(Majority-Owned Susidiary of BMSN)
Regen BioPharma, Inc., a subsidiary of Bio-Matrix Scientific Group, Inc. (OTCBB: BMSN)
is a biotechnology company focused on identifying undervalued regenerative medicine applications
in the stem cell space and rapidly advancing these technologies through pre-clinical andPhase I/ II clinical trials.
"Our business model is to acquire and form companies around
undervalued assets identified froma highly focused analysis of issued
patents in regenerative medicinethat have demonstrated proof of concept"
Dr. Ichim is one of the leading authorities in the
world on stem cell biology.
"A STEM CELL INCUBATOR COMPANY" With an emphasis on stem cell regenerative medicine
Our Business Model | Regen BioPharma
Regen BioPharma has assessed over 20,000 stem cell related issued patents, narrowed down to 2000 patents with commercial applicability, and further identified 30 patents available for licensing. The company seeks to inlicense, take the product to, and through clinical safety and efficacy "signal" and spin out technologies.
Our Approach | Regen BioPharma
REGEN BIOPHARMA AVOIDS WASTE OF "ONE PRODUCT/ONE INFRASTRUCTURE" APPROACH
In the "Conventional Model", stem cell companies are started with one basic technology, infrastructure is developed around that technology, then if the technology fails, significant resources are lost that have been used in the product-specific development Conventional Model
Regen BioPharma Model
Month 1-2: Assembly of Team:
Regen intends to assemble a team of world-class leaders in the spheres of Technology, Intellectual Property assessment, valuation and Clinical development. Regen will seek to compile a team of Physician-Scientists with experience in the area of clinical trials for regenerative medicine/stem cell products, Regulatory experts who have successfully taken products through the FDA and corresponding agencies internationally, and Biotech Entrepreneurs who have track records of excellence in business formation and value optimization. -DONE
Month 1-4: Inlicensing of Intellectual Property:
The Company having already assessed over 20,000 issued patents and havingcompiled a shortlist of 30 targets; Regen will seek to execute licensing deals on an initial core of 3 technologies. Regen focuses onissued patents that have already passed preclinical studies but are not under clinical development. -DONE
Month 3-6: Interaction with Regulatory Agencies:
Regen intends to develop data packages for each of the technologies andinitiate interaction with Regulatory Agencies such as the FDA for initiation of trials.-DONE
Month 6-18: Clinical Implementation:
Regen intends to launch clinical trials with world-leading institutions to obtain human safety data and "signal" of therapeutic efficacy. NEXT UP
Month 18-24: Exit:
It is intended that technologies "incubated" by Regen will be spun off either as separate companies, or sold to Large Pharma companies seeking to enhance their therapeutic pipeline.
"At present there exists a wealth of intellectual property that is 'collecting dust' in the corridors of Academia. Given the field of regenerative medicine and stem cell therapy is so young, and the business models are fuzzy at best in terms of valuation, we see this space as a unique opportunity for acceleration of clinical development/value optimization," said Bio-Matrix Chairman & CEO David Koos about its Regen BioPharma. "Valuations for stem cell companies that have passed the threshold of clinical safety, with signals of efficacy are astronomical. The $1.8 billion Mesoblast-Cephalon deal, as well as recent financings of private companies with as little as 3 patient data such as Promethera ($31 million) or Allocure with 16 patients ($23 million), is testimony to the extremely high valuations that are characteristic of this space."
Regen BioPharma Pipeline
HemaXellerate I™ FDA FILING
[Regen BioPharma filed an Investigational New Drug (IND) Application on February 5th, 2013. Regen BioPharma has received approval from the FDA for the clinical protocol and the product manufacturing information for HemaXellerate I. On May 9, 2014 Regen BioPharma submitted clarification on animal safety studies that the FDA requested with review anticipated within 30 days.]
HemaXellerate I is a cellular therapy designed to heal damaged bone marrow. HemaXellarate I utilizes a collection of cells harvested from the patient’s own adipose (fat) tissue to repair damaged bone marrow and stimulate production of blood cells . The initial application of HemaXellerate I will be the treatment of severe aplastic anemia, a rare and serious condition in which the bone marrow fails to make enough blood cells: red blood cells, white blood cells, and platelets. In practice, the physician is shipped a kit, which is used to collect adipose tissue. The tissue is sent to a processing facility, and a standardized cellular product is delivered in a ready-to-use manner for administration into the patient intravenously.
