A Phase 2, Open-Label, Multicentre Study to Assess the Preliminary Efficacy and Safety of RXC004, in Patients with Advanced Pancreatic Cancer that have Progressed following Therapy with Current Standard of Care

开始日期2024-10-15

申办/合作机构-

NCT04907851 / Completed临床2期

A Modular, Phase II, Open-Label, Multicentre Study to Assess the Preliminary Efficacy and Safety of RXC004, in Patients With Advanced Solid Tumours That Have Progressed Following Therapy With Current Standard of Care

This study is to evaluate the preliminary efficacy and safety of RXC004 monotherapy and in combination with pembrolizumab in advanced solid tumours that have progressed following SoC treatment.

开始日期2021-12-10

申办/合作机构

Redx Pharma Plc

[+1]

NCT04907539 / Completed临床2期

A Multi-arm, Phase II, Open-Label, Multicentre Study to Assess the Preliminary Efficacy of RXC004 in Monotherapy and in Combination With Nivolumab, in Patients With Ring Finger Protein 43 (RNF43) or R-spondin (RSPO) Aberrated, Metastatic, Microsatellite Stable, Colorectal Cancer Who Have Progressed Following Therapy With Current Standard of Care (PORCUPINE)

This is a Phase II, open label, multicentre, multi-arm, study to evaluate the preliminary efficacy and safety of RXC004 as monotherapy and in combination with nivolumab in patients with Ring finger protein 43 (RNF43) or R-spondin (RSPO) aberrated, microsatellite stable (MSS), colorectal cancer (CRC), that have progressed following current standard of care treatment.

开始日期2021-11-08

申办/合作机构

Redx Pharma Plc

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项与 Zamaporvint 相关的文献（医药）

2022-09-02·Cancer research communications

The Wnt Pathway Inhibitor RXC004 Blocks Tumor Growth and Reverses Immune Evasion in Wnt Ligand–dependent Cancer Models

Article

作者: Bingham, Matilda ; Jones, Clifford D. ; Eagle, Catherine ; Thompson, Ben ; Woodcock, Simon A. ; Flanagan, Eimear ; Calcraft, Peter ; Edmenson Cook, Alicia ; Bhamra, Inder ; Phillips, Caroline ; Armer, Richard

Significance::

Wnt pathway dysregulation drives many gastrointestinal cancers; however, there are no approved therapies that target the pathway. RXC004 has demonstrated the potential to block both tumor growth and tumor immune evasion in a genetically defined, clinically actionable subpopulation of Wnt ligand–dependent gastrointestinal cancers. The clinical utility of RXC004, and other Porcupine inhibitors, in such Wnt ligand–dependent cancers is currently being assessed in patient trials.

2021-11-02·Expert opinion on therapeutic patents2区 · 医学

Recent updates on Wnt signaling modulators: a patent review (2014-2020)

2区 · 医学

Review

作者: Patel, Bhumika D. ; Goswami, Vishalgiri G.

Introduction: Wnt signaling is a signal transduction pathway that plays a vital role in embryonic development and normal tissue preservation. Dysfunction of it gives rise to various diseases like cancer, Alzheimer's, metabolic and skeletal disorders, kidney and liver disease, etc. Thus, targeting Wnt pathway can be a potential approach to design and develop novel therapeutic classes.Areas covered: Authors provided an overview of Wnt modulators from 2014 to 2020. Different heterocyclic scaffolds and their pharmacology from a total of 104 PCT applications have been summarized.Expert opinion: The scientific community is working extensively to bring first in the class molecule to the market which targets Wnt pathway. Lorecivivint, Wnt inhibitor, for the treatment of knee Osteoarthritis and SM-04554, Wnt activator, for the treatment of androgenetic alopecia are currently under Phase III. Other molecules, LGK-974, RXC-004, ETC-159, CGX-1321, PRI-724, CWP-232291 and BC-2059 are also under different stages of clinical development for the treatment of cancer. Antibody based Wnt modulator, OTSA101-DTPA-90Y is currently under Phase I for the treatment of Relapsed or Refractory Synovial Sarcoma while OMP-18R5 is under Phase I for Metastatic Breast Cancer. Ongoing preclinical/clinical trials will define the role of the Wnt pathway in different therapeutic areas and open new opportunities.

