Nanomedicine Breakthrough Technology Redefining Drug Delivery, Bioavailability in Oncology

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NEW YORK, Oct. 27, 2025

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(NYSE: PFE)profileOncotelic Therapeutics Inc.'sIO Biotech Inc.Novartis AGBicara Therapeutics Inc.Pfizer Inc.NEW YORKOct. 27, 2025

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The Global Shift Toward Smarter Drug Delivery

The pharmaceutical industry is entering an inflection point driven by therecognition

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, israpidly becoming the leading solution surpass $500 billion by 2032

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

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 nowadvanced into first-in-human clinical trials

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.Sapu-003

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.

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.presented detailed resultsIO Biotech Inc.

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.presentedNovartis AG

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.announcedBicara Therapeutics Inc.

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.announcedPfizer Inc.

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, visitOncotelic Therapeutics Inc.

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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.