An Open-Label, Randomized, Phase 2, Umbrella Study to Investigate the Biological Rational of Various Neoadjuvant Therapies for Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder Who Are Cisplatin-Ineligible or Refuse Cisplatin Therapy and Undergoing Radical Cystectomy

This is a multicenter, open-label, randomized, Phase 2 umbrella study of various neoadjuvant treatment combinations in participants who have muscle-invasive urothelial carcinoma of the bladder and are cisplatin-ineligible or refusing cisplatin therapy and awaiting radical cystectomy.

Start Date14 Jan 2022

Sponsor / Collaborator

Incyte Corp.

NCT04463771

/ Active, not recruitingPhase 2

An Umbrella Study of INCMGA00012 Alone and in Combination With Other Therapies in Participants With Advanced or Metastatic Endometrial Cancer Who Have Progressed on or After Platinum-Based Chemotherapy (POD1UM-204)

This is a multicenter, open-label, nonrandomized, Phase 2 umbrella study of retifanlimab in participants who have advanced or metastatic endometrial cancer that has progressed on or after platinum-based chemotherapy. retifanlimab will be administered as monotherapy or in combination with other immunotherapy or targeted agents.

Start Date26 Jan 2021

Sponsor / Collaborator

Incyte Corp.

[+2]

NCT04231864

/ WithdrawnPhase 2IIT

A Multi-Center, Phase II, Open Label, Single-Arm Trial of Durvalumab and Epacadostat in Patients With Unresectable, Recurrent, and Metastatic EBV+ NPC

This phase II trial studies how well durvalumab and epacadostat work in treating patients with Epstein-Barr virus positive nasopharyngeal cancer that cannot be removed by surgery (unresectable), has come back (recurrent), or has spread to other places in the body (metastatic). Epacadostat blocks the enzyme, IDO1, from working. Blocking this enzyme may allow for a stronger immune response against cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body?s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving durvalumab and epacadostat may work better in treating patients with nasopharyngeal cancer compared to durvalumab alone.

Start Date01 Dec 2020

Sponsor / Collaborator

The University of California, San Francisco

[+2]

100 Clinical Results associated with Epacadostat

100 Translational Medicine associated with Epacadostat

100 Patents (Medical) associated with Epacadostat

224

Literatures (Medical) associated with Epacadostat

19 Aug 2025·Journal of the American Heart Association

IDO‐1 Promotes Pulmonary Vascular Remodeling Via Kynurenine Pathway in Pulmonary Arterial Hypertension

Article

Author: Wang, Sihao ; Yan, Yi ; Tian, Siyu ; Olschewski, Horst ; Nagy, Bence M ; Fu, Yahong ; Tran-Lundmark, Karin ; Deng, Lin ; Fu, Lijun ; Wang, Danan ; Li, Xiaoxuan ; van den Bosch, Thierry P P ; Boomars, Karin A ; Phan, Carole ; Guignabert, Christophe ; Merkus, Daphne ; Tu, Ly ; Cai, Zongye

Background:

Activation of the plasma kynurenine pathway (KP) may contribute to the progression of pulmonary arterial hypertension (PAH). We investigated the functional role and molecular mechanisms of KP activation in PAH.

Methods:

KP activity was measured in the lungs and plasma of humans and rodents with pulmonary hypertension (PH). KP activity was modulated in lung microvascular endothelial cells in vitro, and through daily oral administration of epacadostat, an inhibitor of IDO‐1 (indoleamine 2,3‐dioxygenase), the rate‐limiting enzyme of the KP, in rats with monocrotaline‐induced PH.

Results:

IDO‐1 expression was increased in peripheral blood mononuclear cells but not in lung tissue of patients with PAH and in rats with monocrotaline‐induced PH. Epacadostat prevented KP activation and the development of monocrotaline‐induced PH, significantly reduced right ventricular systolic pressure (58±9 versus 42±4 and 46±6 mm Hg for placebo versus epacadostat 50 and 100 mg/kg, respectively, P <0.001), pulmonary arterial remodeling (wall thickness, 64±3 versus 58±3 and 58±3%, P <0.001), perivascular inflammation, and right ventricular remodeling (Fulton index, 0.49±0.05 versus 0.36±0.06 and 0.39±0.04, P <0.001). IDO‐1 overexpression contributed to KP activation and de novo nicotinamide adenine dinucleotide + synthesis, increased mitochondrial membrane potential, and endothelial cell proliferation. Inhibition of IDO‐1 using siRNA or epacadostat reversed these effects and inhibited the inflammatory response.

