On May 14, 2024 Syros Pharmaceuticals (NASDAQ: SYRS), a biopharmaceutical company committed to advancing new standards of care for the frontline treatment of hematologic malignancies, reported financial results for the quarter ended March 31, 2024 and provided a corporate update (Press release, Syros Pharmaceuticals, MAY 14, 2024, View Source [SID1234643280]).

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"In 2024, we are acutely focused on execution across clinical and pre-commercial activities as we advance tamibarotene toward critical milestones, including additional data from the Phase 2 SELECT-AML-1 trial in the third quarter and pivotal CR data from the Phase 3 SELECT-MDS-1 trial in the fourth quarter," said Conley Chee, Chief Executive Officer of Syros. "We are particularly pleased to share today that an independent data monitoring committee recently completed a pre-specified interim futility analysis on 50% of the patients enrolled in the SELECT-MDS-1 trial to support our primary endpoint analysis, and recommended that our study continue without modification. This recommendation, together with the FDA’s decision to grant Fast Track Designation to tamibarotene in AML, reinforces our confidence in the potential for our RARα agonist to offer improved clinical outcomes to HR-MDS and AML patients with RARA gene overexpression, supported by our belief that tamibarotene has a differentiated safety profile well suited for use in these patients."

Mr. Chee continued, "In addition, following the completion of enrollment in the first quarter of 2024 of the 190 patients necessary for our primary endpoint analysis in the Phase 3 SELECT-MDS-1 trial, we have begun preparing for our first New Drug Application filing and subsequent launch in the United States. We look forward to engaging further with the medical community to drive awareness of tamibarotene and the companion diagnostic to identify RARA overexpression in patients with higher-risk MDS, as we work to deliver tamibarotene as the new frontline standard-of-care for patients with RARA overexpression."

Syros reported plans to host a webcast event on June 25, 2024 to discuss disease biology and the current treatment landscape in HR-MDS, as well as the design of the ongoing pivotal Phase 3 SELECT-MDS-1 trial and opportunity for tamibarotene. The event will feature presentations from medical experts, in addition to Syros management. The event will be webcast live on the Investors & Media section of Syros’ website, www.syros.com. More details for the event are forthcoming.

UPCOMING MILESTONES

Report pivotal complete response (CR) data from the SELECT-MDS-1 Phase 3 trial in newly diagnosed HR-MDS patients with RARA gene overexpression by the middle of the fourth quarter of 2024.
Report clinical activity and tolerability data from a prespecified analysis of over 40 patients from the SELECT-AML-1 Phase 2 trial in unfit AML patients with RARA overexpression in the third quarter of 2024.
RECENT PIPELINE HIGHLIGHTS

In March, the Phase 3 SELECT-MDS-1 clinical trial of tamibarotene passed a pre-specified interim futility analysis based on the CR rate, which was conducted by an Independent Data Monitoring Committee (IDMC). There were no concerning safety signals noted in the analysis and the IDMC recommended SELECT-MDS-1 continue without modification. Syros remains blinded to the data.
In April, the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to tamibarotene in combination with venetoclax and azacitidine for the treatment of newly diagnosed AML with RARA overexpression, as detected by an FDA approved test in adults who are over age 75 and who have comorbidities that preclude the use of intensive induction chemotherapy. The FDA previously granted this designation to tamibarotene in combination with azacitidine for the treatment of adults with HR-MDS and RARA overexpression in January 2023.
First Quarter 2024 Financial Results

The Company did not recognize any revenue in the first quarter of 2024, as compared to $3.0 million for the first quarter of 2023. The decrease reflects the termination of Syros’ collaboration agreement with Pfizer.
Research and development (R&D) expenses were $24.7 million for the first quarter of 2024, as compared to $28.8 million for the first quarter of 2023. The decrease was primarily due to the reduction in external R&D consulting, contract manufacturing, and a reduction in headcount and related expenses.
General and administrative (G&A) expenses were $6.3 million for the first quarter of 2024, as compared to $7.4 million for the first quarter of 2023. The decrease was primarily due to a reduction of headcount and related expenses, consulting fees, and facilities expenses.
For the first quarter of 2024, Syros reported a net loss of $3.7 million, or $0.10 per share, compared to a net loss of $23.8 million, or $0.85 per share, for the same period in 2023.
Cash and Financial Guidance

