On August 18, 2026 Akari Therapeutics, Plc (Nasdaq: AKTX), an oncology biotechnology company developing antibody drug conjugates (ADCs) with novel RNA splicing modulator payloads, reported new preclinical data demonstrating the potential of AKTX-101, the Company’s proprietary TROP2-targeted ADC utilizing its novel PH1 RNA spliceosome modulating payload, as a differentiated therapeutic approach for urothelial cancer in disease settings where currently available ADC therapies may have limited clinical benefit.

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The findings demonstrated meaningful anti-tumor activity across multiple clinically relevant urothelial cancer preclinical models including advanced urothelial cancer with limited response to currently approved ADC therapy, and tumors with acquired resistance following treatment with a first-generation TROP2-directed ADC. Collectively, the data provide additional validation for Akari’s strategy of developing ADCs with a differentiated payload mechanism designed to address emerging limitations associated with existing ADC payload classes, such as microtubule and topoisomerase 1 inhibitors.

"ADC therapies have transformed the treatment landscape across oncology, but the next wave of innovation will require advances beyond conventional payloads classes used with currently approved ADCs," said Abizer Gaslightwala, President and Chief Executive Officer of Akari Therapeutics. "As ADCs continue moving earlier in the treatment paradigm, more patients will ultimately require additional treatment following relapse, thus creating an urgent need for differentiated payload technologies capable of overcoming resistance and enabling effective ADC payload sequencing strategies. We believe our proprietary PH1 RNA spliceosome modulating payload has the potential to address this important challenge, and these new preclinical findings further strengthen our confidence in AKTX-101 as we advance the program toward Phase 1 development."

Urothelial cancer has become one of the fastest-growing categories for ADC therapy, with Padcev (enfortumab vedotin) representing > $3.5B in annual sales. Despite these advances, patients that relapse after receiving PADCEV continue to face significant unmet medical needs and limited treatment options. As the use of ADCs expands, developing novel payload mechanisms capable of maintaining anti-tumor activity following prior ADC exposure has become an increasingly important priority across the oncology field.

In Akari’s most recent preclinical studies, AKTX-101 demonstrated encouraging activity across multiple urothelial cancer models designed to evaluate its potential therapeutic profile across different clinical settings, including:

Demonstrated statistically significant anti-tumor activity in the UM-UC-14 advanced urothelial carcinoma model, which represents metastatic urothelial cancer, a setting where Padcev (enfortumab vedotin) is currently approved as first-line therapy. While Padcev had limited responsiveness on the tumor in this model, AKTX-101 achieved statistically significant tumor growth inhibition compared with vehicle, supporting the potential of its differentiated payload mechanism in settings where current ADC payloads may have reduced effectiveness.
Demonstrated encouraging activity following acquired resistance to the first-generation TROP2-directed ADC Trodelvy (sacituzumab govitecan). Tumors initially treated with Trodelvy subsequently developed resistance and resumed growth. When these resistant tumors were switched from Trodelvy to AKTX-101, tumor growth was again slowed, suggesting that resistance was associated with the Topoisomerase I payload, and that the AKTX-101 PH1 payload mechanism of disrupting RNA splicing can be effective in this resistant setting. These findings support the potential for AKTX-101’s novel PH1 payload to provide therapeutic benefit following prior treatment with first-generation TROP2 ADCs in several areas where these ADCs are currently approved, including potentially breast and lung cancers.
"One of the most important questions facing the ADC field today is how best to treat patients after progression on prior ADC therapies," said Satyajit Mitra, Ph.D., Head of Oncology R&D at Akari Therapeutics. "The activity we observed in tumors that have developed resistance to Trodelvy is particularly encouraging because it suggests resistance may be driven by the payload rather than loss of the TROP2 target itself. These findings provide compelling support for our hypothesis that introducing a differentiated payload mechanism may overcome payload-specific resistance while preserving target tumor engagement, reinforcing the potential of our PH1 platform to address an increasingly important unmet need in oncology."

