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Thursday, Immuneering Corporation (NASDAQ:IMRX) revealed topline results from the ongoing Phase 1 portion of its Phase 1/2a trial of IMM-1-104 in advanced RAS-mutant solid tumors.
Friday, shares are trading lower after several analysts downgraded the stock after the company released the data.
Needham writes that IMM-1-104’s Phase 1b data validated its mechanism of action at the safety, PK/PD, and ctDNA level, but it did not translate into partial response (PR)/ complete response (CR), which raises concerns about its efficacy as a monotherapy.
Needham notes that the lack of positive or complete response in clinical trials may stem from various reasons, such as small sample sizes, a significant proportion of patients with advanced disease, and the majority not responding to previous treatments.
However, there is optimism regarding the potential for improved effectiveness in earlier stages of treatment, especially in melanoma patients with NRAS mutations following immunotherapy and in first-line pancreatic cancer based on preliminary preclinical studies.
The analyst has lowered the price target from $20 to $15, with an unchanged Buy rating.
The Needham analyst notes that despite study limitations, they are concerned about the preliminary clinical activity of IMM-1-104 in Phase 2A, especially in non-small cell lung cancer cohorts.
In NRAS melanoma, IMM-1-104 exhibited superior efficacy when used alone compared to the currently approved Pfizer Inc’s (NYSE:PFE) Mektovi (binimetinib). Additionally, in pancreatic ductal adenocarcinoma (PDAC), IMM-1-104 demonstrated promising results when used in combination with gemcitabine or paclitaxel, with a significant proportion of subjects achieving near complete response in animal studies.
Other analysts’ reaction:
Price Action: IMRX shares are down 31% at $2.01 on the last check Friday.
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