Maintenance therapy of PD-1 monoclonal antibody for Advanced squamous cell lung cancer guided by immune memory markers: a prospective, single-arm phase II clinical study

Start Date30 Jun 2023

Sponsor / Collaborator-

CTR20222220 / Active, not recruitingPhase 2

一项评价QL1706或QL1604注射液联合贝伐珠单抗注射液在晚期肝癌患者中的安全性、药代动力学和初步疗效的Ⅰb/II期临床研究

[Translation] A phase Ib/II clinical study to evaluate the safety, pharmacokinetics and preliminary efficacy of QL1706 or QL1604 injection combined with bevacizumab injection in patients with advanced liver cancer

主要研究目的评估QL1706或QL1604注射液联合贝伐珠单抗注射液在晚期肝癌患者中的安全性和耐受性。次要研究目的 (1) 评估QL1706或QL1604注射液联合贝伐珠单抗注射液在晚期肝癌患者中的初步疗效。 (2) 评估QL1706或QL1604注射液联合贝伐珠单抗注射液在晚期肝癌患者中静脉给药后的药代动力学特征。 (3) 评估QL1706或QL1604注射液联合贝伐珠单抗注射液在晚期肝癌患者中的免疫原性。探索性研究目的探索肿瘤组织中某些生物标志物的表达与QL1706或QL1604抗肿瘤活性的相关性。

[Translation]

Primary study objectives To evaluate the safety and tolerability of QL1706 or QL1604 injection combined with bevacizumab injection in patients with advanced liver cancer. Secondary study objectives (1) To evaluate the preliminary efficacy of QL1706 or QL1604 injection combined with bevacizumab injection in patients with advanced liver cancer. (2) To evaluate the pharmacokinetic characteristics of QL1706 or QL1604 injection combined with bevacizumab injection after intravenous administration in patients with advanced liver cancer. (3) To evaluate the immunogenicity of QL1706 or QL1604 injection combined with bevacizumab injection in patients with advanced liver cancer. Exploratory study objectives To explore the correlation between the expression of certain biomarkers in tumor tissues and the anti-tumor activity of QL1706 or QL1604.

Start Date04 Jan 2022

Sponsor / Collaborator

Qilu Pharmaceutical Co., Ltd.

NCT05603039 / RecruitingPhase 1/2

A Phase Ib/II Trial to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of QL1706 or QL1604 Combined With Bevacizumab in Patients With Advanced Hepatocellular Carcinoma

This is a phase Ib/II trial to evaluate the safety, pharmacokinetics and preliminary efficacy of QL1706 or QL1604 combined with bevacizumab in patients with advanced hepatocellular carcinoma.

Start Date01 Jul 2021

Sponsor / Collaborator

Qilu Pharmaceutical Co., Ltd.

100 Clinical Results associated with Iparomlimab

100 Translational Medicine associated with Iparomlimab

100 Patents (Medical) associated with Iparomlimab

133

Literatures (Medical) associated with Iparomlimab

31 Dec 2024·mAbs

Insights into the mechanisms of serplulimab: a distinctive anti-PD-1 monoclonal antibody, in combination with a TIGIT or LAG3 inhibitor in preclinical tumor immunotherapy studies

Article

Author: Liu, Wei ; Xiong, Aiying ; Zhang, Xuehan ; Han, Chencheng ; Liu, Rui ; Zhang, Yizhou ; Zhang, Mengli ; Song, Ge ; Li, Qianhao ; Shan, Yongqiang ; Zhu, Jun ; Wang, Qingyu ; Hu, Chen ; Yang, Wan-Jen ; Wei, Ruicheng ; Yang, Xinyi

