Regen BioPharma Issues End of Fiscal Year Shareholder Letter
PR Newswire PR NewswireSeptember 19, 2017
SAN DIEGO, September 19, 2017 /PRNewswire/ --
Regen BioPharma Inc. (RGBP) and (RGBPP) President Dr. Harry Lander issued the following fiscal year end shareholder letter:
As the end of Regen's fiscal year 2017 approaches on September 30th, I would like to summarize our progress during the past twelve months and look to the future.
Our decision to focus on small molecules to activate and inhibit our primary target of interest, NR2F6, seems prescient. The M&A market indicates that the autoimmunity and immuno-oncology fields are even hotter at the end of the year than they were at the beginning. Although there have been many transactions over the past twelve months, two very recent deals further support this assertion: the $2.3 billion acquisition of IFM Therapeutics, Inc. by Bristol Myers Squibb (which I commented on previously (http://www.prnewswire.com/news-releases/regen-biopharma-inc-addresses-potential-impact-of-recent-bristol-myers-squibb-23-billion-acquisition-of-ifm-therapeutics-639392183.html), and the $11.9 billion acquisition of Kite Pharmaceuticals by Gilead (http://www.gilead.com/news/press-releases/2017/8/gilead-sciences-to-acquire-kite-pharma-for-119-billion).
A Look Back at our Success:
The scientific program focusing on identifying and optimizing small molecule compounds that activate or inhibit NR2F6 and directly inhibit or activate the immune system, respectively, is proceeding well. To our great excitement, we believe we are only three or four months away from having an optimized activator in hand, which we can then test in several animal models of autoimmunity. Similarly, we also expect to have an optimized inhibitor a few months afterward (in calendar Q1 of 2018), which we can then test it in several animal models of cancer.
Plans for the Immediate Future:
We continue to have discussions with multiple big pharma companies. To create the most value for our shareholders, we have elected to continue to develop the NR2F6 program in-house prior to entering into any potential partnerships. The more mature the products, the greater their valuation in the marketplace.
We are now in the process of identifying the major indications on which we will focus our efficacy studies. Obviously, the market size of an indication is important, but equally or even more important is the likelihood of success. Therefore, although we already have a preferred list of indications, we will test these compounds for efficacy in many models of autoimmunity and cancer. Our goal in 2018 is to develop both an activator and inhibitor of NR2F6 that is effective and not toxic in animal models. At that point, we will begin experiments and process manufacturing, which will enable us to apply for testing these compounds in humans.
The drug development process is slow and steady. However, we have had no scientific setbacks, and the small molecule drugs that we are developing are performing exactly as we had hoped they would. This is not usually the case in science and we remain laser-focused on achieving the scientific goals we have set out to achieve. Thus far, we have met each and every scientific target, and we believe that our planned scientific efforts in 2018 will greatly increase the likelihood of striking strategic partnerships with one or more large pharmaceutical companies in the near future.
With warm regards,
President and Chief Scientific Officer
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Brian Devine, Chairman
Business Advisory Board
Brian is the former Chairman, CEO, and President of PETCO, where he oversaw the company’s expansion from $80 million to approximately $5 billion in sales. He became Chairman Emeritus at Petco Holdings, Inc. in 2016. Prior to that, he held leadership roles at Toys R Us, including Senior Vice President, Director of Stores for the U.S and Canada. Brian served as a Director at National Retail Federation Inc., Retail Industry Leaders Association, Students in Free Enterprise, Georgetown University Board of Regents, Georgetown University College Board of Advisors, San Diego International Sports Council, and the San Diego Padres. He also served as Director, Chairman of Real Estate Committee, Member of Executive Committee and Member of Nominating Committee at Wild Oats Market prior to it being sold to Whole Foods. He currently is on the Board of Directors of the Ron Fowler School of Business at San Diego State University, the San Diego Sports Alliance, the San Diego Hall of Champions, and on private company boards.
PRODUCT PIPELINE | ZANDER THERAPEUTICS, INC
?Zander Therapeutics is a biotechnology company focused on veterinary therapies that enlist the animals’ own immune system. Zander’s main areas of interest include: autoimmune disorders such as arthritis, immunotherapies for cancer treatment in canines and bone marrow suppression therapy for animals treated with chemotherapy and radiation therapy.
??Learn more about bone marrow and aplastic anemia therapy as well as small molecule targeting cancer stem cell genes.