Conclusions:

Increased IDO‐1 expression in peripheral blood mononuclear cells may drive KP activation and promote pulmonary vascular remodeling in PAH. Epacadostat prevents the development of monocrotaline‐induced PH. These findings suggest a novel approach for the treatment of PAH.

01 Aug 2025·JOURNAL OF CONTROLLED RELEASE

A TCR nanovesicle antibody for redirecting T cells and reversing immunosuppression as a tumor immunotherapy strategy

Article

Author: Tang, Yu ; Li, Chunli ; Qi, Hongbo ; Wang, Bozhi ; Jin, Aishun ; Li, Luo ; Zhang, Liang ; Li, Qian

T-cell receptor T-cell engagers (TCR-TCE) are soluble bispecific proteins composed of TCR and anti-CD3 antibodies, which can effectively redirect tumor-infiltrating T cells to kill tumor cells. However, TCR-TCE development and clinical application are significantly hindered by the instability of natural TCRs and immunosuppressive tumor microenvironment, underscoring the urgent need for alternative engineering strategies. Here, we describe a strategy that utilizes artificial cell membrane nanoparticle technology to generate a TCR nanovesicle antibody (TPC NV), which presents tumor-specific TCR, anti-CD3, and PD-1 antibodies on its membrane, representing a novel TCR-TCE with therapeutic efficacy against solid tumors. TPC NV binds to tumor cells through TCR, redirects tumor-infiltrating T cells via anti-CD3 antibodies, and reverses immunosuppression with anti-PD-1 antibodies, thereby inducing a broad-spectrum T cell response that effectively eliminates established tumors. Furthermore, epacadostat, an inhibitor of indoleamine 2,3-dioxygenase, can be loaded into TPC NV to suppress regulatory T cell (Treg) generation and enhance dendritic cell (DC) maturation by inhibiting tumor tryptophan metabolism. This dual action amplifies adaptive immune activation and triggers a robust systemic anti-tumor immune response.

10 Jul 2025·ACS Medicinal Chemistry Letters

Design, Synthesis, and Biological Evaluation of Novel Hydroxyamidine Derivatives as Indoleamine 2,3-Dioxygenase 1 Inhibitors

Article

Author: Zhao, Wuli ; Liu, Yitong ; Zhao, Cong ; Meng, Qingguo ; Zhou, Xia ; Qiu, Xiaodan ; Shan, Guangzhi

Indoleamine 2,3-dioxygenase 1 (IDO1) is a rate-limiting enzyme that catalyzes the conversion of tryptophan into kynurenine and represents a potential target for tumor immunotherapy. In this study, we designed and synthesized a series of N'-hydroxyamidine analogues through pharmacophore fusion and bioisosterism principles. The results indicated that compounds I-1 and I-2 exhibited activity similar to that of Epacadostat in inhibiting recombinant hIDO1 and hIDO1 expression in HeLa cells. Moreover, the compounds not only effectively stimulated T cell proliferation but also inhibited the proliferation of Lewis Lung Carcinoma cells. RNA sequencing analysis indicated that these compounds primarily exert immunotherapeutic effects. Surface plasmon resonance and molecular docking confirmed the interactions between the compounds and IDO1. The physicochemical properties along with pharmacokinetic profiles of both compounds were also predicted, and they were found to possess favorable characteristics. The active compounds developed in this research may serve as valuable references for discovering highly effective IDO1 inhibitors.

