On August 5, 2024 Salubris Biotherapeutics, Inc. (SalubrisBio), a clinical-stage biotechnology company dedicated to discovering and developing novel complex biologic therapeutics, reported it has received approval from the European Medicines Agency (EMA) to initiate a Phase 1 clinical trial of JK06 in a basket of solid tumors known to express 5T4 (Press release, Salubris Biotherapeutics, AUG 5, 2024, View Source [SID1234645345]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
5T4 is an oncofetal protein that is overexpressed in a wide range of tumor types, including lung, breast, renal and genitourinary cancers, and is associated with a poor prognosis and more aggressive tumor progression. JK06 is a first-in-class quadrivalent, biparatopic antibody drug conjugate (ADC) that selectively targets 5T4 with an MMAE payload. JK06 has demonstrated picomolar affinity for 5T4 and rapid internalization due to the biparatopic design. Together with stable, site-specific payload conjugation, JK06 has further demonstrated robust efficacy and a clean safety profile in non-clinical studies.
"JK06 has shown an exceptional therapeutic window in non-clinical evaluation, 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 thrilled to be advancing into the clinic following the EMA’s decision and explore JK06’s ability to improve outcomes for patients."
JK06 will be evaluated in an open-label, dose-escalation and expansion study to assess the safety, pharmacokinetics, and preliminary efficacy of JK06. Phase 1 recruitment is expected to commence in Q3 2024, with up to 155 subjects planned for enrollment.
"5T4 is a very promising tumor target, highly expressed on tumor cells from multiple cancer types as opposed to normal adult tissue and correlated with poor prognosis. 5T4 upregulation is playing a major role in the cancer heterogeneity, aggressiveness and metastatic potential, all of which are key factors that make these cancers harder to treat," said Dr Nuria Kotecki, from Jules Bordet Institute in Brussels. "JK06 holds significant therapeutic potential by enhancing binding affinity and specificity, allowing for more effective delivery of cytotoxic agents directly to 5T4 cells, and we look forward to further evaluating it’s utility in the Phase 1 clinical trial."