S*BIO begins SB1317 Phase 1 clinical trial in patients with advanced/refractory hematologic malignancies

S*BIO Pte Ltd today announced that a fourth novel, potential best-in-class compound discovered and developed by S*BIO has entered a Phase 1 clinical trial. The initiation of the study for S*BIO's oral multi-kinase inhibitor, SB1317 or TG02, in patients with advanced/refractory hematologic malignancies has triggered a payment from S*BIO's development and commercialization partner for the program, Tragara Pharmaceuticals.

"The advancement of our unique oral multi-kinase inhibitor into the clinic indicates the promising biological activities of S*BIO's pre-clinical compounds," said Dr. Jan-Anders Karlsson, CEO of S*BIO. "SB1317 has a unique kinase inhibitory spectrum with excellent pharmaceutical properties for the potential treatment of acute leukemia, multiple myeloma and several solid tumors including breast cancer, small-cell lung cancer and colon cancer. S*BIO intends to utilize the proceeds to further advance its clinical program."

In January 2009, S*BIO granted a worldwide exclusive license to Tragara to develop and commercialize SB1317. Under the terms of the agreement S*BIO was eligible to receive up to US$112.5 million in payments. This included an upfront fee, development and sales milestone payments and up to double-digit royalties. Additionally, S*BIO would perform certain preclinical activities for Tragara under a defined workplan in return for research fees. Tragara was responsible for all IND enabling, development and commercialization activities under the agreement.

Tragara will conduct the Phase 1 study at multiple clinical centers in the U.S. SB1317 will be administered orally to patients with advanced leukemia over a range of doses on two separate schedules. Patients with relapsed multiple myeloma will be enrolled onto a separate arm of the trial. The trial's objective is to determine the dose-limiting toxicity, maximum-tolerated dose, and recommended dose of SB1317 for a Phase 2 study. Secondary objectives include the assessment of the pharmacokinetic profile of SB1317, evaluation of exploratory biomarkers and presence of polymorphisms of genes involved in the metabolism of SB1317. Evidence of anti-tumor activity will also be assessed by objective response, progression-free survival and overall survival. In the near future, Tragara will initiate a Phase 1 study of SB1317 in patients with solid tumors.