Immuneering to Present Data from Three Arms of its Ongoing Phase 2a Trial of IMM-1-104 in Early January 2025
Immuneering (IMRX) announced plans to hold a virtual Investor Event in early January 2025 to present data from its ongoing Phase 2a trial of IMM-1-104 in pancreatic cancer. The presentation will include additional data from IMM-1-104 combined with mGnP in first-line pancreatic cancer, initial data from its combination with mFFX in first-line pancreatic cancer, and initial data from IMM-1-104 monotherapy in second-line pancreatic cancer.
The company will also share initial PK, PD and safety data from the Phase 1 portion of its Phase 1/2a trial of IMM-6-415. The FDA has granted IMM-1-104 Orphan Drug designation in pancreatic cancer and Fast Track designations for both first and second-line pancreatic cancer, as well as advanced melanoma.
Immuneering (IMRX) ha annunciato piani per tenere un evento virtuale per gli investitori all'inizio di gennaio 2025, durante il quale presenterà i dati del suo attuale studio di fase 2a su IMM-1-104 nel carcinoma pancreatico. La presentazione includerà dati aggiuntivi su IMM-1-104 combinato con mGnP nel carcinoma pancreatico in prima linea, dati iniziali dalla sua combinazione con mFFX nel carcinoma pancreatico in prima linea e dati iniziali da monoterapia con IMM-1-104 nel carcinoma pancreatico in seconda linea.
La società condividerà anche i dati iniziali su PK, PD e sicurezza dalla parte di fase 1 del suo studio di fase 1/2a di IMM-6-415. La FDA ha concesso a IMM-1-104 la designazione di Farmaco Orfano per il carcinoma pancreatico e le designazioni Fast Track sia per il carcinoma pancreatico in prima che in seconda linea, oltre al melanoma avanzato.
Immuneering (IMRX) anunció planes para llevar a cabo un evento virtual para inversionistas a principios de enero de 2025, donde presentará datos de su actual ensayo de fase 2a sobre IMM-1-104 en cáncer de páncreas. La presentación incluirá datos adicionales de IMM-1-104 combinado con mGnP en cáncer de páncreas de primera línea, datos iniciales de su combinación con mFFX en cáncer de páncreas de primera línea y datos iniciales de monoterapia con IMM-1-104 en cáncer de páncreas de segunda línea.
La compañía también compartirá datos iniciales de PK, PD y seguridad de la parte de fase 1 de su ensayo de fase 1/2a de IMM-6-415. La FDA ha otorgado a IMM-1-104 la designación de Medicamento Huérfano para cáncer de páncreas y las designaciones de Vía Rápida tanto para cáncer de páncreas de primera como de segunda línea, así como para melanoma avanzado.
Immuneering (IMRX)는 2025년 1월 초에 가상 투자자 이벤트를 개최하여 췌장암에 대한 진행 중인 2a상 시험의 데이터인 IMM-1-104를 발표할 계획을 발표했습니다. 발표에는 첫 번째 췌장암 치료에서 mGnP와 함께한 IMM-1-104의 추가 데이터, 첫 번째 췌장암 치료에서 mFFX와의 조합에 대한 초기 데이터, 그리고 두 번째 췌장암 치료에서 IMM-1-104 단독 요법의 초기 데이터가 포함될 것입니다.
회사는 또한 IMM-6-415의 1상 부분에서 Initial PK, PD 및 안전성 데이터를 공유할 예정입니다. FDA는 췌장암에 대해 IMM-1-104에 고아약 지정 및 1차 및 2차 췌장암, 그리고 진행성 멜라노마에 대한 신속 승인 지정을 부여했습니다.
Immuneering (IMRX) a annoncé des projets pour organiser un événement virtuel pour investisseurs début janvier 2025 afin de présenter des données de son essai en cours de phase 2a sur IMM-1-104 dans le cancer du pancréas. La présentation comprendra des données supplémentaires sur IMM-1-104 combiné avec mGnP dans le cancer du pancréas de première ligne, des données initiales sur sa combinaison avec mFFX dans le cancer du pancréas de première ligne, et des données initiales sur la monothérapie par IMM-1-104 dans le cancer du pancréas de deuxième ligne.
