On December 2, 2025 Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) ("Tiziana" or the "Company"), a biotechnology company developing breakthrough immunomodulation therapies reported that that it intends to develop its fully human anti-IL-6 receptor (IL-6R) monoclonal antibody, TZLS-501, and related assets (together "TZLS-501") via a spinout into a separate publicly traded company, to enhance the strategic focus of each company and to drive value for shareholders. Tiziana shareholders at the record date will retain value from TZLS-501 through the distribution in specie of shares in the new TZLS-501 listed entity.

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The Company recently announced that it would advance development of TZLS-501, a dual-action IL-6R monoclonal antibody targeting both membrane-bound and soluble forms of IL-6R. This decision was based in part on heightened industry interest in the IL-6 pathway—underscored by Novartis’ recent $1.4 billion acquisition of Tourmaline Bio for its IL-6 inhibitor pacibekitug. The Company considers TZLS-501 as having the potential to be a standalone business. Accordingly, the Company intends to proceed with steps for a publicly listed immunology-focused spin-out company, centered on the IL-6 market. The record date for this proposed transaction will be announced in the coming weeks and the transaction will formally be put to shareholders of Tiziana for approval. TZLS-501 will remain an asset of Tiziana Life Sciences until such time as shareholders formally approve proposals for the spin-out entity.

Ivor Elrifi, Chief Executive Officer of Tiziana Life Sciences, commented: "The recent Novartis acquisition of Tourmaline Bio for $1.4 billion highlights the tremendous value and strategic importance of IL-6 pathway therapeutics in addressing systemic inflammation and related diseases. Building on our September announcement to advance TZLS-501, we believe now is the ideal time to position this promising asset as a standalone entity. TZLS-501’s unique dual mechanism—blocking IL-6R signaling while reducing circulating IL-6 cytokines—offers significant potential as a monotherapy or in combination with other agents. This spin-out will unlock dedicated resources for its development, while allowing us to maintain focus on intranasal foralumab as our lead program."

There can be no certainty that the transaction will proceed and any listing will be subject to meeting the required listing criteria.

About TZLS-501

TZLS-501, a fully human mAb, was licensed from Novimmune, SA, (Geneva, CH) in 2017. IL-6 is a cytokine that binds to its receptor subunit IL-6Rα on the cell membrane, and is a major determinant in priming of pathogenic T cells to produce an inflammatory response. The receptor IL-6Rα can be shed in soluble form, sIL6Rα, which binds to circulating IL-6 cytokine in the blood. The downstream signaling from this complex mediates pro-inflammatory effects underlying inflammatory diseases. TZLS-501 acts via a dual mechanism by inhibiting IL-6R signaling and depleting circulating levels of IL-6.

On December 2, 2025 CorriXR Therapeutics, an oncology-focused biotherapeutics company pioneering a ground-breaking gene editing platform technology, InhaTarget Therapeutics, a company dedicated to the early development and clinical validation of innovative treatments of pulmonary diseases by inhalation, and Merxin Ltd, a designer and supplier of inhaler devices, reported to have entered a strategic collaboration to develop a pioneering inhaled genetic therapy targeting lung cancer.

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The partnership draws upon CorriXR’s proprietary CRISPR-based gene editing platform targeting NRF2, InhaTarget’s proprietary formulation platform and strong experience in pulmonary drug development, and Merxin Ltd’s advanced inhalation device technology. Through their combined expertise, they aim to create a patient-friendly inhaled therapy that delivers targeted treatment directly to lung tumors, maximizing efficacy, minimizing systemic side effects, and offering new hope for patients facing one of the world’s deadliest cancers.

Innovative Therapeutic Approach

CorriXR’s patented non-viral gene editing platform disables the transcription factor NRF2, a master regulator of cellular stress responses and known driver of tumor treatment resistance. As reported in a recent paper published in Molecular Therapy Oncology, preclinical data in lung cancer models have demonstrated that disabling NRF2 can meaningfully resensitize tumor response to chemotherapy with minimal off-target effects.

The collaboration seeks to demonstrate effective delivery of the CorriXR compound via InhaTarget’s proprietary lipid-nanoparticle (LNP) formulation platform, which enables encapsulation of active ingredients for inhalation delivery. Merxin Ltd will contribute their customized and patented inhaler device technology for drug delivery to the lungs. Initial studies will be conducted in cell culture and in a lung carcinoma mouse model, with results expected in mid-2026.

Addressing Unmet Medical Needs

Lung cancer continues to be one of the leading causes of cancer-related deaths globally. The study will focus on treatment of squamous cell lung carcinoma (LUSC), a common and aggressive form of non-small cell lung cancer (NSCLC) that comprises 25 – 30% of worldwide cases. With over 380,000 new cases of LUSC diagnosed globally each year and a five-year survival rate below 15%, the need for new therapies is urgent. Chemotherapy plus immunotherapy (IO) or IO alone is the current standard for first-line treatment of LUSC but still typically results in progression after 8 months or less. Many patients develop treatment resistance, leaving limited options beyond dose escalation, which increases toxicity and intolerance and typically worsens quality of life.

Leadership Perspectives

Dr. Eric B. Kmiec, founder and CEO of CorriXR Therapeutics, stated, "This partnership represents a significant step forward in our mission to harness the power of CRISPR-based gene editing for the benefit of patients with cancer by slowing the growth of solid tumors and improving effectiveness of existing treatments. We are excited by the potential of this collaboration to target lung cancer using a non-invasive inhaled delivery approach, which would greatly improve the quality of life for patients."

Dr. Frédéric De Coninck, co-founder and CEO of InhaTarget Therapeutics, commented, "Combining our pulmonary drug delivery LNP platform with CorriXR’s groundbreaking science and Merxin’s device technology has the potential to reshape the landscape of lung cancer treatment. We are eager to advance work on this novel combination."

Dr. Philippe Rogueda, CBO and founder of Merxin Ltd., remarked, "Our advanced inhaler technology is designed to ensure non-invasive, precise, consistent delivery of novel therapeutics. We are excited to contribute to this vital effort and help bring innovative solutions to patients with lung cancer."

(Press release, CorriXR Therapeutics, DEC 2, 2025, View Source [SID1234661073])

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])