AyuVis, a Fort Worth-based healthcare startup, has received a $2.1 million National Institute of Health research grant from the National Heart, Lung, and Blood Institute to fund a first-in-human Phase 1 clinical trial of a new generation of immunotherapies.
This is the fourth NIH grant AyuVis has received since its founding in 2014, doubling its total non-dilutive funding to $4.2 million. The NHLBI is the third largest institute of the NIH in the U.S. Department of Health and Human Services.
Ayuvis Co-Founder and CEO Dr. Suchismita Acharya said she’s excited that her company is moving its lead compound into a human trial.
“This is a huge milestone for AyuVis,” Acharya said in a statement, “and we are one step closer to making a significant difference in saving lives, which was my passion and vision when I started the company nine years ago.”
A new generation of immunotherapies
AyuVis is developing a new generation of immunotherapies, including AVR-48, which provides a well-balanced outcome where mild activation and controlled suppression of the immune system is needed to effectively treat disease, rather than simply activating or suppressing the immune response.
This immunotherapy process allows the drug to control inflammation and infection.
“There is a critical unmet need for a safe, effective, and affordable drug for acute and chronic inflammatory and infectious diseases,” Acharya said. “We’ve assembled an excellent clinical team and clinical research organization. Together we look forward to moving our first compound in the pipeline to the clinic while continuing research on additional drug candidates.”
First clinical trial and first targets for immunotherapy
[Image: chaunpis/istockphoto]
AyuVis said the grant will help it advance to the next level and become a clinical-stage pharmaceutical company.
The company said the first human Phase 1 clinical trial with healthy adults will assess the safety of AVR-48, the new anti-inflammatory and anti-infective small molecule immunotherapy, and will enable Phase 2 clinical trials for multiple AyuVis development programs.
AyuVis said its first target indication is preventing bronchopulmonary dysplasia (BPD), a chronic lung disease in preterm babies where there are no available FDA-approved therapies. Subsequent medically needed indications include the treatment of acute respiratory distress syndrome (ARDS) and ventilator-associated pneumonia (VAP).
Last year, we told you about AyuVis receiving its second patent in a three-month period for immunotherapy treatments that protect pre-term babies from BPD.
The second patent approval from the U.S. Patent and Trademark Office specifically protects AVR-48.
The AVR-48 patent has also been approved in Australia and is under examination in several other international jurisdictions.
How AyuVis immunotherapies work
Dr. Suchismita Acharya [Photo: AyuVis]
AyuVis said that white blood cells are the body’s first line of defense against inflammation and infection and that its immunotherapy is based on a technology of modulating circulating macrophages (white blood cells) to quickly and simultaneously balance the immune system’s response to inflammation and infection.
Because the anti-microbial activity is through boosting phagocytosis—when white blood cells surround and destroy foreign substances, such as bacteria, and remove dead cells—AyuVis expects its therapies to work well with multiple drugs.
Large animal studies of AVR-48 have shown it can promote new lung cell growth and prevent tissue injury that could be caused by hyper-inflammation.
Experience in research and clinical trials
Acharya will be the principal investigator leading the grant.
She has more than 25 years of experience as a pharmaceutical scientist in drug discovery and development with large and small pharmaceutical companies, including Alcon Labs and Novartis, where she led drug development projects and commercialized products.
AyuVis said that Acharya has been highly successful in securing multiple grant fundings from the NIH in the past five years to progress projects from early pre-clinical animal research to human clinical trials.
AyuVis, a member company of nonprofit technology business incubator and accelerator TechFW, is a portfolio company of the Cowtown Angels, an angel investor network affiliated with TechFW; a partner in the University of North Texas HSC Next Innovation Labs; and a participant in the Small Business Innovation Research (SBIR) Phase 0 grant writing program at HSC Next.
Core AyuVis team members are David Riley, MD, MBA, Chief Medical Officer; Mariam Morris, MS, CPA, CFO; Dale Christensen, PhD, Director of Early Development; Stella Robertson, PhD, Drug Development Advisor; William Dean, PhD, Head of Chemistry, Manufacturing and Controls (CMC); Russell Bromley, Director of Operations; Ranjan Misra, Business Advisor; and Sarah Wright, Sr. Operations Manager.
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