CX-2029 / CytomX - LARVOL DELTA

Phase I Safety Study of Anti-Transferrin Receptor 1 Antibody (PPMX-T003) in Patients with Polycythemia Vera and Erythrocythemia (ASH 2024) - P1 | "Except for an antibody drug conjugate (CX-2029), this is the first-in-class trial of an unmodified human antibody other than a P1a trial using a murine antibody conducted in the 1990s. The clinical effect of PPMX-T003 on human erythroid production is expected to offer an alternative to PLB treatment for patients with PV or erythrocythemia. In the future, it will help further develop its potential for a variety of cancer patients."

Clinical • P1 data • Anemia • Fatigue • Hematological Disorders • Oncology • Polycythemia Vera • JAK2 • TFRC

PROCLAIM-CX-2029: A Trial to Find Safe and Active Doses of an Investigational Drug CX-2029 for Patients With Solid Tumors or DLBCL (clinicaltrials.gov) - P1/2 | N=133 | Completed | Sponsor: CytomX Therapeutics | Active, not recruiting ➔ Completed

Metastases • Trial completion • Diffuse Large B Cell Lymphoma • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hematological Malignancies • Lung Cancer • Lymphoma • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Interim Phase I Safety Study of Anti-Transferrin Receptor Antibody(PPMX-T003) in Patients with Polycythemia Vera (ASH 2023) - P1, P1/2 | "Except for an antibody drug conjugate (CX-2029), this is the first-in-class trial of an unmodified human antibody other than the murine P1a trial conducted in the 1990s. AEs are mild as observed within the level of previous healthy volunteer's trial. Efficacy observed in all erythroid parameters including hematocrit, hemoglobin and other parameter shown symptoms seen in iron deficiency anemia. This antibody can specifically suppress erythrocyte differentiation by inhibiting iron influx in the target erythroid lineage, which cells are highly expressed TfR1, without any significant AE on other normal organs with low expression level of TfR."

Clinical • P1 data • Anemia • Fatigue • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology • Polycythemia Vera • TFRC

CytomX Therapeutics Reports Third Quarter 2023 Financial Results and Provides Business Update (GlobeNewswire) - "Research and development expenses decreased by $14.0 million during the three months ended September 30, 2023, to $16.4 million, compared to $30.4 million for the corresponding period in 2022. The reduction in research and development expenses was primarily due to a decrease in personnel related expenses, as well as winding down of laboratory contract services and clinical study activities related to the CX-2009 and CX-2029 programs, partially offset by an increase in laboratory contract services related to IND enabling activities."

Commercial • Oncology

CytomX Therapeutics, Inc. Enter into a Transition Agreement with AbbVie Global Enterprises Ltd. [Google translation] (Market Screener) - "...CytomX Therapeutics, Inc. a transitional agreement with AbbVie Global Enterprises Ltd. under which the company regained exclusive worldwide rights to the development of CX-2029, a CD71-targeted conditionally activated antibody-based drug conjugate. The Transition Agreement supersedes the recently terminated CD71 co-development and licensing agreement entered into between the Company and AbbVie Ireland Unlimited Company in 2016 and grants certain intellectual property rights of AbbVie to enable further development of CX-2029 by the Company for all human and non-human diagnostic, prophylactic and therapeutic uses....The Transition Agreement will survive on a country-by-country basis until the expiration of the obligation to make payments under the Transition Agreement with respect to CX-2029 in each country, unless terminated earlier by either party in accordance with its terms."

Licensing / partnership • Oncology • Solid Tumor

CytomX Therapeutics Reports First Quarter 2023 Financial Results and Provides Business Update (GlobeNewswire) - "First Quarter Business Highlights and Recent Developments: (i) BMS advancement of BMS-986288 to Phase 2 - In February 2023, BMS published pipeline updates that included moving the Anti-CTLA-4 non-fucosylated Probody®, BMS-986288, from Phase 1 to Phase 2; (ii) CD71-Targeting strategies under evaluation - In March 2023, AbbVie notified CytomX that it would not advance the CD71-targeting, conditionally activated ADC, CX-2029, into additional clinical studies and provided notice of termination of the 2016 CD71 License and Collaboration Agreement."

