WHITE PLAINS, N.Y. and BRYAN, Texas, Aug. 6, 2015 /PRNewswire-USNewswire/ — Valor Biotherapeutics, LLC, (Valor) and The Leukemia & Lymphoma Society (LLS) today announced that the U.S. Meals and Drug Administration (FDA) has actually approved an investigational Brand-new drug (IND) application for Valor’s lead product candidate, IGN002. The approved IND is a crucial step in allowing Valor—a joint venture between ImmunGene and Caliber Biotherapeutics—to start a phase 1 clinical study of IGN002 in patients along with non-Hodgkin lymphoma (NHL).
Through its Therapy Acceleration Routine (TAP), a strategic initiative to partner along with biotechnology companies and speed the development of Brand-new therapies, LLS previously committed about $6 million to co-fund the pre-clinical development, manufacturing, and a Phase 1 clinical study of IGN002. Valor, ImmunGene, and LLS staff have actually collaborated over the past two years to finish the pre-clinical development and manufacturing of IGN002 for the IND filing.
“Valor is excited to announce this milestone in the development of IGN002 and we anticipate starting the Phase 1 clinical study later this year,” said Sanjay D. Khare, Ph.D., a founding board member of Valor Biotherapeutics and president and CEO of ImmunGene. “We are grateful for the technical and financial support of The Leukemia & Lymphoma Society and expect continuing our partnership as we job with each other to get there the IGN002 program.”
IGN002 is a Brand-new class of biotherapeutics genetically engineered by fusing an antibody along with interferon, a healthy protein that plays a vital role in regulating the immune system. Together, they form a potent agent that is created to be safer and much less toxic while maximizing its targeted anti-tumor effects. IGN002 has actually the potential to boost treatment outcomes for indolent non-Hodgkin lymphoma (NHL) patients, for whom there are currently few efficient therapies. NHL is a diverse group of blood cancers that impact the lymphatic system, portion of the body’s immune system. In the U.S., indolent subtypes of NHL comprise regarding 30 percent of the about 585,000 individuals living along with or in remission from NHL. IGN002 was produced under the support of a research grant by LLS.
“Non-Hodgkin lymphoma, whether indolent or aggressive, continues to be a illness requiring much more effective, much less toxic therapies and this project shows fantastic promise in assisting to comply with that vital unmet need,” said LLS President and Chief Executive Officer Louis J. DeGennaro, Ph.D. “We are pleased to see an additional example of The Leukemia & Lymphoma Society’s commitment to bridging the gap between academic discovery and drug development. LLS helped accelerate the antibody-fusion technology underlying the IGN002 Routine by providing early funding of an academic grant.”
IGN002, a fusion molecule of anti-CD20 antibody and interferon alpha, two clinically validated anti-cancer drugs, is created to deliver therapeutically efficient doses of interferon alpha to CD20-expressing lymphoma cells to exert direct suppression of tumor cell growth and engage multiple anti-tumor immunologic effector mechanisms, leading to substantially improved efficacy while avoiding the systemic toxicity seen along with free interferon.
About The Leukemia & Lymphoma Society
The Leukemia & Lymphoma Society ® (LLS) is the world’s largest voluntary healthiness agency dedicated to blood cancer. The LLS mission: Cure leukemia, lymphoma, multiple myeloma, and boost the quality of life of patients and their families. LLS funds lifesaving blood cancer research about the world, provides free short article and support services, and is the voice for every one of blood cancer patients seeking access to quality, affordable, coordinated care.
Founded in 1949 and headquartered in
About Valor Biotherapeutics, LLC
Valor Biotherapeutics, a joint venture between ImmunGene, Inc. and Caliber Biotherapeutics, is focused on the clinical development and commercialization of the next generation of monoclonal antibody-based therapeutics to handle cancer. For much more information, please visit: www.valorbio.com.
About ImmunGene Inc.
ImmunGene is a privately held biotechnology company focused on the development of proprietary antibody-cytokine fusion technology and monoclonal antibody-based therapies to handle cancer, autoimmune disorders, and various other diseases. ImmunGene has actually several programs at various stages of development. ImmunGene is funded by federal government grants, including NIH-SBIR and by private investors including several biotechnology executives. much more short article can easily be found at: www.immungene.com.
About Caliber Biotherapeutics, LLC
Caliber Biotherapeutics is a biotechnology company focused on creating and commercializing novel therapeutic proteins and vaccines that boost outcomes for patients along with cancer and various other diseases. Caliber operates the world’s largest N. benthamiana expression-based healthy protein manufacturing facility in College Station, Texas. For much more information, please visit www.caliberbio.com.
The Leukemia & Lymphoma Society
Contact: Andrea Greif
Tel: (914) 821-8958
Cell: (914) 772-3027
Contact: Leah Grant
Tel: (206) 660-4003
SOURCE The Leukemia & Lymphoma Society