The project focuses on developing new experimental models of ovarian cancer that accurately reflect patients who do not respond to first-line platinum-based treatments and who are resistant to PARP inhibitors (PARPi). These models are essential for testing new drugs or drug combinations in preclinical settings that closely mimic real clinical conditions. These models will also help to identify predictive biomarkers of treatment response and to better understand the biological mechanisms behind therapy resistance.

Start Date01 Aug 2026

Sponsor / Collaborator

Istituto di Ricerche Farmacologiche Mario Negri

[+1]

NCT06692491

/ Not yet recruitingPhase 2IIT

A Phase II Clinical Study on Precision Treatment of Rare Tumours in China Guided by Patient-Derived Tumor Organoids (PDO) and Next-Generation Sequencing (NGS)

The objective of this Phase II, open-label, multicenter, non-randomised controlled clinical trial is to guide precision treatment for patients with rare tumours based on Patient-Derived Organoids/Next-Generation Sequencing drug screening.

Start Date01 Jan 2025

Sponsor / Collaborator

Peking University Shenzhen Hospital

ChiCTR2400086484

/ Not yet recruitingPhase 2IIT

Individualized radiotherapy plus PARP inhibitors in locally advanced esophageal cancer

Start Date25 Jun 2024

Sponsor / Collaborator

Shuguang Hospital

100 Clinical Results associated with Pamiparib

100 Translational Medicine associated with Pamiparib

100 Patents (Medical) associated with Pamiparib

Literatures (Medical) associated with Pamiparib

01 May 2026·JOURNAL OF OBSTETRICS AND GYNAECOLOGY RESEARCH

Efficacy and Safety of Pamiparib Monotherapy in Recurrent Ovarian Cancer After Prior PARPi Exposure: A Prospective, Open‐Label, Single‐Arm, Phase II Study

Article

Author: Zhu, Jianqing ; Sun, Lu ; Cheng, Feng ; Shao, Feng ; Jiang, Guangyi ; Yang, Li

ABSTRACT:

Aim:

To evaluate the efficacy and safety of pamiparib monotherapy in recurrent ovarian cancer (rOC) after prior PARPi exposure.

Methods:

This was a prospective clinical trial. Fifteen patients were enrolled between August 2022 and December 2023. Oral pamiparib 60 mg twice daily was administered until conditions specified in the protocol. Primary endpoint was clinical benefit rate ≥ 4 months (CBR4m; percentage of patients who sustained complete response, partial response [PR], and stable disease for at least 4 months). Secondary endpoints included progression‐free survival (PFS), overall response rate (ORR), overall survival (OS), and safety.

Results:

Median number of previous treatment line was 3 (range, 2–6). CBR4m was 26.7% and the study was halted in the first stage according to the pre‐set statistical criteria. Two patients achieved PR for an ORR of 13.3%. With a median follow‐up of 16.1 months, median PFS and OS were respectively 2.8 (95% confidence interval [CI], 1.6–NR) and 15.6 (95% CI, 8.4–NR) months. Subgroup analyses showed CBR4m of 37.5% (3/8) in BRCAmut and 14.3% (1/7) in BRCAwt cohorts. CA‐125 response according to GCIG criteria was observed in 26.7% of patients. There were no treatment‐related serious adverse events or deaths.

Conclusions:

Pamiparib monotherapy preliminarily showed limited efficacy and acceptable safety profiles in heavily pretreated rOC after prior PARPi exposure. The results suggested that single‐agent pamiparib retreatment may not be an effective treatment for this patient population; further investigation of combining PARPi with agents with different mechanisms may be warranted.

01 Jan 2026·Therapeutic Advances in Medical Oncology

Efficacy and safety of PARP inhibitors in metastatic breast cancer patients with homologous recombination repair pathway gene mutations: a retrospective multicenter real-world study

Article

Author: Zhang, Jintao ; Xu, Binghe ; Zhang, Pin ; Wang, Jiani ; Fan, Ying ; Luo, Yang ; Peng, Xuenan ; Mo, Hongnan ; Sun, Xiaoying ; Lan, Bo ; Chen, Shanshan ; Ma, Fei ; Wang, Jiayu ; Li, Qiao ; Song, Ruixia

Background::

The efficacy and safety of poly (ADP-ribose) polymerase inhibitors (PARPis) in the Chinese real-world setting have not been well characterized.

Design::

This is a retrospective analysis of PARPis efficacy in metastatic breast cancer (MBC) patients with homologous recombination repair (HRR) gene pathogenic variants (PVs).

Objectives::

We aimed to evaluate the efficacy and toxicities of PARPis in real-world MBC patients.

Methods::

Patients who received PARPi for MBC at the National Cancer Center and two other centers between January 1, 2019, and December 31, 2024, were consecutively included. The primary endpoint was progression-free survival (PFS). Univariable and multivariable Cox proportional hazard models were used to evaluate the predictive impact of clinicopathologic characteristics on PFS.

Results::

In total, 62 MBC patients treated with olaparib ( N = 55), talazoparib ( N = 4), pamiparib ( N = 2), and fluzoparib ( N = 1) were enrolled. The median PFS (mPFS) in all patients was 6.0 months (95% confidence interval: 4.1–7.9). mPFS in the germline BRCA1 (g BRCA1; N = 19), g BRCA2 ( N = 30), g BRCA ( N = 4), somatic BRCA2 (s BRCA2; N = 1), g PALB2 ( N = 4), and other HRR gene ( N = 4) PVs carriers were 3.7, 8.0, 2.8, 2.7, 5.3, and 7.1 months, respectively ( p = 0.334). In multivariate analysis, ⩽40 years old (hazard ratio (HR): 2.281, p = 0.008), third-line or later therapy (HR: 2.429, p = 0.019), and prior platinum-based treatment (HR: 2.172, p = 0.014) were independently associated with shorter PFS. The incidence of adverse events (AEs) of all grades was 62.5% (35/56). The most common AEs in all grades were anemia (30.4%), nausea (21.4%), and leukopenia (17.9%). Hematologic toxicity was the most common grade ⩾3 AEs.

