Item
1. Business
We
were incorporated April 24, 2012 under the laws of the State of Nevada. We intend to engage primarily in the development of regenerative
medical applications which we intend to license, develop internally or acquire outright from other entities up to the point of successful
completion of Phase I and or Phase II clinical trials after which we would either attempt to sell or license those developed applications
or, alternatively, advance the application further to Phase III clinical trials. The primary factor to be considered by us in arriving
at a decision to advance an application further to Phase III clinical trials would be a greater than anticipated indication of efficacy
seen in Phase I trials.
The
Company has the following therapies in development:
HemaXellarate
: HemaXellarate is a cellular composition of autologous stromal vascular fraction derived from adipose tissue. HemaXellarate contains
endothelial progenitor cells as well as mesenchymal stem cells. Once re-infused into the patient, the patient’s bone marrow is
regenerated and begins to function normally.
dCellVax:
dCellVax is comprised of autologous dendritic cells which have been treated with an siRNA inhibitor of indoleamine-2,3-dioxygenase (IDO),
an immunosuppressive enzyme. By inhibiting this enzyme in these dendritic cells, the patient’s cells can now attack cancers, particularly
breast cancer.
tCellVax:
Immune cells are removed from the patient, treated with siRNA to inhibit NR2F6 and the cells re-infused to the patient. Now that the
inhibitor protein is blocked, the immune system is very activated and kills tumors. siRNA is a double-stranded RNA molecule that is non-coding
and is a powerful tool in drug targeting and therapeutics development as it is used to modulate gene expression through transcriptional
or translational repression. The NR2F6 nuclear receptor has been identified as a potentially very important immune cell inhibitor (an
immune checkpoint) and cancer stem cell differentiator.
DiffronC:
This drug uses our proprietary siRNA in vivo to inhibit cancer growth and activate T cells. The siRNA targets NR2F6. T cells are part
of the immune system and develop from stem cells in the bone marrow.
DuroCAR:
DuroCAR is comprised of CAR-T cells which have been treated with an shRNA targeting the gene NR2F6. By inhibiting NR2F6, we expect our
DuroCAR cells to have greater efficacy and persistence than conventional CAR-T cells and create a new, optimal way to manufacture CAR-T
cells. We are currently in pre-clinical testing of this drug. Chimeric antigen receptor T cells ( CAR-T cells) are T cells that have
been genetically engineered to produce an artificial T cell receptor for use in immunotherapy. Chimeric antigen receptors are receptor
proteins that have been engineered to give T cells the new ability to target a specific antigen.
Small
molecule: We have identified and patented a series of small molecules which can both activate and inhibit NR2F6. We are currently in
pre-clinical testing of these drugs.
As
of September 1, 2022 we have not licensed any existing therapies which may be marketed. On June 23, 2015 Regen Biopharma, Inc. ( “Regen”)
entered into an agreement (“Agreement”) with Zander Therapeutics, Inc. ( “Zander”) whereby Regen granted to Zander
an exclusive worldwide right and license for the development and commercialization of certain intellectual property controlled by Regen
(“ License IP”) for non-human veterinary therapeutic use for a term of fifteen years. Zander is under common control with
the Company.
Pursuant
to the Agreement, Zander shall pay to Regen one-time, non-refundable, upfront payment of one hundred thousand US dollars ($100,000) as
a license initiation fee which must be paid within 90 days of June 23, 2015 and an annual non-refundable payment of one hundred thousand
US dollars ($100,000) on July 15th, 2016 and each subsequent anniversary of the effective date of the Agreement.
The
abovementioned payments may be made, at Zander’s discretion, in cash or newly issued common stock of Zander or in common stock
of Entest BioMedical Inc. valued as of the lowest closing price on the principal exchange upon which said common stock trades publicly
within the 14 trading days prior to issuance.
Pursuant
to the Agreement, Zander shall pay to Regen royalties equal to four percent (4%) of the Net Sales , as such term is defined in the Agreement,
of any Licensed Products, as such term is defined in the Agreement, in a Quarter.
Pursuant
to the Agreement, Zander will pay Regen ten percent (10%) of all consideration (in the case of in-kind consideration, at fair market
value as monetary consideration) received by Zander from sublicensees ( excluding royalties from sublicensees based on Net Sales of any
Licensed Products for which Regen receives payment pursuant to the terms and conditions of the Agreement).
Zander
is obligated pay to Regen minimum annual royalties of ten thousand US dollars ($10,000) payable per year on each anniversary of the Effective
Date of this Agreement, commencing on the second anniversary of June 23, 2015. This minimum annual royalty is only payable to the extent
that royalty payments made during the preceding 12-month period do not exceed ten thousand US dollars ($10,000).
