Cohort study of SABR combined with anti-PD-1 and targeted therapy versus anti-PD-1 and targeted therapy for recurrent or metastatic renal cell carcinoma patients

Start Date01 Apr 2024

Sponsor / Collaborator

Peking University First Hospital

NCT05162755

/ Active, not recruitingPhase 1IIT

A Phase 1a/1b, Open-label, Multicenter Trial Investigating the Safety, Tolerability, and Preliminary Anti-neoplastic Activity of S095029 (Anti-NKG2A) as Monotherapy and in Combination With Sym021 (Anti-PD-1) in Patients With Advanced Solid Tumor Malignancies Followed by an Expansion Part With Triplet Combinations of S095029 and Sym021 and an Anti-HER2 mAb or Anti-EGFR mAbs (Futuximab/Modotuximab) in Patients With Metastatic Gastric or Colorectal Cancers

The purpose of the study is to investigate the safety, tolerability, and preliminary anti-neoplastic activity of S095029 alone and in combination with Sym021 in patients with advanced solid tumor malignancies followed by an expansion phase of triple combinations.
*The study sponsor has made the decision not to move forward to the expansion part of the study due to strategic considerations, unrelated to any safety issues or concerns. The study will be stopped after completion of dose escalation parts 1a and 1b of the study.

Start Date15 Oct 2021

Sponsor / Collaborator

Institut de Recherches Intern Servier

[+1]

NCT04195373

/ WithdrawnPhase 1

A Phase I Open-label, Safety Study of Intra-tumoral Application of TMV-018 in Combination With 5-FC or Anti-PD-1 Therapy in Patients With Tumors of the Gastrointestinal Tract

This study aims to determine the safety and tolerability of TMV-018 when given alone or in combination with the prodrug 5-Fluorocytosine (5-FC) or an anti-PD-1 checkpoint inhibitor in patients with gastrointestinal tumors. Furthermore, the maximum tolerated dose (MTD) and recommended Phase II dose of TMV-018 shall be determined.

Start Date23 Nov 2020

Sponsor / Collaborator

Themis Bioscience GmbH

[+2]

100 Clinical Results associated with Sym-021

100 Translational Medicine associated with Sym-021

100 Patents (Medical) associated with Sym-021

Literatures (Medical) associated with Sym-021

20 Sep 2024·Nan fang yi ke da xue xue bao = Journal of Southern Medical University

[High RNF7 expression enhances PD-1 resistance of non-small cell lung cancer cells by promoting CXCL1 expression and myeloid-derived suppressor cell recruitment via activating NF-κB signaling].

Article

Author: Zhong, N ; Geng, B ; Sun, Z ; Zhao, W ; Wang, H

OBJECTIVE:

To investigate the mechanism of RNF7 for regulating myeloid-derived suppressor cells (MDSCs) in nonsmall cell lung cancer (NSCLC).

METHODS:

TIMER2.0 database and immunohistochemistry were used to analyze RNF7 expression level and its correlation with immune cell infiltration in non-small cell lung cancer. The impact of RNF7 expression levels on prognosis of lung cancer patients was analyzed using Kaplan-Meier survival analysis. CMT-167 cells with RNF7 overexpression or knockdown were inoculated subcutaneously in C57BL/6 mice, and the mice in RNF7 knockdown group were treated with anti-PD-1 or IgG isotype control 7 days after the inoculation. The tumor tissues were harvested after 30 days for tumor volume measurement, detection of S100A8+A9 and Gr-1 expressions with immunohistochemistry, and analysis of MDSC infiltration. Gene set enrichment analysis (GSEA) was performed to identify the potential pathways regulated by RNF7 in NSCLC. Western blotting and luciferase assays were used to assess the impact of RNF7 on the NF-κB signaling pathway. ELISA and RT-qPCR were used to measure chemokine (C-X-C motif) ligand 1 (CXCL1) expression.

RESULTS:

RNF7 expression was significantly upregulated in NSCLC, and high RNF7 expression levels were associated with poor prognosis of the patients (P < 0.001). TIMER2.0 analysis revealed a positive correlation between RNF7 expression and MDSC infiltration (P < 0.001). GSEA suggested that RNF7 was enriched in the NF-κB signaling pathway. In NSCLC cells, RNF7 knockdown significantly inhibited NF-κB activation and reduced CXCL1 expression. In the tumor-bearing mice, RNF7 overexpression significantly increased MDSC infiltration in the tumor tissue, and RNF7 knockdown obviously reduced MDSC infiltration and enhanced the efficacy of anti-PD-1 therapy.

