On August 19, 2026 Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs" or the "Company," Stock Code: 9887.HK) reported that the full abstract of the Phase II clinical study evaluating its proprietary drug candidate LBL-024 (Opamtistomig, a PD-L1/4-1BB bispecific antibody) in combination with chemotherapy as a first-line treatment for non-small cell lung cancer ("NSCLC") has been published on the official website of the World Conference on Lung Cancer (the "WCLC"). Based on data analyzed as of March 6, 2026, LBL-024 in combination with chemotherapy demonstrated an encouraging antitumor activity in the overall population, with robust tumor shrinkage observed in both the squamous and non-squamous NSCLC. The abstract data were based on a median follow‑up of 3.6 months. Updated data with over 7 months of follow‑up will be presented in an oral presentation at WCLC on September 14, 2026.

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According to the abstract, among 60 efficacy-evaluable patients with locally advanced or metastatic NSCLC who received LBL-024 in combination with chemotherapy as first-line treatment, the objective response rate (ORR) was 65.0% and the disease control rate ("DCR") was 95.0%. In the squamous subgroup, the ORR was 77.4% and the DCR was 96.8%, while in the non-squamous subgroup, the ORR was 51.7% and the DCR was 93.1%. The overall safety profile was manageable, with no new safety signals identified.

Importantly, the abstract data reflect only 3.6 months of median follow-up at the time of data cutoff, and updated results based on more than 7 months of follow‑up, to be presented at WCLC are expected to provide further insights into the durability and depth of response. With longer treatment and follow-up, continued tumor shrinkage has been observed in some patients, accompanied by an upward trend in ORR and a favorable trend in progression-free survival (PFS). These findings further support the potential of LBL-024’s differentiated dual-target immune mechanism, designed to both "release the brake and press the accelerator," and its potential to advance a new-generation "IO 2.0" treatment approach in NSCLC.

LBL‑024 is currently being evaluated in 11 clinical studies across multiple tumor types and has demonstrated encouraging efficacy signals across several indications. Data generated to date across its first seven clinical indications have demonstrated promising therapeutic potential, further supporting the broad development potential of this novel PD-L1/4-1BB bispecific antibody.

Executive Commentary

Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, said: "With extended follow‑up, we have observed continued tumor shrinkage in some patients, accompanied by an upward trend in ORR. This encouraging signal suggests that, with additional treatment cycles and longer follow-up, the updated clinical data may further demonstrate the therapeutic potential of LBL‑024. At the WCLC annual meeting, taking place on September 12–15, we will present updated data from more than 7 months of follow-up in an oral presentation, including the updated ORR, 6-month PFS rate, and subgroup analyses by PD-L1 expression levels in both squamous and non-squamous NSCLC. The encouraging efficacy and manageable safety profile observed to date further supports the potential of LBL-024 as a differentiated IO 2.0 approach with broad applicability across tumor types. We will continue to advance the clinical development and regulatory programs for LBL-024 with the goal of bringing this innovative treatment to patients with significant unmet medical needs as quickly as possible."

About NSCLC
According to data from the International Agency for Research on Cancer ("IARC") in 2022, there are approximately 2.48 million new cases of lung cancer and approximately 1.817 million lung cancer-related deaths worldwide each year. According to data published by the National Cancer Center of China, there were approximately 1.176 million new lung cancer cases and approximately 743 thousand lung cancer-related deaths in China in 2024. NSCLC accounts for approximately 85% of all lung cancer cases. Due to the aggressive nature of NSCLC and the lack of effective early screening methods, approximately 70% of patients with NSCLC in China are diagnosed at an advanced stage.