Conclusion::

PARPis showed promising PFS and tolerable toxicity in the real-world treatment of Chinese MBC patients with HRR-related gene mutations.

01 Jan 2026·CURRENT CANCER DRUG TARGETS

Clinical Application of PARP1 Inhibitors and Challenges in Cancer Therapy

Review

Author: Cui, Xuehai ; Chen, Yuekang ; Huang, Xinyu ; Li, Enmin ; Nie, Mingcheng ; Cheng, Yinwei ; Lin, Wan ; Luo, Yunlin ; Xu, Liyan

Among the Poly(ADP-ribose) Polymerase (PARP) family in mammals, PARP1 is the first identified and well-studied member that plays a critical role in DNA damage repair and has been proven to be an effective target for cancer therapy. Here, we have reviewed not only the role of PARP1 in different DNA damage repair pathways, but also the working mechanisms of several PARP inhibitors (PARPi), inhibiting Poly-ADP-ribosylation (PARylation) processing and PAR chains production to trap PARP1 on impaired DNA and inducing Transcription- replication Conflicts (TRCs) by inhibiting the PARP1 activity. This review has systematically summarized the latest clinical application of six authorized PARPi, including olaparib, rucaparib, niraparib, talazoparib, fuzuloparib and pamiparib, in monotherapy and combination therapies with chemotherapy, radiotherapy, and immunotherapy, in different kinds of cancer. Furthermore, probable challenges in PARPi application and drug resistance mechanisms have also been discussed. Despite these challenges, further development of new PARP1 inhibitors appears promising as a valuable approach to cancer treatment.

News (Medical) associated with Pamiparib

23 May 2025

·www.einpresswire.com

HUTCHMED Highlights Clinical Data to be Presented at the 2025 ASCO Annual Meeting

