Polpharma European CDMO Partner & API Manufacturer since 1951 Polpharma European CDMO Partner & API Manufacturer since 1951

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[{"orgOrder":0,"company":"HiberCell","sponsor":"Labcorp Drug Development","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"HiberCell Initiates Phase 1a Clinical Trial of HC-5404-FU, an ER Stress Modulator","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"},{"orgOrder":0,"company":"HiberCell","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"HiberCell Receives Fast Track Designation from FDA for First-in-Human Studies of PERK Inhibitor (PERKi) HC-5404-FU","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"},{"orgOrder":0,"company":"HiberCell","sponsor":"Merck & Co","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"HiberCell to Collaborate with Merck on Phase 2 Clinical Trial of Odetiglucan in Combination with KEYTRUDA\u00ae (pembrolizumab) in Patients with Metastatic Breast Cancer ","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"December 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"HiberCell","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"HiberCell To Present New Data on Odetiglucan Plus Pembrolizumab in Ongoing Phase 2 Metastatic Breast Cancer Trial at San Antonio Breast Cancer Symposium","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"December 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"HiberCell","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"HiberCell to Present Clinical Applications of Odetiglucan and the Role of Beta-Glucan in Cancer Treatment at ESMO Immuno-Oncology Virtual Congress 2021","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"December 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"HiberCell","sponsor":"Imprime PGG","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"HiberCell to Present Clinical Applications of Odetiglucan and the Role of Beta-Glucan in Cancer Treatment","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"March 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"HiberCell","sponsor":"Labcorp Drug Development","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"HiberCell Initiates its Phase 1a\/b Clinical Trial of HC-7366 in Patients with Advanced Solid Tumors","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"February 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"},{"orgOrder":0,"company":"HiberCell","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"HiberCell Announces First Patients Dosed in Phase 2 Clinical Trial of Odetiglucan in Combination with KEYTRUDA (pembrolizumab) in Adult Patients with Metastatic, Hormone-Refractory Breast Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"April 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"HiberCell","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"HiberCell to Present Posters on Novel Candidates Odetiglucan and HC-7366 at the 2022 Annual American Society of Clinical Oncology Meeting","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"May 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"HiberCell","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"HiberCell to Present Preclinical Data from Novel GCN2 Activator and PERK Inhibitor Programs at The Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"November 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"},{"orgOrder":0,"company":"HiberCell","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"HiberCell Maps Forward Path for Novel GCN2 Activator, HC-7366 in Acute Myeloid Leukemia (AML)","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"February 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"},{"orgOrder":0,"company":"HiberCell","sponsor":"Celldex Therapeutics","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"HiberCell Doses First Patient in Phase 1b Study Exploring Novel Combination of Odetiglucan and CD40 Agonistic Monoclonal Antibody (CDX-1140) in Patients With Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) in the Maintenance Setting","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"May 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"},{"orgOrder":0,"company":"HiberCell","sponsor":"Merck & Co","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"HiberCell, Inc. Announces Clinical Collaboration with Merck to Evaluate HC-7366, an Activator of ISR Kinase GCN2, in Combination with WELIREG\u00ae (belzutifan) in a Phase 1b Study of Patients with Clear Cell Renal Cell Carcinoma (ccRCC)","therapeuticArea":"Oncology","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"December 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Preclinical"},{"orgOrder":0,"company":"HiberCell","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"HiberCell Announces Successful Completion and Interim Results of Phase 1 Study of Novel PERK Inhibitor, HC-5404, in Solid Tumors and Maps Forward Path as Monotherapy and in Combinations","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"November 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"},{"orgOrder":0,"company":"HiberCell","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"HiberCell Announces First Patient Dosed in Clinical Collaboration with Merck, Evaluating HC-7366 in Combination with WELIREG\u00ae (belzutifan) in Patients with Advanced ccRCC","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2024","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"}]

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            HC-7366, a selective activator of the general control nonderepressible 2 kinases in combination with Welireg (belzutifan), Merck’s oral HIF-2α inhibitor is being investigated for the treatment of clear cell renal cell carcinoma.

