Immuneering Announces Clinical Supply Agreement with Regeneron Pharmaceuticals to Evaluate IMM-1-104 in Combination with Libtayo® (cemiplimab)
Immuneering (NASDAQ: IMRX) has announced a clinical supply agreement with Regeneron Pharmaceuticals to evaluate its lead product candidate IMM-1-104 in combination with Regeneron's anti-PD-1 therapy, Libtayo (cemiplimab). The combination will be tested in patients with unresectable or metastatic RAS-mutant non-small cell lung cancer (NSCLC) as part of Immuneering's ongoing Phase 2a clinical trial.
This marks Immuneering's first collaboration involving IMM-1-104. Under the agreement terms, Immuneering will sponsor the studies while Regeneron provides Libtayo. Immuneering retains global development and commercialization rights to IMM-1-104. The collaboration is supported by preclinical data presented at AACR 2023, which demonstrated the dual-targeting potential of IMM-1-104 in combination with immuno-oncology agents to break tumor MAPK addiction and enhance anti-tumor immunity.
Immuneering (NASDAQ: IMRX) ha annunciato un accordo per la fornitura clinica con Regeneron Pharmaceuticals per valutare il suo principale candidato prodotto IMM-1-104 in combinazione con la terapia anti-PD-1 di Regeneron, Libtayo (cemiplimab). La combinazione sarà testata in pazienti con cancro al polmone non a piccole cellule (NSCLC) mutante RAS non resecabile o metastatico, nell'ambito della fase 2a dello studio clinico in corso di Immuneering.
Questo segna la prima collaborazione di Immuneering relativa a IMM-1-104. Secondo i termini dell'accordo, Immuneering sponsorizzerà gli studi mentre Regeneron fornisce Libtayo. Immuneering mantiene i diritti globali di sviluppo e commercializzazione per IMM-1-104. La collaborazione è supportata da dati preclinici presentati all'AACR 2023, che hanno dimostrato il potenziale di doppio targeting di IMM-1-104 in combinazione con agenti di immuno-oncologia per interrompere l'ossessione tumorale al MAPK e migliorare l'immunità anti-tumorale.
Immuneering (NASDAQ: IMRX) ha anunciado un acuerdo de suministro clínico con Regeneron Pharmaceuticals para evaluar su candidato principal IMM-1-104 en combinación con la terapia anti-PD-1 de Regeneron, Libtayo (cemiplimab). La combinación se probará en pacientes con cáncer de pulmón no microcítico (NSCLC) mutante RAS no resecable o metastásico, como parte del ensayo clínico de fase 2a en curso de Immuneering.
Esta es la primera colaboración de Immuneering que involucra a IMM-1-104. Según los términos del acuerdo, Immuneering patrocinará los estudios mientras que Regeneron proporciona Libtayo. Immuneering retiene los derechos globales de desarrollo y comercialización para IMM-1-104. La colaboración cuenta con el apoyo de datos preclínicos presentados en el AACR 2023, que demostraron el potencial de doble objetivo de IMM-1-104 en combinación con agentes de inmuno-oncología para romper la adicción a MAPK del tumor y mejorar la inmunidad antitumoral.
Immuneering (NASDAQ: IMRX)는 Regeneron Pharmaceuticals와 임상 공급 계약을 체결하고, Regeneron의 항-PD-1 요법 Libtayo (cemiplimab)와 함께 주요 제품 후보인 IMM-1-104를 평가할 예정입니다. 이 조합은 수술이 불가능하거나 전이된 RAS 변이 비소세포 폐암 (NSCLC) 환자들을 대상으로 Immuneering의 진행 중인 2상 임상 시험의 일환으로 시험될 것입니다.
이번 계약은 IMM-1-104와 관련된 Immuneering의 첫 번째 협력입니다. 계약 조건에 따라 Immuneering이 연구를 후원하며 Regeneron이 Libtayo를 공급하게 됩니다. Immuneering은 IMM-1-104에 대한 글로벌 개발 및 상업화 권리를 보유합니다. 이 협력은 AACR 2023에서 발표된 전임상 데이터를 바탕으로 하여, 면역 항암제와 함께 IMM-1-104의 이중 타겟팅 가능성을 보여주어 종양의 MAPK 의존성을 끊고 항종양 면역을 향상시키는 데 도움을 줄 수 있습니다.
