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NEW YORK , Oct. 27, 2025 /PRNewswire/ -- The global oncology market is rapidly shifting toward smarter drug-delivery systems that enhance efficacy, reduce toxicity and improve patient outcomes. Traditional oral or IV drugs often face poor bioavailability and limited tumor targeting — a major bottleneck in cancer treatment success. Recent breakthroughs in nanomedicine are making headlines, as the FDA and global regulatory bodies increasingly endorse nanocarrier-based delivery for complex drugs. This surge underscores a larger industry trend: the race to improve how drugs reach and act within the body. Oncotelic Therapeutics Inc.'s(OTCQB: OTLC) (profile) Deciparticle(TM) platform exemplifies this shift. It offers a novel approach to increase the bioavailability and therapeutic index of existing cancer drugs, potentially transforming underperforming compounds into next-generation therapies. The recent advancement of Sapu-003 into human trials signals real-world momentum behind this vision, showing how innovation in delivery science can unlock new value across multiple drug candidates. Oncotelic Therapeutics is focused on making its mark in the oncology treatment space, along with other innovative leaders such as IO Biotech Inc. (NASDAQ: IOBT), Novartis AG (NYSE: NVS), Bicara Therapeutics Inc. (NASDAQ: BCAX) and Pfizer Inc. (NYSE: PFE)

• The pharmaceutical industry is entering an inflection point driven by the recognition that highly potent cancer drugs are only as effective as their ability to reach tumors with sufficient concentration.
• Oncotelic Therapeutics' Deciparticle technology directly addresses this effective drug-delivery need with a modular, ultra-high-efficiency nanomedicine delivery engine. 
• Sapu-003 has now advanced into first-in-human clinical trials in Australia, marking a pivotal moment for the platform's external validation.
• The projected $500-billion-plus nanomedicine market by 2032 is anchored more by delivery innovation than by new molecular discoveries.
• Deciparticle-enabled therapies could deliver materially more effective treatment with lower toxicity.

Click here to view the custom infographic of the Oncotelic Therapeutics editorial.

The Global Shift Toward Smarter Drug Delivery

The pharmaceutical industry is entering an inflection point driven by the recognition that highly potent cancer drugs are only as effective as their ability to reach tumors with sufficient concentration. Many promising oncology drugs fail not because the therapy lacks biological power, but because the body absorbs only a fraction of the intended dose. Conventional oral and IV therapies struggle with poor solubility, steep metabolism and imprecise biodistribution, forcing high doses and resulting in systemic toxicity. This is especially problematic in mTOR inhibitors, kinase inhibitors, and vascular-disrupting agents, where dose-limiting toxicity can halt development even when preclinical data were strong.

As a result, the industry is increasingly prioritizing drug-delivery innovation as much as drug discovery itself. Nanomedicine, the engineering of sub-200-nanometer drug carriers, is rapidly becoming the leading solution to address absorption inefficiencies and off-target toxicity. These platforms are designed not only to protect the drug from premature degradation but also control its release and guide it more precisely to tumor environments. Leading market research estimates that the global nanomedicine market could surpass $500 billion by 2032, driven by oncology-focused breakthroughs that materially improve drug absorption and targeting.

Within oncology, nanocarrier delivery has accelerated following regulatory validations such as FDA approvals of nanoparticle-formulated chemotherapies and RNA therapies. These new formulations are not simply incremental improvements; they can transform once-marginal drugs into category-changing assets. As precision medicine evolves from mutation-targeting to delivery-optimizing, companies that control best-in-class bioavailability engines are positioned to redefine the competitive landscape.

Transforming Bioavailability Into Breakthroughs

Oncotelic Therapeutics' Deciparticle technology directly addresses this effective drug-delivery need with a modular, ultra-high-efficiency nanomedicine delivery engine. The platform is designed to elevate drug bioavailability from conventional 10–20% to potentially 80–100% in preclinical models. Rather than inventing entirely new drug molecules, Deciparticle focuses on re-engineering the way existing and emerging drugs are delivered into the body, maximizing their performance without requiring molecular redesign.

This matters because enhanced delivery unlocks multiple advantages at once: the ability to use lower therapeutic doses, to dramatically reduce systemic toxicity and to increase the therapeutic index. A drug that once required high dosing to overcome bioavailability constraints may perform better with a fraction of the dose once delivered via precision nanocarrier. The implications extend beyond improved safety; they represent an efficiency shift that could accelerate clinical timelines across oncology pipelines.

The Deciparticle platform is also versatile by design. Because its core function is physical precision, not disease-specific molecular binding, it can be deployed across multiple drug classes, including mTOR inhibitors, small-molecule anti-angiogenic agents and rare-disease therapeutics. Oncotelic is positioning this as a scalable architecture rather than a one-off formulation, giving the platform multi-asset potential in parallel rather than sequentially.

Clinical Momentum Across the Pipeline

Sapu-003 (Deciparticle Everolimus) has now advanced into first-in-human clinical trials in Australia, marking a pivotal moment for the platform's external validation. The trial, announced by Sapu Nano, an Oncotelic joint initiative, signals that the technology is not merely theoretical but has met the safety and manufacturing requirements required to enter regulated testing environments.

Sapu-003 is based on oral Everolimus (Afinito(R)), a clinically proven but absorption-challenged mTOR inhibitor currently standard of care in multiple cancer indications. In its conventional form, much of the drug is lost to hepatic metabolism and variable pharmacokinetics, requiring tight monitoring and limiting its true potential. The Deciparticle formulation seeks to overcome these limitations by delivering near-complete drug availability at the site of therapeutic action, which could materially amplify its clinical value.

