Leronlimab

Overview

Leronlimab, or PRO-140, is a human monoclonal antibody developed by CytoDyn. It was first described in the literature in 2001. This antibody binds to CCR5, which may be useful in treating HIV, cancers, and severely ill COVID-19 patients.

Indication

Leronlimab is currently being investigated for the treatment of a number of cancers and HIV. Recently leronlimab has begun a phase II clinical trial in severely ill COVID-19 patients. Preliminary data shows a reduction in the 'cytokine storm', particularly IL-6, as well as a normalization of the CD4/CD8 T-cell ratio. These results may mitigate immune mediate injury seen in severely ill COVID-19 patients.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Phase 2 Study of Leronlimab in Combination With TAS-102 + Bevacizumab in Previously Treated Participants With mCRC	2024/11/21	NCT06699836	Phase 2	Recruiting	CytoDyn, Inc.
Leronlimab in Combination With Regorafenib in Patients With CCR5+, Metastatic Colorectal Cancer	2023/02/16	NCT05730673	Phase 2	Withdrawn	CytoDyn, Inc.
Leronlimab in Patients With Coronavirus Disease 2019 (COVID-19) With Need for Mechanical Ventilation or Extracorporeal Membrane Oxygenation	2021/05/25	NCT04901689	Phase 3	Suspended	Hospital Israelita Albert Einstein
Leronlimab in Moderately Ill Patients With COVID-19 Pneumonia	2021/05/25	NCT04901676	Phase 3	Suspended	Hospital Israelita Albert Einstein
Double Blind, Placebo Controlled Study of Safety and Efficacy of Leronlimab in Patients With "Long" COVID-19	2020/12/22	NCT04678830	Phase 2	Completed	CytoDyn, Inc.
Leronlimab (PRO 140) in Patients With Nonalcoholic Steatohepatitis	2020/08/20	NCT04521114	Phase 2	Completed	CytoDyn, Inc.
Basket Study of Leronlimab (PRO 140) in Patients With CCR5+ Locally Advanced or Metastatic Solid Tumors	2020/08/07	NCT04504942	Phase 2	UNKNOWN	CytoDyn, Inc.
Study to Evaluate the Efficacy and Safety of Leronlimab for Patients With Severe or Critical Coronavirus Disease 2019 (COVID-19)	2020/04/15	NCT04347239	Phase 2	UNKNOWN	CytoDyn, Inc.
Study to Evaluate the Efficacy and Safety of Leronlimab for Mild to Moderate COVID-19	2020/04/13	NCT04343651	Phase 2	Completed	CytoDyn, Inc.
A Compassionate Use Study of Leronlimab in Breast Cancer	2020/03/18	NCT04313075	N/A	NO_LONGER_AVAILABLE	CytoDyn, Inc.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Related News

CytoDyn Initiates Phase II Trial of Leronlimab in Relapsed/Refractory Colorectal Cancer

a month ago

CytoDyn has dosed the first patient in a Phase II clinical trial evaluating leronlimab, a CCR5 antagonist, in patients with relapsed/refractory microsatellite stable colorectal cancer.

Blood Test Monitoring PD-L1 Expression Shows Promise for Improving Immunotherapy Outcomes in Metastatic Breast Cancer

4 months ago

Clinical trials demonstrate that the LifeTracDx® blood test can monitor PD-L1 upregulation in metastatic breast cancer patients, with 76% showing increased expression after leronlimab treatment.

Leronlimab Shows Promising Results in Reversing Liver Fibrosis, CytoDyn Reports

5 months ago

• CytoDyn's preclinical studies demonstrate statistically significant reversal of liver fibrosis using leronlimab monotherapy, with p-values below 0.01 across three distinct trials. • The research, conducted with SMC Laboratories, evaluated leronlimab in both metabolic dysfunction associated steatohepatitis (MASH) and chemical-induced liver fibrosis mouse models. • Results suggest leronlimab's CCR5-binding mechanism could have broader applications for treating fibrosis in multiple organs, including lungs and heart.

mTNBC Pipeline Shows Promise with Novel Therapies in Clinical Trials

8 months ago

• The mTNBC pipeline includes over 12 drugs from 10+ companies, targeting novel approaches to improve treatment outcomes for this aggressive breast cancer. • Trilaciclib, a CDK4/6 inhibitor by G1 Therapeutics, is in Phase III trials to preserve bone marrow and immune function during chemotherapy in mTNBC patients. • Olinvacimab, an anti-angiogenic antibody by PharmAbcine/Merck, is in Phase II trials, blocking the VEGF/VEGFR2 pathway to inhibit tumor growth and metastasis. • Emerging therapies focus on intravenous, subcutaneous, and oral routes of administration, with molecule types including monoclonal antibodies and small molecules.

FDA Clears Phase 2 Trial of Leronlimab for Microsatellite-Stable Colorectal Cancer

8 months ago

The FDA has cleared CytoDyn's phase 2 trial of leronlimab in relapsed/refractory microsatellite stable colorectal cancer (MSS CRC).

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