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CaroGen Announces Chronic Hepatitis B Immunotherapy Clinical Candidate Selection, Successful Pre-IND Interaction, U.S. Patent Issuance and SBIR Award Announces Chronic Hepatitis B Immunotherapy Clinical Candidate Selection, Successful Pre-IND Interaction, U.S. Patent Issuance and SBIR Award

June 18, 2018 Farmington, CT

CaroGen, a developer of transformative immunotherapies for infectious disease and cancer, having its initial focus on development of a cure for patients with chronic hepatitis B (CHB), announced that the Company has selected a candidate for advancement into clinical studies. The candidate Virus-Like Vesicle (VLV), known as CARG-101, has many attributes that make it attractive for advancement including expression of three major antigens from Hepatitis B Virus (HBV). “We anticipate an IND and start of phase I in the first half of 2019”, remarked Dr. Bijan Almassian, President and CEO of CaroGen Corporation. He went on to further indicate that “this candidate represents several years of refinement of the VLV platform, which also can be applied as therapy or prevention to other infectious diseases or oncological indications”.

To advance CARG-101 into clinical trials, CaroGen has interacted with the FDA by assembling a pre-IND package last fall. This package was submitted in October 2017 and the responses from the FDA were received in November. “By all accounts, the responses were very positive and our interaction through the pre-IND process has made us very confident in advancing our clinical candidate, CARG-101, further,” said Dr. Valerian Nakaar, Vice President of R&D at CaroGen.

CaroGen also announced that on June 5th , 2018, the USPTO issued US patent 9,987,353 to Yale University for “Virus-Like Vesicles (VLVs) Based Vaccines to Prevent or Treat Chronic Hepatitis B (HBV) Infection.” CaroGen holds an exclusive license to this IP from Yale University. “We are very proud to make this announcement as it adds great value to CaroGen’s patent portfolio and validates our claims to utilize our platform for treatment of chronic Hep B,” said Dr. Almassian.

Lastly, CaroGen announced today that a Small Business Innovation Research (SBIR) Program grant was awarded for “Enhancing Immunogenicity of VLV-Based Vaccines for Treatment of Chronic HBV”. This Phase I grant award from the National Institute for Diabetes and Digestive and Kidney Diseases (NIDDK) for approximately $225,000 is for a term of 1 year.

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Harry H. Penner, the former CEO of Neurogen and a serial entrepreneur, joins the Board of Directors of CaroGen

June 12, 2018 Farmington, CT

CaroGen, a developer of transformative immunotherapies for infectious disease and cancer, having its initial focus on development of a cure for patients chronically infected with hepatitis B virus (HBV), today announced that the company has appointed Mr. Harry Penner to serve on the company's board of directors.

Mr. Penner, a serial entrepreneur, is a Founder of numerous companies including Affinimark Technologies, Inc., Marinus Pharmaceuticals, Inc. (MRNS: Nasdaq), Rib-X Pharmaceuticals (now Melinta Therapeutics, Inc.), Omax Health, Inc., RxGen, Inc., MAK Scientific, LLC, New Haven Pharmaceuticals, Inc., NeuroCyte Therapeutics, Inc., and QCDx, Inc.

Mr. Penner was President, Chief Executive Officer, and Vice Chairman of Neurogen Corporation (a publicly traded bioscience company) from 1993 to 2001. From 1985 to 1993 Mr. Penner was an Executive Vice President of Novo Nordisk A/S (NVO: NYSE), serving from 1985 to 1988 as the company's Executive Vice President and General Counsel in Denmark; and serving from 1988 to 1993 as Executive Vice President for North America and President of Novo Nordisk, North America.

