Akers Biosciences, Inc - KOL Call to Discuss Development Process on the Multi Subunit COVID-19 Vaccine March 25, 2020
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Akers Biosciences, Inc.
KOL Call to Discuss Development Process on the Multi Subunit
COVID-19 Vaccine
March 25, 2020Akers Biosciences, Inc. – KOL Call to Discuss Development Process on the Multi Subunit COVID-19 Vaccine,
March 25, 2020
CORPORAT E PARTICIPANTS
Brett Maas, Investor Relations, Hayden IR
Christopher Schreiber, Executive Chairman
Dr. Prabuddha Kundu, Co-Founder and Managing Director of Premas Biotech
PRESENTATION
Operator
Greetings, and welcome to the Akers Biosciences conference to discuss our licensing announcement
with Premas Biotech.
At this time, all participants are in a listen-only mode. If anyone should require Operator assistance during
the conference, please press star, zero on your telephone keypad. As a reminder, this conference is
being recorded.
I would now like to turn the conference over to your host, Brett Maas, Hayden IR. Please go ahead, sir.
Brett Maas
Good afternoon, and thank you for joining Akers Biosciences conference call to discuss our licensing
announcement yesterday with Premas Biotech for a coronavirus vaccine candidate.
With me this morning is Akers' Executive Chairman, Christopher Schreiber, and Prabuddha Kundu, Co-
Founder and Managing Director of Premas Biotech.
Akers Biosciences issued a press release yesterday with details on its relationship with Premas Biotech
and their joint initiative on a coronavirus vaccine candidate. A copy of the press release is available on
Akers Biosciences website at akersbio.com.
I'd also like to remind everyone that today's call is being recorded. A replay of today's call will be available
by using the telephone numbers and conference ID provided in the press release. In addition, a webcast
will be accessible live and archived on Akers' website.
Finally, I'd like to call your attention to the customary Safe Harbor disclosure regarding forward-looking
information. The conference call today will contain certain forward-looking statements, including these
statements regarding the goals, strategies, beliefs, expectations and future potential results of Akers
Biosciences. Although Management believes these statements are reasonable based on estimates,
assumptions and projections as of today, March 25, 2020, these statements are not guarantees of future
performance. Actual results may differ materially as a result of risks and uncertainties and other factors,
including, but not limited to, the factors set forth in the Company's filings with the SEC. Akers undertakes
no obligation to update or revise any of these forward-looking statements.
1
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reporting of the substance of the conference call. This transcript is being made available for information purposes only.
1-888-562-0262 1-604-929-1352 www.viavid.comAkers Biosciences, Inc. – KOL Call to Discuss Development Process on the Multi Subunit COVID-19 Vaccine,
March 25, 2020
I'd like to now turn the call over to Akers' Executive Chairman, Christopher Schreiber. Chris, the floor is
yours.
Christopher Schreiber
Thanks, Brett, I appreciate it, and good morning to everyone.
Akers announced a licensing agreement with Premas Biotech yesterday that we are really excited about.
Under terms of the agreement, Akers in-licensed the rights to a novel coronavirus vaccine under
development by Premas using Premas' genetically engineered D-Crypt platform. We have partnered with
Premas on this initiative as we seek to advance this candidate through the regulatory process, both with
the FDA in the United States and the office of the drug controller in India.
Akers—many of you may know this, Akers has a 30-year history in the development and manufacturing of
rapid diagnostic tests. We've always been focused on solving health challenges and, unfortunately, we
are tasked with a very serious challenge today with the coronavirus pandemic. Many companies are
joining the race to find the vaccine or effective therapy. We are excited about working with Premas as we
feel their platform, research and scalability can allow us to narrow the gap between us and our
competition in the months to come.
On that, I would now like to introduce Dr. Prabuddha Kundu, Co-Founder and Managing Director of
Premas, who everyone knows as PK.
PK, would you like to walk us through a bit of the science behind our novel product announcement today?
But before we do that, would you mind starting off, could you give the audience a brief background on
yourself?
Dr. Prabuddha Kundu
Thank you, Chris.