CONCLUSION:

High expression of RNF7 in NSCLC cells promotes CXCL1 expression by activating the NF-κB signaling pathway, thus leading to the chemotactic recruitment of MDSCs, which contributes to tumor resistance to antiPD-1 therapy.

01 Dec 2020·Journal of hematology & oncologyQ1 · MEDICINE

CDK7 inhibitor THZ1 enhances antiPD-1 therapy efficacy via the p38α/MYC/PD-L1 signaling in non-small cell lung cancer

Q1 · MEDICINE

ArticleOA

Author: Dong, Xiaorong ; Wu, Gang ; Zhou, Xiaoshu ; Chen, Yaobing ; Xu, Shuangbing ; Zhang, Tao ; Meng, Rui ; Liu, Li ; Zhang, Sheng ; Hong, Jiaxin ; Wang, Jian ; Zhang, Ruiguang ; Tang, Jing ; Zong, Yan ; Lin, Zhenyu ; Yang, Kunyu ; Xu, Yingzhuo

Abstract:

Background:

The cyclin-dependent kinase 7 (CDK7) subunit of TFIIH regulates RNA polymerase-II-based transcription and promotes tumor progression. However, the mechanisms involved in CDK7-mediated immune evasion are unclear in non-small cell lung cancer (NSCLC).

Methods:

RNA silencing and pharmacologic inhibitors were used to evaluate the functions of CDK7/p38α/MYC/PD-L1 axis in cancer cell proliferation and antiPD-1 therapy resistance. Flow cytometry was performed to detect the status of the immune microenvironment after CDK7 inhibition and antiPD-1 therapy in vivo. CD8 depletion antibodies were used to assess the role of CD8+ T cells in combined CDK7 and PD-1 blockade. The associations among CDK7, p38α, MYC, PD-L1, infiltrating T cells, and survival outcomes were validated in two tissue microarrays and public transcriptomic data of NSCLC.

Results:

High CDK7 mRNA and protein levels were identified to be associated with poor prognosis in NSCLC. CDK7 silencing and CDK7 inhibitor THZ1 elicited apoptosis and suppressed tumor growth. Moreover, CDK7 ablation specifically suppressed p38α/MYC-associated genes, and THZ1 inhibited MYC transcriptional activity through downregulating p38α. CDK7 inhibition sensitized NSCLC to p38α inhibitor. Further, THZ1 suppressed PD-L1 expression by inhibiting MYC activity. THZ1 boosted antitumor immunity by recruiting infiltrating CD8+ T cells and synergized with antiPD-1 therapy. The CDK7/MYC/PD-L1 signature and infiltrating T cell status collectively stratified NSCLC patients into different risk groups.

Conclusion:

These data suggest that the combined CDK7 inhibitor THZ1 and antiPD-1 therapy can be an effective treatment in NSCLC.

19 May 2019·mAbsQ2 · MEDICINE

Sym021, a promising anti-PD1 clinical candidate antibody derived from a new chicken antibody discovery platform

Q2 · MEDICINE

Article

Author: Bouquin, Thomas ; Uhlenbrock, Franziska ; Pedersen, Mikkel W ; Lindsted, Trine ; Kragh, Michael ; Gad, Monika ; Horak, Ivan D ; Fröhlich, Camilla ; Galler, Gunther R ; Dietrich, Nikolaj ; Gjetting, Torben ; Melander, Maria C ; Grandal, Michael M ; Koefoed, Klaus ; Bhatia, Vikram K ; Strandh, Magnus ; Lantto, Johan

