Elraglusib

November 2024 saw numerous FDA approvals, designations, and clinical trial advancements in oncology, including revumenib for KMT2A-rearranged acute leukemia, obe-cel for relapsed/refractory B-cell ALL, and fast track designations for ALE.P02 in Claudin-1-positive tumors. Other highlights include orphan drug designations for LBL-024 in neuroendocrine cancer and elraglusib in Ewing sarcoma, and a new drug application for sunvozertinib in EGFR-mutant NSCLC.

The FDA awarded rare pediatric disease designation to elraglusib (9-ING-41), a GSK-3β inhibitor, for treating Ewing sarcoma. The ongoing Actuate-1902 trial is assessing elraglusib's safety and efficacy in pediatric patients with relapsed/refractory malignancies, including Ewing sarcoma. Early data shows promising antitumor activity, with 2 durable complete responses in the first 6 treated patients.

Elraglusib, a GSK-3β inhibitor, received FDA's rare pediatric disease designation for treating Ewing sarcoma. The ongoing Actuate-1902 trial (NCT04239092) assesses its safety and efficacy in pediatric patients with relapsed/refractory malignancies, including Ewing sarcoma. Early data shows promising antitumor activity.

Actuate Therapeutics announces FDA's rare pediatric disease designation for elraglusib, a GSK-3β inhibitor, for treating Ewing sarcoma. Early clinical data shows promising anti-tumor activity, with two durable Complete Responses in relapsed/refractory EWS patients. The designation aims to provide new therapeutic options for this challenging disease.

Actuate Therapeutics will participate in Lantern Pharma’s “Webinar Wednesday” on Oct. 30, 2024, discussing the AI platform’s role in identifying and developing enrichment biomarkers for elraglusib, Actuate’s lead drug candidate. Elraglusib, a GSK-3β inhibitor, is in Phase 2 trials for metastatic pancreatic cancer and Phase 1/2 trials for Ewing Sarcoma.

Lantern Pharma to host two October webinars highlighting RADR® AI platform's role in advancing cancer therapies, including collaborations with Actuate Therapeutics and discussions on drug candidates LP-184 and LP-284.

In September 2024, the FDA approved multiple oncology treatments, including subcutaneous atezolizumab, ribociclib for early breast cancer, isatuximab for multiple myeloma, selpercatinib for medullary thyroid cancer, and osimertinib for advanced NSCLC. Other approvals included OBX-115 for melanoma, FoundationOne CDx and Liquid CDx for prostate cancer, subcutaneous bortezomib, IBI363 for melanoma, 212Pb VMT01 for melanoma, ABD-147 for neuroendocrine carcinoma, certepetide for cholangiocarcinoma, tebapivat for myelodysplastic syndromes, elraglusib for soft tissue sarcoma, VNX-101 for leukemia, P-BCMA-ALLO1 for multiple myeloma, adjuvant ribociclib for breast cancer, pembrolizumab for mesothelioma, ICT01 for leukemia, CF33-hNIS for cholangiocarcinoma, trastuzumab-strf, amivantamab for NSCLC, CD-001, isatuximab for multiple myeloma, EO-3021 for gastric cancer, camrelizumab for HCC, LP-184 for rare pediatric tumors, osimertinib for NSCLC, and selpercatinib for medullary thyroid cancer.

The FDA has granted orphan drug designation to elraglusib, a GSK-3β inhibitor, for treating soft tissue sarcoma. A phase 2 trial is evaluating elraglusib in combination with gemcitabine and docetaxel, targeting disease control rate and progression-free survival. Elraglusib has shown favorable safety and antitumor activity in various solid tumors.

Actuate Therapeutics announces FDA Orphan Drug Designation for elraglusib, a GSK-3β inhibitor for soft tissue sarcoma, highlighting its potential to address unmet medical needs in advanced cancers.

Actuate Therapeutics received FDA Orphan Drug Designation for elraglusib, a GSK-3β inhibitor, for treating soft tissue sarcoma. Elraglusib shows promise in addressing unmet medical needs in advanced cancers, demonstrating safety and antitumor activity. The designation offers benefits like tax credits and marketing exclusivity, highlighting its potential in cancer therapy.