API Partners with Hepion Pharmaceuticals to Develop NASH treatment

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A press release from one of our recent partners Hepion Pharmaceuticals:

Hepion Pharmaceuticals Announces Research Partnership with Applied Pharmaceutical Innovation, Faculty of Pharmacy & Pharmaceutical Sciences at University of Alberta

- Accelerating NASH Research Programs -

EDISON, N.J., July 31, 2019 - Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA),  a biopharmaceutical company focused on the development of therapeutic drugs for the treatment of liver disease arising from non-alcoholic steatohepatitis (“NASH”) and chronic viral infection, today announced it entered into a research partnership with Applied Pharmaceutical Innovation (“API”), an independent institute that launched out of the Faculty of Pharmacy and Pharmaceutical Sciences at the University of Alberta (“FPPS”) in Edmonton, Canada that is focused on empowering the growth and development of the Canadian pharmaceutical industry in collaboration with post-secondary centers of excellence.

The partnership with API and FPPS greatly expands Hepion Pharmaceuticals’ research capabilities, enabling access to cutting edge expertise and facilities in an industry leading commercialization framework. As part of this research partnership, Hepion Pharmaceuticals will immediately begin recruiting post-doctoral fellows (“PDF”) to conduct animal imaging studies examining the time course of the development of NASH and fibrosis in various models, the effects of CRV431, the Company’s lead drug candidate in animal models of NASH, and to further examine CRV431 in cellular assay systems.

“We previously announced that CRV431 has shown anti-fibrotic activity in two separate animal models of NASH and fibrosis in five independent studies and have further characterized the performance of our molecule in phase 1 results in human subjects,” commented Dr. Robert Foster, Hepion Pharmacueticals’ CEO. “Now we will begin examining exactly what CRV431 is doing in organs of animals using state-of-the art imaging techniques. These imaging studies will be enhanced by digging further into the mode of action of CRV431 on a molecular biology level and will complement our current activities conducted in our own research laboratories and clinical studies. We’re thrilled by the environment created by this partnership through API.”

Partial funding for the PDF positions on the Hepion Pharmaceutical research program will be provided through a $6 million collaboration between API and Mitacs, a Canadian Federal Government industry matching program, to support translational research in FPPS.

API and FPPS see partnership with Hepion Pharmaceuticals as a major component of a growing movement to better support innovation in Edmonton.

“Many past Canadian success stories in drug development came out of our Faculty,” said FPPS Dean, Dr. Neal Davies. “We are the only academic institution in Canada with a Health Canada site license for Natural Health Products (NHP) and the ability to do drug development in everything from cannabinoids to radiopharmaceuticals. Our cutting edge GMP clean rooms and manufacturing capacity for clinical trials, as well as our extensive analytical infrastructure and animal facilities, are all world class assets.”

“API launched to support and empower exactly these sorts of collaborations,” commented API CEO, Andrew MacIsaac. “For decades the Faculty of Pharmacy and Pharmaceutical Sciences has been an extremely strong pipeline of talent for the pharmaceutical industry internationally. We’re thrilled to be able to leverage our abilities to support innovation here in Edmonton and we continue to establish Alberta and Canada as a top destination for drug development.”

About Hepion Pharmaceuticals

Hepion Pharmaceuticals is a clinical stage biopharmaceutical company focused on the development of targeted therapies for liver disease arising from non-alcoholic steatohepatitis (NASH) and chronic hepatitis virus infection (HBV, HCV, HDV). The company’s lead drug candidate, CRV431, reduces liver fibrosis and hepatocellular carcinoma tumor burden in experimental models of NASH. Preclinical studies also have demonstrated antiviral activities towards HBV, HCV, and HDV through several mechanisms. These diverse therapeutic activities result from CRV431’s potent inhibition of cyclophilin enzymes, which are involved in many disease processes. Currently in clinical phase development, CRV431 shows potential to play an important role in the overall treatment of liver disease—from triggering events through to end-stage disease. For more information, please visit www.hepionpharma.com.

Forward-Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimated,” and “intend,” among others. These forward-looking statements are based on Hepion Pharmaceuticals’ current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, the design, progress and timing of preclinical and clinical studies; substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; uncertainties with respect to lengthy and expensive clinical trials; that results of earlier studies and trials may not be predictive of future trial results; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any drug candidates under development, there are significant risks in the development, regulatory approval, and commercialization of new products.There are no guarantees that future clinical trials discussed in this press release will be completed or successful, or that any product will receive regulatory approval for any indication or prove to be commercially successful. Hepion Pharmaceuticals does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in Hepion Pharmaceuticals’ Form 10-K for the year ended December 31, 2018 and other periodic reports filed with the Securities and Exchange Commission.

Launching with $25 million in industry partnerships, Applied Pharmaceutical Innovation is on track to transform health innovation in Alberta.

