Compass Therapeutics Presents Novel Biomarker Data Related to CTX-471 Clinical Activity at the 39th Society for Immunotherapy of Cancer (SITC) Annual Meeting
Compass Therapeutics presented new biomarker data for CTX-471, their novel anti-CD137 agonist antibody, at the SITC Annual Meeting. The study revealed a significant correlation between neural cell adhesion molecule (NCAM/CD56) expression and patient response to CTX-471 monotherapy. The data comes from a Phase 1 trial in patients with advanced malignancies who previously progressed on PD-1/PD-L1 inhibitors. Key findings showed that tumor cell NCAM appears to enrich activated NK cells in the tumor microenvironment, suggesting NCAM's potential use as a selection marker for future clinical trials.
Compass Therapeutics ha presentato nuovi dati sui biomarcatori per CTX-471, il loro nuovo anticorpo agonista anti-CD137, durante l'Assemblea Annuale del SITC. Lo studio ha rivelato una correlazione significativa tra l'espressione della molecola di adesione cellulare neurale (NCAM/CD56) e la risposta dei pazienti alla monoterapia con CTX-471. I dati provengono da uno studio di Fase 1 su pazienti con malignità avanzate che in precedenza avevano mostrato progressione con inibitori PD-1/PD-L1. I principali risultati hanno mostrato che la NCAM nelle cellule tumorali sembra arricchire le cellule NK attivate nel microambiente tumorale, suggerendo il potenziale utilizzo della NCAM come marcatore di selezione per futuri studi clinici.
Compass Therapeutics presentó nuevos datos de biomarcadores para CTX-471, su nuevo anticuerpo agonista anti-CD137, en la Reunión Anual de la SITC. El estudio reveló una correlación significativa entre la expresión de la molécula de adhesión celular neural (NCAM/CD56) y la respuesta de los pacientes a la monoterapia con CTX-471. Los datos provienen de un ensayo de Fase 1 en pacientes con malignidades avanzadas que habían progresado previamente en inhibidores de PD-1/PD-L1. Los datos clave mostraron que la NCAM en las células tumorales parece enriquecer las células NK activadas en el microambiente tumoral, sugiriendo el uso potencial de la NCAM como un marcador de selección para futuros ensayos clínicos.
Compass Therapeutics는 SITC 연례 회의에서 그들의 새로운 항-CD137 작용제 항체인 CTX-471에 대한 새로운 바이오마커 데이터를 발표했습니다. 연구 결과, 신경세포 부착 분자(NCAM/CD56)의 발현과 CTX-471 단독 요법에 대한 환자의 반응 사이에 유의미한 상관관계가 있음을 밝혔습니다. 데이터는 PD-1/PD-L1 억제제에서 이전에 진행된 고급 악성 종양 환자를 대상으로 한 1상 시험에서 나왔습니다. 주요 발견은 종양 세포 NCAM이 종양 미세환경에서 활성화된 NK 세포를 증대시키는 것으로 나타났으며, 이는 향후 임상 시험에서 NCAM을 선택 마커로 활용할 수 있는 가능성을 제안합니다.
Compass Therapeutics a présenté de nouvelles données sur les biomarqueurs pour CTX-471, leur nouvel anticorps agoniste anti-CD137, lors de la réunion annuelle du SITC. L'étude a révélé une corrélation significative entre l'expression de la molécule d'adhésion cellulaire neuronale (NCAM/CD56) et la réponse des patients à la monothérapie CTX-471. Les données proviennent d'un essai de phase 1 chez des patients présentant des tumeurs avancées ayant auparavant progressé avec des inhibiteurs de PD-1/PD-L1. Les principales conclusions ont montré que la NCAM des cellules tumorales semble enrichir les cellules NK activées dans le microenvironnement tumoral, suggérant le potentiel d'utilisation de la NCAM en tant que marqueur de sélection pour de futurs essais cliniques.
Compass Therapeutics präsentierte neue Biomarkerdaten für CTX-471, ihren neuartigen anti-CD137 Agonisten-Antikörper, auf dem SITC-Jahrestreffen. Die Studie zeigte eine signifikante Korrelation zwischen der Expression des neuralen Zelladhäsionsmoleküls (NCAM/CD56) und der Patientenreaktion auf die Monotherapie mit CTX-471. Die Daten stammen aus einer Phase-1-Studie mit Patienten mit fortgeschrittenen Malignitäten, die zuvor auf PD-1/PD-L1-Inhibitoren fortgeschritten waren. Die wichtigsten Ergebnisse zeigten, dass Tumorzell-NCAM anscheinend aktivierte NK-Zellen im Tumormikroenvironment anreichert, was auf das potenzielle Nutzung von NCAM als Selektionsmarker für zukünftige klinische Studien hinweist.
- Discovery of NCAM as a potential predictive biomarker for patient response
- Identification of a novel mechanism linking NCAM to NK Cell activation
- Expansion of potential indications for CTX-471 development
- Planning of Phase 2 monotherapy basket study for NCAM-expressing tumors
- None.
Insights
The biomarker data for CTX-471 represents a significant scientific advancement with potential commercial implications. The discovery of NCAM (CD56) correlation with patient response provides a clear pathway for patient selection in future trials, which could substantially improve the drug's efficacy profile.
The identification of this biomarker is particularly valuable because it enables:
- More targeted patient selection for upcoming Phase 2 trials
- Potential expansion into new NCAM-expressing tumor indications
- Enhanced understanding of the drug's mechanism through NK cell activation
- New data showed a correlation between the levels of neural cell adhesion molecule (NCAM or CD56) expression and response and disease control in patients treated with CTX-471 monotherapy.