Beyond Sapu-003, Oncotelic has parallel projects underway scoped to reformulate additional oncology assets using the same delivery framework. These include other chemotherapies and targeted therapiesthat have already demonstrated biological activity but remain constrained by absorption and toxicity factors. Each asset brought onto the platform strengthens the company's positioning as a multi-program nanomedicine developer rather than a single-asset biotech.

Market Opportunity, Value Creation

The projected $500-billion-plus nanomedicine market by 2032 is anchored more by delivery innovation than by new molecular discoveries. Within that expansion, oncology is expected to remain the highest-velocity segment, driven by rising demand for targeted, lower-toxicity, high-response-rate therapies. This aligns with Oncotelic's strategy of creating value by optimizing rather than replacing existing therapeutic molecules.

By dramatically increasing the bioavailability of clinically approved and commercialized drugs, Oncotelic shortens timelines, bypasses early molecular risk by leverging on the pre-existing safety profile and unlocks latent value by unleashing the full efficacy potential. These efficiencies are particularly attractive in a capital-disciplined biotech market, where investors increasingly favor platform companies with reusable architecture over one-drug bets with binary outcomes. In Oncotelic's model, every successful proof point strengthens the perceived value of the platform, not just the individual drug.

This creates dual-track value potential. Near-term catalysts center on clinical readouts and partnership opportunities from Sapu-003 and subsequent pipeline entrants. Over the longer term, the scalability of the Deciparticle platform could position Oncotelic as a critical nanomedicine infrastructure partner for pharmaceutical companies seeking formulation upgrades for high-value but absorption-limited assets.

Elevating Patient Outcomes Through Precision Delivery

For patients, the impact of this platform approach goes beyond technical efficiency. Deciparticle-enabled therapies could deliver materially more effective treatment with lower toxicity, avoiding the dose-limiting complications that often degrade quality of life during cancer care. In some cases, drugs once considered too toxic or too inconsistent in exposure may re-enter clinical and commercial relevance under this new delivery paradigm.

Oncotelic's goal is to unlock a future where high-bioavailability precision nanomedicine becomes not an exception but a default standard across multiple cancer types and rare diseases. Success would not simply improve existing therapies; it could convert them into durably controllable or even curative treatments. In the emerging race to make delivery science the new innovation frontier of oncology, the Deciparticle platform is built to compete at the highest strategic level.

Leading Oncology Firms Drive Progress in Cancer Treatments

The landscape of cancer therapy is experiencing a dynamic period of advancement as oncology companies worldwide accelerate the development and approval of innovative treatments. Across multiple cancer types, new therapies are demonstrating meaningful clinical benefits, extending survival and offering hope for patients facing historically limited options.

IO Biotech Inc.  presented detailed results from its global phase 3 trial of Cylembio(R) (imsapepimut and etimupepimut, adjuvanted), in combination with Merck's anti-PD-1 therapy KEYTRUDA(R) (pembrolizumab), for the first-line treatment of patients with unresectable or metastatic (advanced) melanoma. The data, presented as a proffered paper at the Melanoma and other skin tumors session of the 2025 European Society for Medical Oncology (ESMO) Congress in Berlin, expands upon topline results reported in August 2025.

Novartis AG  presented new Pluvicto(TM) (lutetium [177Lu] vipivotide tetraxetan) data from the phase 3 PSMAddition trial in a presidential symposium at the European Society for Medical Oncology Congress 2025. The PSMAddition data show Novartis Pluvicto delays progression to end-stage prostate cancer. According to the company, most patients with mHSPC progress to metastatic castration-resistant prostate cancer, underscoring the urgent need for new therapies that can reduce risk of progression in earlier disease settings, and Novartis plans to submit to regulatory authorities by end of year.

Bicara Therapeutics Inc. announced that the U.S. Food and Drug Administration (FDA) has granted a key designation. According to the company, the FDA granted Breakthrough Therapy Designation (BTD) to ficerafusp alfa in combination with pembrolizumab for the first line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC) whose tumors express programmed death-ligand 1 with combined positive score (CPS) ≥1, excluding human papillomavirus (HPV)-positive oropharyngeal squamous cell carcinoma. This designation from the FDA underscores the growing recognition of HPV-negative HNSCC as a distinct clinical indication within head and neck cancer, one with particularly poor outcomes and limited therapeutic options.

Pfizer Inc.  and Astellas Pharma U.S. Inc.announced final overall survival (OS) results from the phase 3 EMBARK study evaluating XTANDI(R) (enzalutamide), in combination with leuprolide and as monotherapy, in men with nonmetastatic hormone-sensitive prostate cancer with biochemical recurrence at high risk for metastasis. For the key secondary endpoint of OS, XTANDI plus leuprolide reduced the risk of death by 40.3% compared to leuprolide alone, making this the first and only androgen receptor inhibitor-based regimen to demonstrate an OS benefit in nmHSPC with high-risk BCR.

As the oncology field continues to evolve, the combination of cutting-edge research, regulatory milestones and clinical validation is reshaping treatment paradigms. Progress across multiple cancer indications highlights the potential for transformative therapies to reach patients faster, improve survival rates and reduce treatment gaps. With ongoing innovation and a growing pipeline of advanced therapies, the global oncology sector is poised to deliver sustained impact, bringing new hope to patients and reinforcing the importance of strategic investment in cancer research and development.

For more information, visit Oncotelic Therapeutics Inc.

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