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Artelo Biosciences Secures Notice of Allowance in Japan for Patent Claims for the Intended Commercial Formulation of ART27.13

On August 20, 2026 Artelo Biosciences, Inc. (Nasdaq: ARTL) ("Artelo" or the "Company"), a clinical-stage pharmaceutical company focused on modulating lipid-signalling pathways to develop treatments for people living with cancer, pain, dermatologic, or neurological conditions, reported that the Japanese Patent Office has issued a notification of allowance with a Decision to Grant for the Company’s patent application covering the intended commercial formulation of ART27.13, Artelo’s peripherally selective dual cannabinoid agonist currently being evaluated in two Phase 2 clinical trials.

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The allowed claims in Japan protect compositions of ART27.13 dispersed in polyethylene glycol. These claims are consistent with those previously allowed in the United States and Europe, and all jurisdictions are expected to provide patent protection through 2041. This brings Artelo’s intellectual property estate for ART27.13 to issued or allowance status in three major pharmaceutical markets, the United States, Japan, and Europe, and further strengthens the program’s global IP position while supporting its long-term commercial potential.

"Receiving this allowance decision in Japan represents another important advancement in our global intellectual property and clinical development strategy for ART27.13," said Gregory D. Gorgas, President and Chief Executive Officer of Artelo Biosciences. "The innovator of our investigational drug, AstraZeneca, previously conducted a Phase 1 safety study with ART27.13 in Japan, with no major safety or tolerability concerns, and had concluded the plasma exposure and adverse event profiles were comparable between Japanese and Caucasian participants." ART27.13 was fully licensed to Artelo in 2019.

Currently being evaluated in the Phase 2 portion of CAReS targeting cancer-related anorexia, ART27.13 was well-tolerated in the Phase 1 stage and showed early signs of stabilizing or reversing weight loss in more than 60% of participants. Interim results from the CAReS Phase 2 demonstrated the ability of the drug to reverse cancer-related anorexia in all patients taking the highest dose of 1300 µg whereas the all the participants on placebo continued to lose weight throughout the study.

ART27.13 is also being evaluated in the DREAM study, a pilot Phase 2 in people with glaucoma or ocular hypertension. Funded by Glaucoma UK and the HSC R&D Division in the UK, the investigator-led study is evaluating ART27.13’s potential at a 600 µg orally administered daily dose to reduce intraocular pressure, alongside additional assessments of visual acuity, body weight, mood, safety and tolerability. Initial results are anticipated in the fourth quarter of this year.

"With allowances now secured in the United States, Europe and Japan for claims covering our intended commercial formulation, we believe we have established a strong foundation for ART27.13 across three of the world’s major pharmaceutical markets. This growing patent estate further enhances the strategic and commercial value of the program as ART27.13 advances in multiple potential indications," concluded Mr. Gorgas.

About ART27.13
ART27.13 is a dual cannabinoid agonist and novel benzimidazole derivative. Initially developed by AstraZeneca plc, ART27.13 has been in over seven clinical studies with nearly 300 participants. It is primarily being developed as a once-daily, orally administered agent selectively targeting peripheral CB1 and CB2 receptors, with the potential to reduce muscle degeneration while improving body weight, appetite, and quality of life in cancer patients. Importantly, the drug enables systemic metabolic effects while minimizing central nervous system-mediated toxicity. Artelo is conducting a Phase 2 named the Cancer Appetite Recovery Study (CAReS) evaluating ART27.13 as a supportive care therapy for cancer patients suffering from anorexia and weight loss. Interim Phase 2 data revealed patients who had lost at least 5% of body weight to be included in CAReS and titrated to the highest ART27.13 dose (1300 µg) achieved an average +6% weight gain over 12 weeks, while patients on placebo lost an additional ~5%. Currently, there is no FDA approved treatment for cancer anorexia cachexia syndrome. In addition to CAReS, ART27.13 is also being evaluated in a Phase 2 study in people with glaucoma, called the DREAM study. In DREAM, ART27.13 is administered orally at a daily dose of 600 µg.

(Press release, Artelo Biosciences, AUG 20, 2026, View Source [SID1234670265])

RenovoRx Receives Notice of Allowance for New U.S. Patent Covering RenovoCath®, an Advanced Dual-Occlusion Catheter, for Targeted Therapeutic Drug-Delivery for Cancer Treatment

On August 20, 2026 RenovoRx, Inc. ("RenovoRx" or "the Company") (Nasdaq: RNXT), a life-sciences company developing innovative targeted oncology therapies and commercializing RenovoCath, a patented, FDA-cleared drug-delivery device, reported that the U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance for the Company’s patent application (U.S. Application No. 18/184,620) titled "Methods and Apparatuses for Delivery of Therapeutic Materials for the Treatment of Cancer."

