CYDY

Leronlimab (PRO 140)

COVID-19

Stage (next event)

Next Event

Expected Date

Phase 3 (Interim Analysis)

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January 22, 2021 (Est)

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Catalyst Info & Data Links

TITLE: Leronlimab (PRO 140) in COVID - Interim Analysis

• ClinicalTrial.gov (NCT04347239): Study to Evaluate the Efficacy and Safety of Leronlimab for Patients With Severe or Critical Coronavirus Disease 2019 (COVID-19)

• ClinicalTrial.gov (NCT04343651): Study to Evaluate the Efficacy and Safety of Leronlimab for Mild to Moderate COVID-19

WHAT IS THE CATALYST EVENT?

• 1. Phase 3 (Data) 

• 2. EUA Application with the Philippine FDA

WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?

• 1. January 22, 2021 (Est)

• 2. TBA

PRIOR DATA

PRESS RELEASES

• 12-15-2020 Completes Enrollment for Phase 3 Registrational Trial for 390 Patients with Severe-to-Critical COVID-19

• 11-23-2020 Reaches Enrollment Target of 293 Patients for 2nd DSMC Interim Analysis of Phase 3 COVID-19 Trial and Expects to Enroll the Remaining 97 Patients in the Next Few Weeks to Complete the Trial This Year

• 10-20-2020 Receives Positive DSMC Recommendation after Interim Analysis for Leronlimab Phase 2b/3 COVID-19 Registrational Trial

• 10-19-2020 CytoDyn to Hold Webcast on October 20 to Discuss DSMC’s Recommendations from the Interim Analysis of the Phase 2b/3 Clinical Trial for Severe-to-Critical COVID-19 Patients

• 10-12-2020 Appoints Chiral Pharma to Secure Leronlimab for Local FDA Approval in Philippines

• 09-02-2020 U.K. MHRA Grants Meeting to CytoDyn to Discuss Fast Track Approval of Leronlimab for COVID-19 Patients

• 08-19-2020 Requests “Fast Track Approval” for COVID-19 Patients from U.K.’s Regulatory Agency MHRA based on its Top-line Report Showing Statistically Significant Endpoint, NEWS2 (p < 0.023) and Notable Safety Results

• 08-17-2020 Submits its Top-line Report from its Phase 2 COVID-19 Trial to the U.S. FDA and Requests Emergency Use Approval

• 08-11-2020 Announces Clinically Significant Top-line Results from its Phase 2 Trial in Mild-to-Moderate COVID-19 Patients

• 08-04-2020 Receives Positive DSMC Recommendation for Leronlimab Phase 3 COVID-19 Trial with No Safety Concerns

• 07-21-2020 Results From CytoDyn’s Phase 2 Covid-19 Trial

• 04-30-2020 Reports Strong Results from eIND COVID-19 Patients Treated with Leronlimab; Majority of Patients Have Demonstrated Remarkable Recoveries

• 04-13-2020 Southern California Patients Treated with Leronlimab for COVID-19 under Emergency IND: 4 Patients with Moderate Indications Removed from Oxygen; 3 Patients Discharged from Hospital; 1 Patient Scheduled for Discharge Today; 1 Patient with Severe Indications Discharged, for Total of 5 Patients Discharged

• 04-09-2020 Blood Samples at Day 0, 3 and 7 for Severely Ill COVID-19 Patients Clearly Indicate Leronlimab Has Significantly Reduced the Cytokine Storm in All (7) Patients and All Patients Demonstrated Immunological Benefit at Both Day 3 and Day 7

• 04-09-2020 Severely Ill COVID-19 Patient at Leading Southern California Medical Center Extubated Three Days After Treatment with CytoDyn’s Leronlimab; Two Moderate COVID-19 Patients Removed from External Oxygen Following One Day of Treatment with Leronlimab and Discharged from Hospital

• 04-06-2020 First Two Patients Enrolled in Randomized Phase 2, COVID-19 Trial with Leronlimab; Five More Severely Ill COVID-19 Patients Treated Under Emergency IND and Two Patients Have Already Extubated

• 04-02-2020 Leronlimab Indicates Significant Trend Toward Immunological Restoration in Severely Ill COVID-19 Patients

• 04-01-2020 Files a Clinical Trial Protocol with the FDA to Treat Severely Ill COVID-19 Patients with Leronlimab where the Primary Endpoint is Mortality Rate at Two Week

• 03-31-2020 FDA Clears CytoDyn’s Phase 2 Randomized Trial to Treat Mild-to-Moderately Ill Coronavirus Patients with Leronlimab; Enrollment to Begin Immediately

• 03-27-2020 Files FDA-Suggested Modifications to IND and Protocol for Phase 2 Clinical Trial for COVID-19 Patients with Mild to Moderate Indications and a Second Randomized Protocol for All COVID-19 Patients in Severe Condition Will be Filed Next Week per FDA Recommendation

• 03-27-2020 Leronlimab Used in Seven Patients with Severe COVID-19 Demonstrated Promise with Two Intubated Patients in ICU, Removed from ICU and Extubated with Reduced Pulmonary Inflammation

• 03-19-2020 FDA Grants Emergency IND for Two Coronavirus Patients Treated in New York with CytoDyn’s Leronlimab

• 03-09-2020 Files IND and Protocol for Phase 2 Clinical Trial for Treatment of Coronavirus Patients with Leronlimab (PRO 140)

• 03-04-2020 Treats First Patient with Leronlimab in Phase 2 Trial for GvHD under Modified Trial Protocol

Mechanism of Action

A humanized immunoglobulin (Ig) G4 monoclonal antibody against CC chemokine receptor 5 (CCR5; CD195), with potential activity as a human immunodeficiency virus (HIV) entry blocker and potential protective activity against graft-versus-host disease (GvHD). Upon administration, leronlimab targets and binds to CCR5 expressed on T cells. This blocks HIV cell entry, which prevents HIV infection and/or reduces HIV viral load. In addition, blocking CCR5 by leronlimab decreases CCR5-mediated signaling and the CCR5-induced migration of donor cells into tissues after an allogeneic hematopoietic cell transplantation (HCT). Blocking CCR5 may therefore prevent or reduce GvHD. CCR5, a co-receptor needed for HIV cell entry, plays a key role in immunomodulation. Expressed on monocytes, activated T cells and dendritic cells (DCs), CCR5 can regulate chemotaxis. Lymphocyte trafficking via chemokine receptors, such as CCR5, and recruitment to target organs, plays a critical role in alloreactive responses (Learn more - National Cancer Institute)

HC

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CYDY, Leronlimab, PRO140, CCR5, COVID, Antibody

Prior Data (click to view full image)

Trial Design / Revenue (click to view full image)