On August 5, 2026 Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs" or the "Company," Stock Code: 9887.HK) reported that its Phase II clinical study evaluating Opamtistomig (LBL-024), a proprietary PD-L1/4-1BB bispecific antibody, in combination with bevacizumab for the treatment of first-line hepatocellular carcinoma (HCC) has successfully completed the safety run-in phase assessment following expert review and has advanced into the expansion phase. The study is led by Professor Zhou Jian, President of Zhongshan Hospital, Fudan University, and Academician of the Chinese Academy of Sciences.

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Preliminary clinical data demonstrated that Opamtistomig in combination with bevacizumab has shown encouraging anti-tumor activity and a favorable safety profile in patients with HCC, supporting further clinical evaluation in the expansion phase.

HCC represents a significant global health burden and is the fourth most common malignant tumor and the second leading cause of cancer-related mortality in China, with approximately 368,000 new cases and 317,000 deaths recorded annually. Due to its often insidious onset, fewer than 30% of patients are eligible for potentially curative treatment at diagnosis, making systemic anti-tumor therapies essential for patients with intermediate-to-advanced disease.

Currently, PD-1/PD-L1 inhibitors in combination with bevacizumab have become one of the first-line standard treatments for advanced HCC both in China and globally; however, median overall survival is only approximately 19 to 20 months, median progression-free survival is less than 7 months, and the objective response rate does not exceed 30%. These limitations highlight the urgent need for more effective and durable treatment strategies.

Opamtistomig has demonstrated promising efficacy signals and broad therapeutic potential across multiple tumor types, including extrapulmonary neuroendocrine carcinoma (EP-NEC), non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC) and biliary tract cancer (BTC). Powered by the proprietary X-body platform, which enables tumor-localized activation of 4-1BB signaling, Opamtistomig has maintained a favorable safety profile across nearly 800 treated patients, further supporting its potential as a next-generation IO 2.0 pan-tumor immunotherapy platform. The encouraging clinical findings in HCC further strengthen the clinical validation of Opamtistomig’s differentiated mechanism and therapeutic potential.

Executive Commentary
Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, said: "Advancing this Phase II study of Opamtistomig in first-line HCC into expansion phase is an important milestone in validating its potential as a pan-tumor immunotherapy. While PD-1/PD-L1-based combination therapies have become the standard of care for first-line HCC, significant unmet medical needs remain. The encouraging efficacy signals observed with Opamtistomig in combination with bevacizumab provide further confidence in its potential to improve treatment outcomes for patients with HCC. We will continue to accelerate clinical development and global registration efforts to bring this innovative therapy to patients worldwide as quickly as possible."

About HCC
According to data published by the World Health Organization ("WHO"), the global annual number of new HCC cases reached 865,000 in 2022, ranking sixth among malignant tumors, with 758,000 deaths, ranking third among malignant tumors. HCC is particularly prevalent in China, where it is the fourth most common malignant tumor and the second leading cause of cancer-related deaths. Although China’s population accounts for only 18.4% of the global population, the country accounts for 368,000 new HCC cases and 317,000 deaths annually, representing 42.5% and 41.8% of the global totals, respectively.

HCC is the predominant type of primary liver cancer, accounting for approximately 85% to 90% of cases. It has an insidious onset and is highly aggressive, with most patients diagnosed at an intermediate to advanced stage and a correspondingly poor prognosis. The five-year survival rate is 15% to 19% in North America, compared with only 12.1% in China, posing a serious threat to the health and lives of the Chinese population and making the reduction of the HCC disease burden a major public health issue requiring urgent attention in China.

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 four indications: 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. 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 5, 2026, View Source [SID1234669755])

On August 5, 2026 Fusion Antibodies plc (AIM: FAB), specialists in pre-clinical antibody discovery, engineering and supply for both therapeutic drug and diagnostic applications, reported that IP Australia has issued a notice of acceptance in respect of the Company’s Australian patent application no. 2019365135 (the "Patent Application").

