Syros Pharmaceuticals, Inc.

CAMBRIDGE, Mass.--( BUSINESS WIRE )--Syros Pharmaceuticals (NASDAQ:SYRS), a biopharmaceutical company committed to advancing new standards of care for the frontline treatment of hematologic malignancies, today announced that it will present additional data from the randomized portion of the SELECT-AML-1 Phase 2 clinical trial at the Society of Hematologic Oncology (SOHO) Annual Meeting taking place September 4-7, in Houston, Texas. Additionally, Syros announced that company management will participate in the H.C. Wainwright 26 th Annual Global Investment Conference, being held September 9-11 in New York City. Details are as follows: 12 th Annual Meeting of the Society of Hematologic Oncology (SOHO 2024) Presentation Title: SELECT-AML-1: Phase 2 Randomized Trial of Tamibarotene in Combination With Venetoclax and Azacitidine in Adult Patients With Previously Untreated AML With RARA Overexpression, Who Are Ineligible for Standard Induction Therapy Session Date & Time: Wednesday, September 4, 2024, 5:15-6:30 PM CT (6:15-7:30 PM ET) Location: George R. Brown Convention Center Poster Number: AML-347 The poster will be available on the Publications and Abstracts section of the Syros website at www.syros.com following the session. H.C. Wainwright 26 th Annual Global Investment Conference Presentation Date & Time: Monday, September 9, 2024, 11:30 AM ET Location: Lotte New York Palace A live webcast of the presentation will 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. About Syros Pharmaceuticals Syros is committed to developing new standards of care for the frontline treatment of patients with hematologic malignancies. Driven by the motivation to help patients with blood disorders that have largely eluded other targeted approaches, Syros is developing tamibarotene, an oral selective RARα agonist in frontline patients with higher-risk myelodysplastic syndrome with RARA gene overexpression. For more information, visit www.syros.com and follow us on Twitter ( @SyrosPharma ) and LinkedIn .

Shares in Syros Pharmaceuticals plunged as much as 70% in after-hours trading on Monday after the company announced plans to halt further enrolment in a Phase II study of tamibarotene for front-line acute myeloid leukaemia (AML) patients with RARA gene overexpression. “We are disappointed by this unexpected outcome,” remarked chief medical officer David Roth.The SELECT-AML-1 trial was investigating the oral retinoic acid receptor alpha (RARα) agonist in combination with venetoclax and azacitidine. Syros said that a prespecified analysis of 40 participants from a total of 51 newly diagnosed, unfit patients with AML, showed a complete response (CR)/complete response with incomplete haematologic recovery (CRi) rate of 65% for the tamibarotene-based triplet regimen compared with 70% for the venetoclax-azacitidine doublet regimen. The company noted that the “similar” results for the two arms suggest a low likelihood of the triplet regimen demonstrating superiority in the final analysis. Meanwhile, no new safety signals associated with the triplet were identified.MDS work continuesRoth noted that tamibarotene plus azacitidine demonstrated a 61% CR/CRi rate in newly diagnosed patients with AML in an earlier Phase II study, reinforcing the company’s “conviction” in pursuing a doublet strategy in higher-risk myelodysplastic syndrome (MDS). The Phase III SELECT-MDS-1 study of tamibarotene plus azacitidine to treat newly diagnosed patients with higher-risk MDS overexpressing RARA, which already passed a futility analysis, is expected to read out in the fourth quarter. In a bid to focus resources towards advancing its lead asset tamibarotene, Syros in October slashed 35% of its workforce and scrapped the clinical programme for its acute promyelocytic leukaemia candidate, SY-2101, alongside all other preclinical and discovery-stage programmes. The company also witnessed a leadership change, with the chief commercial and business officer Conley Chee taking over from Nancy Simonian as CEO. The restructuring was also partly fuelled by a pair of axed deals with Incyte and Pfizer earlier in 2023.

Syros still plans to continue the development of tamibarotene in higher-risk myelodysplastic syndromes (HR-MDS) indication, with pivotal complete response data from a Phase III trial expected in Q4 this year. Image Credit: eamesBot / Shutterstock. Syros Pharmaceuticals has discontinued enrolment in the Phase II SELECT-AML-1 trial evaluating its cancer therapy, tamibarotene, after a futility analysis found that the study had a “low” likelihood of success. Following the news, the US-based company’s stock took a nosedive and was down by more than 62% in premarket trading on 13 August, compared to the market close on the previous day. This is a sharp contrast to December when its stock assumed an upward trajectory after Syros shared initial positive data from the Phase II SELECT-AML-1 trial. At its peak, the company’s stock was worth over $7.79 and is currently worth $1.83 in premarket today. Syros’s current market cap is $134.3m. The futility analysis was conducted on the data from the first 40 randomised patients enrolled in the Phase II trial (NCT04905407). The study evaluated the triplet therapy of tamibarotene in combination with AbbVie ’s Venclyxto (venetoclax) and azacitidine versus the double treatment of Venclyxto and azacitidine. The data showed that the complete response (CR)/complete response with incomplete haematologic recovery (CRi) rates observed across both arms were similar, 65% and 70% in the triplet and doublet arms, respectively. The analysis then concluded that the final analysis of 80 randomised patients had a “low probability of success”. See Also: Bavarian Nordic wins positive CHMP opinion to amend Imvanex approval EAN 2024: anti-CGRPs more effective than onabotulinumtoxinA in chronic migraine prevention in real world Tamibarotene is a specific agonist for retinoic acid receptor alpha/beta with possible binding to retinoid X receptors (RXR). The RXR receptors regulate the transcription of signalling pathways that impact numerous hallmarks of cancer by controlling both inflammation and immune responses that modulate the tumour microenvironment. Syros was adamant that the company was not ditching the cancer therapy completely. The company stated that it will continue to evaluate tamibarotene in patients with higher-risk myelodysplastic syndromes (HR-MDS). The Phase III SELECT-MDS-1 trial (NCT04797780) is evaluating tamibarotene in combination with azacitidine. The study passed a prespecified futility analysis in Q1, with pivotal complete response data expected in Q4 this year.