On December 2, 2025 Oncotelic Therapeutics, Inc. (OTCQB: OTLC) 45% owned Joint Venture, Sapu Nano, a clinical-stage nanomedicine company, reported new data demonstrating that its proprietary Deciparticle platform enables broad and consistent formulation of structurally diverse hydrophobic therapeutics-including macrolide mTOR inhibitors, cyclic peptides, linear peptides, ascomycin macrolactams, and polyketides-while maintaining a precise sub-20 nm nanoparticle profile suitable for intravenous (IV) delivery.

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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.

(Press release, Oncotelic, DEC 2, 2025, View Source [SID1234661057])

On December 2, 2025 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, reported it will be presenting positive Phase 2 survival, and Phase 3 biomarker data across three clinical posters at the 2025 San Antonio Breast Cancer Symposium (SABCS ) taking place December 9-12, 2025 at Henry B. Gonzalez Convention Center, 900 E. Market Street, San Antonio, Texas.

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"Our survival and biomarker data at SABCS is very encouraging because it underscores the potential of our novel immunotherapy and precision medicine to treat cancer patients," stated William V. Williams, MD, BriaCell’s President & CEO. "We remain committed to improve survival and clinical outcomes in cancer patients whose medical needs remain unmet."

"We are extremely pleased with biomarker and patient subgroup data suggesting their use for identifying patients who are most likely to benefit from our treatment," stated Dr. Giuseppe Del Priore, BriaCell’s Chief Medical Officer.

The details of the poster presentations are listed below.

Late-Breaking Abstract Number: 3688
Presentation Number: PS1-13-22
Presentation Title: Impact of Prior Therapy, Genotype Matching, and Biomarkers in the Bria-ABC Phase 3 Trial
Poster Presentation Date/Time: Wednesday, December 10, 2025, 12:30 PM – 2:00 PM

A pooled interim analysis of 116 patients with available MHC subtyping in the ongoing pivotal phase III study demonstrated an excellent safety profile, improved progression-free-survival (PFS) n HR+/HER-2 and HER2- low subtypes and potential use of Neutrophil to Lymphocyte Ratio (NLR) as a biomarker of clinical benefit,

Late-Breaking Abstract Number: 3713
Presentation Number: PS1-13-23
Presentation Title: Survival Results of Phase II Bria-IMT Allogenic Whole Cell-Based Cancer Vaccine
Poster Presentation Date/Time: Wednesday, December 10, 2025, 12:30 PM – 2:00 PM

Maturing data analysis of the of the Phase 1/2 study evaluating the Bria-IMT regimen in combination with an anti–PD-1 checkpoint inhibitor (CPI) in 54 metastatic breast cancer demonstrated continued overall survival benefit with potential use of delayed type hypersensitivity (DTH) as a biomarker predictive of clinical benefit.

Abstract Number: 1614
Presentation Number: PS2-09-03
Presentation Title: Th1-biased cytokine signatures as biomarkers of clinical benefit following SV-BR-1-GM cancer vaccination in breast cancer.
Poster Presentation Date/Time: Wednesday, December 10, 2025, 5:00 PM – 6:30 PM

Analysis of 35 different blood cytokines/chemokines from 30 patients enrolled in the Phase 1/2 studies of Bria-IMT alone or in combination with an immune checkpoint inhibitor (CPI) suggests that Th1 biased cytokines and chemokines may serve as potential predictive biomarkers of clinical responses to the Bria-IMT regimen in metastatic breast cancer

Copies of the posters will be made available at View Source

(Press release, BriaCell Therapeutics, DEC 2, 2025, View Source [SID1234661340])

On December 2, 2025 Alpha Tau Medical Ltd. (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported that the FDA has approved an Investigational Device Exemption (IDE) application to initiate a pilot study for the treatment of patients with locally recurrent prostate cancer using the Company’s Alpha DaRT technology.

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"We are excited to bring the Alpha DaRT technology to prostate cancer patients in the U.S.," said Dr. Robert B. Den, Alpha Tau Chief Medical Officer. "According to the National Cancer Institute, over 300,000 new cases of prostate cancer will be diagnosed in 2025, and clinical literature indicates that up to 15% of patients treated with external beam radiation therapy can develop local recurrence within 15 years of treatment. We look forward to exploring Alpha DaRT as a new local salvage therapy for patients with recurrent prostate cancer, as an alternative to systemic androgen deprivation therapy."

The clinical trial is expected to enroll up to 12 U.S. patients with locally recurrent prostate cancer who have demonstrated biochemical recurrence by the Phoenix definition (a rise of PSA levels by 2 ng/mL from the PSA nadir). The primary objective of the study is to evaluate the safety of the treatment, following the Company’s promising results from clinical study treatments in Israel, and the secondary objective of the study is to evaluate the efficacy of Alpha DaRT as assessed by biochemical and clinical evaluation of disease progression as well as overall survival.