With more than 20 anti-PD-1/PD-L1 antibodies currently marketed, anti-PD-1 therapy has become a cornerstone of tumor immunotherapy. These agents, however, exhibit notable disparities in their characteristics and clinical performance. For instance, in the field of small cell lung cancer (SCLC) where the majority of anti-PD-1 antibodies have yielded limited success, serplulimab produced impressive survival improvements and was approved for this indication by China's National Medical Products Administration. Serplulimab's marketing authorization application also received a positive opinion from the European Medicines Agency. Nevertheless, the molecular mechanism underpinning serplulimab's superiority over its competitors remains elusive. We characterized the differences between serplulimab with approved PD-1/PD-L1 inhibitors (pembrolizumab and nivolumab) in terms of their binding features and functions in vitro and anti-tumor activity in vivo. Cellular pathways underlying the efficacy of serplulimab were also investigated. In comparison to competitors, serplulimab robustly induces PD-1 receptor endocytosis while fostering weaker PD-1-CD28 cis interactions. This phenomenon could mitigate the dephosphorylation of CD28 by SHP2, thereby facilitating sustained and robust T cell activation. While serplulimab and pembrolizumab exhibited similar performance in vitro and in vivo studies, serplulimab consistently demonstrated superior tumor killing efficacy compared to pembrolizumab upon co-administration with anti-TIGIT or anti-LAG3 inhibitors. Mechanistically, the serplulimab combination effectively reduces tumor microenvironment Treg cell populations, augments effector and memory T cell populations, and more potently modulates genes associated with diverse facets of the immune system, surpassing the effects of the pembrolizumab combination. In summary, our data underscore serplulimab as a differentiated PD-1 monoclonal antibody with best-in-class therapeutic potential.

01 Dec 2024·STAR protocols

Protocol for analysis of plasma proteomes from patients with hepatocellular carcinoma receiving combination therapy

Article

Author: Liu, Feng ; Du, Ling ; Pan, Zhi-Feng

Plasma shows distinct metabolomic and proteomic signatures in response to combination therapy with lenvatinib and anti-programmed death-1 (PD-1) antibody in treating hepatocellular carcinoma (HCC). Here, we present a protocol for analyzing plasma proteomes from patients with HCC receiving combination therapy. We describe steps for interpreting mass spectrometry data by database searching using MaxQuant and filtering and processing database search outcomes. We then detail procedures for downstream analyses including normalization, differential expression analysis, functional enrichment analysis, correlation analysis, consensus clustering, and survival analysis. For complete details on the use and execution of this protocol, please refer to Li et al.¹.

01 Nov 2024·ADVANCES IN THERAPY

Efficacy and Safety of Iparomlimab, an Anti-PD-1 Antibody, in Patients with Advanced Solid Tumors: A Phase 1c Study

Article

Author: Yang, Mengxiang ; Wang, Zhongfeng ; Niyazi, Huerxidan ; Zhang, Baihui ; Guo, Yabing ; Xu, Zhongyuan ; Xiong, Jianping ; Sun, Ping ; Lou, Hanmei ; Gao, Zhenyuan ; Liu, Ying ; Li, Lingyan ; Ouyang, Weiwei ; Wang, Jianhua ; Kang, Xiaoyan ; Chen, Yan ; Zheng, Ling ; Guo, Weijian ; Zhou, Huan

INTRODUCTION:

Iparomlimab (QL1604) is a humanized immunoglobulin G4 mAb against programmed cell death protein 1 (PD-1). Here, we report the preliminary efficacy, safety, pharmacokinetics, and immunogenicity of iparomlimab in patients with advanced solid tumors.

METHODS:

In this open-label, phase 1c study, patients with advanced or metastatic solid tumors, either failed or had no standard therapies available, were enrolled and received intravenous iparomlimab at 3 mg/kg once every 3 weeks. The primary efficacy endpoint was the objective response rate (ORR) assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

RESULTS:

Between July 20, 2020, and September 6, 2021, 71 patients were enrolled and received at least one dose of iparomlimab. The ORR was 9.9% (7/71) and disease control rate was 36.6% (26/71). Median duration of response of all responders was 10.7 months [95% confidence interval (CI), 1.4-not estimable]. Additionally, the median time to progression, progression-free survival, and overall survival were 1.4 months (95% CI, 1.4-2.8), 1.4 months (95% CI, 1.4-2.7), and 9.7 months (95% CI, 7.2-15.3), respectively. A total of 52 (73.2%) patients experienced treatment-related adverse events (TRAEs) (grade ≥ 3, 19.7%). The most common TRAE (≥ 10%) was anemia (18.3%). A total of 20 (28.2%) experienced immune-related adverse events (grade ≥ 3, 7.0%). TRAEs leading to discontinuation of study drug occurred in 4 (5.6%) patients, including immune-mediated myocarditis (2 patients), Guillain-Barré syndrome (1 patient), and diarrhea (1 patient).

