This Biopharmaceutical Company has Anticipated FDA Approval on Pivotal Drug in $20+ Billion HIV Treatment Space

CytoDyn is a biopharmaceutical company that is focused on the clinical development and commercialization of their flagship product candidate PRO 140 (leronlimab).  

PRO 140 is a weekly dosed, subcutaneous injection that could be a functional cure for HIV, and has all the features of possibly becoming a foremost therapeutic agent in HIV and perhaps in oncology and auto-immune ailments.

The FDA has issued Leronlimab a Fast Track designation to two clinical trials being conducted by CytoDyn for deadly diseases. The first as a combination therapy with HAART for HIV-infected patients and the second trial for metastatic triple-negative breast cancer. 

Multi-Billion Dollar Opportunity in HIV

There are over 130,000 individuals using a currently approved drug for the prevention of HIV, with well known side effects and long-term morbidities such as kidney and liver complications, bone density issues, headaches, abdominal pain and weight loss. 

PRO 140 has already shown efficacy towards inhibiting HIV entry and has hit the primary endpoint in their pivotal trial, a combination therapy for treatment-experienced HIV infected patients. They are now entering a Phase III as a monotherapy, which may make it the first single agent HIV therapy ever.

On June 7th CytoDyn reported that the FDA requested an in-person meeting to deliberate and possibly finalize the phase III protocol for PRO 140’s monotherapy trial, as well as that they are working on an agreement to start an HIV prevention study that will be “conducted by and fully funded by a public health agency in Southeast Asia.”

CytoDyn expects to get approval for leronlimab by end of first quarter of 2020.

As soon as leronlimab is approved, CytoDyn will have about $100 million worth of leronlimab available for commercial sales. SAMSUNG BIOLOGICS has struck a deal as a strategic manufacturing partner and will produce $1.0 billion of Leronlimamb as well.

8 Phase 2 Cancer Trials Costing Only $1.5M

In addition to HIV, CytoDyn is also leading a Phase II trial to assess PRO 140 as a treatment for metastatic triple-negative breast cancer, with the company already having preclinical data that presented the capability of PRO 140 to inhibit breast cancer cell metastasis. CytoDyn is currently in a phase Ib/II clinical trial in metastatic triple-negative breast cancer, as well as pre-clinical trials for PRO 140 in NASH.

It’s rare for a drug to jump immediately into a phase 2 from a preclinical trial unless the drug has a pristine safety profile and has gotten numerous signoff from the Drug Safety Monitoring Board (DSMB) from other clinical trials. CYDY has done it 3 times and is planning on doing it 7 more times.  

The first time was with Graft versus Host Disease (GvHD), the second time was with metastatic Triple Negative Breast Cancer (TNBC) and the third time just happened a few days ago with colon cancer.

CYDY is seeking registration of 13 disease indications.  Cancer drugs typically take $1.0 billion or more to get approved.  What is most impressive is that less than $1.5 million will be spent on preparing 8 phase 2 cancer trials resulting in billions of potential value creation:  

  • HIV COMBINATION THERAPY
  • HIV MONOTHERAPY
  • GvHD
  • TNBC
  • COLON CANCER
  • MELANOMA
  • PANCREATIC CANCER
  • PROSTATE CANCER
  • LUNG CANCER
  • LIVER CANCER
  • STOMACH CANCER
  • NASH
  • PROSTATE CANCER PROGNOSTIC

NASH is the largest unmet medical need in the world and CYDY is weeks away from submitting a phase 2 and IND for it. 

Summary

CYDY may prove to be that once in a lifetime investment opportunity if PRO-140 proves to be a functional cure for HIV. 

It is a weekly dosed, subcutaneous injection within minimum (if any) side effects. This would position it as a foremost therapeutic agent in HIV and conceivably in oncology and auto-immune ailments. This translates into billions in revenue just in HIV treatment, nevermind the other 8 studies following it.

CYDY has done a phenomenal job building the foundation, clinical data, and partnerships needed to receive approval, and go to market. Now in the final push, we see it as being possibly the next big win for savvy Biotech Investors. 

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