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

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

Study SP-03-B101 is an open-label Phase 1b dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of Sapu003 in patients with advanced mTOR-sensitive solid tumors. According to the company, GCT has already completed key regulatory submissions ahead of schedule and has initiated clinical operations, site activation, and study management activities. This accelerated progress underscores the commitment to advancing the development of Sapu003, an intravenous formulation of everolimus developed using Sapu Nano’s Deciparticle platform.

The Deciparticle platform is designed to improve drug delivery and provide more predictable systemic exposure compared to oral administration. This intravenous formulation may offer advantages in terms of bioavailability and pharmacokinetic control, supporting future global registrational studies. The expansion of the program and the engagement of an experienced international CRO are critical steps toward generating the data necessary for regulatory approvals in multiple jurisdictions.

Oncotelic Therapeutics is a clinical-stage biopharmaceutical company focused on developing oncology and immunotherapy products for high-unmet-need cancers and rare pediatric indications. The company benefits from a robust portfolio of inventions by its CEO, Dr. Vuong Trieu, who has filed over 500 patent applications and holds 75 issued patents. Additionally, Oncotelic leverages its proprietary AI-enabled PDAOAI platform to support research, biomarker discovery, and regulatory processes through advanced data analysis and knowledge integration.

Beyond its internal programs, Oncotelic licenses and co-develops select drug candidates through strategic partnerships and joint ventures. The company currently owns a 45% interest in GMP Bio, a joint venture advancing a complementary pipeline of therapeutic candidates that strengthen Oncotelic’s position in oncology and rare disease therapeutics. For more information, visit the company’s newsroom at https://nnw.fm/OTLC.

The full press release is available at https://nnw.fm/olX92.