Genome Protection Announces Publication of the Next Generation Deimmunized TLR5 Agonist, GP532

The substantially improved pharmacological profile of GP532 opens new opportunities for broader therapeutic applications of this class of pharmaceuticals

BUFFALO, NY / ACCESSWIRE / April 14, 2021 / Genome Protection, Inc. (GPI), a joint venture between Cleveland BioLabs, Inc. (NASDAQ:CBLI) and Everon BioSciences, LLC, an innovative biopharmaceutical company focused on developing medical interventions to prevent and treat aging and age-related diseases, announces a publication in Communications Biology, a journal of Nature portfolio, describing the creation, properties and preclinical validation of efficacy of a new deimmunized and pharmacologically optimized Toll-like receptor 5 (TLR5) agonist, named GP532.

The article demonstrates potency of GP532 for prophylaxis and treatment of acute radiation syndrome (ARS) in preclinical models. The therapeutic potency of GP532 is expected not to be affected by neutralizing antibodies developing in humans following administration of the first generation TLR5 agonist entolimod, which has been an obstacle for broadening medical applications of TLR5 agonists beyond radiation countermeasure. Therefore, GP532 could be projected for disease indications requiring long-term repeat administration.

Andrei Gudkov, Ph.D., D.Sci, CBLI’s and GPI’s Chief Scientific Officer and co-author on this article said: “Clinical exploration of multiple valuable applications of TLR5 agonists demonstrated in preclinical studies has been slowed down by the residual immunogenicity of this class of prospective therapeutic agents, derivatives of bacterial protein flagellin. Guided by the results of structural and functional analyses, our team was able to eliminate all major immunogenic B- and T-cell epitopes regardless of the presence of antibodies.”

“Development of GP532 indicates a potential breakthrough in expanding medical applications of TLR5 agonists towards clinical scenarios which may require chronic long-term administrations, something what has not been possible before,” continued Dr. Gudkov. TLR5 agonists in the GPI’s drug portfolio are being developed to treat such aging-related pathologies as idiopathic pulmonary fibrosis and immunosenescence – a commonly occurring decline in immune functions.”

“The radioprotective program of CBLI will also benefit from GP532 since this new generation TLR5 agonist is expected to be efficacious in a subpopulation of about 10% of people who carry neutralizing antibodies against flagellin and cannot benefit from radioprotective activity of entolimod,” added Dr. Gudkov.

The Investigational New Drug (IND) – enabling preclinical development of GP532 for the treatment of idiopathic pulmonary fibrosis (IPF) is supported in part by a $3M grant recently awarded to the company by the US Department of Defense (DoD) via the Congressionally Directed Medical Research Program (CDMRP) the Peer Reviewed Medical Research Program (PRMRP).

Reference: https://www.nature.com/articles/s42003-021-01978-6 .

About Genome Protection, Inc.
Genome Protection, Inc. is a clinical-stage biopharmaceutical company focused on developing medical interventions to prevent and treat aging and age-related diseases. The Company’s technologies are based on deep insights in the intrinsic mechanisms leading to genomic instability, impairment of immunity (“immunosenescence”), and systemic inflammation (“inflammaging”) in aging. Genome Protection develops drugs that counteract these mechanisms, including TLR5 agonists entolimod and GP532, that are projected to improve immune functions in the elderly. The Company is also applying its broad research and development capabilities to fuel a sustainable pipeline of innovative small-molecule and immunotherapeutic drug candidates that target intrinsic mechanisms underlying genomic instability in somatic tissues during aging and cancer progression and driven by the activity of endogenous retroelements (‘retrobiome’). To learn more about Genome Protection, Inc., please visit www.genomeprotection.com.

About Cleveland BioLabs, Inc.
Cleveland BioLabs, Inc. is an innovative biopharmaceutical company developing novel approaches to activate the immune system and address serious medical needs. Cleveland BioLabs’ proprietary platform of Toll-like immune receptor activators addresses conditions such as radiation sickness and cancer treatment side effects. Cleveland Biolabs’ most advanced product candidate, Entolimod is being developed as a medical radiation countermeasure for preventing death from acute radiation syndrome and, through its joint venture with Everon Biosciences, LLC – Genome Protection, Inc. – for other anticancer and antiaging indications. Additionally, Cleveland BioLabs also conducts business in the Russian Federation through a joint venture with Joint Stock Company RUSNANO, Panacela Labs, Inc. Cleveland BioLabs maintains strategic relationships with the Cleveland Clinic and Roswell Park Cancer Institute. To learn more about Cleveland BioLabs, please visit www.cbiolabs.com.

SOURCE: Cleveland BioLabs, Inc

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