NextHERIZON: an Open-Label, Signal Generating, Phase 2 Study of HER-Vaxx in Combination with Chemotherapy or Pembrolizumab in Patients with Metastatic HER2/Neu Over-Expressing Gastric or Gastroesophageal Junction (GEJ) Adenocarcinomas Who Have Previously Received Trastuzumab and Progressed on This Treatment

This is a Phase 2, signal generating, open-label, 2-Arm, non-randomized study, in patients with metastatic HER2/neu over-expressing gastric cancer or gastroesophageal adenocarcinomas.

Start Date17 Aug 2022

Sponsor / Collaborator

Imugene Ltd.

CTRI/2019/04/018775

/ Not yet recruitingPhase 2

A Phase 1b/2 Open-label Study with randomization in Phase 2 of IMU-131 HER2/neu Peptide Vaccine Plus Standard of Care Chemotherapy in Patients with HER2/neu Overexpressing Metastatic or Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction. - IMU-131

Start Date09 Sep 2019

Sponsor / Collaborator

Imugene Ltd.

NCT02795988

/ CompletedPhase 1/2

A Phase 1b/2 Open-Label Study With Randomization in Phase 2 of IMU-131 HER2/Neu Peptide Vaccine Plus Standard of Care Chemotherapy in Patients With HER2/Neu Overexpressing Metastatic or Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction

The Phase 1b study is an open-label, multicenter dose escalation study designed to assess the safety, tolerability, immunogenicity and recommended phase 2 dose (RP2D) of IMU-131. The RP2D will be evaluated in the dose expansion Phase 2 study. The Phase 2 study is a randomized, open label comparison of IMU-131 plus standard of care chemotherapy versus standard of care chemotherapy alone.

Start Date30 Aug 2017

Sponsor / Collaborator

Imugene Ltd.

100 Clinical Results associated with HER2 cancer vaccine(Pevion Biotech AG)

100 Translational Medicine associated with HER2 cancer vaccine(Pevion Biotech AG)

100 Patents (Medical) associated with HER2 cancer vaccine(Pevion Biotech AG)

Literatures (Medical) associated with HER2 cancer vaccine(Pevion Biotech AG)

13 Sep 2024·Clinical Cancer Research

Phase II Trial of HER-Vaxx, a B-cell Peptide-Based Vaccine, in HER2-Overexpressing Advanced Gastric Cancer Patients Under Platinum-Based Chemotherapy (HERIZON)

Article

Author: Wiedermann, Ursula ; Chawla, Tanuj ; Chong, Leslie Mi Ok ; Nikolić, Ivan ; Petrović, Zoran ; Ryspayeva, Dinara ; Yavrom, Sharon ; Nixon, Bonnie ; Ede, Nicholas J. ; Kundi, Michael ; Andrić, Zoran ; Maglakelidze, Marina ; Bulat, Iurie ; Garner-Spitzer, Erika ; Zielinski, Christoph C. ; Nagarkar, Rajnish ; Tobias, Joshua