The
Agreement may be terminated by Regen:
If
Zander has not sold any Licensed Product by ten years of the effective date of the Agreement or Zander has not sold any Licensed Product
for any twelve (12) month period after Zander’s first commercial sale of a Licensed Product.
The
Agreement may be terminated by Zander with regard to any of the License IP if by five years from the date of execution of the Agreement
a patent has not been granted by the United States patent and Trademark Office to Regen with regard to that License IP.
The
Agreement may be terminated by Zander with regard to any of the License IP if a patent that has been granted by the United States patent
and Trademark Office to Regen with regard to that License IP is terminated.
The
Agreement may be terminated by either party in the event of a material breach by the other party.
On
December 17, 2018 Regen Biopharma, Inc.(“Licensor”) , KCL Therapeutics, Inc. (“Assignee”) and Zander Therapeutics,
Inc. (“Licensee”) entered into a LICENSE ASSIGNMENT AND CONSENT AGREEMENT whereby, with regards to certain intellectual property
which was assigned by Regen Biopharma, Inc.(“Assigned Properties”) to its wholly owned subsidiary KCL Therapeutics, Inc.,
Licensor hereby transfers and assigns to Assignee all rights, duties, and obligations of Licensor under the Agreement with respect to
the Assigned Properties , and Assignee agrees to assume such duties and obligations thereunder and be bound to the terms of the Agreement
with respect thereto.
On
April 7, 2021 Regen Biopharma, Inc. (“Regen”) entered into an agreement (“Agreement”) with Oncology Pharma, Inc.
(“Licensee”) whereby Regen granted to Licensee an exclusive right and license for the development and commercialization of
certain intellectual property ( “License IP”) for the treatment in humans of pancreatic cancer for a term of fifteen years
from April 7, 2021.
The
License IP consists of antigen specific cancer vaccines in which modified mRNA is administered to produce epitopes able to produce an
immune response which augments likelihood of successful induction of immunity. An epitope is the part of an antigen that is recognized
by the immune system.
As
consideration to Regen for the rights and license granted pursuant to the Agreement Licensee shall:
| (a) |
|
pay
to Regen a nonrefundable fee of $55,000 no later than April 20,2021 |
| (b) |
|
pay
to Regen royalties equal to five percent (5%) of the Net Sales as Net Sales are defined in the Agreement of any Licensed Products
in a quarter. |
| (c) |
|
pay
to Regen ten percent (10%) of all consideration (in the case of in-kind consideration, at fair market value as monetary consideration)
received by Licensee from sublicensees, excluding royalties from sublicensees based on Net Sales of any Licensed Products for which
Regen receives payment |
Licensed
Product is defined in the Agreement as (a) any method, procedure, service or process that incorporates, uses, used, is covered by, infringes
or would infringe any of the License IP in the U.S. or foreign jurisdictions; and (b) any apparatus, material, equipment, machine or
other product that incorporates, uses, used, is covered by, infringes or would infringe any of the License IP in the U.S. or foreign
jurisdictions but for the rights granted pursuant to the Agreement.
In
the event that development of the License IP by the Licensee is not commenced as of the date that is nine months from the effective date
of the Agreement the rights and license granted pursuant to the Agreement shall become nonexclusive.
The
foregoing description of the Agreement is not complete and is qualified in its entirety by reference to the text of the Agreement , which
is attached to this Current Report on Form 8-K as Exhibit 10.1 and incorporated in this Item 1.01 by reference.
On
April 7, 2021 KCL Therapeutics, Inc. (“KCL”) entered into an agreement (“Agreement”) with Oncology Pharma, Inc.
(“Licensee”) whereby KCL granted to Licensee an exclusive right and license for the development and commercialization of
certain intellectual property (“License IP”) for the treatment in humans of colon cancer for a term of fifteen years from
April 7, 2021.
As
consideration to KCL for the rights and license granted pursuant to the Agreement Licensee shall:
| |
(a) |
pay
to KCL a nonrefundable fee of Fifty Thousand common shares of Oncology Pharma, Inc. no later than April 20,2021 |
| |
(b) |
pay
to KCL royalties equal to five percent (5%) of the Net Sales as Net Sales are defined in the Agreement of any Licensed Products in
a quarter. |
| |
(c) |
pay
to KCL ten percent (10%) of all consideration (in the case of in-kind consideration, at fair market value as monetary consideration)
received by Licensee from sublicensees, excluding royalties from sublicensees based on Net Sales of any Licensed Products for which
KCL receives payment |
Licensed
Product is defined in the Agreement as (a) any method, procedure, service or process that incorporates, uses, used, is covered by, infringes
or would infringe any of the License IP in the U.S. or foreign jurisdictions; and (b) any apparatus, material, equipment, machine or
other product that incorporates, uses, used, is covered by, infringes or would infringe any of the License IP in the U.S. or foreign
jurisdictions but for the rights granted pursuant to the Agreement.
