On March 9, 2026 Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs" or the "Company," Stock Code: 9887.HK) reported that the first patient has been successfully dosed in a Phase Ⅱ clinical study evaluating Opamtistomig (LBL-024), the company’s core investigational PD-L1/4-1BB bispecific antibody, for the first-line treatment of locally advanced or metastatic esophageal squamous cell carcinoma (ESCC).

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ESCC ranks as the seventh most common cancer in China, characterized by insidious onset and poor prognosis. Although immune checkpoint inhibitors combined with chemotherapy have improved objective response rate (ORR), progression-free survival (PFS), and overall survival (OS) compared to chemotherapy alone, median OS remains only 12-17 months. This underscores the limitations of current treatment approaches and the urgent need for improved outcomes, highlighting the necessity to explore more effective innovative strategies to address this significant clinical challenge.

Opamtistomig is a uniquely engineered bispecific antibody designed to simultaneously block PD-1/L1-mediated immune suppression and selectively activate the 4-1BB co-stimulatory pathway. By restoring T-cell functionality and expanding effector T-cell populations within the tumor microenvironment, Opamtistomig has the potential to deliver more potent and durable anti-tumor activity than PD-1/PD-L1 blockade alone, particularly in difficult-to-treat and immunotherapy-resistant tumors. To date, Opamtistomig has demonstrated first- or best-in-class potential in Phase II or registrational clinical trials across three indications: non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and extrapulmonary neuroendocrine carcinoma (EP-NEC).

The open-label, multi-center Phase Ⅱ clinical study is led by Professor Shen Lin of Beijing Cancer Hospital and is being conducted across multiple hospitals in China. The trial aims to evaluate the efficacy and safety of Opamtistomig administered in patients with ESCC.

Executive Commentary
Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, stated: "ESCC is highly prevalent with poor prognosis in China. While immune-chemotherapy combinations have shown progress, the overall survival benefit remains very limited, necessitating breakthrough solutions. The dosing of the first ESCC patient with Opamtistomig marks a critical milestone in our clinical strategy for this core pipeline asset. We anticipate it will overcome current immunotherapy limitations, delivering both higher response rates and prolonged survival benefits for patients."

About ESCC
China is a region with a high incidence of esophageal cancer, accounting for approximately 50% of the newly diagnosed and fatal cases of esophageal cancer worldwide. Esophageal cancer is broadly classified into ESCC and esophageal adenocarcinoma, of which squamous cell carcinoma represents the predominant subtype in China. According to 2022 data published by the International Agency for Research on Cancer (IARC) of the World Health Organization, ESCC ranked seventh among all cancers in China in terms of incidence, with an estimated 224,000 new cases and approximately 187,000 deaths recorded annually. Early-stage esophageal cancer typically presents with no obvious clinical symptoms, and the majority of patients are diagnosed at a locally advanced stage or with distant metastases. As a result, prognosis remains poor, with a five-year survival rate of only 10.0% to 30.0%.

About Opamtistomig (LBL-024)
Opamtistomig (LBL-024) is a potential first-in-class bispecific antibody that simultaneously targets PD-L1 and the co-stimulatory receptor 4-1BB. It is the first 4-1BB–targeting bispecific antibody globally to advance to a single-arm pivotal trial as monotherapy, and it holds promise to become the first approved therapy specifically for extrapulmonary neuroendocrine carcinoma (EP-NEC)—a rare malignancy with substantial unmet clinical need.

Developed using Leads Biolabs’ proprietary X-Body bispecific platform, Opamtistomig features a 2:2 molecular format, incorporating two binding domains each for PD-L1 and 4-1BB with an optimized affinity ratio. This unique design enables dual functionality: reversing PD-L1–mediated immune suppression while selectively enhancing T-cell activation, resulting in a potent and synergistic anti-tumor immune response.

In two ongoing clinical studies in China, Opamtistomig has demonstrated promising efficacy and a favorable safety profile in patients with advanced EP-NEC, both as monotherapy and in combination with chemotherapy. Given the absence of a globally accepted standard of care for EP-NEC, these results support the advancement of a single-arm pivotal study toward potential accelerated approval.

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.

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. Beyond EP-NEC, Opamtistomig has received clinical trial approvals across multiple tumor types with high unmet medical needs, including small cell lung cancer (SCLC), biliary tract cancer (BTC), ovarian cancer (OC), non-small cell lung cancer (NSCLC), esophageal squamous cell carcinoma (ESCC), hepatocellular carcinoma (HCC), gastric cancer (GC), triple-negative breast cancer (TNBC), and malignant melanoma. Encouraging clinical activity has already been observed in NSCLC, SCLC, BTC, OC, and other indications, underscoring Opamtistomig’s potential as a broad-spectrum immuno-oncology therapy.

(Press release, Nanjing Leads Biolabs, MAR 9, 2026, View Source [SID1234663380])

On March 9, 2026 Amplia Therapeutics Limited (ASX:ATX; OTCQB:INNMF), ("Amplia" or the "Company"), reported that compelling data describing new clinical opportunities for its lead drug narmafotinib was presented at the AACR (Free AACR Whitepaper) Special Conference in Cancer Research: RAS Oncogenesis and Therapeutics in Los Angeles, California on Friday March 6.

