This phase II trial tests how well nivolumab in combination with chemotherapy drugs along with radiation therapy works in treating patients with nasopharyngeal cancer. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Researchers want to find out what effects, good and/or bad, adding nivolumab to chemotherapy has on patients with newly diagnosed NPC. In addition, they want to find out if children with NPC may be treated with less radiation therapy and whether this decreases the side effects of therapy.

Start Date17 Jan 2025

Sponsor / Collaborator

National Cancer Institute

NCT06050252 / RecruitingPhase 2IIT

A Phase II Trial of Durvalumab With Gemcitabine and Cisplatin as Neoadjuvant Therapy for High-Risk Resectable Intrahepatic Cholangiocarcinoma

This phase II trial tests how well giving durvalumab with standard chemotherapy, gemcitabine and cisplatin, before surgery works in treating patients with high risk liver cancer (cholangiocarcinoma) that can be removed by surgery (resectable). Durvalumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving durvalumab with gemcitabine and cisplatin before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed in patients with high risk resectable cholangiocarcinoma.

Start Date26 Nov 2024

Sponsor / Collaborator

National Cancer Institute

NCT06029270 / RecruitingPhase 2IIT

A Randomized Phase II Study of Nivolumab Versus Nivolumab and BMS-986016 (Relatlimab) as Maintenance Treatment After First-Line Treatment With Platinum-Gemcitabine-Nivolumab for Patients With Epstein-Barr Virus-Associated Recurrent/Metastatic Nasopharyngeal Carcinoma (REMAIN)

This phase II trial tests the addition of BMS-986016 (relatlimab) to the usual immunotherapy after initial treatment for nasopharyngeal cancer that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Relatlimab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. The usual approach of treatment is initial treatment with chemotherapy such as the combination of cisplatin (or carboplatin) and gemcitabine, along with immunotherapy such as nivolumab. After the initial treatment is finished, patients may continue to receive additional immunotherapy. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid (DNA) and may kill cancer cells. Giving BMS-986016 in addition to the usual immunotherapy after initial treatment may extend the time without the tumor cells grow or spread longer than the usual approach in patients with recurrent or metastatic nasopharyngeal cancer.

Start Date04 Oct 2024

Sponsor / Collaborator

National Cancer Institute

100 Clinical Results associated with Gemcitabine

100 Translational Medicine associated with Gemcitabine

100 Patents (Medical) associated with Gemcitabine

18,872

Literatures (Medical) associated with Gemcitabine

31 Dec 2024·Annals of Medicine

Advances in targeted therapy of cholangiocarcinoma

Review

Author: Peng, Chuang ; Liu, Sulai ; Song, Yinghui ; Yu, Jianfeng ; Zhang, Yujing ; Li, Yuhang

Cholangiocarcinoma (CCA) is a malignant tumor originating in the bile duct and its branching epithelium. Due to its high heterogeneity, there are no specific clinical indications at the early stage, the diagnosis is often in advanced CCA. With surgical resection, the 5-year postoperative survival rate (long-term survival rate) is very poor. The regimen of gemcitabine combined with platinum has been used as the first-line chemotherapy for advanced patients. In recent years, targeted therapy for a variety of malignant tumors has made great progress, showing good efficacy and safety in advanced CCA. However, the current targeted therapy of CCA still has many challenges, such as adverse reactions, drug resistance, and individual differences. Therefore, the researches need to further explore the targeted therapy mechanism of CCA malignancies in depth, develop more effective and safe drugs, and accurately formulate plans based on patient characteristics to further improve patient prognosis in the future. This article reviews the recent progress of targeted therapy for CCA, aiming to provide a strategy for the research and clinical work of targeted therapy for CCA.

31 Dec 2024·International Journal of Hyperthermia

Validation of hyperthermia as an enhancer of chemotherapeutic efficacy: insights from a bladder cancer organoid model

Article

Author: Chen, Guoyi ; Chen, Wanyi ; Yu, Jie ; Ye, Zhangqun ; Xu, Ying ; Li, Huaibiao ; Liu, Chunyan ; Luo, Wanru ; Zhang, Huiping ; Zhao, Kai ; Liu, Haoran ; Hu, Poyi ; Sun, Guoliang ; Wu, Yuqing ; Zhang, Tingke ; Yang, Tiantian

OBJECTIVEThis study aimed to evaluate the combined efficacy of hyperthermia and chemotherapy using a bladder cancer organoid model and to explore hyperthermia-related molecular pathways.METHODTumor organoids were generated by embedding RT4 bladder cancer cells into Matrigel. The resulting organoids were treated with pirarubicin or gemcitabine at 37 °C or 42 °C. Proliferation was determined by Ki67 immunofluorescence staining, and apoptosis was assessed using a TdT-mediated dUTP nick end labeling (TUNEL) assay. RNA sequencing was used to identify the differentially expressed genes.RESULTSBladder cancer organoids were successfully established and exhibited robust proliferative abilities. Treatment with gemcitabine or pirarubicin under hyperthermic conditions caused pronounced structural damage to the organoids and increased cell death compared to that in the normothermically treated group. Furthermore, Ki67 labeling and TUNEL assays showed that the hyperthermia chemotherapy group showed a significantly reduced proliferation rate and high level of apoptosis. Finally, RNA sequencing revealed the IFN-γ signaling pathway to be associated with hyperthermia.CONCLUSIONOverall, hyperthermia combined with chemotherapy exerted better therapeutic effects than those of normothermic chemotherapy in grade 1-2 non-muscle-invasive bladder cancer, potentially through activation of the IFN-γ-JAK-STAT pathway.