Products in Development for Veterinary Use
- ZT 110 is an NR2F6 inhibitor feline leukemia
ZT 240 is an NR2F6 inhibitor for canine cancer
?ZT 396 is an NR2F6 stimulator for exercise induced pulmonary hemorrhage (equine)
ZT 430 is an NR2F6 stimulator for arthritis and autoimmunity (feline & canine)
Small Molecule Therapies Targeting Cancer Stem Cell Genes in Animals?
Small Molecule targeting of the cancer stem cell is the process of “coaxing” the cancer stem cell to turn into a normal cell. Regen BioPharma (licensor) has identified and filed patents on a novel gene controlling the process of cancer stem cell differentiation. Additionally, Zander Therapeutics has filed its own patent applications regarding therapies for animals.?
- Objective is to identify small molecules that can induce differentiation of cancer stem cells
High through-put screening identified 7 “hit” compounds
Currently in pre-clinical development
Additional indications include solid tumors and acute leukemia
Small Molecule Therapies Targeting Autoimmune Diseases Genes in Animals
The Company believes that autoimmune diseases such as arthritis can be controlled and their impact reversed by activating a gene in animals that is believed to modulate this process. This set of therapies is based upon intellectual property licensed by Zander Therapeutics from Regen BioPharma. Zander Therapeutics is pursuing its own intellectual property that will build on currently licensed technology.
- Objective is to identify small molecules that activate NR2F6 check point that appears to control autoimmune diseases
Currently in pre-clinical development
Bone Marrow and Aplastic Anemia Therapy
A personalized cellular therapeutic product designed to stimulate blood production in veterinary patients whose bone marrow is not properly functioning.
- Fat stem cell-based product to treat bone marrow that has been damaged
Bone marrow damage occurs from radiation, chemotherapy or chronic conditions
Uses animal’s own fat as a source of endothelial cells to heal damaged bone marrow
Toxicity studies have been successfully completed by Regen BioPharma Inc., the licensor of this technology to Zander Therapeutics
Aims to provide “natural” replacement to synthetic cytokines
For cats and dogs, Zander will target:
For horses, Zander will target:
United States Food and Drug Administration (FDA) Investigational New Drug Application (IND #15376, status cleared for use in humans by Regen BioPharma Inc. -- licensor to Zander Therapeutics Inc.)
- Exercise Induced Pulmonary Hemorrhage (EIPH)
Zander Therapeutics, Inc.
4700 Spring Street, Suite 304
La Mesa, CA 91942
Telephone: (619) 702-1404
Fax: (619) 330-2328
MANAGEMENT & ADVISORY TEAM | ZANDER THERAPEUTICS, INC.
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David R. Koos, PhD, DBA
Chairman and Chief Executive Officer
David Koos is the Founder, Chairman & CEO of Entest BioMedical Inc. Dr. Koos has over 32 years of investment banking and venture capital experience with a primary focus on fully reporting medical and biotechnology ventures. He holds a Ph.D. degree in Sociology and a Doctor of Business Administration in Finance. Additionally, he has authored or co-authored several peer reviewed journal articles primarily on biotechnology related subjects.
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?Harry Lander, PhD, MBA
President and Chief Scientific Officer
Harry Lander has over 20 years of professional scientific, business and financial management experience related to biomedical research. He has a deep knowledge of operations and research administration. Dr. Lander has a team-oriented management style founded on outstanding communication and interpersonal skills. Highly effective at strategic planning, problem solving and operational excellence. Dr. Lander has extensive relationships with large and small biotechnology / pharmacology companies and entities that Regen BioPharma expects to leverage for company growth.
Formerly he has served as Research Chief / Administration for Sidra Medical and Research Center (Doha, Qatar), Assistant Provost for Weill Cornell Medical College (Cornell University), along with serving as Assistant Dean for Research Administration at Weill Cornell Medical College (Cornell University).
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?Todd S. Caven
Chief Financial Officer
Todd S. Caven is an accomplished executive with 30 years of experience in corporate finance, taxation, mergers & acquisitions, corporate valuations and financing activities for various types of transactions. In March of 2009, Mr. Caven co-founded Saguaro Capital Partners, an Arizona based firm that raises growth capital for medical device, pharmacology and technology based companies throughout the western United States.
