On August 17, 2026 AstraZeneca reported it is discontinuing the eVOLVE-Lung02 Phase III trial evaluating volrustomig in combination with chemotherapy as a 1st-line therapy compared to pembrolizumab and chemotherapy in patients with metastatic non-small cell lung cancer (mNSCLC) whose tumours express PD-L1 <50%.

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This decision is based on the recommendation of the Independent Data Monitoring Committee (IDMC) following a planned review of trial data. The IDMC concluded that the volrustomig combination was unlikely to meet either of the dual primary endpoints of progression-free survival (PFS) or overall survival (OS) in the primary analysis population of patients with PD-L1 negative tumours (<1%) versus the comparator arm.

The safety profile of volrustomig plus chemotherapy was consistent with the known profiles of the individual medicines and no new safety signals were identified.

Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "We initiated the eVOLVE-Lung02 trial aiming to improve the outcomes for patients whose lung cancers have lower PD-L1 expression and a less durable response to current immunotherapy regimens. While we are disappointed, we will learn from this trial and are determined to continue pioneering new medicines from our industry-leading pipeline in our quest to improve outcomes for patients with lung cancer."

The Company will work with investigators to ensure continuity of care and appropriate follow up for patients on the trial. The other Phase III volrustomig trials continue as planned in cervical cancer, head and neck squamous cell carcinoma and mesothelioma.

Notes

NSCLC
Lung cancer is the leading cause of death by cancer globally, accounting for almost one in four (23%) cancer deaths.1 Lung cancer is broadly split into small cell lung cancer or NSCLC, the latter accounting for 80-85% of cases.1-2 Patients are most commonly diagnosed with metastatic disease, when the tumour has spread outside the lung.3 Approximately 12% of people with metastatic NSCLC will still be alive five years after diagnosis.4

eVOLVE-Lung02
eVOLVE-Lung02 is a randomized, open-label, multi-centre, global Phase III trial of volrustomig plus chemotherapy for 1st-line treatment of patients with mNSCLC whose tumours express PD-L1 <50%. Patients were randomized 1:1 to receive 750mg intravenous volrustomig in combination with chemotherapy every three weeks for four cycles followed by volrustomig every three weeks, or 200mg pembrolizumab plus chemotherapy every three weeks for four cycles followed by pembrolizumab every three weeks until completion of 24 months of treatment or disease progression, or other discontinuation criterion are met.

The trial enrolled 895 patients across 25 countries. The dual primary endpoints were progression-free survival (PFS) and overall survival (OS) in patients whose tumours express PD-L1 <1%. Secondary endpoints included PFS and OS in the intent-to-treat population (PD-L1 <50%).

Volrustomig
Volrustomig is a dual checkpoint inhibitor bispecific antibody designed to deliver coordinated and targeted PD-1 and CTLA-4 blockade on the same T cell. AstraZeneca is evaluating volrustomig as monotherapy and in combinations in several tumour types with high unmet need.

(Press release, AstraZeneca, AUG 17, 2026, View Source [SID1234670188])

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 Astrazeneca reported that positive high-level results from the SAFFRON Phase III trial showed Tagrisso (osimertinib) plus Orpathys (savolitinib) demonstrated a statistically significant and clinically meaningful improvement in both progression-free survival (PFS) and overall survival (OS) versus doublet platinum-based chemotherapy in patients with epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC). Patients in the trial had tumours with high levels of MET overexpression or amplification and had progressed on prior treatment with Tagrisso.

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Third-generation EGFR-tyrosine kinase inhibitors (TKIs) have significantly improved outcomes for patients with EGFRm NSCLC.1 However, one in three patients’ tumours will develop MET overexpression or amplification, one of the most common mechanisms of resistance on third-generation EGFR-TKIs.1-2 MET-driven resistance is associated with poor prognosis, and there is a significant unmet need for effective and well-tolerated treatment options in later-line settings.2

Professor Shun Lu, Director of Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine and principal investigator of the trial, said: "These exciting results from SAFFRON represent a critical advance for patients with EGFR-mutated non-small cell lung cancer experiencing MET-driven resistance after osimertinib, a population with poor outcomes and no biomarker-directed treatment options available that are oral and well-tolerated. MET is one of the most common drivers of progression on targeted therapy in this setting, and these data underscore the potential impact of this novel osimertinib plus savolitinib combination and the urgency of MET testing to inform treatment decisions."​ ​

Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "These data demonstrate the clear benefit of adding Orpathys to backbone therapy Tagrisso to address MET overexpression or amplification while maintaining EGFR suppression. By combining Orpathys and Tagrisso, with its established efficacy, safety profile and central nervous system protection, we aim to deliver the first biomarker-directed, all-oral option in this setting to patients across the globe. This further strengthens our leadership in EGFR-mutated lung cancer, reinforcing our strategy to improve patient outcomes across stages and through lines of therapy with novel combinations."