AbstractPurpose:A multicenter, randomized, open-label, phase II study (HERIZON; NCT02795988) was conducted to evaluate the clinical and immunologic efficacy of HER-Vaxx (IMU-131), a B-cell, peptide-based vaccine targeting HER2 overexpressed in 6% to 30% of gastroesophageal adenocarcinomas (GEA).Patients and Methods:Patients (n = 36) with GEA were treated with standard-of-care chemotherapy (n = 17) or HER-Vaxx plus chemotherapy (n = 19), using the recommended phase 2 dose for the vaccine. Overall survival (OS; primary endpoint), safety, progression-free survival (PFS), clinical response (secondary endpoints), and vaccine-induced HER2-specific antibody levels in serum and correlation with tumor response rates (exploratory endpoints) were investigated.Results:A 40% OS benefit [HR, 0.60; median OS, 13.9 months; 80% confidence interval (CI), 7.52–14.32] for patients treated with HER-Vaxx plus chemotherapy compared with OS of 8.31 months (80% CI, 6.01–9.59) in patients that received chemotherapy alone. A 20% PFS difference was obtained for the vaccination arm (HR, 0.80; 80% CI, 0.47, 1.38). No additional toxicity due to HER-Vaxx was observed. The vaccine-induced high levels of HER2-specific total IgG and IgG1 antibodies (P < 0.001 vs. controls) that significantly correlated with tumor reduction (IgG, P = 0.001; IgG1, P = 0.016), had a significant capacity in inhibiting phosphorylation of the intracellular HER2-signaling pathways, mediated antibody-dependent cellular cytotoxicity, and decreased immunosuppressive FOXP3+ regulatory T cells.Conclusions:HER-Vaxx plus standard chemotherapy exhibits an excellent safety profile and improves OS. Furthermore, vaccine-induced immune response was significantly associated with reduced tumor size compared with standard-of-care chemotherapy. The presented vaccination approach may substitute for treatment with trastuzumab, upon unavailability or toxicity, based on further evidence of equivalent treatment efficacy.

01 Jul 2021·Clinical Cancer Research

Clinical and Immunologic Responses to a B-Cell Epitope Vaccine in Patients with HER2/neu-Overexpressing Advanced Gastric Cancer—Results from Phase Ib Trial IMU.ACS.001

Article

Author: Chou, Wen-Chi ; Drinic, Mirjana ; Marino, Mark T. ; Yen, Chia-Jui ; Ungtrakul, Teerapat ; Maglakelidze, Marina ; Sookprasert, Aumkhae ; Tanasanvimon, Suebpong ; Bulat, Iurie ; Yau, Thomas Cheung ; Charoentum, Chaiyut ; Zielinski, Christoph C. ; Tobias, Joshua ; Chong, Leslie ; Bai, Li-Yuan ; Arpornwirat, Wichit ; Chao, Yee ; Good, Anthony J. ; Dechaphunkul, Arunee ; Maneechavakajorn, Jedzada ; Wiedermann, Ursula ; Garner-Spitzer, Erika ; Ede, Nicholas J.

AbstractPurpose:HER2/neu is overexpressed in up to 30% of gastroesophageal adenocarcinomas (GEA) and linked to poor prognosis. Recombinant mAbs to treat HER2/neu-overexpressing cancers are effective with limitations, including resistance and toxicity. Therefore, we developed a therapeutic B-cell epitope vaccine (IMU-131/HER-Vaxx) consisting of three fused B-cell epitopes from the HER2/neu extracellular domain coupled to CRM197 and adjuvanted with Montanide. This phase Ib study aimed to evaluate the optimal/safe dose leading to immunogenicity and clinical responses (https//clinicaltrials.gov/ct2/show/NCT02795988).Patients and Methods:A total of 14 patients with HER2/neu-overexpressing GEA were enrolled, and dose escalation (10, 30, 50 μg) was performed in three cohorts (C). Immunogenicity was evaluated by HER2-specific Abs and cellular responses, clinical responses by CT scans according to RECIST version 1.1.Results:IMU-131 was safe without vaccine-related significant local/systemic reactions or serious adverse events. A total of 11 of 14 patients were evaluable for changes in tumor size and vaccine-specific immune responses. One patient showed complete, 5 partial responses, and 4 stable diseases as their best response. HER2-specific IgG levels were dose dependent. In contrast to patients in C1 and C2, all patients in C3 mounted substantial HER2-specific Ab levels. In addition, cellular vaccine responses, such as Th1-biased cytokine ratios and reduced regulatory T cell numbers, were generated. Progression-free survival was prolonged in C3, correlating with the vaccine-specific humoral and cellular responses.Conclusions:IMU-131 was well tolerated and safe. The induced HER2-specific Abs and cellular responses were dose dependent and correlated with clinical responses. The highest dose (50 μg) was recommended for further evaluation in a phase II trial, with chemotherapy + IMU-131 or chemotherapy alone, which is currently ongoing.

