- |||||||||| Mircera (methoxy polyethylene glycol-epoetin beta) / Roche, CSL Behring, HyPoietin (epoetin alfa biosimilar) / GC Biopharma, Genexine, Fosun Pharma
Biomarker, Clinical, P3 data, Journal, Head-to-Head: Non-Inferiority of Subcutaneous Efepoetin Alfa Compared to Methoxy Polyethylene Glycol-Epoetin Beta in Stage 3 or 4 CKD Patients: Insights From a Phase 3 Trial. (Pubmed Central) - May 15, 2025 Efepoetin alfa demonstrated non-inferiority to methoxy polyethylene glycol-epoetin beta in correcting anaemia and maintaining haemoglobin (Hb) levels among stage 3 and 4 CKD patients. Moreover, the safety profile of efepoetin alfa was comparable to methoxy polyethylene glycol-epoetin beta.
- |||||||||| GX-G6 / Genexine
Trial completion, Trial completion date, Trial primary completion date: A Study of TG103 Injection in the Management of Non-diabetic Overweight or Obesity (clinicaltrials.gov) - May 14, 2025 P2, N=314, Completed, Moreover, the safety profile of efepoetin alfa was comparable to methoxy polyethylene glycol-epoetin beta. Active, not recruiting --> Completed | Trial completion date: Mar 2025 --> Oct 2024 | Trial primary completion date: Dec 2024 --> Sep 2024
- |||||||||| Hyleukin-7 (efineptakin alfa) / Genexine, NeoImmuneTech
NT-I7 increases lymphocytes and enhances chemotherapy and immunotherapy efficacy in HNSCC (Section 35; Poster Board No: 6) - Mar 25, 2025 - Abstract #AACR2025AACR_4476; Active, not recruiting --> Completed | Trial completion date: Mar 2025 --> Oct 2024 | Trial primary completion date: Dec 2024 --> Sep 2024 NT-I7 effectively increases lymphocyte populations in HNSCC preclinical models that demonstrate tumor-associated lymphopenia, and enhances the efficacy of cisplatin and anti-PD-1 in HNSCC preclinical tumor models.
- |||||||||| Hyleukin-7 (efineptakin alfa) / Genexine, NeoImmuneTech
Enrollment closed, Enrollment change, Trial primary completion date: rhIL-7-hyFc on Increasing Lymphocyte Counts in Patients With Newly Diagnosed Non-severe Lymphopenic Gliomas Following Radiation and Temzolomide (clinicaltrials.gov) - Dec 27, 2024 P1/2, N=42, Active, not recruiting, National Cancer Center Onco-Innovation Unit, Korea. Recruiting --> Active, not recruiting | N=70 --> 42 | Trial primary completion date: Jan 2032 --> Feb 2025
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), Hyleukin-7 (efineptakin alfa) / Genexine, NeoImmuneTech
Trial completion date, Trial primary completion date, Tumor mutational burden: Efineptakin Alfa and Pembrolizumab for the Treatment of Recurrent Glioblastoma (clinicaltrials.gov) - Dec 4, 2024 P2, N=44, Recruiting, Recruiting --> Active, not recruiting | N=70 --> 42 | Trial primary completion date: Jan 2032 --> Feb 2025 Trial completion date: Oct 2025 --> Oct 2028 | Trial primary completion date: Oct 2024 --> Oct 2027
- |||||||||| Hyleukin-7 (efineptakin alfa) / Genexine, NeoImmuneTech
IL-7 stimulation remodels the tumor immune microenvironment in lung adenocarcinoma (Exhibit Halls AB - George R. Brown Convention Center) - Oct 4, 2024 - Abstract #SITC2024SITC_1406; The mice received weekly treatments of either NT-I7 (efineptakin alfa, a recombinant human IL-7 agonist) or a vehicle control for 2 weeks...Through this spatial and molecular biology study, potential mechanisms underlying the enhancement of lymphocyte infiltration by IL-7 agonist therapy in lung cancer are unveiled, crucial for improving clinical efficacy of immunotherapy. Moreover, the upregulation of Cd274 in IL-7-treated mice suggests a potential synergy between IL-7 and PD-1/PD-L1 checkpoint blockade therapy.