17 Jun 2024·Nanotechnology

Novel silicene-mesoporous silica nanoparticles conjugated gemcitabine induced cellular apoptosis via upregulating NF-κB p65 nuclear translocation suppresses pancreatic cancer growth in vitro and in vivo

Article

Author: Chen, Yuhang ; Chen, Lianyu ; Dong, Shu ; Yang, Peiwen ; Cheng, Chien-Shan

AbstractPancreatic cancer’s high fatality rates stem from its resistance to systemic drug delivery and aggressive metastasis, limiting the efficacy of conventional treatments. In this study, two-dimensional ultrathin silicene nanosheets were initially synthesized and near-infrared-responsive two-dimensional silicene-mesoporous silica nanoparticles (SMSNs) were successfully constructed to load the clinically-approved conventional pancreatic cancer chemotherapeutic drug gemcitabine. Experiments on nanoparticle characterization show that they have excellent photothermal conversion ability and stability. Then silicene-mesoporous silica nanoparticles loaded with gemcitabine nanoparticles (SMSN@G NPs) were employed in localized photothermal therapy to control pancreatic tumor growth and achieve therapeutic effects. Our research confirmed the functionality of SMSN@G NPs through immunoblotting and apoptotic assays, demonstrating its capacity to enhance the nuclear translocation of the NF-κB p65, further affect the protein levels of apoptosis-related genes, induce the apoptosis of tumor cells, and ultimately inhibit the growth of the tumor. Additionally, the study assessed the inhibitory role of SMSN@G NPs on pancreatic neoplasm growth in vivo, revealing its excellent biocompatibility. SMSN@G NPs have a nice application prospect for anti-pancreatic tumors.