CONCLUSIONS:

Iparomlimab showed preliminary clinical activity and had a manageable safety profile in patients with advanced solid tumors. These results support further investigation of iparomlimab as monotherapy or in combination therapy in advanced solid tumors.

TRIAL REGISTRATION:

ClinicalTrials.gov identifier, NCT05801094. Retrospectively registered in 2023-03-24.

News (Medical) associated with Iparomlimab

25 Nov 2024

·www.prnewswire.com

Innovent to Present Clinical Data of Multiple Novel Molecules at ESMO Asia 2024

SAN FRANCISCO and SUZHOU, China, Nov. 24, 2024 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces that nearly 10 accepted clinical data of its novel oncology molecules, including an oral presentation of updated Phase 1 result of its novel TOPO1i CLDN18.2 ADC (IBI343) in previously-treated pancreatic cancer, will be released at the European Society of Medical Oncology Asia (ESMO Asia) Congress 2024 from Dec 06-08, 2024, in Singapore. Details on the abstracts are listed below: Mini Oral Abstract Title: Anti-claudin18.2 (CLDN18.2) antibody-drug conjugate (ADC) IBI343 in patients with advanced pancreatic ductal adenocarcinoma (PDAC): updated results from a Phase 1 study Abstract No: 132MO Session Type and Title: Mini Oral session: Gastrointestinal tumors Presentation Time: 2024-12-07, 09:50-09:55 Presenter: Jian Zhang, Fudan University Shanghai Cancer Center, CN Abstract Title: mFOLFOX6 + Bevacizumab + PD-1 Monoclonal Antibody in Locally Advanced MSS CRC (BASKETⅡ): A Prospective, Single-Arm, Open-Label, Phase 2 Study Abstract No: 74MO Session Type and Title: Mini Oral session: Gastrointestinal tumors Presentation Time: 2024-12-07, 10:20-10:25 Presenter: Jun Huang, The Sixth Affiliated Hospital, Sun Yat-sen University, CN Posters Abstract Title: Anlotinib plus Sintilimab as First-line Treatment for Patients with Advanced Colorectal Cancer (APICAL-CRC): an Open-Label, Single-arm, Phase 2 study Abstract No: 75P Session Type and Title: Poster Display session Presentation Time: 2024-12-07, 17:50-18:45 Presenter: Zhan Wang, Shanghai Changzheng Hospital, The Second Affiliated Hospital of Naval Medical University, CN Abstract Title: A single-arm, multicenter, Phase 2 study of hepatic arterial infusion chemotherapy (HAIC) combined with donafenib and sintilimab as first-line treatment for unresectable intrahepatic cholangiocarcinoma (CHANCE 2203) Abstract No: 137P Session Type and Title: Poster Display session Presentation Time: 2024-12-07, 17:50-18:45 Presenter: Gaojun Teng, Zhongda Hospital, Southeast University, CN Abstract Title: FOLFOX-HAIC combined with sintilimab and bevacizumab for advanced hepatocellular carcinoma: a single-arm, Phase 2 study Abstract No: 207P Session Type and Title: Poster Display session Presentation Time: 2024-12-07, 17:50-18:45 Presenter: Bin Liang/ Zizhuo Wang, Union Hospital Tongji Medical College Huazhong University of Science and Technology, CN Abstract Title: Updated results from Phase 2 study of HAIC plus sintilimab and bevacizumab biosimilar in patients with advanced hepatocellular carcinoma (HCC) Abstract No: 214P Session Type and Title: Poster Display session Presentation Time: 2024-12-07, 17:50-18:45 Presenter: Haibin Zhang, Eastern Hepatobiliary Surgery Hospital, Third Affiliated Hospital of Naval Medical University, CN Abstract Title: Anlotinib Combined with Sintilimab Versus Chemotherapy Combined with Immunotherapy in Perioperative NSCLC: A Phase 2 Study Abstract No: 599P Session Type and Title: Poster Display session Presentation Time: 2024-12-07, 17:50-18:45 Presenter: Tianqing Chu, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, CN Trial in Progress abstracts (TiP) Abstract Title: A randomized, controlled, multicenter Phase 3 study of IBI310 (anti-CTLA-4 antibody) plus sintilimab (anti-PD-1 antibody) as neoadjuvant treatment for resectable microsatellite instability-high/mismatch repair-deficient (MSI-H/dMMR) colon cancer: Trial in Progress Abstract No.: 119TiP Session Type and Title: Poster Display session Presentation Time: 2024-12-07, 17:50-18:45 Presenter: Ruihua Xu, Sun Yat-sen University Cancer Center, CN Abstract Title: Efficacy and Safety of Combination Therapy of Sintilimab and Chemotherapy with Cryoablation in the First-Line Treatment of Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) Abstract No.: 722TiP Session Type and Title: Poster Display session Presentation Time: 2024-12-07, 17:50-18:45 Presenter: Zhiqiang Gao, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, CN Dr. Hui Zhou, Senior Vice President of Innovent, stated: "We are very pleased to present and share a robust set of clinical data at EAMO Asia 2024. Notably, we are highlighting the breakthrough potential for our TOPO1i CLDN18.2 ADC (IBI343) in pancreatic cancer, a global difficult-to-treat cancer. Consistent with the preliminary signal observed in small patient size, the data in dose expansion stage demonstrated encouraging efficacy and good safety, which reinforced our confidence in advancing its development. Given unique design of Fc-silent antibody, combined with stable linker and potent extecan payload, IBI343 pioneered in the exploration of CLDN18.2 ADC agents for PDAC treatment. As one of the few biopharmaceutical companies with both advanced technology platforms and a robust pipeline in "IO+ADC" areas, Innovent remains dedicated to transforming cancer treatment by delivering innovative, effective, and safe therapeutic options for doctors and patients." About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 11 products in the market. It has 5 new drug applications under regulatory review, 3 assets in Phase III or pivotal clinical trials and 17 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow Innovent on Facebook and LinkedIn. Forward-looking statement This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent Biologics ("Innovent"), are intended to identify certain of such forward-looking statements. The Company does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of the Company with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond the Company's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, the Company's competitive environment and political, economic, legal and social conditions. The Company, the Directors and the employees of the Company assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialise or turn out to be incorrect. SOURCE Innovent Biologics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Phase 1Clinical ResultADCImmunotherapy

