Syros Pharmaceuticals Inc (NASDAQ:SYRS)’s IND for SY-1365 Gets FDA Acceptance To Advance Clinical Study

Syros Pharmaceuticals Inc (NASDAQ:SYRS)’s IND for SY-1365 Gets FDA Acceptance To Advance Clinical Study


Syros Pharmaceuticals Inc (NASDAQ:SYRS) disclosed that the FDA has accepted its Investigational New Drug (IND) application for its SY-1365 to advance its first-in-class selective cyclin-dependent kinase 7 inhibitor into a first stage study in patients who are suffering from advanced solid tumor malignancies. That included transcriptionally dependent cancers like triple negative breast, ovarian and small cell lung cancers. As a result, the company is in line with its planning to commence trial in the second quarter.

Syros Pharmaceuticals revealed that it would enroll about 70 patients in its first stage study for advanced solid tumors. The study would assess the safety, as well as, tolerability of escalating doses of the drug candidate. The objective is to create optimized tolerated dose and a recommended phase two dose.

The company indicated that its other objectives of the trial included evaluating pharmacodynamic changes besides initial signs of biological activity with the help of biomarkers and clinical efficacy. This would be measured through response rate with radiographic measures help. The company intends to extend future clinical development of the drug candidate into acute leukemias based on the data generated during the study.

Syros disclosed that its SY-1365 has demonstrated considerable anti-proliferative, as well as, pro-adoptotic activity in multiple in vitro, as well as, in vivo models of difficult to treat solid tumors. This included triple negative breast and ovarian cancers. The drug candidate has reduced anti-tumor activity in both patient-derived xenograft and cell line-derived xenograft models of triple negative breast cancer.

The company’s CEO, Nancy Simonian, reacted to say, “SY-1365 represents a promising new approach for cancers that are dependent on high expression of oncogenic transcription factors for their growth and survival. By selectively targeting CDK7, SY-1365 has been shown to lower the expression of these disease-driving transcription factors, inducing substantial anti-tumor activity in multiple preclinical models. We are committed to developing SY-1365 as quickly and efficiently as possible for patients with transcriptionally dependent cancers who are in need of better treatment options and have designed the Phase 1 clinical trial to give us early demonstration of proof-of-mechanism.”

The stock closed Friday’s regular trading session at $14.7.