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The poster presentation discloses preclinical data demonstrating that the Company’s best-in-class FAK inhibitor narmafotinib enhances the activity of a new class of drugs called kRAS inhibitors in various models of cancer. In particular, the data indicates that narmafotinib blocks resistance pathways that can emerge with kRAS inhibitor treatment, thereby enhancing efficacy and durability of response.

A copy of the poster is available on the Company’s website.

Inhibitors of mutant kRAS proteins are an exciting new class of drug in development for the treatment of lung, colon and pancreatic cancer, amongst others. There are currently over 50 different kRAS inhibitors undergoing clinical studies across the globe. Despite promising mid-stage clinical data, however, side-effects of these drugs can be significant and treatment-emergent resistance is commonplace.

Dr Chris Burns, CEO of Amplia, commented, "We are excited to present our research findings at this specialist conference focused on RAS inhibition in cancer. We believe there is significant clinical potential in combining narmafotinib with kRAS inhibitors and will be discussing our findings with pharma and biotech companies actively working in this space."

(Press release, Amplia Therapeutics, MAR 9, 2026, View Source [SID1234663397])

On March 9, 2026 HUTCHMED (China) Limited ("HUTCHMED" or the "Company") (Nasdaq/AIM:HCM; HKEX:13) reported an update regarding TAZVERIK (tazemetostat), an oncology therapy licensed from Epizyme, Inc. ("Epizyme"), an Ipsen ("Ipsen") company, in China. Epizyme is the Marketing Authorization Holder of TAZVERIK in the Chinese mainland, for which HUTCHMED Limited (a subsidiary of the Company) acts as the domestic agent/licensee. Ipsen has informed HUTCHMED that it is voluntarily withdrawing TAZVERIK in the US. As a result, steps have been taken to initiate the market withdrawal and product recall in China. Consequently, HUTCHMED Limited has initiated a withdrawal and product recall from the Chinese mainland, Hong Kong and Macau, and is discontinuing all active tazemetostat clinical trials. Existing patients should consult their treating physicians immediately to discuss their treatment options.

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Ipsen is the sponsor of the ongoing Phase Ib/III SYMPHONY-1 trial (evaluating tazemetostat in combination with lenalidomide plus rituximab ("R²") vs R² in follicular lymphoma). As informed by Ipsen, following a review of emerging data from SYMPHONY-1, the study Independent Data Monitoring Committee advised that, based on adverse events of secondary hematologic malignancies, the risks may outweigh potential benefits for patients within this treatment regimen. As a result of these data, Ipsen is withdrawing TAZVERIK effective immediately, including both for follicular lymphoma ("FL") and epithelioid sarcoma (ES).

Ipsen has announced that, in addition to withdrawing TAZVERIK from the market, Ipsen has initiated steps to stop treatment with tazemetostat for all patients currently enrolled in the ongoing SYMPHONY-1 trial. All participants will receive standard of care, lenalidomide plus rituximab only. The study will remain open, with no further enrollment, to continue the long-term safety follow-up of all participants. Ipsen is also discontinuing all active tazemetostat clinical trials and expanded access programs. Ipsen is working with the US Food and Drug Administration ("US FDA") on the next steps to execute the withdrawal of TAZVERIK and provide all necessary information to complete this process.

The safety and wellbeing of patients is HUTCHMED’s top priority. In alignment with this commitment, HUTCHMED Limited has promptly informed healthcare professionals, the China National Medical Products Administration ("NMPA"), the Hong Kong Department of Health and the Macau Health Bureau of this development. Upon becoming aware of this information, HUTCHMED Limited immediately placed the product on hold, suspending all sales and shipments, and notified healthcare institutions to cease prescribing it and pharmacies to stop dispensing it. HUTCHMED Limited has also immediately notified clinical trial sites in China to discontinue the use of tazemetostat. Furthermore, HUTCHMED Limited is also actively cooperating with regulatory authorities to determine the appropriate next steps for the withdrawal and recall of TAZVERIK in the Chinese mainland, Hong Kong and Macau.

TAZVERIK is a first-in-class methyltransferase inhibitor of EZH2 developed by Epizyme. TAZVERIK monotherapy was approved by the US FDA in 2020 under the US FDA accelerated approval program. TAZVERIK received conditional approval from the NMPA for the treatment of FL as an imported drug. This approval pathway incorporates the evaluation of overseas trial data, references overseas regulatory approvals, and bridging study data to adapt foreign trial results to the Chinese population. Continued registration of TAZVERIK is subject to continuing obligations, including reporting of changes in foreign regulatory status, new safety signals and new evidence affecting the benefit-to-risk profile to patients.

The withdrawal is not expected to impact the Company’s financial guidance. In 2025, HUTCHMED sales of TAZVERIK were US$2.5 million.

