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PRESS RELEASE

 

CaroGen 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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PRESS RELEASE

 

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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PRESS RELEASE

 

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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PRESS RELEASE

 

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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PRESS RELEASE

 

CaroGen Forms Zika Vaccine Consortium

 

November 7, 2016, Farmington, CT -- CaroGen Corporation, an emerging immunotherapy company, announced today that it has formed a consortium comprising CaroGen, the University of Connecticut and Yale University School of Medicine scientists to accelerate the development of a Zika vaccine.

 

“This collaboration would allow CaroGen to accelerate its Zika virus vaccine development program by leveraging the expertise and capabilities of two of the best academic institutions in the country: Yale University School of Medicine and the Center of Excellence for Vaccine Research (CEVR) at the University of Connecticut," said Dr. Bijan Almassian, CaroGen's CEO.

 

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PRESS RELEASE

 

CaroGen Raises $1 Million in Series A Funds from a Strategic Partner

 

October 19, 2016, Farmington, CT -- CaroGen Corporation, an emerging immunotherapy company, announced today that it has raised $1 million through GP Fortune Investment Partners (GPFI), LLC, a subsidiary of G.P. Healthcare, a conglomerate organization, based in Shandong, China. The $1 million investment will be used to advance the company’s Hepatitis B Virus (HBV) development in the U.S. CaroGen and GPFI, LLC have also agreed to negotiate an agreement to develop and market CaroGen’s HBV immunotherapy product for the China territory.  In return for the rights of development and marketing of HBV immunotherapy in China, GPFI LLC would invest up to an additional $7 million in CaroGen over the next 36 months based on achieving certain HBV preclinical milestones.

 

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PRESS RELEASE

 

CaroGen Announces Publication of Therapeutic Vaccine Technology Research for Hepatitis B Virus

 

August 17, 2015, Hamden, CT:  CaroGen Corporation, an emerging vaccine company, today announced the electronic publication of a research article entitled “Virus-Like Vesicle-Based Therapeutic Vaccine Vectors for Chronic Hepatitis B Virus Infection,” which appeared in the August online issue of the Journal of Virology.

 

The paper includes research conducted in the laboratories of Dr. John Rose and Dr. Michael Robek, both faculty at Yale University, with the virus-like vesicle (VLV) platform technology, and the results of preclinical vaccine candidates aimed for treatment of chronic hepatitis B virus (HBV) infection. It is the first publication that includes data from induction of immunogenicity and potential application of VLV-based vaccines using both acute and chronic animal models of HBV.

 

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PRESS RELEASE

 

 

CaroGen Fostering Vaccine Development Collaborations with Yale and UConn and Establishing Laboratory at University of Connecticut Incubator Program

 

Farmington CT – January 5, 2015 – CaroGen Corporation today announced that it has chosen UConn’s Technology Incubation Program (TIP) in Farmington to establish a laboratory footprint. This expansion will allow CaroGen to more aggressively pursue the advancement of its proprietary virus-like vesicle (VLV) vaccine technology, development of its HBV vaccine program and evaluation of other potential candidate infectious disease vaccines.

 

“CaroGen is committed to fostering engagement and cooperation among key scientists at the state’s two leading research institutions in addition to specific alliances with the Company. We will leverage the expertise at these two great institutions to support product development,” CEO and Co-Founder Dr. Bijan Almassian said. “Working with the faculty of both universities will not only greatly benefit the company’s scientific aims, but will demonstrate the unique value of such relationships to the state’s life science community.”

 

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PRESS RELEASE

 

CaroGen Corporation Awarded $500,000 in Seed Funding from Connecticut Innovations

 

Hamden CT – December 10, 2014 – CaroGen Corporation announced today that it has been awarded $500,000 from the Connecticut Bioscience Innovation Fund (CBIF) to support continued development of CaroGen’s therapeutic Heptatitis B Virus (HBV) vaccine for chronically infected individuals.  CaroGen is the Connecticut first company to receive such support out of the recently created CBIF program. The award will allow CaroGen to complete preclinical study endpoints with its Virus-like Vesicle (VLV) technology and selection of clinical candidate.  It is estimated that over 240 million people are chronically HBV across the global population with approximately 1.4 million in the U.S. alone.  Chronic infection leads to cirrhosis and 80% of all liver cancer resulting in over 500,000 deaths per year from this form of cancer.

