Immuneering Corporation IMRX announced that it has submitted an investigational new drug (IND) application to the FDA to begin a clinical study on its lead product candidate IMM-1-104 for the treatment of advanced RAS mutant solid tumors.
If the IND is accepted by the regulatory body, Immuneering will initiate a phase I/IIa study on IMM-1-104, an oral once-daily small molecule for treating patients with a broad range of RAS mutant tumors.
Shares of Immuneering were up 7.1% following the announcement of the news. The stock has plunged 53.9% this year compared with the industry’s decline of 24.3%.
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The company decided to begin a clinical study on IMM-1-104, after data from preclinical studies showed that treatment with IMM-1-104 led to robust single-agent anti-tumor activity across a broad range of in vitro and in vivo tumor models driven by MAPK pathway activation events.
Before Immuneering can start with the clinical study, the FDA will do a review of the above IND and decide whether the data package provided is justifiable to predict the safety of IMM-1-104.
Per the company, IMM-1-104 has the potential to be a game-changer for patients with RAS mutant tumors. IMRX remains focused to begin the planned phase I/IIa study evaluating IMM-1-104 for the given indication.
Immuneering plans to begin enrollment of patients in the phase I/IIa study on IMM-1-104 in the fourth quarter of 2022.
This apart, Immuneering is developing another candidate, IMM-6-415, designed to sensitize resistant tumors to select immunotherapies in pre-clinical studies. The company plans to submit an IND application for IMM-6-415 in 2023.
Immuneering has no approved product in its portfolio at the moment. Therefore, pipeline development remains in key focus for the company.
Zacks Rank & Other Stocks to Consider
Immuneering currently carries a Zacks Rank #2 (Buy). Other stocks worth considering in the biotech sector include Achilles Therapeutics plc ACHL, Atara Biotherapeutics, Inc. ATRA and ORIC Pharmaceuticals, Inc. ORIC, all carrying a Zacks Rank #2 at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Achilles Therapeutics’ loss per share estimates narrowed 6.4% for 2022 and 9.6% for 2023 in the past 60 days.
Earnings of Achilles Therapeutics surpassed estimates in three of the trailing four quarters and missed on the remaining occasion. ACHL delivered an earnings surprise of 12.45%, on average.
Atara Biotherapeutics’ loss per share estimates narrowed 43.2% for 2022 and 31.8% for 2023 in the past 60 days.
Earnings of Atara Biotherapeutics surpassed estimates in three of the trailing four quarters and missed on the other occasion. ATRA delivered an earnings surprise of 4.83%, on average.
ORIC Pharmaceuticals’ loss per share estimates narrowed 8.6% for 2022 and 22% for 2023 in the past 60 days.
Earnings of ORIC Pharmaceuticals surpassed estimates in three of the trailing four quarters and missed on the remaining occasion. ORIC delivered an earnings surprise of 8.85%, on average.
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