Weiguo Su, Chief Executive Officer and Chief Scientific Officer of HUTCHMED, said: "Overcoming MET-driven resistance after EGFR-TKI therapy has been a long-standing challenge in clinical practice. The SAFFRON global study further reinforces the robust efficacy previously demonstrated in the SACHI Phase III trial that supported approval in China, with the results providing clear evidence to support global registrations of the Tagrisso and Orpathys combination. We are grateful to everyone who supported this trial. Together with AstraZeneca, we look forward to potentially bringing this landmark treatment to patients around the world."

The safety profile for Tagrisso plus Orpathys was consistent with the known profiles of each medicine, and there were no new safety findings. These data will be presented at a forthcoming medical meeting and shared with global regulatory authorities.

Tagrisso plus Orpathys is approved in China for patients with locally advanced or metastatic EGFRm NSCLC with MET amplification after disease progression on EGFR-TKI therapy based on the SACHI Phase III trial.

Orpathys is being jointly developed by AstraZeneca and HUTCHMED and commercialised by AstraZeneca.

Notes

NSCLC and MET aberrations
Lung cancer is the leading cause of cancer death globally, accounting for almost one in four (23%) cancer deaths.3 Lung cancer is broadly split into NSCLC and small cell lung cancer, with 80-85% of patients diagnosed with NSCLC.4 Approximately 75% of NSCLC patients are diagnosed with advanced disease.5 Additionally, about 10-15% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia, have EGFRm NSCLC.​6-8

MET is a tyrosine kinase receptor that has an essential role in normal cell development.9 MET overexpression or amplification can lead to tumour growth and the metastatic progression of cancer cells.9-10 An estimated 34% of tumours will develop high levels of MET overexpression or amplification after progression on a third-generation EGFR-TKI.1 ​

SAFFRON
SAFFRON is a randomised, open-label, multi-centre, global Phase III trial studying the efficacy of Orpathys (300mg twice daily) added to Tagrisso (80mg once daily) versus doublet platinum-based chemotherapy in 338 patients with EGFRm, locally advanced or metastatic NSCLC with MET overexpression or amplification whose disease progressed following 1st- or 2nd-line treatment with Tagrisso. The trial enrolled patients in 230 centres across 29 countries, including in North America, Europe, South America and Asia. The primary endpoint is PFS and key secondary endpoints include OS and objective response rate.

Patients were prospectively selected for SAFFRON using the high MET level cut-offs identified in the SAVANNAH Phase II trial.​ In SAVANNAH, MET overexpression or amplification levels were determined by two tests: immunohistochemistry (IHC), which detects if cancer cells have a particular protein or marker on their surface, and fluorescence in situ hybridisation (FISH), which detects a specific DNA sequence from cancer cells.

Orpathys
Orpathys (savolitinib) is an oral, potent and highly selective MET-TKI that has demonstrated clinical activity in advanced solid tumours. It blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations or other point mutations), gene amplification or protein overexpression.

Orpathys is approved in China for the treatment of adult patients with locally advanced or metastatic NSCLC with MET exon 14 skipping alteration, representing the first selective MET inhibitor approved in China. Orpathys also received a conditional approval in China for the treatment of patients with locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with MET amplification who have failed at least two prior systemic treatments.

Orpathys in combination with Tagrisso is approved in China for patients with locally advanced or metastatic EGFRm-positive non-squamous NSCLC with MET amplification after disease progression on EGFR-TKI therapy based on the SACHI Phase III trial. The combination was also granted a temporary authorisation in Switzerland for the treatment of patients with locally advanced or metastatic EGFRm NSCLC and high levels of MET overexpression or amplification who progressed on prior treatment with Tagrisso. This was based on results from the global SAVANNAH Phase II trial.

