Pipeline

Clinical Trial Enrollment

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Building a Broad Pipeline of
Indications

Mechanism of Action: Leronlimab as a CCR5 antagonist

Program	Indication	Pre-clinical	Phase 1	Phase 2	Phase 3
HIV
	Combination Therapy ¹	Pre-clinical Phase complete	Phase 1 Phase complete	Phase 2 Phase complete	Phase 3 Phase in progress
	Monotherapy ²	Pre-clinical Phase complete	Phase 1 Phase complete	Phase 2 Phase complete	Phase 3 Phase in progress
Cancer
	Triple-Negative Breast ³	Pre-clinical Phase complete	Phase 1 Phase complete	Phase 2 Phase in progress	Phase 3 Phase not started
	Phase 2 basket trial underway for 22 solid tumors (Including melanoma, brain-glioblastoma, throat, lung, stomach, colon, breast, testicular, ovarian, uterine, pancreas, bladder, among other indications)	Pre-clinical Phase complete	Phase 1 Phase complete	Phase 2 Phase in progress	Phase 3 Phase not started
Immunology
	GvHD ⁴	Pre-clinical Phase complete	Phase 1 Phase complete	Phase 2 Phase in progress	Phase 3 Phase not started
	NASH ⁵	Pre-clinical Phase complete	Phase 1 Phase in progress	Phase 2 Phase not started	Phase 3 Phase not started
	Coronavirus [COVID-19] ⁶	Pre-clinical Phase complete	Phase 1 Phase complete	Phase 2 Phase in progress	Phase 3 Phase not started
	Autoimmune (multiple potential indications including Crohn's disease, IBS (inflammatory bowel disease), MS (Multiple Sclerosis), Hashimoto's thyroiditis, Vasculitis, Psoriasis, Polymyositis, Autoimmune Hepatitis, Grave's disease, Sjogren's syndrome, Myasthenia gravis)	Pre-clinical Phase in progress	Phase 1 Phase not started	Phase 2 Phase not started	Phase 3 Phase not started

BLA filing completed in May 2020 with rolling review
Protocol for pivotal Phase 3 trial filed
Phase 1b/2 trial underway with Fast Track designation
Phase 2 trial underway with Orphan Drug designation
IND and Phase 2 protocol filed
Patient treatment underway via Phase 2 and 2b/3 trials and emergency IND

Licensing Opportunities

Mechanism of Action: Proprietary gene sequencing, A.I.

Program	Indication	510(k)
Prognostic
Prognostic	Prostate Cancer ¹	510(k) Phase in progress

In discussions and seeking 510(k)

Leronlimab for HIV Treatment

Our lead product, Leronlimab (PRO 140), is the world’s first self-injectable, subcutaneous injection for HIV and has many advantages over the current standard of care, HAART, including no serious side effects, enhanced compliance, and longer half-life.

Leronlimab for Cancer Metastasis

Recent research demonstrated the importance of CCR5 in cancer indications and indicates that Leronlimab (PRO 140) is a potential inhibitor of the CCR5 receptor.

Mitigating Acute GVHD with Leronlimab

Graft-versus-host disease (GVHD) is a serious complication that limits the use of Bone Marrow Stem Cell (BMSC) transplantation in patients with blood cancers. Our current clinical trial studies Leronlimab for the prevention of GVHD in patients (RIC) undergoing BMSC transplantation.

Coronavirus Disease 2019

CytoDyn is coordinating with several healthcare partners to provide access to leronlimab for COVID-19 patients through two clinical trials, a Phase 2 trial for those with mild-to-moderate indications and a Phase 2b/3 trial for severe and critically ill patients.

Get In Touch

For more information on Leronlimab, our science, or our new developments, please reach out to us using the link provided.

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