Leronlimab PRO 140

Candidate Pre Phase 1 Phase 2 Phase 3

Leronlimab (PRO 140) belongs to a new class of HIV/AIDS therapeutics -- viral-entry inhibitors -- that are intended to protect healthy cells from viral infection. Leronlimab (PRO 140) is a fully humanized IgG4 monoclonal antibody directed against CCR5, a molecular portal that HIV uses to enter T-cells. Leronlimab (PRO 140) blocks the predominant HIV (R5) subtype entry into T-cells by masking this required co-receptor, CCR5. Importantly leronlimab (PRO 140) does not appear to interfere with the normal function of CCR5 in mediating immune responses.

Leronlimab (PRO 140) has certain unique attributes that distinguish it from other therapies designed to block HIV entry.

  • Leronlimab (PRO 140) is an antibody, not a synthetic drug and has no apparent issues with toxicity.
  • Laboratory studies have shown that leronlimab (PRO 140) does not induce the development of resistant viruses in previous short-term trials.
  • Leronlimab (PRO 140) does not affect the normal function of CCR5, it only blocks the precise site on CCR5 that HIV needs to enter the cell without affecting the normal function of CCR5.

Leronlimab (PRO 140) is one of the most advanced experimental monoclonal antibodies for HIV treatment and has been used in more than 140 HIV-infected subjects in placebo controlled and open label FDA-approved clinical trials. Leronlimab (PRO 140) has been the subject of seven clinical trials, each demonstrating efficacy by significantly reducing or controlling HIV viral load in human test subjects. Leronlimab (PRO 140) has been designated a "fast track" product candidate by the FDA. The leronlimab (PRO 140) antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements as compared to daily drug therapies currently in use.

We believe that leronlimab (PRO 140) may have a number of potential roles in the treatment and prevention of HIV including:

  • Patients with single or multi-drug resistant viruses
  • Patients with difficulty adhering to daily drug regimens
  • Patients who poorly tolerate existing therapies
  • Patients with compromised organ function, i.e., HCV co-infection
  • Patients with complex concomitant medical requirements
  • Pre-exposure (PrEP) or post-exposure (PEP) prophylactic in high risk seronegative individuals

HIV remains a significant global health issue. With limited new drugs in development around the world, CytoDyn believes that monoclonal antibodies are poised to become the next class of anti-viral agents on the market for the treatment of HIV.

CytoDyn is focused on developing monoclonal antibodies for the treatment of HIV infection and disease and is excited to continue the clinical trial development of leronlimab (PRO 140) for HIV.