 

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PRESS RELEASE

 

CaroGen Wins “Entrepreneur Innovation Award” from CTNext

 

Hamden CT – April 3, 2014 – CaroGen was awarded a $10,000 grant by CTNext, a component of Connecticut’s innovation ecosystem to support the success of companies and entrepreneurs, to further support development of its therapeutic vaccine for chronic Hepatitis B (CHB) viral infection.   The award was announced at the Entrepreneur Innovation Awards (EIA), which was held on Wednesday, April 2, at the Connecticut Science Center in Hartford, CT.  CaroGen was one of 8 finalist companies to present to a panel of industry expert judges who made the final decisions for the EIA grants.

 

 

PRESS RELEASE

 

CaroGen Corporation Awarded “Most Promising Life Science Product”

 

Hamden CT - November 8, 2013 - A panel of industry experts, angel and venture capital investors awarded CaroGen Corporation the Most Promising Life Sciences Product at the 2013 Connecticut Innovation Summit.

 

The award was presented to CaroGen CEO, Bijan Almassian, Ph.D., after presenting the company’s technology, management team and its lead vaccine candidate, a therapeutic vaccine chronic Hepatitis B infection, at the annual Summit.  CaroGen was invited to participate after being acknowledged as a 2013 Company to Watch by the Connecticut Technology Council earlier in the year.

 

 

PRESS RELEASE

 

CaroGen’s Corporate Sponsored Research Agreement (SRA) with Yale University

 

Validation of novel virus-like vesicle vaccine technology in Hepatitis B Virus animal models

 

Hamden CT – August 20, 2013 – A corporate research agreement involving CaroGen Corporation’s novel recombinant virus-like vesicle (VLV) technology was signed between the Company and Yale University.  CaroGen is a biotechnology firm pioneering breakthrough technology for the development of novel vaccines.

 

Under the terms of the SRA, the research which shall be performed under the direction of Dr. John Rose and Dr. Michael D. Robek at Yale University School of Medicine is designed to test the safety and potency of CaroGen’s VLV vaccine technology using Hepatitis B virus (HBV) animal models.

 

“The proposed research uniquely combines the expertise of Dr. Rose (VLV technology inventor) and Dr. Robek (HBV immunology)”, said Dr. Valerian Nakaar, Vice President Research and Development.  “These studies are likely to yield important milestones for the one-year proof-of-concept studies”, added Dr. Nakaar.

 

 

PRESS RELEASE

 

Connecticut Innovations Commits $800,000 to High Technology Startups

 

Rocky Hill, CT - August 20, 2013 – Connecticut Innovations (CI), the state’s quasi-public authority responsible for growing Connecticut businesses through innovative financing and strategic assistance, today announced that it has committed funding totaling $800,000 through its Pre-Seed Fund to five startup ventures focused on innovations in biotechnology, clean tech and information technology:

 

CaroGen Corporation (Hamden) $150,000 funding commitment

 

• CMB Exchange LLC

 

• dba American Oil Solutions (Bridgeport) $150,000 funding commitment

 

• Engineered Carbon Solutions Inc. (Norwich) $150,000 funding commitment

 

• ImStem Biotechnology Inc. (Farmington) $150,000 funding commitment

 

• ReadyDock Inc. (West Hartford) $200,000 follow-on funding commitment

 

“CI’s Pre-Seed Fund continues to make its mark on emerging, technology-based companies in all parts of the state,” said Claire Leonardi, chief executive officer of CI. “With these five companies, we have now supported and advised a total of 43 technology ventures through the fund. Building a strong technology community in Connecticut by nurturing innovative companies like these is a high priority of the Malloy administration.”

 

CaroGen Corporation is an emerging biotechnology company with a new platform technology for generating potent and safe vaccines. The company’s platform is based on replication-proficient, virus-like vesicles (rVLVs) that allow target antigens to accumulate in high levels in cells, thereby amplifying specific immune responses and creating more potent immune therapies. CaroGen, which has licensed its core technology from Yale University, will focus initially on a treatment for patients with chronic hepatitis B infections, which can cause chronic liver disease and put patients at high risk of death from cirrhosis of the liver and liver cancer.

 

“CaroGen’s work on developing vaccines is not only important from a public health standpoint, but is part of a growing biotech industry that is creating well-paying, high-tech jobs throughout Connecticut,” said Speaker of the House Brendan Sharkey (D-Hamden). “CaroGen is an important member of our local business community, and I am glad we can help them continue to grow right here in Hamden.”