News (Medical) associated with Epacadostat

08 May 2023

·www.prnewswire.com

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

ImmunotherapyLicense out/inVaccinePhase 1ADC

21 Dec 2022

·www.prnewswire.com

Gastric Cancer Pipeline Space Brims With Novel Emerging Therapies with Over 200 Key Companies Working in the Domain | DelveInsight

The prevalence of gastric cancer has been rising since the past few years, which prompts the growing demand for treatment options. The increasing prevalence of cancer, the robust pipeline, and the growing research and development activities to develop novel therapies to treat Gastric Cancer drive the market. The companies developing the potential therapies in the last stage of development include Henlix Biotech, Eli Lilly and Company, Jiangsu Hengrui Medicine, and several others. LAS VEGAS, Dec. 21, 2022 /PRNewswire/ -- DelveInsight's ' Gastric Cancer Pipeline Insight – 2022 ' report provides comprehensive global coverage of available, marketed, and pipeline gastric cancer therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the gastric cancer pipeline domain. Key Takeaways from the Gastric Cancer Pipeline Report DelveInsight's gastric cancer pipeline report depicts a robust space with 200+ active players working to develop 230+ pipeline therapies for gastric cancer treatment. Key gastric cancer companies such as EMD Serono, Sumitomo Pharma, LintonPharm Co., Ltd., Rapa Therapeutics LLC, Jiangsu HengRui Medicine Co., Ltd., Janssen Pharmaceutical K.K., Genentech, Exelixis, Bristol-Myers Squibb, Pieris Pharmaceuticals, Inc., Pfizer, Leap Therapeutics, CSPC ZhongQi Pharmaceutical, Ellipses Pharma, Amgen, Hanmi Pharmaceutical, Taiho Oncology, Inc., Shanghai Henlius Biotech, LianBio LLC, Chengdu Kanghong Biotech,Eisai Inc., AB Science, Maxinovel Pharmaceuticals, Shanghai Miracogen Inc., GlaxoSmithKline, Hoffmann-La Roche, Merck Sharp & Dohme, Hutchison Medipharma Limited, Genome & Company, Minneamrita Therapeutics LLC, Suzhou Suncadia Biopharmaceuticals Co., Ltd., MacroGenics, ALX Oncology Inc., Codiak BioSciences, Turning Point Therapeutics, Inc., TCRx Therapeutics, InxMed (Shanghai) Co., Ltd., Imugene Limited, SOTIO Biotech, CARsgen Therapeutics Co., Ltd., Zymeworks Inc., NextCure, Inc., Phanes Therapeutics, Pieris Pharmaceuticals, Inc., Athenex, Inc., Curis, Inc., Qurient Co., Ltd., Acepodia Biotech, Inc., Sichuan Baili Pharmaceutical Co., Ltd., Tarus Therapeutics, Inc., Lumicell, Inc., Legend Biotech,Cue Biopharma, TORL Biotherapeutics, LLC, OBI Pharma, Inc, Astellas Pharma, HiberCell, Inc., Celon Pharma SA, Linnaeus Therapeutics, Inc., Inspirna, Inc., Klus Pharma Inc., Genzada Pharmaceuticals, Shanghai PerHum Therapeutics, VM Oncology, LLC, Immunomic Therapeutics, Peptron, and others are evaluating new gastric cancer drugs to improve the treatment landscape. Promising gastric cancer pipeline therapies in various stages of development include Avelumab, BBI608, Camrelizumab, Catumaxomab, RAPA-201, SHR-1210, Amivantamab, Atezolizumab, Bevacizumab, Cabozantinib, Cinrebafusp alfa, Crizotinib, DKN-01, DP303c, Eflornithine, EP0057, Epacadostat, FLX475, Futibatinib, GEN-001, HLX07, HLX22, Infigratinib, KH903, Lenvatinib, Masitinib, MAX-40279, MRG002, MRG003, Niraparib, Savolitinib, Minnelide, SHR-1701, Margetuximab, Bemarituzumab, Evorpacept, Lenvatinib, CDK-004, TPX-0022, TCRx_T Cells, IN10018, IMU-131, SOT102, CT041, AB011, Zanidatamab, NC410, PT 886, PRS-343, Oraxol, CA-4948, Q702, ACE1702, SI-B001, TT-4, LUM015, LB 1908, CUE-102, TORL-2-307-MAB, OBI-833/OBI-821, ASP2138, NC410, SO-C101, HC-5404-FU, CPL304110, LNS8801, RGX-202-01, A166, GZ17-6.02, HMPL-453, CCT303-406, VMD-928, ITI 4000, PAb 001, and others. In December 2022, Daiichi Sankyo and AstraZeneca's ENHERTU (trastuzumab deruxtecan) has been approved in the European Union (EU) as a monotherapy for the treatment of adult patients with advanced HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen. In December 2022, RemeGen Co., Ltd. announced on December 7, 2022, that its latest antibody-drug conjugate (ADC), RC118 for injection, has been granted two orphan drug designations (ODD) by the United States Food and Drug Administration (FDA) for gastric cancer (including gastroesophageal junction cancer) and pancreatic cancer. This marks the Company's fourth, having previously been twice granted ODD for Disitamab Vedotin (RC48) and Telitacicept (RC18) earlier this year. In December 2022, Zhejiang Doer Biologics Co., Ltd. announced that it has entered into a clinical trial collaboration agreement with MSD (Merck & Co., Inc., Rahway, NJ, USA), to investigate Doer Bio's anti-Claudin18.2 antibody DR30303, in combination with MSD's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients with Gastric or Gastroesophageal Junction Cancer. Under this agreement, Doer Bio will conduct a clinical study based on a mutually- agreed and finalized protocol to evaluate the safety and efficacy of DR30303 in combination with KEYTRUDA® in patients with Claudin18.2-positive, locally advanced unresectable or metastatic gastric or gastroesophageal junction (GC/GEJ) cancer. In November 2022, Triumvira Immunologics announced preclinical data for its investigational TAC-T cell therapies CLDN18.2-TAC T and GUCY2C-TAC T, and data on HER2-specific TAC-T products. Data was shared in three posters at the Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting being held virtually and in-person in Boston.Triumvira announced updated data on its novel T cell antigen coupler (TAC)-T cell candidate targeting Claudin 18.2 (CLDN18.2) for the treatment of gastric cancer. The data continue to demonstrate that CLDN18.2-TAC T effectively eliminates CLDN18.2-expressing gastric cancer cells in vitro and in vivo. The study also demonstrated that the activation of CLDN18.2-TAC T cells was specific to target cells that expressed CLDN18.2. In vitro data show strong and persistent anti-tumor activity and in vivo treatment led to complete and sustained tumor clearance with no signs of toxicity. In September 2022, Nuvectis Pharma, Inc. announced positive data for NXP800 in a preclinical xenograft model of ARID1a-mutated gastric carcinoma.Mice in each group were treated with either vehicle or NXP800, and tumor volumes were measured over 28 days. Treatment with NX800 resulted in tumor regression and substantial tumor growth inhibition versus the control. In March 2022, Imugene (ASX: IMU) announced a new clinical trial collaboration and supply agreement with MSD, a tradename of Merck & Co., Inc., Kenilworth, NJ, USA, to evaluate the safety and efficacy of Imugene's HER-Vaxx, B-cell activating immunotherapy, in combination with MSD's anti-PD-1 therapy, pembrolizumab (KEYTRUDA®), in patients with HER-2 positive gastric cancer. Request a sample and discover the recent advances in gastric cancer drug treatment @ Gastric Cancer Pipeline Report The gastric cancer pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage gastric cancer drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the gastric cancer clinical trial landscape. Gastric Cancer Overview Stomach cancer is cancer that begins within the stomach or on the stomach wall. It is also known as gastric cancer. Stomach cancer is more common in the elderly. People aged 75 and above account for approximately 50 out of every 100 cases (around 50%). It affects men more than women. The exact gastric cancer causes are not known. Stomach cancer is linked to Helicobacter pylori, a bacteria that lives in the stomach. The most common gastric cancer symptoms are difficulty swallowing (dysphagia), weight loss, persistent indigestion (dyspepsia), feeling full after eating small amounts, feeling or being sick, and fatigue due to low red blood cell count (anaemia). Several tests, such as ultrasound, imaging tests, blood tests, and others, are used for gastric cancer diagnosis. Gastric cancer patients can receive a variety of treatments. Standard gastric cancer treatment consists of seven types: surgery, endoscopic mucosal resection, chemotherapy, radiation therapy, chemoradiation, targeted therapy, and immunotherapy. Find out more about chemotherapy drugs for gastric cancer @ New Gastric Cancer Drugs A snapshot of the Gastric Cancer Pipeline Drugs mentioned in the report: Learn more about the emerging gastric cancer pipeline therapies @ Gastric Cancer Clinical Trials Gastric Cancer Therapeutics Assessment The gastric cancer pipeline report proffers an integral view of gastric cancer emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Gastric 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: Oral, Parenteral, Intravenous, Subcutaneous, Topical Therapeutics Assessment By Molecule Type: Monoclonal Antibody, Peptides, Polymer, Small molecule, Gene therapy Therapeutics Assessment By Mechanism of Action: Antibody-dependent cell cytotoxicity, Programmed cell death-1 receptor antagonists, T lymphocyte stimulants, Apoptosis stimulants, Macrophage stimulants, Natural killer cell stimulants, Cyclin-dependent kinase 4 inhibitors, Cyclin-dependent kinase 6 inhibitors, Antibody-dependent cell cytotoxicity, Angiogenesis