- |||||||||| Hyleukin-7 (efineptakin alfa) / Genexine, NeoImmuneTech
Trial completion date, Trial primary completion date, IO biomarker: NT-I7 for the Treatment of Recurrent Squamous Cell Carcinoma of Head and Neck Undergoing Surgery (clinicaltrials.gov) - Jun 6, 2024 P1, N=10, Recruiting, Trial completion date: Apr 2027 --> Sep 2027 | Trial primary completion date: Jun 2025 --> Dec 2026 Trial completion date: Mar 2024 --> Mar 2025 | Trial primary completion date: Mar 2024 --> Mar 2025
- |||||||||| Hyleukin-7 (efineptakin alfa) / Genexine, NeoImmuneTech
Journal, Tumor-infiltrating lymphocyte, PD(L)-1 Biomarker, IO biomarker: IL-7-primed bystander CD8 tumor-infiltrating lymphocytes optimize the antitumor efficacy of T (Pubmed Central) - May 22, 2024 Notably, TCE treatment has no major effect on tumor-reactive CD8 TILs. Our results suggest that rhIL-7-hyFc treatment promotes the antitumor efficacy of TCE immunotherapy by increasing TCE-sensitive bystander CD8 TILs in solid tumors.
- |||||||||| Hyleukin-7 (efineptakin alfa) / Genexine, NeoImmuneTech
Expand and pull: A new treatment paradigm for glioblastoma using a long-acting recombinant interleukin-7 and oncolytic viral therapy. (Hall A; Poster Bd #: 342) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3150; Timing the oncolytic ZIKV injection with the NT-I7-induced peak expansion of peripheral CD8 T cells greatly increased tumor infiltration of cytotoxic T cells and improved survival in the immunotherapy resistant SB28 glioma model. This work suggests a new "expand and pull" approach for the treatment of highly immunosuppressive tumors such as GBM: priming the systemic immune system with NT-I7, followed by an oncolytic stimulus to draw them into the TME to engage and clear tumor cells.
- |||||||||| Hyleukin-7 (efineptakin alfa) / Genexine, NeoImmuneTech
Enrollment closed, Trial completion date, Trial primary completion date: KEYNOTE A60: NT-I7 (Efineptakin Alfa) in Combination with Pembrolizumab in Participants with Advanced Solid Tumors (clinicaltrials.gov) - Mar 15, 2024 P1/2, N=215, Active, not recruiting, The integrated use of ELISA and AMS offers valuable insights for the development and optimization of ABT. Trial completion date: Jun 2024 --> Mar 2025 | Trial primary completion date: Jun 2024 --> Nov 2024 | Recruiting --> Active, not recruiting
- |||||||||| Hyleukin-7 (efineptakin alfa) / Genexine, NeoImmuneTech
rhIL-7-hyFc (efineptakin-alfa, NT-I7) increases tumor-specific CD8+ T cells despite FOLFOX cytotoxicity effect (Section 4) - Mar 5, 2024 - Abstract #AACR2024AACR_7009; However, adding FOLFOX does not affect the NT-I7-driven increase of tumor-specific CD8+ T cells within the tumor. Taken together, our data demonstrate that FOLFOX does not compromise NT-I7's ability to increase tumor-specific T cells within the tumor and the combination enhances the anti-tumor response irrespective of the timing of NT-I7 administration.
