Cartography Biosciences and Biosplice Therapeutics Advance Novel Oncology Candidates: CBI-1214 Receives FDA Fast Track Designation for Colorectal Cancer; Cirtuvivint Enters Phase 1 Trial in PARP Inhibitor-Resistant Ovarian Cancer

CBI-1214: IND Application Granted FDA Approval

Cartography Biosciences Announces FDA Approval of IND Application and Fast Track Designation for CBI-1214; Phase 1 Trial in Colorectal Cancer (CRC) Planned for Q1 2026

CBI-1214 is a T-cell engager targeting a novel tumor antigen named LY6G6D.This antigen is hardly expressed in healthy tissues but specifically exists in microsatellite-stable (MSS) and low microsatellite instability (MSI-L) colorectal cancer subtypes – these two groups of patients account for the majority of CRC cases and have significant unmet medical needs. CBI-1214, optimized through protein engineering, aims to enhance its anti-tumor activity and is expected to become a highly specific tumor antigen therapy.

Cirtuvivint: Phase 1 Combination Therapy Trial Completes First Patient Dosing

Biosplice Therapeutics announced that the first patient has been dosed in a Phase 1 clinical trial, which aims to evaluate the combination of the small molecule drug cirtuvivint with the PARP inhibitor olaparib for the treatment of patients carryingBRCAFemale patients with platinum-resistant ovarian cancer harboring mutations and/or HRD. The study specifically targets patients who have previously received PARP inhibitor treatment.Cirtuvivint is a selective pan-CLK/pan-DYRK kinase inhibitor that exerts its anti-tumor effects by modulating RNA alternative splicing (including transcripts involved in oncogenic pathways).

Preclinical studies have shown,Cirtuvivint can indirectly block the "alternative survival pathway" – WNT/TCF signaling pathway – activated in tumor cells under PARP inhibitor stress by inhibiting CLK/DYRK kinases.In multiple high-grade serous ovarian cancer resistance models with various BRCA mutations or HRD, cirtuvivint not only inhibits WNT/TCF transcriptional activity and reduces nuclear β-catenin levels but also induces DNA damage, decreases tumor cell survival ability, and synergizes with olaparib to delay tumor progression and prolong survival (effective in both immunocompetent and immunocompromised animal models). Additionally, the drug can improve the tumor immune microenvironment, such as reducing immunosuppressive PD-1/PD-L1 expressing cells. These data provide strong evidence for clinical exploration of cirtuvivint combined with olaparib to overcome or delay PARP inhibitor resistance.

IMP761: Phase 1 Clinical Trial Data Release

Immutep Announces Positive Progress in First-in-Human, Placebo-Controlled, Double-Blind Phase 1 Clinical Trial in Healthy Subjects: Evaluating IMP761 – A Potential "First-in-Class" LAG-3 Agonist Antibody for the Treatment of Autoimmune Diseases.IMP761 has the potential to intervene in multiple autoimmune diseases at their root by specifically silencing autoreactive memory T cells that accumulate at lesion sites, thereby restoring immune system balance.

The single ascending dose portion of the study has successfully completed dosing in the 2.5 mg/kg and 7 mg/kg dose groups. IMP761 demonstrated a favorable safety profile, with no treatment-related adverse events exceeding mild severity. Additionally, IMP761 showed a clear dose-dependent immunosuppressive effect.On days 2, 9, and 23, IMP761 significantly and durably suppressed the subjects' three T cell-mediated intradermal responses to strong heterologous antigen challenges.The significant reduction in T-cell activity highlightsThe Potential Efficacy of IMP761 in Treating Autoimmune Diseases.