[{"orgOrder":0,"company":"Genexine","sponsor":"Genexine","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Genexine, Binex to co-develop coronavirus vaccine GX-19","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Undisclosed","country":"SOUTH KOREA","productType":"Vaccine","productStatus":"New Molecular Entity","date":"March 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Undisclosed"},{"orgOrder":0,"company":"Genexine","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Genexine Consortium Develops COVID-19 Vaccine for Human Testing","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Preclinical","country":"SOUTH KOREA","productType":"Vaccine","productStatus":"New Molecular Entity","date":"May 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Preclinical"},{"orgOrder":0,"company":"Genexine","sponsor":"PT Kalbe Farma","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Kalbe to Start COVID-19 Vaccine Trial with S. Korean Pharma Firm","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Preclinical","country":"SOUTH KOREA","productType":"Vaccine","productStatus":"New Molecular Entity","date":"May 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Preclinical"},{"orgOrder":0,"company":"Genexine","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Genexine, \u201cHyleukin-7 (GX-I7), US clinical trial approval for COVID-19 treatment for mild patients\u201d","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase I","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"June 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase I"},{"orgOrder":0,"company":"Genexine","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Genexine, COVID-19 Preventive Vaccine, GX-19, clinical 1\/2 Phase Approval","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase I\/ Phase II","country":"SOUTH KOREA","productType":"Vaccine","productStatus":"New Molecular Entity","date":"June 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Genexine","sponsor":"PharmaJet","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"International Pharmaceutical Development Consortium to Partner With PharmaJet for Delivery of COVID-19 DNA Vaccine, GX-19","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase I\/ Phase II","country":"SOUTH KOREA","productType":"Vaccine","productStatus":"New Molecular Entity","date":"September 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Genexine","sponsor":"I-Mab Biopharma","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"I-Mab Receives China CDE Approval to Initiate Phase 3 Clinical Trial of Eftansomatropin in Pediatric Patients with Growth Hormone Deficiency","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase II","country":"SOUTH KOREA","productType":"Peptide","productStatus":"New Molecular Entity","date":"September 2020","url1":"","url2":"","graph1":"Endocrinology","graph2":"Phase II"},{"orgOrder":0,"company":"Genexine","sponsor":"NeoImmuneTech","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Genexine and NeoImmuneTech Announce Data Release for their Phase 1b\/2 Study of GX-I7\/NT-I7 and KEYTRUDA\u00ae in Patients With Triple-Negative Breast Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"November 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Genexine","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Genexine Expected to Apply for Approval of Covid-19 Vaccine Next Fall","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase I\/ Phase II","country":"SOUTH KOREA","productType":"Vaccine","productStatus":"New Molecular Entity","date":"November 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Genexine","sponsor":"Kalbe Genexine Biologics","pharmaFlowCategory":"D","amount":"$1,100.0 million","upfrontCash":"$27.0 million","newsHeadline":"KGBio and Genexine Signed Immuno-Oncology Drug License Agreement GX-17","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"February 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"},{"orgOrder":0,"company":"Genexine","sponsor":"Genexine","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Institut Pasteur Korea & Genexine Sign MOU for Global Clinical Trials for the COVID-19 Vaccine","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase I\/ Phase II","country":"SOUTH KOREA","productType":"Vaccine","productStatus":"New Molecular Entity","date":"April 2021","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Genexine","sponsor":"Hanmi Pharmaceutical","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"S.Korea's Genexine Signs COVID-19 Vaccine Candidate Manufacturing Deal with Hanmi","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase I\/ Phase II","country":"SOUTH KOREA","productType":"Vaccine","productStatus":"New Molecular Entity","date":"May 2021","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Genexine","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Genexine