Immuneering

• Immuneering Corporation has established a clinical supply agreement with Regeneron Pharmaceuticals to evaluate their lead drug IMM-1-104 in combination with Libtayo for advanced RAS-mutant non-small cell lung cancer. • The collaboration builds on promising preclinical data presented at AACR 2023, suggesting the combination could both disrupt tumor MAPK addiction and enhance anti-tumor immune responses. • Under the agreement, Immuneering will maintain global development rights while Regeneron provides Libtayo for the planned Phase 2a trial in advanced solid tumors.

Immuneering's IMM-1-104, combined with modified gemcitabine/nab-paclitaxel, shows a 43% overall response rate and 86% disease control rate in first-line pancreatic cancer.

The FDA has granted Fast Track designation to Immuneering's IMM-1-104 for unresectable or metastatic NRAS-mutant melanoma treatment.

Immuneering reported positive initial Phase 2a data for IMM-1-104 combined with chemotherapy, showing complete and partial responses in first-line pancreatic cancer patients.

Immuneering's IMM-1-104 receives Orphan Drug Designation from the FDA for pancreatic cancer treatment, offering potential tax credits and marketing exclusivity.

• Aethlon Medical's Hemopurifier has received ethics approval in India for a clinical trial targeting solid tumors resistant to anti-PD-1 therapies. • The trial will assess the safety, feasibility, and optimal dosage of Hemopurifier in patients with stable or progressive disease. • Hemopurifier aims to improve therapeutic response by removing tumor-produced extracellular vesicles from the bloodstream. • Aethlon anticipates beginning patient recruitment in Q4 2024, with the trial informing future oncology efficacy studies.

Aethlon Medical activates a clinical trial site in Australia for its Hemopurifier device in patients with solid tumors resistant to anti-PD-1 therapies.

Immuneering's IMM-1-104, combined with modified gemcitabine/nab-paclitaxel, demonstrates an initial 40% overall response rate in first-line pancreatic cancer patients.

The FDA has granted Fast Track designation to Immuneering's IMM-1-104 for pancreatic ductal adenocarcinoma after one prior line of therapy.