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., May 23, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“ HUTCHMED ”) (Nasdaq/AIM:HCM; HKEX:13) today announces that new data from several studies of compounds discovered by HUTCHMED including savolitinib, ranosidenib, fruquintinib and surufatinib, will be presented at the American Society of Clinical Oncology (“ASCO”) Annual Meeting taking place on May 30 – June 3, 2025 in Chicago, USA. Results from the SACHI China Phase III study of savolitinib in combination with osimertinib in patients with locally advanced or metastatic epidermal growth factor receptor (“EGFR”) mutation-positive non-small cell lung cancer (“NSCLC”) with MET amplification after disease progression on EGFR inhibitor therapy will be presented at a late breaking oral presentation. SACHI had met the pre-defined primary endpoint of progression-free survival (PFS) in a planned interim analysis. SACHI data supports the New Drug Application (NDA) for this oral-only treatment, which has been accepted and granted priority review in China. Further data with additional analysis stratified by brain metastasis status from a high MET overexpression and/or amplification treatment subset of the SAVANNAH Phase II study of the savolitinib and osimertinib combination in NSCLC patients harboring EGFR mutation and MET amplification or overexpression after progressing on osimertinib were reported. The savolitinib and osimertinib combination demonstrated better efficacy outcomes compared to savolitinib plus placebo. The combination showed promising central nervous system (“CNS”) activity, with reduced CNS progression and fewer new CNS lesions. Results will be presented from the dose-escalation stage of the Phase I study of ranosidenib (HMPL-306), a novel, small-molecule, highly selective oral dual-inhibitor of both Isocitrate dehydrogenase (“IDH”) 1 and IDH2 enzymes, being studied in patients with locally advanced or metastatic solid tumors with IDH mutations. Results show that the compound was well tolerated, showing target inhibition and durable responses in patients. Efficacy signals were observed especially in the efficacy evaluated group of lower-grade glioma patients (N=14), with an objective response rate (“ORR”) of 7.1% and a disease control rate (“DCR”) of 100%. Results will also be presented from the sub-group analyses of the FRUSICA-1 open-label, single-arm, pivotal Phase II study to evaluate the efficacy and safety of fruquintinib plus sintilimab in previously treated advanced endometrial cancer (EMC) patients with pMMR (proficient mismatch repair) status. Efficacy findings for patients with serous carcinoma (N=27) were clinically meaningful and characterized by responses similar to those observed in full trial population (N=98), with an Independent Review Committee (“IRC”)-assessed ORR of 37.0% and a DCR of 88.9%. The analysis of whether the response was affected by prior neoadjuvant/adjuvant chemotherapy (“NACT/ACT”) showed durable and clinically meaningful responses regardless of whether the patient had received NACT/ACT. Results were comparable for patients with and without prior NACT/ACT, with an IRC-assessed ORR of 34.0% versus 31.4% and DCR of 85.1% versus 82.4%, respectively. Results from two subgroup analyses of a Phase IV study of fruquintinib involving 2,798 colorectal cancer patients in China will be presented. In the subgroup analysis evaluating the safety of fruquintinib as monotherapy and in combination therapy, fruquintinib demonstrated a manageable safety profile in both groups. Treatment-emergent adverse events (TEAE) of Grade 3 or above occurred in 23.94% in the fruquintinib monotherapy group and 26.06% in the combination therapy group with other anti-cancer treatments. The most common treatment related adverse events (TRAE) of any grade in both groups were palmar-plantar erythrodysesthesia (PPES) and hypertension. The combination therapy group exhibited a longer treatment duration, potentially indicating improved patient outcomes. In the subgroup analysis by age, the safety of fruquintinib was assessed in younger (age <50) and late-elderly (age ≥75) patients. The safety profile was comparable across both age groups, with younger patients receiving more intensive treatment. Combination therapy with fruquintinib also showed a longer duration than monotherapy in both age subgroups, which may suggest improved survival potential. Details of the presentations, including links to available abstracts, are as follows: Abstract title Presenter / Lead author Presentation details SPONSORED STUDIES Savolitinib (Savo) combined with osimertinib (osi) versus chemotherapy (chemo) in EGFR-mutant (EGFRm) and MET -amplification ( MET amp) advanced NSCLC after disease progression (PD) on EGFR tyrosine kinase inhibitor (TKI): Results from a randomized phase 3 SACHI study Shun Lu, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China LBA8505 Oral Abstract Session: Lung Cancer - Non-Small Cell Metastatic Sunday, June 1, 2025 9:48 AM CDT Efficacy and CNS results from a randomized subset of the phase 2 SAVANNAH study comparing savolitinib (savo) + osimertinib (osi) combination with savo + placebo (PBO) Benjamin Philip Levy, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD 8513 Rapid Oral Session: Lung Cancer - Non-Small Cell Metastatic Monday, June 2, 2025 8:06 AM CDT Phase I study of HMPL-306, an inhibitor of mutant IDH1/IDH2 (mIDH1/2), in western patients (pts) with advanced mIDH solid tumor, including glioma Jordi Rodon Ahnert, The University of Texas MD Anderson Cancer Center, Houston, TX 2013 Rapid Oral Session: Central Nervous System Tumors Saturday, May 31, 2025 3:06 PM CDT Analysis of serous carcinoma subgroup in FRUSICA-1: Fruquintinib plus sintilimab in treated advanced endometrial cancer (EMC) patients (pts) with pMMR status Xiaohua Wu, Fudan University Shanghai Cancer Center, Shanghai, China 5596 Poster Session: Gynecologic Cancer The Impact of Prior Neoadjuvant/Adjuvant Chemotherapy (NACT/ACT) on Fruquintinib Plus Sintilimab Outcomes in Advanced Endometrial Cancer (EMC) Patients with pMMR Status: A Subgroup Analysis of FRUSICA-1 Jing Wang, Hunan Cancer Hospital, Changsha, China 5611 Poster Session: Gynecologic Cancer Safety of fruquintinib in young and late-elderly Chinese patients with colorectal cancer in real-world clinical practice: Age subgroup analysis of a fruquintinib Phase IV study Yi Wang, Ningbo No.2 Hospital, Ningbo, China e15512 Publication Only: Gastrointestinal Cancer - Colorectal and Anal Safety of fruquintinib monotherapy and combination therapy in Chinese Patients with colorectal cancer in real-world clinical practice: A subgroup analysis from Phase IV study Zhiqiang Wang, Sun Yat-Sen University Cancer Center, Guangzhou, China e15515 Publication Only: Gastrointestinal Cancer - Colorectal and Anal The appropriate therapeutic sequence with angiogenesis inhibitor and chemotherapy in patients with advanced gastric or gastroesophageal junction adenocarcinoma: Exploratory analysis from the Phase III FRUTIGA study Jin Li, Shanghai East Hospital, Tongji University, Shanghai, China e16011 Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary Subgroup analysis of efficacy and safety of fruquintinib plus paclitaxel versus paclitaxel in gastroesophageal junction adenocarcinoma patients from FRUTIGA: A randomized Phase III clinical trial in second-line treatment of gastric/gastroesophageal junction Tianshu Liu, Zhongshan Hospital, Fudan University, Shanghai, Shanghai, China e16012 Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary INVESTIGATOR-INITIATED STUDIES Fruquintinib in combination with camrelizumab and paclitaxel liposome and