Press Releases

March 18, 2013 Qualyst Transporter Solutions, LLC and Hepregen Corporation Execute Letter of Understanding. Agreement Provides First Step to Partnering Arrangement Supporting Use of Qualyst’s Patented B-CLEAR® Technology in Combination with Hepregen’s Proprietary HepatoPac™ Products.

Qualyst Transporter Solutions, LLC and Hepregen Corporation announced today, at the American Association of Pharmaceutical Scientists Workshop on Drug Transporters in ADME, the execution of a Letter of Understanding (“LOU”) between the companies that supports a collaborative application development effort, and permits Hepregen to utilize Qualyst’s patented B-CLEAR® technology for applications involving hepatic transporter proteins in experiments to be conducted with certain key customers. This LOU also serves as a preamble to a broader partnering arrangement being negotiated between the companies, enabling the use of Hepregen’s HepatoPac™ products for routine hepatic transporter protein analysis.

“This combination of our two unique proprietary technologies will provide the pharmaceutical industry with a superior tool for defining how transport of drugs and their metabolites affect the disposition and toxicologic properties of candidate drugs in development,” commented Dr. Vincent Zurawski, Hepregen’s president and chief executive, adding, “Hepregen is delighted with the opportunity to work closely with Qualyst, the clear industry leader in hepatic transporter analysis.” PDF

June 27, 2012 Hepregen Corporation Receives National Science Foundation Grant Under SBIR Phase II-B Program.

Hepregen Corporation, a leading provider of bioengineered solutions for drug development, announced today that the company has received a grant for $500,000 from the National Science Foundation under the SBIR Phase II-B Program. This latest award, along with a Challenge Grant from the National Institutes of Health (NIH), a Mass Life Science Center Small Business Matching Grant and earlier grant awards, total nearly $3.0M in state and federal non-dilutive financing.

“As an enabling technology, the HepatoPac™ platform provides high-value information to the pharmaceutical industry,” commented Bonnie Fendrock, Hepregen’s President and CEO. “Creating predictive in vitro models is an important area of opportunity in drug development. This NSF grant allows us to expand our HepatoPac™ offering to include other preclinical species, which is important in refining and reducing animal studies during drug development. We are very excited by the work that we have done to date with pharmaceutical companies who recognize the potential of HepatoPac™, not only as a predictive platform, but also as an enabling technology in drug discovery.”. PDF

November 2, 2011 Hepregen Corporation and Partners Present Findings at Key Research Meeting. HepatoPac™ Liver Model is touted for its Value to Predict Clinical Parameters of Commercially Available Drugs.

At the annual meeting of the International Society for the Study of Xenobiotics (ISSX), Hepregen Corporation, and two of its pharmaceutical customers, Boehringer Ingelheim Pharmaceuticals, Inc. and Elan Pharmaceuticals presented new preclinical data in poster presentations that tested Hepregen’s proprietary microliver technology platform, HepatoPac™for predicting clearance of drugs which are slowly removed by the liver. Of the commercially available drugs tested, 89 percent were predicted correctly (within two-fold of reported clinical values), while the remaining drugs were within three-to-four fold. Suspension hepatocytes typically used for this type of study do not turn over these drugs sufficiently to make this determination.

These data demonstrated that Hepregen’s HepatoPac™ liver model can be used effectively to predict the clearance of low turnover drugs in humans. PDF

May 26, 2011 Hepregen Corporation Awarded Massachusetts Life Sciences Center 2011 Small Business Matching Grant. Company receives $500,000 grant; continues growth through adoption of its microliver platform, HepatoPac™ by leading biopharmaceutical companies.

The Massachusetts Life Science Center announced yesterday that Hepregen Corporation, a leading provider of bioengineered solutions that increase success in drug development in order to improve patient safety, was awarded a $500,000 grant as part of the Small Business Matching Grants program established by the Life Sciences Act of 2008. The Center’s program, launched in January 2010 as part of the state’s ten-year, $1 billion Life Sciences Initiative, leverages federal small business grant funding that early-stage life sciences companies in the Commonwealth have received for their work in life sciences research and development, commercialization and manufacturing.

Hepregen’s lead product HepatoPac™ launched in March 2011, is a microliver platform for use in clearance predictions, metabolite profiling, transporter studies, drug-drug interactions, and toxicity determination during the drug development process. The utility of HepatoPac™ in ADME/Tox applications is being validated and adopted by several leading biotechnology and pharmaceutical companies. In an announcement earlier this year, Hepregen detailed the expansion of its collaboration with Boehringer Ingelheim for the integration of HepatoPac™ into drug discovery and development programs. PDF

May 25, 2011 Massachusetts Life Sciences Center Announces 2011 Small Business Matching Grant (SBMG) Program Awards. Center Awards $2 million to foster job growth and technology commercialization in the Massachusetts Life Sciences Supercluster.

