inhaled delta-9-tetrahydrocannabinol (HCC011) / Tetra Bio-Pharma - LARVOL DELTA

Hypoxia Drives HIF-1a/YAP-AXL-Mediated Adaptive Resistance to Osimertinib in EGFR-Mutant NSCLC (IASLC-WCLC 2026) - "Results : Hypoxia reduced sensitivity to osimertinib in EGFR-mutant PC-9 and HCC4011 cells...Genetic and pharmacologic targeting of AXL restored osimertinib sensitivity under hypoxic conditions in vitro, and ONO-7475 overcame HIF-1α-driven resistance in vivo. Spatial analyses of patient tumors further support the clinical relevance of CAF-proximal hypoxic niches enriched for AXL-high tumor cells. Together, these findings identify the HIF-1α/YAP-AXL axis as a therapeutically actionable mechanism underlying hypoxia-associated adaptive resistance to osimertinib in EGFR-mutant NSCLC."

Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • AXL • CAFs • EGFR • HIF1A • LATS1

Hypoxia Drives HIF-1a/YAP-AXL-Mediated Adaptive Resistance to Osimertinib in EGFR-Mutant NSCLC (IASLC-WCLC 2026) - "Results : Hypoxia reduced sensitivity to osimertinib in EGFR-mutant PC-9 and HCC4011 cells...Genetic and pharmacologic targeting of AXL restored osimertinib sensitivity under hypoxic conditions in vitro, and ONO-7475 overcame HIF-1α-driven resistance in vivo. Spatial analyses of patient tumors further support the clinical relevance of CAF-proximal hypoxic niches enriched for AXL-high tumor cells. Together, these findings identify the HIF-1α/YAP-AXL axis as a therapeutically actionable mechanism underlying hypoxia-associated adaptive resistance to osimertinib in EGFR-mutant NSCLC."

Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • AXL • CAFs • EGFR • HIF1A • LATS1

Hypoxia-driven HIF-1α/YAP-AXL signaling drives adaptive resistance to TKIs in NSCLC (AACR 2026) - "For spatial analysis of human tumors, multiplex immunofluorescence (HIF-1α, AXL, α-SMA, DAPI) was performed on FFPE EGFR-mutant lung adenocarcinoma specimens and quantified with whole-slide single-cell segmentation and tumor/cancer-associated fibroblast (CAF) classification; CytoMAP nearest-neighbor and 50-µm neighborhood metrics assessed CAF proximity to hypoxic tumor cells. Hypoxia reduced sensitivity to osimertinib in PC-9 and HCC4011 and to brigatinib in H2228...AXL knockdown restored TKI growth inhibition and the suppression of downstream AKT signaling under hypoxia, and the AXL inhibitor ONO-7475 phenocopied these effects... Hypoxia induces adaptive resistance to TKIs via HIF-1α/YAP-AXL signaling, linking oxygen stress to RTK reprogramming. Spatial analyses of patient tumors reveal CAF-proximal hypoxic niches with elevated AXL, providing tissue context for this mechanism. These findings support AXL inhibition as a rational combination partner to TKIs to..."

Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • CAFs • EGFR • HIF1A • LATS1

Tetra Biopharma confirms type B meeting date with FDA regarding HCC011 (GlobeNewswire) - "Tetra Bio-Pharma Inc...is pleased to announce that the U.S. Food & Drug Administration ('FDA') has granted the Company’s request for a Type B meeting related to its proposed clinical program and overall premarketing requirements for the Company’s product HCC011 with Orphan Drug Designation. This meeting has been scheduled for May 29, 2020....On May 29, the FDA will be providing guidance on our planned phase 2 clinical trial, expedited review paths, and 505(b)(2) premarketing requirements."

FDA event • New P2 trial

Tetra Bio-Pharma enters into manufacturing agreement with Vitiprints LLC for Caumz and HCC011 (GlobeNewswire) - "Tetra Bio Pharma Inc...today announced it has signed a definitive manufacturing agreement with Vitiprints LLC, for the commercial scale production of CAUMZ™ and HCC011. This agreement will further protect CAUMZ™ and HCC011 with four additional patents on manufacturing know-how...In exchange of this exclusive license Tetra will be required to make milestones and royalty payments on CAUMZ™ sales. From a financial standpoint this proprietary technology will allow Tetra to reduce it Cost of Goods Sold (COGS) for CAUMZ™ by approximately 75% and will significantly improve CAUMZ™ gross margin."

Licensing / partnership

Tetra Bio-Pharma provides update on its hepatocellular carcinoma drug HCC011 (GlobeNewswire) - "Tetra Bio-Pharma Inc...announced it will be requesting a meeting with the U.S. Food and Drug Administration (FDA) to discuss the drug development program for its Orphan Drug candidate HCC011, inhaled delta-9-tetrahydrocannabinol (THC), in the treatment of hepatocellular carcinoma...The company intends to file an NDA for HCC011 via the 505(b)(2) pathway....Post our meeting with FDA, we hope to gain clarity on our filing and marketing requirements, including input from the Agency on the design of our planned Phase 2 trial for HCC011 in HCC."

FDA event • NDA • New P2 trial

Newly added product (GlobeNewswire) - Preclinical, Oncology, HCC

Pipeline update