Immuneering Granted Orphan Drug Designation for IMM-1-104 by FDA in the Treatment of Pancreatic Cancer
Immuneering (Nasdaq: IMRX) has announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to IMM-1-104 for the treatment of pancreatic cancer. This designation follows the company's recent announcement of positive initial Phase 2a data, including complete and partial responses, for IMM-1-104 in combination with chemotherapy in first-line pancreatic cancer patients.
IMM-1-104 is currently being evaluated in a Phase 2a clinical trial for advanced solid tumors, including pancreatic cancer. The company expects to release initial data from at least one additional arm of the Phase 2a portion of their Phase 1/2a trial by year-end. Immuneering is also studying IMM-1-104 in combination with modified FOLFIRINOX and as a monotherapy for pancreatic cancer.
The FDA's orphan drug designation may qualify Immuneering for incentives such as tax credits for qualified clinical trials, exemptions from certain FDA fees, and additional time for post-approval marketing exclusivity. Earlier this year, Immuneering was also granted FDA Fast Track designation for IMM-1-104 for both first and second-line pancreatic cancer treatment.
Immuneering (Nasdaq: IMRX) ha annunciato che la Food and Drug Administration (FDA) degli Stati Uniti ha conferito la designazione di farmaco orfano a IMM-1-104 per il trattamento del cancro pancreatico. Questa designazione segue l'annuncio recente dell'azienda riguardo a dati iniziali positivi di Fase 2a, incluse risposte complete e parziali, per IMM-1-104 in combinazione con la chemioterapia in pazienti con cancro pancreatico di prima linea.
IMM-1-104 è attualmente in fase di valutazione in un trial clinico di Fase 2a per tumori solidi avanzati, incluso il cancro pancreatico. L'azienda prevede di rilasciare dati iniziali da almeno un ulteriore braccio della porzione di Fase 2a del loro trial di Fase 1/2a entro la fine dell'anno. Immuneering sta anche studiando IMM-1-104 in combinazione con FOLFIRINOX modificato e come monoterapia per il cancro pancreatico.
La designazione di farmaco orfano della FDA potrebbe qualificare Immuneering per incentivi come crediti d'imposta per trial clinici qualificati, esenzioni da alcune tasse FDA e ulteriore tempo per l'esclusiva di marketing post-approvazione. All'inizio di quest'anno, Immuneering ha anche ricevuto la designazione Fast Track dalla FDA per IMM-1-104 sia per il trattamento del cancro pancreatico di prima linea che di seconda linea.
Immuneering (Nasdaq: IMRX) ha anunciado que la Administración de Alimentos y Medicamentos de EE. UU. (FDA) ha otorgado la designación de medicamento huérfano a IMM-1-104 para el tratamiento del cáncer de páncreas. Esta designación sigue al reciente anuncio de la empresa sobre dati iniciales positivos de Fase 2a, incluyendo respuestas completas y parciales, para IMM-1-104 en combinación con quimioterapia en pacientes de primera línea con cáncer de páncreas.
IMM-1-104 se está evaluando actualmente en un ensayo clínico de Fase 2a para tumores sólidos avanzados, incluido el cáncer de páncreas. La empresa espera publicar datos iniciales de al menos un brazo adicional de la parte de Fase 2a de su ensayo de Fase 1/2a antes de que termine el año. Immuneering también está estudiando IMM-1-104 en combinación con FOLFIRINOX modificado y como monoterapia para el cáncer de páncreas.
La designación de medicamento huérfano de la FDA puede calificar a Immuneering para incentivos como créditos fiscales para ensayos clínicos calificados, exenciones de ciertas tarifas de la FDA y tiempo adicional para la exclusividad de comercialización posterior a la aprobación. A principios de este año, Immuneering también recibió la designación Fast Track de la FDA para IMM-1-104 tanto para el tratamiento del cáncer de páncreas de primera línea como de segunda línea.