On May 9, 2024, the Company agreed to amend its Loan Agreement with Oxford Finance LLC. The amendment will increase the amount of term loans available to Syros from $40 million to $100 million with tranches totaling $40.0 million in the aggregate becoming available upon the achievement of certain clinical development, regulatory and equity-raising milestones, and $20.0 million becoming available at Oxford’s discretion. In addition, Oxford will extend the interest only period from September 1, 2024 to November 1, 2025 with further extensions to as late as November 1, 2026 upon achievement of certain milestones.

Cash, cash equivalents and marketable securities as of March 31, 2024, were $108.3 million, as compared with $139.5 million as of December 31, 2023.

Based on its current plans and the recently executed amendment with Oxford, Syros believes that its existing cash, cash equivalents and marketable securities will be sufficient to fund its anticipated operating expenses and capital expenditure requirements into the third quarter of 2025, beyond pivotal Phase 3 data from the SELECT-MDS-1 trial and additional data from the randomized portion of the SELECT-AML-1 trial.

Conference Call and Webcast

Syros will host a conference call today at 8:30 a.m. ET to discuss the first quarter 2024 financial results and provide a corporate update.

To access the live conference call, please dial (800) 549-8228 (domestic) or (289) 819-1520 (international) and refer to conference ID 16518. A webcast of the call will also be available on the Investors & Media section of the Syros website at www.syros.com. An archived replay of the webcast will be available for approximately 30 days following the presentation.

On May 14, 2024 Takeda (TSE: 4502/NYSE:TAK) reported that it will present data from its oncology pipeline and product portfolio at the 60th Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) being held May 31-June 4, 2024, in Chicago, Ill (Press release, Takeda, MAY 14, 2024, View Source [SID1234643279]).

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Takeda’s presentations will span across a range of cancers, including colorectal, lung, lymphoma, multiple myeloma and leukemia and feature both clinical and real-world data generated to optimize treatment approaches and inform patient care.

"At Takeda Oncology, we’re committed to addressing the areas of highest patient need while leveraging our expertise in key disease areas, including colorectal cancer, lung cancer and hematological malignancies," said Phuong Khanh (P.K.) Morrow, M.D., Head of the Oncology Therapeutic Area Unit (OTAU) at Takeda. "Our presentations at ASCO (Free ASCO Whitepaper), including data being presented in Hodgkin lymphoma and colorectal cancer, highlight the importance of combining our internal innovation with external partnerships to introduce new solutions and benefit the lives of people with cancer."

A full list of company-sponsored abstracts can be found here.

On May 14, 2024 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, reported the acceptance of a poster presentation at the upcoming European Hematology Association (EHA) (Free EHA Whitepaper) Hybrid Congress being held in Madrid, Spain from June 13-16, 2024 (Press release, Adicet Bio, MAY 14, 2024, View Source [SID1234643278]).

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Details of the poster presentation are as follows:

Title: ADI-270: An Armored Allogeneic Anti-CD70 CAR γδ T Cell Therapy Designed for Multiple Solid and Hematological Cancer Indications
Presenting Author: Yvan Chanthery, Ph.D.
Date & Time: June 14, 2024 at 18:00 CEST

On May 14, 2024 Immune-Onc Therapeutics, Inc. ("Immune-Onc"), a clinical-stage biopharmaceutical company advancing novel therapies in immunology and oncology by targeting myeloid cell inhibitory receptors, reported the company will present Phase 1b interim data for IO-202 in patients with chronic myelomonocytic leukemia (CMML) at the 2024 European Hematology Association (EHA) (Free EHA Whitepaper) Annual Meeting held virtually and in Madrid, Spain, June 13 – 16 (Press release, Immune-Onc Therapeutics, MAY 14, 2024, View Source [SID1234643277]).

