Kura Oncology Announces FDA Clearance of IND Application for Menin Inhibitor Ziftomenib in Advanced Gastrointestinal Stromal Tumors (GIST)
Kura Oncology (Nasdaq: KURA) announced FDA clearance of an IND application for ziftomenib, their menin inhibitor, to treat advanced gastrointestinal stromal tumors (GIST). A Phase 1 study combining ziftomenib with imatinib is planned for early 2025. Preclinical data suggest this combination could resensitize patients to imatinib and induce durable responses in imatinib-resistant cases. GIST, the most common sarcoma, is typically treated with KIT inhibitors like imatinib. However, many patients develop resistance, limiting treatment options. Ziftomenib targets the menin-MLL complex, which regulates KIT expression in GIST cells. This marks the first IND clearance for a menin inhibitor in GIST treatment, potentially offering a new approach for patients with options.
Kura Oncology (Nasdaq: KURA) ha annunciato l'approvazione da parte della FDA di una domanda IND per ziftomenib, il loro inibitore della menina, per il trattamento di tumori stromali gastrointestinali avanzati (GIST). È previsto uno studio di Fase 1 che combinerà ziftomenib con imatinib, previsto per inizio 2025. I dati preclinici suggeriscono che questa combinazione potrebbe ri-sensibilizzare i pazienti a imatinib e indurre risposte durature nei casi resistenti a imatinib. Il GIST, il sarcoma più comune, viene tipicamente trattato con inibitori di KIT come imatinib. Tuttavia, molti pazienti sviluppano resistenza, limitando le opzioni terapeutiche. Ziftomenib colpisce il complesso menin-MLL, che regola l'espressione di KIT nelle cellule GIST. Questo segna la prima approvazione IND per un inibitore della menina nel trattamento del GIST, offrendo potenzialmente un nuovo approccio per i pazienti con opzioni limitate.
Kura Oncology (Nasdaq: KURA) anunció la autorización de la FDA para una solicitud IND para ziftomenib, su inhibidor de menin, para tratar tumores estromales gastrointestinales avanzados (GIST). Se planea un estudio de Fase 1 que combinará ziftomenib con imatinib, previsto para principios de 2025. Los datos preclínicos sugieren que esta combinación podría volver a sensibilizar a los pacientes a imatinib e inducir respuestas duraderas en casos resistentes a imatinib. GIST, el sarcoma más común, se trata típicamente con inhibidores de KIT como imatinib. Sin embargo, muchos pacientes desarrollan resistencia, limitando las opciones de tratamiento. Ziftomenib actúa sobre el complejo menin-MLL, que regula la expresión de KIT en las células GIST. Esta es la primera autorización IND para un inhibidor de menin en el tratamiento de GIST, lo que podría ofrecer un nuevo enfoque para pacientes con opciones limitadas.
Kura Oncology (Nasdaq: KURA)는 ziftomenib라는 그들의 메닌 억제제를 고급 위장관 스트로마 종양(GIST) 치료를 위한 IND 신청이 FDA 승인을 받았다고 발표했습니다. ziftomenib와 imatinib을 결합한 1상 연구가 2025년 초에 계획되고 있습니다. 전임상 데이터는 이 조합이 환자들을 imatinib에 재센서 시키고 imatinib 내성 환자에서 지속적인 반응을 유도할 수 있음을 시사합니다. GIST는 가장 흔한 육종으로, 일반적으로 imatinib와 같은 KIT 억제제로 치료됩니다. 그러나 많은 환자들이 내성을 발전시켜 치료 옵션이 제한됩니다. Ziftomenib는 GIST 세포에서 KIT 발현을 조절하는 menin-MLL 복합체를 표적으로 합니다. 이는 GIST 치료를 위한 메닌 억제제의 첫 번째 IND 승인을 의미하며, 옵션이 제한된 환자들에게 새로운 접근 방식을 제공할 수 있습니다.
