Outsourcing brings Neovacs to cusp of Ph III partnership
With fewer than 30 employees Neovacs has been reliant on cost-effective use of vendors to develop its pipeline of cytokine-based products. It now has products for three indications, rheumatoid arthritis, Crohn’s disease and lupus, in the clinic and is looking to partner for the push into Phase III.
“We don’t intend to do late stage development on our own”, Piers Whitehead, vice president of corporate development at Neovacs, told Outsourcing-Pharma. Phase II data will see Neovacs reach a “tipping point” at the end of 2011, leading to ongoing discussions becoming more serious.
To reach this point Neovacs has worked with a network of contract research and manufacturing organisations (CRO, CMO). Working with multiple providers has ensured no one external partner has all Neovacs’ know-how, Guy-Charles Fanneau de La Horie, CEO of Neovacs, told Outsourcing-Pharma.
Clinical trials for TNF-Kinoid are being handled by one CRO, although Neovacs is free to work with other providers. Patient enrolment into the rheumatoid arthritis Phase IIa trial is now complete, but recruitment for the Crohn’s disease study has progressed slower than expected, Fanneau said.
Both trials look at patients that have developed a resistance to TNF-inhibitors. France-based Neovacs believes its active immunotherapy approach, which produces a polyclonal antibody response, can help patients who have developed resistance to other treatments.
For its other product in clinical trials, IFNα-Kinoid for treating lupus, Neovacs is looking at the drug’s impact on a specific biomarker. At this stage Neovacs is not recruiting based on the presence of the biomarker, but may consider enrolling a more targeted cohort in later stage development.
Dedicated limpet capacity
In each of Neovacs’ development products a cytokine is chemically linked to a carrier protein, keyhole limpet hemocyanin (KLH), to trigger an immune response. “KLH plays a major role”, Fanneau said.
Neovacs has secured KLH supply through a deal with Stellar Biotechnologies. “We’ve a dedicated herd of limpets”, Fanneau said. Stellar looks after the limpets at its aquaculture site in California, in effect giving Neovacs dedicated KLH capacity that is supplied to two CMOs for formulation.
Fanneauexpects the limpet herd to continue meeting Neovacs’ KLH supply needs for the next few years. Commercialisation of KLH-based products in development at Neovacs and other companies will increase demand, but following talks with Stellar Fanneau is confident output can be scaled-up.