I and a few colleagues co-founded Premas 15 years ago. I have a Ph.D. in biomedical engineering and
have 25 years of experience in protein research having trained as a biomedical engineer and a protein
scientist. My key interests are, among other things, is scale-up and production of difficult proteins,
seeking ways to reduce cost of goods or COGs and positioning assets to successfully take through
clinical trials. I have vast experience in leading teams to find solutions to projects involving both human
and animal health. We have a central theme revolves around expressing difficult proteins as a therapeutic
candidate or vaccine candidate.
For example, an oral insulin clinical candidate in which we were fortunate to partner with Oramed, it is in
late stage clinical trials in the U.S. Premas, along with Oramed developed, scaled up and manufactured
the technology, which allows for oral delivery of insulin. We worked very closely with the Oramed
leadership, including Dr. Miriam Kidron, and Professor Avram Hershko, who, as you may recall, won the
Nobel Prize in Chemistry in 2004. We have completed a very large production of GMP material for the
clinical trial.
A project with similarities to the one we are discussing today was to develop and to work on a novel
vaccine for bacterial infection partnered with one of the top 10 pharmaceutical companies in the world.
We've built the process, scaled it up, we improved COGs and successfully delivered vaccine
complements for three trials.
Christopher Schreiber
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reporting of the substance of the conference call. This transcript is being made available for information purposes only.
1-888-562-0262 1-604-929-1352 www.viavid.comAkers Biosciences, Inc. – KOL Call to Discuss Development Process on the Multi Subunit COVID-19 Vaccine,
March 25, 2020
PK, (inaudible) during our due diligence we were, to say the least, very impressed with Premas'
accomplishments. Could you give the audience some historical perspective on Premas?
Dr. Prabuddha Kundu
Sure. In 2007, our team was working to express certain difficult proteins and we realized after a thorough
search that there weren't dedicated platforms for difficult to express proteins or membrane proteins
readily available or at all. And, that's where the idea to develop our platform came to life, which we now
call D-Crypt. D-Crypt is dedicated to express difficult proteins and membrane surface proteins which are
perhaps some of the hardest to clone, express and manufacture and are a key component in any vaccine
development.
Today, our team is skilled in this specialty. We operate from a 20,000 square foot facility near New Delhi
in India. Premas' ISO9001:2015 certified, cGMP compliant and is capable of process development,
scaling up and production of proteins and have done exactly this for some of the largest pharmaceutical
companies in the world.
Premas has over 125 employees and has delivered over 650 proteins and has completed over 240
separate projects. We have four candidates currently in clinical trials globally, and most notable, an oral
insulin drug candidate with our partner Oramed, which recently completed a Phase 2b trial in the U.S.
As I've indicated about, our platform has been used to develop key proteins and candidates for some of
the most well-known pharmaceutical and biotech companies in human and animal health, amongst
others.
We think of ourselves as problem solvers for our partners. If it is challenging for them to solve, we want to
be involved and bring the solution. To that point, we are enabling our clients and partners to become
more successful and over the past 10 years have worked on some key challenges, especially regarding
vaccine development with major global pharmaceutical companies in human and animal health.
Christopher Schreiber
Thanks, PK. PK, if we could, let's spend some time on the science and dig in a little bit.
Dr. Prabuddha Kundu
Great. Let me talk about the platform for a minute. When you get an infection or exposure, proteins on the
surface of the virus or bacteria, mainly those that are exposed towards the outside, and is what the
immune system gets to see. Certain cells are actually trained to look for them. Years ago, people in this
field would try to kill or attenuate a virus or bacteria with heat or chemicals. The side effects would often
include pain and fever. As science progressed, we found we could take the surface proteins and
formulate them for use as vaccines and not use in whole or the entire virus or bacteria.
As it pertains to the coronavirus, COVID-19, the surface proteins are different than that of other viruses.
Our immune system has not seen or interacted with these proteins, specifically to COVID-19, and hence
the need for a vaccine. Essentially, these are what the immune system defines as the identity of the virus,
and looking at the coronavirus today, there are three major proteins that we have identified as potential
vaccine candidates, specifically, spike protein or S protein, envelope protein or E protein, and membrane
protein or M protein.
