Salubris Biotherapeutics, Inc. (SalubrisBio), a clinical-stage biotechnology company focused on developing innovative biologic therapeutics, announced today that it has received approval from the European Medicines Agency (EMA) to commence a Phase 1 clinical trial of JK06 in various solid tumors that express 5T4. 5T4 is an oncofetal protein overexpressed in a range of cancers, including lung, breast, renal, and genitourinary tumors, and is linked to poor prognosis and aggressive tumor growth.
JK06 is a first-in-class quadrivalent, biparatopic antibody-drug conjugate (ADC) designed to target 5T4 with an MMAE payload. The biparatopic design grants JK06 picomolar affinity for 5T4 and rapid internalization. Coupled with stable, site-specific payload conjugation, JK06 has shown robust efficacy and a favorable safety profile in preclinical studies.
“JK06 has demonstrated an exceptional therapeutic window in non-clinical evaluations, and we believe it has the potential to be a first-in-class and differentiated therapy for patients with 5T4-associated cancers,” said Sam Murphy, Chief Executive Officer of SalubrisBio. “We are excited to advance into clinical trials following the EMA’s approval and explore JK06’s potential to improve patient outcomes.”
The Phase 1 study will be an open-label, dose-escalation and expansion trial to assess the safety, pharmacokinetics, and preliminary efficacy of JK06. Recruitment for the trial is expected to begin in Q3 2024, with plans to enroll up to 155 participants.
“5T4 is a highly promising tumor target, predominantly expressed on cancer cells across multiple tumor types rather than normal adult tissue, and is correlated with poor prognosis. Its upregulation contributes to cancer heterogeneity, aggressiveness, and metastatic potential, making these cancers challenging to treat,” said Dr. Nuria Kotecki from the Jules Bordet Institute in Brussels. “JK06 holds significant therapeutic potential by enhancing binding affinity and specificity, enabling more effective delivery of cytotoxic agents directly to 5T4-expressing cells. We look forward to evaluating its utility in the Phase 1 clinical trial.
