Regen BioPharma President Harry Lander Provides Open Letter to Shareholders on Company's Progress and Developments

Jan 13, 2016, 08:30 ET from Regen BioPharma Inc.

SAN DIEGO, January 13, 2016 /PRNewswire/ --

Regen BioPharma Inc. (OTCBB: RGBP) and (PINK: RGBP) provided the following update for its shareholders:

Dear Shareholders,

As we have now moved into 2016, I would like to take a moment to discuss Regen BioPharma's overall progress during the last 12 months.  It is of note that Regen's goal is to make a difference in the health of patients' lives, particularly those suffering from cancer and disorders of the bone marrow.  By utilizing our scientific expertise and focusing on our most promising programs, we believe that Regen is now at an inflection point where we will indeed be able to help patients in the future.

As the new President and Chief Scientific Officer of Regen, in addition to summarizing some of Regen's accomplishments in 2015, I would also like to define our goals for 2016.

Corporate Development - 2015 

Regen, founded in 2012, has matured in corporate development in 2015.  As you will see on our About Us page at http://www.regenbiopharma.com we hired Todd Caven as our CFO.  Todd has tremendous financial and investment experience and brings with him a large portfolio of potential investors. After a great deal of analysis of the quality and potential of Regen's intellectual property portfolio, I was very excited to join the firm in October.  

Also, Tom Ichim has transitioned to a consultancy role with the Company.  Tom and I interact on an almost daily basis as he continues to contribute greatly towards the Company's scientific development.  

Finally, you will see that we gained tremendous expertise through adding members to our Scientific Advisory Board, and thus we are assured that our scientific strategy going forward will be carefully vetted by world-class experts.  With David Koos' vast capital market experience, Todd's financial and investment acumen and my experience in the management of science, we form a sophisticated management team poised to take Regen to the next level.  Let me tell you what that next level is a bit later on below.

Scientific Development - 2015 

Regen's science has also matured greatly in 2015. On December 10, 2015 Regen was informed by the FDA that Regen had satisfactorily addressed all clinical hold issues related to Regen's Investigational New Drug Application ("IND") for HemaXellerate and may initiate a Phase I clinical trial assessing HemaXellerate in patients with drug-refractory aplastic anemia. We are now considered a clinical stage company. The Phase I clinical trial is intended to determine safety and potential efficacy of intravenously administered autologous stromal vascular fraction (SVF) cells in patients with severe, immune suppressive refractory aplastic anemia with the primary endpoints of safety and feasibility and secondary endpoints of efficacy as determined by patients having complete response, partial response or relapse. Getting this IND cleared was no small feat and required significant financial resources to perform the toxicology studies requested by the FDA.  However, it was money well spent as the FDA was satisfied and cleared the IND - our first one.  

Regen has another IND filed with the FDA, dCellVax, and we are currently performing experiments to address the FDA's comments.  It is standard practice for the FDA to give the IND holder comments that need to be addressed before the application is cleared for clinical testing.

In pre-clinical development is the technology that really attracted me to Regen and what I consider a potential blockbuster - NR2F6.  Regen scientists and others in Austria have identified this nuclear receptor protein as a potential immune checkpoint.  In other words, it normally keeps the immune system turned off.  If you block it, the immune system becomes very active - and kills cancer cells!  Amazingly, blocking it also turns cancer stem cells (those cancer cells that keep dividing and producing more cancer cells) into normal cells.  The current market for these types of drugs, called cancer immuno-therapies, exceeds $20 billion

(Source: http://finance.yahoo.com/news/global-usa-cancer-immunotherapy-market-160000484.html;_ylt=AwrTcdf5IJRWy6MABiYnnIlQ;_ylu=X3oDMTE0dW10cGprBGNvbG8DZ3ExBHBvcwM2BHZ0aWQDUFJEQkNLMV8xBHNlYwNzcg).

The excitement around these drugs is due to the fact that some patients who had very serious forms of cancer are now being cured outright.  In fact, immunotherapy is now curing 20-30% of patients with advanced melanoma

(Source: http://www.uptodate.com/contents/immunotherapy-of-advanced-melanoma-with-immune-checkpoint-inhibition?source=outline_link&view=text&anchor=H177442841#H177442841).  

This is remarkable as the prognosis of these patients up until a few years ago was very poor.  Thus, you can see why I am so excited about our efforts on NR2F6.  In 2015 we made excellent progress on identifying ways to turn off NR2F6, and that momentum continues into 2016.

We have also greatly strengthened our intellectual property portfolio in 2015 by filing 6 provisional patents and receiving one fully issued patent from the US Patent and Trademark Office.

The Year Ahead  

We have recently formulated scientific and financial strategies that I would like to share with you.  

Science:

Unlike many biotechnology companies that have only one product or concept in development, Regen has 4 legs supporting it.  While this is terrific for the long-term stability of the company, we must balance our resources and prioritize programs as we develop each leg.  Here is our scientific strategy and details of how we expect to further it in 2016:

1. NR2F6 Program - as I mentioned above, if the biology continues to pan out as it has in 2015, this has the potential to rival other commercial immuno-oncology treatments currently on the market.  The current drugs this may rival or augment are produced by Bristol Myers Squibb and Merck.  Because of the dramatic potential to help patients if this program is successful, we are intensely focusing our efforts on two areas - identifying small molecules that inhibit NR2F6 and inhibiting the cells' ability to make NR2F6 protein.  While both of these approaches aim to inhibit NR2F6, they use completely unrelated methods and thus we are very likely to succeed even if one approach is found to be troublesome.  This represents two legs of the chair.