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reporting of the substance of the conference call. This transcript is being made available for information purposes only.
1-888-562-0262 1-604-929-1352 www.viavid.comAkers Biosciences, Inc. – KOL Call to Discuss Development Process on the Multi Subunit COVID-19 Vaccine,
March 25, 2020
Our platform should allow us to express each of these proteins singularly, or express them collectively in
two different combinations or all three together. We are using our D-Crypt platform to generate these
clones and express this protein. Once these steps are completed, we plan to develop the vaccine
candidate for clinical trials based on our successful expression of all three proteins.
Our science is strong and (inaudible) working. In fact, in this project, we have already cloned two of the
three proteins. The third is expected to be completed in the near future.
It is important to note that there is additional information about COVID-19 that we are learning everyday
that will help us in our efforts, specifically in biology, the roots of infection.
What makes us more confident in our approach is that emerging thought is that the potential vaccine
candidate that would be best suited would have to target more than one antigen. We believe that having
the ability to express three of the major antigens of the surface of coronavirus simultaneously should
improve our chances of generating a vaccine versus using one antigen, for example, the S protein as a
single option.
The more antigens we put out for the immune system to see should significantly increase the chances for
efficacy of our vaccine. In other infectious diseases, many vaccines under development today are moving
towards multiple antigens or multi-component vaccines. We have already proven we can scale up multi-
component systems successfully and apply them to vaccines such as this candidate.
Our platform has already expressed more than 17 protein systems where there has been more than one
protein co-expressed together and has been structurally and functionally correct. These combinations
have been scaled up rapidly and up to hundreds of liters which we believe demonstrates our platform is
very well suited for a multi-component vaccine.
We believe that expressing all three proteins together should create a very compelling vaccine candidate
in the months to come.
Christopher Schreiber
Thanks, PK. PK, I was wondering, could you expand on current vaccine development? I think our
audience would benefit by having a better understanding of what other platforms are actually out there.
Dr. Prabuddha Kundu
Sure, Chris. There are four major platforms globally for vaccine development that are being considered
out there.
First, RNA's being used by a company called Moderna, which has the only coronavirus vaccine in clinical
human trial today. We are in the news, due to the FDA's willingness, to fast track their trial with an
expedited review and go from proof of concept directly to human trial.
Second, DNA vaccine platforms that require an injection of the DNA as the vaccine candidate.
Third is the whole cell or whole virus, either attenuated or heat killed, as an injectable or oral formulation.
The vaccine often contains an agent or a part of it that is made from a weakened form of the disease
microbe or virus that is then used to stimulate the body's immune system to destroy and recognize the
microorganism in case of later exposures.
4
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reporting of the substance of the conference call. This transcript is being made available for information purposes only.
1-888-562-0262 1-604-929-1352 www.viavid.comAkers Biosciences, Inc. – KOL Call to Discuss Development Process on the Multi Subunit COVID-19 Vaccine,
March 25, 2020
And fourth, a similar line stated above, there is the protein of the recombinant protein vaccine route which
is known to be very safe, and entails the injection of proteins or vaccine antigens into the human body.
This is a well established method that is differentiated primarily via its scalability from both RNA and DNA,
and importantly, it is the method we use.
We believe that the most modern vaccine developers are attempting to generate recombinant protein
vaccines as one of their future strategies.
Christopher Schreiber
That's great. Let's talk about what differentiates us from other structural vaccine platforms. Perhaps we
can spend some time on yeast and what the benefits are as well.
Dr. Prabuddha Kundu
Sure. Our platform D-Crypt is based on baker's yeast or saccharomyces cerevisiae. Premas is one of
only a few companies in the world that has persisted in this particular space to manufacture difficult
proteins using this. We have strived to understand and build know-how over the past 10 years around
these platforms. We have knocked out certain internal proteases and designed specific vectors that work
in synergy with the platform to produce large amounts of membrane proteins or difficult proteins.
