- CTX-471, a novel anti-CD137 agonist antibody, demonstrated anti-tumor activity in the Company’s Phase 1 Dose Escalation and Dose Expansion, first-in-human monotherapy study in patients with metastatic or locally advanced malignancies who had progressed on approved PD-1 or PD-L1 inhibitors.
- Five clinical responses were observed, all in patients who previously received checkpoint inhibitors. A durable partial response (PR) in a patient with small-cell lung cancer (SCLC) converted to a complete response, as confirmed by PET scan. Four additional PRs were also observed, 3 of 11 (27.3%) patients with melanoma (2 confirmed, one unconfirmed) and one of four (25%) patients with mesothelioma (PR confirmed).
- CTX-471 was well tolerated. The dose-limiting toxicity in the dose-escalation portion of the study was thrombocytopenia (decreased platelet count). These two episodes both resolved to normal. There was a low incidence of liver toxicity (6.3%), and the majority (80%) of adverse events were low grade (Grade 1 or Grade 2).
The Company’s Phase 1 open-label, first-in-human study evaluated CTX-471 as a monotherapy in patients with metastatic or locally advanced malignancies that have progressed while receiving an approved PD-1 or PD-L1 inhibitor. The monotherapy portion of this study had two parts: a Dose Escalation phase and a Dose Expansion phase. Monotherapy dose escalation ranged from 0.1–1.2mg/kg intravenous (IV) biweekly, while Dose Expansion explored two dose levels: 0.3 and 0.6 mg/kg. The primary objective was to evaluate the safety and tolerability of CTX-471, with secondary objectives including pharmacokinetics (PK), immunogenicity, and clinical activity.
“We continue to make great strides with our CTX-471 clinical program, and we are excited to report data from the monotherapy arm of our Phase 1 trial,” said
Data highlights from the poster presentation include:
- 19 patients were treated in the dose escalation and 60 patients were treated in the expansion portion of the monotherapy arm of the study (62% were male, median age of 66 years).
- A complete response (CR) was confirmed by PET scan in 1 of 3 patients with small-cell lung cancer. This patient, treated in the third-line setting, had a durable Partial Response (PR) for approximately 3 years prior to converting to a CR. Four additional PRs were also observed: 3 of 11 (27.3%) patients with melanoma and 1 of 4 (25%) patients with mesothelioma.
- CTX-471 monotherapy was observed to be generally well-tolerated, with the majority of adverse events (AEs) being Grade 1-2.
A copy of the presentation materials can be accessed on the News & Events section under “Presentations” of the Company’s website at www.compasstherapeutics.com once the presentation has concluded.
About CTX-471
CTX-471 is a fully human monoclonal antibody that binds and activates a novel epitope of the co-stimulatory receptor CD137, also known as 4-1BB, a member of the tumor necrosis factor receptor superfamily. The antibody is currently being evaluated in a Phase 1b clinical trial in patients with solid tumors that have progressed after at least three months on an approved PD-1 or PD-L1 inhibitor. Initial results reported from a monotherapy cohort of the study included partial responses in melanoma, small cell lung cancer, and mesothelioma, and CTX-471 has been observed to be generally well tolerated. In preclinical studies, CTX-471 has demonstrated potent monotherapy activity against multiple syngeneic tumor models, including the generation of long-term functional immunological memory.
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