Reports Encouraging Top-line Results of the Phase 1b\/2 Clinical Trial With GX-I7 (efineptakin alfa) in Refractory or Recurrent (R\/R) Metastatic Triple Negative Breast Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"June 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Genexine","sponsor":"MSD Pharmaceuticals","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Genexine Selected for Late-Breaking Oral Presentation of Phase 2 Study of GX-188E in Combination with KEYTRUDA\u00ae (pembrolizumab) in Cervical Cancer at European Society for Medical Oncology (ESMO) Congress 2022","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"SOUTH KOREA","productType":"Vaccine","productStatus":"New Molecular Entity","date":"August 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"Genexine","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Genexine to Present Final Phase 2 Clinical Data on Its Cervical Cancer Program Showing a 35.0% Overall Response Rate and Provide a Corporate Overview During JP Morgan Conference","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"SOUTH KOREA","productType":"Vaccine","productStatus":"New Molecular Entity","date":"January 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"Genexine","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Genexine Receives Fast Track Designation from Korean Health Authority (MFDS) for Its Promising DNA Vaccine for Advanced Cervical Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"SOUTH KOREA","productType":"Vaccine","productStatus":"New Molecular Entity","date":"January 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"Genexine","sponsor":"I-Mab Biopharma","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Genexine\u2019s long-acting growth hormone meets Phase 3 primary endpoint","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase III","country":"SOUTH KOREA","productType":"Small molecule","productStatus":"Approved","date":"August 2023","url1":"","url2":"","graph1":"Endocrinology","graph2":"Phase III"},{"orgOrder":0,"company":"Genexine","sponsor":"Kalbe Genexine Biologics","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Genexine and KGbio Received the First Market Approval for Novel Long-acting Erythropoietin, Efepoetin Alfa, from The Indonesian Food and Drug Authority (BPOM)","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Approved","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"Approved","date":"October 2023","url1":"","url2":"","graph1":"Nephrology","graph2":"Approved"}]
Find Clinical Drug Pipeline Developments & Deals by Genexine
Efesa (efepoetin alfa) is a bio-better drug for CKD-induced anemia, developed based on hyFc®, Genexine's proprietary long-acting platform technology, which is investigated for the treatment of chronic kidney disease induced anemia in non-dialysis patients.
Genexine’s, GX-H9, a proprietary long-acting growth hormone shows positive topline results from phase 3 study for growth hormone deficiency, is being conducted in China with I-Mab.
GX-188E (tirvalimogene teraplasmid), a DNA vaccine encoding both E6 and E7 antigens of HPV types 16 and 18, which are responsible for about 70% of cervical cancer. It induces antigen-specific CD8 T cell responses by Flt3L fusion.
GX-188E is a DNA vaccine that encodes the E6/E7 fusion protein of HPV subtypes 16 and 18. Drug induces immune cells to detect E6 and E7 proteins that exist in cervical cancer cells, inducing apoptosis of tumor cells without affecting healthy cells.
GX-188E is a DNA-based therapeutic vaccine that was discovered and is being developed by Genexine for the treatment of cervical cancer and squamous cell carcinoma of the head and neck.
The results indicated that GX-I7 (Efineptakin Alfa) in combination with pembrolizumab was safe and well tolerated and demonstrated promising early anti-tumor activity in patients with R/R metastatic TNBC.
Genexine 's GX-19N COVID-19 vaccine candidate is a DNA based vaccine and showed no severe side effects. Hanmi will begin producing 10M doses of Genexine’s experimental COVID-19 vaccine with an aim to gradually ramp up production capacity to millions of doses by 2022.
IPK and Genexine will join forces together to test the protective efficacy of the GX-19N in the regions such as South Africa, where variants mainly appear, utilizing the international collaboration network of Institut Pasteur Korea.
Through this licensing agreement, KGBio and Genexine aim to develop a and commercialize an immuno-oncology drug GX-I7 (Efineptakin Alpha), namely long-acting interleukin-7 which uses the Genexine hyFc technology platform.
Genexine expects to obtain full data from a Phase I trial of its DNA vaccine GX-19 late this year or early next year, while starting a Phase IIa study within this year and concurrent Phase IIb and III trials in the first half of next year.