CTX-8371 / Compass Therap - LARVOL DELTA

CTX-8371-001: A Phase 1 of CTX-8371 in Patients With Advanced Malignancies (clinicaltrials.gov) - P1 | N=73 | Recruiting | Sponsor: Compass Therapeutics | N=55 ➔ 73 | Trial completion date: Apr 2026 ➔ May 2027 | Trial primary completion date: Oct 2025 ➔ Dec 2026

Enrollment change • Trial completion date • Trial primary completion date • Breast Cancer • Head and Neck Cancer • Hematological Malignancies • Lung Cancer • Lymphoma • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

CTX-8371 (PD-1 x PD-L1 bispecific antibody) (GlobeNewswire) - "The dose escalation portion of the Phase 1 study, including the fifth and final cohort, is fully enrolled. A new response in a third indication has been observed in this fifth cohort. No DLTs have been observed to date at any dose level, potentially differentiating CTX-8371 from current checkpoint inhibitors. Results, including from the fifth cohort, are expected to be presented at a major medical conference in the first half of 2026....Cohort expansions in patients with NSCLC and TNBC are expected to begin this quarter."

P1 data • Trial status • Non Small Cell Lung Cancer • Triple Negative Breast Cancer

A phase 1 study of CTX-8371, a bispecific PD-1/PD-L1 antibody, in patients with advanced malignancies (AACR 2025) - "In addition, CTX-8371 demonstrated superior anti-tumor efficacy compared to pembrolizumab or atezolizumab in checkpoint-inhibitor-sensitive and resistant syngeneic mouse tumor models. This is a Phase 1, open-label, first-in-human study of CTX-8371 as a monotherapy in patients with metastatic or locally advanced malignancies...Patients with TNBC must have received prior sacituzumab govitecan and if PD-L1 ≥10% by CPS pembrolizumab with chemotherapy. Patients with HL must have received at least two prior systemic therapies including brentuximab vedotin (if eligible) and a prior PD-1 inhibitor and must have experienced less than a CR to an anti-PD-1 treatment. The study is recruiting patients across multiple sites in the United States."

Clinical • Metastases • P1 data • Breast Cancer • Head and Neck Cancer • Hematological Malignancies • Hodgkin Lymphoma • Lung Cancer • Lymphoma • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

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 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) - "Fully enrolled the third dosing cohort of the Phase 1 dose-escalation study of CTX-8371 (PD-1 x PD-L1 bispecific) with preliminary data expected in the second half of 2025."

P1 data • Trial status • Hodgkin Lymphoma • Melanoma • Non Small Cell Lung Cancer • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

Compass Therapeutics Reports 2024 Second Quarter Financial Results and Provides Corporate Update (GlobeNewswire) - "CTX-009: Completed enrollment (n=150) in COMPANION-002 in the U.S....Top-line data expected in the first quarter of 2025; CTX-8371: In April 2024, the first patient in this study was dosed in the Phase 1 study. The first cohort of this trial was completed in June 2024 with no dose limiting toxicities observed. The second cohort has been initiated."

P2/3 data • Trial status • Biliary Cancer • Biliary Tract Cancer • Breast Cancer • Cholangiocarcinoma • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

Compass Therapeutics Announces First Patient Dosed in the Phase 1 Study of CTX-8371 in Patients with Solid Tumors (GlobeNewswire) - "Compass Therapeutics...announced that the first patient has been dosed in its Phase 1 dose-escalation clinical trial of CTX-8371, a PD-1 x PD-L1 bispecific antibody, in patients with solid tumors....The Phase 1 CTX-8371 study design includes five ascending doses (0.1, 0.3, 1.0, 3.0, and 10 mg/kg) and the study is enrolling patients with melanoma, non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), Hodgkin Lymphoma, and triple negative breast cancer (TNBC) who have progressed on at least one prior regimen containing checkpoint blocker."

Trial status • Hodgkin Lymphoma • Melanoma • Non Small Cell Lung Cancer • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

A Phase 1 of CTX-8371 in Patients With Advanced Malignancies (clinicaltrials.gov) - P1 | N=55 | Recruiting | Sponsor: Compass Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Breast Cancer • Head and Neck Cancer • Hematological Malignancies • Lung Cancer • Lymphoma • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

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

A bispecific anti-PD-1 and PD-L1 antibody induces PD-1 cleavage and provides enhanced anti-tumor activity. (PubMed, Oncoimmunology) - "The combination of CTX-8371 and an agonistic anti-CD137 antibody further increased the anti-tumor efficacy with long-lasting curative therapeutic effect. In summary, CTX-8371 is a novel checkpoint inhibitor that might provide greater clinical benefit compared to current anti-PD-1 and PD-L1 antibodies, especially when combined with agents with orthogonal mechanisms of action, such as agonistic anti-CD137 antibodies."

