Igenica Biotherapeutics Enrolls First Patient in Phase 1 Study of IGN523 in Acute Myeloid Leukemia

BURLINGAME, Calif. – March 18, 2014 – Igenica Biotherapeutics, a company focused on the discovery and development of innovative antibodies and antibody-drug conjugates (ADCs) for the treatment of cancer, announced today that the first patient has been dosed in a Phase 1 clinical trial of IGN523 in patients with relapsed or refractory acute myeloid leukemia (AML). The trial is designed to assess the safety, pharmacokinetics and clinical activity of IGN523, an antibody targeting CD98, a cell surface protein frequently overexpressed on AML cells.

“There is an urgent need for new treatment options for patients with AML,” said Jorge Cortes, M.D., deputy chair of the Department of Leukemia in the Division of Cancer Medicine at The University of Texas M.D. Anderson Cancer Center. “IGN523, a novel monoclonal antibody with multiple mechanisms of action against a target important for the survival and proliferation of leukemia cells, could be an important advance in this patient population.”

“CD98 plays a central role in the growth and survival of tumor cells, and is implicated in a wide variety of cancers, including AML and squamous cell lung carcinoma,” said William Ho, M.D., Ph.D., vice president of clinical development of Igenica. “IGN523 has been shown to be highly effective in preclinical models and is an innovative approach to treating patients with these types of cancers. As Igenica’s first clinical program, IGN523 showcases our discovery platforms and development capabilities. We look forward to advancing this clinical trial in 2014.”

For more information about the trial, including enrolling centers, please visit www.clinicaltrials.gov.

About IGN523 and CD98

Igenica is developing IGN523 for the treatment of multiple hematologic and solid tumors. IGN523 is a humanized monoclonal antibody that binds to CD98, a cell surface protein involved in amino acid transport and integrin signaling. Expression of CD98 has been shown to be upregulated in a variety of hematologic malignancies, including AML, and in several types of solid tumors, particularly squamous cell carcinomas. IGN523 works through multiple mechanisms of action, including antibody-dependent cell-mediated cytotoxicity (ADCC), inhibition of CD98 function and induction of apoptosis.

About Igenica Biotherapeutics

Igenica Biotherapeutics is focused on the discovery and development of antibodies and antibody-drug conjugates (ADCs) for the treatment of cancer. Igenica is the only biotherapeutic company that fully powers the ADC development spectrum from a patient-based approach to target and functional antibody discovery to the generation and manufacturing of homogeneous ADCs. Igenica’s integrated discovery engine has generated a robust pipeline of site-specific ADC candidates and functional antibodies to address critical needs of cancer patients. Led by a proven team of leaders with expertise in the development of therapeutic antibodies and ADCs, Igenica is funded by a premier group of life science investors including The Column Group, OrbiMed, 5AM Ventures and Third Rock Ventures. For more information, please visit www.igenica.com.

Source: Igenica Biotherapeutics

Posted: March 2014

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