CIGB 300

Summary

CIGB-300 is a novel antineoplastic cyclic peptide developed at the Center for Genetic Engineering and Biotechnology (CIGB) in Cuba. It targets the CK2 phosphorylation pathway, primarily by interacting with nucleophosmin (B23), a CK2 substrate overexpressed in many cancers. Clinical trials have been conducted in cervical cancer and non-small cell lung cancer, with early evidence of antitumor activity and tolerability.

Mechanism of Action

CIGB-300 is a cell-penetrating cyclic peptide that binds to the CK2 phosphoacceptor domain on target substrates (notably B23/nucleophosmin), thereby blocking CK2-mediated phosphorylation. This disrupts CK2-dependent pro-survival signaling, induces apoptosis, and inhibits tumor cell proliferation.

Routes of Administration

Goals & Uses

• Inhibition of CK2-driven pro-survival signalingMolecular Target EngagementModerate
• Induction of apoptosis in tumor cellsCellular PharmacologyModerate
• Antitumor activity in cervical cancerOncologyModerate
• Antitumor activity in non-small cell lung cancerOncologyLow

Contraindications

• Severe hypersensitivity to peptide componentsAllergy / ImmunologyHigh
• Severe hepatic or renal impairmentOrgan ImpairmentModerate
• PregnancyPopulationHighPotential fetal risk or insufficient safety data

Adverse Effects

• Local Injection Site ReactionsDermatologicalCommon
• Fever / flu-like symptomsSystemicUncommon
• NauseaGastrointestinalUncommonFeeling of sickness or urge to vomit
• Hematologic toxicityHematologyRare

Drug Interactions

• Other CK2 inhibitorsModerate
• ImmunosuppressantsLowPotential interaction with immune pathways or infection risk

Population Constraints

• Pediatric patientsAgeRelative
• Pregnant or lactating womenReproductiveRelative
• Patients with autoimmune disordersImmunologicalRelative

Regulatory Status

• European UnionInvestigationalNot approved by EMA; no centralized marketing authorization.
• United StatesInvestigationalNot FDA-approved; no IND status publicly confirmed. Considered experimental.
• United KingdomInvestigationalNot approved by MHRA; investigational use only.

CIGB-300 has been evaluated in clinical trials in Cuba and has received some level of regulatory review in Cuba (CECMED). It has not received FDA, EMA, or MHRA approval. Investigational status applies in most jurisdictions. Orphan or special designations have not been widely reported outside Cuba.

Evidence & Sources

No sources recorded yet.