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The Patent Application entitled "Antibody Library and Method", covers two families of antibodies, and the methods for designing such antibody libraries. The patent, once granted, is expected to be complementary to Fusion’s offering to provide "Opti" designed antibody libraries for a range of applications including: Antibody Discovery; Affinity Maturation; and Sequence Optimisation.

The Company continues to progress additional patent applications in respect of the OptiMAL Library in several other territories worldwide including Europe and China.

Receipt of a notice of acceptance indicates that the claims in the Patent Application are patentable and does not in itself represent a grant of patent rights. Fusion anticipates that the patent will be granted in due course, following completion of certain administrative requirements, including payment of the applicable fees, and the successful completion of a three-month gazetting period.

(Press release, Fusion Antibodies, AUG 5, 2026, View Source [SID1234669754])

On August 5, 2026 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, reported financial results and operational highlights for the second quarter ended June 30, 2026.

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"At Adicet, we continue to advance prula-cel toward our next important clinical milestone, with a Phase 1 clinical update now expected in the third quarter of 2026. The additional follow-up time will allow us to deliver a more comprehensive and mature dataset, including 22 LN/SLE patients with a minimum of 6 months of follow-up, 13 of whom are expected to have reached at least 12 months of follow-up," said Chen Schor, President and Chief Executive Officer of Adicet Bio. "We also had productive interactions with the FDA to align on overall clinical design for a potential pivotal trial for prula-cel in LN, further supporting a clear regulatory path forward. Furthermore, we anticipate sharing additional clinical updates for prula-cel in the second half of 2026 in patients with systemic sclerosis."

Mr. Schor continued, "Beyond prula-cel, we are continuing to advance ADI-212 toward Phase 1 alongside our differentiated in vivo CAR-T platform and pipeline targeting hematologic malignancies and solid tumors. With several planned milestones ahead in 2026, including anticipated clinical data readouts in LN and SLE in the third quarter, clinical data in systemic sclerosis in the second half of the year, and an update on our in vivo CAR T platform and pipeline, we look forward to executing our strategic priorities and positioning the company for long-term value creation."

Second Quarter 2026 and Recent Operational Highlights:

Autoimmune diseases

Phase 1 prula-cel clinical update in LN and SLE patients expected in 3Q/2026. The Company plans to provide its next clinical update in the third quarter of 2026 for its ongoing Phase 1 clinical trial evaluating prula-cel across multiple autoimmune conditions. The update is expected to include data from 22 patients with LN and SLE (16 LN/ 6 SLE) who will have at least 6 months of follow-up, including 13 patients who are expected to have reached at least 12 months of follow-up. Following alignment with the FDA in November 2025, LN and SLE patients in current and future studies may be dosed with prula-cel in an outpatient setting.
Productive FDA interactions to align on overall design for potential pivotal trial design. Based on recent interactions with the FDA, the Company is advancing a potential pivotal trial design in LN and supporting planned start-up activities for a pivotal program anticipated to commence in the second half of 2026, subject to regulatory clearance. The Company plans to provide more details on the potential pivotal trial design as part of its comprehensive clinical update anticipated in the third quarter of 2026.
Solid tumor indications

Regulatory submission for ADI-212 expected in the third quarter of 2026, with Phase 1 initiation anticipated in the fourth quarter of 2026, pending regulatory clearance. Adicet continues to advance ADI-212, its next-generation gene-edited, armored cell therapy candidate targeting prostate-specific membrane antigen (PSMA), engineered with a novel CAR binder designed to enhance tolerability and tumor specific recognition. The program combines membrane tethered IL-12 armoring and CRISPR/Cas9-mediated disruption of subunit 12 of the mediator complex (MED12) designed to improve potency in solid tumors and enable multiple anti-tumor mechanisms within the tumor microenvironment. Adicet expects to submit a regulatory filing for ADI-212 for the treatment of mCRPC in the third quarter of 2026, with initiation of Phase 1 enrollment anticipated in the fourth quarter of 2026, subject to regulatory clearance.
In Vivo CAR-T Program and Pipeline

Advancing innovation through a differentiated cell therapy platform. Adicet is developing a differentiated in vivo CAR-T platform and pipeline targeting hematologic malignancies and solid tumors. A comprehensive update on the platform and pipeline is anticipated in the second half of 2026.
Corporate Update

