On May 27, 2026 Atossa Therapeutics, Inc. (Nasdaq: ATOS) ("Atossa" or the "Company"), a clinical-stage biopharmaceutical company developing novel therapies in oncology and other areas of significant unmet medical need, reported that two abstracts featuring (Z)-endoxifen have been accepted for presentation at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held May 29 to June 2, 2026 in Chicago, IL.

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"Both abstracts highlight the scientific rationale and ongoing clinical development of (Z)-endoxifen in ER-positive breast cancer," said Dr. Steven C. Quay, M.D., Ph.D., President and Chief Executive Officer of Atossa Therapeutics. "Our preclinical data demonstrate that (Z)-endoxifen achieved robust estrogen receptor inhibition across clinically relevant ESR1 mutations associated with endocrine resistance, while the EVANGELINE trial is evaluating its potential in combination with ovarian function suppression in premenopausal women in the neoadjuvant setting. Together, these abstracts underscore our belief that (Z)-endoxifen has the potential to address important unmet needs across multiple treatment settings in ER-positive breast cancer."

Presentation details are as follows:

Session Type: Online Publication
Abstract Title: Effect of (Z)-endoxifen Demonstrates Robust Estrogen Receptor Signaling Inhibition Across Clinically Relevant ESR1 Mutations

Summary: The abstract highlights new preclinical data demonstrating that (Z)-endoxifen delivers robust ER inhibition across clinically relevant estrogen receptor alpha gene (ESR1) mutations. ESR1 mutations are a major mechanism of acquired endocrine resistance in ER-positive breast cancer and remain associated with limited treatment options despite the emergence of next-generation endocrine therapies. These data therefore support the ongoing clinical development of (Z)-endoxifen, as well as its potential as a promising treatment option for breast cancer patients with limited therapeutic alternatives.

Key Data Highlights

(Z)-endoxifen demonstrated robust dose-dependent and statistically significant inhibition of ER signaling across clinically relevant concentrations.
In parental MCF-7 breast cancer cells, ER activity was reduced to 16-26% of control (p < 0.001). In ESR1 wild-type models, studied therapies reduced ER signaling to <5% of control (p < 0.001).
(Z)-endoxifen maintained consistent ER inhibition across key ESR1 mutations (Y537N, Y537S, D538G) (p < 0.01).
Comparator oral Selective Estrogen Receptor Degraders (SERDs), including elacestrant and imlunestrant, showed reduced efficacy in ESR1-mutant settings, particularly in D538G, as compared to (Z)-endoxifen.
The D538G mutation demonstrated the highest resistance, while Y537N remained the most sensitive across treatments.
Session Type: Poster Presentation
Date: June 1, 2026, 1:30 PM-4:30 PM CT
Poster Board Number: 133b
Abstract Title: A Phase 2 Clinical Trial in Progress of (Z)-Endoxifen Plus Goserelin as Neoadjuvant Therapy in Premenopausal Women With ER+/HER2- Breast Cancer (EVANGELINE)
Presenters: Dr. Steven C. Quay & Hayley Erickson

Summary: The abstract describes EVANGELINE (NCT05607004), an ongoing, multicenter, open-label Phase 2 study evaluating daily 40 mg (Z)-endoxifen plus goserelin administered every 28 days as neoadjuvant therapy in premenopausal women with ER+/HER2-negative, cT2-3, cN0-1 breast cancer.

Key Highlights

EVANGELINE is evaluating (Z)-endoxifen plus ovarian function suppression (OFS) as a neoadjuvant therapy in premenopausal women with ER+/HER2-negative, cT2-3, cN0-1 breast cancer.
The primary objective is to determine the proportion of patients with baseline Ki-67 >10% who achieve Ki-67 of 10% or less after 4 weeks of therapy.
A Simon two-stage design is being used to study whether, after four weeks, at least 65% of patients treated achieved a Ki-67 of 10% or less, with 20 patients enrolled in the first stage and, if promising, another 25 patients enrolled in the second stage (cohort A).
A parallel cohort of 20 patients with baseline Ki-67 of 10% or less (cohort B) is enrolled to assess objective response rate at 24 weeks per RECIST v1.1.
Secondary objectives include safety and tolerability, residual cancer burden, and PEPI score; correlative analyses include examining the effect of treatment on select tumor and plasma biomarkers.
A pharmacokinetic run-in phase has been completed and informed selection of (Z)-endoxifen 40 mg daily plus OFS for Phase 2 evaluation. Phase 2 enrollment opened in May 2025.
About ESR1-Mutant Breast Cancer

