Salubris Biotherapeutics Gets EMA Nod for Phase 1 Trial of JK06 in Solid Tumors

Salubris Biotherapeutics, Inc. (SalubrisBio), a biotechnology company focused on developing innovative biologic treatments, has received approval from the European Medicines Agency (EMA) to start a Phase 1 clinical trial of JK06 in various solid tumors known to express the protein 5T4. This announcement marks a significant milestone for the company.

The 5T4 protein is prominently found in several types of cancer, such as lung, breast, renal, and genitourinary cancers, and its presence is typically linked to poorer patient outcomes and more aggressive disease progression. JK06 is a pioneering quadrivalent, biparatopic antibody drug conjugate (ADC) specifically designed to target 5T4 with an MMAE payload. This drug demonstrates high affinity for 5T4 and is characterized by rapid internalization due to its biparatopic structure. Additionally, JK06's stable, site-specific payload conjugation has shown strong efficacy and a favorable safety profile in preclinical studies.

Sam Murphy, the CEO of SalubrisBio, expressed optimism about JK06, citing its promising therapeutic window observed in preclinical evaluations. He emphasized the drug’s potential to be a groundbreaking therapy for patients with 5T4-associated cancers and expressed excitement about advancing the drug into clinical trials following the EMA’s approval. The Phase 1 study aims to explore JK06's potential to improve patient outcomes.

The clinical trial for JK06 will be an open-label study involving dose-escalation and expansion phases to evaluate the safety, pharmacokinetics, and initial efficacy of the drug. Recruitment for this trial is anticipated to begin in the third quarter of 2024, with plans to enroll up to 155 participants.

Dr. Nuria Kotecki from the Jules Bordet Institute in Brussels highlighted the significance of 5T4 as a tumor target. She noted that 5T4 is highly expressed in various cancer cells but not in normal adult tissues, and its upregulation is associated with cancer heterogeneity, aggressiveness, and metastatic potential. These factors contribute to the difficulty in treating such cancers. Dr. Kotecki expressed enthusiasm for JK06’s potential to enhance binding affinity and specificity, thereby allowing for more effective delivery of cytotoxic agents directly to 5T4-expressing cells. She looks forward to further evaluating JK06’s utility in the upcoming clinical trial.

SalubrisBio is known for its dedication to discovering and developing complex biologics aimed at treating cardiovascular, oncology, and neurodegenerative diseases. The company is currently advancing several innovative therapeutics through clinical development. These include JK07, which is considered a potential first disease-modifying biologic for heart failure; JK08, an IL15-CTLA4 antibody fusion designed to broaden the therapeutic window for these potent immune-stimulating agents in cancer treatment; and JK06, the quadrivalent, biparatopic ADC targeting 5T4 for cancer treatment. SalubrisBio is based in Gaithersburg, Maryland.