Statera BioPharma
An American clinical-stage biopharmaceutical company focused on novel immunotherapies.
Last updated August 25, 2026
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Overview
Statera BioPharma, Inc. is an American clinical-stage biopharmaceutical company focused on developing immunotherapies for autoimmune and inflammatory diseases, infectious diseases, and cancer. The company was formed in 2021 through the merger of Cleveland BioLabs, Inc. and Cytocom, Inc., after which the combined business adopted the Statera BioPharma name. Its corporate history therefore combines Cytocom's clinical-stage immunotherapy activities with Cleveland BioLabs' earlier work in oncology, host protection, and medical countermeasures. Cleveland BioLabs was established in 2003 in partnership with the Cleveland Clinic and moved to the Buffalo Niagara Medical Campus in 2007. Before the 2021 merger, it built a research network involving the Cleveland Clinic, Roswell Park Comprehensive Cancer Center, the Children's Cancer Institute Australia, and the Armed Forces Radiobiology Research Institute. Its research programs emphasized compounds intended either to stimulate antitumor immune responses or to protect normal tissue following acute radiation exposure. The company's most advanced disclosed compound is Entolimod, formerly known as Protectan. Entolimod activates Toll-like receptor 5 and was investigated both as a radiation countermeasure and as a cancer therapy. The radiation-countermeasure program was designed around the U.S. Food and Drug Administration's animal efficacy pathway, which can permit development of certain products when human efficacy trials are not ethical or feasible. Its oncology development, by contrast, requires conventional clinical evaluation in human patients. Other disclosed programs included CBL0137 and CBL0102, compounds intended to interfere with the FACT protein complex and thereby affect several cancer-related pathways; CBLB612, an immune and tissue-protection compound based on TLR2/TLR6 activation; Revercom, a preclinical formulation involving the multidrug-resistance inhibitor Reversan; Mobilan, a nanoparticle-formulated non-replicating adenovirus; and Xenomycins, antimicrobial and antifungal compounds. Before the merger, Cleveland BioLabs also pursued development through joint ventures and licensing arrangements. Incuron was established with Russian investment partners to develop CBL0102 and CBL0137 for oncology applications. Panacela Labs was formed with Rusnano and research institutions including Roswell Park, the Children's Cancer Institute Australia, and the Cleveland Clinic Foundation. In 2009, Cleveland BioLabs assigned exclusive development and marketing rights for CBLB612 in China to Zhejiang Hisun Pharmaceutical Co. Ltd. In 2018, it entered a joint venture with Buffalo-based Everon Biosciences called Genome Protection Inc. to investigate possible anti-aging applications for Entolimod. Publicly described information presents Statera BioPharma primarily as a clinical-stage research company rather than a consumer-facing pharmaceutical brand. The available material identifies its therapeutic ambitions and development portfolio but does not establish a currently marketed product, a current headquarters, present ownership, or an active corporate status. Those points require verification from more recent regulatory filings or company disclosures.