La société partagera également des données initiales sur la PK, la PD et la sécurité de la partie phase 1 de son essai phase 1/2a sur IMM-6-415. La FDA a accordé à IMM-1-104 la désignation de médicament orphelin pour le cancer du pancréas ainsi que les désignations Fast Track tant pour le cancer du pancréas de première ligne que de deuxième ligne, ainsi que pour le mélanome avancé.
Immuneering (IMRX) hat Pläne angekündigt, im frühen Januar 2025 eine virtuelle Investorenveranstaltung abzuhalten, um Daten aus seiner laufenden Phase 2a Studie zu IMM-1-104 bei Bauchspeicheldrüsenkrebs zu präsentieren. Die Präsentation wird zusätzliche Daten zu IMM-1-104 in Kombination mit mGnP bei erstlinigem Bauchspeicheldrüsenkrebs, erste Daten aus seiner Kombination mit mFFX bei erstlinigem Bauchspeicheldrüsenkrebs sowie erste Daten zu IMM-1-104 als Monotherapie bei zweitlinigem Bauchspeicheldrüsenkrebs umfassen.
Das Unternehmen wird auch erste PK-, PD- und Sicherheitsdaten aus dem Phase-1-Teil seiner Phase-1/2a-Studie zu IMM-6-415 teilen. Die FDA hat IMM-1-104 die Orphan Drug-Bezeichnung für Bauchspeicheldrüsenkrebs und die Fast-Track-Bezeichnungen sowohl für den erstlinigen als auch den zweitlinigen Bauchspeicheldrüsenkrebs sowie für fortgeschrittenem Melanom gewährt.
- FDA granted Orphan Drug designation for IMM-1-104 in pancreatic cancer
- FDA granted Fast Track designations for IMM-1-104 in first and second-line pancreatic cancer and advanced melanoma
- None.
- The company will provide additional data from IMM-1-104 in combination with modified gemcitabine/nab-paclitaxel (mGnP) in first-line pancreatic cancer -
- The company will also provide initial data from IMM-1-104 in combination with modified FOLFIRINOX (mFFX) in first-line pancreatic cancer, as well as IMM-1-104 monotherapy in second-line pancreatic cancer -
CAMBRIDGE, Mass., Dec. 17, 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 it will hold a virtual Investor Event in early January 2025 to discuss data from its ongoing Phase 2a trial of IMM-1-104.
Specifically, the company plans to present:
- Additional data from IMM-1-104 in combination with mGnP in first-line pancreatic cancer.
- Initial data from IMM-1-104 in combination with mFFX in first-line pancreatic cancer.
- Initial data from IMM-1-104 monotherapy in second-line pancreatic cancer.
- In addition, the company will provide initial PK, PD and safety data from the Phase 1 portion of the company’s Phase 1/2a trial of IMM-6-415.
Details of how to access the Investor Event will be provided in due course.
“We are excited to soon share additional data from our Phase 2a study of IMM-1-104 in patients with pancreatic cancer,” said Ben Zeskind, Ph.D., Co-Founder and CEO of Immuneering. “Pancreatic cancer patients urgently need new options that enable them to live longer and feel better. The FDA has recently granted IMM-1-104 Orphan Drug designation in pancreatic cancer, along with Fast Track designations in first and second-line pancreatic cancer, and advanced melanoma. We look forward to building on our September update with additional data from the Phase 2a study of IMM-1-104.”
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 1/2a 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 and IMM-6-415, alone or in combination with other agents, including chemotherapy; and the timing for release of additional results from the Phase 2a portion of the trial for IMM-1-104 and the Phase 1 portion of the trial for IMM-6-415.
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; our need for additional funding and ability to continue as a going concern; 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 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.
Media Contact:
Gina Nugent
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Investor Contact:
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laurence@newstreetir.com
FAQ
When will Immuneering (IMRX) present Phase 2a trial data for IMM-1-104?
What regulatory designations has IMM-1-104 received from the FDA for pancreatic cancer?
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What additional data will IMRX present about IMM-6-415?