(Press release, Hutchison China MediTech, MAR 9, 2026, View Source [SID1234663363])

On March 9, 2026 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that the Korean Ministry of Intellectual Property (MOIP) has issued a Notice of Allowance for a new patent related to Anixa’s breast cancer vaccine technology. This patent, exclusively licensed from Cleveland Clinic, will provide composition of matter protection for the Company’s novel approach to breast cancer treatment and prevention in South Korea. The patent is titled, "Vaccine Adjuvants and Formulations," and the co-inventors are Dr. Justin Johnson and the late Dr. Vincent Tuohy, both of Cleveland Clinic.

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With this allowance, Anixa continues to expand the international scope of its intellectual property portfolio, reinforcing its leadership in the field of cancer immunotherapy. The Korean patent complements patents issued in the United States and other key global jurisdictions, and represents an important step toward potential future regulatory approvals and commercialization efforts outside the United States.

"This newly allowed patent continues the broad international recognition of the novelty and potential of our breast cancer vaccine," stated Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences. "As we continue clinical development in the U.S., our growing international patent estate further strengthens our ability to pursue global opportunities and potentially partner with larger pharmaceutical companies for worldwide commercialization. In our recently completed Phase 1 clinical trial conducted at Cleveland Clinic, the vaccine met all major primary endpoints, was safe and well tolerated, and generated immune responses in 74% of participants, supporting continued clinical development of this novel preventive approach."

While the breast cancer survival rate is high in South Korea, the incidence rate has been increasing rapidly. In addition, unlike Western nations, the onset of breast cancer tends to occur earlier in life in South Korea. Breast cancer remains the most commonly diagnosed cancer among women worldwide, and currently there are no approved vaccines to prevent the disease.

Anixa’s vaccine is based on immunizing against human α-lactalbumin, a protein associated with lactation that is aberrantly expressed in certain types of breast cancer. This "retired" protein strategy, developed at Cleveland Clinic and licensed exclusively to Anixa, aims to selectively prime the immune system to prevent tumor formation while avoiding harm to normal tissue, particularly in aggressive forms of the disease such as triple-negative breast cancer.

By reinforcing its global patent estate, Anixa is laying the groundwork for future international development and commercialization strategies. The Company’s broader vaccine platform also targets other high-incidence cancers and is designed to transform how the medical community approaches cancer prevention. If successful, the technology could represent one of the first preventive vaccine approaches targeting breast cancer.

(Press release, Anixa Biosciences, MAR 9, 2026, https://www.prnewswire.com/news-releases/anixa-biosciences-receives-notice-of-allowance-from-korean-ministry-of-intellectual-property-moip-for-patent-covering-breast-cancer-vaccine-technology-302707370.html [SID1234663381])

On March 9, 2026 Zelluna (OSE: ZLNA), a company pioneering allogeneic "off-the-shelf" T Cell Receptor-based Natural Killer (TCR-NK) cell therapies for the treatment of solid cancers, reported a collaboration with Etcembly Ltd, a biotechnology company applying advanced machine learning to T cell receptor (TCR) discovery and engineering.

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Highlights:

AI-enabled collaboration to engineer KKLC1-targeting TCRs for Zelluna’s TCR-NK platform
Builds on successful engineering of MAGE-A4 TCR underpinning ZI-MA4-1, approved for clinical testing in February 2026
Expands pipeline with validated solid tumour antigen expressed across multiple difficult-to-treat cancers
AI-guided in silico engineering to enhance specificity, potency and development efficiency
The collaboration will focus on the engineering of high-affinity, tumour-specific TCRs targeting KKLC1, a validated cancer antigen found in multiple difficult-to-treat solid tumours. The engineered receptors will be fully owned by Zelluna and developed for use within Zelluna’s proprietary TCR-NK platform. In-vitro data demonstrating safety, specificity and functional activity is now expected in Q4 2026.

This collaboration builds on Zelluna’s successful engineering of a T cell receptor (TCR) designed to recognise the cancer antigen MAGE-A4. This receptor is the targeting module of the company’s lead product candidate ZI-MA4-1, which in February 2026 received approval from the UK Medicines and Healthcare products Regulatory Agency (UK MHRA) to initiate clinical testing. By engineering receptors targeting KKLC1, Zelluna is expanding its product portfolio beyond MAGE-A4 and can thereby address a broader spectrum of solid cancers and patients.

"Our lead product candidate ZI-MA4-1 is built on an affinity enhanced receptor that recognises cancer cells with the MAGE-A4 protein. We developed this receptor in our first highly successful collaboration with Etcembly," said Luise Weigand, Chief Scientific Officer of Zelluna. "We are now delighted to continue our collaboration on our next programme targeting KKLC1. By combining artificial intelligence with our cell therapy platform, we aim to develop highly precise and potent treatments for solid cancers."

"Our first collaboration with Zelluna demonstrated what AI-guided TCR engineering can achieve: a clinically approved receptor in a fraction of conventional timelines. We are excited to apply EMLy again to expand Zelluna’s pipeline and address cancers that desperately need new treatment options" commented Michelle Teng, Founder and CEO of Etcembly.

(Press release, Zelluna Immunotherapy, MAR 9, 2026, View Source [SID1234663398])