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The Leukemia & Lymphoma Society, Valor Biotherapeutics and ImmunGene, Inc. Create Partnership to Advance Novel Therapy for Non-Hodgkin Lymphoma Patients


5/23/2013 9:14:46 AM

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WHITE PLAINS, N.Y., May 22, 2013 /PRNewswire/ -- The Leukemia & Lymphoma Society (LLS) is committing approximately $6million to Valor Biotherapeutics, LLC, a joint venture between ImmunGene and Caliber, to co-fund the completion of pre-clinical development, manufacturing, and a Phase I clinical trial for a novel fusion protein that may change the poor outcomes faced by many patients with indolent lymphomas who do not respond to standard therapy with rituximab.

Valor's protein, IGN002, is a new class of biotherapeutics produced by fusing antibodies to tumor cell-killing cytokines to create a therapeutic agent with multiple properties in a single, genetically engineered molecule. The result is not just a simple combination of two clinically validated anti-cancer drugs, rituximab and interferon alpha. The fusion molecule directs a targeted interferon alpha mediated cytotoxic effect on lymphoma cells leading to dramatically improved efficacy and safety profiles in preclinical studies. The clinical trial is anticipated to begin in late 2015.

Non-Hodgkin lymphoma (NHL) is the seventh most common cancer in the US yet is a highly diverse disease with many subsets of patients. There are an estimated 530,000 people currently living with NHL or in remission. In 2012, there were approximately 70,000 new cases of NHL diagnosed in the US and about 19,000 NHL patients died in 2012 from their disease, which was unable to be controlled adequately with currently available therapeutic options. Indolent or slowly progressing NHL is estimated to be about 40 percent of NHL cases in the United States.

"Non-Hodgkin lymphoma, whether indolent or aggressive, continues to be a disease requiring more effective treatment options," said LLS Chief Mission Officer Louis J. DeGennaro, Ph.D. "LLS strives to accelerate therapies for blood cancer patients with such unmet medical needs, What makes this project even more exciting to support is that the technology was developed by Professor Sherie Morrison at UCLA while she was funded by a LLS Translational Research Grant. LLS continues to find that funding through its research grant programs leads to discoveries that move on to biotechnology companies like Valor Biotherapeutics, LLC, who are more fully able to bring novel therapeutics to patients with blood cancer."

Dr. Rahul Singhvi, chief executive officer of Valor Biotherapeutics, stated: "We thank LLS for their commitment to our antibody-interferon fusion platform and their crucial financial support of the IGN002 program. This funding represents a substantial investment in the development of IGN002 and will enable its development through Phase 1 clinical testing. In addition, we welcome the opportunity to work with LLS and benefit from their vast experience in the lymphoma area as we advance IGN002 into clinical trials."

"IGN002 has demonstrated dramatic efficacy in rituximab-resistant preclinical models. The financial commitment by our JV partner, Caliber and the LLS will help in advancing this program to the proof-of-concept study in NHL patients. Our R&D team is very excited to work with the LLS and Valor, to advance IGN002 to the clinic," said Sanjay D. Khare, Ph.D., president and CEO of ImmunGene, Inc. "This study will help us in understanding the utility of the technology for several other programs in the ImmunGene pipeline."

About The Leukemia & Lymphoma Society
The Leukemia & Lymphoma Society ® (LLS)is the world's largest voluntary health agency dedicated to blood cancer. The LLS mission: Cure leukemia, lymphoma, Hodgkin's disease and myeloma, and improve the quality of life of patients and their families. LLS funds lifesaving blood cancer research around the world and provides free information and support services. LLS has played a role in funding nearly every currently available treatment for blood cancer patients today. Founded in 1949 andheadquartered in White Plains, NY, LLS has chapters throughout the United States and Canada. To learn more, visit www.LLS.org. Patients and caregivers should contact the Information Resource Center at (800) 955-4572, Monday through Friday, 9 a.m. to 6 p.m. ET.

About Valor Biotherapeutics, LLC
Valor Biotherapeutics is a joint venture between ImmunGene, Inc. and Caliber Biotherapeutics, LLC focused on the clinical development and commercialization of the next generation of monoclonal antibody-based therapeutics to treat cancer.

About ImmunGene Inc.
ImmunGene is a privately held biotechnology company focused on the development of monoclonal antibody-based therapies for the treatment of blood cancers and solid tumors. ImmunGene has several programs at various stages of the development. In addition, the company has developed proprietary antibody-cytokine fusion technology comprised of highly potent cytokines by genetically engineered with monoclonal antibodies. ImmunGene has an exclusive license on the antibody-cytokine fusion protein technology developed by Professor Sherie Morrison at UCLA. A part of the IGN002 preclinical work has been done as a part of collaborative research with Dr. John Timmerman's laboratory. Antibody-fusion proteins are designed to be inactive at therapeutic doses in the bloodstream while highly potent in targeting and killing cancer cells. This approach is likely to spare healthy cells and thus has the potential to reduce known toxic effects of therapeutic cytokines while greatly enhancing the anti-tumor activity of antibodies. ImmunGene is funded by federal government grants, including NIH-SBIR, and Angel investors including several Biotech executives. More information can be found at: www.immungene.com.

About Caliber Biotherapeutics, LLC
Caliber Biotherapeutics, LLC is a biotechnology company based in Bryan, Texas with a mission to develop and commercialize protein-based therapeutics that improve outcomes for patients with cancer and other diseases. The company utilizes technological innovations in biological research, product development and manufacturing to create treatments with increased safety and effectiveness--while reducing both costs and development time. Caliber has created a rich pipeline of monoclonal antibody-based products, including biobetter product candidates applying its expertise in manufacturing of recombinant proteins. Caliber operates the world's largest N. benthamiana expression based protein manufacturing facility in College Station, Texas. Caliber's technologies are being supported by the Cancer Prevention and Research Institution of Texas (CPRIT), DARPA and several Texas based life sciences investors. For more information, please visit www.caliberbio.com.

Contact: Andrea Greif
914.821.8958
andrea.greif@lls.org

SOURCE The Leukemia & Lymphoma Society



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