ADCE-T02 / Multitude Therap, Adcendo - LARVOL DELTA

Tiffany-01: ADCE-T02, a Tissue Factor Targeted Antibody-Drug Conjugate, in Patients With Selected Advanced Solid Tumours (clinicaltrials.gov) - P1 | N=210 | Recruiting | Sponsor: Adcendo ApS | Trial completion date: Dec 2026 ➔ Jun 2027 | Trial primary completion date: Jun 2026 ➔ Mar 2027

First-in-human • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Adcendo ApS Announces Clinical Collaboration and Supply Agreement with MSD to Evaluate ADCE-T02 in Combination with KEYTRUDA (Pembrolizumab) in a Phase Ib Study in Patients with Advanced Solid Tumors (PRNewswire.co.uk) - "Under the terms of the Agreement, MSD will provide pembrolizumab to Adcendo, which will be the sponsor of the Phase Ib clinical combination trial. Adcendo and MSD each retain all commercial rights to their respective compounds, including as monotherapy or as combination therapies...Adcendo anticipates dosing the first patient in the Phase Ib combination study in 2H 2026 and will investigate the safety, tolerability and preliminary efficacy of escalating doses of ADCE-T02 in combination with standard dose pembrolizumab in patients with advanced solid tumors."

Licensing / partnership • New P1 trial • Solid Tumor

ADCE-T02 - A clinical stage antibody drug conjugate targeting tissue factor demonstrates strong efficacy in preclinical models of head and neck squamous cell carcinoma (AACR 2026) - P1 | "The TF-targeted ADC Tisotumab vedotin is approved for treatment of cervical cancer and has demonstrated efficacy in Head and Neck Squamous Cell Carcinoma (HNSCC)1, but treatment is limited by substantial side effects including ocular toxicities, peripheral neuropathy, and bleeding warranting development of a more efficacious and better tolerated modality.ADCE-T02 is a clinical stage TF-targeted ADC composed of a humanized anti-TF antibody specifically designed to limit the impact on blood coagulation, conjugated via a novel T1000 linker moiety to the Topoisomerase-1 inhibitor Exatecan payload at a drug-to-antibody ratio of ~4.The expression level of TF was evaluated in patients with HNSCC, confirming broad and high TF expression in the majority of tumors, regardless of Human Papilloma Virus (HPV) status. A phase I clinical study of ADCE-T02 in patients with advanced solid tumors is currently ongoing and actively recruiting (Clinical Trial ID NCT06597721).1Sun et..."

ADC • Preclinical • Cervical Cancer • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

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..."

ADC • 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

ADCE-T02 - a Next Generation Antibody Drug Conjugate Targeting Tissue Factor Demonstrates Superior Preclinical Efficacy and Tolerability. (PubMed, Mol Cancer Ther) - P1 | "The TF-ADC tisotumab vedotin is approved for cervical cancer treatment but induces substantial side effects including ocular toxicities, peripheral neuropathy, and bleeding, limiting its further clinical development and warranting optimized ADC design to improve the therapeutic window. In summary, ADCE-T02 constitutes a novel TF ADC with a much improved preclinical therapeutic window. Phase I clinical development of ADCE-T02 in patients with advanced solid tumors is ongoing (ClinicalTrials-ID NCT06597721)."

Journal • Preclinical • Cervical Cancer • Head and Neck Cancer • Oncology • Pain • Pancreatic Cancer • Solid Tumor

Two ADCE-T02 publications highlighting important preclinical results at the 2026 AACR Annual Meeting (PRNewswire) - "The poster...(Poulsen, et al) will be presented on April 22, 2026, from 9:00am to 12:00pm PT....The published manuscript highlights the unique design of ADCE-T02 facilitating a strong in vivo efficacy in a range of preclinical models and good tolerability in non-human primates, showing no evidence of ocular, skin and lung toxicity, peripheral nerve damage, or bleedings. These data further support the clinical development of ADCE-T02 as a novel TF-targeting ADC with a potentially superior therapeutic window."

Preclinical • Squamous Cell Carcinoma of Head and Neck

Adcendo ApS Completes $75 Million Series C Financing to Continue Advancing First- and Best-in-class Clinical ADC Pipeline (Adcendo Press Release) - "Proceeds from the fundraise will be used to support Adcendo through multiple upcoming key clinical milestones from the Company’s first- and best-in-class ADC pipeline, including the ADCE-T02 (Tissue Factor ADC) Phase I Tiffany-01 Cohort expansion study in multiple high unmet need tumor indications, the ADCE-D01 (uPARAP) ADCElerate1 dose escalation and expansion study in soft tissue sarcoma and other cancers of mesenchymal origin, and the ADCE-B05 (undisclosed target) dose escalation study in squamous cell carcinomas."

Financing • Soft Tissue Sarcoma • Solid Tumor • Squamous Cell Carcinoma

Adcendo ApS Provides Updates on Pipeline Progress and Recent Achievements for Its First- and Best-in-Class Antibody-Drug Conjugates (PRNewswire) - "The first patients have now been enrolled in the cohort expansion portion of Tiffany-01 across multiple solid tumor indications. The expansion cohorts are designed to evaluate two go-forward dose levels in a randomized setting, supporting dose optimization and enabling additional assessments of safety, anti-tumor activity, and durability of response. These data are expected to further clinical proof of concept and better inform the potential therapeutic profile of ADCE-T02 across multiple solid tumor indications."

Trial status • Colorectal Cancer • Head and Neck Cancer • Non Small Cell Lung Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Tiffany-01: ADCE-T02, a Tissue Factor Targeted Antibody-Drug Conjugate, in Patients With Selected Advanced Solid Tumours (clinicaltrials.gov) - P1 | N=210 | Recruiting | Sponsor: Adcendo ApS | N=66 ➔ 210

Enrollment change • Solid Tumor

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