Akari continues to advance IND-enabling activities for AKTX-101 with the goal of initiating a Phase 1 clinical trial in mid-2027. The Company is also expanding development opportunities for its proprietary PH1 payload platform through additional tumor-specific programs and strategic collaborations designed to maximize the platform’s long-term clinical and commercial potential.

(Press release, Akari Therapeutics, AUG 18, 2026, View Source [SID1234670205])

On August 17, 2026 Defence Therapeutics Inc. ("Defence" or the "Company"), (CSE: DTC, OTCQB: DTCFF, FSE: DTC), a publicly traded biotechnology company developing next-generation precision oncology therapeutics using its proprietary Accum technology, reported the appointment of Ryan Simms, PhD, as Chief Operating Officer ("COO") and Head of Radiopharmaceutical Programs, strengthening the Company’s leadership and development capabilities as it advances its radiopharmaceutical drug conjugate ("RDC") programs.

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"Ryan brings more than 20 years of experience in advancing targeted radiopharmaceuticals from discovery through first-in-human clinical studies, combined with the operational leadership needed to translate complex science into executable development programs," said Dr. Amie Phinney, President and Chief Executive Officer of Defence Therapeutics. "His expertise will be instrumental in accelerating our radiopharmaceutical programs and expanding the potential of the Accum platform."

Dr. Simms brings extensive experience in radiopharmaceutical development and operations, with a track record spanning the advancement of targeted radiopharmaceuticals from discovery through clinical development. He held key leadership roles at Fusion Pharmaceuticals, where he directed chemistry, radiochemistry, clinical manufacturing and external partnerships supporting multiple clinical-stage programs. Fusion Pharmaceuticals became a leading player in targeted radiopharmaceuticals and was acquired by AstraZeneca in 2024 for approximately US$2 billion.

Dr. Simms also held leadership roles at Abdera Therapeutics and the Centre for Probe Development and Commercialization (CPDC), building expertise across CMC strategy, manufacturing, isotope supply, radiochemistry and technical operations. This combination of scientific, development and operational experience will support his broader responsibilities as COO as Defence scales its radiopharmaceutical programs and operations. Dr. Simms holds a PhD in Engineering from Queen’s University and completed postdoctoral research in Chemistry at the University of Toronto.

"I am excited to join Defence at a time when the Company is expanding its capabilities and ambitions in radiopharmaceuticals," said Dr. Simms. "We have promising candidates in development and a clear path to advance them. Our immediate priority is to select a lead candidate and move it systematically through preclinical characterization, while establishing the CMC and manufacturing framework required to support its progression toward the clinic. More details will come soon."

Dr. Simms’ appointment follows the recent appointment of Dr. Amie Phinney as President and CEO and the opening of Defence’s new office at McMaster Innovation Park in Hamilton, at the heart of one of Canada’s leading radiopharmaceutical ecosystems. Together, these milestones position Defence for its next phase of growth.

(Press release, Defence Therapeutics, AUG 17, 2026, View Source;utm_medium=rss&utm_campaign=defence-therapeutics-strengthens-radiopharmaceutical-leadership-with-appointment-of-dr-ryan-simms-as-chief-operating-officer-and-head-of-radiopharmaceutical-programs [SID1234670227])

On August 17, 2026 Zelluna ASA (OSE: ZLNA) reported that the Independent Data Monitoring Committee (IDMC) has completed its review of the first patient’s safety data from the first-in-human ZIMA-101 study and has recommended that the study continues as planned.

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The first patient, treated at the lead clinical site, The Christie NHS Foundation Trust received all three planned doses of the drug candidate ZI-MA4-1 on Days 1, 4 and 8 of the treatment cycle, followed by a protocol defined safety observation period. An independent group of medical and scientific experts – the IDMC – has now reviewed these data. Following its review, the IDMC identified no dose-limiting toxicities or other safety concerns that would preclude continuation of the study at the current dose level. The committee therefore recommended that the study proceed with enrolment of two additional patients at the same dose level.