Patients with NSCLC harboring driver gene mutations such as epidermal growth factor receptor ("EGFR"), anaplastic lymphoma kinase ("ALK") and ROS proto-oncogene 1 ("ROS1") may benefit from corresponding targeted therapies, while patients without driver gene mutations still rely primarily on immunotherapy in combination with chemotherapy. Further prolonging survival and achieving more durable and deeper responses remain key unmet needs in clinical practice. In squamous NSCLC, driver gene mutations are rare and patients generally cannot benefit from targeted therapies. Commonly used drugs such as pemetrexed and bevacizumab are also generally unsuitable for squamous NSCLC due to efficacy or safety concerns, resulting in limited treatment options. Although PD-1/PD-L1 inhibitors in combination with chemotherapy have expanded treatment options for patients with squamous NSCLC, prognosis remains poorer than in non-squamous NSCLC due to differences in biology, clinical features and treatment responses, with a median progression-free survival ("PFS") of only 5 to 8 months and a median overall survival ("OS") of 17 to 27 months, highlighting a significant unmet medical need for more effective treatment options.

About Opamtistomig
Opamtistomig (LBL-024) is emerging as a next-generation pan-cancer backbone therapy with potential overall survival (OS) benefit that simultaneously targets PD-L1 and the co-stimulatory receptor 4-1BB. Developed using Leads Biolabs’ proprietary X-Body bispecific platform, Opamtistomig is designed to simultaneously block PD-1/L1 immune suppression and conditionally activate 4-1BB, an agonist pathway, resulting in a potent and synergistic anti-tumor immune response. It has a safety profile comparable to PD-1/PD-L1 inhibitors and demonstrates broader-spectrum anti-cancer potential. To date, Opamtistomig has demonstrated first- or best-in-class potential in Phase II or registrational clinical trials across multiple indications, including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), biliary tract cancer (BTC), and extrapulmonary neuroendocrine carcinoma (EP-NEC).

As the first 4-1BB–targeting bispecific antibody globally to advance to a single-arm pivotal trial as monotherapy, Opamtistomig has been evaluated in 13 solid tumor indications in China, including 1 pivotal registration trial and 8 proof-of-concept studies. These cover EP-NEC, NSCLC, SCLC, BTC, ovarian cancer (OC), esophageal squamous cell carcinoma (ESCC), hepatocellular carcinoma (HCC), gastric cancer (GC), triple-negative breast cancer (TNBC), malignant melanoma, and other areas with high unmet medical needs.

Mechanistically, 4-1BB agonism can reactivate exhausted T cells and promote robust T-cell proliferation, offering significant promise for PD-1/PD-L1–resistant or immunologically "cold" tumors, and has the potential to deliver durable, long-tail survival benefits. Recognizing its clinical potential, Opamtistomig received Breakthrough Therapy Designation (BTD) from China’s National Medical Products Administration (NMPA) in October 2024, and Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of neuroendocrine carcinoma in November 2024. Additionally, in January 2026, Opamtistomig was granted Fast Track Designation (FTD) by the FDA and ODD by the European Commission for the treatment of EP-NEC, further underscoring its potential to address unmet medical needs in this patient population.

(Press release, Nanjing Leads Biolabs, AUG 19, 2026, View Source [SID1234670240])

On August 19, 2026 NTx Bio, a leader in next-generation biomanufacturing technologies, reported that its NTxscribe CORE platform is being used by researchers at Baylor College of Medicine to manufacture mRNA for a personalized dendritic cell vaccine (DCV) now in clinical use in an industry-sponsored Phase 1 trial for refractory melanoma, marking one of the first publicly disclosed clinical translations of NTx’s continuous-flow manufacturing platform.

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At Baylor, researchers use NTxscribe to amplify tumor mRNA derived from very small surgical biopsies, a foundational step in the double-loaded dendritic cell vaccine platform underlying Diakonos Oncology’s DOC1021 (dubodencel) platform. The mRNA produced by NTxscribe faithfully maintains the full-length range of the patient’s tumor transcriptome, preserving the integrity of longer sequences so that the material carried into the vaccine reflects a full representation of tumor antigens.

