CAMBRIDGE, Mass. - Immuneering Corporation (NASDAQ: IMRX), a clinical-stage oncology company, announced positive topline results from the Phase 1 portion of its Phase 1/2a clinical trial for IMM-1-104, a treatment for advanced RAS-mutant solid tumors. The data, as of February 20, 2024, indicates that IMM-1-104 was well-tolerated and showed promising signs of clinical activity, including suppression of acquired RAS alterations and target lesion regression in over half of the patients at certain doses.
The trial, which includes participants with a variety of RAS mutations across multiple cancer types, primarily pancreatic cancer, is designed to evaluate the safety, tolerability, and preliminary efficacy of IMM-1-104. According to the press release, the Phase 1 results support the selection of a recommended Phase 2 dose (RP2D) of 320 mg once daily (QD), based on tolerability and initial anti-tumor activity.
IMM-1-104 employs a novel approach called Deep Cyclic Inhibition, which aims to provide broader, universal-RAS activity while minimizing toxicity. The trial's findings showed that 100% of evaluable patients treated with IMM-1-104 did not develop new acquired alterations in RAS. Additionally, significant lesion regressions were observed, with the most notable individual lesion regression at -35.7% and the best RECIST sum of longest diameters (SLD) at -18.9%, both at the 320 mg dosage.
The Phase 2a portion of the study is already in progress, focusing on earlier lines of treatment and exploring IMM-1-104 as a single agent and in combination therapies. Initial data from multiple arms of the Phase 2a portion are expected in 2024.
Immuneering's CEO, Ben Zeskind, expressed optimism about the results, stating they demonstrate a clear proof of concept for IMM-1-104. Vincent Chung, M.D., FACP, from City of Hope, and a principal investigator on the study, also highlighted the encouraging initial tumor activity and safety profile in a refractory patient population.
The company plans to present further data from the ongoing Phase 1 trial at a future medical meeting and is also preparing to dose the first patient in a Phase 1/2a trial of another candidate, IMM-6-415, in March 2024.
This news is based on a press release statement from Immuneering Corporation.
InvestingPro Insights
As Immuneering Corporation (NASDAQ: IMRX) advances its clinical trials with promising results for IMM-1-104, InvestingPro data provides a financial perspective on the company's current status. With a market capitalization of $172.19 million, the company's valuation reflects its early-stage nature in the competitive biotech landscape. The P/E ratio, currently at -3.10, underscores the company's pre-profitability phase, which is common among clinical-stage biopharmaceutical companies focusing on research and development.
InvestingPro Tips reveal that while Immuneering holds more cash than debt, which is a positive sign for its financial health, it is also quickly burning through cash, a typical scenario for companies in the midst of intensive clinical trials. Another noteworthy tip points out that the stock has taken a significant hit over the last week, with a one-week price total return of -11.98%. This could be attributed to market volatility or investor reactions to the latest clinical updates.
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