Mutations in ESR1 commonly arise in patients with advanced ER+ breast cancer following endocrine therapy and are associated with resistance to treatment. These mutations drive ligand-independent ER activation, leading to continued tumor growth despite standard therapies. Effective treatment options for ESR1-mutant disease remain limited.

About EVANGELINE

EVANGELINE (NCT05607004) is an ongoing, multicenter, open-label Phase 2 study evaluating (Z)-endoxifen plus goserelin as a neoadjuvant therapy in premenopausal women with ER+/HER2-negative, cT2-3, cN0-1 breast cancer. The study will characterize early antiproliferative activity, clinical response, safety and biologic effects of dual ER and PKCβ1/AKT pathway targeting in this setting.

(Press release, Atossa Therapeutics, MAY 27, 2026, View Source [SID1234666119])

On May 27, 2026 TransCode Therapeutics, Inc. (NASDAQ: RNAZ), a clinical stage company pioneering immuno-oncology and RNA for the treatment of high risk and advanced cancer, reported the initiation of its Phase 2a clinical trial. The study is to evaluate TransCode’s lead therapeutic candidate, TTX‑MC138, in patients with circulating tumor DNA (ctDNA) positive colorectal cancer following curative‑intent therapy. The trial is being conducted in collaboration with Quantum Leap Healthcare Collaborative (QLHC), sponsor of the PRE‑I‑SPY clinical trial platform. The trial builds on growing clinical and scientific momentum supporting ctDNA‑guided strategies targeting minimal residual disease (MRD) in colorectal cancer.

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The Phase 2a clinical trial is expected to enroll up to 45 patients with colorectal cancer who have completed standard curative-intent therapy and have no radiographic evidence of disease, but remain or become ctDNA-positive, indicating the presence of minimal residual disease.

Principal investigators are Dr. Emil Lou of the University of Minnesota and Dr. Zhaohui Jin of the Mayo Clinic Comprehensive Cancer Center. The trial is chaired by Dr. Paula Pohlmann of the MD Anderson Cancer Center.

The trial leverages clinical sites currently participating and actively recruiting in QLHC’s PRE‑I‑SPY platform trial. Several of those clinical sites are part of the National Comprehensive Cancer Network (NCCN). Those centers have considerable expertise and are at the forefront defining standard-of-care practices for the treatment of cancer.

It is anticipated that the trial will produce new data about the importance of ctDNA testing and the role of TTX-MC138 in reducing the risk of cancer recurrence in this at-risk patient population. The trial has been submitted to the U.S. Food and Drug Administration and received Institutional Review Board approval, enabling site activation and commencement of patient enrollment.

This clinical trial aims to evaluate the biological and clinical activity of TTX-MC138 in the minimal residual disease setting where therapeutic intervention may have the greatest opportunity to improve long-term outcomes. ctDNA testing is becoming increasingly important in oncology, particularly in colorectal cancer, because it provides a highly sensitive, real-time measure of residual disease and information about tumor biology that traditional methods often fail to detect. This approach has recently been successfully employed in the treatment of patients with muscle invasive bladder cancer.

"TTX-MC138’s safety profile, coupled with the durability of its anti-tumor effects, observed in TransCode’s Phase 1a clinical trial is particularly encouraging. These findings are consistent with the drug’s mechanism of action and provide a basis for a more rigorous efficacy evaluation. This positions TransCode and its collaborators to potentially intervene earlier in a patient’s disease, and may in the future offer a new therapeutic option for patients at risk of developing metastatic disease" noted Daniel Vlock, MD, TransCode’s Consulting Clinician.