Lloyd Klickstein, M.D., Ph.D. appointed Interim Chief Medical Officer. Following the departure of Dr. Julie Maltzman, Dr. Klickstein, who currently serves on the board of the Company, has been appointed Interim Chief Medical Officer and will lead all clinical development and medical affairs activities while the Company conducts a search for a permanent Chief Medical Officer. Dr. Klickstein is a physician-scientist and biotechnology executive with more than 20 years of experience in rheumatology, immunology and translational medicine. He completed clinical training in rheumatology and immunology at the Brigham and Women’s Hospital and has held senior leadership roles at Novartis, Versanis Bio, which was acquired by Eli Lilly, Adicet Bio, and currently serves as Board Chair of the Lupus Foundation of New England and CEO of Koslapp Therapeutics.
Financial Results for Second Quarter 2026:

Research and Development (R&D) expenses were $18.5 million for the three months ended June 30, 2026. Non-cash stock-based compensation expense included in R&D expense was $0.9 million for the second quarter of 2026.
General and Administrative (G&A) expenses were $3.9 million for the three months ended June 30, 2026. Non-cash stock-based compensation expense included in G&A expense was $0.6 million for the second quarter of 2026.
Net loss was $21.4 million, or a net loss of $1.99 per basic and diluted share for the three months ended June 30, 2026. This net loss includes non-cash charges of $2.8 million that consisted primarily of share-based compensation, depreciation expenses, and noncash lease expense.
Cash, cash equivalents and short-term investments were $118.2 million as of June 30, 2026. The Company expects that current cash, cash equivalents and short-term investments as of June 30, 2026, will be sufficient to fund its operating expenses into the second half of 2027.

(Press release, Adicet Bio, AUG 5, 2026, View Source [SID1234669753])

On August 5, 2026 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported that it has submitted an application to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for approval of the Signatera test in muscle-invasive bladder cancer (MIBC) as a companion diagnostic (CDx).

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The submission advances Natera’s growing presence in Japan, where Signatera received PMDA approval in colorectal cancer in June, becoming the country’s first PMDA-approved molecular residual disease (MRD) test.

The MIBC application is supported by data from IMvigor011, a randomized, double-blind Phase 3 clinical trial. It also builds on recent milestones for Signatera in MIBC: the U.S. FDA’s approval of Signatera CDx as a companion diagnostic for adjuvant atezolizumab (Tecentriq); and a Category 1 recommendation for Signatera MRD-guided adjuvant atezolizumab in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Bladder Cancer.

Bladder cancer affects more than 34,000 people in Japan each year.1 Globally, approximately 20–25% of newly diagnosed bladder cancers are muscle-invasive.2 MIBC is a more aggressive form of the disease, associated with higher recurrence risk and treatment complexity.

"Signatera is a proven tool in bladder cancer management, and this submission reflects our commitment to bringing precision diagnostics to patients in Japan," said Alexey Aleshin, M.D., corporate chief medical officer and general manager of oncology at Natera. "We look forward to engaging with the PMDA and to improving outcomes for patients around the world."

(Press release, Natera, AUG 5, 2026, View Source [SID1234669752])

On August 5, 2026 Summit Therapeutics Inc. (NASDAQ: SMMT) reported the expansion of its global registration-enabling clinical development program for the novel, potential first-in-class investigational bispecific antibody ivonescimab, into urothelial carcinoma, or bladder cancer, with the initiation of the global, multi-regional Phase II/III HARMONi-GU1 trial.

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Summit is starting a randomized Phase II/III clinical study, HARMONi-GU1, to evaluate ivonescimab plus the antibody-drug conjugate (ADC) enfortumab vedotin (EV) compared to pembrolizumab plus EV as first-line therapy in patients with previously untreated locally advanced or metastatic urothelial carcinoma. The comparator arm regimen is widely considered the global standard of care.