**The Company intends to seek Orphan Drug Designation under the Orphan Drug Act of 1983 from the US Food and Drug Administration for HemaXellerate I**
[Regen BioPharma is currently in the preclinical stage of development for dCellVax and plans to file an Investigational New Drug Application in August 2014]
The dCellVax therapeutic product is based on extracting blood from patients, growing a specialized type of immune cell from the blood called the "dendritic cell" and then subsequently genetically modifying the dendritic cell to become resistant to cancer's immune suppressive activity. It is known that cancer modifies the immune system by producing proteins which result in immune suppression. One such protein which cancer stimulates is an enzyme, indolamine 2,3 deoxygenase (IDO), which cancer turns on in dendritic cells. While dendritic cells are usually immune stimulators, dendritic cells found in cancer patients suppress the immune system as a result of expressing IDO.
The dCellVax therapeutic product uses patents that Regen BioPharma has in-licensed from Dr. Wei-Ping Min coupled with patents in-licensed from Benitec BioPharma. By utilizing methods covered in both of these patents Regen BioPharma hopes to develop an immune-based, non-toxic cancer treatment initially targeting breast cancer.
[Regen BioPharma is currently in the preclinical stage of development for HemaXellerate II]
HemaXellerate II is intended to be a universal donor endothelial cell based therapeutic and is intended to be manufactured by obtaining cells from a part of the placenta called the “vascular lobules”. The cells are processed and utilized for the purpose of stimulating bone marrow hematopoetic stem cell repair and proliferation. The mechanism of action for HemaXellerate II is similar to HemaXellerate I whereby the harvested and processed cells would produce growth factors which would mediate the therapeutic effects of the product.
Managent Team | Regen BioPharma
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 26 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.
Thomas E. Ichim, PhD
Chief Scientific Officer and Board Member Dr. Ichim is a seasoned biotechnology entrepreneur with a track record of scientific excellence. He has founded/co-founded several companies including Medvax Pharma Corp, ToleroTech Inc, bioRASI, and OncoMune LLC. Dr. Ichim is a member of Vendevia Group, an innovative venture development organization focused on optimization of value in biotechnology ventures. He is scientific advisor to Orcrist Bio, Entest, and MBVaX. To date he has published 91 peer-reviewed articles and is co-editor of the textbook “RNA Interference: From Bench to Clinical Translation”. Ichim is an ad-hoc editor and sits on several editorial boards. Ichim is inventor on over 30 patents and patent applications. CV
Advisory Board | Regen BioPharma
Weiping Min, M.D.
Dr. Min is Associate Professor, Department of Surgery at the University of Western Ontario. His clinical research is focused on using siRNA to inhibit disease modalities, including cancer and organ rejection. He earned graduate and medical degrees from Nanchang University Medical School and the Ph.D. degree from Kyushu University.
David James Graham White, M.D., Ph.D.
Dr. White is a member of the Surgery and Immunology faculty of The Schulic School of Medicine, University of Western Ontario. He is one of the leading experts on using regenerative medicine transplant procedures to treat pancreatic conditions, including diabetes. He is also the Chief Scientific Officer of Sernova Corp and was formerly a Therapeutic Area Head for Novartis. He received the B.Sc. degree from the University of Surrey and the M.D. and Ph.D. degrees from Cambridge University.
David A. Suhy, PhD
Dr Suhy has a long-term interest in development of shRNA based therapeutics to treat human diseases. He is in the unique position of seeing of directing the research of a RNAi-based therapeutic from its earliest inception until it reaches clinical trials. Development of a shRNA therapeutic against the Hepatitis C virus (HCV) was initiated at Avocel in 2003. Financial constraints caused the company to shutter research operations in 2006.Upon raising venture capital, Tacere Therapeutics acquired the rights to the HCV family of drugs and brought back Dr. Suhy to head the program. Partnered with Pfizer shortly thereafter, this drug is their first foray into gene therapy-based approaches and is the first shRNA program partnered with a large pharma. Given Pfizer’s lack of experience in both areas, Dr. Suhy has played a pivotal role in its development as Tacere has continued to lead the research efforts for advancement of this product into the clinic and has stood side-by-side with Pfizer through all of the regulatory agency meetings.
Current Business Partners | Regen BioPharma