Immuneering (NASDAQ: IMRX) a annoncé un accord de fourniture clinique avec Regeneron Pharmaceuticals pour évaluer son principal candidat produit IMM-1-104 en combinaison avec la thérapie anti-PD-1 de Regeneron, Libtayo (cemiplimab). La combinaison sera testée chez des patients atteints de cancer du poumon non à petites cellules (NSCLC) muté RAS inopérable ou métastatique, dans le cadre de l'essai clinique de phase 2a en cours d'Immuneering.
C'est la première collaboration d'Immuneering impliquant IMM-1-104. Selon les termes de l'accord, Immuneering sponsorisera les études tandis que Regeneron fournira Libtayo. Immuneering conserve les droits mondiaux de développement et de commercialisation pour IMM-1-104. La collaboration est soutenue par des données précliniques présentées à l'AACR 2023, qui ont démontré le potentiel de double ciblage de IMM-1-104 en combinaison avec des agents d'immuno-oncologie pour rompre l'addiction tumorale au MAPK et améliorer l'immunité anti-tumorale.
Immuneering (NASDAQ: IMRX) hat eine klinische Versorgungsvereinbarung mit Regeneron Pharmaceuticals bekannt gegeben, um seinen Hauptproduktkandidaten IMM-1-104 in Kombination mit Regenerons Anti-PD-1-Therapie Libtayo (cemiplimab) zu evaluieren. Die Kombination wird bei Patienten mit nicht resektablem oder metastasiertem RAS-mutiertem nicht-kleinzelligem Lungenkrebs (NSCLC) im Rahmen der laufenden klinischen Phase-2a-Studie von Immuneering getestet.
Dies ist die erste Zusammenarbeit von Immuneering im Zusammenhang mit IMM-1-104. Nach den Bedingungen der Vereinbarung wird Immuneering die Studien sponsern, während Regeneron Libtayo zur Verfügung stellt. Immuneering behält sich die globalen Entwicklungs- und Vermarktungsrechte für IMM-1-104 vor. Die Zusammenarbeit wird durch präklinische Daten unterstützt, die auf der AACR 2023 präsentiert wurden und das Potenzial von IMM-1-104 in Kombination mit immunonkologischen Arzneimitteln zur Unterbrechung der Tumor-MAPK-Abhängigkeit und zur Verbesserung der antitumoralen Immunität demonstrieren.
- First collaboration agreement secured for IMM-1-104 development
- Partnership with major pharmaceutical company Regeneron
- Retention of global development and commercialization rights to IMM-1-104
- No upfront costs for Libtayo supply in the clinical trial
- None.
Insights
This clinical supply agreement represents a pivotal milestone for Immuneering, marking their first collaboration for IMM-1-104 and potentially accelerating their path to market. The combination strategy targeting both MAPK pathway addiction and immune checkpoint inhibition through PD-1 blockade is particularly noteworthy in the context of RAS-mutant NSCLC, which remains a challenging therapeutic area.
The structure of the agreement is strategically favorable for Immuneering, as they maintain global development and commercialization rights while benefiting from Regeneron's established presence in immuno-oncology. This risk-sharing model, where Regeneron provides Libtayo while Immuneering sponsors the studies, optimizes resource allocation and potentially accelerates the development timeline.
The combination's dual-targeting mechanism could provide a competitive edge in the crowded NSCLC market. RAS mutations occur in approximately 30% of NSCLC cases, representing a substantial market opportunity. The preclinical data suggesting synergistic effects between IMM-1-104 and PD-1 inhibitors could translate into improved clinical outcomes, particularly important given the efficacy of current monotherapies in RAS-mutant cancers.
This partnership significantly enhances Immuneering's credibility in the oncology space, particularly valuable for a clinical-stage company with a market cap of
The structure of the agreement is particularly advantageous for Immuneering. By maintaining global development and commercialization rights while accessing Regeneron's established therapy, they preserve long-term value while minimizing development costs. The global NSCLC market, valued at approximately
This agreement positions Immuneering strategically in the competitive landscape of targeted cancer therapies. The combination approach could differentiate their offering from other emerging RAS-targeted therapeutics, potentially leading to increased market share if clinical trials demonstrate superior efficacy.
