Salubris Biotherapeutics Granted EMA Approval to Begin Phase 1 Trial of JK06, a 5T4-Targeted ADC for Solid Tumors
Monday, August 05, 2024
Salubris Biotherapeutics, Inc. (SalubrisBio), a biotech company in the clinical-stage focusing on innovative biologic therapies, has received approval from the European Medicines Agency (EMA) to start a Phase 1 clinical trial for JK06. This trial will assess JK06 in various solid tumors that express the oncofetal protein 5T4.
5T4 is a protein frequently overexpressed in a variety of cancers, including those of the lung, breast, renal, and genitourinary systems. It is associated with poor prognosis and aggressive cancer progression. JK06 is a novel quadrivalent, biparatopic antibody-drug conjugate (ADC) targeting 5T4 with an MMAE payload. It has demonstrated exceptional affinity for 5T4 and efficient internalization in preclinical models, alongside stable, site-specific payload conjugation. These attributes have led to promising efficacy and a favorable safety profile in earlier studies.
Sam Murphy, CEO of SalubrisBio, commented, “We are excited to advance JK06 into clinical trials following EMA’s approval. The preclinical results suggest that JK06 could be a transformative therapy for patients with cancers driven by 5T4, and we look forward to evaluating its potential in clinical settings.”
The Phase 1 study will be open-label, involving dose-escalation and expansion phases to evaluate the safety, pharmacokinetics, and initial efficacy of JK06. Recruitment is anticipated to start in Q3 2024, with plans to enroll up to 155 participants.
Dr. Nuria Kotecki from the Jules Bordet Institute in Brussels emphasized the promise of targeting 5T4, stating, “5T4 is a significant target due to its high expression in various cancers and its association with poor outcomes. JK06’s enhanced binding affinity and specificity have the potential to improve the delivery of cytotoxic agents directly to 5T4-expressing cells. We are eager to further investigate its effectiveness in the upcoming Phase 1 trial.”
Source: salubrisbio.com
