Shots: 

• Following Qnovia’s recent partnership with the University of Virginia, Brian Quigley engages in a stimulating conversation with PharmaShots  

• The collaboration adds two assets, QN-05 for the treatment of pneumonia and QN-06 for the treatment of pulmonary infection caused by B. anthracis, to Qnovia’s portfolio  

• During a discussion of Qnovia's proprietary drug delivery platform RespiRx, Brian revealed that the collaboration aims to identify additional indications where pulmonary delivery could improve patient outcomes  

Saurabh: Give us a broad overview of the UVA collaboration. 

Brian: The objectives of the collaboration between Qnovia and UVA are to identify high-priority use cases where the combination of the University's peptide portfolio and Qnovia's inhaled drug delivery platform can achieve meaningful impacts on treatment for infections caused by specific strains of antibiotic-resistant bacteria. The initial work we completed was focused on aerosolization stability, efficiency, and efficacy post-aerosolization. Our focus moving forward is to advance both the safety and efficacy studies to advance to engagements with the FDA as part of the NDA process.  In addition to advancing the assets we've announced, we will continue to conduct studies identifying additional indications where inhaled delivery of UVA's peptides using our drug delivery platform can demonstrate positive outcomes for patients. 

Saurabh: Can you let us know more about the assets QN-05 & QN-06 & their current developmental status? 

Brian: We've completed the feasibility studies for delivering UVA's lead peptide in our device and we've demonstrated in-vitro efficacy.  This year in working with UVA on QN-05 and QN-06 we expect to complete drug product formulation and to advance to initial in-vivo studies.  Upon the completion of those studies, we will begin engagements with the FDA under the NDA process. 

Saurabh: How will this collaboration with the University of Virginia help with the development of the drug? 

Brian: While the research team at UVA has strong data demonstrating the efficacy of the lead peptide in the portfolio, as we explore additional areas of indication focused on pulmonary infection we expect UVA to continue to optimize the peptide portfolio to expand indications and to improve efficacy. 

Saurabh: Tell us more about your proprietary platform RespiRx. It is remarkable, can we talk about its application to improve the treatment of asthma, COPD & other respiratory infectious diseases? 

Brian: Our drug delivery platform is unique in that it leverages proven medical technology (nebulization) for delivering drugs to the lung via inhalation while optimizing the design to be truly convenient, and portable and there is no cleaning and maintenance required.  Across the other indication areas, we are developing, we've identified 11 APIs that can be delivered via nebulization but where we have the potential to improve efficacy, improve bioavailability, and where direct delivery to the lung can potentially reduce side effects. 

Saurabh: How does inhalation-based technology improve patient outcomes by addressing many of the drawbacks of conventional pharmaceutical medication delivery methods?  

Brian: There are three main advantages of inhaled delivery of the UVA peptide portfolio, including: 

• By directly delivering the antibiotic to the site of the infection in the lung, we expect to reduce the side effects of delivering antibiotics via other routes of administration. 

• Given the risks of increased antibiotic resistance, targeted delivery to the lung could allow for dose sparing and thus achieve efficacy without increased antibiotic resistance. 

• We can also mitigate unnecessary delivery to other organs 

Saurabh: As the company decided to continue the exploration of UVA's bactericidal peptides utilizing Qnovia's drug delivery technology, is there anything more lined up apart from QN-05 & QN-06 in terms of indication?

Brian: Yes, as part of our collaboration one goal will be to identify additional indication areas where pulmonary delivery can yield improved patient outcomes. Given the broad efficacy UVA has demonstrated, we do expect additional indication areas to be announced as we replicate the feasibility and in-vitro studies that we've completed for qn-05 and qn-06. 

Saurabh: Are you planning to develop more molecules under this collaboration, or you are exploring other delivery methods with a respiratory portfolio for the future?  

Brian: As part of our collaboration, UVA will continue to identify opportunities to expand on the IP portfolio with continued improvements to the peptide library. All of our work in this collaboration will be focused on pulmonary delivery. 

Image Source: Canva 

About the Author 

Brian Quigley  

Brian Quigley has 25 years of marketing, regulatory, operations, and general management experience for public companies, private equity-backed businesses, and venture-backed businesses. He developed a focus on inhalation devices through his time in tobacco, which gave him an understanding of the risks of tobacco use, the opportunity to reduce risks for smokers, and the current generation of technologies. 

Brian is currently Chief Executive Officer for Qnovia, Inc., a California venture-backed health technology company focused on commercializing proprietary inhalation device technologies to improve patient outcomes. Qnovia is currently engaged with FDA CEDR to pursue a combination product authorization as the first inhalable prescription smoking cessation therapy.  

Prior to Qnovia, Brian spent 16 years at Altria Group, with seven years as President & CEO for Altria’s Smokeless and Innovative Products/Vapor Businesses. Brian has also been an active venture investor in both the cannabis and alcohol spaces, and he sits on the boards of Mustgrow Biologics and Belle Isle Craft Spirits. He lives in Richmond, VA, with his wife Amy, and three sons. 

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