— A novel, first-in-class non-oncolytic arenavirus-based strategy designed to achieve targeted, potent, and lasting anti-cancer effects against both primary tumors and metastatic sites –
— The Phase 1 trial aims to assess the safety and tolerability of ABX-001 and determine the appropriate Phase 2 dose in individuals with refractory or relapsed solid tumors —
Düsseldorf, Germany, October 23, 2025 – Abalos Therapeutics today announced the administration of the first dose to a patient in its inaugural human clinical study. This study involves individuals with advanced solid tumors who have exhausted all standard treatment options. The trial is evaluating ABX-001, the company’s lead candidate, which is a non-lytic viroimmunotherapy designed to systematically stimulate robust innate (immediate) and adaptive (memory) immune responses against cancer cells, and to actively direct immune cells into the tumor microenvironment. In preclinical investigations, ABX-001 demonstrated enhanced tumor T cell infiltration and T cell-mediated anti-tumor efficacy, alongside an encouraging safety profile.
“Becoming a clinical-stage company represents a significant validation of Abalos’ scientific methodology and the dedication of our team, propelling us forward in our mission to address existing limitations in immunotherapy for a broad spectrum of cancer patients,” stated Gerben Moolhuizen, CEO at Abalos. “We believe ABX-001 possesses distinctive immunostimulatory and anti-tumoral attributes, facilitated by its persistent and sustained replication within cancerous and antigen-presenting cells, without causing their destruction. Through this innovative approach, our goal is to safely engage all critical immune organs in a coordinated assault against a patient’s tumor, including migrating and metastasized cancer cells. This initial human trial will lay a crucial groundwork for the subsequent clinical advancement of ABX-001. We are enthusiastic about its potential benefit for patients and anticipate providing further updates as the study progresses.”
The Phase 1 clinical trial is a first-in-human, open-label, multicenter study focused on evaluating the safety and tolerability, and establishing the recommended Phase 2 dose (RP2D) of ABX-001. It is administered intravenously as a monotherapy to approximately 18 patients suffering from refractory or relapsed advanced solid tumors. Participants will receive a single intravenous dose of ABX-001 via a dose-escalation protocol. In addition to safety and tolerability, preliminary indicators of efficacy will be assessed. These include overall response (OR) based on RECIST 1.1 criteria and immune RECIST, as well as the best percentage change from baseline in the size of target lesions, measured up to 12 weeks from the start of treatment.
The commencement of this clinical trial follows the recent publication of preclinical proof-of-concept data for ABX-001 in a peer-reviewed journal. Across various murine tumor in vivo models, ABX-001 exhibited powerful anti-tumoral efficacy by promoting the expansion of tumor-specific T cells and inducing immune-activating cytokines, including type I interferons. Treatment of non-human primates (NHP) with ABX-001 resulted in markedly increased levels of immunostimulatory cytokines and chemokines, alongside a significant expansion of CD4+ and CD8+ T cells. Abalos’ lead investigational drug demonstrated a highly favorable safety profile, characterized by minimal viral replication in healthy tissues and the absence of severe disease symptoms in mice and NHPs that are highly susceptible to wild-type arenavirus.
About Abalos Therapeutics
Abalos Therapeutics is at the forefront of developing a novel anti-cancer strategy that harnesses the full potential of the immune system, directing its power specifically against cancer cells. Abalos’ drug candidates, based on arenaviruses, are engineered to elicit precise innate and adaptive immune responses from within the tumor itself. These candidates engage all relevant immune cell types in a coordinated attack on both the primary tumor and distant metastases, actively guiding them into the cancerous tissue. Abalos’ leading product candidate, ABX-001, has demonstrated robust anti-tumor efficacy in preclinical studies across multiple tumor models and an excellent preclinical safety profile. It is currently undergoing evaluation in a Phase 1 trial for various solid tumors. Under the leadership of seasoned biotech entrepreneurs and immunology pioneers, Abalos’ ambition is to establish a new therapeutic class within immuno-oncology. For more details, please visit .
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