Oncotelic and Sapu Nano Unveils Broad-Applicability Deciparticle™ Nanomedicine Platform Capable of Formulating Multiple Hydrophobic Peptide, Macrolide, and Polyketide Drugs
Rhea-AI Summary
Oncotelic (OTLC)-owned joint venture Sapu Nano announced Dec 2, 2025 that its proprietary Deciparticle™ platform reproducibly formulates structurally diverse hydrophobic therapeutics into precise sub-20 nm nanoparticles suitable for IV delivery.
Key findings presented at SABCS 2025: monodisperse ~15 nm Deciparticles encapsulate five macrolide mTOR inhibitors (sirolimus, temsirolimus, ridaforolimus, umirolimus, everolimus), ascomycin macrolactam tacrolimus, and peptide drugs (cyclosporine A, exenatide). Pimecrolimus produced particles above the sub-20 nm threshold, defining a steric limit.
Sapu Nano reported an ISO-5 cGMP manufacturing suite supporting one-pot bulk drug manufacturing, sterile filtration, automated fill/finish, lyophilization, tight lot-to-lot particle-size control, and the ability to support multiple INDs annually.
Positive
- Monodisperse nanoparticles at ~15 nm
- Encapsulation of five macrolide mTOR inhibitors
- Formulated hydrophobic cyclic and linear peptides (cyclosporine A, exenatide)
- ISO-5 cGMP facility with sterile filtration and lyophilization
- Capability to support multiple INDs annually
Negative
- Pimecrolimus produced particles above the sub-20 nm threshold
- Presentation reports formulation data but no clinical efficacy readouts
News Market Reaction
On the day this news was published, OTLC declined 4.87%, reflecting a moderate negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
Biotech peers are mostly flat while OTLC is down 0.86%. Among high-affinity names, four trade unchanged and one (HRGN) is down 14.03%, pointing to stock-specific dynamics rather than a coordinated sector move.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Dec 04 | Biomarker framework | Positive | +0.7% | Biomarker signature identified to predict tumor sensitivity to IV Sapu003. |
| Dec 03 | PK preclinical data | Positive | +0.0% | Preclinical PK data showed sharply reduced GI accumulation for IV Sapu003. |
| Dec 02 | Platform capabilities | Positive | -4.9% | Deciparticle™ platform shown to formulate diverse hydrophobic drugs into ~15 nm IV nanoparticles. |
| Nov 25 | JV revaluation | Positive | +6.7% | New independent valuation implied a higher fair value for GMP Bio JV stake. |
| Nov 21 | Valuation spotlight | Positive | -7.4% | Editorial and notice of forthcoming GAAP fair-value remeasurement of GMP Bio stake. |
Recent positive JV, valuation, and platform updates often coincided with flat or negative next-day moves; 3 of the last 5 upbeat releases showed price divergence, suggesting a pattern of investor skepticism or profit-taking around good news.
Over the past few weeks, Oncotelic highlighted JV value and Sapu Nano–related clinical platforms. On Nov 21 and Nov 25, it emphasized independent JV valuation work on its 45% GMP Bio stake, with mixed price reactions. On Dec 2, Sapu Nano’s Deciparticle™ platform was showcased as a versatile sub‑20 nm IV delivery technology. Subsequent Dec 3 and 4 releases added PK and biomarker data for IV Sapu003. Today’s article extends that same Deciparticle™ platform story, reinforcing a cluster of SABCS‑linked news rather than a new directional shift.
Market Pulse Summary
This announcement highlights Sapu Nano’s Deciparticle™ platform as a broadly applicable nanomedicine engine, forming ~15 nm sub‑20 nm IV nanoparticles for macrolides, peptides, and polyketides, backed by an ISO‑5 cGMP facility. Recent news flow around Sapu003 pharmacokinetics and biomarker frameworks shows a coordinated push around SABCS 2025. At the same time, SEC filings disclose no product revenue, net losses and tight liquidity, so investors may watch for future clinical milestones and financing updates alongside platform expansion.
Key Terms
nanomedicine medical
nanoparticle medical
cGMP regulatory
intravenous medical
macrolide medical
polyketides medical
lyophilization technical
Phase 1 regulatory
AI-generated analysis. Not financial advice.
AGOURA HILLS, Calif., Dec. 02, 2025 (GLOBE NEWSWIRE) -- Oncotelic Therapeutics, Inc. (OTCQB: OTLC)
These findings, presented at the 2025 San Antonio Breast Cancer Symposium (SABCS), confirm that the Deciparticle™ technology represents a chemically versatile, cGMP-ready delivery platform with the potential to support an expanding pipeline of oncology and immunology drug products.