inhibitors, Epidermal growth factor receptor antagonists, EIF 2 kinase inhibitors Key Gastric Cancer Companies: EMD Serono, Sumitomo Pharma, LintonPharm Co., Ltd., Rapa Therapeutics LLC, Jiangsu HengRui Medicine Co., Ltd., Janssen Pharmaceutical K.K., Genentech, Exelixis, Bristol-Myers Squibb, Pieris Pharmaceuticals, Inc., Pfizer, Leap Therapeutics, CSPC ZhongQi Pharmaceutical, Ellipses Pharma, Amgen, Hanmi Pharmaceutical, Taiho Oncology, Inc., Shanghai Henlius Biotech, LianBio LLC, Chengdu Kanghong Biotech,Eisai Inc., AB Science, Maxinovel Pharmaceuticals, Shanghai Miracogen Inc., GlaxoSmithKline, Hoffmann-La Roche, Merck Sharp & Dohme, Hutchison Medipharma Limited, Genome & Company, Minneamrita Therapeutics LLC, Suzhou Suncadia Biopharmaceuticals Co., Ltd., MacroGenics, ALX Oncology Inc., Codiak BioSciences, Turning Point Therapeutics, Inc., TCRx Therapeutics, InxMed (Shanghai) Co., Ltd., Imugene Limited, SOTIO Biotech, CARsgen Therapeutics Co., Ltd., Zymeworks Inc., NextCure, Inc., Phanes Therapeutics, Pieris Pharmaceuticals, Inc., Athenex, Inc., Curis, Inc., Qurient Co., Ltd., Acepodia Biotech, Inc., Sichuan Baili Pharmaceutical Co., Ltd., Tarus Therapeutics, Inc., Lumicell, Inc., Legend Biotech,Cue Biopharma, TORL Biotherapeutics, LLC, OBI Pharma, Inc, Astellas Pharma, HiberCell, Inc., Celon Pharma SA, Linnaeus Therapeutics, Inc., Inspirna, Inc., Klus Pharma Inc., Genzada Pharmaceuticals, Shanghai PerHum Therapeutics, VM Oncology, LLC, Immunomic Therapeutics, Peptron, and others. Key Gastric Cancer Pipeline Therapies: Avelumab, BBI608, Camrelizumab, Catumaxomab, RAPA-201, SHR-1210, Amivantamab, Atezolizumab, Bevacizumab, Cabozantinib, Cinrebafusp alfa, Crizotinib, DKN-01, DP303c, Eflornithine, EP0057, Epacadostat, FLX475, Futibatinib, GEN-001, HLX07, HLX22, Infigratinib, KH903, Lenvatinib, Masitinib, MAX-40279, MRG002, MRG003, Niraparib, Savolitinib, Minnelide, SHR-1701, Margetuximab, Bemarituzumab, Evorpacept, Lenvatinib, CDK-004, TPX-0022, TCRx_T Cells, IN10018, IMU-131, SOT102, CT041, AB011, Zanidatamab, NC410, PT 886, PRS-343, Oraxol, CA-4948, Q702, ACE1702, SI-B001, TT-4, LUM015, LB 1908, CUE-102, TORL-2-307-MAB, OBI-833/OBI-821, ASP2138, NC410, SO-C101, HC-5404-FU, CPL304110, LNS8801, RGX-202-01, A166, GZ17-6.02, HMPL-453, CCT303-406, VMD-928, ITI 4000, PAb 001, and others. Dive deep into rich insights for new drugs for gastric cancer treatment; visit @ Gastric Cancer Medications Table of Contents For further information on the gastric cancer pipeline therapeutics, reach out @ Gastric Cancer Drug Treatment Related Reports Gastric Cancer Epidemiology Forecast Gastric Cancer Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, and the gastric cancer epidemiology trends. Gastric Cancer Market Gastric Cancer Market Insight, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key gastric cancer companies, including CSPC ZhongQi Pharmaceutical, Ellipses Pharma, Amgen, Hanmi Pharmaceutical, Taiho Oncology, Inc., Shanghai Henlius Biotech, among others. HER2+ Gastric Cancer Market HER2+ Gastric Cancer Market Insight, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key HER2+ gastric cancer companies, including Pieris Pharmaceuticals, BioInvent International, Bellicum Pharmaceuticals, Mersana Therapeutics, Acepodia Biotech, Inc., Klus Pharma Inc, among others. HER2+ Gastric Cancer Pipeline HER2+ Gastric Cancer Pipeline Insight – 2022 report provides comprehensive insights about the pipeline landscape, including clinical and non-clinical stage products, and the key HER2+ gastric cancer companies, including Pieris Pharmaceuticals, BioInvent International, Bellicum Pharmaceuticals, Mersana Therapeutics, Acepodia Biotech, Inc., Klus Pharma Inc, among others. HER2+ Gastric Cancer Epidemiology HER2+ Gastric Cancer Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, and the HER2+ gastric cancer epidemiology trends. Other Trending Oncology Reports Follicular lymphoma | Indolent lymphoma | Severe Toxicities In Lymphoma | Marginal Zone Lymphoma | Vulvar Squamous Cell Carcinoma | Cholangiocarcinoma | Metastatic Cutaneous Squamous cell Carcinoma | Nasopharyngeal Carcinoma | Ductal Carcinoma in Situ | Oncolytic Virus Cancer Therapy | Cancer Cachexia | Intratumoral Cancer Therapies | Brain Cancer Related Cases Studies Competitive Intelligence Market Assessment Product Assessment Epidemiology Assessment Related Healthcare Services Healthcare Business Consulting Healthcare Competitive Intelligence Services Healthcare Asset Prioritization Services 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