Tagrisso
Tagrisso (osimertinib) is a third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including the treatment of central nervous system metastases. Tagrisso (40mg and 80mg QD oral tablets) has been used to treat more than one million patients across its indications worldwide and AstraZeneca continues to explore Tagrisso as a treatment for patients across multiple stages of EGFRm NSCLC.

Tagrisso is approved as monotherapy in more than 120 countries including the US, EU, China and Japan. Approved indications include for 1st-line treatment of patients with locally advanced or metastatic EGFRm NSCLC, locally advanced or metastatic EGFR T790M mutation-positive NSCLC, adjuvant treatment of early-stage EGFRm NSCLC and locally advanced, unresectable NSCLC following platinum-based chemoradiation therapy. Tagrisso is also approved in combination with chemotherapy in more than 80 countries, including the US, EU, China and Japan, for 1st-line treatment of patients with locally advanced or metastatic EGFRm NSCLC.

There is an extensive body of evidence supporting the use of Tagrisso in EGFRm NSCLC, and it is the only targeted therapy shown to improve patient outcomes across all stages of the disease.

In late-stage disease, Tagrisso demonstrated improved outcomes as monotherapy in the FLAURA Phase III trial and in combination with chemotherapy in the FLAURA2 Phase III trial. Tagrisso is also being investigated in this setting in combination with Datroway (datopotamab deruxtecan or Dato-DXd) in the TROPION-Lung14 and TROPION-Lung15 Phase III trials.

Tagrisso also showed improved outcomes in early-stage disease in the NeoADAURA and ADAURA Phase III trials and in locally advanced stages in the LAURA Phase III trial. As part of AstraZeneca’s ongoing commitment to treating patients as early as possible in lung cancer, Tagrisso is also being investigated in the early-stage adjuvant resectable setting in the ADAURA2 Phase III trial.

(Press release, AstraZeneca, AUG 17, 2026, View Source [SID1234670189])

On August 17, 2026 OncoC4 Inc., a late clinical-stage biopharmaceutical company developing novel medicines for cancer and neurodegenerative diseases, reported dosing of the first patient following the clearance of the Investigational New Drug (IND) application for a Phase 1 clinical trial (NCT07408258) of ONC-783, the company’s investigational T-cell engager developed based on the proprietary neoCD24 platform.

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"This milestone demonstrates OncoC4’s leading position in developing first-in-class cancer therapeutics," said Dr. Yang Liu, CEO and Chief Scientific Officer, "CD24 is expressed in nearly 70% of human cancers 1, and abnormal glycosylation in malignant cells produces the neoCD24 epitope that is largely absent from the normal tissues. By exploiting this cancer-specific epitope, ONC-783 is designed to maximize selectivity for tumor cells while minimizing the risk of on-target/off-tumor toxicity that has limited other T-cell engagers."

ONC-783 is the world’s first and only clinical stage T-cell engager targeting the cancer-specific glycoform of CD24 (neoCD24). The drug candidate is designed to address the limitations of existing immunotherapies by selectively targeting the tumor-specific epitope while redirecting T cells for potent anti-tumor activity. Preclinical studies have demonstrated broad anti-tumor activity for ONC-783 across multiple solid tumor and hematologic malignancies, including pancreatic cancer, lung cancer, breast cancer, colorectal cancer, ovarian cancer, glioblastoma, and mantle cell lymphoma, which supports the potential of ONC-783 as a treatment across multiple tumor types. In addition, a subcutaneous formulation was developed for ONC-783 to enable gradual systemic exposure and provide a potential safety advantage compared with intravenously administered T-cell engagers.

"We are extremely excited to partner with OncoC4 to explore the potential of targeting neoCD24 to bring clinical benefit for cancer patients with limited treatment options," added Dr. Aiwu Ruth He, Professor of Medicine and medical oncologist at Columbia University Irving Medical Center in New York City. "Advanced solid tumors remain a significant challenge, and this innovative mechanism offers a promising new approach for patients who have progressed or intolerant to standard therapy."

ONC-783 is being tested in ONC-783-001, a Phase 1 trial in the US for patients with advanced solid tumors. The first study patient was successfully dosed at Columbia University Irving Medical Center. The treatment was well tolerated. No severe Adverse Events, Cytokine Release Syndrome, or Immune Effector Cell-Associated Neurotoxicity Syndrome have been observed to date. OncoC4 will continue the innovation in cancer immunotherapy and remain committed to the development of first-in-class therapeutics to address the unmet needs in cancer treatments.