- |||||||||| GX-19N / Genexine, Binex, GenNBio, PT Kalbe Farma
Trial completion: Safety and Immunogenicity of GX-19N, a COVID-19 Preventive DNA Vaccine in Elderly Individuals (clinicaltrials.gov) - Mar 1, 2024 P1, N=30, Completed, Taken together, our data demonstrate that FOLFOX does not compromise NT-I7's ability to increase tumor-specific T cells within the tumor and the combination enhances the anti-tumor response irrespective of the timing of NT-I7 administration. Active, not recruiting --> Completed
- |||||||||| Hyleukin-7 (efineptakin alfa) / Genexine, NeoImmuneTech
Enrollment closed, Trial completion date, Trial primary completion date: A Study to Evaluate the Efficacy and Safety of TJ107 in Lympopenic Patients With Newly Diagnosed Glioblastoma Who Completed Standard Concurrent Chemoradiotherapy (CCRT) (clinicaltrials.gov) - Feb 28, 2024 P2, N=160, Active, not recruiting, Active, not recruiting --> Completed Recruiting --> Active, not recruiting | Trial completion date: Feb 2024 --> Dec 2024 | Trial primary completion date: Nov 2023 --> Dec 2024
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), Papitrol (tirvalimogene teraplasmid) / Genexine, National OncoVenture, Hyleukin-7 (efineptakin alfa) / Genexine, NeoImmuneTech
Enrollment change, Trial primary completion date, Metastases: GENUINE: Trial of the Combination of GX-188E Vaccination, GX-I7 and Pembrolizumab in Patients With Advanced, Resectable HPV Type 16 and/or 18 Positive Head and Neck Cancer (clinicaltrials.gov) - Feb 28, 2024 P2, N=56, Recruiting, Recruiting --> Active, not recruiting | Trial completion date: Feb 2024 --> Dec 2024 | Trial primary completion date: Nov 2023 --> Dec 2024 N=25 --> 56 | Trial primary completion date: Dec 2025 --> Aug 2025
- |||||||||| Hyleukin-7 (efineptakin alfa) / Genexine, NeoImmuneTech
Phase classification, Enrollment change, Trial completion date, Trial termination, Trial primary completion date, Combination therapy: High-Risk Skin Cancers With Atezolizumab Plus NT-I7 (clinicaltrials.gov) - Feb 22, 2024 P1/2, N=31, Terminated, Phase classification: P1b/2 --> P1/2 Phase classification: P1b/2a --> P1/2 | N=84 --> 31 | Trial completion date: May 2024 --> Aug 2023 | Active, not recruiting --> Terminated | Trial primary completion date: Feb 2024 --> Aug 2023; Strategic decision by sponsor
- |||||||||| Hyleukin-7 (efineptakin alfa) / Genexine, NeoImmuneTech
Phase classification, CAR T-Cell Therapy: Relapsed/Refractory Large B-cell Lymphoma With NT-I7 Post-CD19 CAR T-cell Therapy (clinicaltrials.gov) - Feb 21, 2024 P1, N=57, Recruiting, Phase classification: P1b/2a --> P1/2 | N=84 --> 31 | Trial completion date: May 2024 --> Aug 2023 | Active, not recruiting --> Terminated | Trial primary completion date: Feb 2024 --> Aug 2023; Strategic decision by sponsor Phase classification: P1b --> P1
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), Hyleukin-7 (efineptakin alfa) / Genexine, NeoImmuneTech
Enrollment closed, Trial completion date, Trial primary completion date: Study to Evaluate Safety and Efficacy of TJ107 Combine With PD-1 in Patients With Solid Tumors (clinicaltrials.gov) - Jan 31, 2024 P2, N=133, Active, not recruiting, Phase classification: P1b --> P1 Recruiting --> Active, not recruiting | Trial completion date: Feb 2024 --> Dec 2024 | Trial primary completion date: Sep 2023 --> Jun 2024
- |||||||||| Hyleukin-7 (efineptakin alfa) / Genexine, NeoImmuneTech
Trial termination: NT-I7 for Kaposi Sarcoma in Patients With or Without HIV (clinicaltrials.gov) - Dec 26, 2023 P1, N=8, Terminated, Trial completion date: Jan 2030 --> Jan 2032 | Trial primary completion date: Jan 2030 --> Jan 2032 Active, not recruiting --> Terminated; Terminated due to end of funding
- |||||||||| Hyleukin-7 (efineptakin alfa) / Genexine, NeoImmuneTech, UCART19 / Allogene Therap, Servier
Journal: An "off-the-shelf" CD2 universal CAR-T therapy for T-cell malignancies. (Pubmed Central) - Nov 29, 2023 Treatment with rhIL-7-hyFc prolonged UCART2 persistence and increased survival in both the tumor re-challenge model and primary patient T-ALL model in vivo. Together, these data suggest that allogeneic fratricide-resistant UCART2, in combination with rhIL-7-hyFc, could be a suitable approach for treating T-cell malignancies.
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