"Manufacturing consistency is one of the biggest hidden challenges in personalized cell and gene therapies, because manufacturing processes for these therapies are largely highly manual," said Joan Haab, Ph.D., CEO of NTx Bio. "Seeing NTxscribe support a program like DOC1021, from a patient’s own tumor DNA all the way to a dosed patient, is exactly the kind of real-world validation we set out to deliver when we built this platform."

The refractory melanoma trial is evaluating DOC1021 in patients whose disease no longer responds to standard treatments such as immune checkpoint inhibitors, a population with limited remaining options. DOC1021 is designed to reprogram a patient’s own immune cells to mount a targeted response against tumor.

"Working with patient-derived material means we don’t get the luxury of a standardized starting point," said William Decker, Ph.D., Professor of Pathology & Immunology at Baylor College of Medicine and inventor of the DOC1021 technology. "Automating the mRNA generation step with NTxscribe is solving the most challenging, time intensive, and variable step in the manufacturing process so we can focus our attention on delivering a high-quality product to more patients."

"NTxscribe has really improved reproducibility while virtually eliminating batch to batch variability," agreed Vanaja Konduri, Ph.D., Assistant Professor of Immunology and inventor of the mRNA amplification procedure.

NTxscribe’s role in the Baylor/Diakonos workflow reflects the same continuous-flow, hollow fiber bioreactor (HFBR) architecture behind NTx’s recently launched NTxscribe FLEX system, and highlights the platform’s benefits for translational and clinical programs, including:

Automating a hands-on process: Generate purified mRNA with minimal manual intervention, eliminating the need for skilled labor and multiple pieces of equipment.
Supporting reproducible output: Automation drives reproducibility. By eliminating certain manual steps and individual unit operations, FLEX ensures a reproducible and quality output every time.
Simplifying change-over and scale: Single-use, fully closed cassettes allow straightforward change-over between patient samples and a clear path to higher throughput.
Shortening translational timelines: The benchtop platform and scalable output makes FLEX suitable for early phase clinical programs while also supporting higher volumes required at later stages.

(Press release, Baylor College of Medicine, AUG 19, 2026, View Source [SID1234670239])

On August 19, 2026 KaliVir Immunotherapeutics, Inc., a clinical-stage biotechnology company developing cutting-edge, multi-mechanistic oncolytic immunotherapy programs, reported the closing of a $14 million extension of its Series A financing. The financing was led by Company K Partners, with participation from SV Investment, Flexus Partners, as well as continued support from existing investors including affiliates of Nextrans and Quad Investment Management.

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The financing brings the total capital raised in the Company’s Series A financing to $25 million, further strengthening KaliVir’s balance sheet and supporting the continued advancement of its lead clinical program, VET3-TGI.

Proceeds from the financing will be used to support the ongoing clinical development of VET3-TGI, including patient enrollment in KaliVir’s STEALTH-001 Phase 1/1b clinical trial in patients with advanced solid tumors, as well as for general corporate purposes. In conjunction with the financing, Woo Young Kim of Company K Partners, Kwang Ha Jung of SV Investment, and JP Hong of Flexus Partners have joined KaliVir’s Board of Directors.

"This financing reflects the confidence of both new and existing investors in the potential of our VET platform and the progress we have made advancing VET3-TGI in the clinic," said Helena Chaye, PhD, JD, Chief Executive Officer of KaliVir Immunotherapeutics. "With this additional capital, we are well positioned to continue executing on the STEALTH-001 study, advance key clinical milestones and further evaluate the potential of VET3-TGI as a differentiated oncolytic immunotherapy for patients with advanced solid tumors. We are pleased to welcome seasoned life sciences investors Woo Young Kim, Kwang Ha Jung and JP Hong to our Board and look forward to their insights and partnership as we continue to build the company."

