Immuneering Corporation - IMRX STOCK NEWS

Immuneering (IMRX) announced plans to hold a virtual Investor Event in early January 2025 to present data from its ongoing Phase 2a trial of IMM-1-104 in pancreatic cancer. The presentation will include additional data from IMM-1-104 combined with mGnP in first-line pancreatic cancer, initial data from its combination with mFFX in first-line pancreatic cancer, and initial data from IMM-1-104 monotherapy in second-line pancreatic cancer.

The company will also share initial PK, PD and safety data from the Phase 1 portion of its Phase 1/2a trial of IMM-6-415. The FDA has granted IMM-1-104 Orphan Drug designation in pancreatic cancer and Fast Track designations for both first and second-line pancreatic cancer, as well as advanced melanoma.

Immuneering (NASDAQ: IMRX) has received FDA Fast Track designation for IMM-1-104 to treat patients with unresectable or metastatic NRAS-mutant melanoma who have progressed on or are intolerant to PD-1/PD-L1 based immune checkpoint inhibitors. The drug is currently in Phase 2a clinical trials for advanced solid tumors, including melanoma.

According to Phase 1 data presented at ESMO 2024, IMM-1-104 demonstrated unique tolerability compared to existing MEK inhibitors used in melanoma treatment. The Fast Track designation may enable more frequent FDA interactions and potential eligibility for accelerated approval and priority review. This is the third Fast Track designation for IMM-1-104, following previous designations for first and second-line pancreatic cancer treatment.

Immuneering (Nasdaq: IMRX), a clinical-stage oncology company focused on universal-RAS/RAF cancer medicines, will participate in the Piper Sandler 36th Annual Healthcare Conference in New York City from December 3-5, 2024. The company's management team will present in a fireside chat format on December 5 from 1:00-1:25 pm ET, discussing their pipeline, platform, and business strategy. The presentation will be available via live webcast and archived on Immuneering's website in the Investor Relations section.

Immuneering (NASDAQ: IMRX) reported Q3 2024 financial results and significant clinical progress. The company announced positive initial data for IMM-1-104 in combination with chemotherapy for first-line pancreatic cancer patients, including complete and partial responses. The FDA granted both Orphan Drug and Fast Track designations for IMM-1-104 in pancreatic cancer treatment.

Financial highlights include cash position of $50.7 million as of September 30, 2024, Q3 net loss of $14.6 million ($0.49 per share), and R&D expenses of $11.3 million. The company expects its cash runway to extend into Q4 2025.

Immuneering (Nasdaq: IMRX) has announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to IMM-1-104 for the treatment of pancreatic cancer. This designation follows the company's recent announcement of positive initial Phase 2a data, including complete and partial responses, for IMM-1-104 in combination with chemotherapy in first-line pancreatic cancer patients.

IMM-1-104 is currently being evaluated in a Phase 2a clinical trial for advanced solid tumors, including pancreatic cancer. The company expects to release initial data from at least one additional arm of the Phase 2a portion of their Phase 1/2a trial by year-end. Immuneering is also studying IMM-1-104 in combination with modified FOLFIRINOX and as a monotherapy for pancreatic cancer.

The FDA's orphan drug designation may qualify Immuneering for incentives such as tax credits for qualified clinical trials, exemptions from certain FDA fees, and additional time for post-approval marketing exclusivity. Earlier this year, Immuneering was also granted FDA Fast Track designation for IMM-1-104 for both first and second-line pancreatic cancer treatment.

Immuneering (Nasdaq: IMRX) announced positive initial Phase 2a data for IMM-1-104 in combination with modified gemcitabine/nab-paclitaxel in first-line pancreatic cancer patients. The initial results show:

• 40% initial response rate (2/5 patients)
• 80% initial disease control rate (4/5 patients)
• One complete response and one partial response observed
• All five patients continuing treatment

The combination has been well-tolerated at 240 mg QD, with additional patients now dosed at 320 mg QD. These results are consistent with preclinical data and exceed expectations for gemcitabine/nab-paclitaxel alone. Immuneering plans to continue clinical development, leveraging IMM-1-104's Fast Track designation for pancreatic cancer treatment.

Immuneering (Nasdaq: IMRX), a clinical-stage oncology company, has announced its participation in the Morgan Stanley 22nd Annual Global Healthcare Conference. The event will take place from September 4-6, 2024, at the Marriott Marquis in New York City.

Key executives, including CEO Ben Zeskind and CSO Brett Hall, will present in a fireside chat format on September 6 from 10:00 – 10:35 am ET. They will discuss Immuneering's pipeline, platform, and business strategy, focusing on their development of universal-RAS/RAF medicines for broad populations of cancer patients.

The presentation will be webcast live and archived on Immuneering's website in the Investor Relations section. This event provides an opportunity for investors to gain insights into the company's progress and future plans in the oncology field.

Immuneering (Nasdaq: IMRX) reported Q2 2024 financial results and provided business updates. Key highlights include:

1. Enrollment progressing well in IMM-1-104 Phase 2a trial, with initial data from multiple arms expected in 2H 2024.

2. FDA Fast Track Designation granted for IMM-1-104 in first-line pancreatic cancer.

3. Preclinical data presented at AACR showing IMM-1-104 combined with chemotherapies yields deeper tumor growth inhibition in pancreatic cancer models.

4. Initial PK, PD, and safety data from IMM-6-415 Phase 1/2a trial expected in 2H 2024.

Financial highlights: Cash position of $59.7 million as of June 30, 2024. Q2 2024 R&D expenses were $10.7 million, G&A expenses were $4.3 million, and net loss was $14.1 million ($0.47 per share). Cash runway expected to fund operations into 2H 2025.

Immuneering (Nasdaq: IMRX) has received FDA Fast Track designation for IMM-1-104 as a first-line treatment for pancreatic ductal adenocarcinoma (PDAC). This follows the February 2024 Fast Track designation for second-line PDAC treatment. IMM-1-104 is designed to provide universal-RAS activity through Deep Cyclic Inhibition of the MAPK pathway with once-daily oral dosing.

The ongoing Phase 2a trial includes multiple arms evaluating IMM-1-104 in combination with chemotherapy for first-line PDAC patients, as monotherapy for first and second-line PDAC, and for RAS-mutant melanoma and lung cancer. Immuneering expects to share initial data from multiple arms in the second half of 2024.