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 / Active, not recruitingPhase 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)

31 Dec 2022·Oncoimmunology

A newly discovered PD-L1 B-cell epitope peptide vaccine (PDL1-Vaxx) exhibits potent immune responses and effective anti-tumor immunity in multiple syngeneic mice models and (synergizes) in combination with a dual HER-2 B-cell vaccine (B-Vaxx)

Article

Author: Overholser, Jay ; Ede, Nicholas J. ; Darby, Heather ; Kaumaya, Pravin T.P ; Guo, Linlin

Blockade of checkpoint receptors with monoclonal antibodies against CTLA-4, PD-1 and PD-L1 has shown great clinical success in several cancer subtypes, yielding unprecedented responses albeit a significant number of patients develop resistance and remain refractory. Both PD-1/PD-L1 and HER-2 signaling pathway inhibitors have limited efficacy and exhibits significant toxicities that limit their use. Ongoing clinical studies support the need for rationale combination of immuno-oncology agents to make a significant impact in the lives of cancer patients. We introduce the development of a novel chimeric PD-L1 B-cell peptide epitope vaccine (amino acid 130-147) linked to a "promiscuous" T cell measles virus fusion (MVF) peptide (MVF-PD-L1(130); PDL1-Vaxx) or linked to tetanus toxoid (TT3) TT3-PD-L1 (130) via a linker (GPSL). These vaccine constructs are highly immunogenic and antigenic in several syngeneic animal models. The PD-L1 vaccines elicited high titers of polyclonal antibodies that inhibit tumor growth in multiple syngeneic cancer models, eliciting antibodies of different subtypes IgG1, IgG2a, IgG2b and IgG3, induced PD-1/PD-L1 blockade, decreased proliferation, induced apoptosis and caused ADCC of tumor cells. The PDL1-Vaxx induces similar inhibition of tumor growth versus the standard anti-mouse PD-L1 antibody in both syngeneic BALB/c and C57BL/6J mouse models. The combination of PDL1-Vaxx with HER-2 vaccine B-Vaxx demonstrated synergistic tumor inhibition in D2F2/E2 carcinoma cell line. The anti-PDL1-Vaxx block PD-1/PD-L1 interaction and significantly prolonged anti-tumor responses in multiple syngeneic tumor models. The combination of HER-2 vaccine (B-Vaxx) with either PDL1-Vaxx or PD1-Vaxx demonstrated synergistic tumor inhibition. PDL1-Vaxx is a promising novel safe checkpoint inhibitor vaccine.

01 Jul 2021·Clinical cancer research : an official journal of the American Association for 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: Tobias, Joshua ; Zielinski, Christoph C. ; Marino, Mark T. ; Yen, Chia-Jui ; Yau, Thomas Cheung ; Chou, Wen-Chi ; Chong, Leslie ; Maneechavakajorn, Jedzada ; Good, Anthony J. ; Drinic, Mirjana ; Dechaphunkul, Arunee ; Chao, Yee ; Tanasanvimon, Suebpong ; Sookprasert, Aumkhae ; Bulat, Iurie ; Maglakelidze, Marina ; Bai, Li-Yuan ; Ungtrakul, Teerapat ; Ede, Nicholas J. ; Arpornwirat, Wichit ; Wiedermann, Ursula ; Garner-Spitzer, Erika ; Charoentum, Chaiyut

Abstract:

Purpose::

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·Cancer immunology, immunotherapy : CIIQ2 · MEDICINE

An HER2 DNA vaccine with evolution-selected amino acid substitutions reveals a fundamental principle for cancer vaccine formulation in HER2 transgenic mice

Q2 · MEDICINE

Article

Author: Gibson, Heather M ; Wei, Wei-Zen ; Jones, Richard F ; Jacob, Jennifer B ; Chen, Kang ; Reyes, Joyce D ; Vaishampayan, Ulka ; Ratner, Stuart