ImmunotherapyOrphan DrugDrug Approval

18 Nov 2021

·www.biospace.com

BriaCell Adds Mary Crowley Cancer Research Center as a Clinical Trial Site for its Phase I/IIa Breast Cancer Study

NEW YORK and VANCOUVER, British Columbia, Nov. 18, 2021 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX-V:BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company specializing in targeted immunotherapies for advanced breast cancer and other cancers, announces that Mary Crowley Cancer Research center in Dallas, Texas is now actively screening and enrolling advanced breast cancer patients in the Phase I/IIa combination study of BriaCell’s lead candidate, Bria-IMT™, with Incyte’s checkpoint inhibitors, retifanlimab and epacadostat. Dr. Minal Barve, the Executive Medical Director and Chief Medical Officer for Mary Crowley Cancer Research center and Board-Certified in medical oncology and internal medicine, will act as the clinical site’s Principal Investigator. Dr. Barve will work closely with Cancer Insight, LLC to manage the clinical and regulatory aspects of the Phase I/IIa clinical trial in advanced breast cancer on behalf of BriaCell. In addition to Mary Crowley Cancer Research center, the clinical sites at St. Joseph Health-Sonoma County, Santa Rosa, Calif. and the Cancer Center of Kansas, Wichita, Kan. are open and actively enrolling patients for BriaCell’s Phase I/IIa advanced breast cancer clinical trial. “We look forward to supporting BriaCell’s efforts to develop safe and effective therapeutics for advanced breast cancer patients with few, if any, treatment options,” stated Dr. Barve. “We are delighted to add Mary Crowley Cancer Research center with Dr. Barve as Principal Investigators to our team. Dr. Barve’s leading knowledge and experience in biological therapies and immunotherapies for cancer will be highly valuable to us. We look forward to working with her team in our advanced breast cancer clinical trial to accelerate patient recruitment,” stated Dr. Williams, BriaCell’s President and CEO. BriaCell anticipates the addition of the Mary Crowley Cancer Research center clinical sites may accelerate patient enrolment to build on our existing patient data. BriaCell had previously reported 12.0 months average overall survival in advanced breast cancer patients in its Phase I/IIa combination study including 13.4 months in patients with 2+ HLA matches and 12.5 months in patients with Grade I/II tumors, compared with 7.2-9.8 months survival in historical comparison treatment studies. The top responder patient showed 21.4 months survival plus 100% resolution of ‘eye-bulging’ orbital tumor. Founded by Dallas entrepreneur Mary C. Crowley and her fundamental belief that cancer patients needed access to better cancer treatments, Mary Crowley Cancer Research center was established in 1997 to provide potentially curative treatments for adult cancer patients. Mary Crowley Cancer Research center’s mission is to bring hope to cancer patients through innovative clinical trials, while advancing treatment for patients in the future. About BriaCell Therapeutics Corp. BriaCell is an immuno-oncology focused biotechnology company developing targeted and effective approaches for the management of cancer. More information is available at . Safe Harbor This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” "will” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on BriaCell’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully under the heading "Risks and Uncertainties" in the Company's most recent Management’s Discussion and Analysis, under “Risks and Uncertainties” in the Company's other filings with the Canadian securities regulatory authorities and the U.S. Securities and Exchange Commission, all of which are available under our profiles on SEDAR at and on EDGAR at . Forward-looking statements contained in this announcement are made as of this date, and BriaCell Therapeutics Corp. undertakes no duty to update such information except as required under applicable law. Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release. Contact Information Company Contact: William V. Williams, MD President & CEO 1-888-485-6340 info@briacell.com Media Relations: Jules Abraham Director of Public Relations CORE IR 917-885-7378 julesa@coreir.com Investor Relations Contact: CORE IR investors@briacell.com