Discovery of therapeutic antibodies is a field of intense development, where immunization of rodents remains a major source of antibody candidates. However, high orthologue protein sequence homology between human and rodent species disfavors generation of antibodies against functionally conserved binding epitopes. Chickens are phylogenetically distant from mammals. Since chickens generate antibodies from a restricted set of germline genes, the possibility of adapting the Symplex antibody discovery platform to chicken immunoglobulin genes and combining it with high-throughput humanization of antibody frameworks by "mass complementarity-determining region grafting" was explored. Hence, wild type chickens were immunized with an immune checkpoint inhibitor programmed cell death 1 (PD1) antigen, and a repertoire of 144 antibodies was generated. The PD1 antibody repertoire was successfully humanized, and we found that most humanized antibodies retained affinity largely similar to that of the parental chicken antibodies. The lead antibody Sym021 blocked PD-L1 and PD-L2 ligand binding, resulting in elevated T-cell cytokine production in vitro. Detailed epitope mapping showed that the epitope recognized by Sym021 was unique compared to the clinically approved PD1 antibodies pembrolizumab and nivolumab. Moreover, Sym021 bound human PD1 with a stronger affinity (30 pM) compared to nivolumab and pembrolizumab, while also cross-reacting with cynomolgus and mouse PD1. This enabled direct testing of Sym021 in the syngeneic mouse in vivo cancer models and evaluation of preclinical toxicology in cynomolgus monkeys. Preclinical in vivo evaluation in various murine and human tumor models demonstrated a pronounced anti-tumor effect of Sym021, supporting its current evaluation in a Phase 1 clinical trial. Abbreviations: ADCC, antibody-dependent cellular cytotoxicity; CD, cluster of differentiation; CDC, complement-dependent cytotoxicity; CDR, complementarity determining region; DC, dendritic cell; ELISA, enzyme-linked immunosorbent assay; FACS, fluorescence activated cell sorting; FR, framework region; GM-CSF, granulocyte-macrophage colony-stimulating factor; HRP, horseradish peroxidase; IgG, immunoglobulin G; IL, interleukin; IFN, interferon; mAb, monoclonal antibody; MLR, mixed lymphocyte reaction; NK, natural killer; PBMC, peripheral blood mono-nuclear cell; PD1, programmed cell death 1; PDL1, programmed cell death ligand 1; RT-PCR, reverse transcription polymerase chain reaction; SEB, Staphylococcus Enterotoxin B; SPR, surface Plasmon Resonance; VL, variable part of light chain; VH, variable part of heavy chain.

News (Medical) associated with Sym-021

11 Oct 2022

·www.prnewswire.com

Esophageal Cancer Clinical Trial Pipeline Insights Featuring 80+ Companies | DelveInsight

