GS-8823 / Gilead - LARVOL DELTA

Gilead Sciences Completes Acquisition of Tubulis Further Strengthening Oncology Portfolio (Businesswire) - "The acquisition brings Gilead next-generation ADC assets and a platform designed to maximize patient benefit through more selective delivery of diverse payloads to tumors....The addition of Tubulis’ lead asset, TUB-040, a NaPi2b-directed topoisomerase-I inhibitor (TOPO1i) ADC, which has demonstrated promising activity in platinum-resistant ovarian cancer, and TUB-030, a 5T4-directed ADC that is being investigated across various solid tumor types, complements Gilead’s existing ADC portfolio....Under the terms of the agreement, Gilead acquired all the outstanding equity of Tubulis for $3.15 billion in upfront considerations on a cash-free, debt-free basis, and up to $1.85 billion in contingent milestone payments."

M&A • Platinum resistant • Ovarian 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."

ADC • Bladder Cancer • Oncology • Solid Tumor • TOP1 • TPBG

Gilead to Acquire Tubulis Adding Potentially Best-in-Class Antibody-Drug Conjugate and Next Generation Platform to Further Strengthen Oncology Pipeline (Businesswire) - "Acquisition Adds TUB-040, a NaPi2b Targeting ADC for Ovarian Cancer and other Solid Tumors, to Gilead Pipeline....Gilead will also acquire TUB-030, a 5T4 targeted ADC, which has demonstrated promising initial clinical data across various solid tumor types....Closing of the transaction is subject to expiration or termination of certain regulatory filings and other customary conditions. The transaction is expected to close in the second quarter of 2026."

Licensing / partnership • Platinum resistant • Non Small Cell Lung Cancer • Ovarian Cancer

5-STAR 1-01: First in Human Study of TUB-030 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=250 | Recruiting | Sponsor: Tubulis GmbH | N=130 ➔ 250

Enrollment change • First-in-human • Breast Cancer • Head and Neck Cancer • Hormone Receptor Positive Breast 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

5-STAR 1-01: A Study to Test the Safety and Effects of a New Cancer Drug (TUB-030) in Patients with Advanced Solid Tumors (clinicaltrialsregister.eu) - P1/2 | N=90 | Recruiting | Sponsor: Tubulis GmbH

First-in-human • New P1/2 trial • Breast Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • CD4 • MSI

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

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