20 Nov 2024

·www.echemi.com

CanSino Biologics’ PD-1/VEGF New Drug Sparks Revolution in Lung Cancer Treatment!

At the World Congress on Lung Cancer in September 2024, Kangfang Biotics released Evoxil monotherapy (PD-1/VEGF bispecial antibody) and Merck Pabolizumab monotherapy in the first-line treatment of PD-L1 expression positive (PD-L1 Key data from a registered Phase III clinical study (HARMONi-2/AK112-303) of locally advanced or metastatic non-small cell lung cancer (NSCLC) with TPS≥1%. Two months later, Merck also introduced a PD-1/VEGF bisspecific antibody: LM-299. In addition to Merck, many well-known pharmaceutical companies have also invested in the field of PD-(L)1 dual antibody. In recent years, there have been frequent deals in this area, with Chinese biotech companies becoming the main transferers. PD-1 and VEGF are often up-regulated and co-expressed in solid tumors. Anti-vegf drugs have synergistic effects with immune checkpoint inhibitors (ICI) in promoting tumor vascular normalization and stimulating immune activation. Kangfang's remarkable achievements in the HARMONi-2 study confirmed that PD-(L)1/VEGF double antibody has the potential to replace PD-1 monoclonal antibody. Eboxizumab is currently approved in China for use in combination with pemetrexed and carboplatin for the treatment of EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC patients who have progressed after treatment with epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKI). A marketing application has also been filed for the first-line treatment of ivoximab in patients with PD-L1 positive (TPS≥1%) NSCLC. Other clinically advanced PD-(L)1/VEGF pipelines are almost all from China, which has triggered a rush to authorize domestic PD-(L)1/VEGF drugs to the sea. However, PD-1 monoclonal antibody still faces problems such as low response rate, safety and drug resistance, so the market is full of expectations for the development of a new generation of immunotherapy. At present, PD-1/VEGF double antibody has been the first to achieve a breakthrough, and we look forward to more exciting progress in this field in the future.

