Sernova Biotherapeutics Inc (PK)【SEOVF】株式ニュース

SEOVF,...there might be something still moving forward based on this article.

i'm still doing d/d after finding this company. this article is part of what i discovered. the author has compiled a informational summary of SEOVF.

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Sernova Corp about to start FDA Cell Pouch Diabetes trials
April 14, 2018

As a general rule, the most successful man in life is the man who has the
best information

Disruptive innovation

Economist Joseph Schumpeter introduced innovation economics in his 1942
book Capitalism, Socialism and Democracy. Schumpeter said that industries
must incessantly revolutionize the economic structure from within by
innovating with better or more effective processes and products, as well as constantly improving their market distribution.

We can define, or limit the term "innovation" to a product, or process that’s original, that’s more effective, and as a new application better meets new requirements or existing market needs.

The term, disruption, describes a process whereby a smaller company with
fewer resources is able to successfully challenge established incumbent
businesses by, a.) displacing an established technology with a better one or b.) inventing a ground-breaking product that creates a completely new
industry.

In his book “The Innovator’s Dilemma” Harvard Business School professor
Clayton Christensen coined the term ‘disruptive innovation.’ A disruptive
innovation displaces an existing market, industry, or technology and
produces something new, more efficient and worthwhile.

Disruptive innovations do this in three ways:
• By harnessing new technologies
• By developing new business models
• By exploiting old technologies in new ways

Michael Raynor in his book “The Innovator’s Manifesto” says all disruptiveinnovations stem from technological or business model advantages.

“History is replete with examples of disruptive innovation, dating back to ancient times. Examples include the compass, the printing press, currency, gunpowder...Imagine that you are Kodak, a company based largely on film, and someone develops digital imaging, or that you are a mainframe computer company like IBM or DEC, and advances in processors lead to the development of inexpensive but powerful personal computers.

In our own lives, we recognize how cable or satellite TV has displaced air antennas and how cell phones have displaced landlines.” Disruptive innovation as a driver of science and medicine, J. Larry Jameson
Disruptive innovations have the potential to truly reshape the world in which we live and work.

A better mousetrap

In 1882, Ralph Waldo Emerson stated; “If a man has good corn or wood, or
boards, or pigs, to sell, or can make better chairs or knives, crucibles or church organs, than anybody else, you will find a broad hard-beaten road to his house, though it be in the woods.”

In 1889, Emerson was credited with having said; “If a man can write a
better book, preach a better sermon, or make a better mousetrap than his
neighbor ...”

Today the common phrasing is of course a metaphor about the power of
innovation - ‘Build a better mousetrap, and the world will beat a path to yourdoor.’

‘Better’ is a relative term. Every business, in every sector, is trying to build a‘better mousetrap.’ Unfortunately, just like the over 4,000 patents for mouse traps, most are not better, they are just different in some small way.

As far as real mousetraps go there has never been, at least for most of us, a better way of killing mice then the spring loaded snap of the trap caused by a mouse trying to take the bait off a trigger plate. Sure, glue on a piece of cardboard might be an improvement for some who worry about getting their fingers caught (and don’t care about a swift humane kill), or maybe a ‘mouse house’ trap for those who get queasy and don’t want to see a dead rodent. But these are not big enough changes to want to make the majority of us change from the existing, perfectly capable technology.

Most often those who claim to have invented the better mousetrap, real or
metaphorically speaking, haven’t - there just isn’t enough of a technological change to force consumers, businesses or institutions to want to or need to make a change. Call it incremental technology looking for a market.

The opposite end of the scale would be a change so great, a technological
change so much more efficient, so much more attractive a switch is made
without question – from 8-tracks to cassettes, to CDs. From black and white TV to color. From bulky poor quality movies on VHS tapes to slim,
lightweight high quality optics on DVD’s. And of course programmable TVs
with high def (and movies on demand) came along and kicked the crap out
of the DVD market. These examples are all innovations that built upon an
existing technology and truly created better mousetraps that were
universally accepted as such.

Failing to create a clear competitive advantage, doing almost exactly the
same thing as your competition, differentiating yourself by only a small
tweak to the existing dominate market share technology is no way to
succeed or even survive in business.

