CytoDyn’s Phase 2 Basket Trial for 22 Solid Cancer Tumors Treats First Patient with Leronlimab; Patient Enrollment Delayed Due to COVID-19
VANCOUVER, Washington, April 15, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (CYDY), (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today it has treated the first patient in its Phase 2 basket trial for 22 solid cancer tumors. The patient has breast cancer, not triple-negative breast cancer.
This Phase 2 basket trial for the treatment of approximately 22 different solid tumor cancers, including melanoma, brain-glioblastoma, throat, lung, stomach, colon carcinoma, breast, testicular, ovarian, uterine, pancreas, bladder, among other indications, will include 30 patients with CCR5+ locally advanced or metastatic solid tumors. Leronlimab will be administered subcutaneously as a weekly dose of 350 mg. Subjects participating in this study will be allowed to receive and continue the standard-of-care chemotherapy as determined by the treating physician.
The clinical trial will take place at multiple sites across the U.S., with preliminary results on each patient expected within three to four weeks after the initial injection of leronlimab. The primary endpoint of the basket trial is progression-free survival.
Bruce Patterson, M.D., Chief Executive Officer and founder of IncellDx, a diagnostic partner and an advisor to CytoDyn, commented, “The results so far in triple-negative breast cancer and HER-2+ breast cancer patients have remarkably demonstrated the shrinking of primary tumors, the shrinking or elimination of metastatic lesions, and the reduction of circulating tumor cells (CTCs) to zero, which has remained stable over several weeks. In other studies, we have seen CTC levels in this cancer >5 and some as high as 20 per 4 mL of blood. Further, these data help define the relationship between CCR5 on immune cell infiltrates and response as we analyze these responding patients. Based on histologic findings in other cancers, we are hopeful that this response translates to the other tumors in this trial.”
Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, concluded, “We are excited to treat our first patient in this basket trial and are optimistic indications will reflect results in our other metastatic breast cancer trials, all of which will be presented to the FDA in our upcoming preliminary Breakthrough Therapy designation meeting.”