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Promising early responses, including 4 out of 5 efficacy evaluable patients achieving complete remission (CR), were observed in the Phase 1b expansion study of hypomethylating agents-naïve CMML patients using the preliminary recommended Phase 2 dose of IO-202 in combination with azacitidine (AZA). Hypomethylating agents, including AZA, are the only FDA-approved treatment option for CMML, with only a 7-17% CR rate.1 Phase 1b interim data demonstrate that IO-202 is well tolerated in combination with azacitidine. All patients who achieved CR exhibited high baseline LILRB4 expression on bone marrow blasts, supporting the mechanism of action of IO-202 as a targeted therapy with antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis. Study enrollment is ongoing, and additional clinical data will be presented at EHA (Free EHA Whitepaper).

"CMML is an incurable cancer with a poor prognosis and limited treatment options. We are highly encouraged by the early complete responses seen in our evaluable patient pool," said Charlene Liao, Ph.D., chief executive officer of Immune-Onc. "We believe that the addition of IO-202 to the standard of care treatment, such as azacitidine, has the potential to change the treatment landscape of CMML."

Poster presentation details:

Abstract Number: P792 (here)
Title: Targeting LILRB4 (ILT3) Using IO-202 in Patients with Chronic Myelomonocytic Leukemia (CMML): Interim Efficacy, Safety, and Mechanism of Action Data from the Phase 1b Expansion Cohort
Presenter: Ahmed Aribi, M.D., assistant professor, Division of Leukemia, City of Hope in Duarte, CA
Session Title: Myelodysplastic Syndromes – Clinical
Session Date and Time: Friday, June 14, 6-7 p.m. CEST

ABOUT CHRONIC MYELOMONOCYTIC LEUKEMIA (CMML)

CMML is a rare form of blood cancer, occurring in 4 of every 1,000,000 people in the United States each year, 1 or about 1,100 annual cases.2 CMML is characterized by the presence of a high monocyte count (>1×109/L peripheral monocytes with monocytes ≥ 10% of white blood count) along with dysplastic features in the bone marrow.1 Current FDA-approved therapies for CMML are all hypomethylating agents, including azacitidine, only achieving a 7%-17% complete response rate.1

ABOUT LILRB4 (also known as ILT3)

LILRB4, also known as ILT3, is an immune-modulatory transmembrane protein found on monocytes and monocyte-derived cells. LILRB4 is expressed on certain hematologic cancer cells, such as myelomonocytic leukemia blasts, and on certain pathogenic cells involved in autoimmunity and inflammatory processes.

About IO-202

IO-202 is a first-in-class IgG1 antibody with specific, high-affinity binding to LILRB4 and depletes LILRB4 positive cells via antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis. As such, IO-202 is a targeted therapy with broad potential in blood cancers and autoimmune and inflammatory diseases.

IO-202 has completed the dose escalation part of the first-in-human, multicenter, open-label Phase 1 study in the U.S., and the data was presented at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress in 2023. This Phase 1 trial has advanced to the dose expansion stage to evaluate IO-202 in combination with azacitidine (NCT04372433) in patients with newly diagnosed chronic myelomonocytic leukemia (CMML) who have not received any hypomethylating agents (HMA).

The U.S. Food and Drug Administration granted IO-202 Fast Track Designations for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML) and relapsed or refractory CMML, respectively. The FDA has also granted IO-202 Orphan Drug Designations for the treatment of AML and CMML, respectively.

On May 14, 2024 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, reported financial results and operational highlights for the first quarter ended March 31, 2024 (Press release, Adicet Bio, MAY 14, 2024, View Source [SID1234643276]).