About TTX-MC138

TTX-MC138 is a first-in-class therapeutic candidate designed to inhibit microRNA-10b, or miR-10b, a microRNA widely believed to be critical to the emergence and progression of many metastatic cancers. TransCode’s Phase 1a first-in-human clinical trial achieved its primary safety endpoint and established a recommended Phase 2 dose, as announced at ESMO (Free ESMO Whitepaper) 2025.

(Press release, TransCode Therapeutics, MAY 27, 2026, View Source [SID1234666118])

On May 27, 2026 Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, reported new patient-reported outcomes data from the pivotal TRUST-II study of IBTROZI (taletrectinib) in patients with advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC). The new data will be presented on Sunday, May 31 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2026.

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"When considering treatment options for these patients, our primary clinical objective is to delay disease progression while simultaneously alleviating symptom burden and ensuring long-term tolerability," said presenting author, Yasir Elamin, M.D., Associate Professor of Thoracic/Head and Neck Medical Oncology at The University of Texas MD Anderson Cancer Center. "The outcomes from TRUST-II are compelling because we see rapid and durable relief from key symptoms, as well as the preservation of cognitive function. This suggests that we can manage the disease without the neurological impairment commonly seen with other treatments."

TRUST-II is a global Phase 2 study evaluating the safety and efficacy of IBTROZI in patients with advanced ROS1+ NSCLC, including both TKI-naïve and TKI-pretreated populations. This analysis evaluated responses from 69 TRUST-II patients (TKI-naïve n=23; TKI-pretreated n=46) in North America and Europe using two validated questionnaires that capture quality-of-life and symptom impact data: European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and EORTC QLQ-LC13. Findings include the following:

Mean changes from baseline improved or remained stable for most domains across both questionnaires.
Quality-of-life and cognitive function scores improved from baseline or remained stable over time in both TKI-naïve and TKI-pretreated patients.
At the first assessment (day 1 of cycle 2), 88% of patients reported improved or stable global health quality-of-life scores, including 93% of TKI-pretreated patients. The majority of patients in both subgroups improved or remained stable across subsequent time points throughout treatment.
At the first assessment, 84-96% of patients reported improved or stable scores for coughing and shortness of breath, with no worsening of cough in TKI-naïve patients, and these improvements were sustained through eight months of treatment.
"Having navigated the lung cancer journey as a caregiver and patient advocate, I know the deep impact this disease can have on quality of life," said Danielle Hicks, Chief Patient Officer for GO2 for Lung Cancer. "Patients with ROS1+ NSCLC tend to be younger, often still working, raising children or managing caregiving responsibilities of their own. Watching a loved one endure the daily burden of physical symptoms like a persistent cough or shortness of breath is incredibly difficult, but the fear of neurological side effects is just as profound. For the community we serve, data showing that treatment can potentially rapidly ease those physical symptoms while preserving a patient’s mental clarity is deeply encouraging. It means patients can experience relief without sacrificing their daily functioning, which is essential for maintaining their quality of life during treatment."

"One of our focuses, and an important measure of success, lies in the patient experience and the ability to maintain or improve their quality of life," said David Hung, M.D., Founder, President and Chief Executive Officer of Nuvation Bio. "These TRUST-II findings, which demonstrate stable or improved cognitive function in addition to the robust efficacy results previously reported for IBTROZI, align clinical goals with the needs and perspectives of the patient community."

Nuvation Bio announced in June 2025 that the U.S. Food and Drug Administration (FDA) approved IBTROZI for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC. In May 2026, the FDA accepted a supplemental New Drug Application (sNDA) with updated data for IBTROZI with a target action date of January 4, 2027. IBTROZI is also approved for patients with advanced ROS1+ NSCLC in Japan, where it is marketed by Nippon Kayaku, and in China, where it is marketed by Innovent Biologics under the brand name DOVBLERON. Additionally, Nuvation Bio, along with its partner Eisai, announced in March 2026 that the Marketing Authorisation Application (MAA) for taletrectinib was validated by the European Medicines Agency for full approval consideration with a standard review timeline.

A separate "Trial in Progress" poster on the TRUST-IV Phase 3 study will also be presented at ASCO (Free ASCO Whitepaper) on Sunday, May 31.