01 Jul 2019·Annals of Oncology

A phase 1b study of IMU-131 her2/neu peptide vaccine plus chemotherapy in patients with HER2/neu overexpressing metastatic or advanced adenocarcinoma of the stomach or gastroesophageal junction

Article

Author: Yau, T ; Charoetum, C ; Maneechavakajon, J ; Chou, W ; Good, A ; Yen, C ; Loong, H ; Ede, N ; Lausoontornsiri, W ; Bulat, I ; Tanasanvimon, S ; Ungtrakul, T ; Chao, Y ; Bai, L ; Maglakelidze, M ; Arpornwirat, W ; Chong, L

Abstract Background HER2/neu is overexpressed in 15% - 25% of gastric cancers. IMU-131 is a B-cell peptide vaccine composed of 3 epitopes of the extracellular domain of HER2/neu. Antibodies against IMU-131 peptides elicit antitumor activity in vitro and a phase I study demonstrated safety and immunogenicity in Her-2 +/ ++ breast cancer patients. Methods IMU-131 was given to patients with HER2/neu positive gastric cancer in an open-label phase 1b dose escalation trial with 14 Asian and Eastern European sites. Each patient received IMU-131 on Days 0, 14, and 35, with cisplatin and 5-fluorouracil or capecitabine every 21 days. Patients remained on study until disease progression. Ongoing patients received boosters at D98 then every 84 days. Results 14 patients were enrolled with 10 HER2 overexpressing (7 x HER2 +++, 3 x HER2 ++ FISH positive) and 4 HER2 ++ expressing tumors. Mean age was 57 yo (range of 21 - 79) with ECOG scores of 0 or 1 in 7 patients each. There were 9 Asian and 5 Caucasian patients with 5 females and 9 males. Dose levels were 10, 30 and 50 µg with 3, 6, and 5 patients respectively. 11 patients received all 3 doses and 3 patients received only 2 doses due to disease progression. P467 and HER2 antibodies were generated at all dose levels with patients dosed at 50µg responding to the vaccine with equally high antibody levels. There were no DLTs or SAEs related to IMU-131. Of the 14 patients dosed 11 were evaluable for tumor progression at day 56 and later. Of those patients, the best response was 1 CR, 5 PR, 4 SD and 1 PD. Two patients, both dosed at 50µg IMU-131, remain on study after D266, with one patient’s tumor reduced by approximately 80% from 177mm at baseline to 37mm at D266. Conclusions Safety data indicate that IMU-131 is well tolerated with no significant local or systemic reactions. There were no dose-limiting toxicities observed, no significant injection site reactions and no IMU-131 related SAEs. The 50µg dose produced the most consistent P467 and HER-2 specific antibodies compared to 10 and 30µg doses with preliminary response data demonstrating 50µg of IMU-131 is associated with tumor size reduction. The 50µg dose of IMU-131 is being used in the phase 2 study. Clinical trial identification Identifier: NCT02795988. Legal entity responsible for the study Imugene Ltd. Funding Imugene Ltd. Disclosure N. Ede: Full / Part-time employment: Imugene. L. Chong: Full / Part-time employment, Officer / Board of Directors: Imugene. A. Good: Full / Part-time employment: Imugene. All other authors have declared no conflicts of interest.

News (Medical) associated with HER2 cancer vaccine(Pevion Biotech AG)

09 Apr 2024

·www.globenewswire.com

Imugene's oncolytic virotherapy VAXINIA and B cell immunotherapy HER-Vaxx featured at the AACR Annual Meeting 2024

