GAITHERSBURG, Md.--(BUSINESS WIRE)--Salubris Biotherapeutics, Inc. (SalubrisBio), a clinical-stage biotechnology company dedicated to discovering and developing novel complex biologic therapeutics, today announced 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.
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.”
About SalubrisBio
SalubrisBio is a clinical-stage biotechnology company dedicated to discovering and developing complex biologics for cardiovascular, oncology, and neurodegenerative diseases. The Company is currently progressing multiple innovative and rationally designed first-in-class therapeutics through clinical development programs, including JK07, the potential first disease-modifying biologic for heart failure; JK08, an IL15-CTLA4 antibody fusion designed to expand the therapeutic window for these two potent immune-stimulating agents in cancer treatment; and JK06, a quadrivalent, biparatopic ADC targeting 5T4 for the treatment of cancer. SalubrisBio is headquartered in Gaithersburg, Maryland. For more information about SalubrisBio, visit us at www.salubrisbio.com and connect with us on LinkedIn.
