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Protein Design Labs licenses development rights to leukemia antibody.

Protein Design Labs, Inc. (Fremont, CA) and Actinium Pharmaceuticals, Inc. (Alexandria, VA) have entered into a licensing agreement that provides API development rights to PDL's SMART M195 antibody conjugated to alpha particle-emitting radioisotopes, including actinium-225. PDL has received an upfront licensing fee, and may receive development milestone payments and royalties on future sales. Additional terms were not disclosed.

SMART M195 is the humanized version of the murine M195 antibody and binds to the CD33 antigen, present on the cancer cells of most patients with acute myeloid leukemia (AML), the most common form of acute leukemia in adults. In May 2002, PDL reported data from a Phase III clinical trial of SMART M195 in patients with relapsed or refractory AML. The data showed that the antibody was well tolerated but did not achieve a statistically significant result in regard to the primary efficacy endpoint in the study.

API is conducting further clinical research using SMART M195 to deliver very potent alpha particle-emitting isotopes to cancer cells for the treatment of AML. Since alpha particles only travel short distances of between 2 and 5 cell diameters, there is less chance of damaging healthy tissue with this type of therapy. API has teamed with Memorial Sloan-Kettering Cancer Center (MSKCC) where 30 patients have been treated to date by Dr. David Scheinberg, Chief of Leukemia Service, using SMART M195 with bismuth-213. The physician's trial has produced promising results. API also intends to commence a physician's trial at MSKCC using SMART M195 and the more powerful isotope actinium-225.

Dr. Maurits Geerlings, API's President and Chief Executive Officer, said, "SMART M195 has demonstrated a clear ability to bind to cancer cells in multiple clinical trials. We believe that its binding specificity makes it a promising candidate to deliver our actinium-225 and bismuth-213 as targeted therapies in acute myeloid leukemia. We are pleased to continue to partner with PDL and are excited to pursue the development project, based on our extensive experience with radiochemical operations and broad-spectrum engineering expertise."

Mark McDade, Chief Executive Officer, PDL, said, "We are extremely pleased to out-license certain rights to SMART M195 and look forward to its continued development in this oncology setting. The agreement also represents the initial result of our renewed commitment to generate new revenues from our platform, in addition to humanization and patent license agreements. We are confident that Actinium will be a strong development partner and will devote energy and resources to the further development of SMART M195. This is an interesting, novel humanized antibody that has shown excellent specificity and is therefore highly appropriate as part of an arming approach, using API's radioisotopes."

Actinium Pharmaceuticals is engaged in the development and commercialization of alpha particle immunotherapeutics based on a unique patent position for the utilization of actinium-225 and bismuth-213. It has facilities located in Oak Ridge, Tenn. and Alexandria, Va.

Protein Design Labs is a leader in the development of therapeutic humanized antibodies for the prevention or treatment of cancer and certain immunologic disorders. PDL currently has antibodies under development for autoimmune and inflammatory conditions, asthma and cancer. PDL holds fundamental patents for its proprietary antibody humanization technology.

Protein Design Labs, Inc.

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Title Annotation:Actinium Pharmaceuticals Inc.
Comment:Protein Design Labs licenses development rights to leukemia antibody.(Actinium Pharmaceuticals Inc.)
Publication:BIOTECH Patent News
Geographic Code:1USA
Date:Mar 1, 2003
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