ZIMA-101 follows a stepwise approach commonly used in early-stage clinical trials, where safety is carefully assessed before additional patients are treated. Following the IDMC’s recommendation, the study can now proceed with enrolment of two additional patients at the first dose level. Patient screening and recruitment are ongoing at both clinical sites in the United Kingdom – The Christie and The Royal Marsden NHS Foundation Trust.

These initial safety observations represent the first clinical data from the ZIMA-101 study, consistent with the Company’s previously communicated guidance that initial clinical data would begin to emerge from mid-2026. The Company expects further data to emerge as additional patients are enrolled and followed over time.

"These encouraging initial safety observations represent an important first step in the clinical evaluation of ZI-MA4-1 and our TCR-NK platform" said Namir Hassan, Chief Executive Officer of Zelluna. "The first patient received all three planned doses, and the independent committee’s recommendation enables us to continue recruitment at the first dose level. We are pleased with the progress to date, while remaining mindful that the study is still at an early stage. We stay firmly focused on patient safety, disciplined clinical execution and the careful generation of further data."

Professor Fiona Thistlethwaite, Consultant Medical Oncologist at The Christie and honorary professor at The University of Manchester said "Following the IDMC review meeting we are very pleased to have permission to continue recruitment and offer the opportunity to patients to participate in this exciting study".

About ZIMA-101

ZIMA-101 is a Phase 1 clinical trial evaluating the safety, tolerability and preliminary anti-tumour activity of ZI-MA4-1 in patients with advanced solid tumours that express the protein MAGE-A4. The study is being conducted at The Christie and The Royal Marsden NHS Foundation Trusts in the United Kingdom. The study design involves treating three patients at each dose level, with an independent committee reviewing safety data from the first patient before recommending enrolment of the remaining two patients at that dose level.

About ZI-MA4-1

ZI-MA4-1 is Zelluna’s lead allogeneic TCR-NK product candidate and the world’s first MAGE-A4-targeting TCR-NK cell- therapy in clinical development. The product combines the natural tumour-killing ability of NK cells with precision targeting of MAGE-A4 – a protein found on the surface of several common cancer types, including ovarian cancer, lung cancer, synovial sarcoma and head and neck cancer. The therapy is manufactured as an "off-the-shelf" product that can be administered directly to patients without individual customisation, making it more accessible than traditional cell therapies.

(Press release, Zelluna Immunotherapy, AUG 17, 2026, View Source [SID1234670198])

On August 17, 2026 Evaxion A/S (NASDAQ: EVAX) ("Evaxion"), a clinical-stage TechBio company developing novel vaccines with its pioneering AI-Immunology platform, reported to expand its pipeline of cancer vaccine programs with EVX-05 against the deadly brain cancer glioblastoma.

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We are collaborating with experts from Duke University School of Medicine to develop EVX-05. This program targets endogenous retrovirus (ERV)-derived antigens shared between glioblastoma patients, which AI-Immunology has unique capabilities in identifying. These ERV-antigens constitute a novel source of highly attractive targets for off-the-shelf cancer vaccines.

With its new therapeutic concept, EVX-05 is being developed as a novel therapeutic approach for glioblastoma. Current therapies are often inadequate, meaning glioblastoma remains one of the most aggressive and deadly cancers.

"We are delighted to transform our discoveries in glioblastoma into a promising new vaccine program with EVX-05, which could hold a significant therapeutic potential in area of massive unmet medical need. We have an outstanding collaboration with Duke University and now see the huge benefits of combining their extensive disease understanding and clinical expertise with the unique target discovery capabilities of AI-Immunology," says Birgitte Rønø, CSO and COO of Evaxion.

"Patients with glioblastoma continue to face limited treatment options and poor outcomes," said Mustafa Khasraw, M.D., professor at Duke University School of Medicine. "The potential of ERVs as therapeutic targets has long been acknowledged, if we can unlock this potential, it would be a significant advancement towards improving care."

