Syros Pharmaceuticals Inc. (SYRS), a biopharmaceutical company developing medicines that control the expression of genes to treat cancer and genetic diseases, has a couple of clinical trial milestones to be achieved this year.
The company’s lead drug candidate is SY-1425, which in combination with Azacitidine, is under a phase III trial in RARA-positive patients with newly diagnosed HR-MDS (Higher-Risk Myelodysplastic Syndrome). The primary endpoint of the trial is complete response (CR) rate.
A phase II trial of SY-1425 in combination with Venetoclax and Azacitidine in RARA-positive newly diagnosed acute myeloid leukemia (AML) patients who are not suitable candidates for standard intensive chemotherapy is expected to be initiated in the second half of 2021. Initial data from this trial is anticipated next year.
Next in the pipeline is SY-2101, a novel oral form of arsenic trioxide, for newly diagnosed acute promyelocytic leukemia.
In a phase I clinical trial, led by investigators at the M.D. Anderson Cancer Center, SY-2101 demonstrated bioavailability, pharmacokinetic (PK) exposures similar to IV arsenic trioxide, and a generally well-tolerated safety profile. IV arsenic trioxide is a standard-of-care regimen for newly diagnosed acute promyelocytic leukemia (APL).
Syros plans to initiate a dose confirmation study of SY-2101 in the second half of 2021. The confirmatory dose and pharmacokinetic data from this study are expected in the first half of 2022. If all goes well as planned, a registration-enabling phase III trial of SY-2101 in patients with newly diagnosed APL is planned for initiation in 2022.
Another clinical program of Syros is SY-5609, which is in a phase I dose-escalation trial in patients with advanced breast, colorectal, lung, ovarian or pancreatic cancer, or with solid tumors of any histology that harbor Rb pathway alterations.
Last October, the company reported encouraging early dose-escalation data from the trial, which demonstrated proof of mechanism of SY-5609 and established a maximum tolerated dose (MTD) for continuous daily dosing.
Additional dose-escalation data, including clinical activity data, from the SY-5609 study in the third quarter of 2021.
The company’s cash, cash equivalents and marketable securities as of March 31, 2021 were $222.1 million, which is expected to be sufficient to fund its operations into 2023.
SYRS has traded in a range of $4.75 to $15.65 in the last 1 year.
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