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"We are poised for a transformational year in 2024 as we advance our gamma delta T cell platform in autoimmune diseases and prepare to initiate a Phase 1 study evaluating our lead candidate ADI-001 in lupus nephritis in the second quarter of this year," said Chen Schor, President and Chief Executive Officer at Adicet Bio. "We recently shared encouraging preclinical data on ADI-270 at the ASGCT (Free ASGCT Whitepaper) annual meeting highlighting its highly differentiated profile and illustrating ADI-270’s robust anti-tumor activity in multiple CD70+ solid and hematological cancer indications and supporting ADI-270’s clinical development. In parallel, we are continuing to enroll mantle cell lymphoma patients in our ongoing Phase 1 study of ADI-001 in relapsed or refractory non-Hodgkin’s lymphoma and expect to share a clinical update in the second half of this year."

First Quarter 2024 and Recent Operational Highlights:

Autoimmune diseases

On track to initiate Phase 1 study of ADI-001 in lupus nephritis in 2Q 2024. In December 2023, the FDA granted clearance for Adicet’s IND application to evaluate ADI-001 in lupus nephritis. The Company plans to commence a Phase 1 clinical trial to assess the safety and efficacy of ADI-001 in lupus nephritis in the second quarter of 2024. Preliminary data from the study are anticipated during the fourth quarter of 2024 or first quarter of 2025, depending on patient enrollment and study site activation.
Continuing to expand ADI-001 into additional autoimmune diseases. Adicet plans to continue broadening the clinical applications of ADI-001 to include additional autoimmune indications. The Company expects to share preliminary clinical data in the fourth quarter of 2024 or first half of 2025, subject to regulatory clearances and contingent upon successful site initiation and patient enrollment in the relevant clinical protocols.
Hematologic malignancies and solid tumor indications

Presentation of preclinical data from ADI-270 at the ASGCT (Free ASGCT Whitepaper) Annual Meeting. In May 2024, Adicet presented promising preclinical data in an oral presentation at the ASGCT (Free ASGCT Whitepaper) annual meeting demonstrating robust anti-tumor activity of ADI-270, an armored allogeneic "off-the-shelf" gamma delta CAR T cell therapy candidate targeting CD70+ cancers, in multiple CD70+ solid and hematological tumor indications. Based on ADI-270’s promising profile in preclinical studies to date, Adicet expects to submit an IND for ADI-270 in renal cell carcinoma in the second quarter of 2024. Following regulatory clearance and contingent upon study initiation progress, the Company intends to present clinical data from a Phase 1 study in the first half of 2025.
Enrollment of mantle cell lymphoma (MCL) patients in ongoing ADI-001 Phase 1 GLEAN study. Adicet is continuing to enroll MCL patients in the Phase 1 trial evaluating ADI-001 in relapsed or refractory non-Hodgkin’s Lymphoma (NHL). The Company remains on track to provide a clinical update on safety, efficacy and 6-month complete response data in MCL patients in the second half of 2024.
Financial Results for First Quarter 2024:

Research and Development (R&D) Expenses: R&D expenses were $23.9 million for the three months ended March 31, 2024, compared to $26.8 million during the same period in 2023. The decrease in R&D expenses was primarily due to a net $3.1 million decrease in expenses related to contract development manufacturing organizations (CDMOs) and other externally conducted research and development.
General and Administrative (G&A) Expenses: G&A expenses were $7.0 million for the three months ended March 31, 2024, compared to $6.6 million during the same period in 2023. The $0.4 million increase was primarily driven by an increase in personnel expenses. The increase was partially offset by a $0.2 million decrease in contractor fees as well as a $0.1 million decrease in professional fees.
Net Loss: Net loss for the three months ended March 31, 2024 was $28.0 million, or a net loss of $0.35 per basic and diluted share, including non-cash stock-based compensation expense of $5.7 million, as compared to a net loss of $30.9 million, or a net loss of $0.72 per basic and diluted share, including non-cash stock-based compensation expense of $4.8 million during the same period in 2023.
Cash Position: Cash and cash equivalents were $247.6 million as of March 31, 2024, compared to $231.6 million during the same period in 2023. The Company expects that current cash and cash equivalents as of March 31, 2024, will be sufficient to fund its operating expenses into the second half of 2026.