About VET3-TGI and the STEALTH-001 Study
VET3-TGI is a novel oncolytic virus developed using KaliVir’s proprietary VET platform, designed to selectively replicate in tumor cells, stimulate local immune responses and remodel the immunosuppressive tumor microenvironment through the expression of IL-12 and a TGFβ inhibitor. The STEALTH-001 study is a first-in-human, open-label, Phase 1/1b dose-escalation and expansion trial evaluating VET3-TGI administered by intratumoral injection or intravenous infusion, both as a monotherapy and in combination with atezolizumab in patients with pathologically confirmed, advanced, unresectable or metastatic solid tumors. The study continues to progress as planned through its dose escalation phase.

(Press release, KaliVir Immunotherapeutics, AUG 19, 2026, View Source [SID1234670238])

On August 19, 2026 Flatiron Health reported its presence at the IASLC 2026 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer, with three research acceptances highlighting real-world evidence that advances precision medicine and treatment optimization in non-small cell lung cancer (NSCLC). The presentations demonstrate how Flatiron’s high-quality, longitudinal data reveals clinical insights that shape oncology decision-making across the globe.

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"Recent advances have fundamentally transformed treatment options for lung cancers, and our research highlights where and when these novel treatments are having an impact for patients in real-world practice," said Emily Castellanos, MD, MPH, Senior Medical Director and Head of Research Oncology at Flatiron Health. "Our WCLC research, spanning disease states, biomarker-defined subgroups, and treatment types, illuminates how to translate innovation into practice. By capturing this real-world complexity at scale through our Panoramic Database, we’re generating the evidence needed to guide clinicians in a rapidly evolving treatment landscape—enabling them to deliver personalized medicine to any patient that is in front of them."

Flatiron’s research at WCLC 2026 underscores the company’s position as the gold standard in oncology intelligence, delivering the trusted insights needed to guide the highest-stakes decisions in cancer care and drug development.

Research highlights include:

Genomic alterations without approved first-line targeted therapies in patients with NSCLC PD-L1 ≥50% treated with immunotherapy: Real-world evidence revealing treatment patterns and outcomes for patients with high PD-L1 expression who lack approved targeted therapy options, demonstrating how immunotherapy is being deployed in clinical practice and informing precision medicine strategies.
Real-world outcomes with chemoradiation and durvalumab consolidation in stage III KRAS G12C–mutant NSCLC in the US: Examining real-world treatment effectiveness and durability of durvalumab consolidation following chemoradiation in patients with stage III KRAS G12C-mutant disease, providing evidence on how emerging targeted approaches are translating to clinical outcomes.
Real-world treatment duration and outcomes among patients with early-stage NSCLC receiving adjuvant osimertinib: A retrospective cohort study analyzing treatment patterns, adherence, and survival outcomes in early-stage NSCLC patients receiving adjuvant osimertinib, revealing how precision medicine is reshaping the adjuvant treatment landscape.
These findings underscore Flatiron’s ability to transform patient experiences into actionable intelligence—connecting evidence to practice and enabling clinicians and researchers to make clearer decisions that drive better outcomes.

Join Flatiron Health at WCLC 2026 and follow Flatiron Health on X and LinkedIn for more updates.

Abstracts and Poster Presentations

Genomic alterations without approved 1L targeted therapies in patients with NSCLC PD-L1 ≥50% treated with immunotherapy
J.W. Riess, S. Viswanathan, S.K. Mhatre, S. Ding, I.K. Dhillon, S. Lambert, X. Ma, B. Herzberg
Author Affiliations: UC Davis Comprehensive Cancer Center, Gilead Sciences, Flatiron Health, Columbia University
Session: P1.106-234. Resectable NSCLC (Stages I–III)
Date/Time: Sunday, September 13, 2026 at 10:30 AM KST / UTC +9; 1h 30m
Location: Exhibits and Posters, Hall C, 3F

