On March 25th, Akers Biosciences (NasdaqCM: AKER) announced a licensing agreement with Premas Biotech to find an effective vaccine for COVID-19. Premas Biotech has over 125 employees and has delivered over 650 proteins and has completed over 240 separate projects for pharmaceutical companies. The company also has four candidates currently in clinical trials globally, and most notable, an oral insulin drug candidate which recently completed a Phase 2b trial in the U.S.
The transcript from that announcement call explains exactly why Akers and Premas believe that the Akers Biosciences/Premas Biotech partnership has the potential to quickly and cost-effectively bring a yeast-based protein COVID-19 vaccine to market.
Transcript. For a recorded version, please follow this link and register.
Christopher Schreiber: 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, 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 that 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: 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.
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 multicomponent 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. They 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.
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: 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 is based on the best expression profile and structural integrity. We have already determined and confirmed expression of two of the antigens and are 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.
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 a 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 authorities. 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 COVID19 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.
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.
Statements in this transcript relating to plans, strategies, trends, specific activities or investments, and other statements that are not descriptions of historical facts and may be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking information is inherently subject to risks and uncertainties, and actual results could differ materially from those currently anticipated due to a number of factors, which include any risks detailed from time to time in Akers’ reports filed with the Securities and Exchange Commission, Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K. Forward-looking statements may be identified by terms such as “may,” “will,” “expects,” “plans,” “intends,” “estimates,” “potential,” or “continue,” or similar terms or the negative of these terms. Although Akers believes the expectations reflected in the forward-looking statements are reasonable, they cannot guarantee that future results, levels of activity, performance or achievements will be obtained. Akers does not have any obligation to update these forward-looking statements other than as required by law.
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