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100 Deals associated with Epacadostat

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KEGG	Wiki	ATC	Drug Bank
D11049	Epacadostat	L01XX58	DB11717

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Non-Small Cell Lung Cancer	Phase 3	United States	Incyte Corp.	27 Dec 2017
Recurrent Non-Small Cell Lung Cancer	Phase 3	United States	Incyte Corp.	27 Dec 2017
Metastatic urothelial carcinoma	Phase 3	United States	Incyte Corp.	22 Dec 2017
Metastatic urothelial carcinoma	Phase 3	Japan	Incyte Corp.	22 Dec 2017
Metastatic urothelial carcinoma	Phase 3	Australia	Incyte Corp.	22 Dec 2017
Metastatic urothelial carcinoma	Phase 3	Canada	Incyte Corp.	22 Dec 2017
Metastatic urothelial carcinoma	Phase 3	Denmark	Incyte Corp.	22 Dec 2017
Metastatic urothelial carcinoma	Phase 3	France	Incyte Corp.	22 Dec 2017
Metastatic urothelial carcinoma	Phase 3	Germany	Incyte Corp.	22 Dec 2017
Metastatic urothelial carcinoma	Phase 3	Hungary	Incyte Corp.	22 Dec 2017

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03532295 (CTIM-23, CTgov)	Phase 2	Glioblastoma Multiforme \| Glioblastoma \| Recurrent Glioblastoma	51	Radiation therapy+Bevacizumab+Retifanlimab (Regimen A: Retifanlimab+RT+Bevacizumab)	hrqaxggyny = qdryfpsinh rqpulymcyl (pbmigspjbq, mfcroagcjq - xrcajjyaxa) View more	-	07 Aug 2025
				Radiation therapy+Bevacizumab+Epacadostat+Retifanlimab (Regimen B: Retifanlimab+RT+Bevacizumab+Epacadostat)	hrqaxggyny = vnfqgqrfnr rqpulymcyl (pbmigspjbq, lclszztdcx - dbzxuqlcsp) View more
NCT03414229 (CTgov)	Phase 2	Malignant Fibrous Histiocytoma \| Leiomyosarcoma \| Hemangiosarcoma ... View more	30	Pembrolizumab+Epacadostat (UPS, Liposarcoma or Pleomorphic Liposarcoma)	qqayttanhx = xkxfxrelgd stqdbbvuay (bvuskemmuw, lweqsrobcz - pocwqzsvuc) View more	-	02 May 2025
				Pembrolizumab+Epacadostat (Leiomyosarcoma)	qqayttanhx = tkpdjkdrwc stqdbbvuay (bvuskemmuw, octhlxuyhu - fespvsebcy) View more
NCT04586244 (Optimus, CTgov)	Phase 2	Muscle Invasive Bladder Urothelial Carcinoma	30	Epacadostat+Retifanlimab (Epacadostat 600 mg BID + Retifanlimab 500 mg Q4W)	nhbouabgnn = ndgvhovqep vtevmpmbqm (wxbgtjjwux, wixixrwxqy - wnakbiftsm) View more	-	10 Mar 2025
				Retifanlimab (Retifanlimab 500 mg Q4W)	rozvmrzbvy(ndpzmfsklz) = nyjdfjdytf mgybhkqvch (srwskqhgib, 0.9332) View more