2021-05-01·Pharmacological research2区 · 医学

Porcupine inhibitors: Novel and emerging anti-cancer therapeutics targeting the Wnt signaling pathway

2区 · 医学

Review

作者: Shah, Karmani ; Patel, Bhumika ; Panchal, Shivangi

Porcupine is a constituent of the 19 membered Wnt family with diverse biological features such as cell differentiation, cell proliferation, cell migration, apoptosis, etc. Porcupine is a membrane-bound o-acyltransferase family protein that modulates Wnt protein through palmitoylation to allow it to depart the secretory pathway and activate cellular responses. Inhibition of Porcupine prevents palmitoylation of Wnt ligands which in turn blocks the transport of Wnt to the extracellular membrane, thus prevents the immoderate production of β-catenin which helps to control the aberrant cell growth. Clinically, Porcupine inhibitors have shown their potential in treating majorly colorectal cancer, pancreatic cancer, hepatocellular carcinoma, head and neck cancer etc. Till date, none of the Porcupine inhibitors have been in the market and only four molecules, LGK974, ETC159, CGX1321 and RXC004 have reached the Phase I clinical trial. Present review gives a comprehensive insight on Porcupine as a novel drug target for the treatment of cancer as well as recent update on many novel heterocyclic Porcupine inhibitors with their chemical structures and pharmacology. Their physico chemical properties were also predicted using SwissADME server. Major concerns during their development have also been summarised which may throw some light for the future development of novel Porcupine inhibitors for the treatment of cancer.

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2024-02-07

·PRNewswire

Jazz Pharmaceuticals Enters Definitive Agreement with Redx Pharma to Acquire Global Rights to KRAS Inhibitor Program

Redx to receive $10 million upfront; potential for up to $870 million in development, regulatory and sales milestone payments in addition to royalties on future net salesPreclinical program expands Jazz's pipeline of targeted oncology therapies DUBLIN and ALDERLEY PARK, United Kingdom, Feb. 7, 2024 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) and Redx Pharma plc (AIM: REDX) today announced that the companies have signed a definitive agreement under which Jazz will acquire Redx's KRAS (Kirsten rat sarcoma virus) inhibitor program. Jazz and Redx will collaborate to advance candidates through IND-enabling studies; Jazz will be responsible for all clinical development, regulatory, manufacturing and commercialization activities. Continue Reading "KRAS is a well-validated oncology target and there remains a high unmet need for innovation in this area based on challenges in developing molecules to target specific KRAS mutations. Redx has discovered a number of preclinical KRAS candidates and we plan to leverage our collective oncology development expertise to identify and advance the most promising molecules toward the clinic," said Robert Iannone, M.D., M.S.C.E., executive vice president, global head of research and development of Jazz Pharmaceuticals. "This transaction further expands our early-stage oncology pipeline, and we are excited to explore novel approaches to improving treatment options for cancer patients." Lisa Anson, Chief Executive Officer of Redx, commented: "Once again, our distinguished expertise in medicinal chemistry has been recognized and we are pleased to secure another strategic transaction with Jazz, with whom we have a track record of collaboration. This agreement will allow us to collaborate on the advancement of novel KRAS inhibitors and we look forward to supporting Jazz in progressing these candidates through IND-enabling studies. Partnerships remain a key pillar of our corporate strategy, allowing us to advance what we believe are differentiated molecules in areas of high unmet need, while also creating long-term shareholder value through non-dilutive funding, with the upfront milestone payment from this agreement extending our current cash runway into 2025." Transaction Terms Under the terms of the agreement, Jazz will make an upfront payment to Redx of $10 million for all rights, patents, title and interest relating to Redx's proprietary KRAS inhibitor program, which includes G12D selective and pan-KRAS