SY-5609 for Select Solid Tumors

Our Vision for SY-5609 is to be a Transformative Targeted Approach for Difficult-to-Treat Cancers
AnneOvarian Cancer Survivor

Our Vision for SY-5609 is to be a Transformative Targeted Approach for Difficult-to-Treat Cancers

SY-5609 is a highly selective and potent oral inhibitor of the cyclin-dependent kinase 7 (CDK7) in development for select solid tumors and blood cancers. As part of a three-pronged combination strategy, we plan to evaluate SY-5609 in combination with chemotherapy in pancreatic cancer patients in an expansion study, in combination with a BTK inhibitor in mantle cell lymphoma (MCL) in a Phase 1b trial, and in combination with immunotherapy in BRAF-mutant colorectal cancer in Roche’s Phase 1/1b INTRINSIC trial.

SY-5609 represents a novel targeted approach that we believe has potential in a range of difficult-to-treat cancers. Data from a dose-escalation study demonstrated single-agent activity, including prolonged stable disease, tumor shrinkage, and tumor marker decreases, across multiple tumor types. Notably, the prolonged stable disease and tumor shrinkage observed in metastatic pancreatic cancer patients is distinct from what one would expect to see in this highly refractory patient population.

Based on these clinical data along with preclinical data supporting various combination approaches, we believe SY-5609 has the opportunity to provide a profound benefit for patients with cancers that have largely eluded treatment to date.

Attacking two fundamental processes in cancer

Cancer cells adapt to hijack or thwart the body’s normal processes to grow out of control, forming tumors and crowding out healthy cells. By inhibiting CDK7, SY-5609 has the potential to disrupt two fundamental processes that cancer cells use to survive and thrive: increased expression of cancer-promoting genes, and uncontrolled cell cycle progression.

SY-5609 Clinical Trial

Our Publications

SY-5609 Publications

TOLERABILITY AND PRELIMINARY CLINICAL ACTIVITY OF SY-5609, A HIGHLY POTENT AND SELECTIVE ORAL CDK7 INHIBITOR, IN PATIENTS WITH ADVANCED SOLID TUMORS

Manish R. Sharma, Babar Bashir, Erika Hamilton, Dejan Juric, Kyriakos Papadopoulos, Debra Richardson, Geoffrey Shapiro, Graeme Hodgson, Nan Ke, Anthony D’Ippolito, Susan Henry, Li Zhu, Maria Rosario, Hina Jolin, David Roth, Virginia Klimek, Kate Madigan, Mike Kelly
ESMO Congress 2021
Oral Presentation
Abstract Number: 518MO
2021

SY-5609, A HIGHLY POTENT AND SELECTIVE ORAL CDK7 INHIBITOR, EXHIBITS ROBUST ANTITUMOR ACTIVITY IN PRECLINICAL MODELS OF KRAS MUTANT CANCERS AS A SINGLE AGENT AND IN COMBINATION WITH CHEMOTHERAPY

Susan Henry, Liv Johannessen, Priyanka Sawant, Ariel Lefkovith, Nan Ke, Anthony D’Ippolito, Wojciech Dworakowski, Graeme Hodgson
ESMO Congress 2021
Abstract Number: 13P
2021

PRECLINICAL EVALUATION OF INTERMITTENT DOSING REGIMENS ON ANTITUMOR AND PD ACTIVITY OF SY-5609, A POTENT AND SELECTIVE ORAL CDK7 INHIBITOR, IN OVARIAN CANCER XENOGRAFTS

Liv Johannessen, Wojciech Dworakowski, Maria Rosario, Priyanka Sawant, Nan Ke, Ariel Lefkovith, Anthony D’Ippolito, Matthew Eaton, Susan Henry, Graeme Hodgson
ESMO Congress 2021
Abstract Number: 14P
2021

EARLY EVIDENCE OF DOSE-DEPENDENT PHARMACODYNAMIC ACTIVITY FOLLOWING TREATMENT WITH SY-5609, A HIGHLY SELECTIVE AND POTENT ORAL CDK7 INHIBITOR, IN PATIENTS WITH ADVANCED SOLID TUMORS

Kyriakos P. Papadopoulos, Manish R. Sharma, Erika Hamilton, Debra Richardson, Babar Bashir, Dejan Juric, Geoffrey Shapiro, Graeme Hodgson, Nan Ke, Anthony D’Ippolito, Liv Johannessen, Qing Kang-Fortner, Li Zhou, Maria Rosario, William Zamboni, Hina A. Jolin, Catherine Madigan, Michael J. Kelly, David A. Roth
32nd EORTC-NCI-AACR Symposium
Abstract Number: 180
2020

ACTIVITY OF SY-5609, AN ORAL, NONCOVALENT, POTENT, AND SELECTIVE CDK7 INHIBITOR, IN PRECLINICAL MODELS OF COLORECTAL CANCER

Liv Johannessen, Nan Ke, Priyanka Sawant, Wojciech Dworakowski, Tony D’ippolito, Shanhu Hu, Nisha Rajagopal, Matthew Eaton, Graeme Hodgson
American Society of Clinical Oncology (ASCO20) Virtual Scientific Program
Abstract Number: 3585
2020

FIRST-IN-HUMAN PHASE I STUDY OF SY-5609, AN ORAL, POTENT, AND SELECTIVE NONCOVALENT CDK7 INHIBITOR, IN ADULT PATIENTS WITH SELECT ADVANCED SOLID TUMORS

Kyriakos P. Papadopoulos, Manish R. Sharma, Erika Hamilton, Debra Richardson, Babar Bashir, Graeme Hodgson, Li Zhou, Angela Volkert, Hina A. Jolin, Catherine Madigan, Michael Kelly, David A. Roth
American Society of Clinical Oncology (ASCO20) Virtual Scientific Program
Abstract Number: TPS3662
2020

PRECLINICAL EVALUATION OF PK, PD, AND ANTI-TUMOR ACTIVITY OF THE ORAL, NON-COVALENT, POTENT AND HIGHLY SELECTIVE CDK7 INHIBITOR, SY-5609, PROVIDES RATIONALE FOR CLINICAL DEVELOPMENT IN MULTIPLE SOLID TUMOR INDICATIONS

LIV JOHANNESSEN, SHANHU HU, NAN KE, ANTHONY D’IPPOLITO, NISHA RAJAGOPAL, PRIYANKA SAWANT, KRISTIN HAMMAN, JASON MARINEAU, ANNELI SAVINAINEN, WILLIAM ZAMBONI, GRAEME HODGSON
31st EORTC-NCI-AACR MOLECULAR TARGETS AND CANCER SYMPOSIUM
ABSTRACT NUMBER: C091
2019

SY-5609, AN ORALLY AVAILABLE SELECTIVE CDK7 INHIBITOR, DEMONSTRATES BROAD ANTI-TUMOR ACTIVITY IN VIVO

Shanhu Hu, Jason Marineau, Kristin Hamman, Michael Bradley, Anneli Savinainen, Sydney Alnemy, John Carulli, Claudio Chuaqui and Eric Olson
American Association for Cancer Research (AACR) Annual Meeting
Abstract Number: 4421
2019

AN ORAL AND SELECTIVE CDK7 INHIBITOR DEMONSTRATES SUBSTANTIAL ANTI-TUMOR EFFECT IN BREAST AND OVARIAN CANCER MODELS

Shanhu Hu, Jason Marineau, Michael Bradley, Kristin Hamman, Sydney Alnemy, Danielle Smith, John Carulli, Claudio Chuaqui
30th EORTC-NCI-AACR Molecular Targets and Cancer Therapeutics Symposium
Abstract Number 96
2018

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