ImmunotherapyPhase 3Drug ApprovalADCPhase 2

15 Nov 2024

·www.globenewswire.com

Arbutus and Barinthus Bio Announce New Data from the IM-PROVE II Trial Showing that the Addition of Nivolumab Increased Rates of HBsAg Loss in People with Chronic Hepatitis B

Significantly greater mean declines in HBsAg levels (p <0.017) were seen in those receiving imdusiran, VTP-300 and low-dose nivolumab compared to other cohorts assessed previously 23% of participants receiving imdusiran, VTP-300 and low-dose nivolumab reached HBsAg loss by Week 48 WARMINSTER, Pa. and OXFORD, United Kingdom, Nov. 15, 2024 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (Nasdaq: ABUS), (“Arbutus” or the “Company”) a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to develop a functional cure for people with chronic hepatitis B virus infection, and Barinthus Biotherapeutics plc (NASDAQ: BRNS), a clinical-stage biopharmaceutical company developing novel immunotherapeutic candidates that guide T cells to control disease, today announced new preliminary data from the Phase 2a IM-PROVE II clinical trial (AB-729-202) of people with chronic hepatitis B virus (cHBV) at the American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting® 2024. The new data are from an additional cohort of participants (Group C) who received repeat doses of imdusiran, Arbutus’ RNAi therapeutic, followed by Barinthus Bio's T-cell stimulating immunotherapeutic, VTP-300, with or without low-dose nivolumab, an anti-PD-1 monoclonal antibody. The data indicated that Group C participants receiving nivolumab experienced increased rates of HBsAg loss (defined as HBsAg 0.5 log10 decline in HBsAg between Weeks 26 and 34). This trial was amended to include an additional cohort (Group C) which enrolled 22 participants, 13 of which were eligible to receive imdusiran (60mg every 8 weeks) for 24 weeks with ongoing NUC therapy followed by VTP-300 at Weeks 26 and 30 plus up to two low doses of nivolumab (0.3 mg/kg), an approved PD-1 monoclonal antibody at Week 30. The remaining 9 participants received the imdusiran/NUC/VTP-300 regimen without nivolumab. Participants could receive a second dose of VTP-300 ± low-dose nivolumab at Week 38 if their HBsAg was ≥10 IU/mL at Week 34. Upon completion of the treatment period at Week 48, all participants who met certain criteria could discontinue NUC therapy and be followed for an additional 48 weeks. Those who did not meet the criteria continued on NUC therapy for an additional 24 weeks of follow-up. About Imdusiran (AB-729) Imdusiran is an RNA interference (RNAi) therapeutic specifically designed to reduce all HBV viral proteins and antigens including hepatitis B surface antigen, which is thought to be a key prerequisite to enable reawakening of a patient’s immune system to respond to the virus. Imdusiran targets hepatocytes using Arbutus’ novel covalently conjugated N-Acetylgalactosamine (GalNAc) delivery technology enabling subcutaneous delivery. Clinical data generated thus far has shown single and multiple doses of imdusiran to be generally safe and well-tolerated, while also providing meaningful reductions in hepatitis B surface antigen and hepatitis B DNA. Imdusiran is currently in multiple Phase 2a clinical trials. About VTP-300 VTP-300 is an immunotherapeutic candidate consisting of an initial dose using the ChAdOx vector and a secondary dose(s) using the MVA vector, both encoding multiple HBsAg, including full-length surface, modified polymerase, and core antigens. VTP-300 is the first antigen-specific immunotherapy that has been shown to induce sustained reductions in HBsAg. Barinthus Bio is studying VTP-300 in combination with other agents, including siRNA and low-dose anti-PD-1 antibodies, to control the infection, and counterbalance the immune suppression and T cell exhaustion in the liver caused by chronic HBV infection. About Arbutus Arbutus Biopharma Corporation (Nasdaq: ABUS) is a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to develop novel therapeutics with distinct mechanisms of action, which can potentially be combined to provide a functional cure for patients with chronic hepatitis B virus (cHBV). Arbutus believes the key to success in developing a functional cure involves suppressing HBV DNA, reducing surface antigen, and boosting HBV-specific immune responses. Arbutus’ pipeline of internally developed, proprietary compounds includes an RNAi therapeutic, imdusiran (AB-729), and an oral PD-L1 inhibitor, AB-101. Imdusiran has generated meaningful clinical data demonstrating an impact on both surface antigen reduction and reawakening of the HBV-specific immune response. Imdusiran is currently in two Phase 2a combination clinical trials. AB-101 is currently being evaluated in a Phase 1a/1b clinical trial. For more information, visit www.arbutusbio.com. About Barinthus Bio Barinthus Biotherapeutics (Nasdaq: BRNS) is a clinical-stage biopharmaceutical company developing novel immunotherapeutic candidates designed to guide the immune system to overcome chronic infectious diseases and autoimmunity. Helping people living with serious diseases and their families is the guiding principle at the heart of Barinthus Bio. With a focused pipeline built around its proprietary platform technologies, Barinthus Bio is advancing immunotherapeutic product candidates in infectious diseases and autoimmunity, including: VTP-300, that utilizing its ChAdOx/MVA platform designed as a potential component of a functional cure for chronic HBV infection and VTP-1000, utilizing our SNAP-Tolerance Immunotherapy (SNAP-TI) platform and is designed to treat people with celiac disease. Barinthus Bio is also conducting a Phase 1 clinical trial for VTP-850, a second-generation immunotherapeutic candidate designed to treat recurrent prostate cancer. Barinthus Bio’s differentiated technology platforms and therapeutic approach, coupled with deep scientific expertise and focus on clinical development, uniquely positions the company to navigate towards delivering treatments that improve the lives of people with chronic