CaroGen’s Co-founder and CEO, Bijan Almassian, PhD, stated, “The addition of Mr. Penner, a seasoned leader in biotechnology and pharmaceutical industries to our board greatly strengthens the CaroGen team, and positions us to execute our HBV program and to continue to build a portfolio of immunotherapies based on our novel virus like vesicles (VLVs) platform technology”. Mr. Harry stated, “I am delighted to join CaroGen’s Board of Directors,” noting that “the CaroGen VLV platform technology holds great promise for addressing unmet needs in several important therapeutic indications, including chronic HBV infection and oncology.”

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CaroGen Strengthens its Board and Discovery Team

April 17, 2017 Farmington, CT

CaroGen Corp, a developer of immunotherapies for HBV as well as other infectious diseases and cancer, announced today an important addition to its Board of Directors and two key senior executive level scientists to its immunotherapy discovery and development team. Bijan Almassian, Ph.D., CaroGen’s CEO stated that, “The addition of these three impressive and experienced individuals, greatly strengthens the CaroGen team and positions the company well with respect to executing on its immunotherapy plans”.

The three new CaroGen additions are:

Jo Viney, Ph.D.
Dr. Viney is CaroGen’s newest Board member and is an entrepreneurial scientist and experienced biotech executive with extensive knowledge in autoimmune and inflammatory disease area. Previously, Jo worked at Biogen in Cambridge, MA where she began as Vice President, Immunology Research and was responsible for building and advancing the company’s immunology portfolio before moving on to become Senior Vice President, Drug Discovery and a member of the senior R&D leadership team. Prior to Biogen, Jo worked at Genentech, Immunex and Amgen with increasing scope of drug discovery responsibilities.

Stephen Mason, Ph.D.
Dr. Mason has been involved in drug discovery research for the past 18 years. Steve was Director of Discovery Virology at Bristol-Myers Squibb, leading research efforts toward remission/eradication of HIV and HBV, as well as projects on HPV and HCV. Previously, he worked for twelve years at Boehringer-Ingelheim as Director of research leading all exploratory research activities in HIV. Dr. Mason is joining CaroGen as Executive Director, Virology and Leader of the HBV Immunotherapy program.

Timur Yarovinsky, M.D., Ph.D.
Dr. Yarovinsky has extensive training in immunology and more than 16 years of research experience in the field of immunology and microbial pathogenesis. He obtained both his MD and PhD (Allergy and Immunology) degrees from Russia State Medical University (Moscow, Russia) and undertook his postdoctoral fellowship at The University of Iowa, Iowa City. In 2007 he joined the Department of Immunobiology, Yale University School of Medicine, New Haven, as Associate Research Scientist. Dr. Yarovinsky had been CaroGen’s Immunology Group Leader and has promoted to Director of Immunology.

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UCONN Health Researchers Collaborate with CaroGen Corporation to Develop Vaccine to Treat Colon Cancer

November 8, 2016 Farmington, CT

The University of Connecticut and CaroGen Corporation, an emerging immunotherapy company, today announced a collaboration aimed at developing a therapeutic vaccine for treatment of patients with colon cancer. CaroGen’s proprietary technology platform will be applied to a specific target studied by UConn Health’s Dr. Kepeng Wang Ph.D., Assistant Professor of Immunology. CaroGen will support this effort with a $70,000 grant to Dr. Wang, and his collaborator Dr. Anthony T. Vella, Ph.D., Professor and Boehringer Ingelheim Chair in Immunology, who will aid in the development of this platform.

Colon cancer is the third leading cause of cancer-related deaths in the United States when men and women are considered separately, and the second leading cause when both sexes are combined. It is expected to cause over 49,000 deaths during 2016. The percentage of colon and rectal cancer deaths is highest among people aged 75-84, and colon cancer death rates increase with age.

“While the death rate from colon cancer has been dropping in both men and women for several decades thanks to screening and improved treatment, our goal is to reach close to a 100 percent survival rate. By combining our platform with Dr. Wang’s very promising target, we hope that a new powerful immunotherapy will be developed to provide patients with that assurance,” said CaroGen’s President and CEO, Dr. Bijan Almassian.

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