The prevalence of esophageal cancer has been rising since the past few years, which prompts the growing demand for the treatment options. The market is driven by the increasing prevalence of cancer and the increase in research & development. The Companies developing the potential therapies in the last stage of development include Celgene,Jiangsu HengRui Medicine Co., Seagen, and several others. LAS VEGAS, Oct. 11, 2022 /PRNewswire/ -- DelveInsight's ' Esophageal Cancer Pipeline Insight – 2022 ' report provides comprehensive global coverage of available, marketed, and pipeline esophageal cancer therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the esophageal cancer pipeline domain. Key Takeaways from the Esophageal Cancer Pipeline Report DelveInsight's esophageal cancer pipeline report depicts a robust space with 80+ active players working to develop 90+ pipeline therapies for esophageal cancer treatment. Leading esophageal cancer companies such as Shanghai Henlius Biotech, CStone Pharmaceuticals, Jiangsu HengRui Medicine Co., Ltd., AstraZeneca, Symphogen, Hoffmann-La Roche, Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Sinocelltech Ltd., Eli Lilly and Company, Ipsen, Jacobio Pharmaceuticals Co., Ltd., Shire, GlaxoSmithKline, Keythera Pharmaceuticals (Australia) Pty Ltd, Sunshine Lake Pharma Co., Ltd., Novartis Pharmaceuticals, Sanofi, Seagen Inc., Rapa Therapeutics LLC, Incyte Corporation, Atreca, Inc., Exelixis, Bayer, BeiGene, Lyell Immunopharma, Sichuan Baili Pharmaceutical, AP Biosciences.,Leap Therapeutics, Inc., Adlai Nortye Biopharma Co., Ltd., Athenex, Inc., Pfizer, Genentech, Hangzhou Neoantigen Therapeutics, Janssen Pharmaceutical, Curis, Inc.,Merck KGaA, Apexigen, Inc,Shenzhen Hornetcorn Bio-technology Company, LTD, MacroGenics, Bristol-Myers Squibb, Integral Molecular, CARTEXELL, EMD Serono, and others are evaluating new drugs for esophageal cancer treatment. Key esophageal cancer pipeline therapies in various stages of development include Serplulimab, CS1001, Camrelizumab, Durvalumab, Sym021, Spartalizumab, Sym022, Sym023, Regorafenib, S095033, INCB099318, RO7121661, XB002, LGK974, Abemaciclib, ladiratuzumab vedotin, ATRC-101, SGN-PDL1V, RO7247669, THOR-707, Letetresgene Autoleucel, TNO155, Anlotinib Hydrochloride, Larotinib, SCT-I10A, KF-0210, SCT200, Ramucirumab, Cabozantinib, JAB-3068, Onivyde, JAB-3312, SGN-B6A, RAPA-201,Ociperlimab, SI B001,Apatinib, AP 203, QEQ278, JAB-3312, DKN-01, AN0025, HR 070803,Oraxol, Sunitinib malate, Tiragolumab, iNeo Vac P01, Amivantamab, CA-4948, M1231, APX005M, DC-CIK, Margetuximab, Temozolomide, and others. In September 2022, Daiichi Sankyo and Sarah Cannon Research Institute (SCRI) announced that extended follow-up data from a phase I/II trial of DS-7300, continued to show promising durable tumor response in patients with several types of heavily pretreated cancers including lung, prostate or esophageal cancer.A response rate of 32% (95% CI: 24-41) was observed with 38 responses (33 confirmed; 28%; 95% CI: 20-37) in 118 patients with various solid tumors including small cell lung cancer (SCLC), squamous non-small cell lung cancer (NSCLC), metastatic castration-resistant prostate cancer (CRPC), esophageal squamous cell carcinoma (ESCC), head and neck squamous cell carcinoma (HNSCC) or endometrial cancer receiving doses of DS-7300 ranging from 4.8 mg/kg to 16.0 mg/kg. In September 2022, Integral Molecular, has licensed a panel of monoclonal antibodies (MAbs) to CARTEXELL, enabling CARTEXELL to develop CAR-T cell therapies using Integral Molecular's Claudin 18.2 (CLDN18.2) MAbs. Under the terms of the agreement, Integral Molecular will provide an exclusive worldwide license to CARTEXELL to use the panel of high-affinity, high-specificity, and fully humanized CLND18.2 MAbs for the development of CAR-T cell therapies against solid tumors including gastric, lung, pancreatic and esophageal cancers. CARTEXELL will be solely responsible for all research, development, and commercial activities. In August 2022, BeiGene announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted a supplemental biologics license application (sBLA) for tislelizumab in combination with chemotherapy as first-line treatment in patients with unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC). In