ATB-301 / Autotelic, Oncotelic - LARVOL DELTA

Key Highlights From the Kyoto 2025 Presentation (GlobeNewswire) - "Dr. Trieu presented evidence that TGFβ2 is a critical driver of immunosuppression, fueling tumor progression by promoting an M2-like macrophage phenotype and blunting antitumor immunity; OT-101’s Clinical Progress and Versatility: In pancreatic ductal adenocarcinoma (PDAC), OT-101 is currently in a Phase 3 clinical trial (the STOP-PC study) combined with mFOLFIRINOX...Combination regimens with CKIs and IL-2 address multiple pathways of immune evasion, potentially amplifying therapeutic benefits; Next Studies Targeting TGF β2 and Beyond: With the newly completed OT-101 and IL-2 Phase 1 trial, Oncotelic is poised to begin further combination trials to determine the added efficacy of OT-101, IL-2, and CKIs in solid tumors such as lung cancer, melanoma, and colorectal cancer; Next wave of clinical trials aiming to knock down TGF β 2 (e.g., with OT-101) paired with intervention with a complementary therapy, checkpoint blockade..."

New trial • Trial status • Colorectal Cancer • Glioma • Lung Cancer • Melanoma • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Oncotelic Therapeutics Announces Successful Completion of Phase 1 Trial of OT-101 and IL-2, Highlights Findings at SWCR 2025 Conference (GlobeNewswire) - P1 | N=9 | NCT04862767 | Sponsor: Autotelicbio | "Phase 1 Trial of OT-101 (TASO) and IL-2 Successfully Completed: The Phase 1 trial (ClinicalTrials.gov ID: NCT04862767) investigated the safety and tolerability of OT-101 in combination with recombinant IL-2 in patients with advanced or metastatic solid tumors; The combination showed a tolerable safety profile at the planned dosing schedule, with no unexpected safety signals identified; Based on the favorable safety data, Oncotelic plans to advance OT-101 plus IL-2 into further clinical studies, exploring synergies with CKIs such as PD-1 blockers."

P1 data • Trial completion • Solid Tumor

ATB-301-001: TASO-001 in Combination With Recombinant Interleukin-2(Aldesleukin) in Advanced or Metastatic Solid Tumor (clinicaltrials.gov) - P1 | N=9 | Completed | Sponsor: Autotelicbio | Recruiting ➔ Completed

Trial completion • Oncology • Solid Tumor

ATB-301-001: TASO-001 in Combination With Recombinant Interleukin-2(Aldesleukin) in Advanced or Metastatic Solid Tumor (clinicaltrials.gov) - P1 | N=9 | Recruiting | Sponsor: Autotelicbio | Trial completion date: Mar 2022 ➔ Dec 2023 | Trial primary completion date: Mar 2022 ➔ Dec 2023

Combination therapy • Metastases • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Oncotelic Presenting Data for OT101 Against Pancreatic Cancer (PDAC) at the SITC 37th Annual Meeting (GlobeNewswire) - "Oncotelic Therapeutics, Inc...today announced that the Company will be presenting at the upcoming SITC 37th Annual Meeting, held November 10-12, 2022, in Boston, MA....'Using deep learning we demonstrated a combinatory approach for treatment of pancreatic cancer leveraging on OT-101 as suppressor of TGF-β. We are initiating late-stage clinical trials around this program and are excite to work with leading thought leaders to bring OT-101 to patients'."

Clinical data • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

TASO-001 in Combination With Recombinant Interleukin-2(Aldesleukin) in Advanced or Metastatic Solid Tumor (clinicaltrials.gov) - P1; N=9; Recruiting; Sponsor: Autotelicbio

Clinical • Combination therapy • New P1 trial • Oncology • Solid Tumor