Journal • Oncology

A Phase 1 of CTX-8371 in Patients With Advanced Malignancies (clinicaltrials.gov) - P1 | N=55 | Not yet recruiting | Sponsor: Compass Therapeutics

New P1 trial • Breast Cancer • Head and Neck Cancer • Hematological Malignancies • Lung Cancer • Lymphoma • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

Compass Therapeutics Reports Third Quarter 2023 Financial Results and Provides Corporate Update (GlobeNewswire) - "Compass Therapeutics, Inc...today reported third quarter and year-to-date, 2023 financial results...Enrolling patients in a U.S. Phase 2/3 study of CTX-009 in combination with Paclitaxel in BTC (COMPANION-002)...Enrollment in the third quarter has increased relative to the first half of 2023 in part due to the opening of several clinical sites at large academic medical centers across the country...FDA cleared the IND for CTX-8371 and we expect to initiate a Phase 1 clinical trial in the fourth quarter of 2023....R&D expenses were $8.8 million for the quarter ended September 30, 2023, as compared to $9.8 million for the same period in 2022, a decrease of approximately $1.0 million or 10%. The decrease was primarily attributable to lower manufacturing expense related to CTX-009 of $1.6M."

Commercial • Enrollment status • New P1 trial • Biliary Cancer • Biliary Tract Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Translational PK/RO model of tetravalent bispecific antibody CTX8371: receptor occupancy estimation, PD1 loss and bispecific binding-related avidity increase in low doses (SITC 2023) - "Predicted PD1 RO for simulated single and multiple doses are consistent with RO during canonical Nivolumab treatment. 3 Increased avidity is observed for low doses of CTX8371 due to the multimeric bsAb complexes formation. PD1 loss demonstrated in vivo for cynomolgus monkeys1 might be described by the internalization of bsAb-Target complexes only."

Oncology • PD-L1

Compass Therapeutics Reports First Quarter Financial Results and Provides Corporate Update (GlobeNewswire) - "Development Pipeline Update and Highlights: (i) CTX-009 (DLL4 and VEGF-A bispecific antibody):...Initial results from...the U.S. Phase 2 study of CTX-009 as a monotherapy in patients with advanced, metastatic colorectal cancer...are expected in the third quarter of 2023; (ii) CTX-8371 (PD-1 x PD-L1): Targeting IND submission in the third quarter of 2023 and initiating a clinical trial in the second half of 2023."

IND • New trial • P2 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Compass Therapeutics Reports Third Quarter 2022 Financial Results and Provides Corporate Update (GlobeNewswire) - "Study site initiations in the United States for a randomized Phase 2/3 study of CTX-009 with paclitaxel in patients with Biliary Tract Cancers (BTC) and a Phase 2 of CTX-009 in patients with Colorectal Cancer (CRC) are ongoing; patient enrollment for both studies is expected during the fourth quarter of 2022 ; Initiated preclinical toxicology studies for CTX-8371; IND filing and first in human clinical study are anticipated in the first half of 2023."

IND • New trial • Preclinical • Trial status • Biliary Tract Cancer • Cholangiocarcinoma • Gastrointestinal Cancer • Oncology • 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

Compass Therapeutics Reports First Quarter 2022 Financial Results and Highlights Recent Company Progress (GlobeNewswire) - "CTX-8371 GMP manufacturing campaign has begun, and the program is on track for an IND in Q1 2023"

IND • Oncology

Dose range finding study in non-human primates confirms the unique mechanism of action of CTX-8371, a novel bispecific antibody blocking PD-1 and PD-L1 (AACR 2022) - "The dual blockade of PD-1 and PD-L1, combined with PD-1 cleavage, may offer superior benefit compared to current checkpoint inhibitor therapies. RO data as well as murine and NHP PK/PD analyses will guide a projected human dose for future development."