In
the event that development of the License IP by the Licensee is not commenced as of the date that is nine months from the effective date
of the Agreement the rights and license granted pursuant to the Agreement shall become nonexclusive.
Zander
and Regen are under common control. David Koos serves as sole officer and director of both Regen BioPharma, Inc. and Zander Therapeutics
Inc.
Both
Zander and Oncology Pharma, Inc. will be required to obtain approval from the United States Food and Drug Administration (“FDA”)
in order to market any Licensed Product which may be developed within the United States and no assurance may be given that such approval
would be granted.
Distribution
methods of the products or services:
It
is anticipated that Regen and /or KCL will enter into licensing and/or sublicensing agreements with outside entities in order that Regen
and/or KCL may obtain royalty income on the products and services which it may develop and commercialize.
Competitive
business conditions and Regen's competitive position in the industry and methods of competition
We
are recently formed and have yet to achieve revenues or profits. The pharmaceutical and biologics industries in which we intend to compete
are highly competitive and characterized by rapid technological advancement. Many of our competitors have greater resources than we do.
Sources
and availability of raw materials and the names of principal suppliers
The
supplies and materials required to conduct our operations are available through a wide variety of sources and may be obtained through
a wide variety of sources.
Patents,
trademarks, licenses, franchises, concessions, royalty agreements or labor contracts, including duration
Patents
and Patent Applications:
The
following is a list of intellectual property (“IP”) controlled by either Regen Biopharma, Inc. ( the “Company”)
or KCL Therapeutics (“KCL”). KCL is a wholly owned subsidiary of the Company.
IP
which has been granted patent protection by the United States Patent and Trademark Office (“USPTO”)
GENE
SILENCING OF THE BROTHER OF THE REGULATOR OF IMPRINTED SITES (BORIS)
Provides
methods and compositions useful for inhibiting expression of the gene encoding the transcription factor, Brother of the Regulatory of
Imprinted Sites (BORIS) by RNA interference. Methods of the present invention can be used to silence BORIS in cancer cells, which results
in apoptosis and may be useful as for treating cancer in mammals. The methods of the invention directed to cancer therapy can be used
alone or in combination with standard cancer treatments such as surgery, radiation, chemotherapy, and immunotherapy.
Patent
No: 8263571
METHODS
AND MEANS OF GENERATING IL-17 ASSOCIATED ANTITUMOR EFFECTOR CELLS BY INHIBITION OF NR2F6 INHIBITION
Means,
methods, and compositions of matter useful for generation of cancer inhibitory effector cells producing interleukin-17 (IL-17). In one
embodiment a cellular population is obtained, said cellular population is exposed to agents capable of inhibiting NR2F6, whereby said
inhibition of NR2F6 results in upregulation of IL-17 production, said upregulation of IL-17 production associated with acquisition of
anti-tumor activity.
Patent
No : 11,053,503
METHODS
OF SCREENING COMPOUNDS THAT CAN MODULATE NR2F6 BY DISPLACEMENT OF A REFERENCE LIGAND
Compositions
of matter, protocols and methods of screening test compounds to identifying agonists and antagonists of the orphan nuclear receptor NR2F6
by measuring the ability of a test compound to occupy the active site of NR2F6, in the presence of a reference compound.
Patent
No: 10,088,485
MODULATION
OF NR2F6 AND METHODS AND USES THEREOF
The
application provides methods of modulating NR2F6 in a cell or animal in need thereof by administering an effective amount of a NR2F6
modulator
Patent
No: 9091696
“UNIVERSAL
DONOR CHECKPOINT INHIBITOR SILENCED/GENE EDITED CORD BLOOD KILLER CELLS”
The
invention encompasses compositions of matters, cells, and treatment protocols useful for induction of anticancer responses in a patient
suffering from cancer. In one embodiment the invention provides the use of NR2F6 silencing or gene editing in cord blood cells possessing
anti-tumor activity in order to induce potentiated killer cells suitable for therapeutic use. In one embodiment said allogeneic cord
blood killer cells are administered to initiate a cascade of antitumor immune responses, with initially responses mediated by allogeneic
killer cells, and followed by endogenous immune responses.
Patent
No: 11,141,471 B2
ANTIGEN
SPECIFIC MRNA CELLULAR CANCER VACCINES
Antigen
specific cancer vaccines in which immunogenic epitopes are produced intracellularly by administration of modified mRNA encoding said
immunogenic epitopes. In one embodiment of the invention, said modified mRNA encodes peptides derived from the protein survivin. By directly
inducing gene expression of the antigens to which an immune response is desired, immunogenic peptides are generated intracellularly,
thus allowing for a wider repertoire of epitopes to be presented to the adaptive immune system, which augments likelihood of successful
induction of immunity.
