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NEW YORK, Oct. 27, 2025 /CNW/ -- 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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USA News Group News Commentary –

Issued on behalf of GT Biopharma, Inc.

VANCOUVER, BC, Oct. 15, 2025 /PRNewswire/ -- USA News Group News Commentary – Biomarker-driven drug development is accelerating across oncology as companies advance novel mechanisms targeting previously difficult-to-treat patient populations. The cancer immunotherapy market reached $226 billion in 2024 and continues expanding rapidly, driven by precision approaches that pair targeted agents with immunotherapy, identify genetic vulnerabilities, and deploy radioligand therapies for metastatic disease^[1]. Recent clinical data demonstrating high response rates in biomarker-selected populations underscore the shift toward molecularly defined patient subgroups, while FDA priority reviews and breakthrough designations are compressing development timelines for innovative platforms. This convergence of scientific innovation and regulatory momentum positions companies advancing differentiated mechanisms across multiple tumor types for significant value creation, including GT Biopharma, Inc. (NASDAQ: GTBP), IDEAYA Biosciences, Inc. (NASDAQ: IDYA), Zymeworks Inc. (NASDAQ: ZYME), Novartis AG (NYSE: NVS), and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN).

The industry's focus on combination strategies and novel targets is yielding promising clinical results, with antibody-drug conjugates, metabolic inhibitors, and immune-activating platforms demonstrating enhanced efficacy when paired with complementary mechanisms^[2]. Major pharmaceutical companies are investing heavily in radioligand therapy and precision medicine infrastructure, while emerging biotech firms leverage genetic screening to identify patient populations most likely to benefit from targeted interventions. These dynamics create compelling opportunities for companies with diversified pipelines addressing both common and rare cancers through validated biological mechanisms, particularly those approaching key clinical readouts and regulatory milestones in high-value indications.

GT Biopharma, Inc. (NASDAQ: GTBP) is a clinical-stage immunotherapy company making significant progress in its fight against difficult-to-treat cancers. The San Francisco-based biotech has been advancing its lead drug candidate, GTB-3650, through a Phase 1 clinical trial targeting blood cancers that have stopped responding to other treatments. In August, the company successfully moved into Cohort 3 after formal safety reviews of the first two patient groups showed no safety or tolerability problems. The trial had treated five patients by mid-August, with encouraging early signals of immune system activation.

"We are pleased with the enrollment momentum in our Phase 1 clinical trial evaluating GTB-3650 in cancer patients, which continues to advance on schedule," said Michael Breen, Executive Chairman and Chief Executive Officer of GT Biopharma. "Moving into the third dose cohort after a successful safety review and encouraging early evidence of immunological activity, mark important steps forward in the development of GTB-3650. We look forward to sharing more data later this year to reinforce the ability of our TriKE constructs to activate endogenous NK cells, and the potential for broader utility with other targets to treat solid tumors (GTB-5550) and autoimmune indications (GTB-7550)."

The Phase 1 trial is testing GTB-3650 in patients with relapsed or refractory CD33-expressing blood cancers, including acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS). These are patients whose cancers have come back or never responded to standard therapies. The drug works by activating the body's own natural killer cells to attack cancer cells. Patients receive the treatment through continuous infusions in two-week cycles, alternating two weeks on and two weeks off, for up to four months based on how well they're responding.

What makes the early data particularly interesting is the biomarker evidence. Multiple blood tests from the first four patients showed measurable increases in natural killer cell activity and expansion. This suggests the drug is doing exactly what it was designed to do—wake up the immune system and direct it against cancer. GT Biopharma expects to release more detailed Phase 1 results later this year after completing additional dose cohorts.

Beyond blood cancers, GT Biopharma has a second drug candidate moving toward the clinic. GTB-5550 targets a protein called B7H3 that appears in many different types of solid tumors, including breast, lung, ovarian, head and neck, pancreatic, bladder, and prostate cancers. The company expects to submit its application to start human testing of GTB-5550 during the fourth quarter of this year. Unlike many cancer immunotherapies that require lengthy hospital infusions, GTB-5550 is being developed as a simple injection that patients could potentially give themselves at home, similar to insulin shots.

Both drug candidates are built on GT Biopharma's proprietary TriKE platform, which uses specialized antibody fragments originally discovered in camels and llamas. These molecules are smaller and more stable than traditional antibodies, allowing them to work more effectively. GT Biopharma holds an exclusive worldwide license from the University of Minnesota to develop and commercialize therapies using this technology.

As of June 30, 2025, GT Biopharmareported cash and cash equivalents of approximately $5.3 million, which management expected would fund operations into the first quarter of 2026.