May 2022, Shanghai Junshi Biosciences Co., Ltd, announced that the China National Medical Products Administration (NMPA) has approved the supplemental new drug application (sNDA) for toripalimab in combination with paclitaxel and cisplatin in the first-line treatment of patients with unresectable locally advanced/recurrent or distant metastatic esophageal squamous cell carcinoma (ESCC). The sNDA was accepted by the NMPA in July 2021. This is the fifth indication approved for toripalimab in China and will benefit Chinese patients with advanced ESCC. In May 2022, Bristol Myers Squibb, announced that the U.S. Food and Drug Administration (FDA) has approved both Opdivo (nivolumab) (injection for intravenous use) in combination with fluoropyrimidine- and platinum-containing chemotherapy and Opdivo plus Yervoy (ipilimumab) as a first-line treatment for adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) regardless of PD-L1 status. The approvals are based on the Phase III CheckMate -648 trial, which evaluated Opdivo in combination with chemotherapy (n=321) and Opdivo plus Yervoy (n=325) each compared to chemotherapy alone (n=324), and was the largest Phase III trial of immunotherapy in first-line ESCC. In January 2022, Lyell Immunopharma, Inc., announced that the U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug (IND) application to initiate a Phase I clinical trial for LYL132, an investigational T-cell receptor (TCR) therapy for patients with solid tumors expressing New York esophageal squamous cell carcinoma 1 (NY-ESO-1) that the company is developing in collaboration with GSK. Request a sample and discover the recent advances in esophageal cancer treatment @ Esophageal Cancer Pipeline Report The esophageal cancer pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage esophageal cancer drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the esophageal cancer pipeline landscape. Esophageal Cancer Overview Esophageal cancer grows in the esophagus, the tube that connects the throat to the stomach. Tumors develop in the mucosa, the inner lining of the esophagus. Esophageal cancer is classified into two types, each with its own set of risk factors: Adenocarcinoma -Adenocarcinomas are cancers that begin in gland cells at the bottom of the esophagus. This is the most common type of esophageal cancer. It usually happens near the stomach. The exact esophageal cancer causes are not known. Most esophageal cancer symptoms do not appear until cancer has progressed to an advanced stage, when it may be challenging to treat. Other, more common conditions can cause esophageal cancer symptoms. The most common esophageal cancer symptom is difficulty swallowing, particularly a sensation of food stuck in the chest. There are several tests used for esophageal cancer diagnosis. The most common include endoscopy with biopsy and endoscopic ultrasonography. Find out more about esophageal cancer drugs in development @ New Treatment for Esophageal Cancer A snapshot of the Esophageal Cancer Pipeline Drugs mentioned in the report: Learn more about the emerging esophageal cancer pipeline therapies @ Esophageal Cancer Clinical Trials Esophageal Cancer Therapeutics Assessment The esophageal cancer pipeline report proffers an integral view of esophageal cancer emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Esophageal Cancer Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Intra-articular, Intraocular, Intrathecal, Intravenous, Ophthalmic, Oral, Parenteral, Subcutaneous, Topical, Transdermal Therapeutics Assessment By Molecule Type: Oligonucleotide, Peptide, Small molecule Therapeutics Assessment By Mechanism of Action: Prostaglandin E EP4 receptor antagonists, ERBB 2 receptor antagonists, Phosphorylation inhibitors, Antibody-dependent cell cytotoxicity, Apoptosis stimulants, CD40 antigen stimulants, Immunostimulants, Programmed cell death-1 receptor antagonists, T lymphocyte stimulants, Programmed cell death-1 ligand-1 inhibitors, Epidermal growth factor receptor antagonists. Key Esophageal Cancer Companies: Shanghai Henlius Biotech, CStone Pharmaceuticals, Jiangsu HengRui Medicine Co., Ltd., AstraZeneca, Symphogen, Hoffmann-La Roche, Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Sinocelltech Ltd., Eli Lilly and