Oncolytic virus CF33-hNIS (VAXINIA) alone or in combination with KEYTRUDA is a safe treatment option for advanced cancer patients.Encouraging VAXINIA efficacy, including a complete response (CR) and two partial responses (PRs), has warranted cohort expansions in biliary tract cancer and other tumour types.Compared to chemotherapy alone, vaccination with HER-Vaxx was associated with a 40% overall survival benefit.HER-Vaxx induced HER2-specific antibody levels correlate with tumour reduction. SYDNEY, Australia, April 09, 2024 (GLOBE NEWSWIRE) -- Imugene Limited (ASX: IMU), a clinical stage immuno-oncology company, is pleased to announce poster presentations featuring its CF33 oncolytic virotherapy VAXINIA and B cell immunotherapy HER-Vaxx at the American Association for Cancer Research (AACR) Annual Meeting 5-10 April 2024, in San Diego, CA. Daneng Li, M.D., a City of Hope associate professor in the Department of Medical Oncology & Therapeutics Research commented, “The results show that our novel oncolytic virus — both alone or in combination with immunotherapy — has the ability to control various cancer types previously resistant to other treatment options, and these early results provide patients with hope of a new treatment option for cancers refractory to standard treatment.” Imugene Managing Director & CEO Leslie Chong said: "Preliminary data from the MAST trial demonstrates encouraging anti-tumour activity with our oncolytic virus CF33-hNIS (VAXINIA). Notably, one patient with cholangiocarcinoma, or biliary tract cancer, achieved an immunological complete response (CR), meaning the disappearance of all signs of their cancer after treatment with VAXINIA, with no known recurrence after one year. These encouraging results warrant further investigation in patients will biliary tract cancer and other cancers. In addition, further analysis of the T cell repertoire reveals that T cell diversity may serve a predictive biomarker, which can be used to prospectively identify appropriate patients for treatment.” Details on the poster presentations are below: Presentation Title: Oncolytic virus CF33-hNIS for the treatment of advanced cancerAbstract Presentation Number: CT182Session Date and Time: Tuesday April 9, 2024, 9:00 AM - 12:30 PM PTSession Title: First-in-Human Phase I Clinical Trials 2Presenter: Daneng Li, MD Highlights include: At the data cut-off of 19 December 2023, there were 31 efficacy-evaluable patients in the MAST study. In the intratumoural (IT) cohorts, 7 of 16 (44%) injected lesions had a reduction in tumour burden and 3 lesions were completely eradicated. Three of the IT treated patients had an objective response: 1 complete response by iRECIST in a patient with cholangiocarcinoma and 2 partial responses by RECIST in patients with melanoma. In the intravenous (IV) cohorts, 9 of 17 (53%) patients achieved stable disease as their best response. Patients who received prior checkpoint blockade therapy derived clinical benefit with and without pembrolizumab. Viral replication, assessed by SPECT, was higher in patients who had a reduction in tumour burden.Patients with a higher level of T cell diversity in peripheral blood (pre-treatment) respond better to VAXINIA therapy, consistent with the known mechanism of action of oncolytic virotherapies and their ability to promote an anti-tumour T cell response.Both IT- and IV-treated patients have promising immunological changes in on-treatment tumour biopsies (including increases in cancer fighting CD8 T cells and PD-L1 expression) indicated that VAXINIA can transform the tumour microenvironment.Several patients have had prior treatment with checkpoint blockade, including a stable disease cholangiocarcinoma patient and two melanoma partial response patients. This suggests that VAXINIA +/- checkpoint inhibitor combination could be used in the checkpoint therapy refractory setting, which is seeing a growing and unmet market in oncology, by altering the tumour microenvironment. Presentation Title: Frontline vaccination with the B-cell peptide compound HER-Vaxx (IMU-131), combined with standard-of-care