"With this IDE approval, our fifth in the U.S. currently active, Alpha Tau continues to broaden its reach in the U.S. across a range of tumor types. We have repeatedly heard the demand from clinicians and patients who want a new, focused alpha-radiation based local salvage therapy for prostate cancer, and are eager to explore the benefits that Alpha DaRT may bring to recurrent prostate cancer patients, who currently face a number of poor available alternatives," added Alpha Tau Chief Executive Officer Uzi Sofer.

About Alpha DaRT

Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by intratumoral delivery of radium-224 impregnated sources. When the radium decays, its short-lived daughters are released from the sources and disperse while emitting high-energy alpha particles with the goal of destroying the tumor. Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT aims to mainly affect the tumor, and to spare the healthy tissue around it.

(Press release, Alpha Tau Medical, DEC 2, 2025, View Source [SID1234661040])

On December 2, 2025 Amplia Therapeutics Limited (ASX:ATX; OTCQB:INNMF), ("Amplia" or the "Company"), reported that it has received formal notification from the US Patent and Trademark Office (USPTO) that a key patent titled A salt and crystal form of a FAK Inhibitor has been granted.The Certificate of Grant follows on from the notification of allowance of the patent from the USPTO received in September.

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This key patent protects the specific form of narmafotinib being developed clinically by the Company. The patent has already been granted in various important jurisdictions including Europe, Japan, India, Korea and Australia. Granting of this patent extends protection of narmafotinib out to a least 2040 in these jurisdictions. Protection in other regions is under review by the respective patent offices.

Amplia CEO Dr Chris Burns says: "With the granting of this patent in the US and other key pharmaceutical markets, we are strengthening narmafotinib’s patent portfolio to protect and maximise the Company’s intellectual property for the long term."

(Press release, Amplia Therapeutics, DEC 2, 2025, View Source [SID1234661058])

On December 2, 2025 Aurigene Oncology Limited, a clinical-stage biopharmaceutical company developing novel therapies in oncology, reported initial clinical results from 1st two cohorts of its ongoing Phase 1 clinical trial evaluating AUR112 in patients with relapsed or refractory lymphoid malignancies. Early findings show that AUR112 is safe, well tolerated, demonstrating meaningful clinical activity, with objective responses observed across multiple lymphoma subtypes, including Mantle Cell Lymphoma (MCL) and Marginal Zone Lymphoma (MZL).

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"We are very encouraged by the early results of the first two cohorts from our Phase 1 study of AUR112," said Dr. Murali Ramachandra, CEO. "AUR112 has shown a promising initial clinical profile, achieving an overall response rate of 63.6% in the efficacy-evaluable population and 58.3% in the intent-to-treat group. These strong early data, combined with its distinct preclinical and safety characteristics, reinforce our belief that AUR112 has the potential to become a best-in-class MALT1 inhibitor."

Study Design and Key Findings

The company is currently conducting a Phase 1 dose-escalation study evaluating AUR112 monotherapy in patients with relapsed/refractory lymphoid malignancies. Primary objectives include characterizing safety and identifying dose-limiting toxicities and secondary objectives include pharmacokinetics, pharmacodynamics, objective response rate, duration of response, and disease control rate.

As of the November 21, 2025 cutoff, 13 patients were evaluable for safety and 11 patients were evaluable for efficacy across three dose cohorts (100 mg, 200 mg, and 400 mg).

Safety: AUR112 was generally well tolerated. While 84.6% of patients experienced Treatment Emergent Adverse Events (TEAEs), only 14 events in 7 patients were treatment-related. No Grade 3 or higher hyperbilirubinemia was observed, and bilirubin elevations resolved even with continued treatment. One dose-limiting toxicity (DLT) (Grade 3 neutropenia) and two DLT-equivalent events were reported.
Pharmacokinetics/Pharmacodynamics: Drug exposure at 200 mg appears to be in the efficacious range, however further results are awaited. Pharmacodynamic data demonstrated rapid and sustained IL-2 inhibition, with all evaluated patients showing IL-2 levels below the limit of quantification by Cycle 1 Day 15.
Efficacy: Among 11 efficacy-evaluable patients (all in 1st two cohorts), the overall response rate was 63.6%, including six partial responses and one complete response. Responses were observed in MCL, MZL, Hodgkin Lymphoma (HL), and Diffuse Large B-Cell Lymphoma (DLBCL).
Based on these encouraging results, the initiation of dose-expansion cohorts in select lymphoid malignancies, including Chronic Lymphocytic Leukemia (CLL), Waldenström’s Macroglobulinemia, MCL, and MZL are being planned.

About AUR112

AUR112 is an oral investigational MALT1 inhibitor designed to target a pivotal signaling node in the NF-κB pathway. Through highly potent and selective inhibition of MALT1, AUR112 aims to disrupt survival mechanisms that drive B-cell malignancies. In preclinical studies, AUR112 exhibited significant monotherapy activity and demonstrated a favorable safety profile.

(Press release, Aurigene Discovery Technologies, DEC 2, 2025, View Source [SID1234661041])