SY-5609 :: Syros Pharmaceuticals, Inc. (SYRS)

Decreasing Expression of Cancer-Driving Genes with CDK7

SY-5609 is a highly selective and potent oral inhibitor of the cyclin-dependent kinase 7 (CDK7) in a Phase 1 trial in patients with advanced breast, colorectal, lung or ovarian cancer, or with solid tumors of any histology that harbor Rb pathway alterations.

SY-5609 represents a new approach to treating cancer that we believe has potential in a range of difficult-to-treat cancers. It has shown robust anti-tumor activity, including complete regressions, in preclinical models of breast, colorectal, lung and ovarian cancers at doses below the maximum tolerated dose. In preclinical studies of breast, lung and ovarian cancers, deeper and more sustained responses were associated with the presence of Rb pathway alterations. SY-5609 has also shown substantial anti-tumor activity in combination with fulvestrant in treatment-resistant models of estrogen receptor-positive breast cancer, including those resistant to both fulvestrant and a CDK4/6 inhibitor.

A Promising Approach for Difficult-to-Treat Cancers

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

Potent and Highly Selective CDK7 Inhibitor

Program	Indication	Target Development	Drug Discovery	IND-Enabling	Early Clinical	Mid Clinical	Pivotal	Commercial Rights
SY-5609 (Oral CDK7 inhibitor)	SY-5609 (Oral CDK7 inhibitor) Select solid tumors	Target Development Phase complete	Drug Discovery Phase complete	IND-Enabling Phase complete	Early Clinical Phase in progress	Mid Clinical Phase not started	Pivotal Phase not started Syros (Global)	Syros (Global)

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
31^st 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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SY-5609 for Select Solid Tumors