arsenic trioxide oral (SY-2101) / Syros - LARVOL DELTA

A pharmacokinetic and safety study of oral arsenic trioxide in patients with acute promyelocytic leukemia. (PubMed, Blood Adv) - P1 | "This study provides the first intrapatient PK crossover results directly comparing SY-2101 to ATO IV and supports the likelihood of clinical equivalence between the two formulations if used to treat patients with APL. NCT04996030."

Journal • PK/PD data • Acute Promyelocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

A Study for Oral SY-2101 for Participants With Acute Promyelocytic Leukemia (clinicaltrials.gov) - P1 | N=16 | Suspended | Sponsor: Syros Pharmaceuticals | N=24 ➔ 16 | Recruiting ➔ Suspended | Trial primary completion date: Apr 2024 ➔ Jan 2024

Enrollment change • Trial primary completion date • Trial suspension • Acute Promyelocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

Syros Announces Planned CEO Leadership Transition and Strategic Reorganization to Support Long-Term Business Growth and Maturation into a Commercial Biopharmaceutical Company (Businesswire) - "Syros Pharmaceuticals...announced a strategic realignment to prioritize key development and pre-launch activities to advance tamibarotene for the frontline treatment of higher-risk myelodysplastic syndrome (HR-MDS) and acute myeloid leukemia (AML)....'As we prepare to report initial data from SELECT-AML-1 later this year and pivotal data from SELECT-MDS-1 next year'...Syros will stop further investment in the clinical development of SY-2101, its novel, oral form of arsenic trioxide (ATO) for the treatment of newly diagnosed acute promyelocytic leukemia (APL), as well as in its preclinical and discovery-stage programs. Syros may pursue further development of SY-2101 subject to additional capital availability."

P2 data • Acute Myelogenous Leukemia • Acute Promyelocytic Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

Syros Reports Second Quarter 2023 Financial Results and Provides a Corporate Update (Syros Press Release) - "UPCOMING MILESTONES...Tamibarotene: Acute Myeloid Leukemia (AML): Report initial data from the randomized portion of the SELECT-AML-1 Phase 2 trial in newly diagnosed unfit AML patients with RARA overexpression in the fourth quarter of 2023. Report additional data from the SELECT-AML-1 Phase 2 trial in 2024. SY-2101: Acute Promyelocytic Leukemia (APL): Provide an update on the dose confirmation study of SY-2101 and the development path and timing for further evaluation of SY-2101 in a registration-enabling study in APL in the second half of 2023."

P2 data • Trial status • Acute Myelogenous Leukemia • Acute Promyelocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

A Study for Oral SY-2101 for Participants With Acute Promyelocytic Leukemia (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Syros Pharmaceuticals | Trial completion date: Mar 2023 ➔ Apr 2024 | Trial primary completion date: Mar 2023 ➔ Apr 2024

Trial completion date • Trial primary completion date • Acute Promyelocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

Syros Reports Fourth Quarter and Full Year 2022 Financial Results and Provides a Corporate Update (Businesswire) - "Tamibarotene: Higher-Risk Myelodysplastic Syndrome (HR-MDS): Complete patient enrollment in the SELECT-MDS-1 Phase 3 trial in newly diagnosed HR-MDS patients with RARA gene overexpression in the fourth quarter of 2023. Report pivotal complete response (CR) data from the SELECT-MDS-1 Phase 3 trial in the third quarter of 2024. Tamibarotene: Acute Myelodysplastic Syndrome (AML): Announce initial data from the randomized portion of the SELECT-AML-1 Phase 2 trial in newly diagnosed unfit AML patients with RARA overexpression in the fourth quarter of 2023. Report additional data from the SELECT-AML-1 Phase 2 trial in 2024. Provide an update on the dose confirmation study of SY-2101, as well as the development path and timing for further evaluation of SY-2101 in a registration-enabling study in APL, in the second half of 2023."

Enrollment status • P2 data • P3 data • Hematological Malignancies • Myelodysplastic Syndrome • Oncology

Syros Announces Clinical Updates and 2023 Strategic Priorities (Syros Press Release) - "...Syros plans to initiate the randomized portion of the SELECT-AML-1 Phase 2 trial in the first quarter of 2023, directly comparing the triplet of tamibarotene, venetoclax and azacitidine to the doublet of venetoclax and azacitidine with initial randomized data expected in the fourth quarter of 2023 and additional data in 2024....Syros plans to provide an update on the dose confirmation study, as well as the development path and timing for further evaluation of SY-2101 in a registration enabling study in APL, in the second half of 2023."

