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

233

Literatures (Medical) associated with Epacadostat

24 May 2025·Journal of biomolecular structure & dynamics

Integration analysis of PLAUR as a sunitinib resistance and macrophage related biomarker in ccRCC, an in silicon and experimental study

Article

Author: Gan, Sishun ; Li, Lin ; Jiang, Aimin ; Chu, Jian ; Yang, Qiwei ; Cao, Jianwei ; Ye, Fangdie ; Tian, Yijun

Sunitinib remains the preferred systemic treatment option for specific patients with advanced RCC who are ineligible for immune therapy. However, it's essential to recognize that Sunitinib fails to elicit a favourable response in all patients. Moreover, most patients eventually develop resistance to Sunitinib. Therefore, identifying new targets associated with Sunitinib resistance is crucial. Utilizing multiple datasets from public cohorts, we conducted an exhaustive analysis and identified a total of 8 microRNAs and 112 mRNAs displaying significant expression differences between Sunitinib responsive and resistant groups. A particular set of six genes, specifically NIPSNAP1, STK40, SDC4, NEU1, TBC1D9, and PLAUR, were identified as highly significant via WGCNA. To delve deeper into the resistance mechanisms, we performed additional investigations using cell, molecular, and flow cytometry tests. These studies confirmed PLAUR's pivotal role in fostering Sunitinib resistance, both in vitro and in vivo. Our findings suggest that PLAUR could be a promising therapeutic target across various cancer types. In conclusion, this investigation not only uncovers vital genes and microRNAs associated with Sunitinib resistance in RCC but also introduces PLAUR as a prospective therapeutic target for diverse cancers. The outcomes contribute to advancing personalized healthcare and developing superior therapeutic strategies.

01 Oct 2024·BIOMEDICINE & PHARMACOTHERAPY

IDO1 inhibitors are synergistic with CXCL10 agonists in inhibiting colon cancer growth

Article

Author: Hu, Rong ; Tan, Yingying ; Fu, Bin ; Chen, Yaxin ; Yang, Mengdi ; Tan, Dashan ; Zhang, Xin ; Xuan, Chenyuan ; Cao, Mengran ; Su, Yongren

Indoleamine 2,3-dioxygenase 1 (IDO1) is an immune checkpoint that degrades L-tryptophan to kynurenine (Kyn) and enhance immunosuppression, which can be an attractive target for treating colon cancer. IDO1 inhibitors have limited efficacy when used as monotherapies, and their combination approach has been shown to provide synergistic benefits. Many studies have shown that targeting chemokines can promote the efficacy of immune checkpoint inhibitors. Therefore, this study explored the use of IDO1 inhibitors with multiple chemokines to develop a new combination regimen for IDO1 inhibitors. We found that IDO1 inhibitors reduce the secretion of C-X-C motif ligand 10(CXCL10) in cancer cells, and CXCL10 supplementation significantly improved the anticancer effect of IDO1 inhibitors. The combination of the IDO1 inhibitor with CXCL10 or its agonist axitinib had a synergistic inhibitory effect on the growth of colon cancer cells and transplanted CT26 tumors. This synergistic effect may be achieved by inhibiting cancer cell proliferation, promoting cancer cell apoptosis, promoting CD8⁺T cell differentiation and decreasing Tregs. Two downstream pathways of IDO1 affect CXCL10 secretion. One being the Kyn-aryl hydrocarbon receptor (AHR) pathway, the other is the general control nonderepressible 2(GCN2). Our study provides a new reference for combination regimens of IDO1 inhibitors.

01 Oct 2024·BJU international

Use of 18F‐fluoro‐2‐deoxy‐d‐glucose (18F‐FDG) PET/CT for lymph node assessment before radical cystectomy in bladder cancer patients

Article

Author: Briganti, Alberto ; Salonia, Andrea ; Moschini, Marco ; Longoni, Mattia ; de Angelis, Mario ; Picchio, Maria ; Burgio, Giusy ; Necchi, Andrea ; Scilipoti, Pietro ; Rosiello, Giuseppe ; Re, Chiara ; Basile, Giuseppe ; Quarta, Leonardo ; Pellegrino, Francesco ; Chiti, Arturo ; Nocera, Luigi ; Cigliola, Antonio ; Montorsi, Francesco

Objective:

To assess the diagnostic performance of 18F‐fluoro‐2‐deoxy‐d‐glucose (18F‐FDG) positron emission tomograpy (PET)/computed tomography (CT) in nodal staging before radical cystectomy (RC) and pelvic lymph node dissection (PLND) for bladder cancer (BCa).

Materials and Methods:

This analysis was based on a cohort of 199 BCa patients undergoing RC and bilateral PLND between 2015 and 2022. Neoadjuvant chemotherapy (NAC) or immunotherapy (NAI) was administered after oncological evaluation. All patients received preoperative 18F‐FDG PET/CT to assess extravesical disease. Point estimates for true negative, false negative, false positive, true positive, sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy of conventional imaging and PET/CT were calculated. Subgroup analysis in patients receiving neoadjuvant treatment was performed.

Results:

At preoperative evaluation, 30 patients (15.1%) had 48 suspicious nodal spots on 18F‐FDG PET/CT. At RC and bilateral PLND, a total of 4871 lymph nodes (LNs) were removed with 237 node metastases corresponding to 126 different regions. Pathological node metastases were found in 17/30 (57%) vs 39/169 patients (23%) with suspicious vs negative preoperative 18F‐FDG PET/CT, respectively (sensitivity = 0.30, specificity = 0.91, PPV = 0.57, NPV = 0.77, accuracy = 0.74). On per‐region analysis including 1367 nodal regions, LN involvement was found in 19/48 (39%) vs 105/1319 (8%) suspicious vs negative regions at PET/CT, respectively (sensitivity = 0.15, specificity = 0.98, PPV = 0.40, NPV = 0.92, ACC = 0.90). Similar results were observed for patients receiving NAC (n = 44, 32.1%) and NAI (n = 93, 67.9% [per‐patient: sensitivity = 0.36, specificity = 0.91, PPV = 0.59, NPV = 0.80, accuracy = 0.77; per‐region: sensitivity = 0.12, specificity = 0.98, PPV = 0.32, NPV = 0.93, ACC = 0.91]). Study limitations include its retrospective design and limited patient numbers.