Licensing / partnership • Phase shift • Oncology • Solid Tumor

CytomX Therapeutics Provides Business Update and Outlines 2023 Company Priorities (GlobeNewswire) - "2023 KEY MILESTONES AND OUTLOOK...CX-2029 (CD71): Determine next steps with AbbVie; BMS CTLA-4: Continued clinical progress on BMS-986249 and BMS-986288; Collaborations: Initiation of R&D activities with our newest collaborators, Regeneron and Moderna."

Pipeline update • Oncology • Solid Tumor

PROCLAIM-CX-2029: A Trial to Find Safe and Active Doses of an Investigational Drug CX-2029 for Patients With Solid Tumors or DLBCL (clinicaltrials.gov) - P1/2 | N=150 | Active, not recruiting | Sponsor: CytomX Therapeutics | Trial completion date: Dec 2022 ➔ Apr 2023 | Trial primary completion date: Dec 2022 ➔ Apr 2023

Metastases • Trial completion date • Trial primary completion date • Diffuse Large B Cell Lymphoma • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hematological Malignancies • Lung Cancer • Lymphoma • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

CytomX Therapeutics Provides Business Update and Outlines 2023 Company Priorities (GlobeNewswire) - P1/2 | N=150 | PROCLAIM-CX-2029 (NCT03543813) | Sponsor: CytomX Therapeutics | "CytomX and AbbVie will determine potential next steps for CX-2029 in 2023....In the 14 patients with squamous esophageal cancer, the ORR was 21.4% (3 patients) and 35.7% (5 patients) had a best response of stable disease (SD)....There were no confirmed responses in E/GEJ patients with non-squamous tumors. 4 patients had a best response of stable disease with two on study greater than 6 months; In the 30 efficacy evaluable patients with sqNSCLC, objective response rate (ORR) by local investigator was 10.0%. 56.7% (17 sqNSCLC patients) of patients had a best response of stable disease; In 28 patients with HNSCC, the confirmed ORR was 4% (1 patient with duration of response of approximately 12 months) and 46.4% (13 patients) had a best response of SD, including one with duration of response of approximately 10 months, and one unconfirmed PR."

P2 data • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

PROCLAIM-CX-2029: A Trial to Find Safe and Active Doses of an Investigational Drug CX-2029 for Patients With Solid Tumors or DLBCL (clinicaltrials.gov) - P1/2 | N=150 | Active, not recruiting | Sponsor: CytomX Therapeutics | Recruiting ➔ Active, not recruiting

Enrollment closed • Diffuse Large B Cell Lymphoma • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hematological Malignancies • Lung Cancer • Lymphoma • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

CytomX Therapeutics Reports Second Quarter 2022 Financial Results and Provides Business Update (GlobeNewswire) - "Priorities for 2022/2023: (i) Provide a data update for the Phase 2 study of CX-2029 in patients with squamous non-small cell lung cancer in the fourth quarter of 2022; (ii) Provide updated data from the Phase 2 study of praluzatamab ravtansine in advanced breast cancer in the fourth quarter of 2022; (iii) Continue enrolling patients with advanced solid tumors in the Phase 1 study of CX-904."

Enrollment status • P2 data • Breast Cancer • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer

Nonclinical efficacy and safety of CX-2029, an anti-CD71 Probody-drug conjugate. (PubMed, Mol Cancer Ther) - "Preclinically, anti-CD71 PDC exhibits a highly efficacious and acceptable safety profile that demonstrates the utility of the Pb-Tx platform to target CD71, an otherwise undruggable target. These data support further clinical development of the anti-CD71 PDC CX-2029 as a novel cancer therapeutic."

Journal • Oncology • TFRC

CytomX Therapeutics Reports First Quarter 2022 Financial Results and Provides Business Update (GlobeNewswire) - "Priorities for 2022: Continue enrolling patients with TNBC in Arms B and C in the Phase 2 study of praluzatamab ravtansine and report initial data from Arms A and B in the second half of 2022; Continue advancing the expansion phase of the Phase 2 study of CX-2029 in collaboration with our partner AbbVie and provide a data update in the second half of 2022; Advance the Phase 1 study of CX-904 in solid tumors."

