On August 2, 2026 Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs" or the "Company," Stock Code: 9887.HK) reported that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has approved the investigational new drug (IND) application for an open-label, multicenter Phase Ib/II clinical trial of its proprietary PD-L1/4-1BB bispecific antibody, Opamtistomig (LBL-024), in combination therapy for metastatic colorectal cancer (mCRC). The study is designed to evaluate the safety and efficacy of Opamtistomig combination regimens in patients with mCRC and to explore potential predictive biomarkers. This marks an important step in expanding the indications for Opamtistomig in gastrointestinal cancers, extending the company’s immuno-oncology footprint from biliary tract cancer, gastric cancer and esophageal squamous cell carcinoma into colorectal cancer (CRC), an area of high unmet clinical need.

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mCRC is difficult to treat and carries a very poor prognosis, with a 5-year survival rate of less than 13%. While immunotherapy has achieved breakthroughs in the microsatellite instability-high (MSI-H)/deficient mismatch repair (dMMR) subtype, these patients account for only about 5% of mCRC cases. For the vast majority—up to 95%—of patients with microsatellite stable (MSS)/mismatch repair proficient (pMMR) tumors, conventional immune checkpoint inhibitors offer limited benefit. The current first- and second-line standard of care remains chemotherapy combined with targeted therapy, leaving an urgent need for more effective immunotherapy options.

Opamtistomig simultaneously blocks PD-1/PD-L1-mediated immunosuppression and conditionally activates 4-1BB co-stimulatory signaling. This dual mechanism restores T cell function while promoting T cell proliferation and long-term memory formation. The mechanistic advantages of Opamtistomig have been validated in 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), and are expected to translate into meaningful clinical benefit in CRC as well, further reinforcing its position as an IO 2.0 pan-tumor cornerstone therapy.

Executive Commentary
Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, stated: "MSS/pMMR mCRC is widely recognized as an immunologically ‘cold’ tumor, and patients continue to face significant unmet medical needs with limited effective treatment options. Through the synergistic dual targeting of PD-L1 and 4-1BB, Opamtistomig has the potential to restore anti-tumor immune activity in cold tumors, a differentiated mechanism that has already shown encouraging preliminary signals in earlier clinical studies. We are excited to further explore this novel combination strategy in the ongoing Phase Ib/II study and hope to bring a more effective immunotherapy option to patients with metastatic colorectal cancer."

About Colorectal Cancer (CRC)
CRC is one of the most common gastrointestinal malignancies worldwide. According to 2022 data from the International Agency for Research on Cancer (IARC), there were approximately 1.926 million new cases and 904,000 deaths from CRC globally, making it the third most common cancer and the second leading cause of cancer-related death. Data from the China National Cancer Center show that in 2022, there were 517,100 new cases and 240,000 deaths from CRC in China, ranking second in incidence and fourth in mortality among all malignancies. Approximately 15%–30% of CRC patients have distant metastases at initial diagnosis, and 20%–50% of patients with initially localized CRC eventually develop mCRC. mCRC is difficult to treat and has a very poor prognosis, with a 5-year survival rate of less than 13%. Currently, immunotherapy is primarily approved for MSI-H/dMMR CRC patients, but these account for only about 5% of mCRC cases. The remaining 95% of patients with MSS/pMMR tumors are resistant to conventional immunotherapy, representing a significant unmet clinical need.

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 2, 2026, View Source [SID1234669595])

On August 2, 2026 Specialised Therapeutics (ST) reported the listing of Minjuvi (tafasitamab), in combination with rituximab and lenalidomide, on the Pharmaceutical Benefits Scheme (PBS) for the treatment of Australian adults with relapsed or refractory follicular lymphoma (R/R FL) (Grade 1-3a).[1] This milestone follows the Australian registration of Minjuvi for R/R FL by the Therapeutic Goods Administration (TGA) in April 2026, via the Project Orbis process.[6]

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The PBS listing of Minjuvi marks the availability of the first and only chemotherapy-free CD19 and CD20 dual-targeted immunotherapy combination regimen funded in Australia for this group of patients.[1],[2] Effective 1 August 2026, eligible patients with FL who have experienced relapses or disease progression on existing therapies will now have equitable access to a new treatment option for this difficult-to-treat condition.[1]

"As the first new therapy to be reimbursed on the PBS for R/R FL in nine years, we are extremely proud to have partnered with Incyte to bring Minjuvi to Australia," said Carlo Montagner, ST Chief Executive Officer. "After securing TGA registration for Minjuvi in R/R FL earlier this year, we have been focused on expediting PBS listing to ensure eligible Australian patients could have subsidised access to a new treatment option that may help lower the risk of disease progression, relapse or death, without delay."

ST entered into an exclusive distribution agreement with Incyte (NASDAQ:INCY) in 2021 to commercialise Minjuvi in Australia, New Zealand and Singapore.

