CX-801 / CytomX - LARVOL DELTA

CX-801 monotherapy biomarker data in advanced melanoma patients to be presented…[at] Society of Immunotherapy of Cancer (SITC) 2025 Annual Meeting… (GlobeNewswire) - "CX-801 monotherapy has been well tolerated at doses exceeding the approved dose of unmasked IFNα2b. Gene expression analysis of pre- and post-treatment patient tumor biopsies demonstrated consistently increased expression of interferon-stimulated genes. Patients demonstrated evidence of T-cell and NK cell activation and upregulation of immune checkpoint genes, including PD-1 and PD-L1....PK analysis also demonstrated dose-proportional exposure of CX-801, which remained predominantly in its intact (masked) form in circulation."

Biomarker • P1 data • Melanoma

The CX-801 Phase 1 study is ongoing with a focus in advanced melanoma (GlobeNewswire) - "CX-801 monotherapy dose escalation has reached the fourth dose level. In May 2025, Phase 1 dose escalation of CX-801 in combination with KEYTRUDA was initiated. Dose escalation of CX-801 in combination with KEYTRUDA is currently enrolling the 2nd dose level."

Trial status • Melanoma

Pharmacodynamic Activity of CX-801, a Masked IFNα2b PROBODY® Cytokine, in Patients with Advanced Melanoma (SITC 2025) - P1 | "Dose escalation of CX-801 as monotherapy and in combination with pembrolizumab is ongoing. Updated PD data will be provided at the conference.Trial Registration NCT06462794"

Clinical • IO biomarker • Metastases • PK/PD data • Melanoma • Oncology • Solid Tumor • CD14 • CD8 • CD80 • CXCL10 • GZMB • IFNA1 • LAG3 • NCR1 • PD-1 • PD-L1

CytomX Therapeutics to Present CX-801 Phase 1 Monotherapy Biomarker Data at the Society for Immunotherapy of Cancer (SITC) Annual Meeting (GlobeNewswire) - "CX-801 (PROBODY interferon alpha-2b) Phase 1 data demonstrate activation of tumor-selective interferon signaling in patients with advanced melanoma....'We look forward to providing Phase 1 clinical data of CX-801 combined with KEYTRUDA in 2026'."

Biomarker • P1 data • Melanoma

CytomX Therapeutics Announces Second Quarter 2025 Financial Results and Provides Business Update (CytomX Press Release) - "CX-2051 (EpCAM PROBODY Topo-1 ADC): Phase 1 data update in advanced CRC in approximately 70 patients is expected by Q1 2026. Planning underway for CX-2051 Phase 2 study initiation in advanced, late-line CRC in 1H 2026. Potential to initiate CX-2051 combination studies in earlier lines of CRC therapy in 2026....CX-801 (PROBODY Interferon alpha-2b): Phase 1 dose escalation of CX-801 monotherapy continues. Preliminary tumor biomarker, pharmacodynamic (PD) and pharmacokinetic (PK) data evaluating the initial molecular performance of CX-801 monotherapy in the ongoing Phase 1 study are expected in the fourth quarter of 2025. In May 2025, Phase 1 dose escalation of CX-801 in combination with KEYTRUDA was initiated. Initial clinical data for the combination therapy in advanced melanoma is anticipated in 2026." "

New P2 trial • P1 data • Colorectal Cancer • Melanoma

CytomX Therapeutics Announces First Patient Dosed in Combination Arm of Phase 1 Study of CX-801 plus KEYTRUDA (pembrolizumab) in Patients with Metastatic Melanoma (GlobeNewswire) - "CytomX Therapeutics, Inc...announced that the first patient has been dosed with CX-801 in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in the ongoing Phase 1 dose escalation study (NCT06462794) evaluating safety and initial clinical activity in patients with metastatic melanoma...CytomX is conducting a focused Phase 1 dose escalation study of CX-801 in metastatic melanoma. The combination arm of the study evaluating CX-801 in combination with KEYTRUDA has been initiated following successful the clearance of the first three CX-801 monotherapy dose escalation cohorts....'We look forward to initial Phase 1a translational and biomarker data in advanced melanoma in the second half of 2025.'"

P1 data • Trial status • Melanoma

CytomX Therapeutics Announces 2024 Financial Results and Provides Business Update (GlobeNewswire) - "Pipeline Program Updates: (i) CX-2051 (EpCAM PROBODY Topo-1 ADC)...The CX-2051 Phase 1 study is ongoing and is evaluating the seventh dose level. Initial Phase 1a data in CRC are expected to be presented in the first half of 2025....; (ii) CX-801 (PROBODY Interferon-alpha 2b):...The Phase 1 study is currently in the fourth monotherapy dose escalation cohort where the dose of CX-801 exceeds the approved dose of the unmasked peginterferon alfa-2b (SYLATRON). Initial Phase 1a translational and biomarker data in advanced melanoma is expected in the second half of 2025."