About ONC-783-001

ONC-783-001 is a Phase 1 open-label, dose-escalation study in the United States (U.S.) to evaluate the safety, pharmacokinetics (PK) and efficacy of ONC-783 as a single agent in patients with advanced/metastatic solid tumors, focusing on colorectal cancer, ovarian cancer, pancreatic cancer, or breast cancer. OncoC4 has engaged several clinical centers across the U.S. to recruit patients for ONC-783-001 including Columbia University Irving Medical Center and The University of Texas MD Anderson Cancer Center. The clinical trial registration number is NCT07408258.

About the NeoCD24 Platform

CD24 is expressed in nearly 70% of human cancers1, along with a significant level of expression also in normal tissues, where it plays a key role in regular cell growth, tissue maintenance, and immune system function. Targeting CD24 as a cancer treatment has been challenging due to the lack of selectivity to tumor cells. OncoC4 has discovered that abnormal glycosylation in malignant cells produces the neoCD24 epitope, a tumor-specific antigen that is largely absent from normal tissues, enabling the development of cancer-specific therapeutics targeting CD24. OncoC4 is developing several first-in-class cancer treatments based on the neoCD24 platform.

(Press release, OncoC4, AUG 17, 2026, View Source [SID1234670190])

On August 17, 2026 AB Science S.A. (the "Company" or "AB Science," Euronext – FR0010557264 – AB) reported the successful settlement and delivery of the securities issued as part of its capital increases subscribed to by a limited number of investors and announced on August 10, 2026 (the "Private Placement").

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As announced on August 10, 2026, the Private Placement, totaling EUR 14.2 million (including the issuance premium and excluding the potential exercise of BSA-1 and BSA-2 warrants), was carried out through the issuance, without preemptive subscription rights and without a priority period, of:

(i) 3,606,560 new common shares of the Company (the "New Shares") issued at a price of EUR 0.61 per share, each accompanied by a stock subscription warrant (a "BSA-1") – five BSA-1s entitle their holder to subscribe for three new common shares of the Company at a price of EUR 1.00 per common share; and

(ii) 19,672,132 New Shares issued at a price of EUR 0.61 per share, each accompanied by a stock subscription warrant (a "BSA-2") – four BSA-2s entitle their holder to subscribe for seven new common shares of the Company at a price of EUR 1.00 per common share.

If all BSA-1s and BSA-2s are exercised, a total of 36,590,166 additional common shares of the Company will be issued, representing total additional proceeds of approximately EUR 36.6 million. Thus, taking into account the issuance of the New Shares and the potential future exercise of the BSA-1 and BSA-2 warrants, the total amount of the Private Placement will amount, if applicable, to approximately EUR 50.8 million.

On this basis, the ownership interest of a shareholder holding 1.00% of the Company’s share capital prior to the completion of the Private Placement and who did not subscribe to it is now 0.7747% on an undiluted basis and 0.6072% on a diluted basis prior to the exercise of the BSA-1 and BSA-2 warrants, and 0.5721% on a non-diluted basis and 0.5332% on a diluted basis after the exercise of BSA-1 and BSA-2 warrants.

Finally, it is confirmed that Stéphane Ledermann, the Company’s Chairman and Chief Executive Officer, participated in the Private Placement in the amount of EUR 150,000.

About masitinib

Masitinib is a novel oral tyrosine kinase inhibitor that is being developed to target mast cells and macrophages, key immune cells, through inhibition of a limited number of kinases. Through its activity on mast cells and microglial cells and therefore its inhibitory effect on the activation of the inflammatory process, masitinib may have an effect on the course of central nervous system diseases.

About AB8939

AB8939 is a new synthetic microtubule-destabilizing drug candidate. Preclinical data suggests that AB8939 has broad anticancer activity, with a notable advantage over standard chemotherapies that target microtubules of being able to overcome P-glycoprotein (Pgp) and myeloperoxidase (MPO) mediated drug resistance. Development of drug resistance often restricts the clinical efficacy of microtubule-targeting chemotherapy drugs (for example, taxanes and vinca alkaloids); thus, AB8939 has the potential to be developed in numerous oncology indications.

(Press release, AB Science, AUG 17, 2026, View Source [SID1234670174])