Once issued, this patent will strengthen RenovoRx’s growing U.S. intellectual property portfolio, reinforcing the Company’s differentiated approach to targeted, local drug-delivery, and broadening protection for its TAMP (Trans-Arterial Micro-Perfusion) platform and RenovoCath device.

The newly allowed application further strengthens RenovoRx’s expanding intellectual property portfolio and provides additional patent protection for RenovoCath, an advanced dual-occlusion catheter, designed to deliver cancer therapies directly to targeted tumor sites. The technology is intended to improve the precision and effectiveness of localized therapies while reducing systemic exposure and treatment related side effects compared with conventional drug delivery. The claims allowed cover RenovoCath’s proprietary catheter system, which includes a primary catheter, multiple ports, and expandable occlusion balloons that seal a segment of a blood vessel to create a controlled treatment zone. A secondary catheter can be advanced through the primary catheter into a branching vessel, allowing highly selective access to adjacent vasculature. This configuration enables clinicians to guide both catheters with dedicated guidewires and establish precisely controlled fluid pathways for targeted delivery, further reinforcing RenovoCath’s differentiated technology platform and strengthening its competitive position in precision oncology.

"This Notice of Allowance underscores the continued innovation driving our proprietary TAMP platform and further strengthens the intellectual property foundation supporting RenovoCath and our commercialization strategy," said Shaun Bagai, Chief Executive Officer of RenovoRx. "By extending protection, we are enhancing our competitive differentiation, broadening the potential applications of our platform, and reinforcing our long-term innovation strategy."

Mr. Bagai continued, "Our robust and growing intellectual property portfolio is an important asset as we advance our commercialization of RenovoCath as a standalone device and support our ongoing Phase III TIGeR-PaC clinical trial. Each new allowance further validates the innovative mechanism behind our proprietary TAMP platform and its potential to address limitations of both conventional systemic and local therapeutic drug-delivery."

With this allowance, RenovoRx’s global intellectual property portfolio now includes 20 issued or allowed patents, along, with 13 pending patents, directed to its TAMP platform and RenovoCath device. RenovoRx continues to grow and protect this portfolio in support of its commercialization strategy, including potential partnerships and licensing opportunities.

(Press release, Renovorx, AUG 20, 2026, https://www.globenewswire.com/news-release/2026/08/20/3348338/0/en/renovorx-receives-notice-of-allowance-for-new-u-s-patent-covering-renovocath-an-advanced-dual-occlusion-catheter-for-targeted-therapeutic-drug-delivery-for-cancer-treatment.html [SID1234670264])

Data on Anti-4CB1 Published in Molecular Cancer Therapeutics Journal

On August 20, 2026 4C Biomed, a biotechnology company developing novel immunotherapeutic monoclonal antibodies, reported preclinical data set on its lead asset, anti-4CB1, published in the prestigious journal, Molecular Cancer Therapeutics. The paper describes its action as a novel selective HVEM-blocking antibody, which enhances T-cell and macrophage immunity against solid tumors.

The full article is entitled "Anti-4CB1: A Novel Selective HVEM-Blocking Antibody Enhancing T-Cell and Macrophage Immunity Against Solid Tumors" and it can be read HERE.

Checkpoint inhibitors, such as anti-PD1 (Keytruda, Opdivo), have transformed cancer treatment for many subsets of patients with common tumors. However, many cancers do not respond, and of those that do, the majority eventually progress. Treatment options for these patients are limited.

4C Biomed’s article introduces its Anti-4CB1, a fully human monoclonal antibody against HVEM (Herpes Virus Entry Mediator, or TNFRSF14), a novel immune checkpoint which is highly expressed in malignant cancer cells across multiple cancers, including melanoma, renal, ovarian, colorectal, endometrial and hepatocellular carcinoma.

HVEM acts as a brake on the immune system through two inhibitory partner molecules, BTLA and CD160. Anti-4CB1 blocks both of these molecules resulting in a much more powerful immune response than blocking either molecule alone. Anti-4CB1 binds HVEM with high affinity; screened against c.6,000 human membrane proteins, HVEM was the only protein it bound, which is highly significant for predicting side effects down the line.

Key features of the published anti-4CB1 data and details of the study:

Activating higher adaptive and innate immune responses: Anti-4CB1 increased killing of melanoma cells by patients’ own tumor-infiltrating lymphocytes by 48%, the same magnitude as anti-PD1, and raised the markers that indicate T-cell activation. Control experiments confirmed the antibody is not itself toxic to tumor cells; it works by mobilizing the immune system. Combined with anti-PD1, anti-4CB1 increased macrophage-mediated destruction of tumor cells by 168%.
Action in real patient tumors in different cancer types: Using 49 freshly collected patient tumor samples spanning multiple cancer types, Anti-4CB1 boosted tumor-cell killing in 28.5% of cases, compared with 14.3% for anti-PD1 alone. The headline finding was that nine of the responding samples responded to Anti-4CB1 but not to anti-PD1. Activity was strongest in melanoma, colon, ovarian and renal cancers.
Potential as a monotherapy or in combination: In colon cancer and melanoma in vivo models, Anti-4CB1 slowed tumor growth as a monotherapy. When combined with anti-PD1, it achieved 95% tumor growth inhibition. Animals in the combination group were still alive when the study ended – they outlived the anti-PD1-only group by a statistically significant margin (p=0.03); in the combination group 80% were still alive while in the PD1 only group, only 40% remained alive. All treatments were well tolerated, with no weight loss or observed adverse events.
Blood-based HVEM – a possible companion test: Melanoma patients who were treated in the clinic with anti-PD1 and responded, had significantly higher HVEM levels in their tumors before treatment began (p=0.004). Separately, in ex-vivo experiments, samples from patients with high levels of soluble HVEM circulating in their blood were less likely to respond to Anti-4CB1. This data suggest HVEM could be a viable biomarker for identifying which patients are most likely to benefit from the immuno-therapy.
Gilli Galore-Haskel, VP R&D of 4C Biomed and one of the lead authors on the paper, said:

"We are proud to publish this data today in such a prestigious journal. Very few preclinical programs are supported by such a range of data based on this many fresh human tumors samples across this many cancer types. Anti-4CB1 showed activity in patient samples where anti-PD1 was ineffective and also boosted its impact when used in combination. Data confirms that the antibody has a clean safety profile and these data show that it works by mobilizing both strands of the immune system – a powerful double action. Finally, data demonstrate that blood-based HVEM could be a valuable biomarker to assess whether patients will respond to Anti-4CB1 or not; a potential companion test is an increasing must-have feature for next generation immuno-oncology therapeutics.

"Taken together, this preclinical dataset supports advancing our anti-4CB1 programme into the clinic as soon as possible, which is our intention in the new year."

(Press release, 4C Biomed, AUG 20, 2026, View Source [SID1234670263])

Adaptin Bio Announces Opening of Enrollment in a Phase 1 Clinical Trial Evaluating Treatment of Malignant Brain Tumors with APTN-101

On August 20, 2026 Adaptin Bio, Inc. (OTCQB: APTN) ("Adaptin" or the "Company"), a biotechnology company focused on developing precision cancer therapies with improved delivery to the brain and other tissues, reported that enrollment has opened for a Phase 1 clinical trial evaluating its proprietary BRiTE (Brain Bispecific T cell Engager) therapeutic, APTN-101, as a treatment for glioblastoma (GBM), the most common and aggressive primary brain tumor. The BRiTE platform was developed by a distinguished team of researchers at Duke University, the study site for the first-in-human clinical trial.

The Phase 1 clinical trial has an open-label, dose-escalation design with the primary objective to evaluate the safety profile and maximum tolerated dose of APTN-101 in patients diagnosed with World Health Organization (WHO) Grade IV Malignant Glioma (GBM that expresses Epidermal Growth Factor Receptor variant III [EGFRvIII]). The study is expected to enroll up to 15 adult patients, and the primary endpoint is the proportion of patients with a dose limiting toxicity observed within each dose level. Secondary endpoints are the pharmacokinetics of APTN-101, and the objective response rate based on modified Response Assessment in Neuro-Oncology Criteria. Exploratory endpoints include an assessment of biological activity as evidenced by changes in cytokine levels, formation of anti-BRiTE antibodies, overall survival and progression free survival.

"Opening enrollment in the Phase 1 trial is an important milestone in the clinical development of APTN-101, a potential best-in-class therapy for the treatment of glioblastoma," said Michael J. Roberts, Ph.D., President and CEO of Adaptin Bio. "In preclinical studies, APTN-101 demonstrated impressive efficacy targeting glioma cells with precision, eliminating some malignant glioma tumors across multiple aggressive disease models. Our proprietary BRiTE technology was developed to enhance APTN-101’s ability to cross the blood-brain barrier, to selectively target and then attack glioma tumor cells. We believe this mechanism of action is a significant innovation that provides a key differentiator compared to standard-of-care therapies. Since such standard-of-care therapies (including surgery, radiotherapy and chemotherapy) are not curative, disease recurrence is common. As a result, patients diagnosed with GBM currently have a median survival of only 12 to 18 months with just 5% of patients surviving beyond five years. Given the promising preclinical data that has been generated for APTN-101 so far, we believe that leveraging the BRiTE technology with APTN-101 has potential to become an important therapeutic option for patients diagnosed with this difficult-to-treat disease."

