Incuron Announce Notice of Allowance from FDA to Commence Clinical Testing with CBL0137.


Incuron, a joint subsidiary of the Bioprocess Capital Ventures closed-end investment fund and Cleveland BioLabs, Inc. (NASDAQ:CBLI), today announced the receipt of a Notice of Allowance from the U.S. Food and Drug Administration (FDA) for an Investigational New Drug (IND) application for CBL0137.

A multi-center, Phase 1, single agent, dose escalation trial evaluating intravenous administration of CBL0137 in patients with metastatic or unresectable advanced solid cancers is being finalized with the FDA. The primary objective of the study is to determine the maximally tolerated dose and recommend a Phase 2 dose for CBL0137 in these patients. Secondary objectives include describing the dose limiting toxicity, adverse event and pharmacokinetic profile of CBL0137, as well as documenting any objective responses. Exploratory objectives for the study include examining the relationship between tumor expression of Facilitates Chromatin Transcription (FACT), the molecular target of CBL0137, tumor response and the effect of CBL0137 on FACT expression in peripheral blood mononuclear cells and on soluble factors in serum.

A Phase 1, single agent, dose escalation study of oral administration of CBL0137 in patients with advanced solid tumors that are resistant or refractory to standard of care treatment is ongoing in the Russian Federation.

"We’re pleased to announce that we’re going to launch investigation of a new drug – CBL0137 – in the USA. Now we’re holding Clinical Trial in Russia with a peroral form that’s why the intravenous form-based trial in the USA will help us open new horizons", says Andrey Leonov, Incuron's CEO. "We’ve lately received some promising data related to the expression of the FACT protein complex, and during these initial US and Russia-based phases of the clinical trial we hope to obtain additional information on how CBL0137 influences the level of expression. These results will allow us to effectively plan further clinical development of CBL0137."

"Permission by the FDA to hold the survey of an innovative molecule in the USA received by a Russian start-up is an exceptional case among Russian companies. We’re proud of this achievement – it makes us even more confident in the future success of the Clinical Trial", says Vladimir Tezov, CEO of Bioprocess Capital Partners LLP Managing Company.

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