Enhancement of endogenous immunity to tumor-associated self-antigens and neoantigens is the goal of preventive vaccination. Toward this goal, we compared the efficacy of the following HER2 DNA vaccine constructs: vaccines encoding wild-type HER2, hybrid HER2 vaccines consisting of human HER2 and rat Neu, HER2 vaccines with single residue substitutions and a novel human HER2 DNA vaccine, ph(es)E2TM. ph(es)E2TM was designed to contain five evolution-selected substitutions: M198V, Q398R, F425L, H473R and A622T that occur frequently in 12 primate HER2 sequences. These ph(es)E2TM substitutions score 0 to 1 in blocks substitutions matrix (BLOSUM), indicating minimal biochemical alterations. h(es)E2TM recombinant protein is recognized by a panel of anti-HER2 mAbs, demonstrating the preservation of HER2 protein structure. Compared to native human HER2, electrovaccination of HER2 transgenic mice with ph(es)E2TM induced a threefold increase in HER2-binding antibody (Ab) and elevated levels of IFNγ-producing T cells. ph(es)E2TM, but not pE2TM immune serum, recognized HER2 peptide p95 ₃₅₅LPESFDGDPASNTAP₃₆₉, suggesting a broadening of epitope recognition induced by the minimally modified HER2 vaccine. ph(es)E2TM vaccination reduced tumor growth more effectively than wild-type HER2 or HER2 vaccines with more extensive modifications. The elevation of tumor immunity by ph(es)E2TM vaccination would create a favorable tumor microenvironment for neoantigen priming, further enhancing the protective immunity. The fundamental principle of exploiting evolution-selected amino acid substitutions is novel, effective and applicable to vaccine development in general.

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

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

17 Nov 2021

·www.biospace.com

Imugene Announces Clinical Trial Supply Agreement with Merck KGaA, Darmstadt, Germany and Pfizer to Evaluate HER-Vaxx in Combination with Avelumab for Treatment of Gastric Cancer

New clinical trial supply agreement with Merck KGaA, Darmstadt, Germany and Pfizer Inc. Avelumab (BAVENCIO®) to be provided to Imugene for Phase 2 clinical study in HER-2 positive gastric or gastroesophageal junction adenocarcinomas (neoHERIZON) neoHERIZON will assess HER-Vaxx in combination with chemotherapy with or without avelumab in HER-2 positive gastric cancer SYDNEY, Australia., Nov. 17, 2021 (GLOBE NEWSWIRE) -- Imugene (ASX: IMU) today announced a new clinical trial supply agreement with Merck KGaA, Darmstadt, Germany (ETR: MRK) and Pfizer Inc. (NYSE: PFE) to evaluate the safety and efficacy of Imugene’s HER-Vaxx, a B-cell activating immunotherapy, in combination with avelumab, an immune checkpoint inhibitor targeting PD-L1, in patients with HER-2 positive gastric cancer. Avelumab, which is marketed as BAVENCIO®, is co-developed and co-commercialized by Merck KGaA, Darmstadt, Germany and Pfizer Inc. neoHERIZON is an open-label, multi-center, randomized, Phase 2 clinical trial designed to assess the safety and efficacy of perioperative HER-Vaxx combined with chemotherapy with or without avelumab compared to chemotherapy alone in patients with HER-2 positive gastric or gastroesophageal junction adenocarcinomas. The study’s primary endpoint is pathologic complete response. Secondary endpoints include safety and biomarker evaluation. “We are very excited for the opportunity to treat patients with this new generation of HER-2 targeted B-cell immunotherapy, which has the potential to address significant unmet need in early HER-2 overexpressing gastric cancer that remains a challenging indication with poor prognosis. The combination of chemotherapy and HER-Vaxx alone or in combination with avelumab in this type of gastric cancer may support a better treatment outcome for patients,” said Dirk Arnold M.D., Ph.D., Director of the Asklepios Tumorzentrum in Hamburg. “Imugene is excited to announce this collaboration with Merck KGaA, Darmstadt, Germany and Pfizer. HER-Vaxx has shown a tolerable safety pro encouraging efficacy in patients with metastatic HER-2 positive gastric cancer, and we are looking forward to evaluating HER-Vaxx with avelumab in the perioperative clinical setting,” said Leslie Chong, Managing Director & Chief Executive Officer of Imugene. “Working together, we’re committed to finding ways to address the unmet needs of patients living with cancer.” Effective immediately, under the terms of the agreement, Imugene will be the sponsor of the study and will fund the clinical study from existing budgets and resources. Merck KGaA, Darmstadt, Germany and Pfizer will provide avelumab for the duration of the study. About Gastric and Gastro-esophageal Cancer Perioperative (pre- and post-surgery) treatment in gastric or gastro-esophageal cancer remains an unmet need for patients with HER-2 positive tumours. The current standard of care is limited to chemotherapy, radiotherapy, and surgery when gastric cancer is diagnosed in its early stages. Immune checkpoint inhibitors have been successfully introduced to metastatic gastric cancer. Moving HER-Vaxx into earlier gastric cancer in combination with chemotherapy or an immune checkpoint inhibitor may improve treatment outcomes for patients with this difficult to treat cancer. About HER-Vaxx Imugene’s HER-Vaxx is a B-cell peptide cancer immunotherapy designed to treat tumours that over-express the HER-2/neu receptor, such as gastric, breast, ovarian, lung and pancreatic cancers. The immunotherapy is constructed from several B cell epitopes derived from the extracellular domain of HER-2/neu. It has been shown in pre-clinical studies and in Phase 1 and 2 studies to stimulate a potent polyclonal antibody response to HER-2/neu, a well-known and validated cancer target. For more information please contact: Leslie Chong Managing Director and Chief Executive Officer info@imugene.com Investor Enquiries investor@imugene.com Media Enquiries Matt Wright matt@nwrcommunications.com.au Follow us on Twitter @TeamImugene Like us on Facebook @Imugene Connect with us on LinkedIn @Imugene Limited 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 product pipeline 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, Level 3, 62 Lygon Street, Carlton, VIC, 3053, Australia

