S*BIO SB1317 enters into Phase 1 trial

The initiation of the study for S*BIO’s SB1317 or TG02 has triggered a payment from S*BIO’s development and commercialisation partner for the program, Tragara Pharmaceuticals.

Earlier, in January 2009, S*BIO granted a worldwide exclusive license to Tragara to develop and commercialise SB1317.

Under the terms of the agreement S*BIO was eligible to receive up to $112.5m in payments which 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 US 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.

However, the 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.

S*BIO CEO Jan-Anders Karlsson said that the advancement of the unique oral multi-kinase inhibitor into the clinic indicates the promising biological activities of S*BIO’s pre-clinical compounds.

"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," Karlsson said.

"S*BIO intends to utilise the proceeds to further advance its clinical program."