Company, Ipsen, Jacobio Pharmaceuticals Co., Ltd., Shire, GlaxoSmithKline, Keythera Pharmaceuticals (Australia) Pty Ltd, Sunshine Lake Pharma Co., Ltd., Novartis Pharmaceuticals, Sanofi, Seagen Inc., Rapa Therapeutics LLC, Incyte Corporation, Atreca, Inc., Exelixis, Bayer, BeiGene, Lyell Immunopharma, Sichuan Baili Pharmaceutical, AP Biosciences.,Leap Therapeutics, Inc., Adlai Nortye Biopharma Co., Ltd., Athenex, Inc., Pfizer, Genentech, Hangzhou Neoantigen Therapeutics, Janssen Pharmaceutical, Curis, Inc.,Merck KGaA, Apexigen, Inc,Shenzhen Hornetcorn Bio-technology Company, LTD, MacroGenics, Bristol-Myers Squibb, Integral Molecular, CARTEXELL and others Key Esophageal Cancer Pipeline Therapies: Serplulimab, CS1001, Camrelizumab, Durvalumab, Sym021, Spartalizumab, Sym022, Sym023, Regorafenib, S095033, INCB099318, RO7121661, XB002, LGK974, Abemaciclib, ladiratuzumab vedotin, ATRC-101, SGN-PDL1V, RO7247669, THOR-707, Letetresgene Autoleucel, TNO155, Anlotinib Hydrochloride, Larotinib, SCT-I10A, KF-0210, SCT200, Ramucirumab, Cabozantinib, JAB-3068, Onivyde, JAB-3312, SGN-B6A, RAPA-201,Ociperlimab, SI B001,Apatinib, AP 203, QEQ278, JAB-3312, DKN-01, AN0025, HR 070803,Oraxol, Sunitinib malate, Tiragolumab, iNeo Vac P01, Amivantamab, CA-4948, M1231, APX005M, DC-CIK, Margetuximab, Temozolomide and others. Dive deep into rich insights for esophageal cancer drugs, visit @ Chemo Drugs for Esophageal Cancer Treatment Table of Contents For further information on the esophageal cancer pipeline therapeutics, reach out @ New Drug for Esophageal Cancer Treatment Related Reports Esophageal Cancer Market Esophageal Cancer Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key esophageal cancer companies including Merck KGaA, Shenzhen Hornetcorn Biotechnology, Apexigen, Inc., Highlight Therapeutics, among others. Esophageal Cancer Epidemiology Forecast Esophageal Cancer Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted esophageal cancer epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Esophageal Squamous Cell Carcinoma Pipeline Esophageal Squamous Cell Carcinoma Pipeline Insight – 2022 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key esophageal squamous cell carcinoma companies, including BeiGene, AstraZeneca, Ipsen, Shire, Sanofi, Seagen, among others. Esophageal Squamous Carcinoma Market Esophageal Squamous Carcinoma Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key esophageal squamous carcinoma companies, including BeiGene, AstraZeneca, Ipsen, Shire, Sanofi, Seagen, among others. Esophageal Squamous Cell Carcinoma Epidemiology Esophageal Squamous Cell Carcinoma Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted esophageal squamous cell carcinoma epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Other Trending Reports Goitre Market | Thymus Cancer Market | US Healthcare Outlook Report | Venous Stenosis Market | Negative Pressure Wound Therapy Systems Market | Global Kinase Inhibitor in Autoimmune Diseases Market | Metrorrhagia Market | Dysfunctional Uterine Bleeding Market | Hypereosinophilic Syndrome Market | Age-related Vision Dysfunction Market | Dental Lasers Market | CRISPR Therapies Pipeline Insight | Cell And Gene Therapy For Multiple Myeloma Market | Drug Hypersensitivity Market | Dysthymia Market | Persistent Depressive Disorder Market | Cancer Vaccines Market | Weight Loss/Weight Management (Obesity) Market | Food Allergy Market | Obsessive-Compulsive Disorder Market | Tumor Ablation Market | Physiotherapy Equipment Market | Chimeric Antigen Receptor (CAR) T-Cell Therapy Market | Anti-hypertension Market | Radiofrequency Ablation Devices Market | Global Messenger RNA (mRNA)-based Vaccines and Therapeutics Market | Gastro Intestinal Bleeding Market | Trastuzumab Biosimilars Insight | Varicose Veins Market | Germ Cell Tumor Market | Intracardiac Echocardiography Devices Market | India Healthcare Report | Crows Feet Market | Seborrhoeic Dermatitis Market | Injectable Drug Delivery Devices Market | Structural Heart Devices Market | Substance (Drug) Abuse Market | Insulin Glargine Biosimilar Insight About DelveInsight DelveInsight is a leading Business Consultant, and Market Research firm focused exclusively on life sciences. Connect with us at LinkedIn Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

