Anti-PD-1 mAb is in development against lymphoma, colorectal cancer, and metastatic melanoma.
Teva Pharmaceutical exercised its option to make an additional $19 million investment in fellow Israeli firm CureTech, and to provide up to $50 million in R&D financing. The investment means Teva now has a 75% holding in CureTech, and also retains an option to acquire the firm outright.
Teva’s decision to up its stake in CureTech was made on the back of positive data from a Phase II study evaluating the latter’s anti-PD-1 monoclonal antibody CT-011 in patients with diffuse large B-cell lymphoma (DLBCL). Results showed treatment with CT-011 led to a significant improvement in both overall survival and progress-free survival. CureTech says it is now planning Phase III trials in the DLBCL indication. Meanwhile, a Phase II study evaluating CT-011 in the treatment of colorectal cancer is ongoing, and a Phase II trial in metastatic melanoma is also scheduled to start in the near future.
“The observation that there is a surge of effector memory cells and the signal that there is an improvement in PFS in a high-risk group of patients with relapsed large cell lymphoma suggests considerable biologic and clinical relevance to CT-011 and is a compelling argument for a Phase III trial,” comments Leo Gordon, M.D., director of the lymphoma program at Chicago’s Northwestern University School of Medicine, and principal investigator for the Phase II DLBCL study. “A successful trial could make this the standard of care in the setting of relapsed lymphoma or even in high-risk lymphoma after initial therapy, but more importantly, lead the way toward the use of PD-1 inhibitors in settings in which enhanced innate immunity is desirable.”
CureTech is focused on developing broad-spectrum immune-modulating antibodies and peptide-based vaccines for the treatment and control of cancer. Lead product CT-011 is a humanized antibody designed to block the function of PD-1 (Programmed Death-1), an inhibitory receptor belonging to the B7-receptor family that is expressed on lymphocytes and myeloid cells. The firm claims inhibiting the function of PD-1 results in the attenuation of apoptotic processed in lymphocytes, primarily effector/memory T cells. CT-011 also augments antitumor activities of NK cells.
CureTech and Teva inked an agreement centered on CT-011 back in 2006, under which Teva invested an initial $6 million in CureTech. The deal was amended in August 2008, when Teva invested an additional $10.5 million to support the Phase II study in diffuse large B cell lymphoma as well as a new Phase II study in previously untreated patients with metastatic colorectal cancer.