- The company’s lead candidate, OT-101, is currently in a Phase 3 trial for pancreatic cancer and is advancing toward combination studies with checkpoint inhibitors.
- A joint venture with GMP Biotechnology enables Oncotelic to conduct low-cost research and development, operate in-house GMP manufacturing, and support a rapidly expanding nanoparticle pipeline trademarked Deciparticle(TM).
- A strategic partnership with Shanghai Medicilon supports rapid IND filings for up to 20 drug candidates, significantly accelerating development timelines.
- Oncotelic’s proprietary AI platform, PDAOAI, enhances regulatory and research workflows while offering public engagement tools for added transparency.
- The company maintains a multi-indication pipeline spanning oncology, Parkinson’s disease, erectile dysfunction and female sexual Dysfunction, providing broad commercialization potentials.
- Recent peer-reviewed publications support OT-101’s mechanism of action and spotlight TGF-β2 as a survival-linked biomarker in younger PDAC patients.
Oncotelic Therapeutics (OTCQB: OTLC) is a clinical-stage biopharmaceutical company developing RNA-based, immunotherapy, and targeted therapeutics for cancer and other underserved diseases. The company is focused on transforming outcomes for patients with difficult-to-treat and rare conditions, particularly pediatric cancers and aggressive solid tumors. Its development strategy centers on novel compound design, nanoparticle drug delivery, and the integration of artificial intelligence to accelerate discovery and regulatory workflows.
At the center of this foundation is Chairman and CEO Dr. Vuong Trieu, a prolific industry pioneer who has filed more than 500 patents with 75 issued patents across biologics, small molecules, nanoparticles, and diagnostics. Dr. Trieu co-invented Abraxane® (sold to Celgene for $2.9 billion), underscoring his track record of creating high-value therapies. Through collaborations with industry leaders and its stake in specialized joint ventures, Oncotelic is positioned to advance a diverse portfolio of oncology assets with greater speed and cost efficiency. The company also operates a proprietary AI platform, PDAOAI, which streamlines scientific writing, regulatory documentation, and data interpretation. This system is accessible to the public through a dedicated Discord server, offering real-time engagement with Oncotelic’s research ecosystem.
With expanded clinical activity and a next-generation development model, Oncotelic continues to evolve as a multi-asset innovator in precision oncology.
The company is headquartered in Agoura Hills, California.
Pipeline and Partnerships
Oncotelic’s lead candidate is OT-101, currently in a Phase 3 trial for pancreatic ductal adenocarcinoma (STOP-PC study) and evaluated in gliomas and metastatic solid tumors in combination with IL-2 and checkpoint inhibitors. The antisense molecule targets TGF-β2, a cytokine known to suppress immune responses and promote tumor growth. A Phase 1 trial combining OT-101 with IL-2 was recently completed, demonstrating safety and paving the way for combination therapies with PD-1 blockers and other immunotherapies.
Recent data have further strengthened the rationale for OT-101 in pancreatic ductal adenocarcinoma (“PDAC”). In June and July 2025, two peer-reviewed studies published in the International Journal of Molecular Sciences identified TGF-β2 gene expression and methylation status as significant prognostic markers in PDAC, particularly among younger patients and those with low CD8+ T-cell infiltration. High TGF-β2 expression correlated with reduced overall survival, while elevated TGF-β2 methylation was associated with improved outcomes. These findings validate TGF-β2 as a high-priority target and support the continued development of OT-101 as a precision therapy. Both studies leveraged Oncotelic’s proprietary AI-driven platform, PDAOAI, to mine and assemble multi-omic datasets, showcasing the system’s role in accelerating insight generation.
The company holds a 45% ownership stake in GMP Biotechnology Limited, a joint venture with Dragon Capital Overseas Limited. GMP Bio owns SAPU Bioscience, which is executing several pipeline programs. SAPU and Oncotelic are jointly utilizing a rapid IND platform through their partnership with Shanghai Medicilon to support regulatory filings for up to 20 drug candidates, with five INDs already underway. This collaboration is central to accelerating development of next-generation anticancer agents.
After the joint venture, Dr. Trieu, with his team, built out a state of the art and GMP-certified R&D facility in San Diego, which operates under SAPU, that manufactures clinical trial materials and supports a proprietary nanoparticle platform trademarked Deciparticle(TM). This platform includes four therapeutic candidates—two of which are in late-stage manufacturing and expected to enter IND filing before the end of 2025.
Additionally, Oncotelic owns AL-101, an intranasal administered apomorphine product intended for the treatment of Parkinson’s disease, Erectile Dysfunction, and Female Sexual Disorders.
Market Opportunity
Oncotelic is targeting large and underserved therapeutic markets with significant commercial potentials. The global pancreatic cancer treatment market alone is projected to grow at a 12.3% CAGR, reaching $5.84 billion by 2030, up from $2.92 billion in 2024, according to Research and Markets. This growth is driven by increased disease prevalence, aging populations, and demand for more effective treatment options. Notably, the incidence of early-onset PDAC is rising at an estimated rate of 4% per year in the 15–34 age group, highlighting an emerging unmet need for targeted therapies among younger patients.
Beyond oncology, Oncotelic intends to develop AL-101 for Parkinson’s disease, which affects over 1 million patients in the U.S. alone and is expected to impact 1.2 million by 2030. Erectile Dysfunction and Female Sexual Dysfunction are also major global health issues, with Erectile Dysfunction affecting up to 70% of men over 60 and Female Sexual Dysfunction impacting approximately 40% of women—both with limited treatment options, particularly for patients who fail to respond to existing medications. These underserved populations offer fertile ground for innovative new therapies.
Leadership Team
Dr. Vuong Trieu is the Chairman and CEO of Oncotelic Inc. An accomplished innovator in pharmaceutical development, Dr. Trieu previously served as President and CEO of Igdrasol, where he pioneered the approval path for paclitaxel nanomedicine via a single bioequivalence trial. After Igdrasol merged with Sorrento Therapeutics, he became Chief Scientific Officer and a Board Director. He also held leadership roles at Cenomed, Abraxis, Applied Molecular Evolution, and Parker Hughes Institute. Dr. Trieu holds a Ph.D. in Molecular Microbiology, a B.S. in Botany, has published widely, and filed over 500 patent applications with 75 issued U.S. patents.
Amit Shah is the Chief Financial Officer of Oncotelic Inc. He has over 20 years of financial leadership in life sciences, including CFO roles at Marina Biotech and Igdrasol, and senior positions at ISTA Pharmaceuticals, Spectrum Pharmaceuticals, and Caraco. He also worked in consulting and ERP implementation. Mr. Shah holds a Bachelor of Commerce from the University of Mumbai, is an Associate Chartered Accountant in India, and is an inactive CPA in Colorado.
Dr. Anthony E. Maida III is the Chief Clinical Officer – Translational Medicine at Oncotelic Inc. He has over 25 years of experience advancing cancer immunotherapies and held senior roles at Northwest Biotherapeutics, PharmaNet, and Jenner Biotherapies. He has raised over $200 million for biotech firms and negotiated licensing deals with institutions such as Pfizer, Eli Lilly, and Yale. Dr. Maida holds dual B.A. degrees in Biology and History, an MBA, an M.A. in Toxicology, and a Ph.D. in Immunology, and is active in ASCO, AACR, and other scientific societies.
For more information, visit the company’s website at www.Oncotelic.com.
NOTE TO INVESTORS: The latest news and updates relating to OTLC are available in the company’s newsroom at https://ibn.fm/OTLC
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