Immuneering Corporation IMRX soared 41.3% on Friday after it reported promising early response data from the first five patients of an ongoing early to mid-stage study evaluating IMM-1-104 combined with chemotherapy (modified gemcitabine/nab-paclitaxel) for treating first-line pancreatic cancer.
IMM-1-104, an investigational RAS medication, is Immuneering’s lead pipeline candidate, which is being evaluated in the phase I/IIa study in patients with advanced solid tumors harboring RAS mutations. The phase IIa portion, from which the latest data was announced, is evaluating the 320mg dose of IMM-1-104 as a monotherapy and in combination with two different chemotherapy regimens to treat pancreatic cancer. The phase IIa portion is also evaluating the candidate as monotherapy for non-small cell lung cancer and melanoma in different treatment arms.
IMRX’s IMM-1-104 Shows Encouraging Initial Efficacy Data
So far, in the first two patients of the phase IIa portion of the study, treatment with the IMM-1-104 combo therapy has shown either complete or partial responses, resulting in an initial response rate of 40%. The disease control rate is 80% (4 out of 5), with the remaining three patients still in the early stages of treatment. All five patients continue to receive therapy.
The observed initial IMM-1-104 data is superior to the benchmark of 23% overall response rate (ORR), and 48% disease control rate observed upon treatment with gemcitabine/nab-paclitaxel alone. The benchmark ORR for modified gemcitabine/nab-paclitaxel therapy is 18.6%.
Year to date, shares of Immuneering have plunged 72.5% against the industry’s 0.5% growth.
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The combo regimen of IMM-1-104 and modified gemcitabine/nab-paclitaxel was also overall well tolerated by the pancreatic cancer patients in the phase IIa portion of the study with a consistent safety profile for both therapeutics.
IMM-1-104 currently enjoys the FDA’s Fast Track designation in the United States for the treatment of first- and second-line pancreatic cancer.
IMRX’s Future Development Plans for IMM-1-104
In the same press release, Immuneering stated that the study's independent monitoring body, after reviewing the safety data so far, has given the green light to enroll more patients in the once-daily IMM-1-104 320mg treatment arm.
The first of these new patients have already started treatment and are now waiting for their initial scans to assess progress.
Immuneering also anticipates to readout initial efficacy data from at least one additional arm of the phase IIa portion of the early to mid-stage study by the end of 2024.
Apart from IMM-1-104, IMRX has a second pipeline drug, IMM-6-415, which is being evaluated in a separate phase I/IIa study in patients with advanced solid tumors harboring RAS or RAF mutations. Initial pharmacokinetic, pharmacodynamic and safety data from the phase I portion is also expected by the end of the year.
Immuneering Corporation Price and Consensus
Immuneering Corporation price-consensus-chart | Immuneering Corporation Quote
Zacks Rank & Stocks to Consider
Immuneering currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Illumina, Inc. ILMN, Krystal Biotech, Inc. KRYS and Fulcrum Therapeutics, Inc. FULC, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Illumina’s 2024 earnings per share have moved up from $1.18 to $3.62. The consensus estimate for 2025 earnings has improved from $2.93 to $4.43. Year to date, shares of ILMN have lost 7.2%.
ILMN’s earnings beat estimates in each of the trailing four quarters, the average surprise being 463.46%.
In the past 60 days, estimates for Krystal Biotech’s 2024 earnings per share have increased from $1.98 to $2.38. The consensus estimate for 2025 earnings has improved from $4.33 to $7.31. Year to date, shares of KRYS have surged 62.5%.
KRYS’ earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, the average surprise being 45.95%.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have narrowed from $1.33 to 32 cents. The consensus estimate for 2025 loss per share has narrowed from $1.71 to $1.22. Year to date, shares of FULC have plunged 52.9%.
FULC’s earnings beat estimates in each of the trailing four quarters, the average surprise being 393.18%.
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