- Predictive biomarkers correlated with response and changes in pharmacodynamic markers were seen in patients treated with CTX-471, a novel anti-CD137 agonist antibody, in an analysis from the Phase 1 monotherapy study.
BOSTON, Nov. 08, 2024 (GLOBE NEWSWIRE) -- Compass Therapeutics, Inc. (Nasdaq: CMPX), a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics, today announced its poster presentation entitled “Pharmacodynamic and Response Biomarkers in the Monotherapy Arm of a Phase 1 Trial of CTX-471, a Novel Anti-CD137 Agonist Antibody” at the 39th Society for Immunotherapy of Cancer (SITC) Annual Meeting, from November 6-10, 2024 in Houston, TX.
“This exciting new response biomarker data is extremely important for CTX-471 and our clinical strategy,” said Thomas Schuetz, MD, PhD, CEO of Compass and Vice Chairman of the Board of Directors. “Through a comprehensive analysis of tissue and blood samples, we discovered an unexpected correlation between NCAM (CD56) and patient response to CTX-471, as well as a possible mechanistic connection to Natural Killer (NK) Cell activation. This adds more potential indications to CTX-471’s development pathway and we are now planning a Phase 2 monotherapy basket study of CTX-471 in patients whose tumors express NCAM. This patient population is substantial.”
These data arise from Compass’s Phase 1 open-label, first-in-human study that 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. Exploratory data reported here complement safety and efficacy data previously published at ASCO 2024. Biopsy specimens and blood samples from patients treated with CTX-471 were analyzed by multi-parameter immunofluorescence, flow cytometry, and a panel of cytokines using the Neogenomics Multi-omyx platform. To measure pharmacodynamic effects, comparisons were made between samples collected before and after CTX-471 treatment. To survey response biomarkers, values from baseline samples obtained from patients with tumors showing complete or partial responses as well as stable disease were compared with tumors showing progressive disease.
Further, the authors propose a mechanism by which NCAM facilitates CTX-471 response. Specifically, tumor cell NCAM appears to enrich activated NK cells in the tumor microenvironment that express the CTX-471 target, CD137 (4-1BB). The dataset shows these effects to be specific for NCAM expressing lymphocytes such as NK cells and is not observed in other lymphocyte subsets such as CD8+ T cells. These findings are novel in a clinical setting and support the potential use of NCAM as a selection marker for future clinical trials.
Data highlights from the poster presentation include:
- CTX-471 pharmacodynamic biomarker changes were consistent with immune stimulation.
- CTX-471 disease control is associated with measurable baseline biomarkers.
- Baseline tumor cell expression of NCAM/CD56 is associated with response and disease control.
- A novel baseline circulating cell phenotype is associated with partial responses to CTX-471.
A copy of the presentation materials can be accessed on the Compass website at https://www.compasstherapeutics.com/pipeline 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. In preclinical studies, CTX-471 has demonstrated potent monotherapy activity against multiple syngeneic tumor models, including the generation of long-term functional immunological memory. 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 five clinical responses, all in patients who previously received checkpoint inhibitors, including a durable partial response (PR) in a patient with small-cell lung cancer that converted to a complete response (as confirmed by PET scan) and four additional PRs (one unconfirmed) in patients with melanoma and mesothelioma. CTX-471 has been generally well tolerated. Clinical Trial information: NCT03881488.
About NCAM (CD56)
Neural cell adhesion molecule (NCAM) is a membrane glycoprotein that belongs to the immunoglobulin superfamily mediating homotypic interactions between cells on which it is expressed. It plays a role in neural cell adhesion and central nervous system development. In cancer, NCAM is linked with tumor invasion and metastases, with the most relevant tumor types being neural crest-derived (e.g., metastatic melanoma, SCLC, and glioblastoma) and neuroendocrine tumors (NET). The prevalence of NCAM high tumors ranges from approximately
About Compass Therapeutics
Compass Therapeutics, Inc. is a clinical-stage oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases. Compass’s scientific focus is on the relationship between angiogenesis, the immune system, and tumor growth. The company pipeline of novel product candidates is designed to target multiple critical biological pathways required for an effective anti-tumor response. These include modulation of the microvasculature via angiogenesis-targeted agents, induction of a potent immune response via activators on effector cells in the tumor microenvironment, and alleviation of immunosuppressive mechanisms used by tumors to evade immune surveillance. Compass plans to advance its product candidates through clinical development as both standalone therapies and in combination with proprietary pipeline antibodies based on supportive clinical and nonclinical data. The company was founded in 2014 and is headquartered in Boston, Massachusetts. For more information, visit the Compass Therapeutics website at https://www.compasstherapeutics.com.
Forward-Looking Statements
This press release contains forward-looking statements. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, statements regarding Compass’s product candidates, such as CTX-471, and the results of scientific and clinical analyses of such product candidates, including their development and clinical trial milestones such as identification of potential biomarkers or other indicators of the therapeutic potential thereof, the expected trial design, timing of enrollment, patient dosing and data readouts, regulatory plans with respect to Compass’s product candidates and the therapeutic potential thereof, and references to Compass’s financial position to continue advancing these product candidates or related business and development plans. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, Compass’s ability to raise the additional funding it will need to continue to pursue its business and product development plans, the inherent uncertainties associated with developing product candidates and operating as a development stage company, Compass’s ability to identify additional product candidates for development, Compass’s ability to develop, complete clinical trials for, obtain approvals for and commercialize any of its product candidates, competition in the industry in which Compass operates and market conditions. These forward-looking statements are made as of the date of this press release, and Compass assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents Compass files with the U.S. Securities and Exchange Commission (SEC) available at www.sec.gov, including without limitation Compass’s latest Annual Report on Form 10-K, Quarterly Report on Form 10-Q and subsequent filings with the SEC.
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