nedaplatin as first-line treatment for advanced esophageal squamous cell carcinoma (ESCC): a single-arm, Phase II study Yanhong Gu, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China 4042 Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary Updated results of fruquintinib combined with PD-1 inhibitors and chemotherapy in the first-line treatment of HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma (FDZL-FIX): a single-arm, open-label Phase II study Chenchen Wang, Fudan University Shanghai Cancer Center, Shanghai, China 4046 Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary Open-label, single-arm, single-center Phase Ib/II clinical study of fruquintinib combined with trastuzumab and XELOX in the first-line treatment of advanced HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma Huifang Lv, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China TPS4203 Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary A multi-cohort real-world study of treatment for metastatic colorectal cancer (mCRC): Overall efficacy analysis and subgroup analysis of previous bevacizumab use or not Wangxia Lv, The Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Hangzhou, China e15530 Publication Only: Gastrointestinal Cancer - Colorectal and Anal Real-world Observational Study of Fruquintinib in Combination with Irinotecan and Capecitabine as Second-line Treatment in Patients with Advanced Colorectal Cancer Ling Xu, the First Hospital of China Medical University, Shenyang, China e15539 Publication Only: Gastrointestinal Cancer - Colorectal and Anal Preliminary results of fruquintinib in combination with FOLFIRI as second-line treatment for RAS-mutant metastatic colorectal cancer: a prospective single-center Phase II study Ru Jia, Fifth Medical Center, Chinese PLA General Hospital, Beijing, China e15541 Publication Only: Gastrointestinal Cancer - Colorectal and Anal Evaluating the efficacy of fruquintinib versus regorafenib and trifluridine/tipiracil in treating advanced metastatic colorectal cancer: A match-adjusted indirect comparison Shukui Qin, Gastrointestinal Cancer Center of Nanjing Tianyinshan Hospital, China Pharmaceutical University, Nanjing, China e15550 Publication Only: Gastrointestinal Cancer - Colorectal and Anal Fruquintinib plus sintilimab and SOX as conversion therapy for initially unresectable gastric/gastroesophageal junction adenocarcinoma (GC/GEJC): Updated response and surgical results from a single-arm, Phase II clinical trial Fei Ma, Henan Cancer Hospital, Zhengzhou, China e16016 Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary A Phase II study to evaluate the efficacy and safety of fruquintinib combined with envafolimab in patients with advanced or unresectable locally advanced osteosarcoma and soft tissue sarcoma Chenliang Zhou, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China e23506 Publication Only: Sarcoma Efficacy and safety of surufatinib (Sur) plus paclitaxel (Pac) as second line (2L) treatment for advanced gastric cancer (aGC): Final results from a Phase II trial Xiuying Xiao, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China 4028 Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary Efficacy and safety of surufatinib (S) plus KN046 (K) and chemotherapy in first line (1L) advanced pancreatic cancer (PC): a single-arm, Phase Ib/II trial Wenquan Wang, Zhongshan Hospital, Fudan University, Shanghai, China 4157 Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary First-Line Treatment with Surufatinib, Camrelizumab, Nab-paclitaxel, and S-1 in Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (PDAC): A Phase Ib/II Randomized Study Ru Jia/ Guanghai Dai, the Fifth Medical Center of the PLA General Hospital, Beijing, China 4161 Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary A prospective, single-arm, Phase II trial exploring the use of pamiparib combined with surufatinib as neoadiuvant therapy for advanced, unresectable ovarian cancer (PASSION) Bairong Xia, The First Affiliated Hospital of University of Science and Technology of China, Hefei, China 5589 Poster Session: Gynecologic Cancer The efficacy and safety of Surufatinib monotherapy as a third-line treatment for advanced hepatocellular carcinoma: A single-arm, open-label, multi-center Phase II study Fuxiang Zhou, Zhongnan Hospital of Wuhan University, Wuhan, China e16209 Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary Surufatinib combined with gemcitabine and cisplatin and immune checkpoint inhibitor (ICI) for unresectable locally advanced or metastatic intrahepatic cholangiocarcinoma Jingtao Zhang/ Xuetao Shi, Cancer Hospital of Shandong First Medical University, Jinan, China e16222 Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary Updated results from a multicenter, single-arm Phase II study of surufatinib plus sintilimab and lBl310 in patients with high-grade advanced neuroendocrine neoplasm (HG-NEN) Ming Lu/ Lin Shen, Peking University Cancer Hospital, Beijing, China e16342 Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary A prospective, single-arm, Phase II study of surufatinib in combination with gemcitabine and nab-paclitaxel for the neoadjuvant treatment of resectable and borderline resectable pancreatic cancer Song Gao/ Jihui Hao, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China e16442 Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary About HUTCHMED HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception it has focused on bringing drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also approved around the world including in the US, Europe and Japan. 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 US Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including but not limited to its expectations regarding the therapeutic potential of savolitinib, ranosidenib, fruquintinib and surufatinib, the further clinical development for savolitinib, ranosidenib, fruquintinib and surufatinib, its expectations as to whether any studies on savolitinib, ranosidenib, fruquintinib and surufatinib would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Such risks and uncertainties include, among other things, assumptions regarding enrollment rates and the timing and availability of subjects meeting a study’s inclusion and exclusion criteria; changes to clinical protocols or regulatory requirements; unexpected adverse events or safety issues; the ability of savolitinib, ranosidenib, fruquintinib and surufatinib, including as combination therapies, to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions and to gain commercial acceptance after obtaining regulatory approval; the potential markets of savolitinib, ranosidenib, fruquintinib and surufatinib for a targeted indication, and the sufficiency of funding. In addition, as certain studies rely on the use of other drug products as combination therapeutics, such risks and uncertainties include assumptions regarding their safety, efficacy, supply and continued regulatory approval. 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 US 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 FTI Consulting – +44 20 3727 1030 / HUTCHMED@fticonsulting.com Ben Atwell / Alex Shaw +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) Brunswick – Zhou Yi +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com Panmure Liberum Nominated Advisor and Joint Broker Atholl Tweedie / Freddy Crossley / Rupert Dearden +44 20 7886 2500 HSBC Joint Broker Simon Alexander / Alina Vaskina / Arnav Kapoor +44 20 7991 8888 Cavendish Joint Broker Geoff Nash / Nigel Birks +44 20 7220 0500 Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Clinical ResultPhase 2ASCOPhase 3Phase 1