Immuneering (Nasdaq: IMRX)는 미국 식품의약국(FDA)이 췌장암 치료를 위해 IMM-1-104에 희귀의약품 지정을 부여했다고 발표했습니다. 이 지정은 FIRST-LINE 췌장암 환자에서 항암 화학요법과 함께 IMM-1-104에 대한 긍정적인 초기 2단계 데이터 발표에 따른 것입니다.
IMM-1-104는 현재 췌장암을 포함한 고급 고형 종양에 대한 2단계 임상 시험에서 평가되고 있습니다. 이 회사는 올해 말까지 1/2a 단계 시험의 2a 부분에서 추가로 최소 하나의 시험 팔에서 초기 데이터를 발표할 것으로 예상하고 있습니다. Immuneering은 또한 췌장암에 대한 모노테라피 및 수정된 FOLFIRINOX와의 병용으로 IMM-1-104를 연구하고 있습니다.
FDA의 희귀의약품 지정은 Immuneering이 자격을 갖춘 임상 시험을 위한 세금 공제, 특정 FDA 수수료 면제 및 허가 후 마케팅 독점 기간을 늘리는 인센티브를 받을 수 있게 할 수 있습니다. 올해 초 Immuneering은 또한 췌장암 1차 및 2차 치료를 위한 IMM-1-104에 대해 FDA의 신속 심사 지정을 받았습니다.
Immuneering (Nasdaq: IMRX) a annoncé que la Food and Drug Administration (FDA) des États-Unis a accordé à IMM-1-104 la désignation de médicament orphelin pour le traitement du cancer du pancréas. Cette désignation suit l'annonce récente de la société concernant des données initiales positives de la phase 2a, incluant des réponses complètes et partielles, pour IMM-1-104 en combinaison avec une chimiothérapie chez des patients atteints de cancer du pancréas en première ligne.
IMM-1-104 est actuellement évalué dans un essai clinique de phase 2a pour des tumeurs solides avancées, y compris le cancer du pancréas. La société prévoit de publier des données initiales provenant d'au moins un bras supplémentaire de la partie phase 2a de leur essai de phase 1/2a d'ici la fin de l'année. Immuneering étudie également IMM-1-104 en combinaison avec le FOLFIRINOX modifié et comme monothérapie pour le cancer du pancréas.
La désignation de médicament orphelin de la FDA pourrait qualifier Immuneering pour des incitations telles que des crédits d'impôt pour des essais cliniques qualifiés, des exonérations de certaines frais de la FDA et un temps supplémentaire pour l'exclusivité de marketing après approbation. Plus tôt cette année, Immuneering a également reçu la désignation Fast Track de la FDA pour IMM-1-104 pour le traitement du cancer du pancréas tant en première qu'en deuxième ligne.
Immuneering (Nasdaq: IMRX) hat angekündigt, dass die US-amerikanische Food and Drug Administration (FDA) der IMM-1-104 für die Behandlung von Bauchspeicheldrüsenkrebs die Orphan-Drug-Designation erteilt hat. Diese Auszeichnung folgt der kürzlichen Bekanntgabe des Unternehmens von positiven frühen Phase-2a-Daten, die vollständige und partielle Ansprechreaktionen für IMM-1-104 in Kombination mit Chemotherapie bei Patienten mit Bauchspeicheldrüsenkrebs in erster Linie umfassen.
IMM-1-104 wird derzeit in einer Phase-2a-Studie für fortgeschrittene solide Tumoren, einschließlich Bauchspeicheldrüsenkrebs, evaluiert. Das Unternehmen erwartet, bis zum Ende des Jahres erste Daten aus mindestens einem weiteren Arm der Phase-2a-Studie seines Phase-1/2a-Tests zu veröffentlichen. Immuneering untersucht auch IMM-1-104 in Kombination mit modifiziertem FOLFIRINOX und als Monotherapie für Bauchspeicheldrüsenkrebs.