Presentation info: PS4-04-21. Deciparticle™ Everolimus (Sapu003): From Cytostasis to Cytotoxicity via a Single mPEG Polymer and Clinic-Ready Manufacturing. Sheng-Hao Min, Kevin Forero, Johnathan Anderson, William Putnam, Can Evizi, Cassidy McCallum, Robert Hoff, Mark Ostrander, and Kwun Ho.
Deciparticle™ Platform Demonstrates Broad Formulation Capability Across Therapeutic Classes
New data from a comprehensive screening effort show that Sapu Nano’s optimized polymer reproducibly forms monodisperse nanoparticles (~15 nm) capable of encapsulating multiple classes of hydrophobic drugs:
Macrolide mTOR Inhibitors
All five clinically relevant macrolide immunosuppressants formed stable Deciparticles™:
- Sirolimus
- Temsirolimus
- Ridaforolimus
- Umirolimus
- Everolimus
Differences in substitution at the C-40/C-42 or C-33 positions did not impair nanoparticle formation, highlighting the platform’s tolerance for structural diversity within the macrolide family.
Ascomycin Macrolactams
- Tacrolimus formed stable sub-20 nm Deciparticles™.
- Pimecrolimus, while encapsulated, produced particle sizes above the Deciparticle™ threshold—defining a steric upper bound for the platform and its suitability for optimized macrolactam design.
Cyclic and Linear Peptides
The Deciparticle™ platform successfully formulated two medically important peptide classes:
- Cyclosporine A (hydrophobic cyclic peptide)
- Exenatide (synthetic linear peptide)
These findings demonstrate the platform’s ability to handle both compact hydrophobic macrocycles and amphipathic linear peptides—an important expansion for peptide-based therapeutic pipelines.
Robust and Scalable cGMP Manufacturing
The platform is supported by Sapu Nano’s ISO-5 cGMP facility capable of:
- One-pot bulk drug manufacturing
- Sterile filtration
- Automated fill/finish
- Lyophilization into a stable, clinic-ready drug product
- High batch reproducibility
- Days to weeks post-reconstitution stability
- Precision particle-size control with tight lot-to-lot consistency
This cGMP infrastructure enables fast, reliable translation from formulation to Phase 1 supply, supporting multiple INDs annually.
“With these new data, the Deciparticle™ platform has emerged as a broad, modular nanomedicine engine capable of formulating multiple classes of hydrophobic drugs that were previously constrained by solubility and delivery barriers,” said Dr. Vuong Trieu, Chief Executive Officer of Sapu Nano. “This platform advances beyond single-asset value to a multi-asset opportunity across oncology, immunology, and peptide therapeutics. Sapu003 is only the beginning.”
About the Deciparticle™ Platform
The Deciparticle™ platform is a proprietary nanotechnology engineered to encapsulate hydrophobic molecules as uniform, sub-20 nm nanoparticles for intravenous administration. The platform improves systemic exposure, reduces GI deposition, and supports precision delivery while maintaining manufacturability at clinical scale.
About Sapu Nano
Sapu Nano is a clinical-stage biotechnology company developing Deciparticle™ nanomedicine therapeutics designed to optimize the delivery of hydrophobic oncology agents and peptide-based therapeutics. The company operates an integrated ISO-5 cGMP manufacturing facility supporting rapid progression from formulation to clinical trial supply.
For more information, visit www.sapunano.com.
