Janssen Pharmaceuticals has given Cidara Therapeutics an Election to Proceed Notice for the continued development of CD388 for the prevention of influenza A and B.
The news comes within the required 90-day period that allows Janssen to retain the development and commercialisation rights for CD388. In July, Cidara announced that its partnership with Janssen was still in effect despite the latter's plans to discontinue the development of JNJ-0953 (CD388).
CD388 is a drug-Fc conjugate (DFCs) immunotherapy developed using Cidara’s proprietary Cloudbreak platform. Cidara states that CD388 is not a vaccine but acts by inhibiting viral proliferation and allowing for immune-mediated viral clearance, which, as per the company, provides an advantage over current flu vaccines.
The announcement led to an 18% increase in Cidara’s stock price at market open on 6 September, compared to market close on the previous day.
Despite retaining ownership of CD388, Janssen is not planning to add the drug to its portfolio, but rather transfer CD388’s rights and obligations to a third party.
The Election to Proceed also unlocks $7m in milestone payments for Cidara. The US-based company is also in line to receive up to $685m in milestone-based payments and royalties from the CD388 influenza programme.
CD388 received a fast track designation by the US Food and Drug Administration (FDA) in June. It is currently being investigated in two Phase I studies (NCT05285137 and NCT05619536) and one Phase IIa (NCT05523089) trial, with all the trial costs being reimbursed by Janssen.
The interim analysis of the Phase IIa data showed a decrease in influenza virus replication with a single dose of CD388. Additionally, the CD388 treatment group reported lower influenza incidence rates, compared to the placebo arm.
There were no treatment-associated adverse events or trial discontinuations. Cidara expects to deliver complete Phase IIa data to Janssen by the end of 2023.
The development of influenza vaccines has seen an uptick in recent years, with two vaccine candidates currently in Phase II clinical development. Osivax’s OVX836 is currently being evaluated in combination with quadrivalent influenza vaccines (QIVs) in a Phase IIa study (NCT05734040). Imutex’s Flu-v, T-cell vaccine is being evaluated for preventing H1N1, and influenza A and B.