NCT03322540 (Pubmed) Manual	Phase 2	PD-L1 positive Non-Small Cell Lung Cancer First line PD-L1	154	pembrolizumab0Epacadostat	rlxxjeuoyt(vegedeqlln) = xcxiothywd rgixojayof (hxoycayitv, 22.2 - 44.1) View more	Negative	25 Jul 2024
				pembrolizumab	rlxxjeuoyt(vegedeqlln) = jmizsmcjzb rgixojayof (hxoycayitv, 28.0 - 50.8) View more
NCT03374488 (ECHO-303 \| KEYNOTE-698, Pubmed) Manual	Phase 3	Advanced Urothelial Carcinoma Second line	42	Epacadostat 100 mg BID plPembrolizumabmab	pyreactyit(xvrmkamvco) = wkhqvmijwx ttzavxager (gbpkunuucp, 16.35 - 48.11) View more	Positive	25 Jul 2024
				Placebo plPembrolizumabmab	pyreactyit(xvrmkamvco) = aloqyqirpn ttzavxager (gbpkunuucp, 4.67 - 29.50) View more
NCT03322566 (ECHO-306/KEYNOTE-715, Pubmed) Manual	Phase 2	metastatic non-small cell lung cancer First line PD-L1 tumor proportion score \| tumor histology	178	Epacadostat-Pembrolizumab-Chemotherapy	fubgeyktbk(myhzogweav) = hbejfvoagu lhhnwdnblg (qmudycjwvd, 17.7 - 36.7) View more	Negative	25 Jul 2024
				Placebo-Pembrolizumab-Chemotherapy	fubgeyktbk(myhzogweav) = gsszkaemmb lhhnwdnblg (qmudycjwvd, 34.1 - 55.9) View more
NCT03260894 (KEYNOTE-679/ECHO-302, Pubmed) Manual	Phase 3	Metastatic Renal Cell Carcinoma First line	129	Pembrolizumab plus epacadostat	tsexyoujlh(uhwkwdkrcg) = ynebrarxes diutsowgwr (zhjaaladhx, 20.2 - 44.1) View more	Negative	25 Jul 2024
				Sunitinib or pazopanib	tsexyoujlh(uhwkwdkrcg) = xycnexvunn diutsowgwr (zhjaaladhx, 18.6 - 41.8) View more
NCT03358472 (KEYNOTE-669/ECHO-304, Pubmed) Manual	Phase 3	Squamous Cell Carcinoma of Head and Neck	89	Pembrolizumab plus epacadostat	jbgedklxhg(xjnkkwyhfz) = noerldeufl zjruvqrfko (qfjpsvjsco, 17 - 49) View more	Positive	25 Jul 2024
				Pembrolizumab monotherapy	jbgedklxhg(xjnkkwyhfz) = tevjmrbamd zjruvqrfko (qfjpsvjsco, 6 - 46) View more
NCT03361865 (ECHO-307/KEYNOTE-672, Pubmed) Manual	Phase 3	Transitional Cell Carcinoma First line circulating kynurenine levels	93	Epacadostat plus Pembrolizumab	eumdtcamio(fmfqzsuzle) = hkrrvmleyv qojnghtdjv (krgqbupipg, 22.46 - 55.24) View more	Negative	25 Jul 2024
				Placebo plus Pembrolizumab	eumdtcamio(fmfqzsuzle) = xsvduezbah qojnghtdjv (krgqbupipg, 15.33 - 43.67) View more
NCT03516708 (AACR2024) Manual	Phase 1	Rectal Cancer	17	epacadostat + SCRT + 6 cycles of CAPOX chemotherapy	yzlbxeezuz(yxebnemeqn) = mygisajrbm cafjuhlkbd (djpyqjqlmk ) View more	Positive	09 Apr 2024

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