Poster Presentations Overview:
Title: Patient-reported outcomes (PROs) and health-related quality of life (HRQoL) with taletrectinib in advanced ROS1+ non-small cell lung cancer (NSCLC) from the TRUST-II study
Presenter: Yasir Elamin, M.D., Associate Professor, Department of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center
Date: Sunday, May 31, 2026
Session Time: 9:00 a.m.-12:00 p.m. CDT
Poster Board Number: 419
Abstract Number: #8629

Title: Trial in progress: Randomized, double-blind, Phase 3 TRUST-IV study of adjuvant taletrectinib vs placebo in patients with stage IB–IIIA ROS1+ non-small cell lung cancer (NSCLC)
Presenter: Alexander Spira, M.D., Ph.D., Medical Oncologist, Virginia Cancer Specialists
Date: Sunday, May 31, 2026
Session Time: 9:00 a.m.-12:00 p.m. CDT
Poster Board Number: 600b
Abstract Number: #TPS8130

The publications will be available on the Publications page of the Nuvation Bio website following their presentation. To learn more about Nuvation Bio, visit Booth #35117 at the ASCO (Free ASCO Whitepaper) Annual Meeting 2026.

About ROS1+ NSCLC
Each year, more than one million people globally are diagnosed with non-small cell lung cancer (NSCLC), the most common form of lung cancer. It is estimated that approximately 2% of patients with NSCLC have ROS1+ disease. About 35% of patients newly diagnosed with metastatic ROS1+ NSCLC have tumors that have spread to their brain. The brain is also the most common site of disease progression, with about 50% of previously treated patients developing central nervous system (CNS) metastases.

About IBTROZI
IBTROZI is an oral, potent, CNS-active, selective, next-generation ROS1 inhibitor therapy. On June 11, 2025, following Priority Review and Breakthrough Therapy designations for both TKI-naïve and TKI-pretreated disease, the U.S. Food and Drug Administration (FDA) approved taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC. Learn more about taletrectinib in the U.S. at IBTROZI.com.

About the TRUST Clinical Program
The TRUST clinical program comprises three registrational studies evaluating the safety and efficacy of IBTROZI. TRUST-I (NCT04395677) and TRUST-II (NCT04919811) are Phase 2 single-arm studies evaluating IBTROZI for the treatment of adults with advanced ROS1+ NSCLC in China (N=173) and globally (N=189), respectively. The primary endpoint of both studies is confirmed objective response rate (cORR) as assessed by an independent review committee. TRUST-IV (NCT07154706) is a Phase 3 placebo-controlled study evaluating IBTROZI for the adjuvant treatment of adults with resected early-stage ROS1+ NSCLC. The study will enroll approximately 180 patients in the U.S., Canada, Europe, Japan and China. The primary endpoint is disease-free survival as determined by investigator, and the primary completion date is estimated to be in 2030. Nuvation Bio is also sponsoring TRUST-III (NCT06564324), a confirmatory randomized Phase 3 study evaluating IBTROZI versus crizotinib in 194 patients in China with advanced ROS1+ NSCLC who have not previously received ROS1 TKIs.

U.S. Indication
IBTROZI is indicated for the treatment of adult patients with locally advanced or metastatic ROS1+ non-small cell lung cancer (NSCLC).

IMPORTANT SAFETY INFORMATION FOR IBTROZI (taletrectinib)

WARNINGS AND PRECAUTIONS

Hepatotoxicity: Hepatotoxicity, including drug-induced liver injury and fatal adverse reactions, can occur. 88% of patients experienced increased AST, including 10% Grade 3/4. 85% of patients experienced increased ALT, including 13% Grade 3/4. Fatal liver events occurred in 0.6% of patients. Median time to first onset of AST or ALT elevation was 15 days (range: 3 days to 20.8 months).

Increased AST or ALT each led to dose interruption in 7% of patients and dose reduction in 5% and 9% of patients, respectively. Permanent discontinuation was caused by increased AST, ALT, or bilirubin each in 0.3% and by hepatotoxicity in 0.6% of patients.

Concurrent elevations in AST or ALT ≥3 times the ULN and total bilirubin ≥2 times the ULN, with normal alkaline phosphatase, occurred in 0.6% of patients.