Enrollment status • P2 data • Trial status • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

CytomX Therapeutics Reports Fourth Quarter and Full Year 2021 Financial Results, and Provides Business Update (GlobeNewswire) - "Priorities for 2022: (i) Initiate a Phase 1 study of CX-904 in advanced solid tumors in the first half of 2022; (ii) Continue patient enrollment in the expansion phase of the Phase 2 study of CX-2029 and provide additional data updates in the second half of 2022; (iii) Report initial data from Arms A and B in the Phase 2 study of praluzatamab ravtansine in patients with breast cancer in the second half of 2022."

Enrollment status • New P1 trial • P2 data • Breast Cancer • Oncology • Solid Tumor

CytomX Therapeutics Announces Preliminary Results for Ongoing Phase 2 Expansion Study of CX-2029, a First-in-Class Antibody-Drug Conjugate Candidate Targeting the Transferrin Receptor, CD71 (PRNewswire) - P1/2, N=150; PROCLAIM-CX-2029 (NCT03543813); Sponsor: CytomX Therapeutics; "In the 16 efficacy evaluable patients with sqNSCLC, objective response rate (ORR) by local investigator was 18.8 percent, including two confirmed partial responses (PRs) and one unconfirmed PR that confirmed seven days after the data cutoff....The disease control rate (DCR), which includes patients with a complete response, PR or stable disease, was 87.5 percent. In the 25 efficacy evaluable patients with HNSCC, there was one confirmed PR (ORR 4.0%) and a DCR of 56.0 percent, including one unconfirmed PR....'We...look forward to completing the expansion phase of the CX-2029 development program and providing further data updates in 2022'."

P2 data • Trial status • Head and Neck Cancer • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

[VIRTUAL] CX-2029, a Probody Drug Conjugate Targeting CD71 in Patients With Selected Tumor Types: PROCLAIM-CX-2029 Dose Expansion Phase (IASLC-WCLC 2020) - P1/2 | "Secondary endpoints include duration of response, progression-free survival, overall survival, safety, and pharmacokinetics. Tumor specimens are required during screening (optional at 3-5 days following the first infusion) for assessment of CD71 parameters and possible correlation with response."

Clinical • Diffuse Large B Cell Lymphoma • Esophageal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hematological Malignancies • Lung Cancer • Lymphoma • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • TFRC

[VIRTUAL] CX-2029, a PROBODY drug conjugate targeting CD71 (transferrin receptor): Results from a first-in-human study (PROCLAIM-CX-2029) in patients (Pts) with advanced cancer. (ASCO 2020) - P1/2 | "The observed safety profile for CX-2029 effectively reduces on-target toxicity for this previously undruggable target, supporting the PROBODY platform. Evidence of anti-tumor activity was observed. Dose escalation continues."

Clinical • P1 data • Fatigue • Leukopenia • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Ocular Melanoma • Oncology • Thoracic Cancer • TFRC

Sarah Cannon to present latest cancer research insights at ASCO20 Virtual Meeting (Businesswire) - "Sarah Cannon announced that it will present its latest cancer research insights at the American Society of Clinical Oncology’s (ASCO®) Annual Meeting being held virtually May 29 – 31, 2020. This year, Sarah Cannon’s drug development and research expertise is featured through more than 110 abstracts and presentations, including data from more than 50 phase 1 studies....Jesus Berdeja, MD...is the discussant on the plenary session focused on 'Carfilzomib, Lenalidomide, and Dexamethasone Versus Bortezomib, Lenalidomide, and Dexamethasone for Initial Therapy of Newly Diagnosed Multiple Myeloma' on Sunday, May 31 from 12-2:30 PM CT. Dr. Berdeja will also highlight data in an oral presentation on 'Update of CARTITUDE-1: A Phase Ib/II Study of JNJ-4528, a B-Cell Maturation Antigen-Directed CAR-T-Cell Therapy, in Relapsed/Refractory Multiple Myeloma.' (Abstract 8505)."

Clinical data • Breast Cancer • Diffuse Large B Cell Lymphoma • Genito-urinary Cancer • Gynecologic Cancers • Hematological Malignancies • Indolent Lymphoma • Lung Cancer • Multiple Myeloma • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Oncology • Ovarian Cancer • Prostate Cancer • Rectal Cancer • Small Cell Lung Cancer • Solid Tumor

Unmasking new promises: expanding the antigen landscape for antibody drug conjugates. (PubMed, Clin Cancer Res) - "Probody therapeutics are masked antibodies that can selectively be activated by proteases in the tumor. CX-2029, is a first in class Probody targeting CD71 with preliminary efficacy and a tolerable safety profile."