P1 data • Trial status • Melanoma • Solid Tumor

CytomX Therapeutics Announces 2025 Strategic Pipeline Priorities and Provides Corporate Update (GlobeNewswire) - "Clinical Program Updates and 2025 Milestones:...CX-801 (PROBODY Interferon-alpha 2b): Phase 1 dose escalation is progressing with a focus in metastatic melanoma. The study commenced in the third quarter of 2024 and has reached monotherapy dose levels that exceed the currently approved dose of unmasked interferon-alpha. The study will evaluate safety and initial clinical activity for CX-801 monotherapy and for CX-801 in combination with KEYTRUDA. Initial Phase 1a data are expected in the second half of 2025."

P1 data • Trial status • Melanoma

CytomX Therapeutics Reports Third Quarter 2024 Financial Results and Provides Business Update (GlobeNewswire) - "Third Quarter Business Highlights and Recent Developments:...(i) CX-2051:...The Phase 1 study of CX-2051 was initiated in Q2 2024 and is currently focused in metastatic colorectal cancer....The study is currently enrolling the fifth dose escalation cohort with favorable safety and tolerability having been observed to date. Initial Phase 1a data are expected in the first half 2025...; (ii) CX-801:...Phase 1 dose escalation is ongoing with a primary focus in melanoma. The study will evaluate safety and initial clinical activity for CX-801 monotherapy and for CX-801 in combination with KEYTRUDA. Initial Phase 1a data are expected in the second half of 2025."

P1 data • Trial status • Colorectal Cancer • Melanoma

CytomX Therapeutics Announces First Patient Dosed with CX-801, a Dually-Masked Interferon-Alpha 2b PROBODY, in a Phase 1 Study in Patients with Solid Tumors (GlobeNewswire) - "CytomX Therapeutics, Inc...announced that the first patient has been dosed with CX-801 monotherapy in a Phase 1 study (NCT06462794) in patients with solid tumors. CX-801 is a dually-masked interferon alpha-2b PROBODY cytokine with potential broad applicability in both traditionally immune-oncology sensitive as well as insensitive (cold) tumors....In dose escalation, the Phase 1 study will enroll patients with select solid tumors including advanced melanoma, renal cell carcinoma, and head and neck squamous cell carcinoma to inform a potential decision to move into Phase 1b indication-specific dose expansion cohorts."

Trial status • Genito-urinary Cancer • Head and Neck Cancer • Kidney Cancer • Melanoma • Oncology • Renal Cell Carcinoma • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

KEYNOTE-F95: First In Human Study of CX-801 in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=121 | Recruiting | Sponsor: CytomX Therapeutics | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Metastases • Monotherapy • Oncology • Solid Tumor

CytomX Therapeutics Reports Second Quarter 2024 Financial Results and Provides Business Update (GlobeNewswire) - "Priorities and Key Milestones: (i) CX-904 (EGFRxCD3): Continued Phase 1a dose escalation in PDAC, HNSCC and NSCLC focused on the selection of recommended Phase 1b dose(s); A CX-904 Phase 1 program update is expected by the end of 2024, including a potential decision to initiate Phase 1b expansion cohorts in specific EGFR positive tumor types; (ii) CX-2051 (EpCAM): Continued Phase 1 dose escalation in solid tumors, primarily CRC; Initial Phase 1a data expected in the first half of 2025; (iii) CX-801 (IFNα2b): Continued Phase 1 dose escalation progress in solid tumors including melanoma, renal, and head and neck squamous cell carcinoma. Initial Phase 1a data expected in the second half of 2025."

P1 data • Trial status • Colorectal Cancer • Melanoma • Non Small Cell Lung Cancer • Pancreatic Ductal Adenocarcinoma • Renal Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

First In Human Study of CX-801 in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=121 | Not yet recruiting | Sponsor: CytomX Therapeutics

Combination therapy • Metastases • Monotherapy • New P1 trial • Oncology • Solid Tumor

CytomX Therapeutics Announces Clinical Collaboration with Merck to Evaluate CX-801 in Combination with KEYTRUDA (pembrolizumab) (GlobeNewswire) - "CytomX Therapeutics...announced that it has entered into a clinical trial collaboration and supply agreement with Merck (known as MSD outside of the US and Canada) for CytomX’s first-in-human Phase 1 clinical trial assessing the clinical activity of CX-801, a dually-masked interferon-alpha2b cytokine in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab)....Phase 1 first-in-human study expected to start in first half of 2024. Clinical trial will evaluate CX-801 as monotherapy and in combination with KEYTRUDA in patients with advanced metastatic solid tumors including melanoma, renal cell carcinoma and head and neck squamous cell carcinoma."

Licensing / partnership • New P1 trial • Melanoma • Renal Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

CytomX Therapeutics Reports 2023 Financial Results and Provides Business Update (GlobeNewswire) - "CX-801 (IFNα2b): Initiation of Phase 1 dose escalation in solid tumors including melanoma, renal, and head and neck squamous cell carcinoma is expected in the first half of 2024."

