Second Drug Candidate to Receive QIDP Designation for Vast
DURHAM, NC – October 8, 2019 – Vast Therapeutics, Inc., a subsidiary of KNOW Bio, LLC, today announced that another of its drug candidates, BIOC11, has been designated as a “Qualified Infectious Disease Product” (QIDP) by the U.S. Food and Drug Administration. Vast is a preclinical-stage pharmaceutical company focused on treating respiratory infections through the power of nitric oxide (NO) in a synthetically derived powder-based form. The QIDP designation, granted for treatment of chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis, will make BIOC11 eligible to benefit from certain incentives for the development of new antibiotics provided under the Generating Antibiotic Incentives Now Act (GAIN Act). These incentives include priority review and eligibility for fast-track status. Further, if ultimately approved by the FDA, BIOC11 is eligible for an additional five-year extension of market exclusivity.
“We are very pleased that the FDA has granted QIDP designation to BIOC11,” said Mark Schoenfisch, President and CSO of Vast Therapeutics. “BIOC11 reflects an advanced platform for the delivery of nitric oxide and demonstrates that our nitric oxide-releasing pipeline is deep with additional candidates. Chronic, persistent lung infections continue to increase in frequency and are a major
factor impacting the quality of life and untimely mortality of patients across a broad spectrum of diseases. The QIDP designation will accelerate the advancement of BIOC11 regulatory approval as a potential treatment for these patients.”
The QIDP designation was created by the Generating Antibiotic Incentives Now (GAIN) Act and creates incentives for the development of certain antibiotics that treat serious or life-threatening infections. The primary incentives are an additional five-year extension of Hatch-Waxman Act exclusivity, as well as priority FDA review of the first marketing application or efficacy supplement for BIOC11 and the indication for the QIDP designation with an opportunity to request Fast Track designation for BIOC11
“The designation of BIOC11 to QIDP status is yet another achievement for Vast and the KNOW Bio group,” said Neal Hunter, CEO and Chairman of the Board of Vast Therapeutics and Managing Director of KNOW Bio, LLC. “This designation for a new materials system underscores our commitment to foundational drug product technology. The QIDP success should decrease the timeline to serve our patients and deliver value to our shareholders.”
Vast Therapeutics is based in the Research Triangle Park area of North Carolina and runs a leveraged drug development model using a small team with high quality service contractors and suppliers.
About Vast Therapeutics, Inc.
Vast Therapeutics, a subsidiary of KNOW Bio, LLC, is an innovative, preclinical-stage pharmaceutical company focused on helping people who suffer from severe respiratory diseases to breathe better and live life more fully. The Company is initially focused on developing a nitric oxide-based drug to treat cystic fibrosis patients battling chronic Pseudomonas aeruginosa infections. The Company anticipates submitting an investigational New Drug application and initiating First-in-Human clinical trials in 2019. More info available at www.vasttherapeutics.com.
About Mark Schoenfisch, PhD
Mark Schoenfisch, PhD is President and Chief Scientific Officer of Vast Therapeutics and a Professor of Chemistry at the University of North Carolina at Chapel Hill. Mark is an active entrepreneur and the inventor of multiple macromolecular nitric oxide-release systems, guiding technologies from research discoveries to manufacturing and clinical trials. With 20 years of experience working with nitric oxide chemistry, Mark has published more than 100 peer-reviewed articles describing the synthesis, characterization, and application of nitric oxide-modified biomaterials. Prior to his current role, Mark co-founded Novan, Inc., where he helped guide the company to its IPO as a member of its Board of Directors.
About Neal Hunter
Neal Hunter is CEO and Chairman of the Board of Vast Therapeutics, Inc. and Managing Director of KNOW Bio, LLC. Prior to his current roles, Neal developed a 25-year track record of successfully raising capital for and building technology companies in the public and private markets, including co-founding Cree, Inc. and LED Lighting Fixtures, Inc. Neal also served as co-founder, co-founding investor or founding investor in over ten significant start-up ventures in the areas of semiconductor materials and devices, aesthetic materials, software, commercial and residential real estate, LED lighting systems and life sciences, where he developed his proven expertise in technology transfer, from inception of innovations to the creation of market-changing products.
Except for historical information, all of the statements, expectations, and assumptions contained in this press release are forward-looking statements. Actual results might differ materially from those explicit or implicit in the forward-looking statements. Important factors that could cause actual results to differ materially include: risks associated with the drug development process; reliance on key personnel; the early stage of our business and our need to raise additional capital to complete development of our drug candidates; competition; and other risks described in other Company press releases and presentations. KNOW Bio and VAST Therapeutics assumes no obligation and does not intend to update these forward-looking statements, except as required by law.
Darlene Dendy, Vice President of Administration
John Oakley, Chief Financial Officer
Follows $25 Million in Corporate Commitment Last December
Company’s Novel Anti-Infective Has Robust Runway
Durham, N.C., May 15, 2019 /PRNewswire/ -- KNOW Bio, LLC, (the Company or KNOW Bio), an RTP based conglomerate of biotechnology and MedTech companies, announced today that the Company has completed its next round of financing with a single investor, Reedy Creek Investments, LLC (Reedy Creek).