            Lead Product(s): HC-7366,Belzutifan

            Therapeutic Area: Oncology Product Name: HC-7366

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 01, 2024

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            The collaboration aims to evaluate HiberCell's HC-7366, a selective activator of the general control nonderepressible 2 kinases in combination with Welireg (belzutifan), Merck’s oral HIF-2α inhibitor for the treatment of clear cell renal cell carcinoma.

            Lead Product(s): HC-7366,Belzutifan

            Therapeutic Area: Oncology Product Name: HC-7366

            Highest Development Status: Preclinical Product Type: Small molecule

            Partner/Sponsor/Collaborator: Merck & Co

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Collaboration December 05, 2023

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            HC-5404 is a first-in-class, first-in-human selective and potent PKR-like endoplasmic reticulum kinase (PERK) inhibitor. Itis being evaluated in phase 1 clinical trials for the treatment of solid tumors.

            Lead Product(s): HC-5404

            Therapeutic Area: Oncology Product Name: HC-5404

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 27, 2023

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            Imprime PGG (odetiglucan) is a pathogen-associated molecular pattern which is designed to enhance innate immune functions, including cytotoxic effector mechanisms, to reverse immunosuppression and facilitate cross-talk with the adaptive immune system.

            Lead Product(s): Odetiglucan,CDX-1140

            Therapeutic Area: Oncology Product Name: Imprime PGG

            Highest Development Status: Phase I Product Type: Large molecule

            Partner/Sponsor/Collaborator: Celldex Therapeutics

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 22, 2023

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            HC-7366, a first-in-class, first-in-human GCN2 activator. In preclinical studies, HC-7366 was observed to have robust anti-tumor and immunomodulatory activity in a variety of models of solid tumors and hematological malignancies.

            Lead Product(s): HC-7366

            Therapeutic Area: Oncology Product Name: HC-7366

            Highest Development Status: Phase I Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 22, 2023

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            The posters will present the immunomodulatory mechanisms of HC-7366, a differentiated selective, orally bioavailable activator of GCN2 (general controlled nonderepressible 2). HiberCell is currently conducting Phase 1 clinical trials in solid tumors for HC-7366.

            Lead Product(s): HC-7366

            Therapeutic Area: Oncology Product Name: HC-7366

            Highest Development Status: Phase I Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 02, 2022

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            Imprime PGG (odetiglucan) is a pathogen-associated molecular pattern which is designed to enhance innate immune functions, including cytotoxic effector mechanisms, to reverse immunosuppression and facilitate cross-talk with the adaptive immune system.

            Lead Product(s): Odetiglucan,Pembrolizumab

            Therapeutic Area: Oncology Product Name: Imprime PGG

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 24, 2022

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            Odetiglucan, a novel intravenously administered investigational innate and adaptive immune modulator, has previously been investigated in combination with pembrolizumab in immune checkpoint inhibitor-naive metastatic triple negative breast cancer patients.

            Lead Product(s): Odetiglucan,Pembrolizumab

            Therapeutic Area: Oncology Product Name: Imprime PGG

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 28, 2022

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            Odetiglucan or Imprime PGG, a Dectin-1, pattern recognition receptor agonist, is currently in phase 2 clinical trial in combination with pembrolizumab, an anti-programmed death receptor-1 therapy used in cancer immunotherapy, for treatment of metastatic breast cancer.

            Lead Product(s): Odetiglucan,Pembrolizumab

            Therapeutic Area: Oncology Product Name: BTH-1677

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Imprime PGG

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 03, 2022

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            Details:

            The first-in-human Phase 1a/b clinical trial, designed to establish maximum tolerated dose, while evaluating safety and tolerability, and to establish recommended Phase 2 dose for HC-7366, selective, orally bioavailable modulator of GNC2 in patients with advanced solid tumors.

            Lead Product(s): HC-7366-K

            Therapeutic Area: Oncology Product Name: HC-7366

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Labcorp Drug Development

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 24, 2022

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