Date: 2011-10-28
Type of information: Licensing agreement
Compound: 177Lu-J591
Company: Atlab Pharma (France) BZL Biologics (USA)
Therapeutic area: Cancer - Oncology
Type agreement: licensing
Action mechanism: 177Lu-J591 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.J591 has shown the ability, in several hundred patients studied to date, 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 - some approved and others in development - 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.
Disease:
Details: ATLAB Pharma and BZL Biologics have entered into a sublicense agreement to develop 177Lu-J591 for cancer treatment. The agreement 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. A large randomized multicenter Phase IIB study is ongoing in CRPC patients with rising PSA but no detectable metastasis (M0 CRPC). According to the agreement, ATLAB Pharma will fund certain product development and clinical trials.
Financial terms:
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