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JFE Engineering and ImaginAb Conclude MOU to Manufacture and Distribute Antibody-Based Radiopharmaceuticals in Japan

Parties to conduct Japanese market assessment and develop distribution strategy for ImaginAb’s anti-PSMA prostate cancer imaging technology.

Los Angeles, CA and Tokyo, Japan – February 23, 2015: ImaginAb, Inc. (ImaginAb) and JFE Engineering Corporation’s (JFE Engineering) “Comfortable Community Creation” sector have concluded an MOU to conduct market and distribution feasibility for ImaginAb’s product portfolio in the Japanese market, with an initial focus on ImaginAb’s product for imaging urologic malignancies (89Zr-Df-IAB2M) currently in Phase II development.

89Zr-Df-IAB2M is ImaginAb’s lead drug candidate, under development as a diagnostic imaging agent for use with positron emission tomography/computed tomography (PET/CT) for detection of soft tissue and bone lesions in men with high risk prostate cancer. IAB2M is an engineered monoclonal antibody fragment targeting an extracellular domain of the prostate-specific membrane antigen (PSMA). PSMA is a highly promising target in prostate cancer, both because of its ubiquity and its potential as a pharmacodynamic marker of androgen depletion.

“Japan is an important global market for new molecular imaging agents with a growing need for better tools to manage patients with urological malignancies,” said Dr. Shintaro Nishimura, Executive Director of ImaginAb Japan KK, a wholly-owned subsidiary of ImaginAb, Inc. “We are pleased to be working with JFE Engineering, a Japanese leader in radiopharmaceuticals, to establish a market assessment, as well as a manufacturing and distribution strategy for our product portfolio in Japan.”

“We are pleased to be working with ImaginAb, a highly innovative US biotechnology company with a highly promising product for the staging and management of prostate cancer,” said Shigeki Yamazaki, Manager of JFE Engineering’s Medical System Division. “JFE Engineering has extensive regulatory and logistics experience with the Japanese radiopharmaceutical market and this MOU represents an important first milestone in our relationship with ImaginAb.”

About 89Zr-Df-IAB2M

89Zr-Df-IAB2M is a radio-labelled antibody fragment (a “Minibody”) under clinical development as a diagnostic imaging agent for use with positron emission tomography/computed tomography (PET/CT) for detection of soft tissue and bone lesions in metastatic prostate cancer. 89Zr-Df-IAB2M targets prostate-specific membrane antigen (PSMA), a transmembrane protein highly expressed in the majority of prostate cancer, both localized and metastatic disease. PSMA has also been shown to be significantly overexpressed in response to androgen depletion, potentially enabling it to be used as a marker of response to anti-androgen therapy in patients with castrate-resistant disease. IAB2M is a hepatically-cleared imaging agent, meaning that there is no renal clearance and no bladder signal to obfuscate small lesions in the prostate bed. Ongoing clinical studies are evaluating the safety of the 89Zr-Df-IAB2M tracer and its ability to accurately determine the extent of disease in several distinct prostate cancer patient populations with unmet clinical need. This immunoPET tracer has not yet been submitted for approval by the US Food and Drug Administration (FDA) or the Japanese Pharmaceutical and Medical Devices Agency (PMDA) for clinical use.

About JFE Engineering Corporation

The JFE Engineering Group is continuing to accelerate the globalization of its engineering business and supply leading-edge technologies to countries around the world. JFE Engineering’s “Comfortable Community Creation” sector is committed to delivering a better standard of living through innovation in waste management, energy and healthcare.

For more information, please visit http://www.jfe-eng.co.jp/

About ImaginAb, Inc.

ImaginAb, Inc. is redefining therapeutic management by harnessing the power of antibody technology for in vivo imaging.  The company's proprietary antibody fragment platform has shown the ability to yield actionable molecular information to guide treatment decisions in cancer and immunology. ImaginAb also collaborates with selected biopharmaceutical partners to design imaging agents as companion diagnostics for therapeutic antibodies.

For more information, visit www.imaginab.com

Media Contact JFE Engineering:

General Affairs Department
JFE Engineering Corporation
Tel: +81-45-505-8953

Media Contact ImaginAb:

Chris Erdman
MacDougall Biomedical Communications
Tel: +1 781-235-3060

cerdman@macbiocom.com