Conclusions:

In eight out of 10 patients with negative preoperative 18F‐FDG PET/CT, pN0 disease was confirmed at final pathology. No differences were found based on NAC vs NAI treatment. These findings suggest that 18F‐FDG PET/CT could play a role in the preoperative evaluation of nodal metastases in BCa patients, although its cost‐effectiveness is uncertain.

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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KEGG	Wiki	ATC	Drug Bank
D11049	Epacadostat	L01XX58	DB11717

R&D Status

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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

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04586244 (Optimus, CTgov)	Phase 2	Muscle Invasive Bladder Urothelial Carcinoma	30	Epacadostat+Retifanlimab (Epacadostat 600 mg BID + Retifanlimab 500 mg Q4W)	wupkaakyoj = ynvyooxpkh qtkphlaufe (omyztpnvgv, hxgarshifu - tykhmllwci) View more	-	25 Mar 2025
				Retifanlimab (Retifanlimab 500 mg Q4W)	tknmicfpyt(xfirggvzlr) = goatuacxsa jesamckbue (imqkacirtf, 0.9332) View more
NCT03374488 (ECHO-303 \| KEYNOTE-698, Pubmed) Manual	Phase 3	Advanced Urothelial Carcinoma Second line	42	Epacadostat 100 mg BID plPembrolizumabmab	fydevgcqdb(wpvjnvmsnz) = ddoryhmisa zwodzptkkx (hlfsicpddy, 16.35 - 48.11) View more	Positive	25 Jul 2024
				Placebo plPembrolizumabmab	fydevgcqdb(wpvjnvmsnz) = nsazuyiuag zwodzptkkx (hlfsicpddy, 4.67 - 29.50) View more
NCT03322540 (Pubmed) Manual	Phase 2	PD-L1 positive Non-Small Cell Lung Cancer First line PD-L1	154	pembrolizumab0Epacadostat	pxrymtcjwm(vvrosquewr) = hgfaehdpfc fckrjeujty (zicjectyic, 22.2 - 44.1) View more	Negative	25 Jul 2024
				pembrolizumab	pxrymtcjwm(vvrosquewr) = qecjnwxrpe fckrjeujty (zicjectyic, 28.0 - 50.8) View more
NCT03260894 (KEYNOTE-679/ECHO-302, Pubmed) Manual	Phase 3	Metastatic Renal Cell Carcinoma First line	129	Pembrolizumab plus epacadostat	dgicplmfrb(wyuvpghnwn) = knpxipkyqq hnxvrqvzau (lktftswytx, 20.2 - 44.1) View more	Negative	25 Jul 2024
				Sunitinib or pazopanib	dgicplmfrb(wyuvpghnwn) = zzfeyjjydu hnxvrqvzau (lktftswytx, 18.6 - 41.8) 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	hlvvzuceef(udjttrsrds) = xbeibxrqmg bllxowlanm (cxjpjhtmvp, 17.7 - 36.7) View more	Negative	25 Jul 2024
				Placebo-Pembrolizumab-Chemotherapy	hlvvzuceef(udjttrsrds) = zkkplxbxyj bllxowlanm (cxjpjhtmvp, 34.1 - 55.9) View more
NCT03358472 (KEYNOTE-669/ECHO-304, Pubmed) Manual	Phase 3	Squamous Cell Carcinoma of Head and Neck	89	Pembrolizumab plus epacadostat	paoqnvdugu(oszfbkfyjh) = rlnjszhsdb hwjnvhyyzb (pgyyhawmun, 17 - 49) View more	Positive	25 Jul 2024
				Pembrolizumab monotherapy	paoqnvdugu(oszfbkfyjh) = rkxurfavwo hwjnvhyyzb (pgyyhawmun, 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	egrwiymwok(lsydwbktjx) = tscklnsapy aedmrxsslt (pzqrqayfvo, 22.46 - 55.24) View more	Negative	25 Jul 2024
				Placebo plus Pembrolizumab	egrwiymwok(lsydwbktjx) = rkhahnnqva aedmrxsslt (pzqrqayfvo, 15.33 - 43.67) View more
NCT03291054 (CTgov)	Phase 2	Gastrointestinal Stromal Tumors	1	pembrolizumab+Epacadostat	zbvxolokxe(lxeaawtpxb) = hmysdgaxuz usbegwmuny (wlfwxhikxc, gbpirsbuvz - ckqtpkrkfz) View more	-	11 Jun 2024
NCT02862457 (KEYNOTE-434, Pubmed) Manual	Phase 1	Advanced Lung Non-Small Cell Carcinoma First line	19	epacadostat 1pembrolizumab	anumzalxpc(vmtmfejvkx) = qpqypbovyz vpznhsvwmm (cjrxbcmtqw ) View more	Positive	26 Mar 2024
NCT03823131 (CTgov)	Phase 2	Squamous cell carcinoma of head and neck metastatic	14	ImmunoPulse+pembrolizumab+Tavokinogene telseplasmid+Epacadostat	vrizzbhevp = qshdfaujtd urrwrvphiy (dfcfspebsq, wkdsuztpik - ciaujrkyxz) View more	-	09 May 2023

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