molecules. Redx is eligible to receive up to $870 million in development, regulatory and commercial milestone payments from Jazz, with the next milestone being an IND clearance from this program from the U.S. Food and Drug Administration. Redx is also eligible for tiered, mid-single digit percentage royalties based on any future net sales. As part of a separate collaboration agreement, signed in parallel, Jazz will pay Redx to perform research and preclinical development activities with the goal of completing IND-enabling studies for both KRAS profiles. About KRAS Inhibitors Rat sarcoma virus (RAS) is the most frequently mutated oncogene across different cancer types, with KRAS mutations accounting for approximately 85% of these mutated oncogenes. Therefore, KRAS inhibitors targeting multiple commonly occurring mutations may offer a treatment option for large segments of colorectal, pancreatic and lung cancer patients who currently have limited treatment options. Developing orally bioavailable agents that generate optimized target coverage is a key opportunity for the next wave of KRAS-targeting agents that act beyond the G12C mutation. About Jazz Pharmaceuticals plc Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases—often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. Within these therapeutic areas, we are identifying new options for patients by actively exploring small molecules and biologics, and through innovative delivery technologies and cannabinoid science. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. Please visit for more information. About Redx Pharma Plc Redx Pharma (AIM: REDX) is a clinical-stage biotechnology company focused on the discovery and development of novel, small molecule, targeted therapeutics for the treatment of fibrotic disease, cancer and the emerging area of cancer-associated fibrosis. Redx aims to progress its programmes to clinical proof of concept before evaluating options for further development and potential value creation. The Company's lead fibrosis product candidate, the selective ROCK2 inhibitor, zelasudil (RXC007), is in development for interstitial lung disease and is undergoing a Phase 2a trial for idiopathic pulmonary fibrosis (IPF) with topline data expected in H1 2024. The Company's second fibrosis candidate, RXC008, a GI-targeted ROCK inhibitor for the treatment of fibrostenotic Crohn's disease, is progressing towards the clinic with a Clinical Trial Application (CTA) submitted during Q4 2023.Redx's lead oncology product candidate, the Porcupine inhibitor RXC004, being developed as a targeted treatment for Wnt-ligand dependent cancers, is expected to report anti-PD-1 combination Phase 2 data during the first half of 2024, following which Redx will seek a partner for ongoing development. The Company has a strong track record of discovering new drug candidates through its core strengths in medicinal chemistry and translational science, enabling the Company to discover and develop differentiated therapeutics against biologically or clinically validated targets. The Company's accomplishments are evidenced not only by its wholly-owned clinical-stage product candidates and discovery pipeline, but also by its strategic transactions, which includes the sale of pirtobrutinib (RXC005, LOXO-305), the only non-covalent or reversible BTK inhibitor now approved by the US FDA, and transactions with both AstraZeneca and Jazz Pharmaceuticals. To subscribe to Email Alerts from Redx, please visit: . Jazz Investor Contact: Andrea N. Flynn, Ph.D. Vice President, Head, Investor Relations Jazz Pharmaceuticals plc [email protected] Ireland +353 1 634 3211 U.S. +1 650 496 2717 Jazz Media Contact: Kristin Bhavnani Head of Global Corporate Communications Jazz Pharmaceuticals plc [email protected] Ireland +353 1 637 2141 U.S. +1 215 867 4948 Redx Contacts: Caitlin Pearson Head of Communications Redx Pharma UK +44 (0)1625 469 918 Matt Davis/ Adam Dawes SPARK Advisory Partners (Nominated Adviser) UK +44 (0)203 368 3550 Claes Spång/ Satheesh Nadarajah/ David Wilson WG Partners LLP (Joint Broker) UK +44 (0)203 705 9330 Rupert Dearden/Freddy Crossley/Emma Earl Panmure Gordon (UK) Limited (Joint Broker) UK +44 (0)207 886 2500 Simon Conway/Ciara Martin FTI Consulting UK +44 (0)203 727 1000 SOURCE Jazz Pharmaceuticals plc