Proteases are enzymes that break down proteins. Yeast has a number of internal proteases, which when
we express external proteins, like recombinant protein expression, these proteases destroy the external
foreign protein being produced in the host. Disabling or knocking off the major internal proteases has
been one of the strategies in building our platform. Yeast has a large endoplasmic reticulum, or ER, which
is a desirable attribute for expressing membrane protein.
In complex cells, ER is where the protein is formed. The larger the surface, the more membrane protein
that can attach to the ER inside the cell. Yeast is also easily manipulated and allows for results to be
gathered quickly. Yeast multiplies 15 times faster than mammalian cells and is cheaper to work with than
mammalian systems, which are much more complex and slower to grow comparatively.
Our platform is the only one we are aware of to have expressed more than 30 different type 1 membrane
proteins, including the flu virus NA protein and the rotavirus spike protein. Our success with expressing
the flu virus NA protein which is very large and complex, gives us great confidence that we can express
other type 1 proteins like those attributed to the COVID-19 vaccine today.
We believe that our yeast platform should allow us to develop vaccine faster than others. We are
confident in this because we believe that we can scale up much faster than RNA and DNA based on prior
vaccine development experience. The world knows how to work with yeast at very large scale. I would
also add our platform is based on yeast and yeast has GRAS status from the FDA, which stands for
Generally Recommended as Safe. We believe this is viewed favorably by the FDA and the office of the
drug controller in India.
Christopher Schreiber
Thanks, PK. PK, everyone sees the news and they're aware of what's happening in the United States.
Can you tell the audience what is happening in India as we sit here today?
Dr. Prabuddha Kundu
5
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reporting of the substance of the conference call. This transcript is being made available for information purposes only.
1-888-562-0262 1-604-929-1352 www.viavid.comAkers Biosciences, Inc. – KOL Call to Discuss Development Process on the Multi Subunit COVID-19 Vaccine,
March 25, 2020
Sure, Chris. India is currently under a complete 21-day lockdown due to COVID-19. We are very grateful
to the authorities. Despite the trying times and the difficult environment, they have provided us with the
permission to continue the work which we feel is a testament to the importance of the ongoing work and
to our government acknowledging that this may help to solve this global problem.
India is the second largest country in the world. We have 17% of the world's population. India has
contributed to global vaccine production and prides itself on vaccine development. In fact, India, through
its significant capacity helped and led the world in eradicating two major infectious diseases, like polio
and small pox as global pandemics.
The office of the drug controller in India has been proactive and announced publicly about its key intent to
fast track technologies' potential vaccine and therapy candidates, diagnostic kits, and other medical
devices for battling this pandemic.
So, we will be reaching out to them and engaging with the office of the drug controller in India and
working very closely to chart a regulatory path forward.
Christopher Schreiber
Let's try and spend some time on where we are now. As I see it now, we all know there are risks, there
are time delays, you name it. That being said, what excites me so much is where we are right now and
the opportunities in the near future. Could you maybe give us your thoughts there?
Dr. Prabuddha Kundu
Sure. We have already expressed two of the three target proteins and expect the third to be completed in
the next two weeks. But, let's talk about the stages and milestones we expect to achieve as we progress
towards the vaccine candidate.
Please note, each phase will require positive results from the stage before. Antigen cloning of the three
proteins is where we clone the three top vaccines in endogens (phon) or antigens into our proprietary
vectors and insert them into the yeast (phon) host or platform.
There is a certain combination that we are attempting to prototype out; for example, how to co-express all
the proteins together. The platform is versatile to the extent we can control the relative amounts we want,
which means, depending on which antigen needs to be expressed more, engineered in that ratio. While
this sounds simple, it is complex and part of the experience gathered over the years. This allows for the
higher flexibility to prototype multiple options and seeking the best one.
Once we have the clones for the complete expression of the three proteins in multiple formats at
prototype combinations, we proceed for expression. Selection's based on the best expression profile and
structural integrity. We have already determined and confirmed expression of two of the antigens and
proceeding with the third. For formulation studies, there will be a need to perform the formulation studies
of the vaccine and then choose the appropriate formulation components and combinations. While I don't
want to make it too complicated, we will also utilize components that are readily scalable.