01 May 2025

·pipelinereview.com

Mabwell Releases 6 Study Results of Innovative Drugs and Platforms at the 2025 AACR Annual Meeting

SHANGHAI, China I April 30, 2025 I Mabwell (688062.SH), an innovation-driven biopharmaceutical company with entire industry chain, presented 6 study results of innovative drugs and platforms in poster format at the American Association for Cancer Research (AACR) annual meeting, held from April 25 to 30, 2025. Poster Presentation 1. A B7-H3-targeting antibody-drug conjugate, 7MW3711, and PARP inhibitors synergistically potentiate the antitumor activity in B7-H3-positive cancers Published Abstract Number: 830 Both PARP inhibitors and B7-H3-targeting ADC are feasible therapies to chemotherapy resistant solid tumors. Mabwell combines its self-developed 7MW3711 with PARP inhibitors to explore the synergistic antitumor activity of the ADC+PARPi combination strategy in preclinical solid tumor models. In this study, the synergistic antitumor activity shown by 7MW3711 in combination with PARPi suggests that it is a promising strategy to combine DNA damage repair inhibitor and B7-H3-targeting ADC for the treatment of B7-H3-positive solid tumors. The data provide evidence for the potential utility of 7MW3711 combination with PARPi for treatment of B7-H3-expressing tumors and support the rationale for further clinical application. 2. Design and synthesis of the novel camptothecin analog MF6 for application into site-specific antibody-drug conjugate Published Abstract Number: 5733 This study preliminarily validated the antitumor activity and safety of MF6, a novel payload based on the Mtoxin™ platform, in multiple in vivo and in vitro models. The experimental results demonstrated that MF6 possessed favorable tumor-killing activity and maintains significant efficacy in multidrug-resistant models resistant to DXd. ADCs constructed using the clinically validated site-specific conjugation technology IDDC™ and our novel payload MF6 demonstrated good uniformity and stability, and exhibited significant antitumor efficacy in multiple CDX models. Additionally, these ADCs show a potent bystander killing effect enabling the killing of nearby tumor cells and thereby further enhancing the antitumor efficacy. ADCs synthesized with MF6 have excellent serum and plasma stability and pharmacokinetic properties, providing strong support for future clinical application. 3. MW-C01/C02, novel CLDN1-targeting antibody-drug conjugates, demonstrate compelling anti-tumor efficacy and favorable safety profiles in preclinical studies Published Abstract Number: 1573 MW-C01/C02 are novel CLDN1-targeting ADCs, developed based on our own ADC site-specific conjugation technology platform IDDC™. Claudins localize to tight junctions in healthy tissues, while their overexpression in solid tumors leads to aberrant exposure outside of these junctions, making them attractive targets for ADC therapies. Studies have shown that high expression of CLDN1 is associated with tumor proliferation, invasion, metastasis, and poor prognosis. MW-C01/C02 exhibit robust binding, rapid internalization, and potent cytotoxicity in CLDN1-positive cancer cell lines. MW-C01/C02 demonstrate potent anti-tumor activity in both preclinical CDX and PDX models and show good PK and safety profiles in primates. 4. 2MW7061, a novel LILRB4xCD3 bispecific T-cell engager targeting monocytic acute myeloid leukemia Published Abstract Number: 2116 2MW7061 (LILRB4xCD3) is a bispecific T-cell engager (TCE) targeting LILRB4 developed based on Mabwell’s TCE platform. With its unique structural design and mechanism of action, 2MW7061 exhibits minimal binding to T cells while demonstrating potent cytotoxicity against tumor cells, thereby significantly improving its safety margin without compromising efficacy. In preclinical models of AML (acute myeloid leukemia), 2MW7061 showed strong anti-tumor activity. Non-primate toxicology studies indicate a favorable safety profile, highlighting its therapeutic potential for treating AML patients. 5. An innovative T cell engager platform with optimized CD3 affinity and formats for targeting hematologic and solid tumors Published Abstract Number: 2866 As a promising cancer therapeutic strategy, T‑cell engagers (TCEs) simultaneously bind to CD3 on T cells and tumor-associated antigens (TAAs) on cancer cells, facilitating the formation of an immunological synapse that activates T cells and directs their cytotoxic activity toward tumor cells. Clinical data have robustly demonstrated the efficacy of TCEs in hematologic malignancies; however, their clinical benefits in solid tumors remain to be fully validated. As agonists, TCEs present significant developmental challenges that require a delicate balance between efficacy and safety. In response, Mabwell has established an innovative TCE platform that meticulously optimizes various parameters—including CD3 affinity, TAA selection, and bispecific antibody format—to effectively widen the therapeutic window and maximize clinical outcomes. 6. 7MW4911, a novel cadherin 17-targeting ADC, demonstrates potent efficacy in preclinical models of gastrointestinal cancers Published Abstract Number: 5466 7MW4911 is a novel ADC developed by Mabwell targeting CDH17, a membrane protein highly expressed in gastrointestinal cancers with limited normal tissue distribution, offering a promising therapeutic strategy for gastrointestinal malignancies. 7MW4911 is composed of a proprietary anti-CDH17 monoclonal antibody, a cleavable linker, and innovative cytotoxic payload Mtoxin™, with full intellectual property ownership. In preclinical CDX and PDX models, 7MW4911 demonstrated robust antitumor activity and superior efficacy over MMAE-based ADCs in multidrug resistance models. Pharmacokinetic and safety studies in non-human primates support a favorable profile and a high non-severely toxic dose (HNSTD), enabling clinical advancement. 7MW4911 represents a differentiated and promising ADC candidate for GI cancers, with an IND submission to the NMPA and FDA planned for H2 2025. About Mabwell Mabwell (688062.SH) is an innovation-driven biopharmaceutical company with the entire value chain of the pharmaceutical industry. We provide more effective and accessible therapy and innovative medicines to fulfill global medical needs. Since 2017, an advanced R&D system which covers target discovery, early discovery, druggability, preclinical, clinical research and manufacturing transformation was established. Mabwell has 16 pipeline products in different stages based on a world-class and state-of-the-art R&D engine, including 12 novel drug candidates and 4 biosimilars. We focus on the therapeutic areas of oncology, immunology, bone disorders, ophthalmology, hematology and infectious diseases, etc. Of these, 3 products have been approved and commercialized, 1 product has been filed for market approval, 3 products are in pivotal trials. We have also undertaken 1 national major scientific and technological special project for “Significant New Drugs Development”, 2 projects for National Key R&D Programmes, and multiple provincial and municipal science and technological innovation projects. Mabwell’s Taizhou factory possesses robust in-house manufacturing capability compliant with international GMP standards regulated by the NMPA, FDA and EMA, and has passed the EU QP Audit. The large-scale manufacturing base in Shanghai and the ADC commercialized manufacturing base in Taizhou are under construction. Our mission is “Explore Life, Benefit Health” and our vision is “Innovation, from ideas to reality”. For more information, please visit www.mabwell.com/en . SOURCE: Mabwell