chemotherapy induces high levels of HER2-specific antibodies mediating ADCC and intracellular phosphorylation inhibition resulting in overall survival benefit in patients with HER2+ metastatic or advanced gastric/GEJ adenocarcinoma – Final results from Phase II/HERIZON studyPoster Number: CT215Session Date and Time: Tuesday April 9, 2024, 9:00 AM - 12:30 PM PTSession Title: Phase II Clinical Trials 1Presenter: Joshua Tobias Ph.D. Highlights include: HER-Vaxx treatment produced robust anti-HER2-IgG and IgG1 antibody response (p<0.001).HER-Vaxx induced HER2-specific antibodies able to mediate antibody-dependent cell cytotoxicity (ADCC) and inhibit intracellular HER2 phosphorylation and correlated with tumour reduction.The HER-Vaxx induced HER2-specific antibodies demonstrate a similar mechanism of action to HERCEPTINâ validating B cell immunotherapy as an alternative anti-cancer agent to monoclonal antibodies. About the MAST TrialThe multicenter Phase 1 MAST trial commenced by delivering a low dose of VAXINIA to patients with metastatic or advanced solid tumours who have had at least two prior lines of standard of care treatment. The City of Hope-developed oncolytic virus has been shown to shrink colon, lung, breast, ovarian and pancreatic cancer tumours in preclinical laboratory and animal models¹. Overall, the study aims to recruit cancer patients across approximately 10 trial sites in the United States and Australia. The clinical trial is titled “A Phase I, Dose Escalation Safety and Tolerability Study of VAXINIA (CF33- hNIS), Administered Intratumorally or Intravenously as a Monotherapy or in Combination with Pembrolizumab in Adult Patients with Metastatic or Advanced Solid Tumours (MAST).” The trial commenced in May 2022 and is anticipated to run for approximately 24 months while being funded from existing budgets and resources. Full study details can also be found on clinicaltrials.gov under study ID: NCT05346484. For more information please contact: Leslie ChongManaging Director and Chief Executive Officerinfo@imugene.com Investor Enquiriesshareholderenquiries@imugene.com U.S Investor EnquiriesHeather Armstrongharmstrong@imugene.com Media EnquiriesMatt Wright matt@nwrcommunications.com.au Connect with us on LinkedIn @Imugene Limited Follow us on Twitter @TeamImugene Watch us on YouTube @ImugeneLimited Join us on InvestorHub; investorhub.imugene.com About Imugene (ASX:IMU) Imugene is a clinical stage immuno-oncology company developing a range of new and novel immunotherapies that seek to activate the immune system of cancer patients to treat and eradicate tumours. Our unique platform technologies seek to harness the body’s immune system against tumours, potentially achieving a similar or greater effect than synthetically manufactured monoclonal antibody and other immunotherapies. Our pipeline includes an off-the-shelf (allogeneic) cell therapy CAR T drug azer-cel (azercabtagene zapreleucel) which targets CD19 to treat blood cancers. Our pipeline also includes multiple immunotherapy B-cell vaccine candidates and an oncolytic virotherapy (CF33) aimed at treating a variety of cancers in combination with standard of care drugs and emerging immunotherapies such as CAR T’s for solid tumours. We are supported by a leading team of international cancer experts with extensive experience in developing new cancer therapies with many approved for sale and marketing for global markets. Our vision is to help transform and improve the treatment of cancer and the lives of the millions of patients who need effective treatments. This vision is backed by a growing body of clinical evidence and peer-reviewed research. Imugene is well funded and resourced, to deliver on its commercial and clinical milestones. Together with leading specialists and medical professionals, we believe Imugene’s immuno-oncology therapies will become foundation treatments for cancer. Our goal is to ensure that Imugene and its shareholders are at the forefront of this rapidly growing global market. Release authorised by the Managing Director and Chief Executive Officer Imugene Limited.