Global clinical trial site activations for HARMONi-GU1 will begin later this year. The multiregional study intends to enroll approximately 800 patients through Phase III. The Phase II will identify the recommended Phase III dose of ivonescimab in combination with EV. The Phase III primary endpoints are progression-free survival (PFS) and overall survival (OS).

"The initiation of HARMONi-GU1 marks another important step in the continued expansion of our global ivonescimab development program into additional tumor types where significant unmet need remains," said Dr. Maky Zanganeh, President and Co-CEO of Summit Therapeutics. "Because both angiogenesis and immune evasion are important features of urothelial carcinoma biology, we believe ivonescimab’s tetravalent, intentionally-engineered PD-1 / VEGF bispecific mechanism offers a compelling scientific rationale for evaluation in bladder cancer. Despite recent progress in the treatment of locally advanced or metastatic urothelial carcinoma, many patients still face disease progression and poor long-term outcomes. We believe there remains an important opportunity to advance the standard of care with new treatment approaches that have the potential to deliver deeper, more durable responses and meaningfully extend survival."

Summit’s internal sponsored pipeline and other clinical collaborations span several tumor types, including lung, colorectal, pancreatic, head and neck, kidney, and, now, bladder cancer. When including Akeso-sponsored clinical trials conducted in China, a total of four Phase III ivonescimab clinical studies have read out to date, all four with positive data, in non-small cell lung cancer. With the addition of HARMONi-GU1, ivonescimab is being evaluated in a total of 16 Phase III clinical trials across multiple tumor types and settings.

"The initiation of HARMONi-GU1 reflects our ambition to realize the full potential of ivonescimab across a broad range of solid tumors," said Robert W. Duggan, Chairman and Co-CEO of Summit Therapeutics. "What began as a single development program has evolved into one of the most expansive and advanced global oncology development efforts for a novel bispecific antibody. We believe the breadth of evidence generated to date, together with the scale of the ongoing clinical program, positions ivonescimab as a potentially important future treatment option for patients worldwide. Our commitment is to move rapidly, generate high-quality clinical evidence globally, and evaluate ivonescimab’s potential wherever we believe it can make the greatest difference for patients."

About Urothelial Carcinoma (Bladder Cancer)

Urothelial carcinoma (UC) is the most common type of bladder cancer and accounts for approximately 90% of all bladder cancer cases.1 Bladder cancer is among the most commonly diagnosed cancers worldwide, with an estimated 635,264 new cases and 227,626 deaths globally in 2024.2 In the United States, approximately 84,530 new cases of bladder cancer are expected to be diagnosed in 2026.3

Locally advanced or metastatic urothelial carcinoma (la/mUC) is associated with poor clinical outcomes and limited long-term survival. Approximately 5-10% of patients are diagnosed with advanced or metastatic disease at presentation, and many others experience recurrence or progression following treatment for earlier-stage disease.4 Despite recent therapeutic advances, many patients with previously untreated la/mUC continue to experience disease progression, highlighting the need for new treatment approaches that can deliver more durable disease control and improve survival outcomes.5

About Ivonescimab

Ivonescimab, known as SMT112 in Summit’s license territories, North America, South America, Europe, the Middle East, Africa, and Japan, and as AK112 outside of Summit’s license territories, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. By design, ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity to PD-1 when in the presence of VEGF.

This design is intended to differentiate ivonescimab as there is potentially higher expression (presence) of both PD-1 and VEGF in tumor tissue and the tumor microenvironment (TME) as compared to normal tissue in the body. Summit believes ivonescimab’s specifically engineered tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) in the TME (Zhong, et al, iScience, 2025). This tetravalent structure, the intentional novel design of the molecule, and bringing these two targets into a single bispecific antibody with cooperative binding qualities have the potential to direct ivonescimab to the tumor tissue versus healthy tissue. The intent of this design, together with a half-life of 6 to 7 days after the first dose (Zhong, et al, iScience, 2025) increasing to approximately 10 days at steady state dosing, is to improve upon previously established efficacy thresholds, side effects, and safety profiles associated with prior approved drugs to these targets.

