Immuneering

Immuneering reported Q3 2024 financial results and significant clinical progress, including positive initial data for IMM-1-104 in combination with chemotherapy for first-line pancreatic cancer patients, with complete and partial responses. The FDA granted Orphan Drug and Fast Track designations for IMM-1-104 in pancreatic cancer treatment. Financial highlights include a cash position of $50.7 million, 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 Corporation reported positive initial data for IMM-1-104 combined with chemotherapy in first-line pancreatic cancer, including complete and partial responses. FDA granted Orphan Drug and Fast Track designations for IMM-1-104. Additional Phase 2a trial data expected by year-end. Cash runway extends into Q4 2025.

Chardan Capital's Geulah Livshits maintains Buy rating on Intellia Therapeutics (NTLA) with a $88.00 price target, citing NTLA-2002's phase II trial data showing 77% reduction in HAE attacks. Despite high expectations not fully met, one-time dosing potential supports the rating. Livshits anticipates positive phase III results and differentiates NTLA-2002 from other treatments.

Immuneering Corp. announced US FDA orphan drug designation for IMM-1-104 in pancreatic cancer, with positive phase 2a data reported in combination with modified gemcitabine/nab-paclitaxel. Initial data from another phase 2a arm is expected by year-end.

Immuneering announced FDA orphan drug designation for IMM-1-104 in pancreatic cancer, with positive initial Phase 2a data showing complete and partial responses in first-line patients treated with IMM-1-104 plus chemotherapy.

FDA grants orphan drug designation to IMM-1-104 for pancreatic cancer, following positive Phase 2a data. Additional Phase 2a trial data expected by year-end.

Immuneering Corporation received FDA orphan drug designation for IMM-1-104, targeting pancreatic cancer, following promising Phase 2a trial results. The status offers benefits like tax credits and marketing exclusivity. IMM-1-104 inhibits the MAPK pathway, with ongoing Phase 1/2a studies. Teva Pharmaceuticals settled legal disputes for $450M and launched a generic acromegaly treatment, showing revenue growth.

The KRAS Inhibitors market is poised for significant growth driven by increasing cancer incidence, treatment access, and a robust pipeline. The market size in the 7MM was $500 million in 2023, expected to rise by 2034. KRAZATI (adagrasib) is projected to outperform LUMAKRAS (sotorasib) in revenue. The US leads in KRAS mutation cases in NSCLC, with 46% of 7MM cases. Competition in G12C NSCLC is intensifying, with Chinese biotechs entering the KRAS space. Despite G12D being the most prevalent KRAS variant, G12C is the primary target in colorectal cancer. KRAZATI is the first KRAS inhibitor approved for KRAS G12C-mutant colorectal cancer. Pancreatic cancer, with 60-90% KRAS mutations, presents a significant market opportunity. Pan-KRAS drugs, targeting multiple mutations, offer broad market potential. Key companies include Novartis, Roche, Genentech, and Mirati Therapeutics. Emerging therapies like JDQ443, Divarasib, and Avutometinib are expected to reshape the market. The KRAS inhibitor market is evolving, driven by high unmet needs, competitive drug development, and regulatory approvals.

Aethlon Medical's Hemopurifier® aims to enhance anti-PD-1 therapy by removing tumor-produced extracellular vesicles, with ethics approval for a clinical trial in India following approvals in Australia. The trial will evaluate Hemopurifier® in solid tumor patients with stable or progressive disease during anti-PD-1 monotherapy, with other companies like Immuneering and Iovance Biotherapeutics also advancing immunotherapy treatments.