Salarius Pharmaceuticals Announces Patient Enrollment to Resume in Investigator-initiated Phase 1/2 Clinical Trial Using Seclidemstat with Azacitidine to Treat Hematologic Cancers
Salarius Pharmaceuticals (SLRX) announces the resumption of patient enrollment in their investigator-initiated Phase 1/2 clinical trial at MD Anderson Cancer Center, evaluating seclidemstat combined with azacitidine for treating myelodysplastic syndrome (MDS) and chronic myelomonocytic leukemia (CMML).
The trial previously reported promising interim results, showing a 43% overall response rate among 14 high-risk patients who had failed prior therapy, with median overall survival of 18.5 months compared to typical 4-6 months. The FDA's partial clinical hold, implemented in July 2024 following a serious adverse event, has now been lifted.
Additionally, Salarius has signed a merger agreement with Decoy Therapeutics, forming a new company focused on peptide conjugate therapeutics for respiratory infections and GI oncology. The company will continue supporting the seclidemstat trial while exploring strategic alternatives for the drug.
Salarius Pharmaceuticals (SLRX) annuncia la ripresa dell'arruolamento di pazienti nel loro studio clinico di Fase 1/2, iniziato da ricercatori, presso il MD Anderson Cancer Center, che valuta seclidemstat combinato con azacitidina per il trattamento della sindrome mielodisplastica (MDS) e della leucemia mielomonocitica cronica (CMML).
Lo studio ha precedentemente riportato risultati intermedi promettenti, mostrando un tasso di risposta globale del 43% tra 14 pazienti ad alto rischio che avevano fallito precedenti terapie, con una sopravvivenza globale mediana di 18,5 mesi rispetto ai tipici 4-6 mesi. La sospensione clinica parziale da parte della FDA, attuata a luglio 2024 a seguito di un evento avverso grave, è stata ora rimossa.
Inoltre, Salarius ha firmato un accordo di fusione con Decoy Therapeutics, formando una nuova azienda focalizzata sulle terapie coniugate a peptide per le infezioni respiratorie e l'oncologia GI. L'azienda continuerà a supportare lo studio su seclidemstat mentre esplora alternative strategiche per il farmaco.
Salarius Pharmaceuticals (SLRX) anuncia la reanudación de la contratación de pacientes en su ensayo clínico de Fase 1/2, iniciado por investigadores, en el MD Anderson Cancer Center, que evalúa seclidemstat combinado con azacitidina para tratar el síndrome mielodisplásico (MDS) y la leucemia mielomonocítica crónica (CMML).
El ensayo había informado previamente resultados interinos prometedores, mostrando una tasa de respuesta global del 43% entre 14 pacientes de alto riesgo que fallaron en terapias previas, con una supervivencia global mediana de 18.5 meses en comparación con los típicos 4-6 meses. La detención clínica parcial por parte de la FDA, implementada en julio de 2024 tras un evento adverso grave, se ha levantado ahora.
Además, Salarius ha firmado un acuerdo de fusión con Decoy Therapeutics, formando una nueva empresa centrada en terapias de conjugados péptidos para infecciones respiratorias y oncología GI. La empresa continuará apoyando el ensayo de seclidemstat mientras explora alternativas estratégicas para el fármaco.
Salarius Pharmaceuticals (SLRX)는 MD Anderson Cancer Center에서 실시하는 연구자 주도 제1/2상 임상 시험에서 환자 등록을 재개한다고 발표했습니다. 이 시험은 골수형성이상증후군(MDS) 및 만성 골수단구성 백혈병(CMML) 치료를 위해 seclidemstat과 azacitidine의 병용 치료를 평가하고 있습니다.
이 시험은 이전에 14명의 고위험 환자에서 43%의 전체 반응률을 보여주는 유망한 중간 결과를 보고했으며, 기존 치료에 실패한 환자들은 4-6개월의 일반적인 생존 기간에 비해 중간 전체 생존 기간이 18.5개월이었습니다. 2024년 7월 심각한 부작용이 발생하여 FDA에 의해 시행된 임상 보류가 이제 해제되었습니다.
또한, Salarius는 Decoy Therapeutics와 통합 계약을 체결하여 호흡기 감염 및 GI 종양학에 대한 펩타이드 결합 치료에 초점을 맞춘 새로운 회사를 형성했습니다. 이 회사는 seclidemstat 시험을 계속 지원하는 동시에 약물에 대한 전략적 대안을 탐색할 것입니다.
Salarius Pharmaceuticals (SLRX) annonce la reprise de l'inscription des patients dans leur essai clinique de Phase 1/2, initié par des chercheurs, au MD Anderson Cancer Center, évaluant seclidemstat combiné avec azacitidine pour le traitement du syndrome myélodysplasique (MDS) et de la leucémie myélomonocytaire chronique (CMML).