About Oncotelic
Oncotelic (f/k/a Mateon Therapeutics, Inc.), was formed in the State of New York in 1988 as OXiGENE, Inc., was reincorporated in the State of Delaware in 1992, and changed its name to Mateon Therapeutics, Inc. in 2016, and Oncotelic Therapeutics, Inc. in November 2020. Oncotelic is seeking to leverage its deep expertise in oncology drug development to improve treatment outcomes and survival of cancer patients with a special emphasis on rare pediatric cancers. Oncotelic has rare pediatric designation for Diffuse Intrinsic Pontine Glioma “DIPG” (through OT-101) through its
Oncotelic acquired AL-101, during the 4th quarter of 2021, for the intranasal delivery of apomorphine. We intend to develop AL-101 for the treatment of Parkinson Disease ("PD"). Over 60,000 new patients are being diagnosed with PD in the United States and currently there are over 1 million patients in the US and expected to increase to over 1.2 million by 2030. In addition, approximately 10 million suffer from this disease globally. https://www.parkinson.org/Understanding-Parkinsons/Statistics. AL-101 is also being developed for Erectile Dysfunction ("ED"). ED is the most prevalent male sexual disorder globally. The percentages of men affected by ED are as follows: 14.3
Oncotelic's Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934 (the “Exchange Act”) that involve substantial risks and uncertainties. We generally identify forward-looking statements by terminology such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “would,” “intend,” “target,” “aim,” “project,” “believe,” “estimate,” “predict,” “potential,” “seek,” “indicate,” or “continue” or the negative of these terms or other similar words, although not all forward-looking statements contain these words. Forward-looking statements include, but are not limited to, statements regarding our or our management’s expectations, hopes, beliefs, intentions or strategies regarding the future, such as our estimates regarding anticipated operating income or losses, future performance, future revenues and projected expense, including that to fund our clinical and other development programs; our liquidity and our expectations regarding our needs for and ability to raise additional capital; our ability to continue as a going concern; our ability to select and capitalize on commercially desirable product opportunities as a result of limited financial resources; our ability to manage our expenses effectively and raise the funds needed to continue our business; our ability to retain the services of our current or future executive officers, directors and principal consultants; the competitive nature of our industry and the possibility that our products or product candidates may become obsolete or may not generate revenues as expected or at all; our ability to obtain and maintain regulatory approval of our existing products and any future products we may develop; the development of and the process of commercializing AI/Blockchain and other technologies for supporting the development of OT- 101 and Artemisinin for COVID-19, OT-101, including development of OT-101, Artemisinin, OXi4503, CA4P and our 2021 in-licensing of apomorphine; the initiation, timing, progress and results of our preclinical and clinical trials, research and development programs; regulatory and legislative developments in the United States and foreign countries; the timing, costs and other limitations involved in obtaining regulatory approval for any product; the further preclinical or clinical development and commercialization of our product candidates; the entering into any corporate transactions to develop our products through partnerships, joint ventures or other corporate transactions; our ability to make a proposed initial public offering between us and our joint-venture partners for the joint venture, statements about future plans related to the operations of the JV, taking the JV into an initial public offering or the success thereof: building and the success of our nanoparticle platform and the related success of launching the platform; the expected valuation of the JV, and therefore a corresponding increase in the valuation of the Company, by virtue of it’s ownership in the JV; the success of the launch of Pet2DAO, a corporation with a DAO infrastructure, the success of Pet2DAO and the plans surrounding the pet and animal health, the ability for the Company to register the tokens of Pet2DAO, the actual filing of a registration statement and approval of the tokens as registrable securities with the Securities and Exchange Commission (“SEC”) through a registration statement, the ability of the tokens to be tradable or any value such tokens may have if they become tradable; our ability to obtain and maintain orphan drug exclusivity for some of our product candidates; the potential benefits of our product candidates over other therapies; our ability to enter into and maintain any collaboration with respect to product candidates; our ability to continue to develop or commercialize our products or product candidates in the event any license agreements in place with third parties expire or are terminated; the performance and conduct of third parties, including our third-party manufacturers and third party service providers used in our clinical trials; our ability to obtain and maintain intellectual property protection for our products and operate our business without infringing upon the intellectual property rights of others; the potential liability exposure related to our products and our insurance coverage for such exposure; our ability to form alliances with other third parties to develop the products in our pipeline through partnerships, joint ventures, mergers or acquisitions; the successful development of our sales and marketing capabilities; the size and growth of the potential markets for our products and our ability to serve those markets; the rate and degree of market acceptance of any future products; the volatility of the price of our common stock; the ability to achieve secondary trading of our stock in certain states; the dilutive effects of potential future equity issuances; our expectation that no dividends will be declared on our common stock in the foreseeable future; our ability to maintain an effective system of internal controls; the payment and reimbursement methods used by private or governmental third-party payers; our ability to retain adequate staffing levels; unfavorable global economic conditions; unfavorable global epidemic and pandemic conditions; a failure of our internal computer systems or those of our contractors and consultants; potential misconduct or other improper activities by our employees, contractors or consultants; the ability of our business continuity and disaster recovery plans to protect us in the event of a natural disaster; and other factors discussed elsewhere in this document or any document incorporated by reference herein or therein.
Contact Information:
For Oncotelic Therapeutics, Inc.:
Investor Relations
ir@oncotelic.com
FAQ
What did Sapu Nano announce on December 2, 2025 about the Deciparticle™ platform (OTLC)?
Which macrolide mTOR inhibitors did Deciparticle™ successfully encapsulate for OTLC?
Does the Deciparticle™ platform support cGMP manufacturing and IND supply for OTLC-related programs?
Are there any formulation limits reported for Deciparticle™ (OTLC)?
What therapeutic classes can Deciparticle™ handle according to the December 2, 2025 announcement?