Patent
No. 11,090,332
METHOD
OF CANCER TREATMENT USING SIRNA SILENCING
Comprises
administering to a subject one or more siRNA constructs capable of inhibiting the expression of an immunosuppressive molecule. The invention
also provides siRNA constructs and compositions.
Patent
No: 8389708
SMALL
MOLECULE AGONISTS AND ANTAGONISTS OF NR2F6 ACTIVITY IN HUMANS.
Patent
No. 11,324,719
The
invention relates to compounds useful to alteration of NR2F6 activity.
Active
Patent Applications:
ENHANCED
DENDRITIC CELL IMMUNE ACTIVATION BY COMBINED INHIBITION OF NR2F6 WITH CANNIBIDIOL;
Application
Number 17035955
REDUCTION
OF POST-SURGERY CANCER METASTASIS BY COMBINATION OF CANNABIDIOL AND NR2F6 INHIBITION.
Application
Number 17037284
SUPPRESSION
OF PATHOLOGICAL ANGIOGENESIS BY INHIBITION OF NR2F6
Application
Number 17087386
STIMULATION
OF T REGULATORY CELLS BY CANNABIDIOL AS A MEANS OF TREATING ARTHRITIS AND AUTOIMMUNITY
Application
Number 17010720
SMALL
MOLECULE AGONISTS AND ANTAGONISTS OF NR2F6 ACTIVITY IN HUMANS
Application
Number 15820324
SMALL
MOLECULE MODULATORS OF NR2F6 ACTIVITY.
Application
Number 15652967
NR2F6
INHIBITED CHIMERIC ANTIGEN RECEPTOR CELLS
Application
Number 15351414
COMBINATION
THERAPY OF SOLID TUMORS USING CHIMERIC ANTIGEN RECEPTOR CELLS REPRESENTING ADAPTIVE AND INNATE IMMUNITY
Application
Number 63400740
ENHANCEMENT
OF CHIMERIC ANTIGEN RECEPTOR T CELL EFFICACY BY DEDIFFERENTIATION
Application
Number 63396419
AUGMENTATION
OF SURVIVIN MODIFIED MRNA VACCINE EFFICACY USING DENDRITIC CELLS
Application
Number 63391889
Treatment
of Liver Cancer through Embolization Depot Delivery of BORIS Gene Silencing Agents
Application
Number US-2017166896-A1
Immune
Modulation by TLR Activation for Treatment of Filovirus Infections Including Ebola
Application
Number US-2016151469-A1
Stimulation
of Immunity to Tumor Specific and Endothelial Specific Proteins by in vivo DC Attraction and Maturation
Application
Number US-2016074489-A1
Cells,
Compositions, and Treatment Methods for Stimulation of Hematopoiesis
Application
Number US-2015037303-A1
Cancer
Therapy by ex vivo Activated Autologous Immune Cells
Application
Number US-2014065096-A1
Acceleration
of Hematopoietic Reconstitution by Placental Endothelial and Endothelial Progenitor Cells
Application
Number US-2013309210-A1
License
Agreements:
On
June 23, 2015 Regen Biopharma, Inc. ( “Regen”) entered into an agreement (“Agreement”) with Zander Therapeutics,
Inc. ( “Zander”) whereby Regen granted to Zander an exclusive worldwide right and license for the development and commercialization
of certain intellectual property controlled by Regen (“ License IP”) for non-human veterinary therapeutic use for a term
of fifteen years. Zander is under common control with the Company.
Pursuant
to the Agreement, Zander shall pay to Regen one-time, non-refundable, upfront payment of one hundred thousand US dollars ($100,000) as
a license initiation fee which must be paid within 90 days of June 23, 2015 and an annual non-refundable payment of one hundred thousand
US dollars ($100,000) on July 15th, 2016 and each subsequent anniversary of the effective date of the Agreement.
he
abovementioned payments may be made, at Zander’s discretion, in cash or newly issued common stock of Zander or in common stock
of Entest BioMedical Inc. valued as of the lowest closing price on the principal exchange upon which said common stock trades publicly
within the 14 trading days prior to issuance.
Pursuant
to the Agreement, Zander shall pay to Regen royalties equal to four percent (4%) of the Net Sales , as such term is defined in the Agreement,
of any Licensed Products, as such term is defined in the Agreement, in a Quarter.
Pursuant
to the Agreement, Zander will pay Regen ten percent (10%) of all consideration (in the case of in-kind consideration, at fair market
value as monetary consideration) received by Zander from sublicensees ( excluding royalties from sublicensees based on Net Sales of any
Licensed Products for which Regen receives payment pursuant to the terms and conditions of the Agreement).