AACRADC

30 Apr 2025

·www.prnewswire.com

Mabwell Releases 6 Study Results of Innovative Drugs and Platforms at the 2025 AACR Annual Meeting

SHANGHAI, April 30, 2025 /PRNewswire/ -- Mabwell (688062.SH), an innovation-driven biopharmaceutical company with entire industry chain, presented 6 study results of innovative drugs and platforms in poster format at the American Association for Cancer Research (AACR) annual meeting, held from April 25 to 30, 2025. Poster Presentation 1. A B7-H3-targeting antibody-drug conjugate, 7MW3711, and PARP inhibitors synergistically potentiate the antitumor activity in B7-H3-positive cancers Published Abstract Number: 830 Both PARP inhibitors and B7-H3-targeting ADC are feasible therapies to chemotherapy resistant solid tumors. Mabwell combines its self-developed 7MW3711 with PARP inhibitors to explore the synergistic antitumor activity of the ADC+PARPi combination strategy in preclinical solid tumor models. In this study, the synergistic antitumor activity shown by 7MW3711 in combination with PARPi suggests that it is a promising strategy to combine DNA damage repair inhibitor and B7-H3-targeting ADC for the treatment of B7-H3-positive solid tumors. The data provide evidence for the potential utility of 7MW3711 combination with PARPi for treatment of B7-H3-expressing tumors and support the rationale for further clinical application. 2. Design and synthesis of the novel camptothecin analog MF6 for application into site-specific antibody-drug conjugate Published Abstract Number: 5733 This study preliminarily validated the antitumor activity and safety of MF6, a novel payload based on the Mtoxin™ platform, in multiple in vivo and in vitro models. The experimental results demonstrated that MF6 possessed favorable tumor-killing activity and maintains significant efficacy in multidrug-resistant models resistant to DXd. ADCs constructed using the clinically validated site-specific conjugation technology IDDC™ and our novel payload MF6 demonstrated good uniformity and stability, and exhibited significant antitumor efficacy in multiple CDX models. Additionally, these ADCs show a potent bystander killing effect enabling the killing of nearby tumor cells and thereby further enhancing the antitumor efficacy. ADCs synthesized with MF6 have excellent serum and plasma stability and pharmacokinetic properties, providing strong support for future clinical application. 3. MW-C01/C02, novel CLDN1-targeting antibody-drug conjugates, demonstrate compelling anti-tumor efficacy and favorable safety profiles in preclinical studies Published Abstract Number: 1573 MW-C01/C02 are novel CLDN1-targeting ADCs, developed based on our own ADC site-specific conjugation technology platform IDDC™. Claudins localize to tight junctions in healthy tissues, while their overexpression in solid tumors leads to aberrant exposure outside of these junctions, making them attractive targets for ADC therapies. Studies have shown that high expression of CLDN1 is associated with tumor proliferation, invasion, metastasis, and poor prognosis. MW-C01/C02 exhibit robust binding, rapid internalization, and potent cytotoxicity in CLDN1-positive cancer cell lines. MW-C01/C02 demonstrate potent anti-tumor activity in both preclinical CDX and PDX models and show good PK and safety profiles in primates. 4. 2MW7061, a novel LILRB4xCD3 bispecific T-cell engager targeting monocytic acute myeloid leukemia Published Abstract Number: 2116 2MW7061 (LILRB4xCD3) is a bispecific T-cell engager (TCE) targeting LILRB4 developed based on Mabwell's TCE platform. With its unique structural design and mechanism of action, 2MW7061 exhibits minimal binding to T cells while demonstrating potent cytotoxicity against tumor cells, thereby significantly improving its safety margin without compromising efficacy. In preclinical models of AML (acute myeloid leukemia), 2MW7061 showed strong anti-tumor activity. Non-primate toxicology studies indicate a favorable safety profile, highlighting its therapeutic potential for treating AML patients. 5. An innovative T cell engager platform with optimized CD3 affinity and formats for targeting hematologic and solid tumors Published Abstract Number: 2866 As a promising cancer therapeutic strategy, T‑cell engagers (TCEs) simultaneously bind to CD3 on T cells and tumor-associated antigens (TAAs) on cancer cells, facilitating the formation of an immunological synapse that activates T cells and directs their cytotoxic activity toward tumor cells. Clinical data have robustly demonstrated the efficacy of TCEs in hematologic malignancies; however, their clinical benefits in solid tumors remain to be fully validated. As agonists, TCEs present significant developmental challenges that require a delicate balance between efficacy and safety. In response, Mabwell has established an innovative TCE platform that meticulously optimizes various parameters—including CD3 affinity, TAA selection, and bispecific antibody format—to effectively widen the therapeutic window and maximize clinical outcomes. 6. 7MW4911, a novel cadherin 17-targeting ADC, demonstrates potent efficacy in preclinical models of gastrointestinal cancers Published Abstract Number: 5466 7MW4911 is a novel ADC developed by Mabwell targeting CDH17, a membrane protein highly expressed in gastrointestinal cancers with limited normal tissue distribution, offering a promising therapeutic strategy for gastrointestinal malignancies. 7MW4911 is composed of a proprietary anti-CDH17 monoclonal antibody, a cleavable linker, and innovative cytotoxic payload Mtoxin™, with full intellectual property ownership. In preclinical CDX and PDX models, 7MW4911 demonstrated robust antitumor activity and superior efficacy over MMAE-based ADCs in multidrug resistance models. Pharmacokinetic and safety studies in non-human primates support a favorable profile and a high non-severely toxic dose (HNSTD), enabling clinical advancement. 7MW4911 represents a differentiated and promising ADC candidate for GI cancers, with an IND submission to the NMPA and FDA planned for H2 2025. About Mabwell Mabwell (688062.SH) is an innovation-driven biopharmaceutical company with the entire value chain of the pharmaceutical industry. We provide more effective and accessible therapy and innovative medicines to fulfill global medical needs. Since 2017, an advanced R&D system which covers target discovery, early discovery, druggability, preclinical, clinical research and manufacturing transformation was established. Mabwell has 16 pipeline products in different stages based on a world-class and state-of-the-art R&D engine, including 12 novel drug candidates and 4 biosimilars. We focus on the therapeutic areas of oncology, immunology, bone disorders, ophthalmology, hematology and infectious diseases, etc. Of these, 3 products have been approved and commercialized, 1 product has been filed for market approval, 3 products are in pivotal trials. We have also undertaken 1 national major scientific and technological special project for "Significant New Drugs Development", 2 projects for National Key R&D Programmes, and multiple provincial and municipal science and technological innovation projects. Mabwell's Taizhou factory possesses robust in-house manufacturing capability compliant with international GMP standards regulated by the NMPA, FDA and EMA, and has passed the EU QP Audit. The large-scale manufacturing base in Shanghai and the ADC commercialized manufacturing base in Taizhou are under construction. Our mission is "Explore Life, Benefit Health" and our vision is "Innovation, from ideas to reality". For more information, please visit . Forward-Looking Statements This press release contains forward-looking statements including, but not limited to, the potential safety, efficacy, regulatory review or approval and commercial success of our product candidates and those relating to the Company's product development, clinical studies, clinical and regulatory milestones and timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. "Forward-looking statements" are statements that are not historical facts and involve a number of risks and uncertainties, which may cause actual results to be materially different from any future results expressed or implied in the forward-looking statements. These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential," "predict," "project," "should," "would," and similar expressions and the negatives of those terms. Forward-looking statements are based on the Company's current expectations and assumptions. Forward-looking statements are subject to a number of risks, uncertainties, and other factors, many of which are beyond the Company's control, including, but not limited to: environment; politic; economy; society; legislation; our dependence on our product candidates, most of which are still in preclinical or various stages of clinical development; our reliance on third-party vendors, such as contract research organizations and contract manufacturing organizations; the uncertainties inherent in clinical testing; our ability to complete required clinical trials for our product candidates and obtain approval from regulatory authorities for our product candidates; our ability to protect our intellectual property; the potential impact of COVID-19; the loss of any executive officers or key personnel. In case one or more of these risks or uncertainties deteriorate, or any assumptions are incorrect, the actual results may be seriously inconsistent with the stated results. The Company cautions all the persons not to place undue reliance on any such forward-looking statements, which speaks only as of the date of this press release. The Company disclaims any obligation, except as specifically required by law and the rules of the applicable Stock authority 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. All forward-looking descriptions, figures and assumptions in this press release are applicable to this statement. SOURCE Mabwell WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