History
Statera BioPharma emerged in 2021 from the merger of Cleveland BioLabs and Cytocom. The transaction brought together two clinical-stage biotechnology businesses with overlapping interests in immune modulation and therapies for serious disease. The merged company adopted the Statera BioPharma name and described its focus as the development of novel immunotherapies for autoimmune, inflammatory, infectious, and oncological indications. A substantial part of Statera's inherited scientific platform came from Cleveland BioLabs. That company was founded in 2003 in partnership with the Cleveland Clinic and relocated to the Buffalo Niagara Medical Campus in 2007. Its collaborations included the Cleveland Clinic, Roswell Park Comprehensive Cancer Center, the Children's Cancer Institute Australia, and the Armed Forces Radiobiology Research Institute. Cleveland BioLabs concentrated on drug candidates that could stimulate immune activity against tumors or reduce mortality and tissue damage after acute radiation exposure. Entolimod, previously called Protectan, became the best-known compound in the inherited portfolio. The molecule activates Toll-like receptor 5 and was investigated in two distinct development settings: as a radiation countermeasure under the FDA's animal efficacy rule and as a conventional human oncology therapy. The company also disclosed several other research programs. CBL0137 and CBL0102 were designed to affect the FACT complex, with reported downstream effects involving NF-kB, heat-shock-factor signaling, and p53 activation. CBLB612 was based on a natural immune-activating mechanism involving TLR2/TLR6. Revercom combined a liposomal formulation with Reversan, an inhibitor of the MRP1 multidrug transporter. Mobilan used a nanoparticle-formulated, non-replicating adenovirus, while the Xenomycins program addressed microbial and fungal targets. Cleveland BioLabs expanded its development model through partnerships, subsidiaries, and licensing. Incuron was created with Russian investment partners to develop CBL0102 and CBL0137 for cancer indications. Panacela Labs was established with Rusnano and research institutions including Roswell Park, the Children's Cancer Institute Australia, and the Cleveland Clinic Foundation. In 2009, Cleveland BioLabs granted Zhejiang Hisun Pharmaceutical exclusive rights to develop and market CBLB612 in China. In 2018, Cleveland BioLabs and Everon Biosciences created Genome Protection Inc. to examine potential anti-aging applications for Entolimod; the venture later received a reported US$10.5 million investment from Roman Abramovich. The available reference material does not document a marketed Statera product, current executives, a current corporate parent, or the company's present operating status. Statera is therefore best characterized from the available evidence as a clinical-stage biopharmaceutical brand whose identity is rooted in immune-based drug discovery and the scientific assets inherited from Cleveland BioLabs and Cytocom.
- 2021
Statera BioPharma is created
[1]Cleveland BioLabs merged with Cytocom, and the combined company adopted the Statera BioPharma name.
- 2018
Genome Protection joint venture is formed
[1]Cleveland BioLabs and Everon Biosciences formed Genome Protection Inc. to investigate possible anti-aging applications for Entolimod.
- 2011
Panacela Labs is established
[1]Cleveland BioLabs formed Panacela Labs with Rusnano and research partners to advance pharmaceutical research.
- 2010
Incuron is established
[1]Cleveland BioLabs and Russian investment partners established Incuron to develop CBL0102 and CBL0137 for oncology indications.
- 2009
China development rights for CBLB612 are assigned
[1]Exclusive development and marketing rights for CBLB612 in China were assigned to Zhejiang Hisun Pharmaceutical.
- 2007
Cleveland BioLabs moves to Buffalo
[1]The company moved to the Buffalo Niagara Medical Campus, strengthening its association with the Buffalo-area biomedical research community.
- 2003
Cleveland BioLabs is founded
[1]Cleveland BioLabs was founded in partnership with the Cleveland Clinic to pursue biotechnology research, including oncology and radiation-protection programs.
Products and positioning
Clinical-stage biopharmaceutical research focused on immunotherapies, oncology, inflammatory and infectious diseases, and radiation protection.
Radiation countermeasure and oncology immunotherapy
Entolimod
Entolimod, formerly known as Protectan, is an immune-modulating compound that activates Toll-like receptor 5. It was developed as both a potential medical countermeasure for acute radiation exposure and a cancer treatment. The radiation indication was pursued under the FDA animal efficacy framework, while the oncology program required human clinical development. The compound was intended to mobilize antitumor immune responses and protect normal tissues from radiation-related injury.
Oncology small molecule
CBL0137
CBL0137 is a small-molecule candidate designed to modulate the FACT, or facilitates chromatin transcription, complex. The reported mechanism affects several cancer-associated pathways, including suppression of NF-kB and heat shock factor 1 activity together with activation of p53. Preclinical antitumor effects were reported across a broad range of animal cancer models, but the available material does not establish a marketed product or a current development stage under Statera.
