Immuneering Granted U.S. Composition of Matter Patent for Highly Differentiated Cancer Drug Candidate Atebimetinib
Immuneering (Nasdaq: IMRX) has secured a crucial U.S. composition of matter patent for atebimetinib, its innovative cancer drug candidate. The patent, expected to provide exclusivity until August 2042, covers this first-in-class deep cyclic MEK inhibitor designed as a once-daily pill to combat cancer drug resistance.
Clinical data has shown remarkable results, with 94% probability of 6-month survival in first-line pancreatic cancer patients treated with atebimetinib plus chemotherapy, compared to 67% with standard care. The drug has received FDA Fast Track designations for first- and second-line pancreatic cancer treatment and NRAS-mutant melanoma, along with orphan drug designation for pancreatic cancer.
Immuneering (Nasdaq: IMRX) ha ottenuto un brevetto fondamentale negli Stati Uniti per la composizione della sostanza attiva di atebimetinib, il suo innovativo candidato farmaco oncologico. Il brevetto, che garantirà l'esclusiva fino ad agosto 2042, riguarda questo inibitore MEK ciclico profondo di prima classe, progettato come compressa da assumere una volta al giorno per contrastare la resistenza ai farmaci antitumorali.
I dati clinici hanno mostrato risultati straordinari, con una probabilità del 94% di sopravvivenza a 6 mesi nei pazienti con tumore pancreatico in prima linea trattati con atebimetinib in combinazione con chemioterapia, rispetto al 67% con la terapia standard. Il farmaco ha ottenuto le designazioni FDA Fast Track per il trattamento del cancro al pancreas in prima e seconda linea e per il melanoma con mutazione NRAS, oltre alla designazione di farmaco orfano per il cancro al pancreas.
Immuneering (Nasdaq: IMRX) ha asegurado una patente crucial en Estados Unidos para la composición de la sustancia de atebimetinib, su innovador candidato a medicamento contra el cáncer. La patente, que se espera brinde exclusividad hasta agosto de 2042, cubre este inhibidor MEK cíclico profundo de primera clase, diseñado como una píldora diaria para combatir la resistencia a los fármacos contra el cáncer.
Los datos clínicos han mostrado resultados notables, con una probabilidad del 94% de supervivencia a 6 meses en pacientes con cáncer de páncreas en primera línea tratados con atebimetinib más quimioterapia, en comparación con el 67% con el tratamiento estándar. El medicamento ha recibido las designaciones FDA Fast Track para el tratamiento del cáncer de páncreas en primera y segunda línea y para melanoma con mutación NRAS, además de la designación de medicamento huérfano para el cáncer de páncreas.
Immuneering (나스닥: IMRX)는 혁신적인 항암 후보 약물인 atebimetinib에 대한 미국 물질 조성 특허를 확보했습니다. 이 특허는 2042년 8월까지 독점권을 제공할 것으로 예상되며, 암 약물 저항성을 극복하기 위해 하루 한 번 복용하는 최초의 심층 고리형 MEK 억제제를 포함합니다.
임상 데이터에 따르면 atebimetinib와 화학요법을 병용한 1차 췌장암 환자의 6개월 생존 확률이 94%로 표준 치료의 67%보다 현저히 높았습니다. 이 약물은 1차 및 2차 췌장암 치료와 NRAS 변이 흑색종에 대해 FDA 패스트 트랙 지정을 받았으며, 췌장암에 대해 희귀 의약품 지정도 받았습니다.
Immuneering (Nasdaq : IMRX) a obtenu un brevet essentiel aux États-Unis pour la composition de matière de atebimetinib, son candidat médicament innovant contre le cancer. Ce brevet, qui devrait garantir l'exclusivité jusqu'en août 2042, couvre cet inhibiteur MEK cyclique profond de première classe, conçu comme un comprimé à prendre une fois par jour pour lutter contre la résistance aux traitements anticancéreux.