Die Orphan-Drug-Designation der FDA könnte Immuneering für Anreize wie Steuervergünstigungen für qualifizierte klinische Studien, Befreiungen von bestimmten FDA-Gebühren und zusätzliche Zeit für das Exklusivrecht nach der Genehmigung qualifizieren. Zu Beginn dieses Jahres erhielt Immuneering außerdem die Fast-Track-Designation der FDA für IMM-1-104 für die Behandlung von Bauchspeicheldrüsenkrebs sowohl in der ersten als auch in der zweiten Linie.
- FDA granted orphan drug designation for IMM-1-104 in pancreatic cancer treatment
- Positive initial Phase 2a data reported for IMM-1-104 in combination with chemotherapy
- Complete and partial responses observed in first-line pancreatic cancer patients
- Additional Phase 2a trial data expected by year-end
- Previously received FDA Fast Track designation for first and second-line pancreatic cancer treatment
- None.
Insights
The FDA's orphan drug designation for IMM-1-104 in pancreatic cancer treatment is a significant milestone for Immuneering. This designation highlights the critical need for innovative therapies in this challenging cancer type and offers several benefits:
- Potential tax credits for clinical trials
- FDA fee exemptions
- Extended market exclusivity post-approval
The recent positive Phase 2a data, showing complete and partial responses in combination with chemotherapy, is particularly promising. This suggests IMM-1-104 could potentially improve upon current standard treatments. The ongoing evaluation of IMM-1-104 in multiple contexts (combination therapy and monotherapy) demonstrates a comprehensive approach to determining its efficacy.
Investors should note that while this news is encouraging, it's still early-stage. The upcoming additional arm data expected by year-end will be important in further assessing the drug's potential. The Fast Track designation received earlier this year also supports an expedited development process, which could accelerate time-to-market if successful.
- Immuneering recently announced positive initial Phase 2a data, including complete and partial responses, with IMM-1-104 in combination with chemotherapy in first-line pancreatic cancer patients -
-Initial data from at least one additional arm of the Phase 2a portion of the Company’s Phase 1/2a trial is expected by year-end -
CAMBRIDGE, Mass., Oct. 15, 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 orphan drug designation to IMM-1-104 in the treatment of pancreatic cancer. IMM-1-104 is currently being evaluated in a Phase 2a clinical trial in patients with advanced solid tumors, including pancreatic cancer, in which positive initial response data was recently reported for first line pancreatic cancer patients treated in combination with modified gemcitabine/nab-paclitaxel.
“The FDA’s granting of orphan drug designation for IMM-1-104 underscores the urgent need for new therapies that meaningfully improve outcomes for pancreatic cancer patients and represents an important milestone in the development of our lead asset,” said Ben Zeskind, Ph.D., Co-Founder and CEO of Immuneering. “I believe our recently announced positive initial Phase 2a data, from our arm investigating IMM-1-104 in combination with modified gemcitabine/nab-paclitaxel in pancreatic cancer, speaks to IMM-1-104's potential to improve upon the current standard of care in this indication. Importantly, in the same trial we are also studying IMM-1-104 in combination with modified FOLFIRINOX, as well as in monotherapy for pancreatic cancer. We look forward to providing initial data from at least one additional arm of the Phase 2a portion of our Phase 1/2a trial before the end of the year.”
FDA orphan drug designation is granted to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people in the United States. Orphan drug designation may qualify sponsors for incentives, including tax credits for qualified clinical trials, exemptions from certain FDA fees and additional time for post-approval marketing exclusivity. Earlier this year, Immuneering was granted FDA Fast Track designation for IMM-1-104 for the treatment of both first and second-line pancreatic cancer.
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, including chemotherapy; the design, enrollment and conduct of the Phase 1/2a IMM-1-104 clinical trial; the possible incentives and other benefits that could result from orphan drug designation of IMM-1-104; and the timing of additional results from 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; 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 three month period ended June 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
What is the significance of the FDA's orphan drug designation for IMM-1-104 (IMRX)?
What were the results of the initial Phase 2a trial for IMM-1-104 (IMRX) in pancreatic cancer?
When will Immuneering (IMRX) release additional data from the Phase 2a trial of IMM-1-104?
What other designations has IMM-1-104 (IMRX) received from the FDA for pancreatic cancer treatment?
