Miami, FL – December 26, 2019 (EmergingGrowth.com NewsWire) — EmergingGrowth.com, a leading independent small cap media portal with an extensive history of providing unparalleled content for the Emerging Growth markets and companies, reports on CytoDyn, Inc. (OTCQB: CYDY).

Cytodyn Inc (OTCQB: CYDY) just announded its intentions to seek a Breakthrough Therapy Designation (BTD) in January 2020 after releasing more preliminary trial results.  Breakthrough Therapy Designations started in 2012 and was designed to get expedite drug development.  According to the 2012 FDA Safety and Innovation Act (FDASIA), in order to apply the drug needs to first treat a “serious condition” like cancer, and second have “preliminary clinical evidence indicating that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint.”  On both counts CYDY appears confident of their filing in January 2020.  The CEO stated

“Due to these very promising clinical data, we feel that the 98% inhibition of metastasis shown by our animal studies may soon become a reality for many cancer patients throughout the world. We are cautiously optimistic and believe we have enough results in an unmet medical need population to justify filing for Breakthrough Therapy Designation in January 2020.”   

BTD’s are a sought after prize in the drug development community and are typically associated with multibillion dollar valuations.  Immununomedics (NASDAQ: IMMU) is the perfect case study for comparison because they are targeting a much smaller subset of the metastatic Triple Negative Breast Cancer (mTNBC) market than CYDY yet enjoys a $4.2 billion market cap.  The estimated patient population is 8,000 in the United States and 14,000 in the European Union and Japan for a total patient population of 22,000.  IMMU is considered a pure play in mTNBC.  IMMU’s lead drug candidate is an antibody-drug conjugate (ADC) called scituzumab goviteacan or IMMU-132.  It has a BTD for the treatment of mTNBC, for patients that have received at least to prior therapies for metastatic disease. In comparison CYDY has approval to proceed with a phase 1b/2 study to add leronlimab (PRO 140) to existing therapies for naïve mTNBC patients.  There are about 170,000 cases of TNBC worldwide every year.  This put CYDY at the top of the food chain with respect to access to first line patients which is a much bigger market of 170,000 patients versus the 22,000 highly experienced patients that have failed at least 2 prior therapies.  

IMMU ran into regulatory issues and just recently resubmitted their BLA on December 3, 2019.  In January 2019, the FDA rejected its breast cancer drug and had issues related “exclusively focused on Chemistry, Manufacturing and Control matters.”  After the debacle the CEO Michael Pehl resigned.        CYDY is about to file its BLA so both these drug companies appear to be in a horse race to getting their respective drugs approved.  CYDY is trying to get it approved for HIV which is a less serious disease than mTNBC but the safety profile of CYDY appears to be a major factor supporting approval and there doesn’t appear to be any issues with the CMC. CYDY is expected to file their BLA at the end of the year but no later than January 2020.  There is no date set for the IMMU BLA acceptance but CYDY enjoys a rolling BLA review and fast track status.  If CYDY files for BTD it could accelerate the pace even more.       

This year Roche’s (OTC Pink: RHHBY) drug Tencentriq was approved for combination use with paclitaxel in first-line  TNBC patients if the cancer spread and cannot be removed by surgery and the cancer tests positive for PD-L1.  The results of the study demonstrated “clinically meaningful improvement” in overall survival of 25 months versus the 15.5 month with the current standard of care.  What is interesting is that the side effects occurred at similar rates between the control group and the combination therapy which indicates the addition didn’t reduce the toxic profile of the chemotherapy.  The two year survival rate was 54% with the new combination therapy versus 37% of chemotherapy only treated patients.  This approval came at basically the same time CYDY got the go ahead to conduct their phase 1b/2 trial which might have been part of the reason behind the slow patient recruitment.  

In mice studies the validated model for mTNBC which shows a 98% reduction in tumor metastasis.  On CYDY’s first couple of patients they are seeing a confirmation of the mouse studies dramatic results.  According to Bruce Patterson, M.C, CEO of IncellDX, the first patient that has been dosed for 11 weeks demonstrated “sustained undetectable levels of Circulating Tumor Cells (CTCs) and a reduction of cancer-associated macrophage like cells (CAMLs).” CTCs over 5 indicate a significantly inferior progression-free survival (PFS) and overall survival (OS) so by keeping the CTC’s under 5 CYDY has a pathway to approval by demonstrating historical PFS. 

Cytodyn’s second patient enrolled in the mTNBC study was an emergency IND.  According to Proactive Investors video update this is the CEO’s mother in law who had been lethargic for close to 2 years and is now up and moving and cooking again.  Dr Patterson indicated the Stage 4 patient had metastasis of the liver, lung, and brain and just after 3 weeks the scans showed “demonstrated shrinkage of the tumors at both timepoints following the first leronlimab injection, reduction in brain edma, and remarkable disappearance of several metastatic tumors.”  The disappearance of metastatic tumors that close to 2 years of treatment was unable to effect is celebratory news indeed.  It’s important to note that in this patient’s remarkable transformation she had 700 mg of treatment which is 2 times dosage of the clinical trial protocol.  Given the outstanding results there could be a request to amend the protocol and increase the dosage which could lead to more favorable outcomes for patients. 

The company only needs about 2 more patients with similar results as the first to have the compelling data required to submit for a BTD.  Based on the increased level of activity the company believes they will have 4 patients enrolled by year end and allow them to file for BTD by the end of January.  

Investment Summary

There is clearly a race to treat mTNBC patients and the top contenders are CYDY and IMMU.  Each of these companies is taking a novel approach to treating the disease but in one case the FDA has been extremely accommodative and in the other case the FDA has been highly inquisitive.  It’s expected that the BLA filings will be about a month apart, but CYDY may have the edge with its rolling BLA review.  In all likelihood the CMC part is done and only the clinical data remains in HIV which is coming in at a 95% responders rate which close to multiples over the existing standard of care.  BLA approval seem given for both companies.  It is clear that CYDY is on a path to file for BTD in mTNBC and if they are approved their market share of mTNBC will greatly overshadow the market share of IMMU.  CYDY has roughly an 8 fold increase in patient population versus IMMU.  However, IMMU enjoys an 18 fold increase in market capitalization over CYDY even though they are neck and neck in the approval process.  As the story evolves we believe this disparity will resolve itself in short order.  What is even stranger than the extremely low market cap of CYDY is that they have an HIV drug, which on its own merits could dethrone Gilead (NASDAQ: GILD).   This is all the more reason for investors to pay attention to this rapidly evolving story.    

https://academic.oup.com/jncics/article/3/2/pkz026/5480691

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