The proof of concept will be completed when we will be able to demonstrate the formation of the multiple
component vaccine, or a virus-like particle, a VLP formation. We intend to engage with the regulatory
authorities, the FDA in the U.S. and the office of the drug controller in India appropriately and scope out
the regulatory path forward.
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reporting of the substance of the conference call. This transcript is being made available for information purposes only.
1-888-562-0262 1-604-929-1352 www.viavid.comAkers Biosciences, Inc. – KOL Call to Discuss Development Process on the Multi Subunit COVID-19 Vaccine,
March 25, 2020
Next, we plan to initiate manufacturing development in parallel, where we would carry out the scaling up
and the manufacturing development alongside with the formulation study.
We wish to initiate animal trials as soon as we have material with us in the coming weeks. There could be
a possibility that the regulatory authorities may allow us to proceed directly to human clinical trials, similar
to Moderna, depending on the discussions and the possible guidance on the matter. At the end of this
phase, we plan to release data associated with the animal trial.
In parallel to the animal studies, we will perform the consistency run and the engineering batches for
manufacturing of the clinical material. Usually, we wait for the data from the animal trial; however, to
expedite the process, we plan to run parallel development study. Next, we hope to initiate human trials,
both in India and U.S., and again, we will be acting in close coordination with the authorities.
Depending on the data of Phase 1, we would be hopeful to enter into human Phase 2 and Phase 3 trials,
sequentially, we will be acting in close coordination with the regulatory authority. In discussing the
approval process and commercially, we believe this is a matter that will be out in the future; however, we
are fully prepped to meet the needs and challenges once we reach at this point.
Christopher Schreiber
PK, I know that you've been working on difficult to express proteins for 15 years as a global leader. I think
it makes sense to end our call asking you what excites you the most today.
Dr. Prabuddha Kundu
Thank you, Chris. In this current regulatory environment, with the expedited review process, our ability to
express three antigens in a single host and the host, which is known to be simple, scalable and
manufacturable, is a milestone that has taken on materially, more significant. We expect our proof of
concept to be completed by mid April, at which time we expect to continue our discussions with the
regulatory bodies, both the drug controller in India, as well as the FDA, in the United States, on an
expedited basis.
As mentioned earlier, the ability of our platform to express the three antigens together in a single host
should allow for greater coherence at all levels of the developmental pathway, including regulatory. It
eliminates the need for multiple media, recipes and process. It provides for a relative ease of scale-up,
manufacturing and tech transfer in the event that we may need to collaborate with other large
manufacturers in other geographies. This is an exciting time for a Premas and Akers to announce their
relationship together.
I'd summarize the following. Premas is an expert in identifying and expressing membrane proteins, which
enables the creation of a potential multi-component vaccine candidate. Our processes would be cheaper
and faster than RNA and DNA based vaccines and very scalable, which, if successful, should provide
Akers with a significant competitive advantage as it moves through the milestone pathway for a COVID-
19 vaccine.
I am excited to take on this challenge with Akers and look forward to sharing more milestone data in the
days and weeks to come.
Christopher Schreiber
Okay. Thanks, PK. I really, really appreciate it and extremely excited about moving forward. This has just
been incredible and very informative.
7
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reporting of the substance of the conference call. This transcript is being made available for information purposes only.
1-888-562-0262 1-604-929-1352 www.viavid.comAkers Biosciences, Inc. – KOL Call to Discuss Development Process on the Multi Subunit COVID-19 Vaccine,
March 25, 2020
Once again, we want to tell our audience how much we look forward to this partnership, and then I'd like
to point out, if any of our investors have any questions, please reach out to Brett Maas at Hayden IR.
With that, I will thank everyone and have a great day. Thank you very much.
Operator
This concludes today's conference. You may disconnect your lines at this time. Thank you for your
participation.
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reporting of the substance of the conference call. This transcript is being made available for information purposes only.
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