CytoDyn Inc (OTCMKTS:CYDY) announced Monday that it has filed for Breakthrough Therapy designation with the US Food and Drug Administration (FDA) for the use of its lead drug leronlimab as an adjuvant therapy for the treatment of metastatic triple-negative breast cancer (mTNBC).
In a statement, the late-stage biotechnology company said the filing is based on data from the first patient in the company’s metastatic triple-negative breast cancer Phase 1b/2 trial. A second patient with metastatic stage four breast cancer has been enrolled in the trial under an emergency use investigational new drug (IND) process, CytoDyn said.
CytoDyn said data from the first patient enrolled show no detectable circulating tumor cells (CTC) in the peripheral blood and additional reductions in CCR5 expression on cancer-associated cells at 11 weeks.
Investors responded well, sending shares nearly 16% higher to $1.14 on the OTC Markets in afternoon trade.
“This patient’s data also demonstrated tumor shrinkage of >20% after just a few weeks of treatment,” said the company.
Since the results of the second patient under an emergency IND were similarly impressive as the first patient, CytoDyn filed for Breakthrough Therapy designation.
The company said data from the second patient under the emergency IND protocol with HER2+ metastatic stage four breast cancer showed no sign of “new metastatic spots in the liver, lung and brain” during the treatment with leronlimab.
“This strong data confirms the power of leronlimab as a CCR5 inhibitor for patients living with mTNBC, and is clearly replicating early animal study results that demonstrated 98% elimination of metastases,” said IncellDx CEO Bruce Patterson, who is both a diagnostic partner and advisor to CytoDyn.
“Our collective team of key opinion leaders believes that all patients with similar cancers in regards to CCR5 expression may also benefit from the use of leronlimab, including melanoma, brain, throat, lung, stomach, breast, ovarian, uterine, pancreatic, bladder, and thyroid cancer patients. We also believe the mechanism of action for leronlimab may have potential indications in autoimmune diseases such as multiple sclerosis, polymyolitis, Crohn’s disease, inflammatory bowel syndrome and psoriasis,” he added.
Meanwhile, CytoDyn CEO Nader Pourhassan noted that in the early stages of these clinical trials, the company was seeing “remarkable improvements” in patients living with metastatic breast cancer.
“We now have several different types of cancer patients reaching out to us to be treated with leronlimab under both the expanded access program, and the Right to Try Act. Currently, we have four patients enrolled (2 in the Phase 1b/2 mTNBC trial and 2 under the emergency IND protocol (expanded access program),” revealed Dr Pourhassan.
The CytoDyn boss said thought leaders believed that leronlimab may have the potential to treat “over 20 different cancer indications” and at least 10 autoimmune diseases, including graft versus host disease (GvHD) and non-alcoholic steatohepatitis (NASH).
“Based on the number of indications we intend to pursue, we believe we have one of the broadest platform technologies in biotech and are extremely excited to accelerate development of future indications,” said Dr Pourhassan.
CytoDyn has been cleared by the FDA to proceed with its Phase 2 trials for both GvHD and NASH.
Breakthrough Therapy designation is designed to expedite the development and review of medicines aimed at serious conditions. To win the key status, preliminary clinical evidence must show the new drug is a substantial improvement over available therapies.
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 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.
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