Accession Therapeutics Limited announced it has dosed the first patient in its Phase 1 clinical trial evaluating TROCEPT-01 (ATTR-01), marking a significant milestone for the company's proprietary TROCEPT platform technology. The patient has completed the treatment cycle, representing a major step forward in developing what could be a transformative treatment for solid tumors.
Novel Tumor-Activated Viral Immunotherapy Mechanism
TROCEPT-01 (ATTR-01) represents a first-in-class, tumor-activated viral immunotherapy that delivers a genetically encoded immune checkpoint inhibitor (anti-PD-L1) directly to tumor cells following systemic administration. The therapy is designed to selectively generate a clinically validated checkpoint inhibitor within tumors by targeting αvβ6 integrin on epithelial tumors, optimizing efficacy while minimizing damage to healthy tissue.
This innovative approach enables cancer cells to locally produce and secrete therapeutic proteins within the tumor microenvironment, creating a potent anti-tumor response while minimizing systemic exposure. Unlike conventional immunotherapies administered systemically, TROCEPT-01's tumor-targeted mechanism has demonstrated in preclinical studies the potential to enhance drug concentration at the tumor site compared to healthy tissues, significantly improving the therapeutic window.
ATTEST Trial Design and Objectives
The ATTEST trial is an open-label, dose-escalation and dose expansion study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of TROCEPT-01 (ATTR-01) in patients with advanced carcinomas who have had at least one prior treatment course. The trial is being conducted at leading clinical sites across the UK, with additional trial sites planned for activation as the study progresses, including in Spain where there is established expertise in treating solid tumors.
Professor Adel Samson, Professor of Cancer Medicine and Immunotherapy at Leeds University School of Medicine and lead investigator in the ATTEST study, expressed enthusiasm about the therapy's potential: "As a clinician, I am very excited about the potential of TROCEPT-01 (ATTR-01) and the TROCEPT platform to increase clinical response rates through high tumour-localised production of anti-cancer drugs. This program is targeted at solid tumours where there is significant need for better treatment outcomes."
Preclinical Evidence and Therapeutic Potential
Preclinical studies have demonstrated strong anti-tumor activity across multiple solid tumor models, supporting TROCEPT-01's potential as a targeted therapy for aggressive cancers. The therapy is designed to overcome limitations of current checkpoint inhibitors by increasing response rates in immunologically "cold" tumors and reducing off-target immune-related adverse events.
Administered intravenously, TROCEPT-01 represents a promising new modality in cancer treatment, with potential applications across multiple solid tumor types. The approach addresses significant unmet medical needs in oncology by potentially expanding the indications where checkpoint inhibitors have been successful.
Company Leadership Perspectives
Bent Jakobsen, PhD FMedSci, CEO of Accession Therapeutics, highlighted the significance of this milestone: "Dosing the first patient in our TROCEPT-01 clinical trial is a pivotal moment for Accession Therapeutics and a testament to the dedication of our team and collaborators. In TROCEPT, we have created a unique, highly versatile platform that enables novel drugs to be made inside cancer cells. The platform gives us multiple opportunities to generate valuable products to transform outcomes for cancer patients. TROCEPT-01 (ATTR-01) has the potential to expand the indications where checkpoint inhibitors have been successful."
Professor Hardev Pandha, FRCP, FRACP, PhD, Medical Director of Accession Therapeutics, added: "TROCEPT-01 (ATTR-01) represents a novel approach to target hard-to-treat cancers, and we are excited to advance this promising therapy into clinical development. We anticipate the clinical data will show that the virus gets to the tumours when given systemically, and that the drug is produced within the tumours. Our goal in the ATTEST study is to establish a strong safety profile while identifying early signals of efficacy to benefit patients with limited treatment options."
Company Background
Accession Therapeutics is a clinical-stage biopharmaceutical company developing a novel class of tumor-targeted immunotherapies through its proprietary TROCEPT platform. Since its inception in 2021, the company has raised $70 million to advance its TROCEPT technology and programs. The company is advancing a pipeline of first-in-class therapies designed to transform cancer treatment by enabling localized production of therapeutic proteins within tumors while minimizing systemic exposure, potentially offering superior efficacy and safety profiles to existing immuno-oncology approaches.
