boditrectinib (AUM-601) / Handok, CMG Pharma, AUM Biosci - LARVOL DELTA

A first-in-human, open-label, dose-escalation study to investigate the safety and tolerability of CHC2014, a tropomyosin receptor kinase (TRK) inhibitor, in adult patients with advanced solid tumors (ESMO-TAT 2022) - P1 | "CHC2014 was safe and well-tolerated at dose levels of 50 to 300 mg QD. Doses of 200 and 300 mg QD were defined as RP2D based on PK profile and safety . A multi-national phase 2 study will be conducted to assess the efficacy and safety in patients with NTRK fusions."

Clinical • P1 data • Brain Cancer • Glioblastoma • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Uterine Cancer • NTRK

AUM Biosciences and Asymchem Complete Phase II API Production Campaign of Novel TRK Inhibitor (Canada Newswire) - "Asymchem...and AUM Biosciences...jointly announced today the completion of their first GMP production campaign of AUM601....The partnership resulted in 10 kg GMP bulk drug substance of AUM 601, which will be used to supply Phase II clinical trials."

Commercial • Oncology • Solid Tumor

AUM Biosciences Receives FDA Orphan Drug Designation for AUM601 for the Treatment of Solid Tumors with the NTRK Fusion Gene (GlobeNewswire) - "AUM Biosciences...announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to AUM601, a highly selective, oral small molecule that inhibits not only pan-TRK (TRKA, TRKB, and TRKC), but also resistance mutations of TRKs, by blocking the activity of tyrosine kinases....'We look forward to beginning the phase 2 trial soon and providing additional insight into its indisputable advantage over current treatment options'."

Orphan drug • Oncology • Solid Tumor

AUM Biosciences and HANDOK Presented Phase 1 Data for AUM-601 at ESMO Targeted Anticancer Therapies Congress 2022 (GlobeNewswire) - "AUM Biosciences...Handok Inc...jointly announced Phase 1 data for AUM-601 (CHC2014), a selective second generation 'Pan-TRK' Inhibitor, was presented as a poster presentation at the ESMO Targeted Anticancer Congress 2022. The conference was held virtually March 7-8, 2022....Study Conclusions: AUM601 (CHC2014) was safe and well-tolerated at dose levels of 50 to 300 mg QD. Doses of 200 and 300 mg QD were defined as recommend Phase 2 dose (RP2D) based on PK profile and safety results. A multi-national phase 2 study will be conducted to assess the efficacy and safety in patients with NTRK fusions."

P1 data • Oncology • Solid Tumor

[VIRTUAL] A first-in-human study of NOV1601 (CHC2014), small-molecule inhibitor of TRK family proteins, in adult patients with solid organ malignancies (ESMO 2020) - P1 | "& National OncoVenture. Clinical trial identification: NCT04014257."

Clinical • P1 data • Oncology • Solid Tumor • NTRK • NTRK1

A Phase 1 Study of NOV1601(CHC2014) in Adult Subjects With Solid Organ Malignancies (clinicaltrials.gov) - P1; N=17; Completed; Sponsor: Handok Inc.; Recruiting ➔ Completed; N=25 ➔ 17; Trial primary completion date: Jul 2020 ➔ Jan 2021

Clinical • Enrollment change • Trial completion • Trial primary completion date • Oncology • Solid Tumor

CMG Pharm completes phase 1 clinical trial of 'CHC2014', a new targeted anticancer drug [Google translation] (E-Today) - "CMG Pharmaceuticals announced on the 31st that it has successfully completed the domestic phase 1 clinical trial of 'CHC2014',....According to the Clinical Trial Results Report (CSR), CMG Pharma and Handok conducted a phase 1 clinical trial in three hospitals including Bundang CHA Hospital targeting 17 patients with malignant solid cancer in Korea....According to the technology export transfer contract, AUM Bioscience plans to conduct its own global phase 2 clinical trial in the future."

Trial completion • Oncology • Solid Tumor

Handok, CMG to transfer solid tumor drug tech to Singapore’s AUM (Korea Biomedical Review) - "Handok Pharmaceuticals and CMG Pharmaceutical have agreed to transfer the technology of anticancer drug CHC2014, which targets Pan-TRK inhibitor in solid tumors, to Singapore’s AUM Biosciences for 193.4 billion won ($173 million). The two companies will grant rights to AUM Biosciences to develop, manufacture, and commercialize the drug candidate in countries outside of Korea."

Licensing / partnership • Oncology • Solid Tumor

A Phase 1 Study of NOV1601(CHC2014) in Adult Subjects With Solid Organ Malignancies (clinicaltrials.gov) - P1; N=25; Recruiting; Sponsor: National OncoVenture; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

A Phase 1 Study of NOV1601(CHC2014) in Adult Subjects With Solid Organ Malignancies (clinicaltrials.gov) - P1; N=25; Not yet recruiting; Sponsor: National OncoVenture

Clinical • New P1 trial