921

News (Medical) associated with Gemcitabine

14 May 2024

·www.biospace.com

Innate Pharma Reports First Quarter 2024 Business Update and Financial Results

First preclinical data set for IPH45, a pre-IND anti-Nectin-4 Antibody Drug Conjugate, presented as an oral presentation at AACR 2024 Progression of Sanofi-developed NK Cell Engager SAR443579/IPH6101 to Phase 2 in blood cancers Five ASCO Annual Meeting 2024 abstracts: Final TELLOMAK Phase 2 data for lacutamab in Mycosis Fungoides Two posters on IPH6501, Innate's second generation ANKET® in B‑cell Non-Hodgkin's Lymphoma AstraZeneca to present poster on updated results for monalizumab from Phase 2 stage III unresectable NSCLC trial Monalizumab SCLC Phase 2 MOZART trial poster Cash position of €113.9 million1 as of March 31, 2024 (not including the €4.0 million payment to be received from Sanofi), anticipated cash runway into end 2025 Conference call to be held today at 2:00 p.m. CEST / 8:00 a.m. EDT MARSEILLE, France--(BUSINESS WIRE)-- Regulatory News: Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) today reported its consolidated financial results for the quarter ending March 31, 2024. “We are executing our strategy of building on our partnered drug candidates while advancing our next generation of proprietary medicines,” said Hervé Brailly, Chief Executive Officer ad interim of Innate Pharma. “Our second generation ANKET®, IPH6501 began clinical development for NHL. We presented preclinical data for IPH45, our Nectin-4 ADC, at the recently held AACR Annual Meeting. Our partner Sanofi also advanced SAR443579, a tri-functional NK Cell Engager targeting CD123, to Phase 2 in blood cancer. We expect to have several data presentations at ASCO, including data from the TELLOMAK Phase 2 trial with lacutamab in mycosis fungoides, as we prepare to submit an IND for IPH45 later this year.” Webcast and conference call will be held today at 2:00pm CEST (8:00am EDT) The live webcast will be available at the following link: Participants may also join via telephone using the following registration link: This information can also be found on the Investors section of the Innate Pharma website, . A replay of the webcast will be available on the Company website for 90 days following the event. 1 Including short term investments (€21.3 million) and non-current financial instruments (€10.1 million). Pipeline highlights: Lacutamab (anti-KIR3DL2 antibody): Cutaneous T Cell lymphoma TELLOMAK is a global, open-label, multi-cohort Phase 2 clinical trial evaluating lacutamab in patients with Sézary syndrome and mycosis fungoides (MF). Top-line results in MF patients will be presented at the ASCO Annual Meeting 2024 being held May 31 – June 4 in Chicago. Title of the abstract is: Lacutamab in patients with relapsed and/or refractory mycosis fungoides: results from the TELLOMAK Phase 2 trial. The full abstract will be released at 5:00 PM ET on Thursday, May 23, 2024 on the ASCO Annual Meeting website. In January 2024, Innate announced that the US Food and Drug Administration (FDA) has lifted the partial clinical hold previously placed on the lacutamab IND on October 2023 following a patient death in the TELLOMAK study. The FDA decision to lift the partial clinical hold is based on the FDA review of the fatal case which Innate, together with a steering committee of independent experts, determined to be related to aggressive disease progression and lacutamab unrelated. Peripheral T Cell lymphoma (PTCL) The Phase 2 KILT (anti-KIR in T Cell Lymphoma) trial, an investigator-sponsored, randomized controlled trial led by the Lymphoma Study Association (LYSA) to evaluate lacutamab in combination with chemotherapy GEMOX (gemcitabine in combination with oxaliplatin) versus GEMOX alone in patients with KIR3DL2-expressing relapsed/refractory PTCL is ongoing and continues to recruit patients. ANKET® (Antibody-based NK cell Engager Therapeutics): ANKET® is Innate’s proprietary platform for developing next-generation, multi-specific NK cell engagers to treat certain types of cancer. Innate’s pipeline includes five public drug candidates born from the ANKET® platform: SAR443579 (SAR’579/IPH6101) (CD123-targeted), SAR445514 (SAR’514/IPH6401) (BCMA-targeted), IPH62 (B7-H3-targeted), IPH67 (target undisclosed, solid tumors) and tetra-specific IPH6501 (CD20-targeted with IL‑2v). Several other undisclosed proprietary preclinical targets are being explored. IPH6501 (proprietary) IPH6501 is Innate’s proprietary CD20-targeted IL-2v bearing second-generation ANKET®. Innate will present 2 posters on IPH6501 at the upcoming ASCO Annual Meeting 2024, being held from May 31 to June 4 in Chicago. Titles of the abstract are: A Phase 1/2, Open-Label, Multicenter Trial Investigating the Safety, Tolerability, and