ADCE-T02 / Multitude Therap, Adcendo - LARVOL DELTA

ADCE-T02: A first-in-class topoisomerase-1 inhibitor based antibody drug conjugate against tissue factor demonstrates excellent preclinical efficacy and tolerability (AACR 2025) - P1 | "The TF-ADC tisotumab-vedotin (Tivdak®) has been approved for treatment of cervical cancer but is associated with serious side effects including ocular toxicities, peripheral neuropathy, and bleeding.ADCE-T02 is a first-in-class Topoisomerase-1 inhibitor TF-ADC composed of a humanized anti-TF IgG1 monoclonal antibody (Ab-754), conjugated via a novel T1000 linker moiety to the Topoisomerase-1 inhibitor Exatecan payload at a drug-to-antibody ratio (DAR) of 4.ADCE-T02 binds with high affinity to human recombinant TF protein and multiple TF positive cell lines. In vivo, ADCE-T02 shows strong anti-tumor activity in a wide range of solid tumor models including pancreatic cancer, esophageal squamous cell carcinoma, NSCLC and HNSCC and is well tolerated in non-human primate toxicology studies with no evidence of ocular toxicity, peripheral neuropathy, or bleeding.In summary, ADCE-T02 constitutes a novel first-in-class Topoisomerase-1 inhibitor ADC targeting TF with a..."

Preclinical • Cervical Cancer • Colorectal Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Adcendo ApS to Present Data on its Clinical Stage ADCs ADCE-T02 and ADCE-D01 at the 2025 American Association for Cancer Research (AACR) Annual Meeting (PRNewswire) - "Adcendo ApS...will be presenting data on its two novel ADC programs ADCE-T02, targeting Tissue Factor, and ADCE-D01, targeting uPARAP, at the American Association for Cancer Research (AACR) Annual Meeting, held in Chicago, Illinois, from April 25th to April 30th, 2025."

Preclinical • Oncology • Solid Tumor

Adcendo ApS Announces U.S. FDA Clearance of IND Application for Phase I Tiffany-01 Trial of ADCE-T02 (PRNewswire) - "Adcendo...announced that the U.S. Food & Drug Administration (FDA) has provided clearance of the IND application for a Phase I study evaluating ADCE-T02 in patients with advanced solid tumors. Tiffany-01 is an ongoing first-in-human Phase I multicenter, open-label, dose escalation study of ADCE-T02 as a monotherapy in patients with advanced solid tumors."

IND • Oncology • Solid Tumor

ADCE-T02, a Tissue Factor Targeted Antibody-Drug Conjugate, in Patients With Selected Advanced Solid Tumours (clinicaltrials.gov) - P1 | N=66 | Recruiting | Sponsor: Adcendo ApS | N=50 ➔ 66 | Not yet recruiting ➔ Recruiting

Enrollment change • Enrollment open • Oncology • Solid Tumor

Adcendo ApS Completes Oversubscribed $135 Million Series B Financing to Advance First-in-class ADC Pipeline (PRNewswire) - "Adcendo...announced the successful closing of an oversubscribed $135 million Series B financing round. Proceeds from the fundraise will be used to advance, broaden, and accelerate the development of the Company's first-in-class ADC pipeline, including the ADCE-T02 (Tissue Factor ADC), ADCE-D01 (uPARAP ADC), ADCE-B05 and A0401 programs. The financing round was led by TCGX, with participation from new investors TPG Life Sciences Innovations, Orbimed Advisors, Venrock Healthcare Capital Partners, Surveyor Capital (a Citadel company), and Logos Capital, as well as all existing investors, including RA Capital Management, Novo Holdings, Pontifax Venture Capital, Dawn Biopharma, a platform controlled by KKR, HealthCap, Gilde Healthcare and Ysios Capital."

Financing • Oncology

AMT-754 in Patients With Selected Advanced Solid Tumours (clinicaltrials.gov) - P1 | N=50 | Not yet recruiting | Sponsor: Multitude Therapeutics Inc.

Metastases • New P1 trial • Oncology • Solid Tumor

Adcendo ApS and Multitude Therapeutics Inc. Announce Global Development and Commercialization Agreement on First-in-class ADC Drug Candidate Targeting Tissue Factor (PRNewswire) - "Adcendo ApS...and Multitude Therapeutics Inc...jointly announced today that they have signed a licensing agreement for the development...with the development code ADCE-T02. Under this agreement, Adcendo will obtain the exclusive development and commercialization rights for the asset globally, except for the Greater China region...where Multitude will retain development and commercialization rights. According to the financial terms of the agreement, Multitude would receive upfront and milestone payments upon achieving development, regulatory, and commercial milestones totally over $1 billion, as well as single-digit to low double-digit tiered royalties on potential future product sales....Clinical Trial Notification for ADCE-T02 has been submitted in Australia, and an IND application in the United States is planned in the near future. The start of the Phase I study in Australia is expected in Q4 2024."

Licensing / partnership • New P1 trial • Oncology