneron continue to diversify our arsenal of immuno-oncology approaches, which include multiple combinations with our anti-PD-1 backbone, as well as novel delivery and re-targeting mechanisms,” said Israel Lowy, M.D., Ph.D., Senior Vice President and Head of Clinical and Translational Sciences, Oncology at Regeneron. “We are eager to explore the combination of Voyager-V1 and Libtayo in patients with different tumor types in the short term, and see long-term promising synergies with our existing areas of strength, particularly in antibody development and viral vector technologies. We look forward to working together to help cancer patients in need.”
“We are thrilled to partner with Regeneron in this far-reaching collaboration to develop novel cancer treatments,” said Stephen Russell, M.D., Ph.D., President and Chief Executive Officer of Vyriad. “We are optimistic that the clinical combination of Voyager-V1 with Libtayo will result in effective anticancer activity, and we are very excited to join forces with Regeneron scientists to develop a new generation of precision targeted VSV therapies. Through the collaboration, we expect that the emerging power of oncolytic virotherapy can finally integrate with proven capabilities of antibody engineering, with the potential to create life-changing medicines for cancer patients.”
Under the agreement, Vyriad will receive an upfront payment and Regeneron will make an equity investment in the company. Regeneron will have an exclusive option to license Voyager-V1 and other collaboration products. Vyriad is eligible to receive additional payments based on the achievement of specified development and commercial milestones, as well as royalties on net sales of potential future VSV-based collaboration products. During the five-year collaboration term, Vyriad will work exclusively with Regeneron to research and develop VSV technologies. Specific financial terms were not disclosed.
More About Voyager-V1
Voyager-V1 is an investigational oncolytic virus that was designed for enhanced safety, efficacy, and traceability through the inclusion of an interferon beta gene, enabling the virus to replicate quickly in cancer cells without damaging healthy cells, recruit cancer-fighting immune cells to the tumor, and secrete a measurable reporter protein into the blood. Voyager-V1 was also engineered to include an iodine transporter NIS gene that facilitates tracking of the virus’ spread to cancer cells throughout the body. Voyager-V1 is under evaluation as both a monotherapy and combination therapy in multiple Phase 1-2 studies for metastatic colorectal cancer, endometrial cancer, non-small cell lung cancer, squamous cell carcinoma of the head and neck and various blood cancers.
More About Libtayo
Libtayo is approved in the U.S., European Union, Canada and Brazil for adult patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. In the U.S., the generic name for Libtayo is cemiplimab-rwlc, with rwlc as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the U.S. Food and Drug Administration.
Beyond the ongoing EMPOWER-CSCC-1 trial, Libtayo is also being investigated in adjuvant and neoadjuvant trials in CSCC and in potential registrational trials in non-small cell lung cancer, basal cell carcinoma and cervical cancer. Additional studies include trials in squamous cell carcinoma of the head and neck, melanoma, colorectal cancer, prostate cancer, multiple myeloma, Hodgkin’s lymphoma and non-Hodgkin’s lymphoma. These trials are designed to investigate Libtayo as monotherapy; in combination with conventional treatments like chemotherapy; or in combination with other investigational agents, including vaccines, oncolytic viruses and bispecific antibodies, among others. These potential uses are investigational, and their safety and efficacy have not been evaluated by any regulatory authority.
What is Libtayo?
Libtayo is a prescription medicine used to treat people with a type of skin cancer called cutaneous squamous cell carcinoma (CSCC) that has spread or cannot be cured by surgery or radiation.
It is not known if Libtayo is safe and effective in children.
About Regeneron
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, including VelocImmune® which uses a unique genetically-humanized mouse to produce optimized fully-human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.
About Vyriad
Vyriad is a clinical-stage company developing proprietary oncolytic virus therapies for the treatment of cancers with significant unmet needs. Founded by scientists at Mayo Clinic and the University of Miami, Vyriad programs viruses to selectively attack cancer cells, thereby igniting antitumor immune responses that can complete the process of tumor destruction and prevent disease recurrence. Our lead platforms, derived from vesicular stomatitis and measles viruses, are being evaluated in ongoing Phase 1-2 clinical trials addressing multiple cancer types. Vyriad is a privately held company based in Rochester, Minnesota. For more information, visit www.vyriad.com.
SOURCE: Vyriad
Post Views: 21
Phase 2 trial will evaluate combination of PD-1 inhibitor Libtayo® (cemiplimab-rwlc) and oncolytic virus Voyager-V1; preclinical research collaboration will explore new oncolytic virus treatments
Vyriad to receive upfront payment and equity investment from Regeneron
TARRYTOWN, NY and ROCHESTER, MN, USA I November 6, 2019 I Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Vyriad, Inc. today announced a research collaboration and option licensing agreement focused on the development of new oncolytic (cancer-killing) virus-based treatments for various forms of cancer. The agreement includes a Phase 2 clinical study, slated to begin in 2020, evaluating Regeneron’s PD-1 inhibitor Libtayo® (cemiplimab-rwlc) in combination with Vyriad’s oncolytic virus Voyager-V1 in multiple types of cancer, including melanoma, lung, liver and endometrial cancers. The companies will also enter into a five-year research effort that utilizes Regeneron’s VelociSuite® technologies to jointly design and validate novel Vesicular Stomatitis Virus (VSV)-based oncolytic virus treatments.