Preliminary Antineoplastic Activity of IPH6501 in Patients With Relapsed and/or Refractory CD20-expressing Non-Hodgkin Lymphoma Preclinical assessment of IPH6501, a first-in-class IL2v-armed tetraspecific NK Cell Engager directed against CD20 for R/R B-NHL, in comparison to a CD20-targeting T Cell Engager The full abstracts will be released at 5:00 PM ET on Thursday, May 23, 2024 on the ASCO Annual Meeting website. In March 2024 the first patient was dosed in the Phase 1/2 clinical trial evaluating IPH6501 in B cell Non-Hodgkin’s lymphoma (B-NHL). The study is planned to enroll up to 184 patients. SAR443579, SAR445514, IPH62 and IPH67 (under development by Sanofi) SAR443579/IPH6101 The Phase 1/2 clinical trial, currently under development, by Sanofi is progressing well, evaluating SAR443579 / IPH6101, a trifunctional anti-CD123 NKp46×CD16 NK cell engager and ANKET® platform lead asset, in patients with relapsed or refractory acute myeloid leukemia (R/R AML), B-cell acute lymphoblastic leukemia (B-ALL) or high-risk myelodysplastic syndrome (HR-MDS). In April 2024, Sanofi advanced SAR443579 / IPH6101, to the Phase 2 dose expansion of the trial. Under the terms of the 2016 research collaboration with Sanofi, the progression to the dose expansion part of the trial has triggered a milestone payment from Sanofi to Innate of €4m (which has been booked as revenue in the first quarter but had not been received from Sanofi in the quarter, and has therefore not been included in the cash position). SAR445514/IPH6401 The Sanofi led Phase 1/2 clinical trial with SAR’514 / IPH6401, a trifunctional anti-BCMA Nkp46xCD16 NK cell engager, in patients with Relapsed/Refractory Multiple Myeloma and Relapsed/Refractory Light-chain Amyloidosis is ongoing. IPH62 IPH62 is a NK cell engager program targeting B7-H3 from Innate’s ANKET® platform under development. Upon candidate selection, Sanofi will be responsible for all development, manufacturing and commercialization. IPH67 IPH67 is a NK cell engager program in solid tumors from Innate’s ANKET® platform under development. Following a research collaboration period, Sanofi will be responsible for all development, manufacturing and commercialization. Sanofi still retains the option of one additional ANKET® target under the terms of the 2022 research collaboration and license agreement. Antibody Drug Conjugates: Innate develops different approaches for the treatment of cancer utilizing its antibody engineering capabilities to deliver novel assets, with its innovative ANKET® platform and is also exploring Antibody Drug Conjugates (ADC) formats. Beyond its proprietary programs, Innate has an ongoing agreement with Takeda on ADCs. IPH45 (Nectin-4 ADC): IPH45 is Innate’s proprietary and differentiated exatecan-Antibody Drug Conjugate (ADC) targeting Nectin-4. First preclinical data were presented in an oral presentation at the American Association for Cancer Research (AACR) Annual Meeting 2024. In preclinical studies, IPH45 shows anti-tumor efficacy in vivo, in Nectin-4 expressing tumors including in Enfortumab Vedotin (EV) refractory models. Importantly, IPH45 shows stronger activity than EV, in multiple urothelial carcinoma patient-derived xenografted (PDX) mice models, across Nectin-4 high and Nectin-4 low expression levels. In addition, IPH45 has anti-tumor activity in combination with anti-PD1 treatment in PD-1 resistant model in vivo and has a favorable safety pro relevant animal toxicology models. IPH45 continues towards IND filing in 2024. Monalizumab (anti-NKG2A antibody), partnered with AstraZeneca: The Phase 3 PACIFIC-9 trial run by AstraZeneca evaluating durvalumab (anti-PD-L1) in combination with monalizumab or AstraZeneca’s oleclumab (anti-CD73) in patients with unresectable, Stage III non-small cell lung cancer (NSCLC) who have not progressed following definitive platinum-based concurrent chemoradiation therapy (CRT) is ongoing. AstraZeneca will present a poster at ASCO titled: “Updated results from COAST, a phase 2 study of durvalumab (D) ± oleclumab (O) or monalizumab (M) in patients (pts) with stage III unresectable non-small cell lung cancer (uNSCLC).” A poster at ASCO will also be presented titled “A phase II trial of monalizumab in combination with durvalumab (MEDI4736) plus platinum-based chemotherapy for first-line treatment of extensive stage small cell lung cancer (MOZART): Hoosier Cancer Research Network LUN21-530 study.” IPH5201 (anti-CD39), partnered with AstraZeneca: The MATISSE Phase 2 clinical trial conducted by Innate in neoadjuvant lung cancer for IPH5201, an anti-CD39 blocking monoclonal antibody developed in collaboration with AstraZeneca, is ongoing and recruitment is on track. IPH5301 (anti-CD73): The investigator-sponsored CHANCES Phase 1 trial of