Interstitial Lung Disease (ILD)/Pneumonitis: Severe, life-threatening, or fatal ILD or pneumonitis can occur. ILD/pneumonitis occurred in 2.3% of patients, including 1.1% Grade 3/4. One fatal ILD case occurred at the 400 mg daily dose. Median time to first onset of ILD/pneumonitis was 3.8 months (range: 12 days to 11.8 months).

ILD/pneumonitis led to dose interruption in 1.1% of patients, dose reduction in 0.6% of patients, and permanent discontinuation in 0.6% of patients.

QTc Interval Prolongation: QTc interval prolongation can occur, which can increase the risk for ventricular tachyarrhythmias (e.g., torsades de pointes) or sudden death. IBTROZI prolongs the QTc interval in a concentration-dependent manner.

In patients who received IBTROZI and underwent at least one post baseline ECG, QTcF increase of >60 msec compared to baseline and QTcF >500 msec occurred in 13% and 2.6% of patients, respectively. 3.4% of patients experienced Grade ≥3. Median time from first dose of IBTROZI to onset of ECG QT prolongation was 22 days (range: 1 day to 38.7 months). Dose interruption and dose reduction each occurred in 2.8% of patients.

Significant QTc interval prolongation may occur when IBTROZI is taken with food, strong and moderate CYP3A inhibitors, and/or drugs with a known potential to prolong QTc. Administer IBTROZI on an empty stomach. Avoid concomitant use with strong and moderate CYP3A inhibitors and/or drugs with a known potential to prolong QTc.

Hyperuricemia: Hyperuricemia can occur and was reported in 14% of patients, with 16% of these requiring urate-lowering medication without pre-existing gout or hyperuricemia. 0.3% of patients experienced Grade ≥3. Median time to first onset was 2.1 months (range: 7 days to 35.8 months). Dose interruption occurred in 0.3% of patients.

Myalgia with Creatine Phosphokinase (CPK) Elevation: Myalgia with or without CPK elevation can occur. Myalgia occurred in 10% of patients. Median time to first onset was 11 days (range: 2 days to 10 months).

Concurrent myalgia with increased CPK within a 7-day time period occurred in 0.9% of patients. Dose interruption occurred in 0.3% of patients with myalgia and concurrent CPK elevation.

Skeletal Fractures: IBTROZI can increase the risk of fractures. ROS1 inhibitors as a class have been associated with skeletal fractures. 3.4% of patients experienced fractures, including 1.4% Grade 3. Some fractures occurred in the setting of a fall or other predisposing factors. Median time to first onset of fracture was 10.7 months (range: 26 days to 29.1 months). Dose interruption occurred in 0.3% of patients.

Embryo-Fetal Toxicity: Based on literature, animal studies, and its mechanism of action, IBTROZI can cause fetal harm when administered to a pregnant woman.

ADVERSE REACTIONS
Among patients who received IBTROZI, the most frequently reported adverse reactions (≥20%) were diarrhea (64%), nausea (47%), vomiting (43%), dizziness (22%), rash (22%), constipation (21%), and fatigue (20%).

The most frequently reported Grade 3/4 laboratory abnormalities (≥5%) were increased ALT (13%), increased AST (10%), decreased neutrophils (5%), and increased creatine phosphokinase (5%).

DRUG INTERACTIONS

Strong and Moderate CYP3A Inhibitors/CYP3A Inducers and Drugs that Prolong the QTc Interval: Avoid concomitant use.
Gastric Acid Reducing Agents: Avoid concomitant use with PPIs and H2 receptor antagonists. If an acid-reducing agent cannot be avoided, administer locally acting antacids at least 2 hours before or 2 hours after taking IBTROZI.
OTHER CONSIDERATIONS

Pregnancy: Please see important information in Warnings and Precautions under Embryo-Fetal Toxicity.
Lactation: Advise women not to breastfeed during treatment and for 3 weeks after the last dose.
Effect on Fertility: Based on findings in animals, IBTROZI may impair fertility in males and females. The effects on animal fertility were reversible.
Pediatric Use: The safety and effectiveness of IBTROZI in pediatric patients has not been established.
Photosensitivity: IBTROZI can cause photosensitivity. Advise patients to minimize sun exposure and to use sun protection, including broad-spectrum sunscreen, during treatment and for at least 5 days after discontinuation.

