Phase IIb candidate combines Lutetium-177 radioisotope with PSMA-targeting antibody.
BZL Biologics and Atlab Pharma signed a sublicense agreement centered on global development of a radiolabeled monoclonal antibody cancer therapy combining Atlab’s 177Lutetium radioisotope with BZL’s prostate-specific membrane antigen (PSMA)-targeting antibody J591. The deal includes a joint Phase IIb/III clinical validation program. Atlab will be responsible for funding certain aspects of product develpment and clinical trials.
177Lu-J591 is currently undergoing a Phase IIb trial in men with castration-resistant prostate cancer (MCRPC) who demonstrate rising prostate-specific antigen levels, but no detectable metastases. The firms say there are currently no approved therapy for patients in this specific category. The candidate has successfully completed a Phase II trial in castrate-resistant metastatic prostate cancer patients.
France-based Atlab says the 177Lu radioisotope emits radiation over a very short range, which is ideal for eradicating small-volume lesions commonly found in the bone marrow and lymph nodes of prostate cancer patients, including premetastatic or micrometastatic lesions that can’t be detected through imaging studies. The firm is focused on developing a pipeline of targeted anticancer drugs including antibodies, Lutetium-177-beta-emitting radiopharmaceuticals, and astatine-211 alpha-emitting radiopharmaceuticals.
The PSMA-antibody platform is the basis of New York-based BZL’s IP. The firm holds the exclusive license from Cornell University to a worldwide patent portfolio covering antibodies to the extracellular domain of PSMA, a target that is present on the cell membrane of all prostate cancer cells and in the blood vessel cells of all solid tumors, but not normal blood vessels.
BZL’s license covers the development of PSMA-targeting antibody-drug conjugates, radiolabeled antibodies, naked antibodies, and related diagnostic and therapeutic methods, as well as rights to key issued patents for the targeting of PSMA expressed on solid tumor neovasculature. J591 has been the subject of 11 completed clinical trials involving more than 300 patients with prostate and other solid tumors.