CytoDyn Reports Remarkable Outcomes for Additional

CytoDyn Reports Remarkable Outcomes for Additional Cancer Patients in mTNBC Trial; Following an Overwhelming Community Response, CytoDyn Expects to Enroll More Than 20 Patients in its 22 Solid Tumor Cancer Trial in the Next 60 Days

Download as PDFMarch 02, 2020 6:00am EST

VANCOUVER, Washington, March 02, 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 continued positive data for its mTNBC and MBC patients.

Metastatic triple-negative breast cancer (mTNBC), an aggressive histological subtype, has a poor prognosis. In addition, metastatic breast cancer (MBC) is breast cancer that has spread beyond the breast and lymph nodes to other organs in the body (typically the bones, liver, lungs, or brain). Both types of cancer pose significant challenges for patients due to their aggressiveness and limited treatment options. An integral part of CytoDyn’s mission and purpose is to provide effective therapeutic solutions to these patients. Results of the first five patients are as follows:

Patient #1: Enrolled in mTNBC Phase 1b/2 - Injected on 9/27/2019. CTC (circulating tumor cells) dropped to zero in two weeks on 10/11/2019. Total CTC and EMT (Epithelial Mesenchymal Transition in Tumor Metastasis) dropped to zero after about one month of treatment with leronlimab (once-a-week 350 mg dose). Results from the patient’s earlier CT scan indicated a more than 25% tumor shrinkage within the first few weeks of treatment with leronlimab. Most importantly, after more than five months of treatment with leronlimab and Carboplatin, the patient not only has zero CTC and zero EMT, but also zero detectible CAML (cancer-associated microphages like cells).

Patient #2: Enrolled in single IND. Patient is MBC with HER2+ stage 4 metastasis to lung, liver, and brain. Patient’s radiologist cancelled 2nd round of treatment due to leronlimab’s effect on shrinking the largest tumor in the brain by 56% and other lesions being stable. Leronlimab has and continues to be the only treatment in place for brain metastasis after radiation was administered to this patient in July 2019. Four and one-half months after successful radiation treatment, the patient received her first dose of leronlimab (700 mg) and no other drugs to treat the brain metastasis. The 56% shrinkage in the brain lesions occurred after only two once-weekly injections of leronlimab. After 10 weeks of treatment with leronlimab, this patient’s CTC and EMT results were all zeros (results reported on 2/12/2020). The patient’s CT scan in mid-February was reported as stable.

Patient #3: Enrolled on 1/3/2020. This patient’s CAML counts decreased from 45 to 30. CTC+EMT are stable and there has been no change in the total number. Despite positive results, this patient stopped treatment due to complications with her implanted port, which was unrelated to leronlimab.

Patient #4: Enrolled on 1/7/2020. This patient’s total CTC dropped by 75% in the first two weeks of treatment with leronlimab. After almost five weeks of treatment, the CTC remained at zero.

Patient #5: Enrolled on 2/4/2020. This patient has traveled from England to receive leronlimab. Initial response from treatment indicated tumor shrinkage and, importantly, CTC dropped to zero after three weeks of leronlimab treatment.

Patients #6 and #7: Enrolled and waiting for the first results post-baseline results.

Patients #8 through #10: Will be injected in early March.

Bruce Patterson, M.D., chief executive officer and founder of IncellDx, a diagnostic partner and advisor to CytoDyn, commented, “Patients continue to be actively enrolled in this trial based on the expression of CCR5 on lymphocytes and macrophages in the tumor microenvironment. The proposed mechanism of action (MOA) consisting of inhibition of Tregs and repolarization of macrophages has demonstrated a predictable, sustained response that has reduced the size of primary and metastatic tumors and reduced circulating tumor cells in all patients tested so far.”

Nader Pourhassan, Ph.D., president and chief executive officer of CytoDyn, added, “These findings are solidifying our belief of the four mechanism of actions (MOA) for leronlimab in the treatment of cancer, as previously verified through preclinical animal studies and in published papers. These MOAs indicate that leronlimab may potentially stop metastasis in many types of solid tumor cancers, trigger the body’s immune response system to destroy the cancer tumor and perhaps more. This could represent the beginning of the transformation of CytoDyn from a potential leader in HIV therapy to providing potentially a new innovative treatment opportunity to patients with various forms of cancer and potentially NASH, GvHD, MS, and perhaps many more indications. With the possibility of our first approval in HIV late this year, we could have over 30 label expansion opportunities post-HIV approval.”