TRX-221 / Therapex - LARVOL DELTA

A Study to Investigate Safety, PK, And Anti-Tumor Activity of TRX-221 In EGFR Mutant NSCLC: TRX-221-001 In Progress (IASLC-WCLC 2024) - P1/2 | "Preclinically, TRX-221 has shown robust anti-tumor activity in various osimertinib-resistant patient-derived xenograft (PDX) models harboring C797S mutation. Patients will be treated continuously until disease progression or any other pre-defined discontinuation criteria are met. Clinical Trial Information: NCT06186076"

Clinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

A Study to Investigate Safety, Tolerability, PK and Anti-tumor Activity of TRX-221 in EGFRm NSCLC Patients (clinicaltrials.gov) - P1/2 | N=115 | Recruiting | Sponsor: Therapex Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Therapex begins 1st dosing of EGFR-mutated NSCLC drug in Korea (Korea Biomedical Review) - "Therapex...said on Monday it initiated dosing of the first patient in the local phase 1 clinical trial of TRX-221, an antitumor drug targeting EGFR-mutated non-small cell lung cancer (NSCLC), at Samsung Medical Center in Seoul....The phase 1/2 clinical trial of TRX-221 will be conducted in three phases. The phase-1a dose-escalation study will evaluate the safety and tolerability of the drug through stepwise dose escalation, while the phase-1b dose exploration will determine the maximum tolerated dose or recommended population dose (RP2D) for the phase 2 trial."

Trial status • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study to Investigate Safety, Tolerability, PK and Anti-tumor Activity of TRX-221 in EGFRm NSCLC Patients (clinicaltrials.gov) - P1/2 | N=115 | Not yet recruiting | Sponsor: Therapex Co., Ltd

New P1/2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

TRX-221, a 4th generation, mutant-selective, and CNS-active EGFR inhibitor with robust antitumor activity in osimertinib-resistant tumor models harboring C797S mutation (ESMO 2023) - "TRX-221 demonstrates strong antitumor efficacy in osimertinib-resistant tumor models, and thus has potential to treat patients who have developed resistance to 3rd generation EGFR TKI treatment. Initiation of first-in human clinical trial is expected in Q4 2023."

Preclinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Therapex announces preclinical research results for non-small cell lung cancer targeted anticancer drug at ESMO [Google translation] (HIT News) - "Therapex...announced the results of preclinical follow-up research on ‘TRX-221 (development code name)’, a targeted anti-cancer drug for non-small cell lung cancer, at the European Society of Medical Oncology (ESMO 2023) held in Madrid, Spain from the 20th to the 24th (local time). presented in poster form. t this conference, Therapex presented TRX-221's pharmacokinetics/pharmacodynamics (PK/PD) modeling, in vivo selectivity using an EGFR wild-type tumor transplant mouse model, and experimental results on brain permeability, etc. announced about it....The results of the study showed that even though a high dose of TRX-221 was administered to an EGFR wild-type tumor transplant mouse model, TRX-221 showed a much weaker tumor growth inhibition effect than gefitinib (1st generation inhibitor) and osimertinib (3rd generation inhibitor)."

PK/PD data • Preclinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Terapex announces 4th generation EGFR TKI preclinical study results at ESMO [Google translation] (docdocdoc.co.kr) - "Gradient subsidiary Terrapex announced that it will participate in the European Society of Medical Oncology (ESMO 2023) held in Madrid, Spain from the 20th to the 24th (local time)....Following AACR 2023 held in April, Therapex plans to share the results of preclinical follow-up research on 'TRX-221', a targeted anti-cancer drug candidate for non-small cell lung cancer, at ESMO 2023 and conduct related discussions with experts in the field."

Preclinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Therapex 4th generation EGFR lung cancer treatment approved for phase 1 in the US [Google translation] (docdocdoc.co.kr) - "Therapex announced on the 28th that it has received approval from the US Food and Drug Administration (FDA) for a phase 1 clinical trial of 'TRX-221', a non-small cell lung cancer target anti-cancer drug candidate....Through this clinical trial, Therapex plans to confirm the anti-tumor effect of TRX-221 on non-small cell lung cancer patients with EGFR mutation C797S, which is caused by resistance to existing drugs for non-small cell lung cancer with EGFR mutation, especially third-generation EGFR inhibitors. Therapex is also expected to confirm antitumor effects against a wide spectrum of EGFR mutations."

