Shares in Cleveland BioLabs Inc (NASDAQ:CBLI) shot up over 53% as the FDA gave it the go-ahead for a biocomparability study on entolimod and the European Medicines Agency (EMA) accepted its pediatric investigation plan (PIP) for the candidate.
The latter point paves the way for submitting a Marketing Authorization Application (MAA) for it as a medical radiation countermeasure.
The biotech's flagship product is being developed to mitigate the life-threatening consequences of a radiological or nuclear attack.
In the US, the FDA has now completed a review of a side-by-side analytical comparison of two formulations of entolimod and agrees with Cleveland BioLabs that the data shows the in vitro analytical comparability of the formulations.
The aim of this study is to compare the historical drug formulation used in prior nonclinical and clinical studies versus the to-be-marketed drug formulation of entolimod submitted for approval under CBLI's application for pre-Emergency Use Authorization (pre-EUA).
Meanwhile, as part of the regulatory process for submitting an MAA in the Europe, pharma firms must provide a PIP outlining their strategy of the new medicinal product in children.
Yakov Kogan, the group's chief executive officer, said: "We are excited to have received a positive opinion from the EMA on our PIP. In addition, we have held a series of encouraging meetings with the EMA concerning our MAA submission. We look forward to continuing our discussions with the agency as we move forward with the MAA
Separately, he said: "Following completion of the in vivo study and discussion of the submitted study results with the FDA, we expect the agency to resume the review of our pre-EUA dossier."
The planned study is funded in part by the Department of Defense (DoD) Joint Warfighter Medical Research Program (JWMRP).
This contract is valued at up to $9.2 million and supports further development of entolimod as a medical radiation countermeasure.
Cleveland shares rose 53.21% to $2.39.