Hartford Business Journal

8 Hartford Business Journal • March 7, 2016 www.HartfordBusiness.com FOCUS HEALTHCARE/BIOSCIENCE Q&A CT backs CaroGen's quest to fight cancer, hepatitis B 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 incu- bator space in Farm- ington last year, the company's main viral target had been hep- atitis B. Where is CaroGen with the hepatitis B vaccine? A: Currently, we are in the process of optimizing our immu- notherapy to train the immune system to attack multiple HBV targets. This strategy increases the likeli- hood of effectiveness of a chronic viral infec- tion 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) appli- cation with the Food and Drug Administration and initi- ate a phase-I human clinical trial. Q: What's the global impact of developing a hepatitis B vaccine? A: Worldwide, over 240 mil- lion people live with chronic HBV infection and over 600,000 die each year from HBV-associ- ated liver diseases. Over time, chronic HBV causes liver dis- ease and puts many people at high risk of death from cir- rhosis. Chronic HBV is also a major cause of liver cancer. The current standard of care, com- prising 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 accom- panied 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 actu- ally 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 capabili- ties that permit the growth and spread of cancer cells. Immu- notherapy-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, leuke - mia or melanoma. In collaboration with a UConn professor we are working to develop an immu- notherapy for colon cancer that targets multiple known anti- gens associated with colon cancer using CaroGen's VLV vac- cine platform and UConn's expertise in the field of colon can- cer 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 Con- necticut? 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 origi- nally developed at Yale Univer- sity and initial HBV discovery was conducted by Yale scien- tists 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 help- ful in providing access to resourc- es (i.e. internship program) that have been supportive of our labo- ratory R&D efforts and provided valuable experience to young scientists. Finally, CaroGen is a member of the UConn Technol- ogy Incubation Program (TIP) in Farmington, providing access to state-of-the-art laboratories and BIJAN ALMASSIAN President and CEO of CaroGen Protein Sciences seeks to expand vaccine market share By Matthew Broderick Special to the Hartford Business Journal W hen Protein Sciences first launched Flublok in 2013 — the only egg- and preservative-free flu vaccine on the market — Manon Cox, the company's president and CEO, expected the product to put the Meriden-based drug developer on the map in a global influenza vaccine market expected to be worth $3.8 billion by 2018. "I thought it would take off," Cox said, noting the Food and Drug Administration-approved product remains the only vaccination for people with egg allergies. "But it's taken longer than expected." While production of Flublok quadrupled from 300,000 doses two years ago to 1.2 million doses last year, Cox says her company's ambitious five-year goal to produce 30 million doses annually will require building many more relationships, includ- ing with national retailers like Walmart, Rite Aid and CVS. She anticipates vaccines will, over time, account for 90 percent of her company's revenue. As part of a multi-pronged approach to promote and dis- tribute Flublok, Protein Sciences recently collaborated with Wallingford-based Gaylord Hospital, Hartford Healthcare, and Hunter Ambulance to provide mobile vaccinations, a strategy that not only increased aware- ness of Flublok, but may also grow to serve as a national model for community vaccinations. In fact, this past fall, according to Susan Mangenello, Protein Science's director of medical services, the col- laboration helped vaccinate more than 2,200 people at 68 mobile clinics, including senior centers, fire depart- ments, local businesses and healthcare facilities. More than one-quarter of the people served through the pro- gram were employees of Gaylord Hospital, which — like a growing number of healthcare providers — mandates that all employees receive an influenza vaccine. "About 92 percent of our employees received their vac- cination through this program," said Dr. Stephen Holland, Gaylord's chief medical officer, who noted that collabora- tions between health-related organizations are becoming a bigger trend in the industry. "We are looking for these types of relationships, where we can meet joint goals, improve quality of care and cut costs," he said. "It's a very cost-effective solution for a hospital," said Mangenello, adding the program saved the hospi- tal staff time and reduced administrative paperwork — both of which were handled through program staff. But for Mangenello, the program was as much about raising understanding about a product that, although FDA-approved, still raises concerns as a new vaccine. "Some people were scared to try Flublok," she said, "and needed to be educated." Mangenello, who is also a registered nurse, under- stands those concerns. She explained that while tradi- tional flu vaccines have been made using an egg-based manufacturing process for the past 70 years, Flublok is a recombinant vaccine, which uses a production tech- nology only approved in the U.S. since 2013 — and does not include an egg-grown vaccine virus. Not only has the recombinant approach made the product the only vaccination option for people with egg allergies — with fewer side effects, Mangenello says — but it involves a much faster production schedule than traditional egg-based produc- tion, according to the Center for Disease Control (CDC). "We can [mass] produce a vaccine in 12 weeks," Cox said, noting egg-based manufactur- ing typically takes six to eight months. "It's a major advantage of our technology." Those production capabilities have proven to be a cash boon for Protein Sciences, which has ben- efitted from hefty government investment — $150 million to date — to help accelerate vaccine production methods to address a potential pandemic outbreak, like the H1N1 virus in 2009. That infusion of government capital helped Protein Sciences expand its workforce, manufacturing capabili- ties, and revenue — $45 million in 2014 in alone — but Cox says some of that past funding is less available as government entities like the National Institutes of Health are investing in the development of their own vaccine, which just adds one more potential competitor to a landscape dominated by a handful of major players. That's been a challenge for Protein Sciences. "Because we produce smaller doses [than the market leading compa- nies] our wholesale price of $35 is higher than the average of $32," Cox said. She said her company is seeking a partner — a larger drug manufacturer — to help expand Flublok's marketing and distribution to the world's largest retailers. For now, Cox says, Protein Sciences is encouraged by success of its mobile vaccinations and is looking to expand its grassroots outreach to more sites next flu season. The program is also helping test new healthcare delivery models. "Mobile integrated health care is part of our compa- ny's short- and long-term planning," said Donna Hunter, owner of Hunter's Ambulance, which provided the fleet of vehicles as mobile vaccine units. "Our healthcare system is moving from fee-for-service treatment to a preventative care model." Cox is happy her flu vaccine has part of that solution. "We continue to experiment," she said. "It might serve as a national model," and put her vaccine — and company — on the map in the vaccine market. n Manon Cox says Protein Sciences must ink deals with national retailers like CVS and Walmart to expand the market share of its egg-free flu vaccine, Flublok. Protein Sciences used a mobile clinic (shown above) to expand the use of its egg-free flu vaccine in Connecticut. P H O T O | C O N T R I B U T E D P H O T O | H B J F I L E

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