Zander
is obligated pay to Regen minimum annual royalties of ten thousand US dollars ($10,000) payable per year on each anniversary of the Effective
Date of this Agreement, commencing on the second anniversary of June 23, 2015. This minimum annual royalty is only payable to the extent
that royalty payments made during the preceding 12-month period do not exceed ten thousand US dollars ($10,000).
The
Agreement may be terminated by Regen:
If
Zander has not sold any Licensed Product by ten years of the effective date of the Agreement or Zander has not sold any Licensed Product
for any twelve (12) month period after Zander’s first commercial sale of a Licensed Product.
The
Agreement may be terminated by Zander with regard to any of the License IP if by five years from the date of execution of the Agreement
a patent has not been granted by the United States patent and Trademark Office to Regen with regard to that License IP.
The
Agreement may be terminated by Zander with regard to any of the License IP if a patent that has been granted by the United States patent
and Trademark Office to Regen with regard to that License IP is terminated.
The
Agreement may be terminated by either party in the event of a material breach by the other party.
On
December 17, 2018 Regen Biopharma, Inc.(“Licensor”) , KCL Therapeutics, Inc. (“Assignee”) and Zander Therapeutics,
Inc. (“Licensee”) entered into a LICENSE ASSIGNMENT AND CONSENT AGREEMENT whereby, with regards to certain intellectual property
which was assigned by Regen Biopharma, Inc.(“Assigned Properties”) to its wholly owned subsidiary KCL Therapeutics, Inc.,
Licensor hereby transfers and assigns to Assignee all rights, duties, and obligations of Licensor under the Agreement with respect to
the Assigned Properties , and Assignee agrees to assume such duties and obligations thereunder and be bound to the terms of the Agreement
with respect thereto.
On
April 7, 2021 Regen Biopharma, Inc. (“Regen”) entered into an agreement (“Agreement”) with Oncology Pharma, Inc.
(“Licensee”) whereby Regen granted to Licensee an exclusive right and license for the development and commercialization of
certain intellectual property ( “License IP”) for the treatment in humans of pancreatic cancer for a term of fifteen years
from April 7, 2021.
The
License IP consists of antigen specific cancer vaccines in which modified mRNA is administered to produce epitopes able to produce an
immune response which augments likelihood of successful induction of immunity. An epitope is the part of an antigen that is recognized
by the immune system.
As
consideration to Regen for the rights and license granted pursuant to the Agreement Licensee shall:
| (a) |
|
pay
to Regen a nonrefundable fee of $55,000 no later than April 20,2021 |
| (b) |
|
pay
to Regen royalties equal to five percent (5%) of the Net Sales as Net Sales are defined in the Agreement of any Licensed Products
in a quarter. |
| (c) |
|
pay
to Regen ten percent (10%) of all consideration (in the case of in-kind consideration, at fair market value as monetary consideration)
received by Licensee from sublicensees, excluding royalties from sublicensees based on Net Sales of any Licensed Products for which
Regen receives payment |
Licensed
Product is defined in the Agreement as (a) any method, procedure, service or process that incorporates, uses, used, is covered by, infringes
or would infringe any of the License IP in the U.S. or foreign jurisdictions; and (b) any apparatus, material, equipment, machine or
other product that incorporates, uses, used, is covered by, infringes or would infringe any of the License IP in the U.S. or foreign
jurisdictions but for the rights granted pursuant to the Agreement.
In
the event that development of the License IP by the Licensee is not commenced as of the date that is nine months from the effective date
of the Agreement the rights and license granted pursuant to the Agreement shall become nonexclusive.
The
foregoing description of the Agreement is not complete and is qualified in its entirety by reference to the text of the Agreement , which
is attached to this Current Report on Form 8-K as Exhibit 10.1 and incorporated in this Item 1.01 by reference.
On
April 7, 2021 KCL Therapeutics, Inc. (“KCL”) entered into an agreement (“Agreement”) with Oncology Pharma, Inc.
(“Licensee”) whereby KCL granted to Licensee an exclusive right and license for the development and commercialization of
certain intellectual property (“License IP”) for the treatment in humans of colon cancer for a term of fifteen years from
April 7, 2021.
As
consideration to KCL for the rights and license granted pursuant to the Agreement Licensee shall:
| |
(a) |
pay
to KCL a nonrefundable fee of Fifty Thousand common shares of Oncology Pharma, Inc. no later than April 20,2021 |
| |
(b) |
pay
to KCL royalties equal to five percent (5%) of the Net Sales as Net Sales are defined in the Agreement of any Licensed Products in
a quarter. |
| |
(c) |
pay
to KCL ten percent (10%) of all consideration (in the case of in-kind consideration, at fair market value as monetary consideration)
received by Licensee from sublicensees, excluding royalties from sublicensees based on Net Sales of any Licensed Products for which
KCL receives payment |
Licensed
Product is defined in the Agreement as (a) any method, procedure, service or process that incorporates, uses, used, is covered by, infringes
or would infringe any of the License IP in the U.S. or foreign jurisdictions; and (b) any apparatus, material, equipment, machine or
other product that incorporates, uses, used, is covered by, infringes or would infringe any of the License IP in the U.S. or foreign
jurisdictions but for the rights granted pursuant to the Agreement.