BRiTE’s unique delivery mechanism and mode of action harness the ability of T cells to precisely target and destroy glioma cells while effectively navigating the brain’s unique environment. Specifically, APTN-101 is engineered to cross the blood-brain barrier (BBB) to target EGFRvIII, a specific protein linked to aggressive brain tumors. In preclinical studies, APTN-101 demonstrated a greater than 7-fold increase in distribution of the EGFRvIII T-cell engager into the brain compared to the EGFRvIII T-cell engager alone. This resulted in complete eradication of EGFRvIII GMB tumors in 70%-80% of mice. The novel treatment is associated with an excellent safety profile and minimal off-target effects in preclinical models.

"Glioblastoma is a disease with a significant unmet clinical need, limited therapeutic options, and little improvement in outcomes," said Mustafa Khasraw, M.D., professor at Duke University School of Medicine, who led the preclinical development team for APTN-101 and is the principal investigator of the upcoming clinical trial. "By combining immune-based tumor targeting with enhanced delivery to the brain, APTN-101 is designed to address two major challenges in glioblastoma treatment. This first-in-human study is an important step in determining whether this approach can translate into meaningful benefit for patients."

Glioblastoma is one of the most aggressive and deadly forms of brain cancer, accounting for approximately 15,000 new cases per year in the U.S. Secondary malignant brain tumors account for about 200,000 new cases annually. The glioblastoma multiforme treatment market is valued at $3.02 billion in 2025, and researchers forecast an 8% CAGR over the next five years, reaching $4.44 billion by 2030.1 Growing demand for therapies that prolong survival is a top driver of the projected growth.

About BRiTE

Adaptin Bio’s proprietary BRiTE technology leverages the enhanced "hitchhiking" capabilities of manipulated immune cells to deliver therapeutic agents directly to brain tumors. This innovative approach has demonstrated high specificity for EGFRvIII expressing glioma cells, dose-responsive efficacy against diverse patient-derived glioma cell lines, and a favorable safety profile. Additional BRiTE targets are being evaluated. By manipulating the immune system either in vivo or ex vivo, BRiTE aims to overcome traditional treatment barriers and offer a promising new therapeutic option for patients with intracerebral malignancies.

(Press release, Adaptin Bio, AUG 20, 2026, View Source [SID1234670262])

FairJourney Bio Delivers Antibody Engineering for Novel Tumor-Conditional IL-12 Therapeutic Approach That Unlocks the Potential of Localized Cytokine Activation

On August 20, 2026 FairJourney Bio ("FJBio"), a global antibody discovery expert, reported the publication of a peer-reviewed study in mAbs describing a novel approach with the potential to improve the therapeutic window of IL-12, a potent anti-tumor cytokine1. FJBio delivered the end-to-end antibody discovery and engineering campaign for the venture-backed oncology program across its sites in Porto, Portugal, and Cambridge, UK.

IL-12 is one of the most potent anti-tumor cytokines, but its development has been limited by severe immune-related systemic toxicity. Previous strategies to improve its therapeutic window, including intratumoral dosing, half-life extension and protease-cleavable pro-drugs, have had limited clinical success.

The paper, ‘Conditional activation of IL-12 through a Fibronectin-EDB dependent switch gate’, reports the generation of a dual-specificity antigen-binding fragment (Fab) engineered to bind competitively to IL-12 and fibronectin-EDB (FN-EDB), a tumor-associated matrix antigen. This reversible switch is designed to mask IL-12 until it encounters FN-EDB, enabling its conditional activation in the tumor microenvironment.

The study describes what the authors report as the first demonstration of a reversible trans-activation logic gate for tumor-conditional cytokine delivery. In vitro data demonstrates FN-EDB-dependent IL-12 availability and activity, while quantitative systems pharmacology (QSP) modeling predicts a substantially improved therapeutic window for the approach.

The novel format combines a dual-specificity switch arm with a separate, higher-affinity FN-EDB targeting arm. QSP modeling was used to define the binding parameters required for the switch to function before a candidate existed. Working to this predefined affinity window, FJBio introduced IL-12 binding into existing FN-EDB binders using targeted mutagenesis, before optimizing both specificities through a two-stage combinatorial engineering campaign. The resulting affinities were then tuned against one another, enabling the switch arm to bind competitively to IL-12 or FN-EDB, while the targeting arm supports avidity-driven localization to the tumor and conditional activation of IL-12.

Teresa Barata, PhD, Chief Scientific Officer and co-author, FairJourney Bio, commented: "Harnessing the potent anti-tumor activity of IL-12 while limiting systemic toxicity has challenged researchers for almost 30 years. We are proud of the role our teams played in engineering this complex antibody format, developing a switch molecule that unmasks IL-12 only where it is needed. This campaign demonstrates FJBio’s ability to partner at the most challenging end of discovery, engineering to a narrow, pre-defined specification and delivering a solution that recognizes two completely unrelated targets and holds them in balance. We are hugely excited by the potential this has in oncology and future treatments."

(Press release, FairJourney Biologics, AUG 20, 2026, View Source [SID1234670261])