NANTES, France--(BUSINESS WIRE)--ATLAB Pharma SAS and BZL Biologics LLC have entered into a sublicense agreement to develop 177Lu-J591 for cancer treatment. It includes exclusive rights to manufacture, develop and commercialize this radiopharmaceutical product worldwide as well as a joint Phase IIB/III clinical validation program.
177Lu -J591 has shown a highly attractive efficacy and tolerability profile in phase I and Phase II trials involving 108 patients with metastatic castrate-resistant prostate cancer (M+ CRPC). A large randomized multicenter Phase IIB study is ongoing in CRPC patients with rising PSA but no detectable metastasis (M0 CRPC), a clinical condition affecting more than a million men worldwide, for whom there is no approved therapy.
ATLAB Pharma will fund certain product development and clinical trials.
“177Lu-J591 has a very good therapeutic profile in metastatic prostate cancer patients, validated by several clinical trials and an exceptional scientific rationale. 177Lu -J591 has a large market potential in CRPC patients and beyond. We are very happy to join forces with BZL to hasten the development of this unique drug.” Dr. Jean-Marc Le Doussal, President of ATLAB Pharma.
“Our partner BZL shares our vision that targeted radiotherapy drugs have the unique ability to eradicate micro-metastatic disease at an early stage of cancer progression. We believe that current trials will confirm the 177Lu -J591 survival benefit at the micro-metastatic stage of castrate resistant prostate cancer progression” added Dr. Jean-Francois Chatal, Chief Medical Director at ATLAB Pharma.
Meet Atlab Pharma at Bio Europe 2011 Düsseldorf
It combines the humanized J591 monoclonal antibody targeting prostate-specific membrane antigen (PSMA) plus the 177Lu radioisotope creating the first tumor-specific delivery system able to target radiation to radio-sensitive prostate cancer cells wherever they are in the body.
PSMA is the single most well-validated prostate cancer-specific cell membrane antigen known. It is present at high levels in 95% of prostate cancers, and it is rapidly internalized leading to accumulation of significant amounts of isotopes or drugs that can be linked to the J591 Ab.
J591 has shown the ability, to exclusively target prostate cancer cells wherever they are in the body without targeting normal cells. While localized prostate cancers are commonly treated by radiation, the ability to target radiation to prostate cancer sites elsewhere in the body has been limited until now. Efforts to overcome this limitation have been attempted through the use of agents that indirectly target prostate cancer by targeting sites of increased bone turnover. While these agents, have shown the ability to improve symptoms and prolong survival, they only indirectly target the tumor, are unable to target disease outside of bone and cannot target small, pre-metastatic sites.
177Lu is a radioisotope that, once internalized into the cell, is irreversibly sequestered within the targeted tumor cell. It emits radiation over a short range that is ideal for eradication of the small volume lesions commonly found in the bone marrow and lymph nodes of prostate cancer patients, especially those “pre-metastatic” or “micro-metastatic” lesions that are not large enough to be seen on imaging studies.
About ATLAB Pharma
ATLAB Pharma SAS is a French biotechnology company based in Nantes. ATLAB is developing a pipeline of targeted anti-cancer drugs including antibodies, Lutetium-177 beta-emitting radiopharmaceuticals, and astatine-211 alpha-emitting radiopharmaceuticals.
About BZL Biologics LLC
BZL Biologics LLC is a privately held biotechnology company based in New York. Its lead program is based on antibody (Ab) targeting of Prostate Specific Membrane Antigen (PSMA).