Real-world outcomes with chemoradiation and durvalumab consolidation in stage III KRAS G12C–mutant NSCLC in the US
D. Bruno, K. Sheffield, A. Brnabic, Q. Ma, R. Singh, K. Thoele, T. Puri, C.F. Avile, K. Schwed, M. Bye, A.M. Mehta, M. Pesavento
Author Affiliations: City of Hope Cancer Center, Eli Lilly and Company, Flatiron Health
Session: P2.249-276. Unresectable NSCLC (Stages I–III)
Date/Time: Monday, September 14, 2026 at 10:30 AM KST
Location: Exhibits and Posters, Hall C, 3F

Real-world treatment duration and outcomes among patients with early-stage NSCLC receiving adjuvant osimertinib: a retrospective cohort study
E. Singhi, X. Ma, C. Rinaldi, L. Kovacevic, Y. Liang, D. Simmons, M. Lupicka, I. Arslan, M. Sandelin, J. Pye, D. Nguyen
Author Affiliations: The University of Texas MD Anderson Cancer Center, Flatiron Health, AstraZeneca, City of Hope
Date/Time: Tuesday, September 15, 2026 at 11:55 AM KST
Location: Exhibits and Posters, Hall C, 3F

(Press release, Flatiron Health, AUG 19, 2026, View Source [SID1234670237])

On August 19, 2026 Taiho Oncology, Inc. and Cullinan Therapeutics, Inc. (Nasdaq: CGEM) reported that results from the planned interim analysis of the Phase 3 REZILIENT3 trial have been selected for presentation in the Presidential Symposium 2 at the International Association for the Study of Lung Cancer’s (IASLC) 2026 World Conference on Lung Cancer (WCLC), to be held September 12-15, 2026, in Seoul, South Korea. REZILIENT3 evaluates zipalertinib plus chemotherapy versus chemotherapy alone in the first-line treatment of patients with epidermal growth factor receptor (EGFR) exon 20 insertion mutation-positive non-small cell lung cancer (NSCLC).

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The Presidential Symposium 2 is a premier plenary session featuring notable advances in lung cancer research and treatment with the potential to change clinical practice.

Session information for the abstract is listed below. Full abstract details will be available via the conference website in accordance with IASLC embargo policies.

Title: Zipalertinib plus Chemotherapy for 1st-line NSCLC with EGFR Exon 20 Insertions: Results from the Phase 3 Trial (REZILIENT3)
Presenting Author: Dr. Daniel Tan Shao Weng, Duke Health, Singapore
Session Name: PL03 Presidential Symposium 2 Including Lectureship Award Presentations
Session Type: Presidential Symposium
Session Date: Monday, September 14, 2026
Session Time: 8 a.m. KST
Location: Plenary, Hall D2, 3F

About the REZILIENT3 Trial

This multicenter, randomized, controlled, open-label global trial enrolled 285 adults with previously untreated, locally advanced or metastatic non-squamous NSCLC with EGFR exon 20 insertion mutations. The primary objective of this trial is to assess progression-free survival in the zipalertinib plus chemotherapy arm versus the chemotherapy arm.

About Zipalertinib

Zipalertinib (development code: CLN-081/TAS6417) is an orally available small molecule designed to target activating mutations in EGFR. The molecule was selected because of its ability to inhibit EGFR variants with exon 20 insertion mutations. Zipalertinib is designed as a next generation, irreversible EGFR inhibitor for the treatment of a genetically defined subset of patients with non-small cell lung cancer. Zipalertinib is investigational and has not been approved by any health authority.

Zipalertinib is being developed by Taiho Oncology, Inc., its parent company, Taiho Pharmaceutical Co., Ltd., and in collaboration with Cullinan Therapeutics, Inc. in the U.S.

About EGFR Exon 20 Insertion Mutations

NSCLC is a common form of lung cancer and up to 4% of all cases globally have EGFR ex20ins.1 In the United States, approximately 16% of patients with NSCLC harbor EGFR mutations,1 with insertions at exon 20 accounting for up to 12% of these mutations.

(Press release, Taiho, AUG 19, 2026, View Source [SID1234670236])