When you hear about a ‘better mousetrap’ ask yourself:
Better for who - do people really need or want a better mousetrap? Is this new mousetrap market growing, or shrinking?

Regenerative medicine

Regenerative medicine means replacing, engineering or regenerating human
cells, tissues or organs with the goal being to re-establish normality for conditions that currently are beyond repair.

An example of a highly disruptive technology in regenerative medicine is
where living therapeutic cells placed within an implanted medical device
manufacture and release required medicines into the body as needed.
For diabetes, this technology has the potential to disrupt the entire
multibillion insulin and insulin pump market as the therapeutic cells can read blood sugar levels and manufacture and release all the hormones required to appropriately control blood sugar.

The same can occur in other therapeutic areas such as hemophilia where Factor VIII can be produced by therapeutic cells within an implanted device rather than being infused multiple times weekly.

“Disruptive innovations, like we’ve seen in other industries, can bring
complex and expensive health care products and services to greater levels of affordability and accessibility.” Jerome Grossman, MD and Jason Hwang, MD, MBA, The Innovator’s Prescription

A Pure Regenerative Medicine Play

The promise of regenerative medicine is to treat disease and injury by replacing, regenerating or rejuvenating various parts of the human body that have been damaged by chronic disease, traumatic injury, heart attack, stroke, or aging. Treatments include both in vivo (studies and trials performed inside the living body) and in vitro (treatments applied to the body through implantation of a therapy studied inside the laboratory) procedures.

It has to be pretty clear by now that regenerative medicine, although still in the early stages, is in the process of changing the practice of medicine.

These therapies will not only change healthcare, but will also lead to
commercial success for the company and success in the market for
investors.

One regenerative medicine company that’s currently off investors radar
screens is Sernova Corp. (TSX-V: SVA, OTCQB: SEOVF, FSE: PSH).
However, with all Sernova has going on for it, the academic partnerships
and R&D alliances, the company will begin to attract serious market
attention, and possibly big pharma attention, in 2018.

Sernova Corp. is a clinical stage regenerative medicine company developing their Cell Pouch System™ for the treatment of chronic debilitating metabolic diseases such as diabetes, blood disorders including hemophilia and other diseases treated through replacement of proteins or hormones missing or in short supply within the body.

Sernova Corp. has developed the subcutaneous Cell Pouch™ and has
specifically designed it to overcome the issues with previous implanted
devices for cell transplantation.

Sernova’s implantable prevascularized macro-encapsulated Cell Pouch™ is a
versatile and scalable, first-in-class medical device made entirely of FDA approved materials. The Cell Pouch System™ provides a natural “organ-like” environment rich in tissue matrix and micro-vessels. This is the ideal environment for therapeutic cells to thrive which then release proteins and/or hormones as required.

Sernova’s extensive preclinical safety and efficacy studies have shown this device to be both safe and effective, while being sparing of islets, supporting its design and function. The Cell Pouch™ being thin and typically smaller than a business card, fits easily under the skin with virtually no visibility.

Sernova Corp.’s Cell Pouch™, using human donor islet cells to produce
insulin, will begin formal U.S. Food and Drug Administration (FDA) directedclinical testing in Type I/II diabetes in the second half of 2018.

Phase I clinical human testing with porcine-derived islets and formal human studies using stem cell-derived islet cells will follow.
Sernova has entered into partnerships with the University of Toronto (a stem cell-derived diabetes technology licensing/alliance), Harvard University and the University of Chicago.

Sernova has also entered into R&D alliances with leading regenerative
medicine and disease-specific organizations like the University of Toronto-affiliated Centre for Commercialization of Regenerative Medicine and the Juvenile Diabetes Research Foundation.

Sernova’s Cell Pouch™ potential is not limited to just islet cell
transplantation in diabetes. Sernova has an R&D collaboration ongoing to
develop cell therapies for treating hemophilia A (already funded from the
European Commission’s Horizon 2020 program), and a separate alliance with
the University of British Columbia focused on thyroid disorders.

