Specialist contract research organization hVIVO (HVO) has reached a major milestone in its development efforts by announcing a partnership with a North American biopharmaceutical company to develop a human metapneumovirus (hMPV) challenge model.
"We are delighted to be developing the industry's first commercial hMPV human challenge model”, said hVIVO's CEO, Yamin 'Mo' Khan, adding, "This is really a significant milestone for the company... It meets our goal and our objectives to continue to grow the diversity in the portfolio of our challenge models."
The client, a US biotech company and existing customer, chose the human challenge model approach because running studies on hMPV in the field would have required a large number of patients to determine the drug's efficacy.
However, hVIVO's unique human challenge model allows for a more efficient testing process. Mr Khan explained, "For these types of trials or viruses, it actually makes logical sense before you spend the big bucks in conducting a large phase three study to get efficacy data...before you actually propagate and do the phase three trial."
hMPV is a respiratory virus closely related to the respiratory syncytial virus (RSV), primarily affecting young infants, the elderly, and immunocompromised individuals, and leading to over 16,000 deaths worldwide in children under the age of five each year. Currently, there is no approved vaccine or antiviral treatment available for hMPV. The development of a vaccine and antiviral for hMPV is crucial, and hVIVO's collaboration positions them at the forefront of this effort.
Dr Andrew Catchpole, Chief Scientific Officer of hVIVO, emphasized the significance of their expertise in providing a full human challenge service. He stated, "hVIVO's unique expertise and world-leading capabilities enable us to provide our clients with a full human challenge service offering, including the development of bespoke challenge models. As demonstrated with RSV, hVIVO can also play a vital role in speeding up drug development for hMPV, which currently has no approved vaccine or antiviral treatment."
The process of bringing the hMPV challenge model to fruition will involve three distinct steps. First, hVIVO will undertake Good Manufacturing Practice (GMP) compliant virus manufacturing activities to produce the virus at a clinical-grade level. The manufacturing process is expected to be completed in the first half of 2024.
Following that, a characterisation study will be conducted to determine a safe and infectious dose of the wild-type hMPV in up to 36 healthy adult volunteers. Upon successful completion of the characterisation study and regulatory approvals, hVIVO plans to proceed with hMPV challenge trials in the second half of 2024.
Most of the revenue from this comprehensive human challenge service is expected to be recognized in 2024, adding to an already healthy order book that Mr Khan noted gives the company visibility well into next year.
This collaboration not only marks a significant milestone for hVIVO but also holds great promise for the pharmaceutical industry as a whole. The utilization of the human challenge model approach allows for expedited drug development, providing tangible data and potentially accelerating the availability of vaccines and antiviral treatments for hMPV. "The human challenge market is definitely increasing,” said Mr Khan, noting that drug developers are increasingly recognising their value in "getting drugs to market and into patients faster".
The author holds shares in hVivo