Singapore, Oct. 22, 2008 - S*BIO Pte Ltd today announced that multiple presentations of pre-clinical and early clinical data for its HDAC inhibitor SB939 will be made at the 20th EORTC-NCI-AACR Symposium on “Molecular Targets and Cancer Therapeutics” in Geneva, Switzerland. The results demonstrate that the “best-in-class” pre-clinical profile of S*BIO’s novel anti-cancer drug SB939 translates into the clinic.
“We are pleased to announce clinical data from the ongoing Phase 1 trials of our orally-active HDAC inhibitor SB939,” said Dr. Jan-Anders Karlsson, CEO of S*BIO. “The pharmacokinetic and pharmacodynamic data obtained with SB939 in patients with advanced cancers are consistent with the superior HDAC inhibitor profile that we have previously demonstrated in pre-clinical studies.”
“We continue to develop SB939 in the clinic to gain additional data on its anti-cancer activity as well as to demonstrate further its good tolerability and superior oral PK/PD profile.”
Poster No. 136
Discovery of SB939, an HDAC inhibitor with a superior pre-clinical profile
SB939 is a potent HDAC inhibitor with superior anti-tumor efficacy and tolerability in pharmacological cancer models. The drug candidate also has favourable ADME, safety and pharmaceutical properties resulting in high and dose-proportional exposure after oral dosing. SB939 has a prolonged duration of action and is enriched in tumor tissue which may contribute to its potent anti-tumor activity and “best-in-class” profile. The structure-activity relationships leading to the discovery of SB939 will be discussed.
Poster No. 83
A robust and quantitative biomarker assay for SB939, a potent, orally-active HDAC inhibitor
A robust, sensitive and quantitative Western blot assay for measuring acetylated histone 3 in tissues has been developed to evaluate the target efficacy of SB939 and is currently being used to study PK/PD relationships in the ongoing Phase 1 clinical trials. These data demonstrate that the excellent PK/PD relationship observed in pre-clinical models is mirroredin patients with advanced solid malignancies.
Poster No. 413
A Phase 1 dose escalation study of oral SB939 when administered thrice weekly (every other day) for 3 weeks in a 4-week cycle in patients with advanced solid malignancies SB939 shows excellent linear and dose-dependent oral exposure. It has a good PK/PD relationship, as well as promising clinical activity with a manageable toxicity profile. The recommended Phase 2 dose has been selected.
About S*BIO Pte Ltd
S*BIO is a privately-held biotech company focused on the research and clinical development of novel targeted small molecule drugs for the treatment of cancer with leading programs around histone deacetylases (HDAC) and kinases. S*BIO’s lead candidate, SB939, entered the clinic in 2007. Its second compound, SB1518, commenced Phase1 clinical trials in 2008 and has received orphan drug designation from the U.S. FDA. A third compound, SB1317, is in pre-clinical development. In line with its vision to be a leading fully-integrated oncology-focused biotech company in Asia Pacific, S*BIO has established a state-of-the-art R&D infrastructure, complemented by a strong clinical development team. S*BIO has strong links with a network of medical oncologists in Asia Pacific and its investors include Bio*One Capital, Aravis Venture, Novartis Bioventures and other international funds. More information about S*BIO can be found at www.sbio.com.
S*BIO Pte Ltd: Russo Partners:
Stephen Keith Rhind, Ph.D. Tony Russo +1 212-845-4251
Senior Vice President, Corporate Development Tony.Russo@russopartnersllc.com
Tel: +65 6827 5000 (Singapore) Andreas Marathovouniotis +1 212-845-4235