New P1 trial • Genito-urinary Cancer • Head and Neck Cancer • Kidney Cancer • Melanoma • Oncology • Renal Cell Carcinoma • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

CytomX Therapeutics Announces FDA Clearance of IND Applications for CX-2051, a Probody Antibody Drug Conjugate (ADC) Targeting EpCAM and CX-801, a Conditionally Activated Interferon Alpha-2b (GlobeNewswire) - "CytomX Therapeutics...announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) applications for the conditionally activated Probody therapeutics CX-2051, an EpCAM-directed ADC, and CX-801, a dually-masked version of interferon-alpha 2b. CX-2051 has been cleared for the initiation of Phase 1 dose escalation in solid tumors with known EpCAM expression and CX-801 has been cleared for the initiation of Phase 1 dose escalation in solid tumors including melanoma, renal, and head and neck squamous cell carcinoma. Both programs are expected to start Phase 1 studies in the first half of 2024."

IND • New P1 trial • Melanoma • Renal Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

CytomX Therapeutics Outlines 2024 Company Priorities and Milestones (GlobeNewswire) - "CX-2051 (EpCAM): Initiation of Phase 1 dose escalation in solid tumors with known EpCAM expression including metastatic colorectal cancer as one priority indication is expected in the first half of 2024; CX-801 (IFNα2b): Initiation of Phase 1 dose escalation in solid tumors including melanoma, renal, and head and neck squamous cell carcinoma is expected in the first half of 2024."

New P1 trial • Colorectal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Melanoma • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

CytomX Therapeutics Reports Third Quarter 2023 Financial Results and Provides Business Update (GlobeNewswire) - "Preclinically, Probody^® IFN-a2b has demonstrated a widened predicted therapeutic index with an improved tolerability profile compared to unmasked interferon alpha-2b, including preferential anti-cancer activity in the tumor microenvironment and increased anti-tumor effects when combined with checkpoint inhibitors. In November 2023, at the Society for Immunotherapy for Cancer (SITC) 38th Annual Meeting, additional preclinical data were presented demonstrating enhancement of PD-1 anti-tumor efficacy and inflammation of the tumor microenvironment by Probody IFN-a2b. An IND filing for CX-801 is expected by the end of 2023 with planned clinical initiation in 2024....The Phase 2 clinical evaluation of BMS-986288 is ongoing and includes proof of concept studies for microsatellite stable (MSS) colorectal cancer (CRC) and non-small cell lung cancer (NSCLC). BMS anticipates data from the study will be available in 2024."

IND • New trial • P2 data • Preclinical • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

CytomX Therapeutics to Present Preclinical Data for Conditionally Activated Interferon Alpha-2b at the SITC 2023 Annual Meeting (GlobeNewswire) - "CytomX Therapeutics, Inc...today announced that preclinical data supporting CX-801, its conditionally activated cytokine program, will be presented at the Society for Immunotherapy of Cancer (SITC) Annual Meeting in San Diego, California."

Preclinical • Oncology • Solid Tumor

CytomX Therapeutics Reports Second Quarter 2023 Financial Results and Provides Business Update (GlobeNewswire) - "Priorities for 2023: (i) File 2 New INDs (wholly-owned): CX-801 (IFNa2b) and CX-2051 (EpCAM) INDs projected in the fourth quarter of 2023."

IND • Oncology

CytomX Therapeutics Reports Full Year 2022 Financial Results and Provides Business Update (GlobeNewswire) - "IND filings anticipated in 2H 2023 for Wholly Owned CX-801, Interferon (IFN) alpha-2b, and CX-2051, EpCAM-directed ADC."

IND • Oncology • Solid Tumor

CytomX Therapeutics Provides Business Update and Outlines 2023 Company Priorities (GlobeNewswire) - "2023 KEY MILESTONES AND OUTLOOK - CX-904 (EGFRxCD3): Continue patient enrollment and dose escalation in ongoing Phase 1 study; File 2 New INDs: CX-801 (IFNa2b) and CX-2051 (EpCAM) projected in 2H 2023."

IND • Trial status • Oncology • Solid Tumor

CytomX Therapeutics to Present Preclinical Data for Conditionally Activated Interferon Alpha-2b (CX-801) at the SITC 2022 Annual Meeting (GlobeNewswire) - "CytomX Therapeutics...announced that preclinical data for CX-801, its conditionally activated cytokine program, will be presented at the Society for Immunotherapy of Cancer (SITC) Annual Meeting....'We will report encouraging preclinical data that support the development of CX-801 based on its single agent activity as well as its enhanced activity when combined with PD-L1 blockade'."

Preclinical • Oncology

CytomX Therapeutics Reports Second Quarter 2022 Financial Results and Provides Business Update (GlobeNewswire) - "Priorities for 2022/2023: (i) Submit INDs for CX-801 and CX-2051 in the second half of 2023."

IND • Oncology

CytomX Therapeutics Provides Strategic Update (GlobeNewswire) - "CX-801 has broad potential applicability in traditionally immuno-oncology sensitive as well as insensitive (cold) tumors. An IND submission is planned in 2023. EpCAM-directed ADC program - CX-2051 is a wholly-owned conditionally activated ADC directed toward EpCAM, with potential applicability across multiple EpCAM-expressing epithelial cancers. An IND submission is planned in 2023."

IND • Oncology • Solid Tumor