CONTINUED… Read this and more news for GT Biopharma, Inc. at:   https://usanewsgroup.com/2025/10/03/the-small-biotech-thats-cracking-the-code-big-pharma-paid-billions-for/

IDEAYA Biosciences, Inc. (NASDAQ: IDYA) has reported positive Phase 1/2 data for its combination of IDE397, a potential first-in-class MAT2A inhibitor, with Gilead's Trodelvy® in MTAP-deletion urothelial cancer, achieving an overall response rate of 57% at the higher dose level. The trial enrolled patients with late-line MTAP-deletion urothelial cancer, where MTAP-deletion is estimated to occur in approximately 25-30% of urothelial cancer patients, with 68% of participants having progressed after two or more prior therapies.

"We are pleased with the progress we are making with the Trodelvy and IDE397 combination and are encouraged by the early response rate data we are seeing in previously treated MTAP-deleted urothelial cancer," said Darrin Beaupre, Chief Medical Officer of IDEAYA Biosciences. "These results set the stage for further testing of the combination in non-small cell lung cancer, where we have just dosed the first patient in our clinical trial."

The combination demonstrated a manageable safety profile consistent with known adverse events of both drugs as single agents, with no treatment-related serious adverse events observed at the recommended expansion dose. IDEAYA is targeting selection of the recommended Phase 2 dose by end of 2025, with the next update planned for a medical conference in the first half of 2026.

Zymeworks Inc. (NASDAQ: ZYME) will present preliminary Phase 1 data for ZW191, an antibody-drug conjugate targeting folate receptor-α, at the AACR-NCI-EORTC Conference on October 22-26, 2025. ZW191 is engineered to target a protein found in approximately 75% of high-grade serous ovarian carcinomas and 70% of lung adenocarcinomas, utilizing Zymeworks' proprietary bystander active topoisomerase-1 inhibitor payload, ZD06519.

"We are excited to share early clinical data from Part 1 of our first-in-human, Phase 1 trial of ZW191 in patients with advanced solid tumors," said Sabeen Mekan, M.D., Senior Vice President of Clinical Development of Zymeworks. "These initial results reinforce our confidence in our novel ADC design and its potential to deliver improved treatments for broader patient populations."

The company will host a live webcast on October 23, 2025 at 3:30 pm ET to discuss the data with lead author Patricia LoRusso and senior management. Zymeworks is rapidly advancing a robust pipeline of wholly-owned product candidates, with ZW251 expected to enter clinical trials in 2025.

Novartis AG (NYSE: NVS) will present new data from 34 abstracts across its oncology portfolio at the European Society for Medical Oncology Congress 2025 in Berlin from October 17-21, 2025. Key data from the PSMAddition trial has been selected for a Presidential session, showcasing the efficacy and safety of Pluvicto plus standard of care versus standard of care alone in PSMA-positive metastatic hormone-sensitive prostate cancer, while the NATALEE five-year analysis will provide further long-term insights into Kisqali's risk of recurrence reduction in early breast cancer.

"We look forward to sharing new clinical data that underscores how we are reimagining treatment for breast and prostate cancer, advancing highly effective therapies designed to improve quality of life, enable more personalized care and ultimately provide more time for cancer patients," said Dushen Chetty, Ph.D., Global Head of Oncology Development, Novartis, Ad Interim. "Our ambition is to set new standards of care in some of the most prevalent cancers by pioneering novel technologies like radioligand therapy."

The oncology strategy of Novartis focuses on people living with cancer and their caregivers, with approximately 35 research and development projects across solid tumors, hematology and radioligand therapy. The company is committed to using technology, leading science and patient-centered research to deliver pioneering cancer care for all those in need.

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced that the U.S. FDA has approved Libtayo® (cemiplimab-rwlc) as the first and only immunotherapy for adjuvant treatment of adult patients with cutaneous squamous cell carcinoma at high risk of recurrence after surgery and radiation. The approval, granted under Priority Review, is based on the pivotal Phase 3 C-POST trial showing Libtayo significantly reduced the risk of disease recurrence or death by 68% compared to placebo (hazard ratio: 0.32; 95% confidence interval: 0.20-0.51; p<0.0001), with results published in the New England Journal of Medicine and presented at ASCO 2025.

"This approval provides patients with CSCC at high risk of disease recurrence following surgery and radiation a much-needed option, as Libtayo is the only immunotherapy to demonstrate efficacy in this setting," said George D. Yancopoulos, M.D., Ph.D., Board co-Chair, President and Chief Scientific Officer of Regeneron. "Now with five FDA-approved indications, Libtayo is firmly established as a strong and versatile PD-1 inhibitor option for patients with a variety of cancers."

An additional regulatory application is under review in the European Union, with a decision expected by the first half of 2026. Regeneron has launched Libtayo Surround™, offering financial and educational resources to help support patients throughout their treatment journey, with cutaneous squamous cell carcinoma being one of the most common skin cancers with an estimated 1.8 million cases diagnosed annually in the U.S.

Article Sources: https://usanewsgroup.com/2025/10/03/the-small-biotech-thats-cracking-the-code-big-pharma-paid-billions-for/ 

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SOURCES:

1. https://www.grandviewresearch.com/industry-analysis/cancer-immunotherapy-market  
2. https://www.labiotech.eu/in-depth/oncology-trends-2025/

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