In
the event that development of the License IP by the Licensee is not commenced as of the date that is nine months from the effective date
of the Agreement the rights and license granted pursuant to the Agreement shall become nonexclusive.
Zander
and Regen are under common control. David Koos serves as sole officer and director of both Regen BioPharma, Inc. and Zander Therapeutics
Inc.
Both
Zander and Oncology Pharma, Inc. will be required to obtain approval from the United States Food and Drug Administration (“FDA”)
in order to market any Licensed Product which may be developed within the United States and no assurance may be given that such approval
would be granted.
Principal
Products and Services
dCellVax
is intended to be a therapy whereby dendritic cells of the cancer patient are harvested from the body, treated with siRNA that has the
ability to block the dendritic cell from expressing indoleamine 2,3-dioxygenase (“IDO”) and subsequently reimplanted in the
cancer patient.
The
dendritic cells that are treated with the IDO-blocking RNA become resistant to the influence of tumor cells which produce factors which
cause the dendritic cell to express the IDO. Expression of IDO in the dendritic cell halts the dendritic cell from activating T cells
and causes the dendritic cell to suppress T cells. T lymphocytes (‘T cells”) are a lymphocyte that play a central role in
the human immune system’s attempt to eradicate tumors. The Company has filed an Investigational New Drug (IND) application with
the United States Food and Drug Administration (“FDA”) to initiate a Phase I/II clinical trial assessing safety with signals
of efficacy of the dCellVax gene-silenced dendritic cell immunotherapy for treating breast cancer. The proposed trial will recruit 10
patients with metastatic breast cancer and will involve 4 monthly injections of the dCellVax gene-silenced dendritic cell therapy. The
trial is anticipated to last one year, with tumor assessment before therapy and at 6 and 12 months.
On
May 12, 2021 the “Company executed a consulting agreement with Biotech Research Group Corporation, an FDA Specialist Group and
Global Regulatory and Scientific Experts, for the purpose of review and guidance with regard to the planned reinstatement of the Company’s
inactive Investigational New Drug applications (INDs) #15376 (HemaXellerate) and #16200 (dCellVax) filed with the United States Food
and Drug Administration (“FDA”). The securing of the services to be provided to the Company pursuant to this consulting agreement
marks the first step taken by the Company with regard to activating the Company’s currently inactive applications to initiate clinical
trials
HemaXellerate,
a cellular therapy designed to heal damaged bone marrow. HemaXellerate is a patient-specific composition of cells that have been demonstrated
to repair damaged bone marrow and stimulate production of blood cells based in previous animal studies. The initial application of HemaXellerate
will be the treatment of severe aplastic anemia which is characterized by immune-mediated bone marrow hypoplasia (underdevelopment or
incomplete development of a tissue) and pancytopenia (reduction in the number of blood cells and platelets).
Adipose
tissue is collected from the patient and processed in order to separate, extract and isolate Stromal Vascular Fraction (SVF), a mix of
various cell types including mesenchymal stem cells and endothelial cells. Mesenchymal stem cells are connective tissue cells that can
differentiate into a variety of cell types and endothelial cells are the cells that line the interior surface of blood vessels and lymphatic
vessels and which play a vital role in angiogenesis (the physiological process through which new blood vessels form from pre-existing
vessels).
The
isolated SVF is then intravenously administered to the patient. The Company believes that the isolated SVF will generate growth factors
with the ability to repair damaged hematopoietic stem cells. Hematopoietic stem cells are immature cells that can develop into all types
of blood cells, including white blood cells, red blood cells, and platelets. Hematopoietic stem cells are found in the peripheral blood
and the bone marrow.
On
February 5, 2013 Regen filed an Investigational New Drug (IND) application with the United States Food and Drug Administration (“FDA”)
to initiate a Phase I clinical trial assessing HemaXellerate in patients with drug-refractory aplastic anemia. The Phase I clinical trial
is intended to determine safety and potential efficacy of intravenously administered autologous 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.
Under
the Orphan Drug Act, the FDA may designate a product as an orphan drug if it is a previously unapproved drug or biologic intended to
treat a rare disease or condition, which is generally defined as a patient population of fewer than 200,000 individuals annually in the
United States. Generally, if a product with an orphan drug designation subsequently receives the first marketing approval for the indication
for which it has such designation, the product is entitled to a seven year period of marketing exclusivity, which precludes the FDA from
approving another marketing application for the same drug for that time period. The sponsor of the product would also be entitled to
a United States federal tax credit equal to 50% of clinical investigation expenses as well as exemptions from certain fees.
