Immuneering Granted FDA Fast Track Designation for IMM-1-104 in Advanced Melanoma
Immuneering (NASDAQ: IMRX) has received FDA Fast Track designation for IMM-1-104 to treat patients with unresectable or metastatic NRAS-mutant melanoma who have progressed on or are intolerant to PD-1/PD-L1 based immune checkpoint inhibitors. The drug is currently in Phase 2a clinical trials for advanced solid tumors, including melanoma.
According to Phase 1 data presented at ESMO 2024, IMM-1-104 demonstrated unique tolerability compared to existing MEK inhibitors used in melanoma treatment. The Fast Track designation may enable more frequent FDA interactions and potential eligibility for accelerated approval and priority review. This is the third Fast Track designation for IMM-1-104, following previous designations for first and second-line pancreatic cancer treatment.
Immuneering (NASDAQ: IMRX) ha ricevuto la designazione Fast Track della FDA per IMM-1-104, un trattamento per pazienti con melanoma mutante NRAS non resectabile o metastatico che hanno mostrato progressione o intolleranza agli inibitori dei checkpoint immunitari basati su PD-1/PD-L1. Attualmente, il farmaco è in fase di sperimentazione clinica di fase 2a per tumori solidi avanzati, incluso il melanoma.
Secondo i dati della fase 1 presentati all'ESMO 2024, IMM-1-104 ha dimostrato una tollerabilità unica rispetto agli inibitori MEK esistenti usati nel trattamento del melanoma. La designazione Fast Track potrebbe consentire interazioni più frequenti con la FDA e potenziale idoneità per approvazioni accelerate e revisioni prioritarie. Questa è la terza designazione Fast Track per IMM-1-104, dopo le precedenti designazioni per il trattamento del cancro pancreatico di prima e seconda linea.
Immuneering (NASDAQ: IMRX) ha recibido la designación de Vía Rápida por parte de la FDA para IMM-1-104, un tratamiento para pacientes con melanoma metastásico o no resecable mutante NRAS que han progresado o son intolerantes a los inhibidores de puntos de control inmunitario basados en PD-1/PD-L1. Actualmente, el fármaco se encuentra en ensayos clínicos de fase 2a para tumores sólidos avanzados, incluido el melanoma.
Según los datos de la fase 1 presentados en ESMO 2024, IMM-1-104 mostró una tolerabilidad única en comparación con los inhibidores de MEK existentes utilizados en el tratamiento del melanoma. La designación de Vía Rápida puede permitir interacciones más frecuentes con la FDA y la posible elegibilidad para aprobación acelerada y revisión prioritaria. Esta es la tercera designación de Vía Rápida para IMM-1-104, tras las designaciones previas para el tratamiento del cáncer de páncreas en primera y segunda línea.
Immuneering (NASDAQ: IMRX)는 PD-1/PD-L1 기반 면역 체크포인트 억제제에서 진행이 되었거나 내성이 있는 절제 불가능하거나 전이성 NRAS 변이 흑색종 환자를 치료하기 위해 IMM-1-104에 대한 FDA 신속 심사 지정을 받았습니다. 이 약물은 현재 흑색종을 포함한 진행성 고형 종양에 대한 2a상 임상 시험 중입니다.
2024년 ESMO에서 발표된 1상 데이터에 따르면, IMM-1-104는 흑색종 치료에 사용되는 기존 MEK 억제제에 비해 독특한 내약성을 보여주었습니다. 신속 심사 지정을 통해 FDA와의 더 빈번한 상호작용과 가속 승인 및 우선 심사 가능성을 얻을 수 있습니다. 이는 IMM-1-104에 대한 세 번째 신속 심사 지정이며, 이전의 첫 번째 및 두 번째 라인 췌장암 치료에 대한 지정이 있습니다.
Immuneering (NASDAQ: IMRX) a reçu la désignation Fast Track de la FDA pour IMM-1-104, un traitement à destination de patients atteints de mélanome muté NRAS non résécable ou métastatique qui ont progressé ou sont intolérants aux inhibiteurs de points de contrôle immunitaires basés sur PD-1/PD-L1. Le médicament est actuellement en essais cliniques de phase 2a pour des tumeurs solides avancées, y compris le mélanome.
