ABL501 / ABL Bio, Handok - LARVOL DELTA

[Exclusive] ABL Bio, which chose selection and focus, completes phase 1 clinical trial of 'ABL501', temporarily suspends follow-up clinical trial [Google translation] (Pharm News) - P1 | N=24 | NCT05101109 | Sponsor: ABL Bio, Inc.| "ABL Bio is temporarily suspending the follow-up clinical trial of ABL 501, which recently announced the results of Phase 1. The strategy is to strengthen competitiveness by focusing on core technologies such as the dual antibody immunotherapy (Grabody-T) based on 4-1BB, the IGF1R-based BBB shuttle platform (Grabody-B), and the dual antibody ADC....In clinical results, dose-limiting toxicity (DLT) occurred in 1 subject in Cohort 6 at the maximum dose among a total of 21 subjects, so the maximum tolerated dose (MTD) was not reached...In terms of efficacy, the ORR (Overall response rate) was 25% (3/12) and the DCR (Disease control rate) was 66.67% (8/12) at the cohort 6 dose, which is the potential optimal dose."

P1 data • Trial suspension • Solid Tumor

Study to Evaluate the Safety and Tolerability of ABL501, and to Determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of ABL501 in Subjects With Any Progressive, Locally Advanced (Unresectable) or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: ABL Bio, Inc. | Recruiting ➔ Completed | N=36 ➔ 24 | Trial completion date: Dec 2024 ➔ May 2024

Enrollment change • Metastases • Trial completion • Trial completion date • Oncology • Solid Tumor

ABL Bio obtains approval for use of immunotherapy drug ABL501 for lung cancer from the Ministry of Food and Drug Safety [Google translation] - "BL Bio (298380), a bispecific antibody specialist company, received its first approval for use for therapeutic purposes from the Ministry of Food and Drug Safety (MFDS) on the 23rd for its immuno-anticancer bispecific antibody ABL501...According to the Ministry of Food and Drug Safety, there are a total of two approvals for use for therapeutic purposes. The applicants are Asan Medical Center and Yonsei University Severance Hospital, and the target disease is small cell lung cancer....In June 2022, a paper analyzing the mechanism of action and anti-cancer effect was published online in the SCI-level international academic journal 'Molecular Therapy', and in November of the same year, Japanese patent registration was completed and ABL501 and its products will be developed by 2039. The right to use it in Japan is guaranteed."

Non-US regulatory • Patent • Small Cell Lung Cancer

Study to Evaluate the Safety and Tolerability of ABL501, and to Determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of ABL501 in Subjects With Any Progressive, Locally Advanced (Unresectable) or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: ABL Bio, Inc. | Trial completion date: Jul 2024 ➔ Dec 2024 | Trial primary completion date: Dec 2023 ➔ Jun 2024

Metastases • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Study to Evaluate the Safety and Tolerability of ABL501, and to Determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of ABL501 in Subjects With Any Progressive, Locally Advanced (Unresectable) or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: ABL Bio, Inc. | Trial completion date: Jul 2023 ➔ Jul 2024 | Trial primary completion date: Jul 2022 ➔ Dec 2023

Metastases • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

ABL Bio, ABL501 patent registration in Japan [Google translation] (HIT News) - "ABL Bio...announced that it has completed registration of a Japanese patent for ABL501, an immuno-oncology bispecific antibody. As a result, ABL Bio will be guaranteed rights in Japan for ABL501 and its uses until 2039. "

Patent • Oncology

LAG-3xPD-L1 bispecific antibody potentiates antitumor responses of T cells through dendritic cell activation. (PubMed, Mol Ther) - P1 | "The immune profiling analysis of peripheral blood reveals an increased abundance of LAG-3PD-1 memory CD4T cell subset in relapsed cholangiocarcinoma patients after gemcitabine plus cisplatin therapy, which are more responsive to ABL501. This study supports the clinical evaluation of ABL501 as a novel cancer immunotherapeutic, and a first-in-human trial has started (NCT05101109)."

Journal • Biliary Cancer • Cholangiocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • CD4 • CD8

Phase 1 Study of ABL501 as a Single Agent in Subjects With Any Progressive, Locally Advanced (Unresectable) or Metastatic Solid Tumors (clinicaltrials.gov) - P1; N=36; Recruiting; Sponsor: ABL Bio, Inc.

Clinical • New P1 trial • Oncology • Solid Tumor

Ministry of Food and Drug Safety approved 26 clinical trials last week … 3 cases of phase 3, 7 cases of viability [Google translation] (Health Korea News) - "The Ministry of Food and Drug Safety has approved a total of 26 clinical trials over the past week (2nd to 6th)...Eight phase 1 trials were also approved this week [including] Sovagen's 'SVG101' (everolimus)...Crystal Genomics' Ivaltinostat...and ABL Bio's 'ABL501'."

New P1 trial • Oncology • Solid Tumor

ABL Bio Receives IND Approval for Phase 1 Clinical Trial of ABL501, an anti-LAG-3/PD-L1 Bispecific Antibody (PRNewswire) - "ABL Bio, Inc...announced that the Investigational New Drug (IND) application for ABL501 has been approved by South Korea's Ministry of Food and Drug Safety....The Phase 1 clinical trial is an open-label, multi-center dose escalation and dose expansion study designed to evaluate the safety, tolerability, maximum tolerated dose (MTD) and preliminary efficacy of ABL501 in patients with advanced or metastatic solid tumors."

New P1 trial • Oncology • Solid Tumor

[VIRTUAL] ABL501, PD-L1 x LAG-3, a bispecific antibody promotes enhanced human T cell activation through targeting simultaneously two immune checkpoint inhibitors, LAG-3 and PD-L1 (AACR 2021) - "Together with safety profile in the toxicology study, the preclinical studies support that ABL501 effectively suppressed tumor growth through activation of immune cells by releasing immune suppressive environments. This alternative therapeutic strategy may have a potential to overcome limitations of the current immune-oncology therapy for further clinical evaluation."

Checkpoint inhibition • IO biomarker • Lung Cancer • Oncology • Solid Tumor • LAG3