Study Start Marks Sunesis’ Second Kinase Inhibitor Program to Enter the Clinic
SOUTH SAN FRANCISCO, CA, USA I March 23, 2016 I Sunesis Pharmaceuticals, Inc. (SNSS) today announced that the first subject has been dosed in a Phase 1A, randomized, double-blind, placebo-controlled dose-ranging study to investigate the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of its oral, next-generation, non-covalently binding BTK-inhibitor, SNS-062, in healthy subjects. The Phase 1A study is being conducted in Belgium, pursuant to a Clinical Trial Application (CTA). With a successful study outcome, SNS-062 is expected to proceed to a Phase 1B/2 study in patients with B-cell malignancies later this year.
“As a non-covalently binding kinase inhibitor with preclinical activity against Cys-481S mutated B-cell malignancies, SNS-062 is an important new drug candidate with the potential to address the emerging resistance to currently marketed and clinical-stage covalent-binding BTK inhibitors,” said Daniel Swisher, Chief Executive Officer of Sunesis. “SNS-062’s distinct kinase selectivity profile also lends the potential for activity in a broader range of cancers. This is the second of Sunesis’ kinase inhibitors, after the Takeda-partnered TAK-580, to enter the clinic. Together with the ongoing review of our vosaroxin marketing authorization application in Europe, these programs provide for a milestone-rich period in the coming quarters.”
“BTK inhibitors remain an area of keen interest among investigators and major industry participants, and we believe our clinical strategy will allow us to rapidly differentiate and reach proof-of-concept with SNS-062 in this important field of study,” said Deborah Thomas, Ph.D., Senior Vice President, Regulatory Affairs, Quality Assurance, and Non-Clinical Development. “Through the CTA process, Sunesis is able to efficiently understand important aspects of SNS-062’s PK/PD profile in humans, identify a pharmacologically active dose and gather initial safety information, allowing us to move into a targeted patient population, including patients with relapsed chronic lymphoid leukemia with acquired mutations in Cys-481S, later this year.”
The Phase 1A study will be conducted in three stages and is expected to enroll 52 subjects. In the first stage, the safety, pharmacokinetics, and pharmacodynamics of SNS-062 will be assessed over a range of doses. In the second stage, the effects of food on the pharmacokinetics of the drug will be assessed. In the last stage, a drug-drug interaction assessment will be conducted exploring the effects of CYP3A4 inhibition on the pharmacokinetics of SNS-062. The primary endpoint of the study is safety. The secondary endpoints are pharmacokinetics and pharmacodynamics.
About SNS-062
SNS-062 is a non-covalently binding inhibitor of Bruton’s tyrosine kinase (BTK). This target mediates signaling through the B-cell receptor, or BCR, which is critical for adhesion, migration, proliferation and survival of normal and malignant B-lineage lymphoid cells. BTK has been well validated as a target for treatment of B-cell malignancies, with a BTK inhibitor approved for relapsed/refractory mantle cell lymphoma, frontline and relapsed/refractory chronic lymphocytic leukemia, or CLL, CLL with 17p depletion and Waldenström’s macroglobulinemia. Because SNS-062 has a distinct binding site and favorable pharmacokinetic profile in preclinical studies, SNS-062 may provide differentiated opportunities for treatment of B-cell malignancies and other blood cancers. The rights to develop SNS-062 for oncology indications were in-licensed from Biogen in December 2013. SNS-062 is currently being evaluated in a Phase 1A Trial in healthy volunteers.
About Sunesis Pharmaceuticals
Sunesis is a biopharmaceutical company focused on the development and commercialization of new oncology therapeutics for the potential treatment of solid and hematologic cancers. Sunesis has built a highly experienced cancer drug development organization committed to improving the lives of people with cancer and is currently pursuing regulatory approval in Europe for its lead product candidate, vosaroxin, for the treatment of relapsed or refractory acute myeloid leukemia in patients aged 60 and older. In addition, the company is advancing its kinase-inhibitor pipeline of novel targeted therapies into the clinic.
