Privately-held CaroGen Corporation today announced the develop-ment of its novel AVIDIO/SARS-CoV-2 recombinant vaccine for COVID-19 in collaboration with scien-tists at the Yale University School of Medicine.
CaroGen, headquartered in Farmington, CT, is a spin-off from Yale University School of Medicine. The Company is developing first-in-class vaccines and immunotherapies based on its transformative patented AVIDIO (Artificial Virus for Infectious Diseases and Immune-Oncology) technology platform.
The AVIDIO platform was discovered at Yale School of Medicine by Professor John Rose who is a Co-founder and Chairman of the Scientific Advisory Board at CaroGen. Dr. Rose previously conducted groundbreaking studies on an effective SARS vaccine and published three papers on this topic from 2005-2008. Dr. Rose and his collaborators developed a vaccine shown to be protective, in animal models, against infection by the SARS-CoV coronavirus, which is genetically similar to the new SARS-CoV-2 coronavirus which causes COVID-19 disease.
The CaroGen-Yale team has launched a program to employ its new AVIDIO platform to develop a vaccine for COVID-19, based upon mechanisms discovered in prior vaccine/immunotherapy research programs. They are generating vaccines expressing the SARS CoV-2 spike glycoprotein (S) and testing them for im-munogenicity in animals. “We hope to select candidate(s) for human clinical studies within the next several months,” said Dr. Rose. He added, “We are accelerating the development of an AVIDIO/COVID-19 vaccine because of the promise of our novel AVIDIO platform and the global health crisis caused by COVID-19.
CaroGen Corporation, a biotechnology company, today announced three distinguished additions to its Scientific Advisory Board:
CaroGen, a spin-off from Yale University School of Medicine, is a developer of first-in-class immunotherapies based on its transformative and patented AVIDIO (Artificial Virus for Infectious Diseases and Immune-Oncology) technology platform.
CaroGen, a spin-off from Yale University School of Medicine and a developer of first-in-class and transformative immunotherapies for cancer and infectious diseases, today announced that the United States Patent and Trademark Office (USPTO) has issued its first composition of matter patent (Patent#10435712, issue date October 8, 2018) for its Artificial Virus (AV) for Infectious Diseases (ID) and Immuno/Oncology (IO) platform dubbed “AVIDIO”.
CaroGen’s CEO and Co-founder, Bijan Almassian, PhD, stated, “Receiving such a broad patent claims by the USPTO is great welcome news as we are advancing our first AVIDIO-based immunotherapy CARG-201 for potential cure of patients chronically infected with hepatitis B virus (HBV) into human clinical trials and investigating AVIDIO based immunotherapies for colon and other cancer targets in collaboration with academic institutes.”
“AVIDIO is built from components of two different non-human based viruses. It is safe, self ad-juvanting and can be engineered to deliver multiple DNA sequences for antigens, cytokines, pep-tides and check point inhibitors such as sh-RNA rendering it to work through multiple mechanism of immune responses including Toll-Like Receptors (TLRs), T cell and antibody responses in preclinical models. AVIDIO could potentially overcome the deficiencies of other immunotherapy approaches in cancer and infectious diseases that are effective but have narrow mechanism of actions,” said Valerian Nakaar, Ph.D., Vice President Research and Development.
CaroGen, a spin off from Yale School of Medicine and a developer of transformative immunotherapies for infectious disease and cancer, today announced that the Company has received a SBIR grant from NIH in the amount of $1,400,000. This grant will accelerate development of CaroGen’s lead product, CARG-201, for the potential cure of patients chronically infected with HBV.
This award is the culmination of years of collaborative efforts and dedication of the scientific teams at CaroGen led by Valerian Nakaar, PhD, a co-founder of the Company and the Vice President, Research & Development and those at Yale University School of Medicine and Albany Medical College led by Professor John Rose, PhD and Professor Michael Robek, PhD, respectively. Professor Rose, a world-renowned virologist, and Professor Robek, an opinion leader in the field of HBV, are co-founders of the Company and co-investigators on this grant.
CaroGen’s CEO, President, and Co-founder, Bijan Almassian, PhD, stated, “Receiving a total of $1,625,000 so far in SBIR funding in support of our HBV program is a testament to the quality and competitiveness of our data, our sound development plan, and the promise of CARG-201 as a novel immunotherapy for the potential cure of HBV. There are over 250 million people in the world who are chronically infected with HBV and who have increased risk of serious liver disease, including cirrhosis and cancer. Currently there is no cure available. Thus CARG-201 has the potential of satisfying a huge unmet medical need.”
CaroGen, a developer of transformative immunotherapies for infectious disease and cancer, today announced that the Company has appointed Harry H. Penner, Jr. to serve as CaroGen’s Chairman of the Board of Directors.
Mr. Penner, a serial entrepreneur, is a Founder of numerous companies including Affi-nimark 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. He serves on the board of Celldex Therapeutics (CLDX: Nasdaq) and has previously served on the boards of several other public and private biopharmaceutical companies.
Mr. Penner was President, Chief Executive Officer, and Vice Chairman of Neurogen Corporation (a publicly traded bioscience company) from 1993 to 2001. From 1981 to 1993, Mr. Penner served in different capacities at Novo Nordisk A/S (NVO: NYSE). He initially served as US Vice President and General Counsel, then served as global Ex-ecutive Vice President and General Counsel in Denmark from 1985 to 1988; and finally from 1988 to 1993, he continued as a Novo Nordisk Executive Vice President while serving as President of Novo Nordisk, North America.
He has also served as Bioscience Advisor to the Governor of the State of Connecticut, Chair of the Connecticut Board of Governors of Higher Education, Chair of the Connecticut Technology Council, and as Co-Chair of CURE (now BioCT).
Mr. Penner holds a B.A. from the University of Virginia, a J.D. from Fordham University, an L.L.M. in International Law from New York University, and certificates from Stanford University’s GSB executive management programs.
CaroGen’s Co-founder and CEO, Bijan Almassian, PhD, stated, “The election of Mr. Penner, a seasoned leader in biotechnology and pharmaceutical industries, as Chair-man of the Board greatly strengthens the CaroGen team, positioning us to execute our Hepatitis B Virus (HBV) program and to continue to build a portfolio of immunotherapies based on our novel Virus-Like Vesicles (VLVs) platform technology”. Mr. Penner stated, “I am delighted to join CaroGen’s management team and 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.”
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.
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.”
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.
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.