The Massachusetts Life Sciences Center’s Board of Directors (“the Center”) today awarded $2 million in Small Business Matching Grants to four life sciences companies. Each company will receive $500,000 from the Center that matches federal small business grant funding that the companies have been awarded previously. The grants represent the second round of awards issued under the Center’s Small Business Matching Grant (“SBMG”) Program, established by the Life Sciences Act of 2008. Three companies received $1.5 million in grants through the Center’s first round of awards in May of 2010. The Center’s Small Business Matching Grant Program, launched in January 2010 as part of the state’s ten-year, $1 billion Life Sciences Initiative, leverages federal small business grant funding that early-stage life sciences companies in the Commonwealth have received for their work in life sciences research and development, commercialization and manufacturing. Goals of the Center’s program include the creation of jobs in Massachusetts through the commercialization of products with high potential for market adoption and penetration. PDF

March 10, 2011 Hepregen Corporation Presents Results of Liver Toxicity Study at Annual Meeting of The Society of Toxicoloty. Hepregen’s Microliver Platform, HepatoPac™ Provides Increased Confidence in Drug Development to Impact Patient Safety.

At the 50th Anniversary of the Annual Meeting of Society of Toxicology (SOT), Hepregen Corporation announced today the successful use of its HepatoPac™ platform in an in vitro study demonstrating the species-specific liver toxicity of Fialuridine (FIAU). The results of the study are being presented today in a poster session. Hepregen Corporation is a leading provider of bioengineered solutions that increase success in drug development in order to improve patient safety. HepatoPac™ is a microliver platform for use in clearance predictions, metabolite profiling, transporter studies, and toxicity determination during the drug development process. Hepregen’s HepatoPac™ products will be available through its services model initially and then later this year through direct product sales. Researchers from Hepregen Corporation, in collaboration with Alnylam Pharmaceuticals, investigated the acute and chronic toxicity profiles of FIAU and several analogues in Human and Rat HepatoPac™. Using multiple endpoints, FIAU exhibited acute (4 day) and chronic (15 day) dose-dependent toxicity in human HepatoPac™. The toxicity was specific to FIAU alone, whereas other nucleoside analogues did not cause toxicity to the same extent. By contrast, Rat Hepatocytes in the HepatoPac™ platform were not affected by FIAU in the short term and were only mildly impacted chronically, mimicking the species specific in vivo observations. PDF

March 3, 2011 Hepregen Corporation Announces Commercial Launch of HepatoPac™™ Microliver Platform for In Vitro ADME/Tox Applications.

Hepregen Corporation, a leading provider of bioengineered solutions that increase success in drug development in order to improve patient safety, will launch its proprietary technology platform, HepatoPac™, at the SOT 50th Anniversary Annual Meeting and ToxExpo in Washington, D.C. on March 7, 2011. PDF

January 6, 2011 Hepregen Corporation Expands Agreement with Boehringer Ingelheim for the Adoption of HepatoPac™.

Hepregen Corporation, a leading provider of bioengineered solutions to improve patient outcomes, announced today that it has extended and expanded its agreement with Boehringer Ingelheim Pharmaceuticals, Inc. for the adoption of its proprietary technology platform, HepatoPac™. The expansion results from collaborative efforts the two companies began in 2009 aimed at evaluating HepatoPac™ for ADME/Tox applications. Under the terms of the new agreement, Hepregen will work with Boehringer Ingelheim Pharmaceuticals, Inc. to integrate HepatoPac™ into drug discovery and development programs. PDF

January 13, 2010 Hepregen Corporation Receives SBIR Phase II Grant from the National Science Foundation and Presents Corporate Update at OneMedForum.

Hepregen Corporation, a leading provider of bioengineered solutions for drug development, announced today that it has received a Phase II SBIR grant from the National Science Foundation for $500,000. This latest award, in addition to the company’s receipt of a prestigious Challenge Grant from the National Institutes of Health (NIH), along with earlier grant awards, approaches $2.0M in federal funding. Hepregen will also be a featured speaker this afternoon at OneMedForum, where CEO Bernadette (Bonnie) Fendrock will highlight the company’s successful progress since its Series A financing in 2008 from Battelle Ventures, as well as outline important milestones for 2010 and beyond. PDF

February 25, 2009 Battelle Ventures Spins Out Life Science Company from MIT, Committing $5 Million in Series A Funding to Hepregen Corp.

Battelle Ventures, LP, has spun out Hepregen Corporation from the Massachusetts Institute of Technology (MIT), with a commitment of a $5-million Series A investment from the fund and its Tennessee affiliate, Innovation Valley Partners. The company, which is developing bioengineered solutions for drug development, received the first $3 million from the funds last summer, leaving an additional $2 million committed and available at management’s request. PDF

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