IND • New P1 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Therapex unveils preclinical results of novel NSCLC treatment at AACR (Korea Biomedical Review) - "Therapex said it has presented the preclinical trial results of TRX-221, its fourth-generation non-small cell lung cancer (NSCLC) drug candidate, at the American Association for Cancer Research (AACR) 2023 Conference in Orlando, Florida, the U.S., on Tuesday....Participants also paid significant attention to data showing a significant increase in survival time compared to the control group when TRX-221 was administered to a Tagrisso-resistant brain tumor mouse model and the drug's blood-brain barrier (BBB) penetration mechanism....Lee stressed that his company plans to file a phase 1 investigational new drug (IND) application with the Ministry of Food and Drug Safety and the U.S. Food and Drug Administration (FDA) in June, with plans to begin the trials in patients in the second half of the year."

IND • New P1 trial • Preclinical • Brain Cancer • CNS Tumor • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

TRX-221, a novel 4th-generation EGFR inhibitor for overcoming C797S mutation-mediated acquired resistance in NSCLC (AACR 2023) - "With favorable DMPK profiles, once-daily oral dosing of TRX-221 induced strong anti-tumor effects in a dose-dependent manner in a variety of osimertinib-resistant CDX and PDX models. As a reversible, selective, and broad-spectrum 4th-generation EGFR-TKI, TRX-221 is currently undergoing IND-enabling studies and shows strong potential as a therapeutic solution to treat advanced NSCLC patients harboring EGFR mutations."

Preclinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Therapex Co., Ltd. holds a clinical advisory committee for 'TRX-221', a candidate for 4th generation non-small cell lung cancer treatment (Health in News) - "Therapex Co., Ltd...announced on the 23rd that it held the 1st clinical advisory committee meeting for 'TRX-221', a 4th generation non-small cell lung cancer treatment (EGFR inhibitor) candidate, at the Intercontinental Hotel on the 22nd....The advisory members who attended the Clinical Advisory Committee confirmed the dose-dependent anticancer effect without weight loss with once-a-day oral administration in 'C797S' mutant animal models as well as various EGFR mutant tumor models. confirmed. In particular, the company explained that it paid attention to the result of confirming the efficacy of 'complete remission' that previous competing drugs did not reach in the same model with TRX-221 monotherapy alone in a tumor model derived from a patient resistant to Tagrisso."

Preclinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology

The world's top three cancer societies 'AACR' opens next month… K-Bio gun dispatch (Newsis) - "Curocell will also present the research results of CAR-T treatment for the treatment of T-cell (immune cell) lymphoma....ViGencell is also planning to release animal test data to evaluate the efficacy of antigen-targeting CAR-T. Therapex plans to introduce the preclinical results of 'TRX-221', a candidate for lung cancer treatment....Aptamer Science will present the research results of 'CD25-ApDC Immuno-Oncology'."

Preclinical • Hematological Malignancies • Lung Cancer • Lymphoma • Oncology • Solid Tumor

Therapex, '4th generation EGFR TKI' AACR unveiled..”Clinical trial this year“ (Biospectator) - "'Phase 1 IND submission in Korea and the US in the first half of this year. Aim to start clinical trials in the second half'....Therapex will present the preclinical results of the 4th generation EGFR TKI 'TRX-221', which inhibits C797S, which is being developed as a treatment for non-small cell lung cancer, at the 2023 American Association for Cancer Research (AACR 2023) to be held from April 14th...In cell line-based in vitro experiments, TRX-221 showed inhibitory effects on double mutations (Del19/C797S, L858R/C797S) and triple mutations (Del19/T790M/C797S, L858R/T790M/C797S), including C797S. These results were also reproduced in an in vivo tumor model. Therapex confirmed the efficacy of inhibiting tumor growth in a dose-dependent manner when TRX-221 was orally administered once a day in various EGFR mutation tumor models including the C797S mutation."

IND • New P1 trial • Preclinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology