CTX-471 / Compass Therap - LARVOL DELTA

CTX-471 (CD137 agonist antibody) (GlobeNewswire) - "Compass expects to initiate a Phase 2 trial of CTX-471 in patients with tumors expressing NCAM (CD56) in Q1 2026."

New P2 trial • Solid Tumor

KEYNOTE-E65: Study of CTX-471 as a Monotherapy or in Combination With Pembrolizumab in Patients Post PD-1/PD-L1 Inhibitors in Metastatic or Locally Advanced Malignancies (clinicaltrials.gov) - P1 | N=100 | Completed | Sponsor: Compass Therapeutics | Active, not recruiting ➔ Completed

Checkpoint inhibition • Monotherapy • Trial completion • Head and Neck Cancer • Lung Cancer • Melanoma • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Compass Therapeutics Reports 2025 First Quarter Financial Results and Provides Corporate Update (GlobeNewswire) - "Successfully completed a pre-IND meeting for CTX-10726 (PD-1 x VEGF-A bispecific antibody), maintaining progress towards expected Q4 2025 IND filing and 2026 clinical data. Advanced the Phase 1 dose-escalation study of CTX-8371 in a post-checkpoint inhibitor patient population to the fourth dosing cohort with no dose-limiting toxicities observed to date; data from this study are expected in the second half of 2025....Phase 2 trial initiation of CTX-471 in patients with tumors expressing NCAM (CD56) is expected in the second half of 2025."

IND • New P2 trial • P1 data • Hodgkin Lymphoma • Melanoma • Non Small Cell Lung Cancer • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

Compass Therapeutics Presents Data on Enhanced Efficacy of CTX-471 in Combination with Tovecimig in Checkpoint-Refractory Models at the American Association for Cancer Research (AACR) Annual Meeting (GlobeNewswire) - "CTX-471 monotherapy demonstrated efficacy in multiple murine models, including models highly resistant to immune checkpoint inhibitors; Combining CTX-471 with tovecimig (CTX-009) markedly increased anti-tumor efficacy in these models; Tovecimig in combination with CTX-471 showed evidence of enhanced innate and adaptive anti-tumor immunity ranging from increased tumor cell killing to increased antigen presentation and interferon signaling; The combination of tovecimig and CTX-471 has the potential to be an effective therapeutic regimen in patients where checkpoint inhibitors have failed, including anti-PD-1 and anti-PD-L1 antibodies."

Preclinical • Oncology

Enhanced efficacy of CTX-471, a CD137 agonist antibody, in models of immune checkpoint failure via simultaneous blockade of neo-angiogenesis (AACR 2025) - "Coupling VEGF-A/Dll4 targeting with CD137 agonism markedly increased the anti-tumor efficacy of the individual treatments alone in the MC38B2m-/-, MC38H-2k1-/-, CT26B2m-/- models as well as in the highly IO resistant CT26B2m-/-E model. Tumor growth inhibition was accompanied by pharmacodynamic evidence consistent with decrease of vascular bed density and enhancement of cellular cytotoxic immunity. CTX-471 monotherapy was still efficacious, albeit blunted, in these IO resistant models."

Clinical • IO biomarker • Colorectal Cancer • Oncology • Solid Tumor • B2M

Compass Therapeutics Reports 2024 Financial Results and Provides Corporate Update (GlobeNewswire) - "Fully enrolled the third dosing cohort in the Phase 1 dose-escalation study of CTX-8371 (PD-1 x PD-L1 bispecific antibody), with preliminary data expected in the second half of 2025...In 2024, initiated dosing of the Phase 1 dose-escalation study of CTX-8371. As of February 2025, we have enrolled the third dosing cohort of the dose escalation study with no dose limiting toxicities (DLTs) observed to date....R&D expenses were $42.3 million for the year ended December 31, 2024, as compared to $38.1 million for the same period in 2023, an increase of $4.2 million or 11%. This increase was primarily attributable to additional program spending on tovecimig of $2.4 million and $1.3 million on CTX-471."

Commercial • P1 data • Trial status • Biliary Tract Cancer • Hematological Malignancies

Compass Therapeutics Provides Corporate Update (GlobeNewswire) - "Phase 2 trial initiation of CTX-471 in patients with tumors expressing neural cell adhesion molecule (NCAM or CD56) is expected in mid-2025."

New trial • Solid Tumor

Compass Therapeutics Reports 2024 Third Quarter Financial Results and Provides Corporate Update (GlobeNewswire) - "Fully enrolled the Phase 2/3 trial of lead asset CTX-009 (DLL4 and VEGF-A bispecific antibody) in patients with biliary tract cancers (BTC); top-line data readout is on track for the end of the first quarter of 2025. Designing a Phase 2 trial of CTX-009 in combination with chemotherapy in patients with DLL4-positive colorectal cancer (CRC) treated in the second-line setting; trial initiation expected in mid-2025. Identified neural cell adhesion molecule (NCAM or CD56) as a potential biomarker of response to CTX-471 based on data from the Phase 1 trial; planning a Phase 2 trial in patients with tumors expressing NCAM for mid-2025."

New P2 trial • P2/3 data • Biliary Cancer • Biliary Tract Cancer • Colorectal Cancer • Oncology • Solid Tumor

Pharmacodynamic and response biomarkers in the monotherapy arm of a phase 1 trial of CTX-471, a novel anti-CD137 agonist antibody (SITC 2024) - P1 | "NCT03881488. Approval Number: 20190565 Board Name: Western IRB (WIRB) Board Affiliation: Copernicus Group IRB."

Biomarker • IO biomarker • Monotherapy • P1 data • PK/PD data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • NCAM1 • PD-1 • TNFRSF9

Compass Therapeutics Presents Novel Biomarker Data Related to CTX-471 Clinical Activity at the 39th Society for Immunotherapy of Cancer (SITC) Annual Meeting (GlobeNewswire) - P1 | N=100 | NCT03881488 | Sponsor: Compass Therapeutics | "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."

P1 data • Solid Tumor

Compass Therapeutics Announces Upcoming Poster Presentation at the 39th Society for Immunotherapy of Cancer Annual Meeting (GlobeNewswire) - "Compass Therapeutics, Inc...today announced the acceptance of an abstract for poster presentation at the upcoming 39th Society for Immunotherapy of Cancer (SITC) Annual Meeting, being held from November 8–10, 2024 at the George R. Brown Convention Center in Houston, TX."

P1 data • Oncology • Solid Tumor

KEYNOTE-E65: Study of CTX-471 as a Monotherapy or in Combination With Pembrolizumab in Patients Post PD-1/PD-L1 Inhibitors in Metastatic or Locally Advanced Malignancies (clinicaltrials.gov) - P1 | N=100 | Active, not recruiting | Sponsor: Compass Therapeutics | Recruiting ➔ Active, not recruiting | N=157 ➔ 100

Checkpoint inhibition • Combination therapy • Enrollment change • Enrollment closed • Metastases • Monotherapy • Head and Neck Cancer • Lung Cancer • Melanoma • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Compass Therapeutics Reports 2024 Second Quarter Financial Results and Provides Corporate Update (GlobeNewswire) - "Ongoing analysis of biopsy specimens from the Phase 1b study revealed a potential biomarker of response; planning a Phase 2 monotherapy study of CTX-471 in patients whose tumors express this biomarker is underway. Data will be presented at a scientific conference later this year; In the Phase 1b dose-expansion cohort of CTX-471 in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab), an unexpected suppression of proinflammatory cytokines was observed which did not occur with CTX-471 as a monotherapy; as a result, the combination study will be discontinued."

New P2 trial • P1 data • Trial status • Lung Cancer • Non Small Cell Lung Cancer

Phase 1 study of CTX-471, a novel CD137 agonist antibody, in patients with progressive disease following PD-1/PD-L1 inhibitors in metastatic or locally advanced malignancies. (ASCO 2024) - P1 | "In this phase 1 study, CTX-471 was shown to be a safe and well-tolerated, novel anti-CD137 antibody. CTX-471 monotherapy demonstrates promising monotherapy anti-tumor activity in refractory patients whose tumors have progressed on approved PD-1 or PD-L1 inhibitors. The combination arm with pembrolizumab is ongoing and will be reported at a later date."

Clinical • Metastases • P1 data • Head and Neck Cancer • Hematological Disorders • Lung Cancer • Melanoma • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Thrombocytopenia

Compass Therapeutics to Present Phase 1 Data for CTX-471, A Novel CD137 Agonist Antibody, Demonstrating Anti-Tumor Activity in Patients Who Have Progressed on Approved PD-1 or PD-L1 Inhibitors at the American Society of Clinical Oncology (ASCO) Annual Meeting 2024 (GlobeNewswire) - P1 | N=157 | NCT03881488 | Sponsor: Compass Therapeutics | "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."

P1 data • Melanoma • Mesothelioma • Small Cell Lung Cancer

The combination of DLL4/VEGF-a blockade and immunomodulation can eliminate MHC class I negative tumors in mice (AACR 2024) - "This implies that NK cells might be involved in controlling tumor growth in this setting, and that the combined action of CTX-471 and CTX-009 in the tumor stroma enhances NK cell activity. The findings presented here suggest that CTX-009 may provide enhanced clinical benefit when combined with immunomodulatory agents, such as agonistic anti-CD137 antibodies or PD-1/PD-L1 blockers in tumors where immune checkpoint inhibitors have failed."

Immunomodulating • Preclinical • Biliary Cancer • Biliary Tract Cancer • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • B2M

Compass Therapeutics Presents Data Demonstrating Elimination of MHC Class I Negative Tumors in In Vivo Models at the 2024 American Association for Cancer Research (AACR) Annual Meeting (GlobeNewswire) - "Data highlights from the poster presentation include: The combination of mCTX-009 and mCTX-471 demonstrated superior efficacy in both Checkpoint Inhibitor (CPI)-sensitive and CPI-refractory models with markedly enhanced anti-tumor activity compared with either monotherapy. Following mCTX-009 and mCTX-471 combination treatment, superior efficacy was observed in MHC Class I negative tumors. Deletion of B2m produced MHC-I null phenotypes in two colorectal cancer cell lines. Tumor elimination was in part mediated by NK cells."

Preclinical • Colorectal Cancer • Oncology

Compass Therapeutics Reports 2023 Financial Results and Provides Corporate Update (GlobeNewswire) - P1b | N=157 | NCT03881488 | Sponsor: Compass Therapeutics | "In the Phase 1B monotherapy study, five responses were observed, all in patients who previously received checkpoint inhibitors. A durable partial response (PR) in a patient with SCLC has converted to a complete response (CR), as confirmed by a PET scan. Additionally, a new PR in a patient with advanced melanoma, was observed, leading to an objective response rate (ORR) in the subset of patients with advanced melanoma of 27% (3 of 11). The fifth response occurred in a patient with mesothelioma; Ongoing analysis of biopsy specimens from the Phase 1b study revealed a potential biomarker of response. As a result, planning for a Phase 2 monotherapy study in patients with melanoma whose tumors express this biomarker is underway; Ongoing enrollment of up to 60 patients in the Phase 1b dose-expansion cohort of the combination arm of CTX-471 and...KEYTRUDA (pembrolizumab) with melanoma, NSCLC and SCLC..."

Enrollment status • P1 data • Lung Cancer • Melanoma • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Skin Cancer • Small Cell Lung Cancer • Solid Tumor

Compass Therapeutics Announces Publication of CTX-8371 Preclinical Data in OncoImmunology, its Bispecific Antibody Checkpoint Inhibitor, now Advancing to First-in-Human Clinical Trial (GlobeNewswire) - "CTX-8371 provides enhanced anti-tumor activity relative to approved anti-PD-1 and PD-L1 therapies in a series of in vitro and in vivo experimental settings and models...The combination of CTX-8371 and the Compass agonistic anti-CD137 antibody, CTX-471, further increased anti-tumor efficacy in a mouse tumor model....Our IND was cleared by the FDA at the end of 2023, and we expect to dose a first patient before the end of this quarter."

Preclinical • Trial status • Oncology • Solid Tumor

Compass Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business Update (GlobeNewswire) - "(i) CTX-009 (DLL4 and VEGF-A bispecific antibody):...Initial results from...Phase 2/3 study of CTX-009 in combination with Paclitaxel in BTC...are expected in the first half of 2024.... (ii) CTX-471 (CD137 agonistic monoclonal antibody):...Patients enrolled in the study are treated with CTX-471 in combination with KEYTRUDA® with the goal of restoring a response....Initial results from the combination arm are expected in the second half of 2023."

P1 data • P2/3 data • Biliary Cancer • Biliary Tract Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Skin Cancer • Solid Tumor

Study of CTX-471 as a Monotherapy or in Combination With Pembrolizumab in Patients Post PD-1/PD-L1 Inhibitors in Metastatic or Locally Advanced Malignancies (clinicaltrials.gov) - P1 | N=157 | Recruiting | Sponsor: Compass Therapeutics | N=96 ➔ 157 | Trial completion date: Sep 2022 ➔ Apr 2025 | Trial primary completion date: Jul 2022 ➔ Feb 2025

Checkpoint inhibition • Combination therapy • Enrollment change • Monotherapy • Trial completion date • Trial primary completion date • Head and Neck Cancer • Lung Cancer • Melanoma • Mesothelioma • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Compass Therapeutics Announces First Patient Dosed in the Phase 1b CTX-471 Combination Trial with KEYTRUDA (pembrolizumab) (GlobeNewswire) - P1 | N=96 | NCT03881488 | Sponsor: Compass Therapeutics | "Compass Therapeutics, Inc...today announced that the first patient has been dosed in the Phase 1b study of CTX-471 in combination with KEYTRUDA®, Merck’s anti-PD-1 therapy, in patients with advanced solid tumors....This study enrolls patients with metastatic or locally advanced non-small cell lung cancer, melanoma, small cell lung cancer, mesothelioma, and head and neck cancer that have progressed after treatment with a checkpoint inhibitor....CTX-471 has completed a Phase 1 dose escalation and cohort expansion study, where it was shown to be well-tolerated."

P1 data • Trial status • Head and Neck Cancer • Lung Cancer • Melanoma • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Skin Cancer • Small Cell Lung Cancer • Solid Tumor

Compass Therapeutics Announces Clinical Collaboration with Merck to Evaluate CTX-471 in Combination with KEYTRUDA (pembrolizumab) (GlobeNewswire) - "Compass Therapeutics, Inc...announced a clinical trial collaboration and supply agreement with Merck (known as MSD outside the United States and Canada). The collaboration enables the evaluation of the safety and efficacy of Compass’ CTX-471, a fully human monoclonal antibody that binds and activates a novel epitope of the co-stimulatory receptor CD137 (expressed on T cells and NK cells) in combination with Merck’s anti-PD-1 therapy KEYTRUDA^® (pembrolizumab) in a Phase 1b trial. Under the agreement, Compass is the study sponsor, and Merck will provide the clinical supply of KEYTRUDA; the companies will form a Joint Development Committee to review the clinical trial results....The combination arm of the Phase 1b trial will enroll patients with metastatic or locally advanced non-small cell lung cancer, melanoma, small cell lung cancer, mesothelioma, and head and neck cancer that have progressed after treatment with a PD-1 or PD-L1 inhibitor."

Licensing / partnership • Head and Neck Cancer • Lung Cancer • Melanoma • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Skin Cancer • Small Cell Lung Cancer • Solid Tumor

Compass Therapeutics Reports Second Quarter 2022 Financial Results and Provides Corporate Update (GlobeNewswire) - "Compass Therapeutics, Inc...today reported second quarter and year-to-date 2022 financial results and provided a corporate update....CTX-009 (DLL4 and VEGF-A bispecific antibody): The Company anticipates initiating a Phase 2/3 study in patients with advanced BTC in the U.S. in Q3 2022....The Company also plans to initiate a Phase 2 trial in patients with advanced metastatic CRC in the U.S. during Q4 2022....CTX-471 (CD137 agonist): This Phase 1b study in patients with advanced solid tumors who have received at least one checkpoint blocker containing regimen is on track for completion in Q4 2022. In Q4 2022, the Company plans to begin a combination study with CTX-471 and a commercially available PD-1 blocker in patients who have progressed following initial response to a PD-1 regimen. CTX-8371 (PD-1 and PD-L1 bispecific antibody: GMP manufacturing campaign was completed, and the program remains on track for an IND submission in Q1 2023."

IND • New P2 trial • New P2/3 trial • New trial • Trial completion date • Biliary Tract Cancer • Colorectal Cancer • Gastrointestinal Cancer • Mesothelioma • Oncology • Solid Tumor

Study of CTX-471 in Patients Post PD-1/PD-L1 Inhibitors in Metastatic or Locally Advanced Malignancies (clinicaltrials.gov) - P1; N=96; Recruiting; Sponsor: Compass Therapeutics; Trial completion date: Jul 2021 ➔ Sep 2022; Trial primary completion date: Mar 2021 ➔ Jul 2022

Checkpoint inhibition • Clinical • Trial completion date • Trial primary completion date • Oncology • Solid Tumor