Cleveland BioLabs and Incuron Announce Start of US Trial With CBL0137

Cleveland BioLabs, Inc.

and Incuron, LLC, a joint venture between the Company and Bioprocess Capital Ventures, today announced that a multi-center, Phase 1, single agent, dose escalation trial evaluating intravenous administration of CBL0137 in patients with metastatic or unresectable advanced solid cancers and lymphomas is open for enrollment and that treatment of the first patient has been initiated. 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. FACT expression will also be tested on patient's tumor tissue retrospectively to determine if the tumor signal can help guide patient selection for future studies. The Company recently announced the publication of studies describing FACT as an accelerator of tumor transformation and a potential marker and target for aggressive cancers in Cell Reports. The published work concluded that FACT's role in cancer likely involves selective chromatin remodeling of genes that stimulate proliferation, inhibit cell death and differentiation, and regulate cellular stress responses, making it an enabler of oncogene-induced transformation. Further studies are underway to determine if this biomarker can serve as a companion diagnostic to screen patients for CBL0137 treatment. Jean Viallet, M.D., Chief Development Officer at Cleveland BioLabs, commented, "We are excited to have a second study with CBL0137 underway. The role of FACT as an enhancer of oncogenic transcription supports the clinical potential for CBL0137." Additional information about the trial may be found at: www.clinicaltrials.gov. 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. About Cleveland BioLabs, Inc. Cleveland BioLabs, Inc. is a clinical-stage biotechnology company leveraging deep mechanistic understanding of the cell death process, apoptosis, to develop a robust pipeline of compounds primarily focused on oncology applications and mitigation of radiation injury. The Company's lead compound is being developed as both a radiation countermeasure and a cancer treatment. The Company has two operating subsidiaries, Incuron, LLC, and Panacela Labs, Inc., and strategic relationships with the Cleveland Clinic, Roswell Park Cancer Institute, the Children's Cancer Institute Australia and the Armed Forces Radiobiology Research Institute. To learn more about Cleveland BioLabs, Inc., please visit the Company's website at http://www.cbiolabs.com.