CytoDyn gets FDA nod for a preliminary Breakthrough Therapy designation meeting for leronlimab

CytoDyn Inc (OTCMKTS:CYDY), which is developing leronlimab (PRO 140) to treat different types of breast cancer and other diseases, announced Thursday the US Food and Drug Administration has recommended it request a preliminary Breakthrough Therapy designation meeting. 

Meanwhile, the Vancouver, Washington-based company also reported positive data for its patients with metastatic triple-negative breast cancer (mTNBC) and metastatic breast cancer (MBC). 

mTNBC has a poor prognosis. In addition, MBC spreads 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.

READ: CytoDyn files with the FDA to study leronlimab as a treatment for coronavirus respiratory symptoms

Clinical results from the first cancer patient in CytoDyn’s Phase 1b/2 mTNBC trial are as follows:

• Patient #1: Enrolled in mTNBC Phase 1b/2 with first treatment in late September 2019. CTC (circulating tumor cells) dropped to zero after two treatments with leronlimab and carboplatin. 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 and carboplatin. After approximately 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). The patient’s oncologist has now ordered this patient’s treatment to consist only of leronlimab and has discontinued treatment with carboplatin (a chemotherapy drug). 

Testimony provided to the company from the patient stated: “So far my experience with leronlimab has been very positive. I didn’t expect it to be so easy and tolerable with virtually zero side effects. The results so far have been super impressive. I’m very grateful to be part of this clinical trial study and it really makes me feel hopeful that this otherwise fatal disease can be turned into a manageable disease in the near future.”

FDA meeting

Dr Bruce Patterson, CEO of IncellDx and a diagnostic partner and advisor to CytoDyn, called the FDA recommendation for a meeting on CytoDyn’s BTD application “a tremendous opportunity” to present data from Phase 1b/2 mTNBC study.

“Included in this discussion will be the recent decision by the oncologist of Patient #1 to, based on continued unremarkable changes to her condition, remove carboplatin from the patient’s regimen with continued therapy with leronlimab,” he said.

CytoDyn CEO Nader Pourhassan noted that the first patient in the Phase 1b/2 trial has shown remission of the tumor and her oncologist has attributed this primarily to leronlimab and discontinued the carboplatin.

“This patient’s latest results of zero CTC, EMT, and CAML is unique and we now have another patient with three zeros identical to the first patient. We are very excited to continue enrolling patients and hopeful to have our first patient treated in our basket trial for 22 solid tumor cancers very soon. We are also very hopeful to have several more patients in our Phase 1b/2 mTNBC trial before our preliminary meeting with the FDA for Breakthrough Therapy designation,” Pourhassan said. 

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Story by ProactiveInvestors