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March 7, 2016 Q&A

CT backs CaroGen’s quest to fight cancer, hepatitis B

PHOTO | Contributed Bijan Almassian, president and CEO of CaroGen, a Farmington-based bioscience company

Q&A talks with Bijan Almassian, president and CEO of CaroGen, a Farmington-based bioscience company developing a hepatitis B virus (HBV) immunotherapy, using replication-proficient virus-like vesicles (VLVs) technology.

Q: When you opened your lab at the UConn incubator space in Farmington last year, the company's main viral target had been hepatitis B. Where is CaroGen with the hepatitis B vaccine?

A: Currently, we are in the process of optimizing our immunotherapy to train the immune system to attack multiple HBV targets. This strategy increases the likelihood of effectiveness of a chronic viral infection where the immune system has become unresponsive to the infection. Within 18 months of successful financing, we plan to file an Investigational New Drug (IND) application with the Food and Drug Administration and initiate a phase-I human clinical trial.

Q: What's the global impact of developing a hepatitis B vaccine?

A: Worldwide, over 240 million people live with chronic HBV infection and over 600,000 die each year from HBV-associated liver diseases. Over time, chronic HBV causes liver disease and puts many people at high risk of death from cirrhosis. Chronic HBV is also a major cause of liver cancer. The current standard of care, comprising anti-viral and immune enhancement drugs, suppresses the viral infection but typically does not eliminate the virus and in many cases can lead to drug resistance. Cessation of anti-viral therapy is usually accompanied by a rebound in the virus in most patients. As a result, in the U.S. and Europe, only about 10 percent of treatment eligible chronic HBV individuals actually receive treatment.

Q: In partnership with a UConn professor, CaroGen is also developing a vaccine against colorectal cancer. How unusual are cancer vaccines?

A: One mechanism of tumor formation and progression stems from a loss of the immune system's surveillance capabilities that permit the growth and spread of cancer cells. Immunotherapy-based approaches strive to re-train/stimulate the patient's immune system to attack cancer cells.

Immunotherapy may be an option for patients if they have breast, prostate, brain, colon, kidney or spinal cancer, along with non-Hodgkin lymphoma, leukemia or melanoma. In collaboration with a UConn professor we are working to develop an immunotherapy for colon cancer that targets multiple known antigens associated with colon cancer using CaroGen's VLV vaccine platform and UConn's expertise in the field of colon cancer and their relevant animal models to test the approach. Cancer vaccines represent an emerging area of therapeutic development and CaroGen intends to be at the forefront of this promising approach to cancer.

Q: How is the climate for a business like yours in Connecticut? Does proximity to Yale and UConn bolster your efforts? Are there negatives to being here?

A: CaroGen is among the very few biotechnology companies within Connecticut that utilizes the expertise and resources of both Yale and UConn. Our VLV vaccine technology was originally developed at Yale University and initial HBV discovery was conducted by Yale scientists under a sponsored research agreement.

We continue our collaboration with Yale and also are expanding our academic relationship into UConn to demonstrate the use of a VLV-based vaccine in important infectious diseases. We're also looking to demonstrate the use of the technology in oncology, and colon cancer is only one example of this. UConn has also been helpful in providing access to resources (i.e. internship program) that have been supportive of our laboratory R&D efforts and provided valuable experience to young scientists. Finally, CaroGen is a member of the UConn Technology Incubation Program (TIP) in Farmington, providing access to state-of-the-art laboratories and core facilities, which are accompanied by well-designed office space.

Q: Are you able to find venture investment to continue your research?

A: The financing climate for building an early stage biotechnology company in Connecticut has been difficult over the last decade, but it is getting better. The state has allocated additional funds to support startup biotechnology companies through Connecticut Innovations (CI), most notably the $200 million Connecticut Bioscience Innovation Fund (CBIF) that CI manages. The state has also expanded available workspace provided by UConn's incubator program, which has just added 32 new labs/offices in Farmington.

The major challenge for biotechnology entrepreneurs in Connecticut is raising private-sector capital for further development of their products/programs needed to fund activities leading to regulatory approval and subsequent commercialization. There are a limited number of angel and early stage venture capital (VC) life science investors in the state, and the ones who will consider investing require, in most cases, a larger, blue-chip life science VC to lead the financing.

We have received our initial pre-seed and follow-on financing through CI, which has helped us generate the data we need to seek out additional funding from either private investors and/or potential strategic investment from corporate partners.

Q: Can medical companies like yours accomplish your goals without public support?

A: No. We owe our existence and the development of our company to Connecticut Innovations' pre-seed and seed investments and UConn's assistance, both on the research side of things and physical facility/support programs. However, it is essential that the company attract private funding. We estimate it will take over 10 years to develop and launch a therapeutic vaccine and cost in excess of $250 million.

CaroGen is currently seeking to raise $10 million within the next 12 months to help finance clinical trials and establish proof-of-concept in animal models.

Like many biopharmaceutical companies, our corporate strategy is to advance our HBV vaccine beyond phase I human clinical trial and then enter into a partnership with a major pharmaceutical partner to complete the product development. In other words, the $10 million should advance our HBV program far enough along to show proof of concept in humans, which will likely allow the company to enter into a strategic partnership to fund the HBV program, and potentially other programs (e.g., in cancer and other infectious disease) moving forward.

Q: What are the long-term goals for Carogen?

A. Our goal is to develop a pipeline of three to four vaccines within the next five years resulting in corporate partnerships and a high possibility of an initial public offering (IPO). We believe the power and uniqueness of the VLV technology is of significant interest to global vaccine developers and therefore the company will be an extremely attractive opportunity for investment and for corporate partnerships, in the process allowing us to build a robust biotechnology company in Connecticut.

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