Impressive Results Continue from CytoDyn’s Clinical Trials Evaluating Two Patients with Leronlimab, One in mTNBC and One in MBC

First patient with metastatic triple-negative breast cancer (mTNBC) continues to show no detectable circulating tumor cells (CTC) or putative metastatic tumor cells after 15 weeks of treatment with leronlimab in combination with carboplatin

Second patient with stage 4 HER2+ metastatic breast cancer (MBC) shows 50 percent shrinkage in the primary tumor and no new signs of metastasis in the brain after treatment with leronlimab as a monotherapy

VANCOUVER, Washington, Jan. 22, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: 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 additional promising results from its clinical trials evaluating leronlimab for the treatment of metastatic triple-negative breast cancer (mTNBC) and metastatic breast cancer (MBC).

New data from the first patient enrolled in the Company’s metastatic triple-negative breast (mTNBC) Phase 1b/2 trial continues to show no detectable levels of circulating tumor cells (CTC) or putative metastatic cells in the peripheral blood following 15 weeks of treatment with leronlimab in combination with carboplatin.

The second patient, enrolled through an emergency investigational new drug (IND) with stage 4 HER2+ MBC that has metastasized to the liver, lung and brain, showed a 50 percent shrinkage of the primary tumor and no new metastasis in the brain after treatment with leronlimab as a monotherapy. The patient was previously treated with pertuzumab and trastuzumab for over a year and a half. This patient has been taking leronlimab since November 25, 2019 with one 700 mg dose each week.

“Recent testing of the first patient demonstrated continued absence of CTCs in all blood tubes with only one cancer-associated macrophage like cells (CAMLs) in one of two tubes. In the second patient, the follow up brain scan conducted on January 17, 2020, showed that the largest brain lesion had a greater than 4-fold reduction in size,” said Bruce Patterson, M.D., chief executive officer and founder of IncellDx, a diagnostic partner and an advisor to CytoDyn. “Other smaller lesions on the second patient’s brain have not changed in size and cerebral edema remains at decreased levels since the last imaging studies. Taken together, these results suggest continued response of both primary and metastatic tumors to treatment with leronlimab for both the first and second patient.”