The
Company believes that this application of HemaXellerate qualifies for Orphan designation under the Orphan Drug Act due to the fact that
aplastic anemia is a rare disease with prevalence in the United States of less than 200,000 and intends to apply to the FDA for Orphan
designation for HemaXellerate.
On
December 10, 2015 Regen was informed by the United States Food and Drug Administration that Regen has satisfactorily addressed all clinical
hold issues related to Regen’s Investigational New Drug Application for HemaXellerate and may initiate a Phase I clinical trial
assessing HemaXellerate in patients with drug-refractory aplastic anemia. 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.
tCellVax
is intended to be a therapy where immune cells are removed from the cancer patient, treated with siRNA which inhibits NR2F6 and the cells
re-infused to the patient. NR2F6 normally acts as a brake on the ability of various immune cells from being activated. The immune cells
that are treated with the NR2F6-blocking siRNA become highly activated and can efficiently kill tumors. . The Company has filed an Investigational
New Drug (IND) application with the United States Food and Drug Administration (“FDA”) to initiate a Phase I clinical trial
assessing safety and feasibility of the dCellVax gene-silenced immune cell immunotherapy for treating patients with solid tumors that
are metastatic or not able to be removed surgically. The proposed trial will recruit 25 patients with metastatic cancer and will involve
3 monthly injections of the dCellVax gene-silenced dendritic cell therapy. The trial is anticipated to last one year, with tumor assessment
before therapy and at 6 and 12 months.
DiffronC:
NR2F6 is a transcription factor that is present in many cells in the body, including immune cells but also highly expressed in certain
solid tumors. NR2F6 normally acts as a brake on the ability of various immune cells from being activated and also allows tumor cells
to keep growing. The Company has developed a proprietary drug that is based on shRNA technology, which prevents NR2F6 from being expressed.
By inhibiting the expression of NR2F6, immune cells that are treated with the NR2F6-blocking shRNA become highly activated and can efficiently
kill tumors and tumors that have NR2F6 suppressed begin to differentiate. . We are currently in pre-clinical testing of this drug to
optimize its delivery in vivo.
DuroCAR:
DuroCAR is a new cellular therapy being developed by the Company. It is comprised of CAR-T cells which have been treated with an shRNA
targeting the gene NR2F6. CAR-T cells are T cells (the lymphoid cells of the body that kill tumors) isolated from a cancer patient that
have been modified by expressing a chimeric antigen receptor (CAR) which is specific for the patient’s tumor. These CAR-T cells
are then re-infused back into the patient. The CAR-T cells then home in directly on the tumor because they have been given the tumor-specific
address via the CAR. While CAR-T cells are very effective in treating leukemias, they are not effective at treating most solid tumors.
The reason for this is believed to be that the CAR-T cells are “turned-off” by the physical environment surround solid tumors.
By inhibiting NR2F6, we expect our DuroCAR cells to have greater efficacy and persistence than conventional CAR-T cells and create a
new, optimal way to manufacture CAR-T cells. We are currently in pre-clinical testing of this drug.
Small
molecule: We have identified and patented a series of small molecules which can both activate and inhibit NR2F6. NR2F6 normally acts
as a brake on the ability of various immune cells from being activated and also allows tumor cells to keep growing. By inhibiting the
function of NR2F6 using small molecules, immune cells that are treated with the NR2F6-blocking agents, similar to using the shRNA approach,
should become highly activated and efficiently kill tumors. In addition, tumors that have NR2F6 blocked by using these small molecules
should begin to differentiate. Conversely, activating NR2F6 is expected to suppress the immune system. This ability to suppress the immune
system can be very useful for treating autoimmune disorders. We are currently in pre-clinical testing of these drugs.
Distribution
methods of the products or services:
It
is anticipated that Regen and /or KCL will enter into licensing and/or sublicensing agreements with outside entities in order that Regen
and/or KCL may obtain royalty income on the products and services which it may develop and commercialize.
Need
for any government approval of principal products or services, effect of existing or probable governmental regulations on the business.
Need
for any government approval of principal products or services, effect of existing or probable governmental regulations on the business.
The
US Food and Drug Administration (“FDA”) and foreign regulatory authorities will regulate our proposed products as drugs or
biologics, , depending upon such factors as the use to which the product will be put, the chemical composition, and the interaction of
the product on the human body. In the United States, products that are intended to be introduced into the body will generally be regulated
as drugs, while tissues and cells intended for transplant into the human body will be generally be regulated as biologics.
Our
domestic human drug and biological products will be subject to rigorous FDA review and approval procedures. After testing in animals,
an Investigational New Drug Application (“IND”) must be filed with the FDA to obtain authorization for human testing. Extensive
clinical testing, which is generally done in three phases, must then be undertaken at a hospital or medical center to demonstrate optimal
use, safety, and efficacy of each product in humans.