Les données cliniques ont montré des résultats remarquables, avec une probabilité de survie à 6 mois de 94 % chez les patients atteints de cancer du pancréas en première ligne traités par atebimetinib en association avec une chimiothérapie, contre 67 % avec les soins standards. Le médicament a reçu les désignations FDA Fast Track pour le traitement du cancer du pancréas en première et deuxième ligne ainsi que pour le mélanome mutant NRAS, en plus de la désignation de médicament orphelin pour le cancer du pancréas.
Immuneering (Nasdaq: IMRX) hat ein wichtiges US-Patent für die Stoffzusammensetzung von atebimetinib, seinem innovativen Krebsmedikamentenkandidaten, erhalten. Das Patent, das voraussichtlich bis August 2042 Exklusivität bietet, deckt diesen neuartigen, tiefzyklischen MEK-Inhibitor der ersten Klasse ab, der als einmal täglich einzunehmende Tablette zur Bekämpfung von Krebsmedikamentenresistenz entwickelt wurde.
Klinische Daten zeigten bemerkenswerte Ergebnisse mit einer 94%igen Wahrscheinlichkeit für ein 6-monatiges Überleben bei Patienten mit erstlinientherapiertem Bauchspeicheldrüsenkrebs, die mit atebimetinib plus Chemotherapie behandelt wurden, im Vergleich zu 67% unter Standardtherapie. Das Medikament erhielt FDA Fast Track-Zulassungen für die Behandlung von Bauchspeicheldrüsenkrebs in der Erst- und Zweitlinie sowie für NRAS-mutiertes Melanom und wurde zusätzlich als Orphan Drug für Bauchspeicheldrüsenkrebs eingestuft.
- Patent protection secured until 2042 with potential for extension
- 94% 6-month survival probability in pancreatic cancer patients vs 67% with standard care
- FDA Fast Track designations received for multiple indications
- Favorable tolerability profile reported in clinical trials
- Multiple pending patent applications could extend protection to 2044
- Additional clinical trials and regulatory approvals still required before commercialization
Insights
Immuneering's new patent for atebimetinib strengthens their market position with exclusivity through 2042, protecting their promising pancreatic cancer treatment.
Immuneering has secured critical intellectual property protection with the USPTO granting a composition of matter patent for atebimetinib (IMM-1-104), their MEK inhibitor designed to overcome cancer resistance mechanisms. This patent provides exclusivity until August 2042, with potential for further extension through regulatory adjustments.
The patent's value is significantly enhanced by atebimetinib's remarkable clinical data in pancreatic cancer treatment - patients receiving atebimetinib plus chemotherapy showed
The composition of matter claim represents the strongest form of pharmaceutical patent protection, covering the molecule itself rather than just applications or formulations. This provides Immuneering robust defense against potential competitors. Their patent strategy appears comprehensive, with additional applications pending that could extend protection to 2044 through methods of use and pharmaceutical composition claims.
The FDA's granting of Fast Track designations for first- and second-line pancreatic cancer and NRAS-mutant melanoma, plus orphan drug designation for pancreatic cancer, complements this patent protection by providing regulatory benefits and potential market exclusivity. Together, these elements create a formidable competitive moat for Immuneering's lead asset with protection extending over two decades.
Atebimetinib shows exceptional survival benefit for pancreatic cancer with minimal side effects, potentially transforming treatment standards across multiple cancers.
Atebimetinib represents a significant advancement in targeted cancer therapy as a deep cyclic MEK inhibitor addressing a fundamental challenge in oncology: drug resistance. Unlike conventional MEK inhibitors, this approach is designed to sustain efficacy by staying ahead of cancer's adaptive resistance mechanisms, potentially leading to longer-lasting treatment responses.
The clinical data cited is particularly impressive for pancreatic ductal adenocarcinoma (PDAC), one of the most lethal cancers with dismal survival rates. The
Equally significant is the reported favorable tolerability profile. MEK inhibitors typically cause substantial toxicities that limit their clinical utility, but atebimetinib appears to overcome this limitation. This safety advantage is critical for pancreatic cancer patients who often struggle with treatment-related morbidity alongside their disease symptoms.