Gene TherapyAntibodyBiosimilarOligonucleotideCell Therapy

15 Jul 2022

·www.biospace.com

Who Wants to Buy Pfizer-backed CStone? Rumors of Sale Circulate

Could WuXi Healthcare Venture and Pfizer-backed CStone Pharmaceuticals be snapped up by a larger pharma company? Rumors are circulating that executives with the China-based company are exploring strategic options that could include a sale of the company. According to Bloomberg, unnamed sources “familiar with the matter” have informed the publication that the company’s leadership team is working with Goldman Sachs to determine if there are interested buyers. It was unclear if the company was looking for a complete sale or sale of a controlling interest. It is also unclear if the company is primarily looking at a sale to Chinese investors or to western pharmaceutical companies. WuXi Healthcare Venture is CStones’s biggest investor. It owns about one-fourth of the company’s outstanding shares. Two years ago, Pfizer acquired a 10% stake in CStone after investing $200 million to support the development of a checkpoint inhibitor aimed at the oncology market in China. That investment has paid off. In 2021, China’s National Medical Products Administration approved the said checkpoint inhibitor, sugemalimab, as a consolidation therapy in patients with unresectable stage III non-small cell lung cancer (NSCLC). The company said the approval marks a first as sugemalimab becomes the “world’s first anti-PD-1/PD-L1 monoclonal antibody to significantly improve progression-free survival in patients with stage III [NSCLC] without disease progression after concurrent or sequential chemoradiotherapy.” Last month, sugemalimab picked up another regulatory win. The NMPA approved the checkpoint inhibitor as a treatment for stage III NSCLC whose disease has not progressed following concurrent or sequential platinum-based chemoradiotherapy. At this point, those in the know about a potential sale are keeping quiet. Bloomberg said neither Goldman Sachs nor CStone’s leadership team is talking about a potential sale. CStone has a market value of about $764 million. Its shares, which are listed on the Hong Kong stock exchange, fell more than 3% Friday, closing at 5.05 Hong Kong dollars, which is approximately 64 cents per share in U.S. dollars. In addition to Pfizer, CStone has partnered with other companies within the industry. Some of those collaborations have yielded fruit, even in the U.S. market. Last year, CStone and Servier Pharmaceuticals won U.S. approval for Tibsovo (ivosidenib tablets) for the treatment of adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with an IDH1 mutation. At the time, the companies said Tibsovo was the first and only targeted therapy that had been approved for patients with previously treated IDH1-mutated cholangiocarcinoma, a cancer of the bile ducts. The company also has a partnership with Bayer pairing sugemalimab with regorafenib, a multi-kinase inhibitor for the treatment of multiple cancers, including gastric cancer. And in November, the company entered into a $200 million collaboration with Jiangsu Hengrui Pharmaceuticals. Earlier this year, CStone dosed its first patient in a U.S.-based Phase I clinical trial assessing CS5001, a potential best-in-class antibody-drug conjugate (ADC) designed to target receptor tyrosine kinase-like orphan receptor 1. The company plans to develop CS5001, which was licensed from LegoChem Biosciences, for advanced B cell lymphomas and solid tumors.

AntibodyADCCollaborate

15 Jul 2022

·www.biospace.com

Who Wants to Buy Pfizer-backed CStone? Rumors of Sale Circulate

Man using calculator bymuratdeniz/Getty Images Unnamed sources “familiar with the matter” informed Bloomberg that CStone’s leadership team is working with Goldman Sachs to determine if there are interested buyers. Could WuXi Healthcare Venture and Pfizer -backed CStone Pharmaceuticals be snapped up by a larger pharma company? Rumors are circulating that executives with the China-based company are exploring strategic options that could include a sale of the company. According to Bloomberg , unnamed sources “familiar with the matter” have informed the publication that the company’s leadership team is working with Goldman Sachs to determine if there are interested buyers. It was unclear if the company was looking for a complete sale or sale of a controlling interest. It is also unclear if the company is primarily looking at a sale to Chinese investors or to western pharmaceutical companies. WuXi Healthcare Venture is CStones’s biggest investor. It owns about one-fourth of the company’s outstanding shares. Two years ago, Pfizer acquired a 10% stake in CStone after investing $200 million to support the development of a checkpoint inhibitor aimed at the oncology market in China. That investment has paid off. In 2021, China’s National Medical Products Administration approved the said checkpoint inhibitor, sugemalimab, as a consolidation therapy in patients with unresectable stage III non-small cell lung cancer (NSCLC). The company said the approval marks a first as sugemalimab becomes the “world’s first anti-PD-1/PD-L1 monoclonal antibody to significantly improve progression-free survival in patients with stage III [NSCLC] without disease progression after concurrent or sequential chemoradiotherapy.” Last month, sugemalimab picked up another regulatory win. The NMPA approved the checkpoint inhibitor as a treatment for stage III NSCLC whose disease has not progressed following concurrent or sequential platinum-based chemoradiotherapy. At this point, those in the know about a potential sale are keeping quiet. Bloomberg said neither Goldman Sachs nor CStone’s leadership team is talking about a potential sale. CStone has a market value of about $764 million. Its shares, which are listed on the Hong Kong stock exchange, fell more than 3% Friday, closing at 5.05 Hong Kong dollars, which is approximately 64 cents per share in U.S. dollars. In addition to Pfizer, CStone has partnered with other companies within the industry. Some of those collaborations have yielded fruit, even in the U.S. market. Last year, CStone and Servier Pharmaceuticals won U.S. approval for Tibsovo (ivosidenib tablets) for the treatment of adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with an IDH1 mutation. At the time, the companies said Tibsovo was the first and only targeted therapy that had been approved for patients with previously treated IDH1-mutated cholangiocarcinoma, a cancer of the bile ducts. The company also has a partnership with Bayer pairing sugemalimab with regorafenib, a multi-kinase inhibitor for the treatment of multiple cancers, including gastric cancer. And in November, the company entered into a $200 million collaboration with Jiangsu Hengrui Pharmaceuticals. Earlier this year, CStone dosed its first patient in a U.S.-based Phase I clinical trial assessing CS5001, a potential best-in-class antibody-drug conjugate (ADC) designed to target receptor tyrosine kinase-like orphan receptor 1. The company plans to develop CS5001, which was licensed from LegoChem Biosciences, for advanced B cell lymphomas and solid tumors.