The financing provides $30 million in additional funds for research & development and general operations. Vast Therapeutics, one of the Company’s majority owned subsidiaries, is working on a range of products with the top objective to deliver solutions to battle respiratory infections in patients with cystic fibrosis (CF). Currently, 80% of the CF population will succumb to infections in what is now an average lifespan of 40 years. The Company has eradicated 29 strains of Pseudomonas aeruginosa (PA), the primary pathogen that causes the majority of exacerbations in CF patients. At all ages, CF patients are at risk of being hospitalized for months at a time using antibiotics capable of only managing the PA infection. The Company’s therapeutics in development have shown efficacy in both in vitro lab testing and in animal models including the ability to eradicate the aggressive bacteria from the sputum of actual CF patients.
Neal Hunter, CEO and Chairman of the Board of Managers of KNOW Bio stated “The ability to partner with Reedy Creek is a real benefit for our company and prospective patients. With this investment, our team will push forward advancement of our research in nitric oxide-enabled technologies at a more rapid pace as we have a duty to get this promising technology into patients of need. Our objective is to completely disrupt the paradigm of treating infections, especially antibiotic-resistant bacteria. We believe our technology can solve a major problem at a time when that problem is creating a dire situation for public health. This investment will allow us to take multiple drug candidates forward in parallel and complete studies at a faster pace bringing a solution to those in need much more quickly. We look forward to the great things ahead for our Company, investors and most importantly, those prospective patients.”
John Oakley, the Company’s CFO added, “It’s an important time at KNOW Bio. We have now matched our technical innovation with strong financial execution that can allow us to execute a multi-year, robust plan across our subsidiaries. While our plan is to build out teams for each operating company and add needed equipment and facilities, we will continue to operate using a strategy of leveraging our small team with effective partners. Such a system utilizes capital more efficiently by keeping fixed costs low while maximizing productivity.”
KNOW Bio is expanding its team in selected high impact areas by initiating searches for a Vice President of Drug Development, Chief Medical Officer, Clinical Operations Specialist, B2C Sales Director for Medical Devices and a Controller for the combined group. Contact the Company if you would like to join this fast-paced team to bring needed solutions to today’s world.
About KNOW Bio, LLC
KNOW Bio, LLC is a life science company focused on using its extensive intellectual property developed internally as well as licensed patents and applications in the field of nitric oxide across a vast majority of therapeutic applications to redefine the standard of care in a number of diseases and conditions. Vast Therapeutics, Inc. (www.vasttherapeutics.com) and PhotonMD, Inc. (www.photonmd.com) are two companies that have emerged from the KNOW Bio platform. Corporate strategy involves forming subsidiaries to focus on specific diseases and conditions, assemble teams of experienced personnel in each and incentivize them to succeed by granting them equity in their respective subsidiary, with KNOW Bio retaining controlling ownership of each unless and until an appropriate opportunity for a subsidiary sale, IPO or other financing makes sense.
About Neal Hunter
Neal Hunter, Chairman of the Board and CEO of Vast Therapeutics, has a 25-year track record of successfully raising capital for and building technology companies in both the public and private markets beginning as a Co-founder of Cree, Inc. Mr. Hunter served multiple roles at Cree, including as the public company CEO and Chairman from 1994 to 2001 and then Chairman until 2005. He was also instrumental in the creation and start-up of LED Lighting Fixtures, Inc. which he co-founded in 2005 to accelerate the use of LEDs in general illumination applications and sold in 2008 for over $100M. In total, Mr. Hunter has been either co-founder, founder, co-founding investor or founding investor in over ten significant start-up ventures in the areas of semiconductor materials and devices, aesthetic materials, software, commercial and residential real estate, LED lighting systems and life sciences. Mr. Hunter’s proven expertise in technology transfer, from inception of innovations to the creation of market-changing products, has led to the transition to his new role as Managing Director of KNOW Bio.
Except for historical information, all of the statements, expectations, and assumptions contained in this press release are forward-looking statements. Actual results might differ materially from those explicit or implicit in the forward-looking statements. Important factors that could cause actual results to differ materially include: risks associated with the drug development process; reliance on key personnel; the early stage of our business; competition; and other risks described in other Company press releases and presentations. KNOW Bio and its subsidiaries assume no obligation and do not intend to update these forward-looking statements, except as required by law.
Darlene Dendy, Director of Administration
John Oakley, Chief Financial Officer
Vast Therapeutics Announces Funding from Cystic Fibrosis Foundation for Further Development of BIOC51
Vast Therapeutics (formerly Novoclem) Announces Results Showing Eradication of all In Vitro Tested Multi-Drug Resistant Bacteria and a 99% Reduction of Nontuberculous Mycobacteria (NTM) in Animal Model.