Regenerative medicine could potentially provide lasting solutions to some of the world's leading chronic diseases. That will massively impact the medical industry in coming years. The regenerative medicine market, still in its infancy, offers a genuine opportunity for investors.

Big pharmaceutical companies are beginning to show increased interest by
making various acquisitions and engaging in partnership programs with
startup research companies.

“The rapid aging of the global population and the increasing prevalence of obesity is leading to a significant and growing rate of inflammatory and degenerative diseases of all types. These demographically driven changes are generating significant interest from large, multi-national pharmaceutical companies now targeting small biotechnology start-ups engaged in developing diagnostics and treatments for these degenerative diseases.”

By the year 2020, baby boomers - people aged 65 and up - will outnumber
children under age 5 globally. Also, by the year 2020, the Department of
Health and Human Services predicts the market for regenerative medicine
will reach $300 billion.

Companies, such as Sernova Corp., are the leaders in preclinical research
and many, like SVA is, are entering Phase I/II clinical trials. These
company’s become significant targets once they successfully get their
products to a stage warranting the attention of the big players.
From SVA’s most recent Management Discussion and Analysis (MD&A)
Report comes the following.

"Research and Development Outlook for the 2018 Calendar Year Our
research and development program for 2018 includes the following:

• Initiate a clinical trial of our Cell Pouch™ in collaboration with JDRF under our recently cleared US IND for patients with hypoglycemia unawareness using human donor islets and a standard of care anti-rejection drug regimen to further study the safety and efficacy of the device and islets.
• Clinical evaluation of the Cell Pouch™ for insulin-dependent diabetes who have received an islet transplant.
• In coordination with the EU Horizon 2020 HemAcure Consortium. conduct
cell production and preclinical studies for treatment of hemophilia A
consisting of factor VIII releasing therapeutic cells transplanted within
Sernovas Cell Pouch.
• Conduct preclinical studies for treatment of hypo-thyroid disease consisting of thyroid hormone releasing tissue transplanted within Sernova’s Cell Pouch.
• Production of human stem-cell-derived cells for diabetes and in vivo proof of principle assessment of these differentiated human stem cells for their safety and efficacy within Sernova’s Cell Pouch™ for the treatment of insulin-dependent diabetes.
• Assessment of novel micro-encapsulation technologies within the Cell
Pouch™ cells, to further develop and advance Sernova’s therapeutic vision
for diabetes of a product consisting of locally immune protected therapeutic cells within the Cell Pouch/.
• Continue to collaborate with pharmaceutical companies to assess safety
and efficacy of our combined technologies in preclinical studies for potential negotiation of a licensing arrangement and commercial development partnership for our hemophilia and diabetes programs."

A busy year indeed.

The magnitude of the present opportunity for an investment into Sernova is
equaled only by the enormous potential return once one of SVA’s therapies
reaches the market, or more likely draws the attention of big pharma.
“A new branch of medicine will develop that attempts to change the course
of chronic disease and in many instances will regenerate tired and failing organ systems." Leland Kaiser, recognized futurist and acknowledged authority on the changing American healthcare system

A better ‘mousetrap’

The Edmonton Protocol is a method of implantation of pancreatic islets into the portal vein of the recipient's pancreas along with a steroid free anti-rejection drug regimen. The pancreatic islets are sourced/extracted from pancreases removed from recently deceased adult donors.

Each recipient receives islets from one to four donors. The islets are infused into the patient's portal vein, and are then kept from being destroyed by the recipient's immune system through the use of two immuno-suppressant drugs as well as an antibody drug specifically used in transplant patients.

A search has been on for an alternative site for islet transplantation as well as for an optimal medical device in which to implant the islets. Several subcutaneous devices have previously been developed for islet
transplantation but from a preclinical and clinical perspective the results from these products have been generally disappointing.
Sernova Corp. (SVA.v) has developed the subcutaneous Cell Pouch™
specifically designed to overcome the issues with previous implanted devices for cell transplantation. Sernova’s extensive preclinical safety and efficacy studies have shown this device to be both safe and effective, while being sparing of islets, supporting its design and function.

