CytoDyn Inc.

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Pipeline

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
Immunology
GvHD 3
Pre-clinical Phase complete
Phase 1 Phase complete
Phase 2 Phase in progress
Phase 3 Phase not started
NASH
Pre-clinical Phase complete
Phase 1 Phase complete
Phase 2 Phase in progress
Phase 3 Phase not started
Cancer
Triple-Negative Breast 4
Pre-clinical Phase complete
Phase 1 Phase complete
Phase 2 Phase in progress
Phase 3 Phase not started
Colon
Pre-clinical Phase complete
Phase 1 Phase complete
Phase 2 Phase in progress
Phase 3 Phase not started
Prostate
Pre-clinical Phase in progress
Phase 1 Phase not started
Phase 2 Phase not started
Phase 3 Phase not started
Pancreatic
Pre-clinical Phase in progress
Phase 1 Phase not started
Phase 2 Phase not started
Phase 3 Phase not started
Melanoma
Pre-clinical Phase in progress
Phase 1 Phase not started
Phase 2 Phase not started
Phase 3 Phase not started
Liver
Pre-clinical Phase in progress
Phase 1 Phase not started
Phase 2 Phase not started
Phase 3 Phase not started
Lung
Pre-clinical Phase in progress
Phase 1 Phase not started
Phase 2 Phase not started
Phase 3 Phase not started
Stomach
Pre-clinical Phase in progress
Phase 1 Phase not started
Phase 2 Phase not started
Phase 3 Phase not started
  1. BLA filing underway, 1/3 completed
  2. Protocol for pivotal Phase 3 trial filed
  3. Trial underway with Orphan Drug Designation
  4. Trial underway with Fast Track Designation

Licensing Opportunities

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

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

Read More on Leronlimab

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.

Read More on CCR5

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.

Read More on GVHD

PCa Test for Accurate Prostate Cancer Diagnosis

Our PCa Test is an unbiased and valuable tool to provide guidance to assist the physician and prostate cancer patient to make a more informed decision regarding a potentially life-altering surgery based on their true risk profile.

Read More on PCa Test

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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