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CytoDyn says it has strong preliminary results from 30 metastatic triple-negative breast cancer patients treated with leronlimab

The company will seek US Food & Drug Administration (FDA) guidance on proceeding with an expedited regulatory plan for approval of leronlimab with existing FDA Fast Track designation for mTNBC

CytoDyn Inc. - CytoDyn has strong prelim results from 30 metastatic triple-negative breast cancer patients treated with leronlimab
There were decreases in cancer-associated macrophage-like cells after four doses of leronlimab in over 70% of patients and it was associated with a 450% increase in overall survival at 12-month analysis

CytoDyn Inc (OTCQB:CYDY) has shared strong preliminary results from its Phase 1b/2 trials and compassionate use study of its flagship drug candidate leronlimab in 30 metastatic triple-negative breast cancer (mTNBC) patients.

The leronlimab trial is being carried out in combination with carboplatin for the treatment of metastatic triple-negative breast cancer.

In a statement, Creatv MicroTech Director of Clinical Research & Development Daniel Adams said: “While these are only interim results at the 12-month point, our ability to rapidly monitor and identify patients that appear to respond to leronlimab using a single tube of blood is quite an encouraging finding.”

READ: CytoDyn advances to Phase 2 trial with leronlimab for mTNBC metastatic breast cancer treatment

“The fact that greater than 70% of patients saw positive changes in circulating tumor cells after a single dose of leronlimab was made even more informative by their dramatic increases in both progression-free survival and overall survival, Adams added

He said that the fact that “a large group of patients taking leronlimab had mean progression-free survival (mPFS) of around 6 months is well beyond that experienced with current treatment options available to these women, who typically have mPFS of approximately 2 months.”

In a clinical trial, measuring overall survival is one way to see how well a new treatment works.

“This result is even more amazing as these women did not even reach mean overall survival (mOS) in 12 months, considering the typical mOS in this population is only 6 to 7 months,” added Adams.

Key findings from the interim 12-month analysis included that 72% of patients had a decrease in cancer-associated macrophage-like cells (CAMLs) around 30 days after induction of leronlimab. The decrease in CAMLs was associated with:

  • An around 300% increase in mean progression-free survival (mPFS)
  • A significant around 450% increase in overall survival (OS) at 12 months
  • High CCR5 in tumor tissue biopsies may help to stratify patients likely to progress on leronlimab
  • Decreases in CAMLs and circulating tumor cells (CTCs) appear to be related to slower progression and lower mortality
  • CAMLs appear to identify populations that are responding to leronlimab

Meanwhile, CytoDyn chief medical officer Scott Kelly said the company is “very excited” about the preliminary results and are eager to discuss the next regulatory steps based on this data.

“Based on leronlimab’s mechanism of action, we believe these results may provide tangible hope for patients suffering from mTNBC, and potentially other forms of cancer,” said Kelly. “As we have said previously, we believe CytoDyn will evolve into an oncology-focused company as well as other potential indications.”  

CytoDyn CEO Nader Pourhassan noted that the results “validate the strategic decision by CytoDyn to pursue leronlimab’s potential cancer indications.”

“We have built a team that is now advancing leronlimab towards potential marketing approval across many indications and therapeutic areas,” said Dr Pourhassan. “The importance of this opportunity is tremendous, especially in patients with limited therapeutic options such as mTNBC.”

The US Food and Drug Administration (FDA) granted CytoDyn Fast Track designation to explore two potential indications using leronlimab to treat Human Immunodeficiency Virus (HIV) and metastatic cancer. The first indication is combination therapy with HAART for HIV-infected patients, and the second is for metastatic triple-negative breast cancer.

Contact the author Uttara Choudhury at uttara@proactiveinvestors.com

Follow her on Twitter: @UttaraProactive

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