CollaborateAntibodyVaccineImmunotherapy

08 Jul 2021

·www.biospace.com

Imugene Cancer Vaccine Displays Promise in Gastric Tumors, Mid-Stage Data Shows

An investigational cancer vaccine is showing significant promise in reducing tumors and the risk of death. Data from a Phase II study shows the vaccine being developed by Imugene Limited improved survival rates and overall response in patients with HER2-positive stomach or gastroesophageal junction cancer. The data, presented earlier this month at the European Society for Medical Oncology (ESMO) World Congress on Gastrointestinal Cancer meeting, builds on interim data announced earlier this year. That data showed Imugene’s HER-Vaxx vaccine program showed a statistically significant overall survival of 58.2% compares to chemotherapy alone. Data showed that the experimental vaccine provided 14.2 months of additional overall survival compared to 8.8 months for patients on chemotherapy alone. Imugene said the updated Phase II data shows a clinical proof-of-concept signal for HER-Vaxx when added to chemotherapy. Additionally, the data indicate that B-cell activating immunotherapy vaccines can induce clinically active antibody responses. In its latest data presented at ESMO, Imugene showcased promising overall response rate data. The company said treatment with HER-Vaxx resulted in a 50% overall response rate than 29% of patients treated with chemotherapy alone. The data shows that inoculation with HER-Vaxx provides high levels of HER2-specific antibodies early in the treatment protocol. Those antibodies are maintained during treatment and maintenance phase with the use of booster doses. Imugene noted that tumor response in patients correlated with the number of antibody levels in patients. Those with levels higher than 1050ng/ml saw a 50% tumor reduction, which is much higher than those who received chemotherapy alone. Imugene said this could potentially serve as a biomarker for treatment. HER-Vaxx is a B-cell activating cancer immunotherapy that is designed to treat tumors that overexpress the HER-2/neu receptor. That type of tumor can be found in multiple cancers, including gastric, breast, ovarian, lung, and pancreatic cancers. Earlier this year, Imugene bolstered its pipeline with a novel CD19-expressing oncolytic virus licensed from the City of Hope. It will be developed in combination with a CD19-CAR T cell therapy. The goal of the combination therapy is for the CD19-expressing oncolytic virus to enable CD19-directed CAR-T to impact solid tumors. To date, CAR-T therapies have only been approved for use in blood-borne cancers. Imugene anticipates conducting a Phase I study of this combination immunotherapy in 2022. Under the terms of the agreement, Imugene gained worldwide rights to develop and commercialize the patents covering the CF33-CD19 oncolytic virus. The patents cover the cell therapy technology, which includes CF33-CD19 that tag cancer cells for CAR T cell destruction. Leslie Chong, managing director and chief executive officer of Imugene, said the new platform opens an entirely new space for cell therapy. “The CAR T cell field currently only treats ~10% of all cancers such as blood or liquid tumors, whereas this technology has the potential to open up the solid tumor market,” Chong said in a statement.