In 2003, Mr. Caven founded Rock Ridge Enterprises, a Minnesota-based boutique Private Equity firm that focuses on the acquisition of manufacturing, distribution, construction and business services firms in the upper Midwest. Prior to founding Rock Ridge Enterprises, he served as the CFO of Atterro Human Capital Group (formerly Pro Staff), a $500 million privately held firm in the Staffing and Recruiting industry. Prior to Atterro, Todd held senior-level finance and marketing positions at Nordic Track and the Carlson Companies, both in Minneapolis, Minnesota. He started his career in corporate finance at Amoco Corporation in Chicago, Illinois (now British Petroleum).
Todd earned a Bachelors degree in Accounting from the Tippie College of Business at the University of Iowa, and he received an MBA from the J.L. Kellogg Graduate School of Management at Northwestern University.
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Thomas Donnelly, DVM
Senior Veterinary Advisor
Tom is a board-certified specialist in the field of laboratory animal medicine. He is also Adjunct Associate Professor at Tufts University Cummings School of Veterinary Medicine and Professor (teaching & research) at Ecole Nationale Veterinaire d’Alfort. He provides regulatory guidance, research advice, medical attention and welfare supervision to researchers using animals in scientific investigation and testing. Tom is a board-certified specialist in the field of exotic mammals, and sees primary care and referred patients. His work links the understanding of animal diseases and their complexities with the development of novel therapies for humans and animals.
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Linda L. Black, DVM, PhD
Senior Veterinary Advisor
Linda is a leading researcher, published author and currently COO and Vice President of Clinical Science for Medicus Biosciences, a biotech company focused on drug delivery for ophthalmology, advanced wound healing, osteoarthritis, and regenerative medicine applications for pets and people. She has extensive experience in veterinary stem cell research and commercialization. She holds a PhD in Molecular and Cell Biology from The Wistar Institute at University of Pennsylvania School of Medicine, a DVM from University of Wisconsin School of Veterinary Medicine and attended undergraduate training at the University of California at Davis. She completed her post doctoral fellowship at GlaxoSmithKline.
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?Thomas Ichim, PhD
Senior Research Consultant
Dr. Ichim has extensive experience with stem cell therapy and cellular product development through FDA regulatory pathways. He spent over seven years as President and Chief Scientific Officer of Medistem, developing and commercializing a novel stem cell, the Endometrial Regenerative Cell, through drug discovery, optimization, preclinical testing, IND filing, and up through Phase II clinical trials with the FDA. Subsequent to the acquisition of Medistem by Intrexon, in a deal worth $26 million, Dr. Ichim was brought on to the parent company in its cell engineering unit as Vice President of Cellular Therapy.
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Director of Business Development
The Dorsee Company, founded by Debbie Dorsee, is a leader in public relations for businesses and individuals. With an integrated focus on community relations, marketing, fundraising/capital raising, and business development, The Dorsee Company offers a unique promotional approach that opens doors, forges partnerships, and drives results.
Debbie Dorsee, a San Diego native, founded The Dorsee Company in 2003. Drawing from her life’s fabric of political campaigns, social events and promotional fundraising, she uses her behind-the-scenes knowledge and community contacts to promote public awareness and drive business results. Debbie was the recipient of the San Diego North Chamber of Commerce’s Volunteer of the Year honor and was named one of San Diego Metropolitan Magazine’s Metro Movers to Watch
Jonathan Baell, PhD
Scientific Advisory Board
Dr. Baell is a professor or Medicinal Chemist at Monash University (Australia) whose research is focused on the discovery of new medicines for treating diseases with an unmet medical need. A proven record of undertaking original research with a total of 120 publications and patents. He is published in top-ranked journals in the field (e.g. 12 in Journal of Medicinal Chemistry, Nature Chemical Biology,Nature). He has 40 granted patents listed in www.lens.org.
He has won a national award for my discovery of a new class of potential multiple sclerosis therapeutics. Additionally he has achieved successful outcomes in a diverse array of drug discovery arenas, from rational design of peptidomimetics to heterocyclic drug discovery.
For the period 2012-16, Dr. Baell is Chief InvestIgator on competitive grants that currently are totalling $4.73M. In addition, he has been awarded a prestigious NHMRC Senior Research Fellowship for the period 2012-2016. In 2011 and elected as the Australian representative to the Board of Directors for the Inaugural International Chemical Biology Society and appointed Chair of Membership.
Recent News! Check out Zander therapeutics website.