Conclusion

Harnessing the power of therapeutic cells to repair or replace cells, tissues or organs that are damaged by trauma or disease means we are entering an era where treatments for some of the world's most devastating diseases are developed.

Lab manufactured therapeutic cells hosted in the human body, in SVA’s
prevascularized Cell Pouch System™ monitoring, regulating, manufacturing
and secreting the necessary hormones, factors and proteins to control
diabetes and hemophilia would be a major accomplishment, and a truly
disruptive innovation.

Schumpeter said that industries must incessantly revolutionize the economic structure from within by innovating with better or more effective processes and products.

Sernova Corp’s disruptive innovation, it’s better ‘mousetrap,’ is going to do
just that.

For these reasons Sernova Corp TSX.V – SVA (OTCQB: SEOVF, FSE: PSH), is
on my radar screen. Is it on yours?

If not, maybe it should be.

Richard (Rick) Mills
aheadoftheherd.com

Sernova Corp is a clinical stage company, developing highly disruptive platform technologies to treat chronic diseases through a regenerative medicine approach. Sernova’s primary focus is in developing technologies for the treatment of patients with insulin-dependent (TI) diabetes, and haemophilia A.

Sernova’s novel approach uses therapeutic cells placed into an implanted medical device to produce proteins or hormones which are in short supply or missing from the body due to the underlying disease state. The Cell Pouch System™, is an implantable, scalable medical device about the size of a business card which provides a natural “organ-like” environment for the long term survival and function of therapeutic cells such as insulin producing islets to treat diabetes. The Therapeutic Cells placed into the device may be natural (human) donor cells, or cells that can be a source to treat millions of patients including stem cell derived insulin responsive cells or xenogeneic cells. Sernova uses proprietary local immune protection technologies which protect therapeutic cells within the Cell Pouch™ from immune system attack reducing or eliminating the need for daily anti-rejection drugs. Sernova’s approach is designed to make future therapeutic cell replacement a simple outpatient procedure that can be performed in virtually any hospital setting. Using a medical device and therapeutic cell strategy to treat chronic diseases, Sernova is positioned for significant revenue upon commercialization of its “disruptive paradigm-shifting” platform technology.

Sernova’s team is focused on development of the Cell Pouch System™ for diabetes to treat both Type-1 and Type-2 patients who become insulin dependent – representing a treatable population of an estimated 50M patients worldwide currently taking insulin within Sernova’s patented countries. Sernova is also focused on development of the Cell Pouch System™ for the treatment of Hemophilia A through use of corrected patient’s cells placed in the Cell Pouch™ which is then expected to release Factor VIII at a constant rate.

TECHNOLOGY HIGHLIGHTS

The Standard of Care for patients with reduced or missing critical hormones or proteins such as insulin is often monitoring blood levels and injecting these proteins multiple times a day with a consequence of poor compliance and serious side effects resulting in over $150B/yr hospital costs for diabetes alone. Cell therapy is an alternative for patients with chronic diseases; however, there is no currently approved device to house and protect these cells in the body and no method to make the therapy a simple outpatient procedure. Instead, often cells are injected multiple times into blood vessels in an extremely expensive (>$100,000) and risky procedure, where many cells die through blood-derived inflammation and clotting, resulting in the need for repeat operations. Hence, the current standard of care for local cell therapy is limited by expensive procedures, poor cell survival and inappropriate delivery coupled with a lack of donors.
Sernova’s Cell Pouch System™ is a versatile, scalable implantable medical device made of materials approved for permanent use in the body, designed by biomedical engineers and biologists. Placed under the skin or in other locations, it develops organ-like characteristics (including vascularization) for survival and long term function of therapeutic cells. A natural environment where therapeutic cells are housed within a tissue matrix, rich in microvessels is expected to conserve cell number, and promote natural function - increasing cell survival, while significantly increasing the number of treatable patients beyond those with severe disease.
Sernova’s Therapeutic Cell technologies involve the use of natural donor cells, stem cell derived insulin responsive cells or xenogeneic cells to replace cells in the body that no longer produce the therapeutic proteins.
Sernova’s Local Immune Protection Technologies placed within the Cell Pouch™ with therapeutic cells is expected to eliminate the need for systemically administered toxic and expensive anti-rejection drugs ($10-15,000/yr).