P1 data • P2 data • Trial status • Acute Myelogenous Leukemia • Acute Promyelocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

Syros Announces Closing of Merger with Tyme Technologies and Concurrent Private Placement (Businesswire) - "We remain on track to report data from the safety lead-in portions of our SELECT-AML-1 trial of tamibarotene and Phase 1 trial of SY-5609 in pancreatic cancer later this year and pivotal data from the SELECT-MDS-1 trial of tamibarotene in late 2023 or early 2024, and look forward to initiating our Phase 3 trial of SY-2101 in the second half of 2023."

New P3 trial • P1 data • P3 data • Acute Myelogenous Leukemia • Gastrointestinal Cancer • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • Pancreatic Cancer • Solid Tumor

Syros Pharmaceuticals Reports First Quarter 2022 Financial Results and Provides a Corporate Update (Businesswire) - "On Track to Report Data from Ongoing SELECT-MDS-1 Pivotal Trial in Q4 2023/Q1 2024...with a potential new drug application (NDA) filing expected in 2024....Three Data Readouts Expected in 2022: Data from the Safety Lead-ins of the SY-5609 Trial in Pancreatic Cancer and of the SELECT-AML-1 Phase 2 Trial; Data from the Dose Confirmation Study of SY-2101 in APL."

NDA • P2 data • P3 data • Acute Myelogenous Leukemia • Gastrointestinal Cancer • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • Pancreatic Cancer

Syros Reports Fourth Quarter and Full Year 2021 Financial Results and Highlights Key Accomplishments and Upcoming Milestones (Businesswire) - "SY-2101: Report pharmacokinetic (PK) and safety data from ongoing dose confirmation trial in newly diagnosed acute promyelocytic leukemia (APL) patients in mid-2022; Initiate Phase 3 trial in first quarter of 2023 with data expected in 2025."

New P3 trial • P1 data • Acute Promyelocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

Syros Announces Clinical Updates and 2022 Goals to Support its Advancement to a Fully Integrated Biopharmaceutical Company (Businesswire) - "CLINICAL PROGRAM UPDATES AND UPCOMING MILESTONES: SY-2101: Oral arsenic trioxide (ATO) - Syros is evaluating SY-2101 in patients with newly diagnosed acute promyelocytic leukemia (APL). The Company expects to report PK and safety data from its ongoing dose confirmation trial in mid-2022....Based on the feedback...from a Type C meeting with the U.S. Food and Drug Administration (FDA)..., Syros now expects the trial to enroll approximately 215 patients randomized two to one to receive SY-2101 or intravenously administered (IV) ATO. The IV ATO arm will allow safety and tolerability comparisons. Syros now expects to initiate the Phase 3 trial in the first quarter of 2023 and to announce data in 2025."

Clinical protocol • New P3 trial • P1 data • PK/PD data • Acute Promyelocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

Syros Reports Third Quarter 2021 Financial Results and Highlights Key Accomplishments and Upcoming Milestones (Syros Press Release) - "Tamibarotene: Report initial data from SELECT-AML-1 trial in 2022....SY-2101: Report confirmatory dose and pharmacokinetic data from the dose confirmation trial in the first half of 2022.; Initiate Phase 3 trial in newly diagnosed APL patients in 2022."

Clinical data • New P3 trial • P2 data • Acute Myelogenous Leukemia • Acute Promyelocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

Syros Announces First Patient in Dose Confirmation Study of SY-2101, a Novel Oral Form of Arsenic Trioxide, in Acute Promyelocytic Leukemia (Businesswire) - “Syros Pharmaceuticals…announced that the first patient has been dosed in the dose confirmation study of SY-2101, a novel oral form of arsenic trioxide (ATO). The trial will evaluate the pharmacokinetics (PK), safety, and tolerability of SY-2101 to confirm the optimal dose to advance into a planned Phase 3 clinical trial in newly diagnosed acute promyelocytic leukemia (APL) patients….‘We plan to move swiftly from our dose confirmation study into a Phase 3 trial next year, with the goal of filing a New Drug Application (NDA) in 2024’. The dose confirmation study is expected to enroll up to 24 patients with newly diagnosed APL and will evaluate safety, tolerability, and PK as well as the effect of food on the absorption of SY-2101….Syros expects to report data from this study in the first half of 2022.”