Journal • Oncology • TFRC

CytomX Therapeutics Announces Publication of First-in-Human Data for CX-2029 in Clinical Cancer Research (Businesswire) - P1, N=150; NCT03543813; Sponsor: CytomX Therapeutics; “Encouraging preliminary clinical activity was observed at doses of 2 mg/kg and higher. Notably, three of four patients with squamous non-small cell lung carcinoma (NSCLC) had stable disease (SD) or better, including two confirmed partial responses (PRs) (at doses of 3 and 5 mg/kg); and seven of eight patients with head and neck squamous cell carcinoma (HNSCC) had SD or better, including one confirmed PR at 3 mg/kg and one prolonged SD ongoing at approximately 25 weeks, as of the reported August 2020 data cutoff. Despite having received a median of three prior lines of cancer regimens (range, 1–16), these heavily-pretreated patients generally tolerated CX-2029 well…The ongoing Phase 2 expansion study is evaluating CX-2029 as monotherapy in four cohorts…Initial results are expected in the fourth quarter of 2021.”

P1 data • P1/2 data • Diffuse Large B Cell Lymphoma • Esophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Head and Neck Cancer • Hematological Malignancies • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

Phase I, First-in-Human Study of the Probody Therapeutic CX-2029 in Adults with Advanced Solid Tumor Malignancies. (PubMed, Clin Cancer Res) - "The Probody therapeutic platform enables targeting CD71, a previously undruggable ADC target, at tolerable doses associated with clinical activity."

Clinical • Journal • P1 data • Hematological Disorders • Neutropenia • Oncology • Solid Tumor • TFRC

CytomX Therapeutics to Host Virtual Investor Event on April 7, 2021 (GlobeNewswire) - "CytomX Therapeutics, Inc. (Nasdaq: CTMX), a clinical-stage, oncology-focused biopharmaceutical company pioneering a novel class of investigational conditionally activated antibody therapeutics based on its Probody® technology platform, today announced that it will host a virtual investor event at 1:00 p.m. – 3:00 p.m. ET / 10:00 a.m. – 12:00 p.m. PT on Wednesday, April 7, 2021...The event will focus on CytomX’s Probody technology platform and the two conditionally activated ADCs, praluzatamab ravtansine (CX-2009) and CX-2029."

Clinical • Oncology

CytomX Therapeutics Announces Fourth Quarter and Full Year 2020 Financial Results and Provides Business Update (CytomX Press Release) - "Anticipated Events: Report initial data from the praluzatamab ravtansine (CX-2009) Phase 2 study in the fourth quarter of 2021. Report initial data from the CX-2029 Phase 2 expansion study in the fourth quarter of 2021. Submit IND applications for CX-2043 and CX-904 in late 2021. Virtual analyst and investor briefing with Key Opinion Leaders in April 2021 to discuss our Probody technology platform with focus on praluzatamab ravtansine and CX-2029."

Clinical • IND • P2 data • Diffuse Large B Cell Lymphoma • Esophageal Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Head and Neck Cancer • Hematological Malignancies • Lung Cancer • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Oncology • Ovarian Cancer • Solid Tumor

CytomX Therapeutics Announces Proposed Public Offering of Common Stock (GlobeNewswire) - “In particular, CytomX expects to use the net proceeds, together with existing cash resources, to fund: (i) the advancement and expansion of the clinical development program for CX-2009, including the ongoing Phase 2 study of CX-2009 as monotherapy and in combination with CX-072 in breast cancer; (ii) the advancement and expansion of the clinical development program for CX-2029, including the ongoing Phase 2 study of CX-2029 in four types of cancer; (iii) IND enabling studies for CX-2043 and CX-904, their IND submissions and Phase 1 clinical development…”

Commercial • Breast Cancer • Oncology

Investigators from US Oncology Research and McKesson Present Data Highlighting Key Advances in Oncology Research at the 2020 American Society of Clinical Oncology Annual Meeting and Exposition - "'Immunotherapy research continues to expand and the body of evidence, in totality, holds immense promise for the future,' said Dr. Spira. 'There is much to learn yet in the area of precision oncology and targeted therapies, but we are making continued progress towards promising therapies that could yield better results for patients with specific solid tumor mutations.'"

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