Clinical ResultImmunotherapyPhase 1AACRPhase 2

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

22 Mar 2022

·www.biospace.com

Merck’s Keytruda Adds Advanced Endometrial Carcinoma to Winning Roster

Courtesy of Kena Betancur/Getty Images Merck’s Keytruda has become an approved treatment for yet another indication: unresectable or metastatic advanced endometrial carcinoma. Know more about it here. Keytruda is an approved treatment for endometrial carcinoma. (Courtesy of Kena Betancur/Getty Images) Merck ’s Keytruda (pembrolizumab) has become a Food and Drug Administration (FDA) -approved treatment for yet another indication- unresectable or metastatic advanced endometrial carcinoma that is microsatellite instability-high or mismatch repair (MSI-H or dMMR). This announcement adds another win to Merck’s trophy case, as the biologic has already impressed the biopharmaceutical industry with an extensive array of indications, including for three other gynecological cancers. Keytruda is an anti-programmed death receptor therapy that utilizes monoclonal antibodies to block interactions between PD-1 and ligands. This interaction typically results suppresses T lymphocyte activation, allowing the proliferation of tumor cells. Patients must have attempted systemic therapy treatments without success and cannot be candidates for curative surgery or radiation. About the Trial of Keytruda for Endometrial Carcinoma The KEYNOTE-158 Phase II trial ( NCT02628067 ) is a non-randomized, open-label trial that spans 27 study locations and involves various cohorts to evaluate Keytruda intervention of a multitude of advanced solid tumors. The cohort of endometrial carcinoma patients is comprised of 90 patients aged between 35 and 56 and resulted in a 46% treatment response rate. The treatment regimen included an intravenous injection every three weeks for up to two years, so long as the patient did not display signs of disease progression or toxicity. Patients underwent an average of 8.3 months of treatment before reaching either of these points. For 68% of the patients who responded to treatment, the positive physiological response continued for at least 12 months, with a smaller cohort experiencing 24 months of response. The classification of endometrial carcinoma as MSI-H or dMMR accounts for 30% of cases. Previously, combination therapy with lenvatinib was approved, indicated for advanced endometrial carcinoma that is not categorized as MSI-H or dMMR. Over 65,000 women are diagnosed with endometrial carcinoma, and 12,500 fatalities are attributed to the disease annually. Endometrial carcinoma is the most prevalent of uterine cancers. Along with endometrial carcinoma, Keytruda has been approved for treatment of non-small cell lung cancer, unresectable or metastatic melanoma, recurrent head and neck squamous cell carcinoma, Hodgkin lymphoma, B-cell lymphoma, urothelial carcinoma, non-muscle-invasive bladder cancer and microsatellite instability-high or mismatch repair deficient cancer. Additionally, ongoing clinical trials are investigating Keytruda indicated for ovarian cancer, triple-negative breast cancer, metastatic castration-resistant prostate cancer , advanced-stage lung cancer, renal cell carcinoma and solid tumors with certain biomarkers. The biologic will likely continue to impress, as it is involved in over 1,700 clinical trials, evaluating how broad the treatment can reach. Humanized monoclonal antibody treatments such as Keytruda have been heavily represented in the news since the onset of the COVID-19 pandemic, as the immunotherapeutic mechanism works to heighten the body’s immune response. Other than using it to treat endometrial carcinoma, a Phase II collaboration with Imugene was also announced last week that will investigate the safety and efficacy of Keytruda in combination with Imugene’s HER-Vaxx., an immunotherapeutic B-cell activator. The collaboration, nextHERIZON, seeks to gather data on how patients with metastatic HER-2/neu over-expressing of gastroesophageal junction adenocarcinomas respond to the combination therapy. Keytruda has been granted Orphan Drug Designation for research into rare cancers, in exchange for market exclusivity that aids in Merck’s financial successes.

Clinical ResultPhase 2Orphan DrugImmunotherapyDrug Approval

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R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Adenocarcinoma	Phase 2	Ukraine	Imugene Ltd.	30 Aug 2017
Adenocarcinoma	Phase 2	Georgia	Imugene Ltd.	30 Aug 2017
HER2 positive Gastrooesophageal junction cancer	Phase 2	Georgia	Imugene Ltd.	30 Aug 2017
HER2 positive Gastrooesophageal junction cancer	Phase 2	Ukraine	Imugene Ltd.	30 Aug 2017
HER2 positive Gastrooesophageal junction cancer	Phase 2	Taiwan Province	Imugene Ltd.	30 Aug 2017
HER2 positive Gastrooesophageal junction cancer	Phase 2	Serbia	Imugene Ltd.	30 Aug 2017
HER2 positive Gastrooesophageal junction cancer	Phase 2	India	Imugene Ltd.	30 Aug 2017
HER2 positive Gastrooesophageal junction cancer	Phase 2	United States	Imugene Ltd.	30 Aug 2017
HER2 positive Gastrooesophageal junction cancer	Phase 2	Thailand	Imugene Ltd.	30 Aug 2017
Gastrooesophageal junction cancer	Phase 2	United States	Imugene Ltd.	-

