CytoDyn Gets US FDA Nod to Begin Phase II Oncology Trial of Leronlimab

CytoDyn Gets US FDA Nod to Begin Phase II Oncology Trial of Leronlimab

By, Admin 7 November 2024

CytoDyn gets US FDA nod to begin phase II oncology trial of leronlimab in patients with r/r microsatellite stable colorectal cancer

Overview

CytoDyn Inc., a biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced that it has received clearance from the US FDA to commence its phase II oncology trial. The study will evaluate the efficacy of leronlimab in patients with relapsed/refractory (r/r) microsatellite stable colorectal cancer (CRC).

Relationship with the FDA

  • This milestone reflects the continued positive development of the company’s improved relationship with the FDA. 
  • Clearance for the phase II oncology trial was achieved following productive feedback sessions with the FDA over the past few months and the submission of a final study protocol to the FDA in September 2024. 
  • As previously announced, the trial will be conducted in partnership with Syneos Health. 
  • A trial kickoff meeting has been set for late November 2024 and patient enrollment will begin in early 2025.

From the CEO: CytoDyn

  • We have appreciated the opportunity to work constructively with the FDA on the review and finalization of our CRC protocol,” said Dr Jacob Lalezari CEO. 
  • With the agency’s input and our partnership with Syneos Health, we are well positioned to advance our clinical evaluation of leronlimab for oncology and make real strides towards developing the treatment paths of tomorrow.

About the Company: CytoDyn

CytoDyn is a clinical-stage biotechnology company focused on the development and commercialization of leronlimab, an investigational humanized IgG4 monoclonal antibody (mAb) that is designed to bind to C-C chemokine receptor type 5 (CCR5), a protein on the surface of certain immune system cells that is believed to play a role in numerous disease processes.

About the Company: Syneos Health

  • Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. 
  • Syneos Health translates unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

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