L'essai avait précédemment rapporté des résultats intermédiaires prometteurs, montrant un taux de réponse global de 43% parmi 14 patients à haut risque ayant échoué à des thérapies antérieures, avec une survie globale médiane de 18,5 mois par rapport aux 4-6 mois habituels. La suspension clinique partielle de la FDA, mise en œuvre en juillet 2024 à la suite d'un événement indésirable sérieux, a maintenant été levée.
De plus, Salarius a signé un accord de fusion avec Decoy Therapeutics, formant une nouvelle société axée sur les thérapies par conjugés peptidiques pour les infections respiratoires et l'oncologie GI. L'entreprise continuera de soutenir l'essai sur le seclidemstat tout en explorant des alternatives stratégiques pour le médicament.
Salarius Pharmaceuticals (SLRX) kündigt die Wiederaufnahme der Patientenrekrutierung in ihrer von Forschern initiierten Phase-1/2-Studie am MD Anderson Cancer Center an, die seclidemstat in Kombination mit Azacitidin zur Behandlung des myelodysplastischen Syndroms (MDS) und der chronischen myelomonocytären Leukämie (CMML) untersucht.
Die Studie hatte zuvor vielversprechende Zwischenergebnisse gemeldet, mit einer Gesamtansprechrate von 43% bei 14 Hochrisikopatienten, die zuvor nicht auf eine Behandlung angesprochen hatten, wobei die mediane Gesamtüberlebenszeit 18,5 Monate betrug im Vergleich zu typischen 4-6 Monaten. Die teilweise klinische Aussetzung der FDA, die im Juli 2024 nach einem schwerwiegenden unerwünschten Ereignis verhängt wurde, wurde nun aufgehoben.
Darüber hinaus hat Salarius eine Fusionsvereinbarung mit Decoy Therapeutics unterzeichnet und ein neues Unternehmen gegründet, das sich auf peptidkonjugierte Therapeutika für Atemwegsinfektionen und GI-Onkologie konzentriert. Das Unternehmen wird die Seclidemstat-Studie weiterhin unterstützen, während es strategische Alternativen für das Medikament untersucht.
- 43% overall response rate in Phase 1/2 trial for MDS and CMML patients
- Median overall survival of 18.5 months vs typical 4-6 months
- FDA partial clinical hold lifted, allowing trial resumption
- Strategic merger with Decoy Therapeutics announced
- Serious adverse event led to temporary FDA clinical hold
- Company seeking strategic alternatives for seclidemstat, indicating possible deprioritization
Insights
The resumption of the Phase 1/2 trial for seclidemstat presents a significant clinical milestone with compelling implications. The interim data shows remarkable promise - the 43% overall response rate in predominantly higher-risk MDS and CMML patients who failed prior therapy is particularly noteworthy. The median overall survival of 18.5 months represents a substantial improvement over typical post-hypomethylating agent survival of 4-6 months.
The lifting of the FDA's partial clinical hold, implemented after a serious adverse event, demonstrates that safety concerns have been adequately addressed by MD Anderson. This regulatory clearance is important for maintaining development momentum and validates the risk-benefit profile of the seclidemstat-azacitidine combination.
However, this positive development must be viewed through the lens of Salarius's recently announced merger with Decoy Therapeutics. While the company states it will continue supporting the ongoing trial, the strategic focus appears to be shifting toward Decoy's peptide conjugate platform and respiratory/GI oncology pipeline. The statement about 'evaluating strategic alternatives for seclidemstat' suggests potential partnering or out-licensing opportunities may be pursued.
The MDS/CMML market represents a significant opportunity, with effective options for patients who fail first-line therapy. Seclidemstat's novel LSD1 inhibition mechanism and encouraging survival data position it as a potentially valuable asset, though its ultimate development path may depend on strategic decisions following the merger's completion.
HOUSTON, Feb. 03, 2025 (GLOBE NEWSWIRE) -- Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX) announces that patient enrollment will resume in the investigator-initiated Phase 1/2 clinical trial evaluating seclidemstat in combination with azacitidine for the treatment of myelodysplastic syndrome (MDS) and chronic myelomonocytic leukemia (CMML). The trial is being conducted at the University of Texas MD Anderson Cancer Center (MDACC) and is listed as recruiting on clinical trials.gov – trial NCT04734990.
Seclidemstat is a novel oral reversible inhibitor of the LSD1 enzyme. Inhibiting LSD1 in preclinical in vivo hematologic models has previously demonstrated reprogramed cancer cell differentiation, reduced tumor burden and prolonged survival of treated animals studied.
As previously announced at the June 2024 European Hematology Association Annual Meeting, researchers at MDACC reported interim clinical trial results from this trial including a
In July 2024 the U.S. Food and Drug Administration (FDA) placed the MDACC investigator-initiated trial under a partial clinical hold following a serious and unexpected adverse event. MDACC has addressed the FDA’s questions, and the partial clinical hold has been lifted.