Selon les données de phase 1 présentées à l'ESMO 2024, IMM-1-104 a démontré une tolérabilité unique par rapport aux inhibiteurs de MEK existants utilisés dans le traitement du mélanome. La désignation Fast Track pourrait permettre des interactions plus fréquentes avec la FDA et une éligibilité potentielle pour une approbation accélérée et une révision prioritaire. C'est la troisième désignation Fast Track pour IMM-1-104, après des désignations précédentes pour le traitement du cancer du pancréas de première et deuxième ligne.
Immuneering (NASDAQ: IMRX) hat von der FDA die Fast-Track-Qualifizierung für IMM-1-104 erhalten, um Patienten mit nicht operablem oder metastasierendem NRAS-mutiertem Melanom zu behandeln, die bei PD-1/PD-L1-basierten Immun-Checkpoint-Inhibitoren Fortschritte gemacht haben oder intolerant sind. Das Medikament befindet sich derzeit in klinischen Phase-2a-Studien für fortgeschrittene solide Tumoren, einschließlich Melanomen.
Laut den in ESMO 2024 präsentierten Phase-1-Daten zeigte IMM-1-104 im Vergleich zu bestehenden MEK-Inhibitoren, die bei der Behandlung von Melanomen eingesetzt werden, eine einzigartige Tolerabilität. Die Fast-Track-Qualifizierung könnte häufigere Interaktionen mit der FDA und die potenzielle Berechtigung für eine beschleunigte Zulassung und eine vorrangige Überprüfung ermöglichen. Dies ist die dritte Fast-Track-Qualifizierung für IMM-1-104, nach vorherigen Qualifizierungen für die Behandlung von Bauchspeicheldrüsenkrebs in erster und zweiter Linie.
- Received FDA Fast Track designation for melanoma treatment
- Demonstrated better tolerability in Phase 1 compared to existing MEK inhibitors
- Currently enrolling patients in Phase 2a clinical trial
- Previously received Fast Track designations for pancreatic cancer indications
- None.
Insights
The FDA Fast Track designation for IMM-1-104 in advanced melanoma represents a significant regulatory milestone. The drug's novel approach as a MEK inhibitor with improved tolerability addresses a critical gap in melanoma treatment, particularly for patients who have failed checkpoint inhibitor therapy. Phase 1 data demonstrated a notably better safety profile compared to existing MEK inhibitors, which have historically been by toxicity issues. This is the third Fast Track designation for IMM-1-104, following previous designations in pancreatic cancer, suggesting broad potential across multiple indications.
The ongoing Phase 2a trial's inclusion of melanoma patients, combined with this regulatory support, could accelerate the development timeline. The potential for combination therapy with RAF inhibitors and checkpoint inhibitors could expand the drug's market opportunity significantly. The unmet need in NRAS-mutant melanoma is substantial, as these patients currently have treatment options after progression on immunotherapy.
This regulatory milestone strengthens IMRX's market position in the competitive oncology space. Fast Track designation provides several strategic advantages, including increased FDA interaction and potential eligibility for accelerated approval, which could significantly reduce time-to-market and development costs. The company's focus on universal-RAS/RAF medicines targets a substantial market opportunity, particularly given the drug's potential in multiple indications including melanoma and pancreatic cancer.
With a relatively modest market cap of
- IMM-1-104 has the potential to benefit melanoma patients who have progressed on or are intolerant to immune checkpoint inhibitors -
- IMM-1-104 was observed to be uniquely well tolerated in Phase 1 data shared at ESMO 2024, relative to MEK inhibitors currently used to treat melanoma -
- Melanoma patients actively enrolling in one of five arms in the company’s ongoing Phase 2a clinical study of IMM-1-104 -
CAMBRIDGE, Mass., Dec. 12, 2024 (GLOBE NEWSWIRE) -- Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company seeking to develop and commercialize universal-RAS/RAF medicines for broad populations of cancer patients, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its lead clinical-stage program, IMM-1-104, as a treatment for patients with unresectable or metastatic NRAS-mutant melanoma who have progressed on or are intolerant to PD-1/PD-L1 based immune checkpoint inhibitors. IMM-1-104 is currently being evaluated in a Phase 2a clinical trial in patients with advanced solid tumors, including melanoma.