Libtayo is a fully-human monoclonal antibody targeting the immune checkpoint receptor PD-1 (programmed cell death protein-1) and is being jointly developed and commercialized by Regeneron and Sanofi under a global collaboration agreement. Libtayo was invented by Regeneron using the company’s proprietary VelocImmune® technology which uses a unique genetically-humanized mouse to produce optimized fully-human antibodies.
Vyriad’s investigational drug candidate Voyager-V1 is a potent VSV programmed to attack cancer cells selectively, while also activating the immune system to kill local and distant cancer cells. Further, it amplifies inflammatory and antitumor immune system responses that help turn “cold” tumors “hot,” which potentially enhances anti-PD-1 activity. Voyager-V1 is deliverable by intravenous infusion.
“Vyriad’s differentiated oncolytic virotherapy platform helps Regeneron continue to diversify our arsenal of immuno-oncology approaches, which include multiple combinations with our anti-PD-1 backbone, as well as novel delivery and re-targeting mechanisms,” said Israel Lowy, M.D., Ph.D., Senior Vice President and Head of Clinical and Translational Sciences, Oncology at Regeneron. “We are eager to explore the combination of Voyager-V1 and Libtayo in patients with different tumor types in the short term, and see long-term promising synergies with our existing areas of strength, particularly in antibody development and viral vector technologies. We look forward to working together to help cancer patients in need.”
“We are thrilled to partner with Regeneron in this far-reaching collaboration to develop novel cancer treatments,” said Stephen Russell, M.D., Ph.D., President and Chief Executive Officer of Vyriad. “We are optimistic that the clinical combination of Voyager-V1 with Libtayo will result in effective anticancer activity, and we are very excited to join forces with Regeneron scientists to develop a new generation of precision targeted VSV therapies. Through the collaboration, we expect that the emerging power of oncolytic virotherapy can finally integrate with proven capabilities of antibody engineering, with the potential to create life-changing medicines for cancer patients.”
Under the agreement, Vyriad will receive an upfront payment and Regeneron will make an equity investment in the company. Regeneron will have an exclusive option to license Voyager-V1 and other collaboration products. Vyriad is eligible to receive additional payments based on the achievement of specified development and commercial milestones, as well as royalties on net sales of potential future VSV-based collaboration products. During the five-year collaboration term, Vyriad will work exclusively with Regeneron to research and develop VSV technologies. Specific financial terms were not disclosed.
More About Voyager-V1
Voyager-V1 is an investigational oncolytic virus that was designed for enhanced safety, efficacy, and traceability through the inclusion of an interferon beta gene, enabling the virus to replicate quickly in cancer cells without damaging healthy cells, recruit cancer-fighting immune cells to the tumor, and secrete a measurable reporter protein into the blood. Voyager-V1 was also engineered to include an iodine transporter NIS gene that facilitates tracking of the virus’ spread to cancer cells throughout the body. Voyager-V1 is under evaluation as both a monotherapy and combination therapy in multiple Phase 1-2 studies for metastatic colorectal cancer, endometrial cancer, non-small cell lung cancer, squamous cell carcinoma of the head and neck and various blood cancers.
More About Libtayo
Libtayo is approved in the U.S., European Union, Canada and Brazil for adult patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. In the U.S., the generic name for Libtayo is cemiplimab-rwlc, with rwlc as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the U.S. Food and Drug Administration.
Beyond the ongoing EMPOWER-CSCC-1 trial, Libtayo is also being investigated in adjuvant and neoadjuvant trials in CSCC and in potential registrational trials in non-small cell lung cancer, basal cell carcinoma and cervical cancer. Additional studies include trials in squamous cell carcinoma of the head and neck, melanoma, colorectal cancer, prostate cancer, multiple myeloma, Hodgkin’s lymphoma and non-Hodgkin’s lymphoma. These trials are designed to investigate Libtayo as monotherapy; in combination with conventional treatments like chemotherapy; or in combination with other investigational agents, including vaccines, oncolytic viruses and bispecific antibodies, among others. These potential uses are investigational, and their safety and efficacy have not been evaluated by any regulatory authority.
What is Libtayo?
Libtayo is a prescription medicine used to treat people with a type of skin cancer called cutaneous squamous cell carcinoma (CSCC) that has spread or cannot be cured by surgery or radiation.
It is not known if Libtayo is safe and effective in children.
About Regeneron
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, including VelocImmune® which uses a unique genetically-humanized mouse to produce optimized fully-human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.
About Vyriad
Vyriad is a clinical-stage company developing proprietary oncolytic virus therapies for the treatment of cancers with significant unmet needs. Founded by scientists at Mayo Clinic and the University of Miami, Vyriad programs viruses to selectively attack cancer cells, thereby igniting antitumor immune responses that can complete the process of tumor destruction and prevent disease recurrence. Our lead platforms, derived from vesicular stomatitis and measles viruses, are being evaluated in ongoing Phase 1-2 clinical trials addressing multiple cancer types. Vyriad is a privately held company based in Rochester, Minnesota. For more information, visit www.vyriad.com.
SOURCE: Vyriad
Post Views: 21