The FDA's granting of Fast Track designations for both first- and second-line PDAC treatment reflects regulatory recognition of atebimetinib's potential to address significant unmet needs. The additional Fast Track designation in NRAS-mutant melanoma suggests broader applicability across RAS-pathway driven cancers, which represent approximately
- Newly issued U.S. composition of matter patent expected to provide exclusivity into 2042, with subsequent opportunity for patent term extension -
- First U.S. patent granted on a deep cyclic inhibitor: a once-daily pill that aims to drive longer-lasting benefit by outpacing resistance mechanisms that cause cancer drugs to stop working -
- Additional patent applications pending for atebimetinib directed to compounds, pharmaceutical compositions, and methods of use with expiration expected into 2044 -
CAMBRIDGE, Mass., July 09, 2025 (GLOBE NEWSWIRE) -- Immuneering (Nasdaq: IMRX), a clinical-stage oncology company outpacing cancer to help patients outlive their disease, today announced that the United States Patent and Trademark Office (USPTO) granted the company a composition of matter patent for atebimetinib (IMM-1-104), an oral once-daily deep cyclic inhibitor of MEK. MEK is a key component of the signaling pathway that drives the majority of cancers, including pancreatic cancer.
First-line pancreatic cancer patients treated with atebimetinib plus chemotherapy had a remarkable
U.S. Patent No. 12,351,566, titled: “MEK Inhibitors and Therapeutic Uses Thereof”, includes claims to atebimetinib’s composition of matter. The patent’s term, which includes a patent term adjustment, is currently expected to expire in August 2042. The patent may also be eligible for patent term extension to recover a portion of the time required to fulfill regulatory approval requirements.
“Our priorities are to make medicines that keep working, so cancer patients keep living, and to make medicines that have fewer side effects, so cancer patients can feel like themselves and live normal lives. We have already observed exceptional durability and a markedly favorable tolerability profile in first-line pancreatic cancer patients treated with atebimetinib+mGnP, and this is just the beginning of the important impact that we believe atebimetinib and our entire pipeline of deep cyclic inhibitors will have on the treatment of cancer,” said Ben Zeskind, Ph.D., Co-founder and Chief Executive Officer of Immuneering.
“We believe the granting of our composition of matter patent validates the novelty of our approach and secures key intellectual property around our lead product candidate, as part of a broader intellectual property strategy,” Zeskind continued. “We expect that the long patent runway we are forging for atebimetinib will support our efforts to maximize its full therapeutic potential, starting with first-line pancreatic cancer and extending to many different cancer types and combinations.”
Atebimetinib previously received FDA Fast Track designations for the treatment of first- and second-line pancreatic ductal adenocarcinoma (PDAC), as well as 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. The FDA also previously granted atebimetinib orphan drug designation for the treatment of pancreatic cancer. Immuneering has also announced plans to study atebimetinib in combination with other therapeutics - in a variety of additional cancers.
About Immuneering Corporation
Immuneering is a clinical-stage oncology company outpacing cancer to help patients outlive their disease. The Company’s lead product candidate, atebimetinib (IMM-1-104), is an oral, once-daily deep cyclic inhibitor of MEK designed to improve durability and tolerability, and expand indications to include MAPK pathway-driven tumors such as most pancreatic cancers. Atebimetinib is currently in a Phase 2a trial in patients with advanced solid tumors including pancreatic cancer. The Company’s development pipeline also includes 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: our plans to develop, manufacture and commercialize our product candidates; the treatment potential of atebimetinib, alone or in combination with other agents to treat cancer, including modified Gemcitabine/nab-paclitaxel (mGnP) in first-line pancreatic cancer; the treatment potential of our pipeline product candidates in other types of cancer; the plans and objectives of Company management for future operations, including with respect to the timing, planning and execution of enrollment, additional atebimetinib combination trials; the expected expiration of our issued and pending patents and additional planned patent applications, including the U.S. composition of matter patent covering atebimetinib; our ability to obtain patent term extension on our U.S. composition of matter patent; and our expectations for a long patent runway we are forging for atebimetinib will support our efforts to maximize its full therapeutic potential, extending to many different cancer types and combinations.
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 the three months ended March 31, 2025, 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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