TUB-030 / Tubulis - LARVOL DELTA

EXPRESSION OF ONCOFETAL ANTIGEN 5T4 IN SARCOMA SUBTYPES AND PRECLINICAL ACTIVITY OF TUB-030, A NOVEL 5T4-TARGETING ANTIBODY-DRUG CONJUGATE (ADC) (CTOS 2025) - P1/2 | "5T4 is broadly expressed in sarcoma subtypes and preclinical data provide rationale for further investigation of TUB-030 in patients with sarcomas."

Preclinical • Fibrosarcoma • Leiomyosarcoma • Liposarcoma • Oncology • Osteosarcoma • Rhabdomyosarcoma • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Undifferentiated Pleomorphic Sarcoma • Uterine Leiomyosarcoma • TPBG

Tubulis Raises €308 Million Series C to Accelerate Clinical Development of Lead ADC Candidate TUB-040 and Expand Pipeline (Yahoo Finance) - "The proceeds from the Series C financing will be used to expand the clinical development of TUB-040, Tubulis’ lead antibody-drug conjugate (ADC) candidate, into earlier lines of therapy and additional tumor indications....The capital will also advance Tubulis’ pipeline, including the clinical-stage ADC candidate TUB-030, several preclinical programs, and expand its proprietary ADC platform technologies to bring ADCs into novel applications."

Financing • Platinum resistant • Non Small Cell Lung Cancer • Ovarian Cancer

TUB-030, a Novel Adc: A Phase I/IIA Multi-Center, FIH Trial (5-STAR 1-01) in Patients With Advanced/Metastatic Solid Tumors (IASLC-WCLC 2025) - P1/2 | "Backfill cohorts in NSCLC are planned to evaluate the safety and efficacy profile at doses at or below the MTD. In Phase IIa, dose-optimization will evaluate two or more dose levels to identify the recommended Phase II dose for further development."

Clinical • Metastases • P1/2 data • Lung Cancer • Malignant Pleural Mesothelioma • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Pleural Mesothelioma • Small Cell Lung Cancer • Solid Tumor • TPBG

TUB-030, a novel ADC targeting 5T4: A phase I/IIa multi-center, first-in-human clinical trial (5-STAR 1-01) in patients with advanced solid tumors. (ASCO 2025) - P1/2 | "Enrollment of approximately 130 patients across the US and Canada is planned, with dose escalation currently underway. This study investigates TUB-030, a novel 5T4 targeted ADC as a therapy for advanced/metastatic solid tumors."

Clinical • Metastases • P1/2 data • Bladder Cancer • Breast Cancer • Cervical Cancer • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Genito-urinary Cancer • Head and Neck Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Malignant Pleural Mesothelioma • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Osteosarcoma • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pleural Mesothelioma • Prostate Cancer • Sarcoma • Small Cell Lung Cancer • Soft Tissue Sarcoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • HER-2 • STAR • TPBG

Tubulis Announces First Patient Dosed in Phase I/IIa Trial Evaluating ADC TUB-030 in Advanced Solid Tumors (Businesswire) - "Tubulis announced today that its second drug candidate, TUB-030, has entered clinical evaluation with successful dosing of the first patient in the 5-STAR 1-01 Phase I/IIa trial (NCT06657222). The study is evaluating TUB-030, Tubulis’ next-generation antibody-drug conjugate (ADC), in patients with advanced solid tumors....The trial will enroll a total of 130 patients and will be conducted at sites across the US and Canada."

Trial status • Solid Tumor

5-STAR 1-01: First in Human Study of TUB-030 in Patients with Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=130 | Recruiting | Sponsor: Tubulis GmbH | Not yet recruiting ➔ Recruiting

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

First in Human Study of TUB-030 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=130 | Not yet recruiting | Sponsor: Tubulis GmbH

New P1/2 trial • Breast Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

Enabling 5T4 for targeted cancer therapy: TUB-030, a novel ADC built with ethynylphosphonamidate conjugation chemistry, shows long-lasting anti-tumor activity via Topoisomerase-I inhibition with an optimized therapeutic index (AACR 2024) - "Preliminary repeat-dose toxicological assessment of TUB-030 in a pharmacologically relevant non-human primate species demonstrated that TUB-030 is well tolerated. The preclinical results underline that TUB-030 with novel ADC technology has the potential to enable 5T4 as a therapeutic target and provide treatment options in numerous solid cancer indications with high unmet medical need supporting further development towards the clinic."

Bladder Cancer • Oncology • Solid Tumor • TOP1 • TPBG

Tubulis Presents Preclinical Data for Solid Tumor Targeting ADC Candidates TUB-030 and TUB-040 Demonstrating Superior Efficacy Profile and a Wide Therapeutic Window at the AACR Annual Meeting 2024 (Businesswire) - "Tubulis...presented comprehensive preclinical data on its two lead antibody-drug conjugate (ADC) candidates TUB-030 and TUB-040 at this year’s Annual Meeting of the American Association for Cancer Research....TUB-030:...A single treatment with TUB-030 was shown to eliminate tumors in a triple negative breast cancer mouse model, whereas PF06263507, a clinically tested comparator ADC led to re-growth of tumors. In over 25 patient derived xenograft mouse models of various types of cancer, TUB-030 showed high efficacy rates even at low 5T4 expression levels and achieved long-lasting and durable anti-tumor activity. TUB-030 was well tolerated in non-human primates and showed highly restricted binding to normal fresh frozen human tissues."

Preclinical • Triple Negative Breast Cancer

Tubulis Closes Upsized €128 Million Series B2 to Accelerate Clinical Development of Solid Tumor-Focused ADC Pipeline (Businesswire) - "The proceeds of the Series B2 will primarily support progress in Tubulis’ pipeline of next-generation ADCs toward clinical evaluation and help achieve clinical proof-of-concept for lead candidates, TUB-040 and TUB-030...The company expects to start its first Phase 1/2a clinical trial, including dose escalation and dose optimization cohorts in 2024."

Financing • New P1/2 trial • Lung Cancer • Ovarian Cancer

Tubulis to Present Preclinical Proof-of-Concept Data for Two Lead ADC Candidates Targeting Solid Tumors at the AACR Annual Meeting 2024 (Businesswire) - "The poster will highlight the pre-clinical proof-of-concept data for TUB-030, an ADC that targets the oncofetal 5T4 antigen....TUB-030 has shown strong cytotoxicity towards cancer cells from different tumor indications with a broad range of 5T4 expression levels. Pharmacokinetic analysis further demonstrated the highly stable profile of TUB-030, enabling the efficient delivery of the payload to the tumor."

Preclinical • Solid Tumor