临床2期引进/卖出上市批准

2023-05-08

·PRNewswire

Global Pancreatic Cancer Competitive Landscape Report 2023: Comprehensive Insights about 250+ Companies and 300+ Drugs

DUBLIN, May 8, 2023 /PRNewswire/ -- The "Pancreatic Cancer - Competitive landscape, 2023" report has been added to ResearchAndMarkets.com's offering. This "Pancreatic Cancer- Competitive landscape, 2023" report provides comprehensive insights about 250+ companies and 300+ drugs in Pancreatic Cancer Competitive landscape. It covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. In March 2023, Adaptimmune Therapeutics plc. and TCR Therapeutics Inc. (NASDAQ: TCRR), announced entry into a definitive agreement under which Adaptimmune will combine with TCR in an all-stock transaction to create a preeminent cell therapy company focused on treating solid tumors. The combination provides extensive benefits for clinical development and product delivery supported by complementary technology platforms. As a result, and following the closing of the transaction, it is anticipated that the combined company's cash runway will extend into 2026. In February 2023, Akamis Bio, announced an expansion of its ongoing partnership with the Parker Institute for Cancer Immunotherapy (PICI) to include a clinical collaboration with the Cancer Research Institute (CRI) that will focus on advancing novel treatments for pancreatic cancer. As part of the Akamis Bio, PICI, and CRI partnership, NG-350A, an immuno-stimulatory tumor gene therapy driving intratumoral expression of a CD40 agonist monoclonal antibody, will be evaluated in combination with standard-of-care chemotherapy and the CTLA-4 inhibitor ipilimumab (YERVOY). In February 2023, Gritstone bio, Inc. announced that it has entered into a clinical trial agreement with the National Cancer Institute (NCI), an institute of the National Institutes of Health, to evaluate an autologous T cell therapy expressing a T cell receptor targeting mutated KRAS in combination with Gritstone's KRAS-directed vaccine candidate, SLATE-KRAS, in a Phase 1 study. Under the terms of the agreement, NCI will identify patients with metastatic cancer that are eligible for adoptive cell transfer based on the presence of a G12V or G12D KRAS mutation (KRASmut). In February 2023, Keymed Biosciences Inc., jointly announced a global exclusive license agreement with AstraZeneca for CMG901, a potential first-in-class Claudin 18.2 antibody drug conjugate (ADC). Under the license agreement, AstraZeneca will be responsible for the research, development, manufacture and commercialization of CMG901 globally. CMG901 is currently in a Phase I clinical trial for the treatment of Claudin 18.2-positive solid tumors. In January 2023, AIM ImmunoTech Inc. announced it has entered into an external sponsored collaborative clinical research agreement with Erasmus MC and AstraZeneca. Under the agreement, Erasmus MC is planning to perform an investigator-initiated clinical study, entitled "Combining anti-PD-L1 immune checkpoint inhibitor durvalumab with TLR-3 agonist rintatolimod in patients with metastatic pancreatic ductal adenocarcinoma for therapy effect. DURIPANC Study," in which it will use both Study Drugs provided by AstraZeneca and AIM ImmunoTech. Pancreatic Cancer Analytical Perspective In-depth Commercial Assessment: Pancreatic Cancer Collaboration Analysis by Companies The Report provides in-depth commercial assessment of drugs that have been included, which comprises collaboration, agreement, licensing and acquisition - deals values trends. The sub-segmentation is described in the report which provide company-company collaboration (licensing/partnering), company academic collaboration and acquisition analysis in tabulated form. Key Questions Answered Current Treatment Scenario and Emerging Therapies: How many companies are developing Pancreatic Cancer drugs? How many Pancreatic Cancer drugs are developed by each company? How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Pancreatic Cancer? What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Pancreatic Cancer therapeutics? What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies? What are the clinical studies going on for Pancreatic Cancer and their status? What are the key designations that have been granted to the emerging and approved drugs? Key Players Panbela Therapeutics ERYtech Pharma Jiangsu HengRui Medicine Co., Ltd. FibroGen Novartis AG AB Science TME Pharma AG Intensity Therapeutics Silenseed LTD SynerGene Therapeutics Elevation oncology Salspera LLC Redx Pharma Plc AIM ImmunoTech Inc. Rain Oncology Jazz Pharmaceuticals Invyte Corporation Immodulon Therapeutics Ltd GSK plc Merck Sharp & Dohme LLC Roche Helsinn Healthcare SA Argenus Inc. Actuate Therapeutics OSE Immunotherapeutics Incyte Corporation Galera Therapeutics CSPC ZhongQi Pharmaceutical Technology Astellas Pharma Global Development, Inc. NanOlogy Theriva Biologics AstraZeneca Berg, LLC Agenus ABVC BioPharma, Inc. Boehringer Ingelheim Alligator Bioscience CARsgenTherapeutics Co.,Ltd Purple Biotech Ltd. Lisata Therapeutics Chongqing Precision Biotech Co., Ltd Cybrexa Therapeutics Bold Therapeutics BioNTech SE Bristol-Myers Squibb DEKA Biosciences Senhwa Biosciences Cue Biopharma Carisma Therapeutics Inc Key Products Olaptesed pegol INT230-6 SBP-101 Masitinib NIS793 siG12D LODER SGT-53 Seribantumab Salmonella-IL2 RXC004 Rintatolimod RAIN-32 Lurbinectedin Retifanlimab IMM-101 GSK2256098 Belzutifan Atezolizumab Anamorelin AGEN1423 Elraglusib OSE2101 Epacadostat GC4711 Docetaxel Zolbetuximab NanoPac VCN-01 Danvatirsen BPM31510 Botensilimab ABV-1703 BI 907828 Mitazalimab CT041 CM24 CEND-1 CEA-targeted CAR-T cells CBX-12 BOLD-100 BNT141 BMS-813160 DK210 CX-5461 CUE-102 CT-0508 For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

免疫疗法引进/卖出疫苗临床1期抗体药物偶联物

2023-03-08

·FierceBiotech

Redx stung by porcupine inhibitor flop in biliary tract cancer, setting biotech back before Jounce merger