In order to ensure success in these approaches, we have and will continue to enter into some combination of academic, biotechnology and big pharma collaborations.  To date, our discussions for collaborations span the U.S., Australia, Spain, Germany and Canada - we will not let geography stop us from working with the best people. We expect to announce some of these collaborations in Q1 2016.

2. HemaXellerate Program - with the clearance of our IND from the FDA in December, we are now allowed to begin our first clinical trial.  HemaXellerate is aimed at helping people with a potentially fatal disorder, refractory aplastic anemia.  While Thomas Ichim and I have significant experience setting up clinical trials, we will likely outsource this to a company that does this on a daily basis (called Contract Research Organizations (CRO)).  We want to ensure that the data we get will be of the highest quality and that the FDA will have no questions as to the quality and reproducibility.  Therefore, we are going to carefully craft the clinical trial along with our CRO partner and begin the trial once we have the logistical pieces in place.  Because aplastic anemia is a rare disease, we expect that the FDA will grant it Orphan Drug Status and thus accelerate any approvals as the product is developed. We expect to begin the clinical trial by Q3 2016. This is the third leg.


3. dCellVax Program - We have submitted an IND to, and received comments from, the FDA regarding this product.  With dCellVax, we will take cells from a patient with breast cancer, expand a select portion of their immune cells (called dendritic cells), inhibit the expression of a specific protein in these cells (called IDO) and then reinject back these modified dendritic cells into the patient.  The FDA asked us to perform additional experiments before clearing this IND application.  Due to the complexity of the experiments, we are collaborating with Dr. Santosh Kesari, head of Neuro-Oncology at the John Wayne Cancer Center in Los Angeles, to address these comments.  We expect to have the experiments completed in Q2 2016. This is the fourth leg.


Finance:

Research and development costs money.  The U.S. government spends about $40 billion a year on biomedical research and the private sector another $70 billion

(Source: http://www.researchamerica.org/sites/default/files/uploads/healthdollar12.pdf).  

And, of course, there is never a guarantee of success.  Yet, new treatments are emerging, and 2015 was a record year for FDA approvals of new drugs.  As life expectancy continues to increase, quality of life becomes a major issue.  For example, diseases like Alzheimer's, Huntington's and many cancers were practically unheard of before the discovery of penicillin, and human life expectancy jumped. Thus, the money Regen spends on research and development is focused on diseases which will continue to plague humankind.  

As a start-up company, Regen must raise money and spend money judiciously.  To date, Regen, like most start-ups, has raised money through private placements relatively cheaply.  Regen did not have any products approved, and the pre-clinical studies, though promising, were still early-stage.  With recent developments at Regen, we expect the cost of investing to increase and that investors after Q1 2016 will no longer have the same historical discount that Regen extended.  This will reduce the dilutive effect of raising capital.  In addition, we are exploring other opportunities to take advantage of capital market financing.

We have prioritized our R&D spending as I outlined above: NR2F6>HemaXellerate>dCellVax.  This balances our desire to best help patients while at the same time swinging for the fences.  While Regen owns other very exciting intellectual property that I have not discussed today, we intend to initially focus on these 4 legs.  Should additional capital become available, we will increase the breadth of our pipeline appropriately.

Below is a list of milestones that we are aiming to hit in 2016:

  1. Announce new partnerships or collaborations with academic, biotechnology and/or big pharma (Q1 2016)
  2. IND response to the FDA comments for dCellVax (Q2 2016)
  3. Initial IND submission to the FDA for inhibition of NR2F6 in an indication to be determined (Q2 2016)
  4. Begin HemaXellerate clinical trial (Q3 2016)
  5. Identify small molecule inhibitor of NR2F6 (Q3 2016)

Lastly, let me say thank you - I can only assume you have invested in Regen because you think the company is headed in the right direction.  I am personally very, very excited about Regen and am working tirelessly to reward our shareholders.  David Koos, Todd Caven and I each believe that as a biotechnology company, if we can help patients, then all boats will rise and our shareholders will benefit greatly.

With warm regards,

Harry M. Lander, Ph.D., MBA

President and Chief Scientific Officer

Harry.Lander@regenbiopharma.com

ABOUT REGEN BIOPHARMA INC.: Regen BioPharma Inc. is a publicly traded biotechnology company (OTCBB: RGBP) (OTC PINK: RGBP). The Company seeks to identify undervalued regenerative medicine applications in the immunotherapy and stem cell space. The Company is focused on rapidly advancing these technologies through pre-clinical and Phase I/ II clinical trials. Currently the Company is centering on gene silencing therapy for treating cancer, telomeres and small molecule therapies, along with developing stem cell treatments for aplastic anemia.

Disclaimer: This news release may contain forward-looking statements. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Future events and actual results could differ materially from those set forth in, contemplated by, or underlying the forward-looking statements. The risks and uncertainties to which forward looking statements are subject include, but are not limited to, the effect of government regulation, competition and other material risks.

CONTACT INFORMATION
Regen BioPharma Inc. 
David R. Koos, PhD 
Chairman & Chief Executive Officer
+1-619-702-1404 Phone
+1-619-330-2328 Fax
http://www.regenbiopharma.com
david.koos@regenbiopharma.com

SOURCE Regen BioPharma Inc.