infectious diseases and autoimmunity. For more information, visit www.barinthusbio.com. Arbutus Forward Looking Statements and Information This press release contains forward-looking statements within the meaning of the Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and forward-looking information within the meaning of Canadian securities laws (collectively, forward-looking statements). Forward-looking statements in this press release include statements about Arbutus’ future development plans for its product candidates; the expected cost, timing and results of its clinical development plans and clinical trials with respect to Arbutus’ product candidates; Arbutus’ expectations with respect to the release of data from its clinical trials and the expected timing thereof; Arbutus’ expectations and goals for its collaborations with third parties and any potential benefits related thereto; and the potential for Arbutus’ product candidates to achieve success in clinical trials. With respect to the forward-looking statements contained in this press release, Arbutus has made numerous assumptions regarding, among other things: the effectiveness and timeliness of preclinical studies and clinical trials, and the usefulness of the data; the timeliness of regulatory approvals; the continued demand for Arbutus’ assets; and the stability of economic and market conditions. While Arbutus considers these assumptions to be reasonable, these assumptions are inherently subject to significant business, economic, competitive, market and social uncertainties and contingencies, including uncertainties and contingencies related to patent litigation matters. Additionally, there are known and unknown risk factors which could cause Arbutus’ actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements contained herein. Known risk factors include, among others: anticipated pre-clinical studies and clinical trials may be more costly or take longer to complete than anticipated, and may never be initiated or completed, or may not generate results that warrant future development of the tested product candidate; Arbutus may elect to change its strategy regarding its product candidates and clinical development activities; Arbutus may not receive the necessary regulatory approvals for the clinical development of Arbutus’ products; economic and market conditions may worsen; Arbutus may not realize the anticipated benefits from its recent organizational changes; Arbutus may incur additional unexpected expenses in connection with the organizational changes; Arbutus may experience additional employee turnover as a result of the organizational changes; uncertainties associated with litigation generally and patent litigation specifically; and Arbutus and its collaborators may never realize the expected benefits of the collaborations; and market shifts may require a change in strategic focus. A more complete discussion of the risks and uncertainties facing Arbutus appears in Arbutus’ Annual Report on Form 10-K, Arbutus’ Quarterly Reports on Form 10-Q and Arbutus’ continuous and periodic disclosure filings, which are available at www.sedar.com and at www.sec.gov. All forward-looking statements herein are qualified in their entirety by this cautionary statement, and Arbutus disclaims any obligation to revise or update any such forward-looking statements or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, except as required by law. Barinthus Bio’s Forward Looking Statements This press release contains forward-looking statements regarding Barinthus Bio within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, which can generally be identified as such by use of the words “may,” “will,” “plan,” “forward,” “encouraging,” “believe,” “potential,” “expect,” and similar expressions, although not all forward-looking statements contain these identifying words. These forward-looking statements include, without limitation, express or implied statements regarding our future expectations, plans and prospects, including our product development activities and clinical trials, including timing for readouts of any preliminary, interim or final data or next steps for any of our programs, and our ability to develop and advance our current and future product candidates and programs. Any forward-looking statements in this press release are based on our management’s current expectations and beliefs and are subject to numerous risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks and uncertainties related to the success, cost and timing of our pipeline development activities and planned and ongoing clinical trials, including the risk that the timing for preliminary, interim or final data or initiation of our clinical trials may be delayed, the risk that interim or topline data may not reflect final data or results, our ability to execute on our strategy, regulatory developments, the risk that we may not achieve the anticipated benefits of our pipeline prioritization and corporate restructuring, our ability to fund our operations and access capital, our cash runway, including the risk that our estimate of our cash runway may be incorrect, global economic uncertainty, including disruptions in the banking industry, the conflicts in Ukraine, Israel and Gaza, and other risks identified in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K for the year ended December 31, 2023, our Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. We expressly disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Arbutus Biopharma Contacts: Investor & Media Contact:Lisa M. CaperelliVice President, Investor Relations1-215-206-1822lcaperelli@arbutusbio.com Barinthus Bio Contacts: IR contacts:Christopher M. Calabrese Managing Director LifeSci Advisors+1 917-680-5608ccalabrese@lifesciadvisors.com Kevin GardnerManaging DirectorLifeSci Advisors+1 617-283-2856kgardner@lifesciadvisors.com Media contact:Audra FriisSam Brown, Inc.+1 917-519-9577audrafriis@sambrown.com Company contact:Jonothan BlackbournIR & PR ManagerBarinthus Bioir@barinthusbio.com