 

American Oil Solutions (AOS) is an emerging clean tech company that has developed an advanced, closed-loop, pollution-free pyrolysis and post-processing system to turn used tires into high-value products. When tires are pyrolyzed, they are heated in an oxygen-free environment to generate gas, oil, scrap steel and carbon char. The gas is recycled and used to feed the energy needs of the pyrolysis. The oil (for heating and fuel), scrap steel and carbon char can be sold to commodity dealers. AOS’s technology focuses on the post-processing steps and helps to maximize the value of the marketable pyrolysis end products.

 

Engineered Carbon Solutions Inc. (ECS) is an emerging clean tech company that has developed a hybrid fuel from recycled materials. This fuel serves as a cost-effective substitute for existing wood pellets as an alternative heating fuel. The company’s Frog City Fuel brand pellets, made from recycled paper, waste coal and biodiesel, are compatible with existing home heating pellet stoves and boilers and provide the same BTU content as premium wood pellets at a lower cost, delivering heat to households at a fraction of the cost of home heating oil.

 

“I am thrilled that Engineered Carbon Solutions Inc. of Norwich is the recipient of Pre-Seed Fund assistance,” remarked State Representative Emmett Riley (D – Norwich). “This company is an asset to the area and a benefit to Connecticut as it continues to explore and develop alternative fuel sources.”

 

ImStem Biotechnology Inc. is an emerging biotechnology company developing cell therapeutic products derived from human embryonic stem cells for use in tissue repair and treatment of neural, heart, vascular and blood system and autoimmune diseases. ImStem is currently focused on developing a cell therapy product for the treatment of multiple sclerosis and other autoimmune diseases. The company’s core technology, licensed from the University of Connecticut Health Center, revolves around a unique method to derive mesenchymal stem cells with high efficiency.

 

ReadyDock Inc. is a developer of modular technology for secure storage, charging and disinfecting of computer tablet devices. Its technology is useful in hospitals, laboratories and anywhere bacterial infection is a risk. A main driver of the need for ReadyDock’s technology is hospital-acquired infections (HAIs). HAIs can have a significant adverse financial impact on hospitals, making disinfection technology such as that provided by ReadyDock an attractive solution. In addition to receiving this follow-on investment commitment of $200,000 from CI, ReadyDock received an investment of $150,000 through CI’s Pre-Seed Fund in 2012.

 

CI’s Pre-Seed Fund is an important catalyst in the state’s high-tech economic development engine. It supports the formation of new Connecticut technology companies by providing funding, mentoring and access to business and technical resources.

 

About Connecticut Innovations Inc.

 

Connecticut Innovations (CI) is the leading source of financing and ongoing support for Connecticut’s innovative, growing companies. To maximize each business’s growth potential, CI tailors its solutions and often combines its funds with resources from other financial leaders to provide venture capital and strategic support for early-stage technology companies; flexible loans for established companies with new innovations; grants that support innovation and collaboration; and connections to its well-established network of partners and professionals. Through all these initiatives, CI has helped bring $4 billion in financing to Connecticut companies. The state’s most active early-stage investor, CI has created more than 26,000 jobs.

 

 

PRESS RELEASE

 

 

CaroGen Announces Closing of Pre-Seed Financing

 

Hamden, CT -  July 17, 2013 - CaroGen Corporation (www.carogencorp.com), a leader in development of therapeutic vaccines announces receipt of pre-seed financing.

 

“The funds from Connecticut Innovations and an additional individual investor will allow CaroGen to complete its proof of concept (POC) in animal studies within the next 12 months for its chronic hepatitis B (CHB) therapeutic vaccine”, according to Bijan Almassian, Ph.D., cofounder and Chairman of the Company. The studies will be conducted under a Cooperative Research Agreement with Yale University, where CaroGen’s Virus-Like-Vesicles (VLVs) vaccine platform technology was discovered by Dr. John Rose.  Dr. Rose, Professor and Director, Molecular Virology Program at the Yale School of Medicine; and Dr. Michael Robek, Associate Professor of Pathology, are cofounders of the Company and will lead the CHB POC studies.

 

For further information please contact:

CaroGen Corporation:

 

Dr. Bijan Almassian

Chairman

295 Washington Ave, Suite 4N

Hamden, CT 06518

Tel: 203-230-8596

Email: balmassian@carogencorp.com

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