Phase
I
Phase
1 trials are designed to assess the safety (pharmacovigilance), tolerability, pharmacokinetics, and pharmacodynamics of a drug. These
trials are often conducted in an inpatient clinic, where the subject can be observed by full-time staff. The subject who receives the
drug is usually observed until several half-lives of the drug have passed. Phase I trials normally include dose-ranging, also called
dose escalation, studies so that the appropriate dose for therapeutic use can be found. The tested range of doses usually are a fraction
of the dose that causes harm in animal testing and involve a small group of healthy volunteers. However, there are some circumstances
when real patients are used, such as patients who have end-stage disease and lack other treatment options.
Phase
II
Phase
II trials are designed to assess how well the drug or biologic works, as well as to continue Phase I safety assessments in a larger group
of volunteers and patients. Phase II trials are performed on larger groups.
Phase
III
Phase
III trials are aimed at being the definitive assessment of how effective the product is in comparison with current best standard treatment
and to provide an adequate basis for physician labeling. Phase III trials may also be conducted for the purposes of (i) "label expansion"
(to show the product works for additional types of patients/diseases beyond the original use for which the drug was approved for marketing
or (ii) to obtain additional safety data, or to support marketing claims for the product.
On
occasion Phase IV (Post Approval) trials may be required by the FDA. Phase IV trials involve the safety surveillance (pharmacovigilance)
and ongoing technical support of a drug after it receives permission to be sold.The safety surveillance is designed to detect any rare
or long-term adverse effects over a much larger patient population and longer time period than was possible during the Phase I-III clinical
trials.
All
phases, must be undertaken at a hospital or medical center to demonstrate optimal use, safety, and efficacy of each product in humans.
Each clinical study is conducted under the auspices of an independent Institutional Review Board (“IRB”). The IRB will consider,
among other things, ethical factors, the safety of human subjects, and the possible liability of the institution. The time and expense
required to perform this clinical testing can far exceed the time and expense of the research and development initially required to create
the product. No action can be taken to market any therapeutic product in the United States until an appropriate New Drug Application
(“NDA”) or Biologic License Application (“BLA”) or has been approved by the FDA. FDA regulations also restrict
the export of therapeutic products for clinical use prior to NDA or BLA approval.
Even
after initial FDA approval has been obtained, further studies may be required to provide additional data on safety or to gain approval
for the use of a product as a treatment for clinical indications other than those initially targeted. In addition, use of these products
during testing and after marketing could reveal side effects that could delay, impede, or prevent FDA marketing approval, resulting in
FDA-ordered product recall, or in FDA-imposed limitations on permissible
The
FDA regulates the manufacturing process of pharmaceutical products, and human tissue and cell products, requiring that they be produced
in compliance with Current Good Manufacturing Practices (“cGMP”) . The FDA also regulates the content of advertisements used
to market pharmaceutical products. Generally, claims made in advertisements concerning the safety and efficacy of a product, or any advantages
of a product over another product, must be supported by clinical data filed as part of an NDA or an amendment to an NDA, and statements
regarding the use of a product must be consistent with the FDA approved labeling and dosage information for that product.
Sales
of drugs and biologics outside the United States are subject to foreign regulatory requirements that vary widely from country to country.
Even if FDA approval has been obtained, approval of a product by comparable regulatory authorities of foreign countries must be obtained
prior to the commencement of marketing the product in those countries. The time required to obtain such approval may be longer or shorter
than that required for FDA approval
Amount
spent during the fiscal year ended September 30, 2022 on research and development activities
During
the fiscal year ended September 30, 2022 we expended $275,388 on research and development activities.
Costs
and effects of compliance with environmental laws (federal, state and local)
Regen
has not incurred any unusual or significant costs to remain in compliance with any environmental laws and does not expect to incur any
unusual or significant costs to remain in compliance with any environmental laws in the foreseeable future.
Number
of total employees and number of full-time employees
As
of October 28, 2022 Regen has 1 employee of which one is full time.
Item
2. Properties
The Company
currently occupies 2,320 square feet of office space at 4700 Spring Street, Suite 304, La Mesa, California 91942. The property is utilized
as office space. We believe that the foregoing properties are adequate to meet our current needs for office space.
On January
13, 2022 Regen Biopharma, Inc. entered into a sublease agreement with BST Partners (“BST”) whereby Regen Biopharma, Inc.
would sublet the aforementioned office space located at 4700 Spring Street, Suite 304, La Mesa, California 91942 from BST on a month
to month basis for $5,000 per month beginning January 14, 2022. BST Partners is controlled by David Koos who serves as the sole officer
and director of Regen Biopharma, Inc.