Page 8 Medical & Healthcare Expert Guide 2019
P. 8
Expert Guide |
Litigation & Dispute Resolution 2018
8
What have been the biggest challenges you
have had to overcome to date?
Funding. It is always difficult to attract money at the early stages of
developing a new idea. We have been very fortunate to have been
funded entirely by non-diluting NIH grants. I think we are now ready
for investors – we have a disruptive, novel approach, a technology
platform (multiple shots on goal) and data in transgenic animals
and patient-derived stem cells. Investment in Cenna could lead
to a mega-million dollar strategic deal and a high level return to
investors.
Where are you currently at in terms of
development?
We are at late preclinical stage. We hope to file an IND with the FDA
this year for Phase 1 clinical trials to begin soon afterwards.
What is the next stage?
Filing an IND with the FDA once our GLP toxicology studies are
completed and Phase 1 clinical trials to follow.
What are Cenna Bioscience’s goals for the
coming years?
Key milestones over the next 12 months are to complete the pre-
clinical development of our lead candidate and prepare a preclinical
scientific package that will include the necessary experimentation
in animals to satisfy the preclinical requirements for filing an IND.
Clinical safety and efficacy will be established up to the filing of a
Phase IIA NDA with the FDA. Further clinical testing, product license
manufacturing, distribution and sales will be accomplished by
means of a joint venture with an appropriate industry partner.
Cenna’s model is to build value toward an exit through leveraged
strategic partnerships. The primary activities are to develop Cenna’s
existing technology to complete the pre-clinical development of its
drug candidate. Cenna will develop a preclinical scientific package
that will include the necessary experimentation in animals required
for filing an IND. Once Cenna’s drug candidate has IND clearance,
the company will be sufficiently advanced to attract Series A
venture capital to move the compound on to Clinical Phase I and
II trials. We will also enter into strategic collaborative partnerships
with pharmaceutical companies to complete remaining clinical
efforts and regulatory approvals. Such partnerships can provide the
resources required, operating scale, manufacturing capacity, and
distribution channels to successfully take a drug to market. Cenna
can offer an exclusive license to its technology with a commitment
to advance the science through the right partnership.
Is there anything else you would like to share
with our readers?
It is anticipated that Cenna’s therapeutics will have a significant
impact in both treatment and prevention modes and be useful
throughout the course of disease. An effective disease-modifying
therapeutic that slows progression or prevents AD will have
significant commercial and societal benefits related to the quality
of life for an ageing population. It is estimated that the revenue
potential for disease-modifying agents in Alzheimer’s disease is
>$15 billion per year, worldwide. Once the long-term use of Cenna’s
drug is deemed safe, the drug may be taken as a prophylactic by
everyone over the age of 65, in much the same way as statins are
used for heart disease. That could be the opportunity to perhaps
eliminate AD altogether, with an impact that would indeed be
transformational.
Investment in Cenna could
lead to a mega-million dollar
strategic deal and a high
level return to investors.
Litigation & Dispute Resolution 2018
8
What have been the biggest challenges you
have had to overcome to date?
Funding. It is always difficult to attract money at the early stages of
developing a new idea. We have been very fortunate to have been
funded entirely by non-diluting NIH grants. I think we are now ready
for investors – we have a disruptive, novel approach, a technology
platform (multiple shots on goal) and data in transgenic animals
and patient-derived stem cells. Investment in Cenna could lead
to a mega-million dollar strategic deal and a high level return to
investors.
Where are you currently at in terms of
development?
We are at late preclinical stage. We hope to file an IND with the FDA
this year for Phase 1 clinical trials to begin soon afterwards.
What is the next stage?
Filing an IND with the FDA once our GLP toxicology studies are
completed and Phase 1 clinical trials to follow.
What are Cenna Bioscience’s goals for the
coming years?
Key milestones over the next 12 months are to complete the pre-
clinical development of our lead candidate and prepare a preclinical
scientific package that will include the necessary experimentation
in animals to satisfy the preclinical requirements for filing an IND.
Clinical safety and efficacy will be established up to the filing of a
Phase IIA NDA with the FDA. Further clinical testing, product license
manufacturing, distribution and sales will be accomplished by
means of a joint venture with an appropriate industry partner.
Cenna’s model is to build value toward an exit through leveraged
strategic partnerships. The primary activities are to develop Cenna’s
existing technology to complete the pre-clinical development of its
drug candidate. Cenna will develop a preclinical scientific package
that will include the necessary experimentation in animals required
for filing an IND. Once Cenna’s drug candidate has IND clearance,
the company will be sufficiently advanced to attract Series A
venture capital to move the compound on to Clinical Phase I and
II trials. We will also enter into strategic collaborative partnerships
with pharmaceutical companies to complete remaining clinical
efforts and regulatory approvals. Such partnerships can provide the
resources required, operating scale, manufacturing capacity, and
distribution channels to successfully take a drug to market. Cenna
can offer an exclusive license to its technology with a commitment
to advance the science through the right partnership.
Is there anything else you would like to share
with our readers?
It is anticipated that Cenna’s therapeutics will have a significant
impact in both treatment and prevention modes and be useful
throughout the course of disease. An effective disease-modifying
therapeutic that slows progression or prevents AD will have
significant commercial and societal benefits related to the quality
of life for an ageing population. It is estimated that the revenue
potential for disease-modifying agents in Alzheimer’s disease is
>$15 billion per year, worldwide. Once the long-term use of Cenna’s
drug is deemed safe, the drug may be taken as a prophylactic by
everyone over the age of 65, in much the same way as statins are
used for heart disease. That could be the opportunity to perhaps
eliminate AD altogether, with an impact that would indeed be
transformational.
Investment in Cenna could
lead to a mega-million dollar
strategic deal and a high
level return to investors.