SOURCE: Sunesis Pharmaceuticals
Post Views: 68
Study Start Marks Sunesis’ Second Kinase Inhibitor Program to Enter the Clinic
SOUTH SAN FRANCISCO, CA, USA I March 23, 2016 I Sunesis Pharmaceuticals, Inc. (SNSS) today announced that the first subject has been dosed in a Phase 1A, randomized, double-blind, placebo-controlled dose-ranging study to investigate the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of its oral, next-generation, non-covalently binding BTK-inhibitor, SNS-062, in healthy subjects. The Phase 1A study is being conducted in Belgium, pursuant to a Clinical Trial Application (CTA). With a successful study outcome, SNS-062 is expected to proceed to a Phase 1B/2 study in patients with B-cell malignancies later this year.
“As a non-covalently binding kinase inhibitor with preclinical activity against Cys-481S mutated B-cell malignancies, SNS-062 is an important new drug candidate with the potential to address the emerging resistance to currently marketed and clinical-stage covalent-binding BTK inhibitors,” said Daniel Swisher, Chief Executive Officer of Sunesis. “SNS-062’s distinct kinase selectivity profile also lends the potential for activity in a broader range of cancers. This is the second of Sunesis’ kinase inhibitors, after the Takeda-partnered TAK-580, to enter the clinic. Together with the ongoing review of our vosaroxin marketing authorization application in Europe, these programs provide for a milestone-rich period in the coming quarters.”
“BTK inhibitors remain an area of keen interest among investigators and major industry participants, and we believe our clinical strategy will allow us to rapidly differentiate and reach proof-of-concept with SNS-062 in this important field of study,” said Deborah Thomas, Ph.D., Senior Vice President, Regulatory Affairs, Quality Assurance, and Non-Clinical Development. “Through the CTA process, Sunesis is able to efficiently understand important aspects of SNS-062’s PK/PD profile in humans, identify a pharmacologically active dose and gather initial safety information, allowing us to move into a targeted patient population, including patients with relapsed chronic lymphoid leukemia with acquired mutations in Cys-481S, later this year.”
The Phase 1A study will be conducted in three stages and is expected to enroll 52 subjects. In the first stage, the safety, pharmacokinetics, and pharmacodynamics of SNS-062 will be assessed over a range of doses. In the second stage, the effects of food on the pharmacokinetics of the drug will be assessed. In the last stage, a drug-drug interaction assessment will be conducted exploring the effects of CYP3A4 inhibition on the pharmacokinetics of SNS-062. The primary endpoint of the study is safety. The secondary endpoints are pharmacokinetics and pharmacodynamics.
About SNS-062
SNS-062 is a non-covalently binding inhibitor of Bruton’s tyrosine kinase (BTK). This target mediates signaling through the B-cell receptor, or BCR, which is critical for adhesion, migration, proliferation and survival of normal and malignant B-lineage lymphoid cells. BTK has been well validated as a target for treatment of B-cell malignancies, with a BTK inhibitor approved for relapsed/refractory mantle cell lymphoma, frontline and relapsed/refractory chronic lymphocytic leukemia, or CLL, CLL with 17p depletion and Waldenström’s macroglobulinemia. Because SNS-062 has a distinct binding site and favorable pharmacokinetic profile in preclinical studies, SNS-062 may provide differentiated opportunities for treatment of B-cell malignancies and other blood cancers. The rights to develop SNS-062 for oncology indications were in-licensed from Biogen in December 2013. SNS-062 is currently being evaluated in a Phase 1A Trial in healthy volunteers.
About Sunesis Pharmaceuticals
Sunesis is a biopharmaceutical company focused on the development and commercialization of new oncology therapeutics for the potential treatment of solid and hematologic cancers. Sunesis has built a highly experienced cancer drug development organization committed to improving the lives of people with cancer and is currently pursuing regulatory approval in Europe for its lead product candidate, vosaroxin, for the treatment of relapsed or refractory acute myeloid leukemia in patients aged 60 and older. In addition, the company is advancing its kinase-inhibitor pipeline of novel targeted therapies into the clinic.
SOURCE: Sunesis Pharmaceuticals
Post Views: 68