Kura Oncology (Nasdaq: KURA) a annoncé l'approbation par la FDA d'une demande IND pour ziftomenib, leur inhibiteur de menine, afin de traiter les tumeurs stromales gastro-intestinales avancées (GIST). Une étude de phase 1 combinant ziftomenib avec imatinib est prévue pour début 2025. Les données précliniques suggèrent que cette combinaison pourrait redisensibiliser les patients à l'imatinib et induire des réponses durables dans les cas résistants à l'imatinib. Le GIST, le sarcome le plus courant, est généralement traité avec des inhibiteurs de KIT tels que l'imatinib. Cependant, de nombreux patients développent une résistance, limitant les options de traitement. Ziftomenib cible le complexe menin-MLL, qui régule l'expression de KIT dans les cellules GIST. Cela marque la première approbation IND pour un inhibiteur de menine dans le traitement du GIST, offrant potentiellement une nouvelle approche pour les patients avec des options limitées.
Kura Oncology (Nasdaq: KURA) hat die Genehmigung der FDA für einen IND-Antrag für ziftomenib, ihren Menin-Hemmer, zur Behandlung von fortgeschrittenen gastrointestinalen Stromatumoren (GIST), angekündigt. Eine Phase-1-Studie, die ziftomenib mit imatinib kombiniert, ist für Anfang 2025 geplant. Präklinische Daten deuten darauf hin, dass diese Kombination Patienten wieder gegenüber imatinib sensibilisieren und in imatinib-resistenten Fällen dauerhafte Antworten hervorrufen könnte. GIST, der häufigste Sarkom, wird normalerweise mit KIT-Hemmern wie imatinib behandelt. Viele Patienten entwickeln jedoch Resistenzen, was die Behandlungsoptionen einschränkt. Ziftomenib zielt auf den Menin-MLL-Komplex ab, der die KIT-Expression in GIST-Zellen reguliert. Dies markiert die erste IND-Genehmigung für einen Menin-Hemmer in der GIST-Behandlung, was möglicherweise einen neuen Ansatz für Patienten mit eingeschränkten Optionen bietet.
- FDA clearance of IND application for ziftomenib in advanced GIST
- Preclinical data shows potential to resensitize patients to imatinib
- First menin inhibitor to receive IND clearance for GIST treatment
- Planned Phase 1 study combining ziftomenib with imatinib in early 2025
- None.
The FDA clearance of Kura Oncology's IND for ziftomenib in advanced GIST is a significant milestone in the field of targeted cancer therapies. This menin inhibitor's potential to resensitize patients to imatinib could be a game-changer for GIST treatment. Here's why:
- GIST patients often develop resistance to imatinib, leaving them with options.
- The preclinical data suggesting ziftomenib can overcome this resistance is highly promising.
- If successful, this combination could extend the efficacy of first-line treatment, potentially improving patient outcomes.
However, it's important to note that the proof-of-concept study won't begin until 1H 2025, indicating a long road ahead before potential clinical application. Investors should monitor the upcoming preclinical data presentation for further insights into ziftomenib's potential.
Kura Oncology's FDA clearance for ziftomenib's IND in GIST represents a strategic expansion into solid tumors, diversifying their pipeline beyond hematological malignancies. Key points for investors:
- This move into GIST, a niche market with competition, could provide a significant opportunity if successful.
- The combination approach with imatinib is cost-effective and could accelerate market adoption if proven effective.
- However, the 2025 study initiation suggests a long timeline to potential commercialization, impacting near-term value.
While this news is positive for Kura's long-term prospects, investors should temper short-term expectations. The company's ability to execute on this program while advancing its other pipeline assets will be important to watch.
The FDA clearance for ziftomenib's IND in GIST is a positive development, but several factors warrant consideration:
- The Phase 1 first-in-human study indicates we're at an early stage, with safety and dosing yet to be established.
- The 2025 start date suggests a lengthy timeline before potential efficacy data becomes available.
- Combination trials can be complex, potentially affecting patient recruitment and trial duration.
While the preclinical data is promising, it's important to remember that many candidates fail in the transition from preclinical to clinical stages. The upcoming scientific presentation of preclinical data will be vital for assessing the strength of the evidence supporting this approach. Investors should maintain a cautiously optimistic outlook, recognizing the long road ahead in clinical development.
– Preclinical data suggest combination of ziftomenib and imatinib has potential to resensitize patients to imatinib and induce durable responses –
– Proof-of-concept study evaluating ziftomenib and imatinib in patients with advanced GIST to begin in 1H 2025 –
SAN DIEGO, Aug. 08, 2024 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced clearance by the U.S. Food and Drug Administration (FDA) of the Investigational New Drug (IND) application for ziftomenib, the Company’s potent and selective menin inhibitor, for the treatment of advanced gastrointestinal stromal tumors (GIST). The Company plans to initiate a Phase 1 first-in-human study of ziftomenib in combination with imatinib, a targeted therapy approved for the treatment of GIST, in early 2025.