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Below is the press release for our official launch

FOR IMMEDIATE RELEASE

EDMONTON, AB, July 30, 2019 - Applied Pharmaceutical Innovation (API) incorporated as a not-for-profit institute in November 2018, launching out of the University of Alberta’s Faculty of Pharmacy and Pharmaceutical Sciences. With one goal in mind - to transform the pharmaceutical and biotech landscape in Alberta and Canada by filling the gaps in the drug development system that currently stifle investment and economic diversification - API has seen tremendous success. In its quiet phase over the past 8 months, API attracted over $25 million in industry investment to Alberta from over 19 companies in areas ranging from early stage drug development to phase II and III clinical trials for areas such as local SMES, large multinational pharmaceutical companies, the cannabis industry, and more.

To achieve its goal, API works to attract and facilitate industry research while training post-doctoral fellow and graduate students on real world projects through its network model with the University of Alberta and Mitacs—a federal granting organization—to support more than 100 internships over the next 5 years. The Mitacs partnership—valued at $6M—expands the impact of the $25M in industry funded research that API has already attracted. “It’s a game changer for students and post-doctoral researchers,” says API CEO, Andrew MacIsaac. “Finding meaningful opportunities in the pharmaceutical industry used to mean moving to San Diego or Boston. Now careers can be launched here in Edmonton, working at the cutting edge of the pharmaceutical industry with global players.”

API is also bringing back investment that had previously left Canada. One of Edmonton’s biggest names in biotech, Robert Foster, founder of Isotechnika, has signed a significant partnership with API through Hepion Pharmaceuticals, his current New Jersey-based company. “We’re thrilled by the environment created by this partnership through API,” says Foster. “We’re able to access world-class infrastructure and talent to support our work developing therapeutic drugs for the treatment of liver disease.”

API doesn’t only aim to help established companies. At the core of its mission, API also works to support successful commercialization of university research. “Previously, medical researchers who made discoveries within our post-secondary institutions were forced to utilize contract research organizations outside of Canada to gain the specific pharmaceutical science and regulatory expertise needed for them to enter into the complex and arduous process of drug development. In most cases, they were unable to afford such services, and if they could, they would remain a virtual company with little investment staying in the province,” says MacIsaac. “Under API’s model, they can do it in Alberta for less, while training the team who can take the company forward locally as they gain investment.” Currently, API is working to connect itself within the existing commercialization frameworks of the province, working to support startups and provide them with the niche expertise they need prior to and during their time with incubators and accelerators such as TEC Edmonton and Innovate Calgary.

For more information or to request a media kit, please contact:

Jerry Zhang |  jerry.zhang@appliedpharma.ca | 780-716-8319

6 Month Update

It’s been nearly six months since API was launched as an accelerator for innovation and economic development and we are pleased to announce some of our early successes.

17 PARTNERSHIPS WITH SMES, PHARMA, AND THE CANNABIS INDUSTRY - since our launch we have started partnerships with over 17 companies in a wide range of areas, from pharmacokinetics work for large Canadian and international pharmaceutical companies, ADME and toxicology for spinoffs within the TEC Merck Accelerator, to formulation, analytical work, and clinical trials for many of the major players in the cannabis industry.

OVER 15 POST DOCTORAL FELLOWS AND GRADUATE STUDENTS HIRED - we have begun training over 15 employees for the pharmaceutical industry as part of our partnerships, working on real world projects, providing support for local SMES and putting Alberta and Canada on the map with large pharma R&D.

ATTRACTION OF TWO INTERNATIONAL PHARMACEUTICAL COMPANIES TO ALBERTA - through our work we have developed partnerships that are beginning to bring the pharmaceutical industry to Canada. As a result of our collaborations one of our partners made the decision to be headquartered in the province and is buying a manufacturing facility in Edmonton to be staffed with current trainees working with API.

We’ll continue to keep you updated in the months to come as we’re currently working on much more.

Advisory Committee Members

API has launched its Advisory Committee. With a broad group of expertise from multiple areas of the drug development world our committee includes the following members:

Advisory Committee

Launa Aspeslet

CEO, TRIO

Brian Corrigan

Global Head, Clinical Pharmacology, Pfizer

Matt Coffey

CEO, Oncolytics

Salma Jutt

Chief Commercial Officer, Acer Therapeutics

Sailaja Bhaskar

Executive Director, R&D, Purdue Pharma

Robert Foster

CEO, ContraVir

Jamie Lucien

Biotech Patent Lawyer

Majid Vakilynejad

Senior Director, Takeda

A bridge across the "Valley of Death"

The challenge faced by academic innovators

In the biotech community, there is a problem so common and so frustratingly difficult for many innovators to overcome that it is called the “Valley of Death”. The Valley of Death is where laboratory discoveries and cutting edge innovations die; running out of traction before they ever receive the opportunity to become potential life-saving treatments and provide value to our society.

