Immuneering Announces First Patient Dosed in its Phase 1/2a Trial of IMM-6-415 to Treat Advanced Solid Tumors with RAF or RAS Mutations
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Insights
The initiation of a Phase 1/2a trial for IMM-6-415 by Immuneering Corporation represents a significant step in oncology drug development, particularly for patients with advanced solid tumors harboring RAF or RAS mutations. The focus on Deep Cyclic Inhibitors (DCIs) of the MAPK pathway is noteworthy, as this pathway is a well-established target in cancer therapy due to its role in cell proliferation and survival. IMM-6-415's unique drug-like properties, such as a shorter half-life designed for twice-daily dosing, could offer an advantage over existing therapies by potentially reducing drug resistance and side effects associated with continuous MAPK pathway inhibition.
From a clinical development perspective, the Bayesian mTPI-2 escalation design is an adaptive approach that allows for more efficient dose-finding, potentially reducing the time and number of patients required to establish the recommended Phase 2 dose (RP2D). This design also reflects a growing trend in oncology trials to utilize sophisticated statistical models to improve trial outcomes. The potential for IMM-6-415 to provide a treatment option for a broad patient population is promising, given the prevalence of RAS and RAF mutations across various cancer types.
The pharmacokinetic (PK) and pharmacodynamic (PD) aspects of IMM-6-415 are central to its therapeutic profile. The shorter half-life of this compound could result in a more favorable safety profile, as it allows for periods where the drug is not active, potentially reducing the risk of toxicity. This 'on-off' approach to dosing is designed to exploit the cancer cells' dependency on continuous MAPK signaling, a strategy that may lead to improved efficacy and tolerability compared to therapies with longer half-lives that maintain constant pathway suppression.
Moreover, the initial PK/PD and safety data expected in 2024 will be instrumental in understanding the drug's behavior in the human body and its interaction with the target pathway. These data will guide dose optimization and provide early indicators of the drug's potential clinical benefit. The pharmacology of IMM-6-415, if proven effective, could influence future designs of kinase inhibitors and other targeted oncology therapies.
The advancement of IMM-6-415 into clinical trials could have implications for the oncology market, especially within the subset of patients with RAF or RAS mutations. The MAPK pathway is a key target in oncology and any new therapy that demonstrates improved outcomes or reduced side effects can capture significant market share. The competitive landscape includes a range of MAPK inhibitors and the success of IMM-6-415 will depend on its differentiation in terms of efficacy, safety and dosing convenience.
The market response to the trial's progression will be closely watched by investors, as early clinical data can significantly impact the valuation of biotech companies like Immuneering Corporation. The company's stock price may reflect investor sentiment on the potential success of IMM-6-415 and its ability to meet unmet medical needs. However, it is important to consider the inherent risks of drug development, as many compounds fail to translate preclinical success into clinical benefit.
- Deep Cyclic Inhibitor of the MAPK pathway demonstrated strong tumor growth inhibition in preclinical studies of RAF or RAS mutant tumors, both as monotherapy and in combination -
- Phase 1 portion of the Phase 1/2a trial designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of IMM-6-415 and establish a candidate recommended Phase 2 dose (RP2D) -
-Initial PK, PD and safety data expected in 2024 -
CAMBRIDGE, Mass., March 27, 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 first patient has been dosed in its Phase 1/2a trial of IMM-6-415 to treat advanced solid tumors with RAF or RAS mutations.
IMM-6-415 is a Deep Cyclic Inhibitor (DCI) of the MAPK pathway designed with unique drug-like properties including a shorter half-life than IMM-1-104 for an accelerated cadence that will be evaluated as an oral, twice-daily treatment in humans. In animal studies, IMM-6-415 strongly inhibited the growth of tumors with RAF or RAS mutations, as both a monotherapy and in combinations.
During the 2023 AACR-NCI-EORTC conference, Immuneering presented data showing that IMM-6-415 in combination with encorafenib achieved greater tumor growth inhibition and improved durability when compared head-to-head with binimetinib plus encorafenib, in animal models of RAF mutant melanoma and colorectal cancer, consistent with the thesis that DCI can outperform chronic MAPK inhibition.
“We are pleased to have dosed the first patient in our Phase 1/2a trial for IMM-6-415, our second product candidate to enter the clinic,” said Ben Zeskind, Chief Executive Officer, Immuneering Corporation. “IMM-6-415 is designed to deprive malignant cells of the continuous MAPK signaling they need by strongly inhibiting the pathway twice per day, while also providing healthy cells with MAPK signaling twice per day through near-zero drug troughs. We believe the shorter half-life of IMM-6-415 could provide a potential treatment option for a broad patient population with RAS or RAF mutations. We look forward to sharing initial PK/PD and safety data from the Phase 1 portion of our Phase 1/2a trial in 2024.”
The Phase 1 portion of the Phase 1/2a clinical trial is an open-label study designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of IMM-6-415 in patients with advanced RAF/RAS mutant solid tumors. The trial will include solid tumor patients with any mutation in RAF, KRAS, NRAS, or HRAS who meet the enrollment criteria. The Phase 1 portion of the trial will evaluate IMM-6-415 following a Bayesian mTPI-2 escalation design, which includes a dose escalation phase and dose evaluation phase to establish a candidate recommended phase 2 dose (RP2D), with the RP2D to be evaluated in specific tumor cohorts in the Phase 2a portion of the trial.
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 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-6-415; the design, enrollment criteria and conduct of the Phase 1/2a IMM-1-104 and IMM-6-415 clinical trials; the translation of preclinical data into human clinical data; the potential advantages and effectiveness of Immuneering’s clinical and preclinical candidates; and the indications to be pursued by Immuneering including in the Phase 2a portion of the IMM-6-415 trial and timing of results.
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 Annual Report on Form 10-K for the annual period ended December 31, 2023, 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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