“This important milestone represents the first IND clearance of a menin inhibitor to treat GIST, a solid tumor indication with limited treatment options for patients with advanced disease,” said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. “Although imatinib is utilized in frontline GIST patients, many eventually develop resistance. Our preclinical data suggest ziftomenib has potential to resensitize patients to imatinib and induce deep, durable responses. We look forward to presenting the preclinical data for the combination at an upcoming scientific meeting and initiating a proof-of-concept clinical study early next year.”
GIST is the most common form of sarcoma, characterized as KIT-dependent solid tumors. KIT inhibitors are associated with favorable outcomes for patients with GIST, and imatinib is the standard of care in this patient population. For patients who progress on imatinib, subsequent treatment options include other KIT inhibitors; however, these options are limited by moderate efficacy and challenging tolerability. The menin-MLL complex regulates KIT expression in GIST cells, and menin inhibitors display additive therapeutic activity with imatinib in imatinib-sensitive GIST models1. Preclinical data in imatinib-resistant PDX models suggest that ziftomenib in combination with imatinib has the potential to resensitize patients to imatinib and induce durable responses. Kura plans to initiate a proof-of-concept study evaluating ziftomenib in combination with imatinib in patients with advanced GIST after imatinib failure.
About Kura Oncology
Kura Oncology is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. The Company’s pipeline consists of small molecule drug candidates that target cancer signaling pathways. Ziftomenib, a once-daily, oral drug candidate targeting the menin-KMT2A protein-protein interaction, has received Breakthrough Therapy Designation for the treatment of relapsed/refractory (R/R) NPM1-mutant acute myeloid leukemia (AML). Kura has completed enrollment in a Phase 2 registration-directed trial of ziftomenib in R/R NPM1-mutant AML (KOMET-001). The Company is also conducting a series of clinical trials to evaluate ziftomenib in combination with current standards of care in newly diagnosed and R/R NPM1-mutant and KMT2A-rearranged AML. Tipifarnib, a potent and selective farnesyl transferase inhibitor (FTI), is currently in a Phase 1/2 trial in combination with alpelisib for patients with PIK3CA-dependent head and neck squamous cell carcinoma (KURRENT-HN). Kura is also evaluating KO-2806, a next-generation FTI, in a Phase 1 dose-escalation trial as a monotherapy and in combination with targeted therapies (FIT-001). For additional information, please visit Kura’s website at www.kuraoncology.com and follow us on X and LinkedIn.
Forward-Looking Statements
This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, the efficacy, safety and therapeutic potential of ziftomenib, potential benefits of combining ziftomenib with appropriate standards of care, and progress and expected timing of the ziftomenib program and clinical trials. Factors that may cause actual results to differ materially include the risk that compounds that appeared promising in early research or clinical trials do not demonstrate safety and/or efficacy in later preclinical studies or clinical trials, the risk that Kura may not obtain approval to market its product candidates, uncertainties associated with performing clinical trials, regulatory filings, applications and other interactions with regulatory bodies, risks associated with reliance on third parties to successfully conduct clinical trials, the risks associated with reliance on outside financing to meet capital requirements, and other risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. You are urged to consider statements that include the words “may,” “will,” “would,” “could,” “should,” “believes,” “estimates,” “projects,” “promise,” “potential,” “expects,” “plans,” “anticipates,” “intends,” “continues,” “designed,” “goal,” or the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties the Company faces, please refer to the Company’s periodic and other filings with the Securities and Exchange Commission, which are available at www.sec.gov. Such forward-looking statements are current only as of the date they are made, and Kura assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
Contacts
Investors:
Pete De Spain
Executive Vice President, Investor Relations &
Corporate Communications
(858) 500-8833
pete@kuraoncology.com
Media:
Cassidy McClain
Vice President
Inizio Evoke Comms
(619) 849-6009
cassidy.mcclain@inizioevoke.com
1 Hemming ML et al., Cancer Discov. 2022;12:1804-1823.
FAQ
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