CytoDyn Inc (OTCMKTS:CYDY), a late-stage biotechnology company, revealed additional “promising results” Wednesday from its clinical trials evaluating its lead drug leronlimab (PRO 140) for the treatment of metastatic triple-negative breast cancer (mTNBC) and metastatic breast cancer (MBC).
In a statement, the company said that 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” in the peripheral blood following “15 weeks of treatment with leronlimab in combination with carboplatin.”
Similarly, the second patient enrolled through an emergency investigational new drug (IND) process with metastatic stage four breast cancer that had metastasized to the liver, lung and brain, showed “a 50% shrinkage of the primary tumor and no new metastasis in the brain” after treatment with leronlimab as a monotherapy.
READ: CytoDyn files for breakthrough therapy status for leronlimab in metastatic triple-negative breast cancer
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 circulating tumor cells in all blood tubes with only one cancer-associated macrophage-like cells in one of two tubes. In the second patient, the follow up brain scan conducted on January 17, showed that the largest brain lesion had a greater than 4-fold reduction in size,” said IncellDx founder CEO Bruce Patterson, who is both a diagnostic partner and advisor to CytoDyn.
Patterson noted that 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,” he added.
Meanwhile, CytoDyn CEO Nader Pourhassan, said the company was “thrilled” to see the additional data that further supported leronlimab as a potential treatment option for patients with triple-negative breast cancer and metastatic breast cancer.
“As a company, we look forward to continuing our work in the oncology space and developing a potentially safe and effective treatment option for patients suffering from this deadly disease,” said Dr Pourhassan.
Triple-Negative Breast Cancer
Triple-negative breast cancer is a type of breast cancer characterized by the absence of the three most common types of receptors in the cancer tumor known to fuel most breast cancer – estrogen receptors, progesterone receptors and the hormone epidermal growth factor receptor 2 (HER-2) gene. It occurs in about 20% of diagnosed breast cancers and can be more aggressive and likely to spread and recur. Since the triple negative tumor cells lack these receptors, common treatments for breast cancer such as hormone therapy and drugs that target estrogen and progesterone are ineffective. Currently, there are no targeted therapies approved to treat triple negative breast cancer.
CytoDyn, based in Vancouver, Washington, is developing leronlimab to battle multiple diseases. The company has filed an IND application and a Phase 2 clinical trial protocol with the US Food and Drug Administration (FDA) for leronlimab to treat patients with NASH.
Leronlimab has also already completed nine clinical trials and been given to 800 patients in HIV treatment programs, without a single drug-related serious adverse event.
The FDA has granted Fast Track designation to leronlimab for a combination therapy with Highly Active Antiretroviral Therapy for HIV-infected patients and for metastatic triple-negative breast cancer.
Contact the author Uttara Choudhury at [email protected]
Follow her on Twitter: @UttaraProactive