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Approved

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Indication	Country/Location	Organization	Date
BRCA-mutated Fallopian Tube Carcinoma	China	BeOne Pharmaceutical (Suzhou) Co. Ltd.	30 Apr 2021
BRCA-mutated Fallopian Tube Carcinoma	China	BeOne Medicines Ltd.	30 Apr 2021
BRCA-mutated Ovarian Cancer	China	BeOne Medicines Ltd.	30 Apr 2021
BRCA-mutated Ovarian Cancer	China	BeOne Pharmaceutical (Suzhou) Co. Ltd.	30 Apr 2021
BRCA-mutated Peritoneal Neoplasms	China	BeOne Medicines Ltd.	30 Apr 2021
BRCA-mutated Peritoneal Neoplasms	China	BeOne Pharmaceutical (Suzhou) Co. Ltd.	30 Apr 2021

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced cancer	Phase 3	United States	BeOne Medicines Ltd.	19 Dec 2019
Advanced cancer	Phase 3	China	BeOne Medicines Ltd.	19 Dec 2019
Advanced cancer	Phase 3	Japan	BeOne Medicines Ltd.	19 Dec 2019
Advanced cancer	Phase 3	Australia	BeOne Medicines Ltd.	19 Dec 2019
Advanced cancer	Phase 3	France	BeOne Medicines Ltd.	19 Dec 2019
Advanced cancer	Phase 3	Italy	BeOne Medicines Ltd.	19 Dec 2019
Advanced cancer	Phase 3	Malaysia	BeOne Medicines Ltd.	19 Dec 2019
Advanced cancer	Phase 3	New Zealand	BeOne Medicines Ltd.	19 Dec 2019
Advanced cancer	Phase 3	Poland	BeOne Medicines Ltd.	19 Dec 2019
Advanced cancer	Phase 3	South Korea	BeOne Medicines Ltd.	19 Dec 2019