The setback comes as Redx prepares to merge with Jounce Therapeutics to secure a Nasdaq listing. Redx has hit a thorny patch. In the first data from a phase 2 program, Redx’s porcupine inhibitor RXC004 failed to improve progression-free survival in biliary tract cancer (BTC), prompting the British biotech to stop monotherapy development and focus on combinations in the indication. RXC004 is designed to inhibit the porcupine enzyme, which is involved in the Wnt signaling pathway, and thereby both directly slow tumor growth and address immune resistance. Evidence of the two modes of attack on cancer led Redx to run a phase 2 program featuring monotherapy and checkpoint inhibitor combination cohorts. The first phase 2 data have dented Redx’s monotherapy ambitions. The results come from PORCUPINE2, one of two midphase trials initiated by the biotech. One of the PORCUPINE2 modules enrolled patients with advanced or metastatic BTC who had progressed after first-line treatment. After reviewing data on 16 patients in the module, Redx has called time on the monotherapy cohort. The biotech said some patients received durable clinical benefit from RXC004 but overall the results failed to support further monotherapy development in the setting. The setback wiped 26% off Redx’s stock in early trading in London, sinking its share price to 30 pence (35 cents). Redx still has other shots at finding a place for RXC004. The other modules of PORCUPINE2, which are testing RXC004 in pancreatic cancer and in combination with Merck & Co.’s Keytruda in BTC, are continuing. And another clinical trial, PORCUPINE, is testing RXC004 with and without Bristol Myers Squibb’s Opdivo in colorectal cancer. Redx’s confidence in the combinations is undimmed. “Our primary efficacy hypothesis is that in combination it can overcome immune evasion and anti-PD-1 resistance, which could open new patient segments. While today's results do not support further clinical development of RXC004 as monotherapy in recurrent BTC ... they are nonetheless consistent with the overall hypothesis that RXC004 has potential as an active component of combination therapy,” Jane Robertson, chief medical officer at Redx, said in a statement. The setback comes as Redx prepares to merge with Jounce Therapeutics to secure a Nasdaq listing and cash for its R&D plans. RXC004 plays second fiddle in the R&D strategy to RXC007, a ROCK2 inhibitor that is in midphase development as a treatment for idiopathic pulmonary fibrosis.

临床2期临床结果

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适应症	最高研发状态	国家/地区	公司	日期
胆管上皮癌	临床2期	-	Redx Pharma Plc	2022-04-08
胆道肿瘤	临床2期	英国	Redx Oncology Ltd.	2022-01-30
胰腺癌	临床2期	英国	Redx Oncology Ltd.	2022-01-30
晚期恶性实体瘤	临床2期	澳大利亚	Redx Pharma Plc	2021-12-10
晚期恶性实体瘤	临床2期	英国	Redx Pharma Plc	2021-12-10
转移性微卫星稳定结直肠癌	临床2期	美国	Redx Pharma Plc	2021-11-08
转移性微卫星稳定结直肠癌	临床2期	韩国	Redx Pharma Plc	2021-11-08
转移性微卫星稳定结直肠癌	临床2期	西班牙	Redx Pharma Plc	2021-11-08
转移性微卫星稳定结直肠癌	临床2期	英国	Redx Pharma Plc	2021-11-08

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03447470 (AACR2024) 人工标引	临床1期	晚期恶性实体瘤	46	RXC004	鬱鏇製簾鹹糧壓構衊鏇(鑰憲糧鏇觸顧顧夢範築) = 鹹餘遞蓋蓋觸鏇憲築構繭淵網廠膚襯築選積願 (鑰鹽鬱餘範範襯襯鏇壓 ) 更多	积极	2024-04-05
				RXC004 + nivolumab	鬱鏇製簾鹹糧壓構衊鏇(鑰憲糧鏇觸顧顧夢範築) = 繭衊蓋襯築餘醖鏇觸願繭淵網廠膚襯築選積願 (鑰鹽鬱餘範範襯襯鏇壓 ) 更多
NCT03447470 (AACR2024) 人工标引	临床1期	实体瘤	-	RXC004 continuous monotherapy dosing	選築積膚鹹鹹繭鏇憲鏇(簾鏇襯夢繭夢鏇衊襯廠) = the most common AEs were fatigue, diarrhoea, dysgeusia and decreased appetite; no grade 4/5 AEs or bone fragility events were reported. 醖顧顧顧積夢築繭蓋齋 (襯繭鹹製壓範夢醖鹹醖 )	积极	2024-04-05
				RXC004 + nivolumab
EUCTR2017-000720-98-GB \| NCT03447470 (SITC2022) 人工标引	临床1期	HR阳性/HER2低表达实体瘤	14	nivolumab+RXC004	願顧網窪窪顧顧積鹹鹽(淵廠憲積範鏇醖夢廠鬱) = 1.5mg QD 醖簾顧淵憲製觸鹽鹽膚 (鏇鑰蓋鏇構醖觸壓簾獵 ) 更多	积极	2022-11-01