Clinical ResultPhase 2ImmunotherapyPhase 1

100 Deals associated with Iparomlimab

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Neoplasms	NDA/BLA	CN	Qilu Pharmaceutical Co., Ltd.	17 Sep 2023
Metastatic Carcinoma to the Uterine Cervix	Phase 3	CN	Qilu Pharmaceutical Co., Ltd.	23 Sep 2020
Adenocarcinoma	Phase 3	CN	Qilu Pharmaceutical Co., Ltd.	01 Jul 2020
Advanced Gastric Adenocarcinoma	Phase 3	CN	Qilu Pharmaceutical Co., Ltd.	01 Jul 2020
Advanced Hepatocellular Carcinoma	Phase 2	CN	Qilu Pharmaceutical Co., Ltd.	01 Jul 2021
Advanced cancer	Phase 2	CN	Qilu Pharmaceutical Co., Ltd.	08 Jul 2020
Microsatellite instability-high colorectal cancer	Phase 2	CN	Qilu Pharmaceutical Co., Ltd.	08 Jul 2020
Microsatellite Instability-high Solid Tumors	Phase 2	CN	Qilu Pharmaceutical Co., Ltd.	08 Jul 2020
Advanced Malignant Solid Neoplasm	Phase 2	CN	Qilu Pharmaceutical Co., Ltd.	19 Jun 2020

Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05801094 (Pubmed \| Adv Ther) Manual	Phase 1	Advanced Malignant Solid Neoplasm	71	Iparomlimab 3 mg/kg	exnixjwpmr(zarmxiqlrh) = lcxiepuxka dwwarqjyni (djccvyqlyd ) View more	Positive	14 Sep 2024
NCT04326829 (ASCO2024) Manual	Phase 2	Microsatellite Instability-high Solid Tumors MSI-High \| Deficient DNA Mismatch Repair (dMMR)	120	Iparomlimab 200 mg	etxafywdmp(nkqcepckof) = plyeexitba fmdkcqdjen (bmifbpkfnj, 39.1 - 57.6) View more	Positive	24 May 2024
NCT04326829 (ASCO2024) Manual	Phase 2		120	Iparomlimab (FAS)	etxafywdmp(nkqcepckof) = cmierktzfa fmdkcqdjen (bmifbpkfnj, 36.8 - 63.2) View more	Positive	24 May 2024
NCT04864782 (Pubmed) Manual	Phase 2	Uterine Cervical Cancer First line	46	QL1604 paclitaxeltcisplatinlcarboplatinlatin	kmotcfkmos(yxmrzukevl) = grade≥3 TRAEs (>30%) were neutrophil count decrease (50.0%), anemia (32.6%), and white blood cell count decrease (30.4%). yinabfmljr (pzrvyrcszx )	Positive	29 Mar 2024
PRNewswire Manual	Phase 2	Microsatellite instability-high cancer Deficient DNA Mismatch Repair (dMMR) \| MSI-High	120	艾帕洛利单抗	tybsugmpmw(njrlerlsax) = cpybhfygqw ckghpamojv (zknvjuhsgb, 36.7 - 55.2) View more	Positive	06 Dec 2023
PRNewswire Manual	Phase 2		120	艾帕洛利单抗 (结直肠癌)	tybsugmpmw(njrlerlsax) = wjpbrzwumg ckghpamojv (zknvjuhsgb, 31.5 - 54.1) View more	Positive	06 Dec 2023
NCT04326829 (ESMO_ASIA2023)	Phase 2	Microsatellite Instability-high Solid Tumors	120	QL1604	jlebgmkxgd(loidscasvp) = tuzkvsvifq hbhfezxebf (sxprwgxaap, 36.7% - 55.2) View more	Positive	02 Dec 2023
Biospace Manual	Phase 1	Solid tumor	35	Iparomlimab	vnowuazjzv(aebakbaoex) = fetvbhvicj tlhbcxvfck (zkojztmgzu ) View more	Positive	06 Nov 2023
Biospace Manual	Phase 1	Solid tumor	35	Iparomlimab (3 mg/kg Q2W)	bvylnlqgmy(vanzkbnogr) = bpoesmlfck cdjuqyznhg (avcdwzaqav )	Positive	06 Nov 2023
NCT05649761 (Literature) Manual	Phase 1	Solid tumor	35	QL1604	daolwyfbhd(dwwtqignyr) = sbkidpvgrr vhjifntubf (rcekkipjlu ) View more	Positive	23 Oct 2023
NCT05603039 (ASCO 12023 \| ASCO 22023) Manual	Phase 1/2	Advanced Hepatocellular Carcinoma First line	76	Bevacizumab+QL 1706	dkljhnievo(yczaasfjug) = gopcgckgzg uueemacqjd (ejmtarpnwi ) View more	Positive	26 May 2023
NCT05603039 (ASCO 12023 \| ASCO 22023) Manual	Phase 1/2	Advanced Hepatocellular Carcinoma First line	76	Bevacizumab+QL 1604	dkljhnievo(yczaasfjug) = pqhktbrbaz uueemacqjd (ejmtarpnwi ) View more	Positive	26 May 2023
NCT04864782 (ESMO_ASIA2022) Manual	Phase 2/3	Metastatic Carcinoma to the Uterine Cervix First line	46	QL1604 200 mg+Paclitaxel 175 mg/m2+Cisplatin 70 mg/m2 or Carboplatin	whsjcjqwwv(bplbxloxfb) = ozuftblkpw vypdosnxtv (gzlkdafxrg ) View more	Positive	04 Dec 2022

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