IPH5301 by Institut Paoli-Calmettes is ongoing. Corporate Update: Early January 2024, two new Executive Board members were appointed. Arvind Sood, Executive Vice President (EVP), President of US Operations, Dr Sonia Quaratino, EVP, Chief Medical Officer, joining Hervé Brailly, interim Chief Executive Officer and Yannis Morel, EVP, appointed Chief Operating Officer. In connection with Innate’s previous announcement that it had established an at-the-market (“ATM”) program, on January 16, 2024 Innate filed a new Registration Statement on Form F-3 (Registration No. 333-276164). On February 6, 2024, Innate filed a prospectus supplement relating to its previously established ATM program, pursuant to which it may, from time to time, offer and sell to eligible investors a total gross amount of up to $75 million of American Depositary Shares (“ADS”). Each ADS represents one ordinary share of Innate. As of March 31, 2024, no sales have been made under the program. Financial Results: Cash, cash equivalents and financial assets of the Company amounted to €113.9 million as of March 31, 2024. At the same date, financial liabilities amounted to €37.7 million. Cash, cash equivalents and financial assets as of March 31, 2024 do not include the €4.0 million payment to be received from Sanofi. Revenues for the first three months of 2024 amounted to €6.6 million (€26.0 million for the same period in 2023). For the three-month period, ended March 31, 2024, revenue from collaboration and licensing agreements mainly results from the partial or entire recognition of the proceeds received pursuant to the agreements with AstraZeneca and Sanofi. About Innate Pharma Innate Pharma S.A. is a global, clinical-stage biotechnology company developing immunotherapies for cancer patients. Its innovative approach aims to harness the innate immune system through therapeutic antibodies and its ANKET® (Antibody-based NK cell Engager Therapeutics) proprietary platform. Innate’s portfolio includes lead proprietary program lacutamab, developed in advanced form of cutaneous T cell lymphomas and peripheral T cell lymphomas, monalizumab developed with AstraZeneca in non-small cell lung cancer, as well as ANKET® multi-specific NK cell engagers to address multiple tumor types. Innate Pharma is a trusted partner to biopharmaceutical companies such as Sanofi and AstraZeneca, as well as leading research institutions, to accelerate innovation, research and development for the benefit of patients. Headquartered in Marseille, France with a US office in Rockville, MD, Innate Pharma is listed on Euronext Paris and Nasdaq in the US. Learn more about Innate Pharma at and follow us on LinkedIn and X. Information about Innate Pharma shares ISIN code Ticker code LEI FR0010331421 Euronext: IPH Nasdaq: IPHA 9695002Y8420ZB8HJE29 Disclaimer on forward-looking information and risk factors This press release contains certain forward-looking statements, including those within the meaning of the Private Securities Litigation Reform Act of 1995. The use of certain words, including “believe,” “potential,” “expect” and “will” and similar expressions, is intended to identify forward-looking statements. Although the company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. These risks and uncertainties include, among other things, the uncertainties inherent in research and development, including related to safety, progression of and results from its ongoing and planned clinical trials and preclinical studies, review and approvals by regulatory authorities of its product candidates, the Company’s commercialization efforts and the Company’s continued ability to raise capital to fund its development. For an additional discussion of risks and uncertainties which could cause the company's actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors (“Facteurs de Risque") section of the Universal Registration Document filed with the French Financial Markets Authority (“AMF”), which is available on the AMF website or on Innate Pharma’s website, and public filings and reports filed with the U.S. Securities and Exchange Commission (“SEC”), including the Company’s Annual Report on Form 20-F for the year ended December 31, 2023, and subsequent filings and reports filed with the AMF or SEC, or otherwise made public, by the Company. This press release and the information contained herein do not constitute an offer to sell or a solicitation of an offer to buy or subscribe to shares in Innate Pharma in any country. View source version on businesswire.com: Contacts Investors Innate Pharma Henry Wheeler Tel.: +33 (0)4 84 90 32 88 Henry.wheeler@innate-pharma.fr Media Relations NewCap Arthur Rouillé Tel.: +33 (0)1 44 71 00 15 innate@newcap.eu Source: Innate Pharma SA View this news release online at:

Phase 2License out/inPhase 1

14 May 2024

·www.globenewswire.com

HUTCHMED Initiates Phase II/III Trial of the Combination of Surufatinib and Camrelizumab for Treatment-Naïve Pancreatic Ductal Adenocarcinoma in Collaboration with Hengrui

— Almost half a million people diagnosed each year across the globe — — Collaboration based on synergistic potential of inhibiting angiogenesis and tumor-associated macrophages with HUTCHMED’s surufatinib and anti-PD-1 activity with Hengrui’s camrelizumab, promoting the immune response against tumor cells — HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., May 14, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces the initiation of a Phase II/III trial to evaluate the efficacy of a combination of the HUTCHMED drug candidate surufatinib, the Jiangsu Hengrui Pharmaceuticals Co., Ltd (“Hengrui Pharma”) PD-1 antibody camrelizumab, nab-paclitaxel and gemcitabine as a first-line treatment for patients with metastatic pancreatic ductal adenocarcinoma (“PDAC”) in China. PDAC is an exocrine tumor and the most common form of pancreatic cancer. The first patient received the first dose on May 8, 2024. PDAC is a highly aggressive form of cancer, representing over 90% of pancreatic cancer cases. Globally, an estimated 511,000 people were diagnosed with pancreatic cancer, leading to approximately 467,000 deaths in 2022, with an average five-year survival rate of less than 10%. In China, an estimated 119,000 people were diagnosed with pancreatic cancer, causing approximately 106,000 deaths in 2022.1 Treatments such as chemotherapy, surgery and radiation are commonly employed, but have not shown significant improvement in patient outcomes. Under 20% of metastatic pancreatic cancer patients survive more than a year.2 The trial is a multicenter, randomized, open-label, active-controlled, Phase II/III trial to evaluate the efficacy and safety of surufatinib combined with camrelizumab, nab-paclitaxel, and gemcitabine versus nab-paclitaxel plus gemcitabine as a treatment for adults with metastatic pancreatic cancer who have not been previously treated with a systemic anti-tumor therapy. After an initial safety run-in stage, the Phase II/III stage of the study may enroll a further 500 patients, with a primary endpoint of overall survival (OS). Other endpoints include objective response rate (ORR), progression free survival (PFS), disease control rate (DCR), safety, quality of life, duration of response and time to response. Additional details may be found at clinicaltrials.gov, using identifier NCT06361888. Dr Weiguo Su, Chief Executive Officer and Chief Scientific Officer of HUTCHMED, said, “Emerging data including those from an investigator-initiated study presented at the ASCO Gastrointestinal Cancers Symposium, demonstrated that combinations of surufatinib, camrelizumab and chemotherapy have promising efficacy in comparison with existing chemotherapy-based treatments in metastatic PDAC.3 We hope that this partnership will enable us to bring new, potentially life-changing treatment options to patients.” About Surufatinib Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with vascular endothelial growth factor receptors (VEGFRs) and fibroblast growth factor receptor (FGFR), which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R), which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. Its unique dual mechanism of action may be very suitable for possible combinations with other immunotherapies, where there may be synergistic anti-tumor effects. Surufatinib is marketed in China by HUTCHMED under the brand name SULANDA®, and was first included in the China National Reimbursement Drug List (NRDL) in January 2022 for the treatment of non-pancreatic and pancreatic neuroendocrine tumors (NETs). About Camrelizumab Camrelizumab (SHR-1210) is a humanized monoclonal antibody targeting the programmed death-1 (PD-1) receptor. Blockade of the PD-1/PD-L1 signaling pathway is a therapeutic strategy showing success in a wide variety of solid and hematological cancers. Currently, more than 10 clinical trials are underway worldwide in a broad range of tumors and treatment settings. Camrelizumab, under the brand name AiRuiKa®, is currently approved for nine indications in China, including hepatocellular carcinoma (“HCC”) (second-line and first-line), relapsed/refractory classic Hodgkin’s lymphoma (third-line), esophageal squamous cell carcinoma (second-line) and nasopharyngeal carcinoma (third-line or further) and in combination with chemotherapy for the treatment of non-small cell lung cancer (non-squamous and squamous), esophageal squamous cell carcinoma, and nasopharyngeal carcinoma in the first-line setting. All indications have been included in China’s national medical insurance catalog, making it the leading domestic PD-1 product in terms of approved indications and tumor types covered. The U.S. Food and Drug Administration (“FDA”) granted Orphan Drug Designation to camrelizumab for advanced HCC in April 2021, and accepted a New Drug Application (NDA) for camrelizumab and rivoceranib as a first-line therapy for unresectable HCC, with FDA Prescription Drug User Fee Act (PDUFA) dates in May 2024. About Hengrui Pharma Hengrui Pharma is a leading global pharmaceutical company headquartered in China with a focus on research, development, manufacturing, and commercialization of innovative and high-quality healthcare products. Innovation is the core development strategy. Hengrui Pharma ranked 24th among top 1,000 global pharmaceutical companies in 2021. Hengrui Pharma has been on the Pharma Exec’s annual listing of the top 50 global pharmaceutical companies for the fifth consecutive year. About HUTCHMED HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery, global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has approximately 5,000 personnel across all its companies, at the center of which is a team of about 1,800 in oncology/immunology. Since inception, HUTCHMED has focused on bringing cancer drug candidates from in-house discovery to patients around the world. Its first three medicines are marketed in China, the first of which is also marketed in the U.S. For more information, please visit: www.hutch-med.com or follow us on LinkedIn. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including its expectations regarding the therapeutic potential of surufatinib for the treatment of patients with PDAC and the further development of surufatinib in this and other indications. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding the timing and outcome of clinical studies and the sufficiency of clinical data to support an NDA submission of surufatinib for the treatment of patients with PDAC or other indications in China or other jurisdictions, its potential to gain approvals from regulatory authorities on an expedited basis or at all, the efficacy and safety profile of surufatinib, HUTCHMED’s ability to fund, implement and complete its further clinical development and commercialization plans for surufatinib and the timing of these events. In addition, as certain studies rely on the use of other drug products such as camrelizumab as combination therapeutics with surufatinib, such risks and uncertainties include assumptions regarding the safety, efficacy, supply and continued regulatory approval of these therapeutics. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the U.S. Securities and Exchange Commission, The Stock Exchange of Hong Kong Limited and on AIM. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. Medical Information This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. CONTACTS Investor Enquiries+852 2121 8200 / ir@hutch-med.com Media Enquiries Ben Atwell / Alex Shaw, FTI Consulting+44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) / HUTCHMED@fticonsulting.comZhou Yi, Brunswick+852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com Nominated Advisor Atholl Tweedie / Freddy Crossley / Daphne Zhang, Panmure Gordon+44 (20) 7886 2500 _______________________REFERENCES 1 The Global Cancer Observatory, World Fact Sheets. Accessed April 9, 2024.2 Sarantis P et al. Pancreatic ductal adenocarcinoma: Treatment hurdles, tumor microenvironment and immunotherapy. World J Gastrointest Oncol. 2020;12(2):173-181. DOI:10.4251/wjgo.v12.i2.1733 Jia R et al. Updated results of a phase 1b/2 study of surufatinib plus camrelizumab, nab-paclitaxel and S-1 (NASCA) as first-line therapy for metastatic pancreatic adenocarcinoma (mPDAC). JCO 42, 671-671(2024). DOI:10.1200/JCO.2024.42.3_suppl.671

