Oncotelic Therapeutics Expands Sapu003 Phase 1b Program, Appoints Global CRO for International Study Execution

Oncotelic Therapeutics, Inc. (OTCQB: OTLC) announced the expansion of its Phase 1b clinical development program for Sapu003 (Everolimus for Injection) and the appointment of Global Clinical Trials (GCT) as the lead contract research organization for international execution of Study SP-03-B101. The move follows recent regulatory approvals supporting study expansion and marks the transition of the Sapu003 program from an Australia-based clinical effort toward a broader multinational development strategy, including planned expansion into Europe.

SP-03-B101 is an open-label Phase 1b dose-escalation study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of Sapu003 in patients with advanced mTOR-sensitive solid tumors. The company said GCT has already completed key regulatory submissions ahead of schedule and initiated clinical operations, site activation and study management activities. Sapu003 is an intravenous formulation of everolimus developed using Sapu Nano’s Deciparticle platform, which is designed to improve drug delivery and provide more predictable systemic exposure than oral administration while supporting future global registrational studies.

This expansion is significant because it moves Sapu003 closer to potential global registration and commercialization. By shifting from a single-country study to a multinational effort, Oncotelic can accelerate patient enrollment and gather data across diverse populations, which is crucial for regulatory approvals in major markets like Europe. The appointment of GCT, a global CRO with experience in international trials, further enhances the program’s credibility and operational efficiency.

Oncotelic Therapeutics is a clinical-stage biopharmaceutical company focused on oncology and immunotherapy products, addressing high-unmet-need cancers and rare pediatric indications. The company leverages its proprietary AI-enabled PDAOAI platform for research and biomarker discovery. Beyond its internal programs, Oncotelic licenses and co-develops drug candidates through strategic partnerships. The company currently owns a 45% interest in GMP Bio, a joint venture advancing a complementary pipeline of therapeutic candidates.

The implications of this announcement are twofold. First, it demonstrates Oncotelic’s ability to execute on its clinical development strategy and secure regulatory approvals for study expansion. Second, it highlights the potential of Sapu003 as a differentiated therapy for mTOR-sensitive tumors, which could address a significant unmet medical need. If successful, Sapu003 could offer a more predictable and effective treatment option compared to oral everolimus, potentially improving patient outcomes.

For more information, visit the company’s newsroom at https://nnw.fm/OTLC.

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