Ivonescimab was engineered by Akeso Inc. (HKEX Code: 9926.HK) and is currently utilized in multiple Phase III clinical trials. Over 4,000 patients have been treated with ivonescimab in clinical studies globally, and over 70,000 patients when considering those treated in a commercial setting in China, as noted by Akeso.

There are currently 16 Phase III clinical studies that are either announced, ongoing, or have been completed studying ivonescimab, five of which are Summit-sponsored global studies, one of which is a multiregional study sponsored by a cooperative group, and 10 of which are being or have been conducted in China by Akeso. Summit began its clinical development of ivonescimab in NSCLC, commencing enrollment in 2023 in two multiregional Phase III clinical trials, HARMONi and HARMONi-3. In 2025, Summit began enrolling patients in HARMONi-7. Summit expanded its Phase III clinical development program into colorectal cancer (CRC) in the fourth quarter of 2025 by initiating enrollment in HARMONi-GI3. In 2026, Summit announced initiation of HARMONi-GU1, a Phase II/III study in urothelial carcinoma (bladder cancer) with global clinical trial site activations planned to begin by the fourth quarter of 2026.

HARMONi is a Phase III clinical trial evaluating ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a third-generation EGFR TKI (e.g., osimertinib). Detailed results of the study were provided in September 2025, and a Biologics License Application (BLA) was submitted to the United States Food and Drug Administration (FDA) for marketing authorization, which the FDA accepted for filing in January 2026; the goal Prescription Drug User Fee Act (PDUFA) date is November 14, 2026.

HARMONi-3 is a Phase III clinical trial evaluating ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic, squamous or non-squamous NSCLC, irrespective of PD-L1 expression. The clinical trial is evaluating the two histologies as individual, separately powered cohorts with independent statistical powering.

HARMONi-7 is a Phase III clinical trial evaluating ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression.

HARMONi-GI3 is a Phase III clinical trial evaluating ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy in patients with first-line unresectable metastatic CRC.

HARMONi-GU1 is a Phase II/III clinical trial evaluating ivonescimab plus the antibody drug conjugate (ADC) enfortumab vedotin (EV) compared to pembrolizumab plus EV as first-line therapy in patients with previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC).

ILLUMINE is a Phase III study being conducted by GORTEC, a cooperative group dedicated to Head and Neck Oncology, in recurrent / metastatic head and neck squamous cell carcinoma (r/m HNSCC). ILLUMINE is a three-arm Phase III clinical trial designed to evaluate ivonescimab monotherapy, as well as ivonescimab in combination with ligufalimab, Akeso’s proprietary anti-CD47 monoclonal antibody, compared to monotherapy pembrolizumab in patients with PD-L1 positive r/m HNSCC.

Four Phase III ivonescimab clinical trials have read out to date, all four with positive data, in NSCLC. In addition to Summit’s positive HARMONi study, Akeso has had positive read-outs in three single-region (China), randomized Phase III clinical trials, HARMONi-A, HARMONi-2, and HARMONi-6, for ivonescimab in NSCLC, including a statistically significant overall survival benefit in both the HARMONi-A and HARMONi-6 studies. A manageable, consistent safety profile was achieved in each of these studies.

HARMONi-A was a Phase III clinical trial which evaluated ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with an EGFR TKI.

HARMONi-2 is a Phase III clinical trial evaluating monotherapy ivonescimab against monotherapy pembrolizumab in patients with locally advanced or metastatic NSCLC whose tumors have positive PD-L1 expression.

HARMONi-6 is a Phase III clinical trial evaluating ivonescimab in combination with platinum-based chemotherapy compared with tislelizumab, an anti-PD-1 antibody, in combination with platinum-based chemotherapy in patients with locally advanced or metastatic squamous NSCLC, irrespective of PD-L1 expression.

Akeso is actively conducting multiple Phase III clinical studies in settings outside of NSCLC, including biliary-tract cancer, triple-negative breast cancer, head and neck squamous cell carcinoma, small cell lung cancer, colorectal cancer, and pancreatic cancer.

Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. Ivonescimab was initially approved for marketing authorization in China in May 2024.

(Press release, Summit Therapeutics, AUG 5, 2026, View Source [SID1234669751])