“Coming off partial clinical hold is welcome news for Salarius stakeholders and for patients with advanced MDS and CMML, and we are excited for MDACC to enroll additional patients and build upon seclidemstat’s growing clinical database,” said David Arthur, President and CEO of Salarius Pharmaceuticals.
As announced on January 13, 2025, Salarius signed a definitive agreement under which Decoy Therapeutics, Inc. will merge with a wholly owned subsidiary of Salarius Pharmaceuticals, subject to certain closing conditions in the agreement. The newly formed company will be named Decoy Therapeutics. The proposed transaction is expected to facilitate multiple value-creating inflection points with Decoy’s pipeline of peptide conjugate therapeutics engineered by its IMP3ACT™ platform, which allows for the rapid computational design and manufacturing of innovative peptide conjugate therapeutics including rapid response to novel viral pathogens such as avian H5N1 flu. Decoy’s product pipeline targets unmet needs in respiratory infectious diseases and gastroenterology (GI) oncology indications.
In addition, the combined company intends to incorporate Salarius’ oral small molecule protein degrader SP-3164 into a highly targeted peptide-based proteolysis targeting chimera (PROTACS) drug candidate. The ongoing development of Salarius’ seclidemstat for hematologic cancers in the investigator-initiated Phase 1/2 clinical trial at MDACC will be supported while the company evaluates strategic alternatives for seclidemstat.
Salarius Pharmaceuticals, Inc.
Salarius Pharmaceuticals is a clinical-stage biopharmaceutical company with two drug candidates for patients with cancer in need of new treatment options. Salarius’ product portfolio includes seclidemstat, the company’s lead candidate, which is being studied in an investigator-initiated Phase 1/2 clinical study in hematologic cancers underway at MD Anderson Cancer Center as a potential treatment for MDS and CML in patients with limited treatment options. SP-3164, the company’s IND-stage second asset, is an oral small molecule protein degrader. Salarius previously received financial support for seclidemstat for the treatment of Ewing sarcoma from the National Pediatric Cancer Foundation and was a recipient of a Product Development Award from the Cancer Prevention and Research Institute of Texas (CPRIT). For more information, please visit www.salariuspharma.com.
About Decoy Therapeutics, Inc.
Decoy Therapeutics is a preclinical-stage biotechnology company that is leveraging machine learning and artificial intelligence tools alongside high-speed synthesis techniques to rapidly design, engineer and manufacture peptide conjugate drug candidates that target serious unmet medical needs. The company’s initial pipeline is focused on respiratory viruses and GI cancers. Decoy has attracted financing from institutional investors as well as significant non-dilutive capital from the Gates Foundation, the Massachusetts Life Sciences Seed Fund, the Google AI startup program and the NVIDIA Inception program. The company has also received QuickFire Challenge award funding provided by BARDA through BLUE KNIGHT™, a collaboration between Johnson & Johnson Innovation – JLABS and the Biomedical Advanced Research and Development Authority within the Administration for Strategic Preparedness and Response. For more information, please visit www.DecoyTx.com.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release are forward-looking statements. These forward-looking statements may be identified by terms such as “will,” “believe,” “developing,” “expect,” “may,” “progress,” “potential,” “could,” “look forward,” “encouraging,” “might,” “should,” and similar terms or expressions or the negative thereof. Examples of such statements include, but are not limited to, statements relating to: Salarius, Decoy, the proposed merger and other related matters, including without limitation, statements relating to the combined company and plans and expectations relating to the business, the combined company’s products and product candidates including expected achievement of milestones for its lead asset and future prospects of Decoy and the combined company; Salarius’ expectation that the proposed transaction will facilitate multiple value-creating inflection points with Decoy’s pipeline of peptide conjugate therapeutics engineered by its IMP3ACT™ platform; the combined company’s intention to incorporate Salarius’ oral small molecule protein degrader SP-3164 into a highly targeted peptide-based proteolysis targeting chimera (PROTACS) drug candidate; Salarius’ belief that the ongoing development of Salarius’ seclidemstat for hematologic cancers in the investigator-initiated Phase 1/2 clinical trial at MDACC will be supported while the company evaluates strategic alternatives for seclidemstat.
Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the risk that the announced transaction with Decoy may not close; the risk that the conditions to the closing of the merger are not satisfied, including uncertainties as to the timing of the consummation of the proposed merger; the ability of each of Salarius and Decoy to consummate the merger. Readers are urged to carefully review and consider the various disclosures made by us in our reports filed with the SEC, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2023, as revised or supplemented by its Quarterly Reports on Form 10-Q and the risk factors contained in Salarius’ Current Report on Form 8-K filed on January 13, 2025 which attempt to advise interested parties of the risks and factors that may affect the merger and other documents filed with the SEC. The forward-looking statements contained in this press release speak only as of the date of this press release and are based on management’s assumptions and estimates as of such date. Salarius disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made.
CONTACT:
Alliance Advisors IR
Jody Cain
jcain@allianceadvisors.com
310-691-7100
FAQ
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