Drug development is an extremely costly endeavor with a multitude of complex and specialized areas in which a potential drug can fail along its path to commercialization. Even when an innovation has received large-scale investment, the odds are still stacked against it ever coming to market. As a result, knowledgeable investors in the space do everything they can to ensure their dollars are placed in areas where there is the highest chance of success.

With this in mind, there are many steps that a discovery in a test tube or petri dish must go through before it will gain traction with potential partners who can bring it to market. Unfortunately, many of these steps lie outside the areas of expertise of the academic investigators who have made the initial discovery. This is the Valley of Death: a skills and expertise gap that includes many of the following aspects.

Business Case and Patent Strategy

A potential drug requires thorough market, intellectual property, pharmacoeconomic, and financial analysis. This analysis differs from the standard business case that can be analyzed by staff in a university commercialization accelerator due to the immensely complex regulatory frameworks and industry specific hurdles that drug candidates must overcome. It requires business strategies that are built into the scientific work and strategically managed in a holistic manner. It is seldom a straightforward route and requires expertise that can understand all aspects of drug development and is engaged as early as possible in the drug development process. A lead compound may demonstrate spectacular efficacy, but it will fail if there is not a strong market and patent strategy behind it.

Pharmaceutical Sciences

The steps between a discovery in the lab and successful testing in humans lies within the disciplines of the pharmaceutical sciences. To develop a drug requires a team of experts in toxicology, pharmacokinetics and dynamics, formulation, pharmacology, and medicinal chemistry. While other disciplines touch on some of the concepts found within these areas, there are a myriad of subtleties that can be missed and cripple a development program.

Regulatory Compliant Science

A very common reason that potential drugs fail is that development and pre-clinical study results do not meet regulatory requirements. While an idea may show promise in a university lab, studies must be performed in accordance with a properly documented quality control system to ensure that the results are consistently reliable and reproducible. The pharmaceutical industry no longer accepts standard academic laboratory results even as proof of concept. In order to be of interest, research on a drug candidate must be done at a GLP/GMP/GCP level. This work also needs to be structured in a manner that will address as questions about a drug candidate’s efficacy and safety as early in the development process as possible.

A Proof of Concept with Time for Development

Once there is a patent on a drug candidate, a clock begins ticking. The longer it takes an innovator to develop a very solid proof of concept at a regulatory compliant level, the less likely it is that s/he will find investment. The period of market exclusivity diminishes with each passing day. Generally, a drug candidate needs to finish a regulatory compliant Phase II clinical trial before it will attract a licensing partner or investment, but if it gets there with not much time left on its patent, there won’t be a strong case for an investor to spend the hundreds of millions of dollars required to move through Phase III.

With all of these factors in mind, researchers are faced with a seemingly insurmountable challenge if they choose to move down the path of drug development. Current frameworks in Canada simply do not provide the support to move biotech innovation forward. Researchers faced by this Valley of Death are left looking for funding to hire a professional contract research organization (CRO) to meet some of these requirements—something that can cost millions of dollars simply for a proof of concept that could determine a drug candidate to be nonviable. Even if they are successful in achieving regulatory compliant proofs of concept, if they missed something in their business case and patent strategy, or have run out the clock on their market exclusivity, they will be faced with a dead end in their ability to gain investment required to complete Phase III. Life-saving discoveries are trapped, public investments made in post-secondary innovation are crippled, and world-class researchers spend years on a dead end.

Bridging the Gap with API

Applied Pharmaceutical Innovation (API), an institute working closely with the University of Alberta’s Faculty of Pharmacy and Pharmaceutical Sciences and institutions across Canada, provides a framework that bridges this gap, offering the relevant expertise, infrastructure, and capacity at all stages of the drug development process.

API provides researchers with the capabilities of a large industry drug development program in a structure that removes barriers for success. Following an initial consultation program, participants are provided with:

  • Expertise in regulatory support, business and patent strategy

  • GLP/GMP/GCP compliant clinical pharmacology, computational biology, medicinal chemistry, pharmacology, pharmacokinetics and dynamics, pharmacometrics, and toxicology

  • Access to resources in a cost recovery model that leverages public funding to achieve milestones towards a regulatory compliant completion of pre-clinical work and Phase I and II clinical trials

For more information on how to access the services of API please click below.

API Soft Launch

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After extensive industry engagement that included over 150 consultation meetings with members of the pharmaceutical industry, government partners, and stakeholders, API is now active.

We have piloted our model with over $4M in successful partnerships over the past year, and have now launched the capacity to provide a full service one-stop-shop for industry and academia alike.

We look forward to partnering as we work to unlock the potential of university research and build a vibrant pharmaceutical industry in Canada.