VaccineAntibodyCell TherapyImmunotherapy

100 Deals associated with HER2 cancer vaccine(Pevion Biotech AG)

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic Gastric Carcinoma	Phase 2	AU	Imugene Ltd.	17 Aug 2022
Metastatic Gastric Carcinoma	Phase 2	TW	Imugene Ltd.	17 Aug 2022
stomach adenocarcinoma	Phase 2	AU	Imugene Ltd.	17 Aug 2022
stomach adenocarcinoma	Phase 2	TW	Imugene Ltd.	17 Aug 2022
HER2-positive gastric cancer	Phase 2	US	Imugene Ltd.	30 Aug 2017
Metastatic Gastroesophageal Junction Adenocarcinoma	Phase 2	US	Imugene Ltd.	30 Aug 2017
Gastrooesophageal junction cancer	Phase 2	US	Imugene Ltd.	-

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02795988 (HERIZON, AACR2024) Manual	Phase 2	HER2 positive Gastroesophageal Junction Adenocarcinoma \| HER2 Positive Stomach Adenocarcinoma HER2 Positive	36	HER-Vaxx + chemotherapy	veanohwjiy(dgemycxfok) = dpglfmfkfg uhwwvrzvif (suhnfdahay, 7.5 - 14.3)	Positive	05 Apr 2024
				Chemotherapy	veanohwjiy(dgemycxfok) = hfmjdcbynq uhwwvrzvif (suhnfdahay, 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	mbnnznqsbl(cnijvlxxlz) = rvfwdtzlqb zvjropnsup (oykqkjlngw ) View more	Positive	24 Jan 2023
				chemotherapy	mbnnznqsbl(cnijvlxxlz) = tctaltblnv zvjropnsup (oykqkjlngw ) View more
NCT02795988 (HERIZON, ESMO_ASIA2022) Manual	Phase 1/2	Metastatic HER2 positive gastroesophageal junction cancer HER2 overexpressing	36	IMU-131+chemotherapy	oaykfogkbm(zjgxdkyrpf) = hhruunpyjv swsbvvmiqw (tyvelbcxjc ) View more	Positive	04 Dec 2022
				chemotherapy	oaykfogkbm(zjgxdkyrpf) = zrptqtdqbb swsbvvmiqw (tyvelbcxjc )
NCT02795988 (P-159 HERIZON, ESMO_GI2021)	Phase 2	HER2-expressing Gastroesophageal Junction Adenocarcinoma HER2/neu overexpressing	27	HER-Vaxx plus standard chemotherapy	wxxtugheqv(wubfjqbhec): HR = 0.418 (80% CI, 0.186 - 0.942), P-Value = 0.083 View more	Positive	03 Jul 2021
				Standard chemotherapy alone
NCT02795988 (ASCO2019) Manual	Phase 1	Advanced Gastric Adenocarcinoma HER2/neu Overexpression	14	chemotherapy+HER2 cancer vaccine	wdeomfhxxj(rgehkvndrd) = none phrvmhfhpp (fcgbqzvqdq ) View more	Positive	03 Jun 2019
ASCO2018	Phase 2	Salivary duct carcinoma	152	Conventional therapy	wyurjkyqys(rnnmrlqqqp) = eigaupcmub oorxfbxxyw (ijuvvxxrqg )	Positive	01 Jun 2018
				HER2-targeted therapy	wyurjkyqys(rnnmrlqqqp) = bctnqkkepw oorxfbxxyw (ijuvvxxrqg )
ASCO2015	Not Applicable	Metastatic human epidermal growth factor 2 positive carcinoma of breast	26	Trastuzumab	tkipntkltg(fpcipaiaqs) = cxbldzemth gxktjjogyu (kjeijfwhfk )	-	20 May 2015
ASCO2009	Phase 1	-	52	HER2 peptide vaccine	vosoqfgtjk(zvknqdjkef) = ncofwisyju vfrngdicim (cglsaqiael )	-	20 May 2009

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