Drug ApprovalPhase 1ADC

100 Deals associated with Sym-021

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Advanced Malignant Solid Neoplasm	Phase 1	United States	Adir SRL	15 Oct 2021
Advanced Malignant Solid Neoplasm	Phase 1	Canada	Adir SRL	15 Oct 2021
Relapsed Solid Neoplasm	Phase 1	United States	Symphogen A/S	12 Oct 2020
Relapsed Solid Neoplasm	Phase 1	Canada	Symphogen A/S	12 Oct 2020
Relapsed Solid Neoplasm	Phase 1	France	Symphogen A/S	12 Oct 2020
Relapsed Solid Neoplasm	Phase 1	Spain	Symphogen A/S	12 Oct 2020
Locally Advanced Malignant Solid Neoplasm	Phase 1	United States	Symphogen A/S	20 Nov 2017
Locally Advanced Malignant Solid Neoplasm	Phase 1	Canada	Symphogen A/S	20 Nov 2017
Lymphoma	Phase 1	United States	Symphogen A/S	20 Nov 2017
Lymphoma	Phase 1	Canada	Symphogen A/S	20 Nov 2017

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASCO2024	Not Applicable	Recurrent Squamous Cell Carcinoma of the Head and Neck PD-L1 positive (CPS≥1)	89	anti-PD-1 (irAEs)	zhphagywkr(qydscwcoan) = 10% jdspzakuoj (prqwxskbxp ) View more	Positive	24 May 2024
				anti-PD-1 (non-irAEs)
ASCO2023	Not Applicable	Melanoma	86	Anti-PD-1 antibody plus ipilimumab therapy	wogybnmywl(tboxhxywse) = tevbqqfrei kurrytlljj (apsyzolbjx ) View more	Positive	31 May 2023
NCT03489343 \| NCT03311412 \| NCT03489369 (ESMO2020)	Phase 1	Neoplasm Metastasis \| Advanced Malignant Solid Neoplasm \| Lymphoma	-	Sym021	eallhzyaxt(dxewnhrvdd) = Sym021, Sym022 and Sym023 alone and Sym021 in combination with either Sym022 or Sym023 were well tolerated with AE profiles typical of immune checkpoint inhibitors dlqkpeancf (zjlikjgeij )	-	20 Sep 2020
				Sym022
AUA2020	Not Applicable	Urogenital Neoplasms HLA-I genotypes \| HLA-C genotypes \| KIR ligands ... View more	51	anti-PD-1 drugs (HLA-A2 supertype)	gjtwxijwdu(bjoyntkale) = jamcvpzlvk ozrxgygyin (nuemecrbdj )	-	01 Apr 2020
				anti-PD-1 drugs (Patients without HLA-A2 supertype)	gjtwxijwdu(bjoyntkale) = mqgitmlktd ozrxgygyin (nuemecrbdj )
ESMO2019	Not Applicable	Melanoma Last line	200	Ipilimumab	bmhxosfsev(cjxqgdgsvp) = gqjrljmlce etqyldyrru (bghdqteusq ) View more	-	30 Sep 2019
ASCO2017	Not Applicable	Metastatic melanoma	-	aPD1	xkvrzeuygl(ndoluwmjzu) = awxbulkiqc eibgzclzep (ytihoakdvz ) View more	-	30 May 2017
				aPD1 + IPI	pyhqdfpiag(hziookzjqb) = riuxnhqmgn nclrbrdbvx (sretvqaknz ) View more
ASCO2017	Not Applicable	Metastatic melanoma	64	aPD1 + aCTLA4	uywhvsqzkd(ebpprhlkgh) = One death from irAEs occurred related to Toxic Epidermal Necrolysis (TEN) ncgqocjjhv (wtqxshmkcl ) View more	Positive	30 May 2017

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