World-leading expertise
Evaxion is currently undertaking optimization of a lead vaccine candidate for the EVX-05 program as part of advancing it towards initial clinical testing. This is expected to be carried out by Professor Khasraw and his team, allowing for world-leading clinical expertise and knowledge of patient needs to help guide clinical development. The collaboration also potentially allows a cost-efficient way for Evaxion to study EVX-05 in a clinical phase 1 trial.

EVX-05 builds on the same ground-breaking ERV-targeting concept as EVX-04, Evaxion’s vaccine candidate against acute myeloid leukemia. This confirms the broad applicability of the concept across cancers where immunotherapies remain inadequate and conserved immunogenic antigens can be identified.

Both programs draw on learnings from the EVX-03 program, which has now been discontinued and removed from our R&D pipeline as a matter of portfolio management. The costs related to EVX-05 are captured within Evaxion’s existing budgets and hence does not impact on our cash runway, which continues to stretch into second half of 2027.

Conference call and webcast
This coming Thursday, August 20, Evaxion’s Executive Management will host a conference call and webcast at 8.30 ET/14.30 CET today, presenting our Q2 2026 business update and financial results as well as taking questions. EVX-05 will be one of the topics discussed.

To join the conference call, listen to the presentation and ask verbal questions, please register in advance via this link to receive the dial-in telephone numbers and a unique PIN code. The call can be accessed 15 minutes prior to the start of the live event.

To join the webcast, please click on this link. The webcast recording will be available on our website shortly after the event.

About glioblastoma
Glioblastoma is the most aggressive malignant primary brain tumor. It has an incidence rate of 3.19 per 100,000 persons in the United States and a median age of 64 years (National Institute of Health).

No cure exists for glioblastoma, and treatment outcomes remain poor: 50% of patients die approximately one year from diagnosis (New England Journal of Medicine, 2005).

(Press release, Evaxion, AUG 17, 2026, View Source [SID1234670197])

On August 17, 2026 Artelo Biosciences, Inc. (Nasdaq: ARTL), 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 United States Patent and Trademark Office has issued a Notice of Allowance for a U.S. patent application covering the intended commercial formulation of ART27.13, the Company’s peripherally selective cannabinoid agonist currently being evaluated in the Phase 2 CAReS trial for cancer-related anorexia and the Phase 2 DREAM study in patients with glaucoma or ocular hypertension.

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The allowed claims protect compositions of ART27.13 dispersed in polyethylene glycol, including the Company’s intended commercial formulation. This development marks a major milestone in Artelo’s global intellectual property strategy and positions the Company for long-term value creation.

"This U.S. Notice of Allowance and near-term expectation of the issuance of the patent further strengthens the intellectual property foundation supporting ART27.13 and its long-term development potential," said Gregory D. Gorgas, President and Chief Executive Officer of Artelo Biosciences. "As ART27.13 advances in multiple Phase 2 studies, we believe protecting the intended commercial formulation is an important step in building value around the program and preserving opportunities across multiple indications."

ART27.13 is being evaluated in the Phase 2 portion of CAReS trial targeting cancer-related anorexia. The investigational drug 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 Phase 2 portion of CAReS demonstrated the ability of the drug to reverse cancer-related anorexia in all patients taking the highest dose 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 Phase 2 in patients with glaucoma or ocular hypertension. The investigator-led study, funded by Glaucoma UK and the HSC R&D Division, is evaluating ART27.13’s potential as a once-daily, orally administered treatment to reduce intraocular pressure, with initial results anticipated in the fourth quarter of this year.

About ART27.13
ART27.13 is a novel benzimidazole derivative and dual cannabinoid agonist. Initially developed by AstraZeneca plc, ART27.13 has been in seven clinical studies with over 280 participants. It is 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. A statistically significant and dose-dependent increase in body weight was observed in people with back pain who were otherwise healthy. 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 at a daily dose of 650 µg.

(Press release, Artelo Biosciences, AUG 17, 2026, View Source [SID1234670196])