Orphan DrugImmunotherapyDrug ApprovalClinical Study

13 May 2024

·www.prnewswire.com

Leads Biolabs is Proud to Announce its Participation in the 2024 ASCO Annual Meeting with One Oral Presentation and Two Posters.

NANJING, China, May 13, 2024 /PRNewswire/ -- The 2024 American Society of Clinical Oncology (ASCO) Annual Meeting will be held in Chicago from May 31 to June 4, 2024. As the largest and most academically prestigious international oncology conference in the world, the ASCO Annual Meeting gathers the latest and most cutting-edge research findings in the field of oncology. Leads Biolabs will present the exciting clinical data on its four innovative clinical programs at the ASCO meeting. These presentations will include one oral presentation, two posters, and one online publication, showcasing advancements in various cancer indications such as nasopharyngeal cancer (NPC), extrapulmonary neuroendocrine carcinoma (EP-NEC), hepatocellular carcinoma (HCC), and renal cell carcinoma (RCC). Oral Presentation ：A novel and uniquely designed bispecific antibody (LBL-024) against PD-L1 and 4-1BB in patients with advanced malignant tumors and neuroendocrine carcinoma: A report of safety and robust efficacy of LBL-024 monotherapy in phase Ⅰ/Ⅱ first in human, open-label, multicenter, dose escalation/expansion Study Date and Time：2024.06.02 4:30 PM-6:00 PM CDT Abstract Number：4010 LBL-024, a bispecific antibody composed of an anti-Programmed Cell Death Ligand-1 (PD-L1) and an anti-4-1BB (CD137) antibody. LBL-024 blocks the immunosuppressive pathway of tumor cells by targeting PD-L1 and effectively localizes 4-1BB co-stimulation to the tumor microenvironment, to improve the anti-tumor immune response. LBL-024 received IND approvals from FDA and NMPA on July 30, 2021 and September 9, 2021 respectively to conduct phase Ⅰ/Ⅱ clinical research. Subsequently, the therapy has achieved outstanding results. On April 30, 2024, it received approval from China's Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) to conduct a single-arm pivotal study for registration and market authorization. According to the results in the oral presentation, LBL-024 demonstrated good safety profile and very promising antitumor effects in patients with advanced malignant tumors, particularly extrapulmonary neuroendocrine carcinomas (EP-NEC) patients who failed at least one line of chemotherapy. Notably, the efficacy observed in EP-NEC surpassed historic reports with immunotherapy and chemotherapy. The extremely robust efficacy and good safety profiles support the advancement to a pivotal study to accelerate the development of LBL-024 in EP-NEC, a deadly disease of high unmet medical need. Poster ：Anti-LAG-3 antibody LBL-007 in combination with anti-PD-1 antibody Tislelizumab with or without chemotherapy, in patients with advanced nasopharyngeal cancer and other malignant tumors A phase Ⅰb/Ⅱ dose escalation/expansion Study Date and Time：2024.06.02 9:00 AM-12:00 PM CDT Abstract Number：6033 LBL-007 is a fully humanized monoclonal antibody against Lymphocyte Activation Gene-3 (LAG-3). By specifically binding to human LAG-3, it relieves the inhibitory effect of LAG-3 on T cells, restores the immune function, and inhibits tumor growth. Dual inhibition of programmed cell death receptor-1 (PD-1) and LAG-3 is expected to synergistically increase immune response against tumor growth while chemotherapy can enhance the efficacy of immunotherapy through various mechanisms. This phase Ⅰb/Ⅱ study indicates that the combination of LBL-007 and tislelizumab is well-tolerated in patients with advanced malignant tumors. Additionally, the combination of LBL-007, tislelizumab, and gemcitabine and cisplatin had demonstrated a good safety profile and robust antitumor activity in previously untreated and advanced NPC patients. These promising clinical data support a pivotal study to evaluate the combination of LBL-007, tislelizumab, and gemcitabine and cisplatin for the treatment of NPC. Poster：Anti-PD-1/TGF-βRII Bispecific Antibody Fusion Protein LBL-015 in patients with advanced malignant tumors：A phase Ⅰ, first-in-human, open-label, multicenter, dose-escalation Study Date and Time：2024.06.01 9:00 AM-12:00 PM CDT Abstract Number：2592 LBL-015 is a bifunctional antibody fusion protein targeting PD-1 and Transforming Growth Factor Beta Receptor 2 (TGF-βR2). LBL-015 blocks both PD-1/PD-L1 and TGF-β/TGF-βR2 signaling pathways to reverse immunosuppression and boost immune responses. In addition, LBL-015 can boost immune cell response and inhibit tumor metastasis by blocking TGF-β in the tumor microenvironment. In a Phase 1 clinical study, LBL-015 has demonstrated a good safety profile and encouraging preliminary efficacy signals in patients with advanced solid tumors. Online Publication ：Anti-TNFR2 monoclonal antibody LBL-019 in patients with advanced malignant tumors: A phase Ⅰ, first-in-human, open-label, multicenter, dose escalation Study Date and Time：2024.05.23 5:00 PM EDT Abstract Number：e14580 LBL-019 is a humanized IgG1 monoclonal antibody against Tumor Necrosis Factor Receptor 2 (TNFR2). LBL-019 binds specifically to TNFR2 with high affinity and co-stimulates TNFR2 in an Fc crosslinking-dependent manner. This leads to the activation of NF-κB signaling, T cell activation and expansion, thereby promoting antitumor immunity. The data from the Phase 1 study indicate that LBL-019 is well tolerable and has demonstrated preliminary efficacy in patients with advanced malignant tumors. Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, said "Leads Biolabs will be presenting four clinical projects at 2024 ASCO. Among them, the efficacy of LBL-024 is significantly higher than the historic reports with immunotherapy and chemotherapy, providing tremendous support for the approval and accelerated development of our pivotal study. The encouraging efficacy and safety profile of LBL-007 is impressive, which is conducive to advancing the pivotal study of LBL-007 in combination with tislelizumab, gemcitabine and cisplatin for NPC. We have adopted a differentiated, innovative, and efficient clinical development strategy, aiming to bring more effective therapies to market sooner. This is a manifestation of Leads Biolabs' unwavering commitment to addressing patient needs and delivering clinical value, aligning with the company's mission of 'care for life'." SOURCE Leads Biolabs