- Immuneering plans to evaluate IMM-1-104 in combination with Libtayo in patients with advanced non-small cell lung cancer in its ongoing Phase 2a trial –
- Data presented at AACR 2023 supports dual-targeting potential of IMM-1-104 in combination with anti-PD-1 –
CAMBRIDGE, Mass., Feb. 06, 2025 (GLOBE NEWSWIRE) -- Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company seeking to develop and commercialize more effective and better tolerated therapies for cancer patients, today announced a clinical supply agreement with Regeneron Pharmaceuticals for its anti-PD-1 therapy, Libtayo (cemiplimab). The supply agreement supports the evaluation of Immuneering’s lead product candidate, IMM-1-104, in combination with Libtayo in patients with unresectable or metastatic RAS-mutant non-small cell lung cancer (NSCLC) in Immuneering’s ongoing Phase 2a clinical trial of IMM-1-104 in advanced solid tumors.
“We are excited to announce this collaboration, which is the first that Immuneering has entered with IMM-1-104. Regeneron is a global leader in cancer research and development, and the combination of IMM-1-104 and Libtayo in advanced non-small cell lung cancer has the potential to address unmet needs for patients with this disease,” said E.B. Brakewood, Chief Business Officer of Immuneering.
“Preclinical data presented at the American Association for Cancer Research (AACR) 2023 annual meeting supports the dual-targeting potential of IMM-1-104 in combination with immuno-oncology agents, including PD-1 inhibitors, to both break tumor MAPK addiction and enhance anti-tumor immunity,” said Brett Hall, Ph.D., Chief Scientific Officer of Immuneering. Under the terms of the clinical supply agreement, Immuneering will sponsor the planned studies and Regeneron will provide Libtayo. Immuneering will maintain global development and commercialization rights to IMM-1-104. Regeneron develops and commercializes Libtayo globally.
About Immuneering Corporation
Immuneering is a clinical-stage oncology company seeking to develop and commercialize more effective and better tolerated therapies for cancer patients. The Company’s lead product candidate, IMM-1-104, is an oral, once-daily deep cyclic inhibitor of MEK designed to improve tolerability and expand indications to include RAS-driven tumors such as most pancreatic cancers. IMM-1-104 is currently in a Phase 1/2a trial in patients with advanced solid tumors including pancreatic cancer. IMM-6-415 is an oral, twice-daily deep cyclic inhibitor of MEK 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 IMM-1-104 alone or in combination; the treatment potential of IMM-1-104, alone or in combination; and the timing, design, enrollment and conduct of the Phase 2a clinical trial of 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 Immuneering’s 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; that Immuneering has incurred significant losses, is not currently profitable and may never become profitable; Immuneering’s projected cash runway; Immuneering’s need for additional funding and ability to continue as a going concern; Immuneering’s unproven approach to therapeutic intervention; Immuneering’s 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; Immuneering’s reliance on third parties and collaborators to conduct its clinical trials, manufacture its product candidates, and develop and commercialize its product candidates, if approved; failure to compete successfully against other drug companies; protection of Immuneering’s proprietary technology and the confidentiality of Immuneering’s trade secrets; potential lawsuits for, or claims of, infringement of third-party intellectual property or challenges to the ownership of Immuneering’s intellectual property; Immuneering’s 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 Immuneering Corporation’s Quarterly Report on Form 10-Q for the period ended September 30, 2024, and its 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 Immuneering management's estimates as of the date of this press release. While Immuneering may elect to update such forward-looking statements at some point in the future, except as required by law, Immuneering disclaims any obligation to do so, even if subsequent events cause its views to change. These forward-looking statements should not be relied upon as representing Immuneering’s views as of any date subsequent to the date of this press release.
Media Contact for Immuneering:
Gina Nugent
gina@nugentcommunications.com
Investor Contact for Immuneering:
Laurence Watts
619-916-7620
laurence@newstreetir.com
FAQ
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