(Press release, Nuvation Bio, MAY 27, 2026, View Source [SID1234666117])

On May 27, 2026 Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for the treatment of oncology and hematological diseases, reported that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted and granted priority review to the New Drug Application (NDA) for ZEGFROVY (sunvozertinib) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins).

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ZEGFROVY was granted accelerated approval previously by China’s CDE and the U.S. Food and Drug Administration (FDA). The new sNDA is based on the results of WU-KONG28 study, a confirmatory, multinational, randomized phase 3 study evaluating ZEGFROVY versus platinum-containing chemo doublet as first-line treatment in advanced NSCLC patients with EGFR exon20ins. The study met its primary endpoint with statistically significant and clinically meaningful improvement in Progression Free Survival (PFS). The detailed data will be presented as a Late-Breaking Abstract (LBA) oral presentation at the upcoming 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

"The NDA acceptance and priority review designation for ZEGFROVY in first-line EGFR exon20ins NSCLC is an important step forward for us to make the drug available to our patients globally," said Dr. Xiaolin Zhang, CEO of Dizal. "Supported by positive results from WU-KONG28, we believe ZEGFROVY has the potential to be a practice-changing drug for this underserved patient population. We are working very hard to submit NDAs to other regulatory agencies globally as soon as possible."

Lung cancer with EGFR exon20ins are particularly challenging to treat due to its high heterogeneity. Currently, the first-line treatment for EGFR exon20ins NSCLC largely relies on chemotherapy-based regimens. There remains an unmet need for effective, chemotherapy-free, oral targeted therapies for newly diagnosed patients.

Globally, no oral targeted therapies have been approved for the first-line treatment of EGFR exon20ins NSCLC. ZEGFROVY monotherapy has received Breakthrough Therapy Designations (BTDs) from both the U.S. FDA and China’s CDE for this treatment-naïve patient population.

About ZEGFROVY(sunvozertinib)
ZEGFROVY is an irreversible EGFR inhibitor discovered by Dizal scientists targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity. ZEGFROVY is approved in the U.S. and China for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins), whose disease has progressed on or after platinum-based chemotherapy. The approval in China is based on the results of the pivotal WU-KONG6 study in platinum-based chemotherapy pretreated NSCLC with EGFR exon20ins. The U.S. approval is supported by WU-KONG1 Part B, a multinational pivotal study investigating the efficacy and safety of ZEGFROVY in the same indication.

In addition, ZEGFROVY also demonstrated encouraging anti-tumor activity in NSCLC patients with EGFR sensitizing, T790M, and uncommon mutations, as well as HER2 exon20ins.

ZEGFROVY showed a well-tolerated and manageable safety profile in the clinic. The most common drug-related TEAEs (treatment-emergent adverse event) were Grade 1/2 in nature and clinically manageable.

WU-KONG28, a multinational, randomized Phase 3 study conducted across 16 countries and regions evaluating ZEGFROVY as first-line treatment for patients with EGFR exon20ins NSCLC, met its primary endpoint.

Pre-clinical and clinical results of ZEGFROVY were published in peer-reviewed journals including Cancer Discovery, The Lancet Respiratory Medicine and Journal of Clinical Oncology.

(Press release, Dizal Pharma, MAY 27, 2026, View Source [SID1234666116])

On May 27, 2026 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biotech company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for autoimmune diseases, solid tumors and hematological malignancies indications, reported that following review by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA), the company has received CDE endorsement to conduct the pivotal Phase III CLINCH-3 study of ATG-022, a Claudin 18.2 (CLDN18.2) antibody-drug conjugate (ADC), for the treatment of CLDN18.2+ advanced gastric or gastroesophageal junction adenocarcinoma. The study is expected to be initiated in China first and is planned as a multi-regional clinical trial (MRCT).