“Immune checkpoint inhibitors play a vital role in the treatment of melanoma, yet patients who progress on or are intolerant to them have limited options,” said Ben Zeskind, Ph.D., Co-Founder and CEO of Immuneering. “Targeted therapies including MEK and RAF inhibitors have shown promise in melanoma but historically are severely limited by toxicity. As we presented at the European Society for Medical Oncology 2024 congress, IMM-1-104 is a new kind of MEK inhibitor that was observed to be uniquely well tolerated in our Phase 1 trial, relative to MEK inhibitors currently used to treat melanoma. We believe this creates opportunities for IMM-1-104 to benefit melanoma patients both alone and in combination with RAF inhibitors and/or immune checkpoint inhibitors. Against this backdrop, we are pleased with the FDA’s decision to grant Fast Track designation for IMM-1-104 in advanced melanoma, an area of significant unmet need. Melanoma patients are actively enrolling in one of the five arms of our Phase 2a clinical trial, and this designation follows our announcements earlier this year that IMM-1-104 has also been granted Fast Track designations for the treatment of both first and second-line pancreatic cancer.”
Fast Track designation is a program designed to facilitate the development and expedite the review of medicines with the potential to treat serious conditions and fulfill an unmet medical need. An investigational medicine that receives Fast Track designation may be eligible for more frequent interactions with the FDA to discuss the candidate’s development plan and, if relevant criteria are met, may be eligible for accelerated approval and priority review.
About IMM-1-104
IMM-1-104 aims to achieve universal-RAS activity that selectively impacts cancer cells to a greater extent than healthy cells, through Deep Cyclic Inhibition of the MAPK pathway with once-daily dosing. IMM-1-104 is currently being evaluated in a Phase 1/2a study in patients with advanced solid tumors harboring RAS mutations (NCT05585320).
About Immuneering Corporation
Immuneering is a clinical-stage oncology company seeking to develop and commercialize universal-RAS/RAF medicines for broad populations of cancer patients with an initial aim to develop a universal-RAS therapy. The Company aims to achieve universal activity through Deep Cyclic Inhibition of the MAPK pathway, impacting cancer cells while sparing healthy cells. Immuneering’s lead product candidate, IMM-1-104, is an oral, once-daily Deep Cyclic Inhibitor currently in a Phase 2a trial in patients with advanced solid tumors including those harboring RAS mutations. IMM-6-415 is an oral, twice-daily Deep Cyclic Inhibitor currently in a Phase 1/2a trial in patients with advanced solid tumors harboring RAS or RAF mutations. The company’s development pipeline also includes several early-stage programs. For more information, please visit www.immuneering.com.
Forward-Looking Statements
This press release contains forward-looking statements, including within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding: Immuneering’s plans to develop, manufacture and commercialize its product candidates; the treatment potential of IMM-1-104, alone or in combination with other agents; the design, enrollment criteria and conduct of the Phase 1/2a clinical trial of IMM-1-104; the potential for Fast Track designation to accelerate or otherwise benefit development of IMM-1-104 in advanced melanoma; and the timing of results of the Phase 2a portion of the trial for IMM-1-104.
These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the risks inherent in oncology drug research and development, including target discovery, target validation, lead compound identification, and lead compound optimization; we have incurred significant losses, are not currently profitable and may never become profitable; our projected cash runway and ability to continue as a going concern; our need for additional funding; our unproven approach to therapeutic intervention; our ability to address regulatory questions and the uncertainties relating to regulatory filings, reviews and approvals; the lengthy, expensive, and uncertain process of clinical drug development, including potential delays in or failure to obtain regulatory approvals; our reliance on third parties and collaborators to conduct our clinical trials, manufacture our product candidates, and develop and commercialize our product candidates, if approved; failure to compete successfully against other drug companies; protection of our proprietary technology and the confidentiality of our trade secrets; potential lawsuits for, or claims of, infringement of third-party intellectual property or challenges to the ownership of our intellectual property; our patents being found invalid or unenforceable; costs and resources of operating as a public company; and unfavorable or no analyst research or reports.
These and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the period ended September 30, 2024, and our other reports filed with the U.S. Securities and Exchange Commission, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
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FAQ
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