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02795988 (HERIZON \| P-159 HERIZON, CTgov)	Phase 1/2	Adenocarcinoma \| HER2 positive Gastrooesophageal junction cancer \| HER2-positive gastric cancer	64	IMU-131 (Phase 1b: 10 μg IMU-131 Plus Chemotherapy)	ztkdmqtqap(mdzvoqnmjj) = jnttafnmys bixvvytium (cskiwrzqks, oxaoinpsph - sdynkblmqs) View more	-	16 Apr 2025
				IMU-131 (Phase 1b: 30 μg IMU-131 Plus Chemotherapy)	ztkdmqtqap(mdzvoqnmjj) = ccomllbejm bixvvytium (cskiwrzqks, eqcqagbjdm - byvkokgvwo) View more
NCT02795988 (HERIZON, ESMO2024) Manual	Phase 2	HER2 positive Gastrooesophageal junction cancer HER2-overexpressing	36	HER-Vaxx plus chemotherapy	(wvndyyzzoa) = jushfrxmgf wdjgdawezq (xcyheatnrm, 7.52 - 14.32)	Positive	16 Sep 2024
				Chemotherapy alone	(wvndyyzzoa) = rqwyklvade wdjgdawezq (xcyheatnrm, 6.01 - 9.59)
NCT02795988 (HERIZON, AACR2024) Manual	Phase 2	HER2 positive Gastroesophageal Junction Adenocarcinoma \| HER2 Positive Stomach Adenocarcinoma	36	HER-Vaxx plus chemotherapy	(gbshhqpwbh) = fxzmpxyqjq turdlqtheg (haetsbwbjh, 7.5 - 14.3)	Positive	05 Apr 2024
				Chemotherapy alone	(gbshhqpwbh) = vwkaltndbm turdlqtheg (haetsbwbjh, 6.0 - 9.6)
NCT02795988 (HERIZON, ASCO_GI2023) Manual	Phase 2	HER2-positive gastric cancer \| HER2 positive Gastroesophageal Junction Adenocarcinoma HER2-overexpressing	32	HER-Vaxx 50 µg+chemotherapy	(ghpocdwshv) = bxxdrvwmmx akecojhyum (vteglkcecl ) View more	Positive	24 Jan 2023
				chemotherapy	(ghpocdwshv) = ucfcdebjfg akecojhyum (vteglkcecl ) View more
NCT02795988 (HERIZON, ESMO_ASIA2022) Manual	Phase 1/2	Metastatic HER2 positive gastroesophageal junction cancer HER2 overexpressing	36	IMU-131+chemotherapy	(zsocepxqfu) = yuzqolbxyy brefvegijp (wxrknfjcrd ) View more	Positive	04 Dec 2022
				chemotherapy	(zsocepxqfu) = cdbpdgkbne brefvegijp (wxrknfjcrd )
NCT02795988 (P-159 HERIZON, ESMO_GI2021)	Phase 2	HER2-expressing Gastroesophageal Junction Adenocarcinoma HER2/neu overexpressing	27	HER-Vaxx plus standard chemotherapy	(jflpvodwas): HR = 0.418 (80% CI, 0.186 - 0.942), P-Value = 0.083 View more	Positive	03 Jul 2021
				Standard chemotherapy alone
NCT02795988 (ASCO 12019 \| ASCO 22019) Manual	Phase 1	Advanced Gastric Adenocarcinoma HER2/neu Overexpression	14	chemotherapy+HER2 cancer vaccine	(fmbunqqzhe) = none deodglvebn (qyqxrilgwt ) View more	Positive	03 Jun 2019

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