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
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
  1. BLA filing completed in May 2020 with rolling review
  2. Protocol for pivotal Phase 3 trial filed
  3. Phase 1b/2 trial underway with Fast Track designation
  4. Phase 2 trial underway with Orphan Drug designation
  5. IND and Phase 2 protocol filed
  6. 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
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

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.

Read More on COVID-19

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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