Phase 1ImmunotherapyASCOClinical ResultIND

100 Deals associated with Gemcitabine

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Indication	Highest Phase	Country/Location	Organization	Date
Pancreatic Cancer	Phase 3	-	RenovoRx, Inc.	01 Jun 2023
Metastatic Pancreatic Ductal Adenocarcinoma	Phase 3	AU	Panbela Therapeutics, Inc.	04 Aug 2022
Locally Advanced Pancreatic Adenocarcinoma	Phase 2	US	RenovoRx, Inc.	12 Mar 2018
Advanced Triple-Negative Breast Carcinoma	Phase 2	CN	Fudan University	01 Jan 2011
Non-Small Cell Lung Cancer	Phase 2	SG	National University Hospital	01 Oct 2006
Advanced Lung Non-Small Cell Carcinoma	Phase 2	IT	Sanofi	01 May 2005
Refractory Malignant Germ Cell Tumor	Phase 2	US	Sanofi	01 Nov 2004
Locally Advanced Pancreatic Adenocarcinoma	Phase 1	BE	RenovoRx, Inc.	12 Mar 2018
Non-small cell lung cancer stage IIIB	Phase 1	CN	Xinjiang Medical University	01 Dec 2013
Breast Cancer	Preclinical	SG	National University Hospital	01 Oct 2006

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NEWS Manual	Phase 2	Pancreatic Cancer	-	Antroquinonol+白蛋白结合型紫杉醇+吉西他滨	(xabtvzrrrw) = zlevtufucp bzeagikopl (nmdqwpimma ) View more	Positive	19 Jan 2024
				白蛋白结合型紫杉醇+吉西他滨	(xabtvzrrrw) = bqvablkdrr bzeagikopl (nmdqwpimma ) View more
NCT04570410 (ASCO_GU2024) Manual	Phase 2	Bladder Cancer Neoadjuvant	14	Tislelizumab + Gemcitabine + Cisplatin	(ixzkisvfrr) = ziobkzncle szqjytyjfm (rfiynwyrbw ) View more	Positive	25 Jan 2024
NCT02177695 (S1314-COXEN, ASCO_GU2024) Manual	Phase 2	Muscle Invasive Bladder Carcinoma Neoadjuvant	180	gemcitabine+cisplatin or methotrexate+vinblastine+adriamycin+doxorubicin+cisplatin	(nannhdnver) = lgrmmeggof dnktvsqshc (sujtnhqmoz )	Positive	25 Jan 2024
ASCO_GI2024 Manual	Not Applicable	Carcinoma of ampulla of Vater Adjuvant	81	5-FU or gemcitabine	(ybbimtigtz) = sugmiviumb tcclhygzdt (wvwqrkoqhg )	Negative	18 Jan 2024
NCT02564146 (AIO-PAK-0114（ALPACA ）, ASCO_GI2024) Manual	Phase 2	Pancreatic Cancer First line	325	Gemcitabine+nab-paclitaxel (alternating treatment arm)	(nnylorqxhe) = bdicrffnhi zgqzaslcfz (ygzmldplab ) View more	Positive	18 Jan 2024
				Gemcitabine+nab-paclitaxel (standard treatment arm)	(nnylorqxhe) = brcphwjsnk zgqzaslcfz (ygzmldplab ) View more
NCT04099589 (ASCO_GU2024) Manual	Phase 2	Renal Pelvis and Ureter Urothelial Carcinoma Neoadjuvant	15	Gemcitabine+Cisplatin +Toripalimab	(hqyngsmctc) = tndjbvgvkx veskaasodm (djjyoclkem ) View more	Positive	25 Jan 2024
NCT02650804 (Biospace) Manual	Phase 2	Pancreatic Cancer Second line \| Third line	19	BPM31510+gemcitabine	(sawkbgbjcb) = uibtgqrcnd gizwjbkicp (ucpzwhctnp )	Positive	18 Jan 2024
				Gemcitabine	(sawkbgbjcb) = kzozmgztrd gizwjbkicp (ucpzwhctnp )
UMIN000012720 (GENESECT, ASCO_GI2024) Manual	Not Applicable	Pancreatic Cancer	50	gemcitabine (ABCC5 1146A>G)	(xidcflhfyf) = kuovnzpzba vlomuvmjpb (ghzzawzhkl )	Positive	18 Jan 2024
				gemcitabine (AG/GG)	(xidcflhfyf) = ftxmrsgfxi vlomuvmjpb (ghzzawzhkl )
NCT04223856 (EV-302, Literature) Manual	Phase 3	Transitional Cell Carcinoma First line	886	Enfortumab vedotin + Pembrolizumab	(hqwflllpdy) = yzmjymmrmn kqgalibrxe (vodoqpwpmq ) View more	Positive	07 Mar 2024
				Gemcitabine + Cisplatin/Carboplatin	(hqwflllpdy) = vwidvzbcpq kqgalibrxe (vodoqpwpmq ) View more
ChiCTR2100050763 (ASCO_GU2024) Manual	Phase 2	Muscle Invasive Bladder Carcinoma Neoadjuvant	21	cisplatin or carboplatin+gemcitabine + Tislelizumab	fcddxshmxc(odnuakpzal) = rthlavnsia blexarxoeq (kdmjjjvpcu )	Positive	25 Jan 2024

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