Oncology • CD4 • CD8

Compass Therapeutics Presents Data on CTX-8371, a Bispecific Antibody Targeting PD-1 and PD-L1, at the 2022 AACR Annual Meeting (GlobeNewswire) - "Key data presented includes the following: Treatment with CTX-8371 leads to PD-1 loss from the surface of intra-tumoral T cells in tumor-bearing transgenic hPD-1/h-PD-L1 mice, and on peripheral blood T cells in cynomolgus macaques...Treatment with CTX-8371 in the aggressive MC38-hPD-L1 colorectal mouse model led to a dose-proportional reduction in tumor volume and a complete eradication of tumors at the highest dose. Taken together, the murine and cynomolgus monkey PK data, receptor occupancy data, and in vivo efficacy data in murine models will be used to calculate the predicted human efficacious dose range for CTX-8371. 'These findings further provide in vivo evidence for the differentiated mechanism of action of CTX-8371 and inform its clinical development, which is projected to begin in the first half of 2023,' said Thomas Schuetz, MD, PhD, CEO and Scientific Founder of Compass Therapeutics."

Preclinical • Oncology

Compass Therapeutics Announces Presentation on CTX-8371, A Bispecific Antibody Targeting PD-1 and PD-L1, at the 2022 AACR Annual Meeting in New Orleans (GlobeNewswire) - "Compass Therapeutics Inc...announced today that it will present preclinical data on CTX-8371, a next generation bispecific checkpoint inhibitor that simultaneously targets PD-1 and PD-L1 at the upcoming American Association for Cancer Research (AACR) Annual Meeting, which is being held April 8-13, 2022, at the Ernest N. Morial Convention Center in New Orleans, Louisiana."

Preclinical • Oncology

Compass Therapeutics Reports Third Quarter 2021 Financial Results and Provides Corporate Update (Businesswire) - "CTX-009 (DLL4 and VEGF-A bispecific antibody): The study is being conducted in South Korea by Handok Pharmaceuticals and the clinicaltrials.gov identifier for the study is NCT04492033. Compass plans to submit an Investigational New Drug (IND) application to the Food and Drug Administration (FDA) in the fourth quarter of 2021 and subject to the IND clearance with the FDA, to initiate a Phase 2 study in 2022 in the United States....CTX-471: We expect to complete the Phase 1b stage of this study during the first half of 2022....CTX-8371: we are currently targeting an IND submission in the second half of 2022."

Enrollment status • IND • New P2 trial • Oncology • Solid Tumor

[VIRTUAL] Bispecific anti-PD-1/PD-L1 antibody CTX-8371 to promote cellular clustering and PD-1 shedding, antitumor activity and tolerability. (ASCO 2021) - "Furthermore, CTX-8371 demonstrated superior anti-tumor efficacy compared to Keytruda or atezolizumab in checkpoint inhibitors-sensitive and resistant syngeneic mouse tumor models . CTX-8371 displays multiple mechanisms of action over monoclonal PD1/PD-L1 blockade . These unique pharmacological properties of CTX-8371 could explain the enhanced T cell responses to tumor antigens and superior efficacy over current monoclonal antibody therapies . With favorable PK/PD and toxicology profiles in mice and cynomolgus monkeys, CTX-8371 warrants further advancement to clinical testing."

Oncology • Solid Tumor

Compass Therapeutics Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Business Update (Businesswire) - "CTX-8371, a PD-1 X PD-L1 Bispecific:...Initiated preparation of IND submission materials with the goal of submission of the IND in early 2022 and potential for early safety and top-line data later in 2022...Published preclinical data in the journal Science supporting the potential of CTX-2026, a novel antibody to the butyrophilin BTN3A1 in ovarian cancer tumor models...R&D expenses were $4.4 million during the fourth quarter of 2020, as compared to $3.3 million for the same period in 2019, an increase of $1.1 million or 33%. The higher costs were primarily related to manufacturing expenses and toxicological studies for CTX-8371."

Clinical data • Commercial • Preclinical • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

Compass Therapeutics to present at the 40th Cowen Health Care Conference (Businesswire) - “Compass Therapeutics…announced that Thomas Schuetz, M.D., Ph.D., co-founder and chief executive officer, will present a company overview at the 40th Annual Cowen Health Care Conference in Boston on Tuesday, March 3, 2020. Dr. Schuetz’s presentation will feature an update on the ongoing Phase 1 trial of…CTX-471, a fully human agonistic antibody of CD137 being evaluated in patients with advanced solid tumors. Dr. Schuetz will also share the company’s progress on CTX-8371, a novel PD-1/PD-L1 bispecific, which has shown significantly increased activity in preclinical testing compared to PD-1 or PD-L1 monoclonal antibody therapies available commercially.”

P1 data • Preclinical