FIRST THERAPEUTIC APPLICATION - DIABETES
The Cell Pouch™ has been contract manufactured in accordance with the strict guidelines of ISO13485, as mandated by the FDA. In preclinical safety and efficacy studies, the Cell Pouch™ with islets has been shown to be safe and to control sugar levels in small (isograft – similar cell transplants) and large animal transplantation models of diabetes including an autograft model (self-islets are placed into the Cell Pouch™) and an allograft model (donor islets are placed into the Cell Pouch™). Sernova’s technologies have been independently proven under collaboration at the University of Alberta in a marginal islet mass study showing that a small dose of islets can make diabetic animals insulin independent at the 100 day time point. Several of Sernova’s important preclinical studies have been funded in part by agencies such as the National Research Council (IRAP) of Canada. In addition to these studies, the Cell Pouch™ has been shown to be biocompatible in a series of FDA mandated preclinical studies (ISO10993).

Sernova Corp., received Health Canada Approval to conduct a Phase I/II human clinical trial assessing the safety and efficacy of Sernova's Cell Pouch™ with transplanted insulin-producing islets in patients with insulin-dependent diabetes. The primary endpoint of safety and biocompatibility has been demonstrated. Results have been presented at the International Pancreas and Islet Transplantation Association and at the 2015 American Diabetes Association Meeting. The Company is currently preparing for a U.S. clinical study of the Cell Pouch to assess efficacy in diabetes at a major transplantation center.

ADDITIONAL PRODUCT OPPORTUNITIES/PARTNERING/M&A
Sernova is also developing its local immune technologies to reduce or eliminate the need for antirejection regimens. Furthermore, with the success of the Cell Pouch™ to date, Sernova is developing technologies to provide an unlimited source of locally immune protected cells including stem cell derived insulin responsive cells and xenogeneic cells to treat the 50M patients currently taking insulin worldwide.

The Company is currently also developing a product for Haemophilia A as member of a European Consortium (HemAcure) which has recently received approximately 5.6M EU ($8.5M CAD) funding from the European Union with a successful, highly prestigious European Union Horizon 2020 grant. The grant is to develop the product for clinical trials in patients with Hemophilia A and is expected to reduce or eliminate the need for multiple weekly infusions of Factor VIII. The current market for Factor VIII which must be infused thrice weekly for prophylactic treatment is approximately $5.0B/yr. Sernova plans to develop other indications using the Cell Pouch System™ to treat diseases such as Thyroid disease, with approximately 250,000 patients/yr who could benefit from a cell therapy approach. The company is seeking corporate partners for these therapies and plans to in-license additional complementary technologies.

SERNOVA’S MANAGEMENT/BOARD/ADVISORY BOARD

Management Team: President and CEO since May 2009 – Dr. Philip Toleikis: Former VP Pharmacology R&D, Angiotech Pharmaceuticals, where he was part of the team that developed the multi-billion dollar drug-eluting stent and other drug-eluting medical devices; Chief Financial Officer, Ralph Deiterding: CPA, CA, CMA is a finance veteran with over 20 years of experience, primarily in senior finance roles at Toronto Stock Exchange listed software vendors; Senior Director R&D - Delfina Siroen: BSc. Hon. MSc. with over 20 years in managing academic and corporate R&D teams; Business Development – Nick Borrelly: 25 years corporate development (Ciba-Geigy, Novartis and Sanofi-Aventis).

Board of Directors: Chairman Frank Holler – CEO and partner BC Advantage Funds; Jeffery Bacha – CEO Delmar Pharmaceuticals, Inc.; Bruce Weber – V.P Clinical, Regulatory and QA Innovia LLC; James Parsons, CA; Dr. Philip Toleikis, President and CEO Sernova Corp.

As Servova approaches near-future catalysts, this clinical stage regenerative medicine company is poised to a become a ‘difference maker’ for millions of patients globally suffering from Diabetes and Hemophilia. For a quick cursory read, please clickhttp://www.sernova.com/pdf/Sernova%20Corp%20Fact%20Sheet%202015.pdf.