Oncology small molecule
CBL0102
CBL0102 is a quinacrine-based compound investigated for anticancer activity. Quinacrine has a long history of human use in other conditions, while the CBL0102 program focused on its interaction with the FACT complex and associated effects on NF-kB, heat shock factor 1, and p53 signaling. The compound showed activity in reported laboratory and xenograft studies involving several tumor types and was among the candidates assigned to the Incuron development venture.
Immune and tissue-protection compound
CBLB612
CBLB612 is a proprietary compound based on a natural activator of the TLR2/TLR6 receptor pair. It was designed to stimulate NF-kB signaling, support immune activation, reduce cell death, and promote tissue protection and regeneration. Cleveland BioLabs assigned exclusive Chinese development and marketing rights to Zhejiang Hisun Pharmaceutical in 2009.
Preclinical oncology therapy
Revercom
Revercom is a preclinical cancer-therapy concept consisting of a liposome-packaged formulation of Reversan. Reversan inhibits the multidrug transporter MRP1, a mechanism associated with resistance to chemotherapy. The program was intended to address tumor drug resistance rather than function as a conventional stand-alone cytotoxic treatment.
Cancer gene-therapy platform
Mobilan
Mobilan is a nanoparticle-formulated, recombinant, non-replicating adenovirus investigated as a broadly applicable cancer therapy. The available reference material identifies it as a platform candidate but does not provide sufficient information on clinical testing, commercial launch, or its status within the later Statera portfolio.
Antimicrobial and antifungal agents
Xenomycins
Xenomycins are a group of antimicrobial and antifungal candidates intended to target basic microbial transcription and replication processes by binding pathogen DNA. They represent the anti-infective portion of the inherited Cleveland BioLabs research portfolio.
Brand decisions
2021
Merger with Cytocom and corporate renamingM&ABackground
Cleveland BioLabs and Cytocom were both clinical-stage companies developing immune-related therapies.
Action taken
The companies merged and the combined organization changed its name to Statera BioPharma.
Aftermath
Statera presented itself as a biopharmaceutical company focused on immunotherapies for autoimmune, inflammatory, infectious, and cancer indications. Current corporate status and product commercialization are not established by the available reference.
2018
Creation of Genome Protection Inc.StrategyBackground
Cleveland BioLabs explored uses of Entolimod beyond radiation protection and oncology.
Action taken
It entered a joint venture with Everon Biosciences to investigate potential anti-aging pharmaceutical applications.
Aftermath
The joint venture later received a reported US$10.5 million investment from Roman Abramovich. The available material does not establish the venture's subsequent operating status.
Investment. US$10.5 million (Subsequent to the 2018 formation of Genome Protection Inc.; exact year not stated)
2009
Grant of exclusive Chinese rights for CBLB612StrategyBackground
Cleveland BioLabs sought a regional development and commercialization partner for CBLB612.
Action taken
The company assigned Zhejiang Hisun Pharmaceutical exclusive development and marketing rights for CBLB612 in China.
Aftermath
The reference material does not describe subsequent regulatory approval, commercialization, or financial results from the arrangement.
Recent events
- 2021
Cleveland BioLabs merges with Cytocom and adopts the Statera BioPharma name[1]
M&A · Leadership change
The merger combined Cleveland BioLabs and Cytocom, two clinical-stage biotechnology businesses, and created a company operating under the Statera BioPharma name.
- 2018
Cleveland BioLabs forms Genome Protection joint venture with Everon Biosciences[1]
M&A
The Buffalo-based joint venture was established to explore pharmaceutical applications related to aging using Cleveland BioLabs' Entolimod program.
- 2009
Cleveland BioLabs grants China rights for CBLB612[1]
Other
Cleveland BioLabs assigned Zhejiang Hisun Pharmaceutical exclusive development and marketing rights for CBLB612 in China.
Genome Protection receives investment from Roman Abramovich[1]
Other
The Genome Protection joint venture subsequently received a reported US$10.5 million investment from Russian investor Roman Abramovich.
Sources1 sources
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