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03914742 (CTgov)	Phase 1/2	Recurrent Glioma \| Recurrent WHO Grade II Glioma \| Recurrent Glioblastoma	67	PARP Inhibitor BGB-290+Temozolomide (Phase 1: Dose Finding)	igeieaxolu = mjxvqfaggw swpotkdacn (jslxxsksbj, wuzmclhsvt - fjmfwikjfu) View more	-	16 Dec 2024
				PARP Inhibitor BGB-290+Temozolomide (Phase 2: Arm A Alkylator-resistant)	xboavbcnld = rmqqppelja xarfrefdqj (ikawdcdpqi, istalvflde - hkgzkjonto) View more
NCT05327621 (ESMO_Asia)	Phase 2	Castration-Resistant Prostatic Cancer	25	帕米帕利	fmlpyufheu(civjkcvnot) = abuuexfsuu ufdbozvfdi (anyaclwhbd ) View more	Positive	08 Dec 2024
NCT05489926 (ESMO2024) Manual	Phase 2	Recurrent ovarian cancer Third line BRCA1/2 mutation	15	Pamiparib 60 mg po BID	ryucvyiyne(gznoleuszz) = ljoeraphhd mhlknzkpdv (sgxmlohotu ) View more	Negative	14 Sep 2024
				Pamiparib 60 mg po BID (BRCAmut pts)	ryucvyiyne(gznoleuszz) = dngdssnqis mhlknzkpdv (sgxmlohotu )
NCT05044871 (BRIGHT, ESMO2024)	Phase 2	Platinum-Resistant Ovarian Carcinoma BRCA mutation status \| CD8+ TILs count	105	Pamiparib + Bevacizumab	odmsqwertj(byehadflrv) = lsdbzqagoa cqgswtcdgu (xqfzvibqun ) View more	Positive	14 Sep 2024
				Tislelizumab + Bevacizumab + Nab-paclitaxel	odmsqwertj(byehadflrv) = hwicsevopb cqgswtcdgu (xqfzvibqun ) View more
NCT05044871 (BRIGHT, Pubmed 1 \| Pubmed 2 \| Int J Gynecol Cancer)	Phase 2	Recurrent Platinum-Resistant Ovarian Carcinoma BRCA1 mutations \| BRCA2 mutations \| wild-type BRCA1/2 ... View more	160	Tislelizumab + Bevacizumab + Nab-paclitaxel (BRCAwt + CD8+ TILs ≥3)	isjhxiyfra(wbrmfudlzy) = otivdperel ctzkhuctpu (ygmmiangmd )	Positive	01 Sep 2024
NCT04614909 (AACR2024) Manual	Early Phase 1	Glioblastoma	41	pamiparib + olaparib + radiotherapy (newly-diagnosed GBM)	rerdmrchya(pdckfchvla) = rsujlezlhc wqpbtlwppi (vvgxzlbafa ) View more	Positive	09 Apr 2024
				pamiparib + olaparib + radiotherapy (recurrent GBM)	rerdmrchya(pdckfchvla) = ezxfcriaqh wqpbtlwppi (vvgxzlbafa ) View more
NCT03333915 (CTgov)	Phase 1/2	Ovarian Cancer \| Platinum-Sensitive Ovarian Carcinoma \| Advanced Malignant Solid Neoplasm ... View more	128	Pamiparib (Phase 1: 20 mg Pamiparib)	zrkvqrzygm = txazjjzlib cssnlhjpfk (nbvjxjurva, uyapooenkn - dqobkpijaf) View more	-	22 Feb 2024
				Pamiparib (Phase 1: 40 mg Pamiparib)	zrkvqrzygm = vkzugsiolk cssnlhjpfk (nbvjxjurva, fwbevaqhsq - igbuvnldwc) View more
NCT05376722 (ASCO_GU2024)	Phase 2	Prostatic Cancer Neoadjuvant	30	阿比特龙+帕米帕利+ADT	ypujmxedfp(urhongutqt) = yzestgtubo otgnigextd (kagduomvei ) View more	Positive	23 Jan 2024
ABTC 1801 (SNO2023)	Phase 2	Glioma IDH1-mutant \| MGMT methylated	39	Pamiparib 60 mg BID + Temozolomide 20 mg daily	jbakcafpqh(bdwdmxqeiq) = jsvqjjuokl xevdourmvt (zrvmlrdfex ) View more	Negative	10 Nov 2023
				Placebo	lxsnsneubv(nvvlgvygtd) = zkgkrmwbma jajkiyftuv (iidikvnrad ) View more
NCT05652283 (ESMO 12023 \| ESMO 22023) Manual	Phase 2	Ovarian Cancer Neoadjuvant myChoice HRD Positive \| BRCA1 mutations \| BRCA2 mutations	20	Pamiparib+ Surufatinib	pmbnrwwtqo(tokruvbfjq) = hxeqiyndhp rwskpowqlf (crzqcktznb )	Positive	22 Oct 2023
				Pamiparib+ Surufatinib (completed NAT)	bxdjdtwjlf(pdjqyfmeji) = yiycmxtdhu orhmhcxrux (beqposledq ) View more

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