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"Receiving CDE endorsement to conduct the pivotal Phase III CLINCH-3 study represents a defining milestone for Antengene." said Dr. Jay Mei, Founder, Chairman and Chief Executive Officer of Antengene. "This achievement underscores Antengene’s fully integrated R&D capabilities, from the design and discovery of novel molecules to clinical translation and registrational development. The Breakthrough Therapy Designation previously granted by CDE provided an important basis for our regulatory discussions on this pivotal study and enabled efficient feedback from CDE. We are highly encouraged by the potential of ATG-022 to address the significant unmet medical needs of patients with CLDN18.2+ advanced gastric or gastroesophageal junction adenocarcinoma, and we look forward to working closely with investigators to advance this important study."

The CLINCH-3 study will be led by Prof. Lin Shen from Peking University Cancer Hospital as the principal investigator. This is a randomized, controlled, open-label, multicenter Phase III clinical study designed to evaluate the efficacy and safety of ATG-022 versus treatment of investigator’s choice in patients with CLDN18.2+ advanced gastric or gastroesophageal junction adenocarcinoma. As a pivotal registrational study, CLINCH-3 is intended to support a future marketing approval application for ATG-022 as monotherapy for the treatment of CLDN18.2+ advanced gastric or gastroesophageal junction adenocarcinoma. The primary endpoints of the study are progression-free survival as assessed by independent review committee (PFS by IRC) and overall survival (OS). Secondary endpoints include objective response rate (ORR), duration of response (DOR), disease control rate (DCR), safety, and other measures. The initiation of this pivotal study is supported by encouraging results from the Phase I/II CLINCH study, which showed that ATG-022, as monotherapy, demonstrated a differentiated efficacy and safety profile in patients with advanced gastric or gastroesophageal junction adenocarcinoma. As of December 25, 2025, among patients whose tumors had CLDN18.2 expression of IHC 2+ >20%, ATG-022 achieved ORRs of 46.7% and 40.0% at 1.8 mg/kg and 2.4 mg/kg, respectively, with corresponding DCRs of 86.7% and 90.0%. Median PFS (mPFS) was 6.97 months and 5.09 months, respectively, while median OS (mOS) was not yet reached in the 1.8 mg/kg cohort and was 14.72 months in the 2.4 mg/kg cohort. In the 1.8 mg/kg cohort, the incidence of Grade 3 or higher treatment-related adverse events (TRAEs) was 19.4%, highlighting a highly differentiated safety profile for an ADC. Together with its robust antitumor activity, encouraging survival outcomes and favorable tolerability, these data position ATG-022 as a potential best-in-disease therapy for gastric cancer or gastroesophageal junction adenocarcinoma.

"Advanced gastric and gastroesophageal junction adenocarcinoma remains one of the most difficult solid tumors to treat, and the challenge is particularly acute in the 3L setting, where current options, including chemotherapy, anti-angiogenic agents and immunotherapy, provide limited efficacy, low objective response rates and insufficient survival benefit," said Professor Lin Shen of Peking University Cancer Hospital, principal investigator of the CLINCH-3 study. "ATG-022 has shown a compelling clinical profile as monotherapy at 1.8 mg/kg, with strong anti-tumor activity, meaningful survival benefit and a favorable safety profile. The CDE endorsement to conduct this pivotal Phase III study represents an important step toward potentially transforming the treatment landscape for patients with CLDN18.2+ advanced gastric or gastroesophageal junction adenocarcinoma. I am pleased to lead CLINCH-3 and look forward to working with Antengene to bring this promising therapy to more patients."

Antengene will continue to advance a comprehensive clinical development strategy for ATG-022 across multiple settings, including its pivotal monotherapy study in advanced gastric or gastroesophageal junction adenocarcinoma, ongoing combination studies with anti-PD-1 therapy and chemotherapy in the 1L gastric cancer setting, and further exploration in other CLDN18.2+ solid tumors, including tumor types beyond the digestive system where encouraging efficacy signals with confirmed tumor responses, have been observed. Through this strategy, the company aims to maximize the clinical potential of ATG-022 and bring innovative, impactful therapies to patients in China and around the world.

(Press release, Antengene, MAY 27, 2026, View Source [SID1234666115])