Minjuvi is a CD19 targeting immunotherapy that works within a patient’s immune system to help find and eliminate malignant B-cells.[7] In combination with rituximab and lenalidomide, Minjuvi delivers a complementary immune-mediated approach that helps control disease progression and supports improved long-term outcomes for patients with follicular lymphoma.[7]

The PBS reimbursement underscores the growing recognition of innovative immunotherapy-based treatment strategies in follicular lymphoma and reinforces ST’s commitment to improving access to life-changing therapies for patients across the Asia-Pacific region.

"While follicular lymphoma can be a slow-growing disease that usually responds well to the first treatment, most patients are not cured. Many patients experience frequent relapses and require multiple therapies over their lifetime, which become progressively less effective, especially for those whose disease comes back soon after initial chemotherapy treatment," said Associate Professor Philip Thompson, Clinical Haematologist at the Peter MacCallum Cancer Centre and Royal Melbourne Hospital in Melbourne. "Today’s PBS listing announcement is welcome news for the Australian clinical and patient community, providing us with a new, chemotherapy-free immunotherapy treatment for R/R FL."

Minjuvi is administered via intravenous (IV) infusion in a clinic or hospital setting.[7] Patients with R/R FL receive up to 12 treatment cycles of Minjuvi, along with oral lenalidomide capsules, while rituximab is delivered intravenously for the first five cycles.[7]

"Knowing that a chemotherapy-free immunotherapy is now funded by the PBS is an important development for the follicular lymphoma community," said Sharon Winton, Chief Executive Officer of Lymphoma Australia. "As patients manage the challenges of recurring disease, this new treatment milestone offers a valuable option that is deeply meaningful to them and their families."

The PBS listing of Minjuvi for R/R FL means these patients will now have equitable access to a new targeted immunotherapy combination treatment when they need it. It is important that patients with R/R FL speak with their doctor to understand the most suitable treatment option available for them.

For further details on Minjuvi, contact your healthcare professional and please refer to the approved Australian Consumer Medicine Information or Product Information available from the TGA website.

(Press release, Specialised Therapeutics Australia, AUG 2, 2026, View Source [SID1234669594])

On August 2, 2026 GlycoNex Inc. (TPEx: 4168) reported that the first patient has been successfully dosed in the First-in-Human (FIH) Phase I clinical trial of GNX1021, the Company’s novel glycan-targeting antibody-drug conjugate (ADC), in Japan. The milestone marks GNX1021’s transition into clinical development and initiates the generation of the first human data for the Company’s lead oncology asset.

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The start of dosing represents an important value inflection point for GlycoNex. It advances GNX1021 from preclinical development into the clinic, reducing development uncertainty, increasing the maturity of the asset, and establishing the foundation for clinical safety, pharmacokinetic and early activity data that will define the program’s future direction and strengthen its positioning for strategic collaboration.

GNX1021 is directed at the branched Lewis B/Y (bLeB/Y) glycan antigen, which is highly expressed in gastric cancer and other gastrointestinal malignancies while showing limited expression in normal tissue. Rather than targeting a single protein receptor — the approach taken by most ADCs currently in development — GNX1021 recognizes a tumor-associated glycan structure presented across multiple carrier molecules on the cancer-cell surface. This differentiated mechanism is designed to broaden the pool of addressable targets, enhance tumor selectivity, and address the therapeutic challenges posed by tumor heterogeneity, positioning GNX1021 distinctly within a competitive ADC landscape. GNX1021 is the lead program to emerge from GlycoNex’s proprietary GlycoSH anti-glycan antibody library, which continues to generate a pipeline of glycan-directed ADCs and related candidates.

The FIH study is a multinational, multicenter Phase I trial being conducted in Japan and Taiwan in patients with advanced solid tumors, evaluating GNX1021 across multiple dose levels for safety and tolerability, pharmacokinetics, immunogenicity, preliminary anti-tumor activity, and the recommended dose for subsequent development. Data from the study are expected to inform dose selection and the future development strategy for GNX1021, including its potential evaluation in selected gastrointestinal cancer populations.

GlycoNex intends to explore potential regional and global licensing, co-development, and other strategic collaboration opportunities for GNX1021. The Company will continue to advance the program within its broader glycan-directed oncology pipeline and assess the development and partnership strategies most appropriate for its long-term clinical and commercial development.

"Dosing the first patient in the GNX1021 Phase I trial is a major achievement for GlycoNex and an important value inflection point for our oncology portfolio," said Dr. Mei-Chun Yang, President and CEO of GlycoNex. "GNX1021 is designed to address tumor-associated glycan structures that conventional protein-targeted therapies may not adequately capture. Advancing this differentiated program into the clinic allows us to evaluate its potential in patients while building a stronger foundation for future development and strategic collaboration."

(Press release, GlycoNex, AUG 2, 2026, View Source [SID1234669593])