NDA • New P3 trial • P1 data • Trial status • Acute Promyelocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

A Study for Oral SY-2101 for Participants With Acute Promyelocytic Leukemia (clinicaltrials.gov) - P1; N=24; Recruiting; Sponsor: Syros Pharmaceuticals; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Acute Promyelocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • PCR

A Study for Oral SY-2101 for Participants With Acute Promyelocytic Leukemia (clinicaltrials.gov) - P1; N=24; Not yet recruiting; Sponsor: Syros Pharmaceuticals

New P1 trial • Acute Promyelocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • PCR

Syros to Host Key Opinion Leader Webcast Series on Targeted Hematology Portfolio (Businesswire) - “Syros Pharmaceuticals…announced that it plans to host a three-part key opinion leader (KOL) webcast series on its portfolio of investigational targeted therapies in hematology. The series will consist of presentations from Syros leaders, as well as KOLs, who will review recent progress for SY-1425 in newly diagnosed higher-risk myelodysplastic syndrome (MDS) and newly diagnosed unfit acute myeloid leukemia (AML) and for SY-2101 in acute promyelocytic leukemia (APL), and discuss the unmet need and evolving treatment landscape in these diseases.”

Clinical data • Acute Myelogenous Leukemia • Acute Promyelocytic Leukemia • Hematological Malignancies • Myelodysplastic Syndrome • Oncology

Syros Reports First Quarter 2021 Financial Results and Highlights Key Accomplishments and Upcoming Milestones (Businesswire) - “Upcoming Milestones: SY-1425: Oral RARa agonist - Initiate randomized Phase 2 trial of SY-1425 in combination with venetoclax and azacitidine in the second half of 2021 in RARA-positive newly diagnosed AML patients who are not suitable candidates for standard intensive chemotherapy. Report initial data from the randomized Phase 2 trial in 2022; SY-2101: Oral arsenic trioxide (ATO) - Initiate dose-confirmation study of SY-2101 in the second half of 2021. Report confirmatory dose and pharmacokinetic data in first half of 2022. Initiate Phase 3 trial in patients with newly diagnosed APL in 2022.”

P2 data • Trial initiation date • Trial status • Acute Myelogenous Leukemia • Hematological Malignancies • Oncology

Syros Reports Fourth Quarter and Full Year 2020 Financial Results and Highlights Key Accomplishments and Upcoming Milestones (Businesswire) - "Upcoming Milestones...Initiate dose confirmation study of SY-2101 in the second half of 2021; Report confirmatory dose and pharmacokinetic data in first half of 2022; Initiate Phase 3 trial in 2022 in patients with newly diagnosed acute promyelocytic leukemia (APL)."

Clinical data • New P3 trial • New trial • Acute Myelogenous Leukemia • Hematological Malignancies • Oncology

Syros Acquires Clinical-Stage Drug Candidate for Acute Promyelocytic Leukemia, Expanding Its Pipeline of Targeted Therapies for Hematologic Malignancies (Syros Press Release) - "Syros Pharmaceuticals...announced that it has acquired from Orsenix, LLC (Orsenix) all of its assets related to SY-2101, formerly known as ORH-2014, a novel oral form of arsenic trioxide (ATO). SY-2101 represents a strategic opportunity to leverage Syros’ expertise and capabilities to advance its growing footprint in hematologic disorders, with a targeted clinical-stage drug candidate that has the potential to dramatically reduce the treatment burden of a standard-of-care regimen for newly diagnosed acute promyelocytic leukemia (APL)....Dose Confirmation Study Expected to Begin in Second Half of 2021, Followed by Registration-Enabling Phase 3 Trial in 2022....If successful, Syros believes it could file a New Drug Application (NDA) with the FDA in 2024."

M&A • NDA • New P3 trial • New trial • Acute Promyelocytic Leukemia • Hematological Malignancies • Oncology

Syros Goes For Reboot With New Investors And Leukemia Licensing (Scripintelligence) - "Bain Capital Leads $90.5m Investment..."

M&A • Hematological Malignancies • Leukemia • Oncology