ASN004 / Asana BioSci, Kirilys - LARVOL DELTA

Phase I dose escalation trial to evaluate safety and preliminary efficacy of ACR246, an innovative 5T4- antibody drug conjugate (ADC), in patients (pts) with advanced solid tumors (ESMO 2024) - P1 | "Previously, several 5T4-ADCs were developed and advanced to phase 1 clinical trials, including PF-06263507, ASN004 and SYD1875. Dose limiting toxicity (DLT) will be assessed at each dose level. The DLT evaluation period will be 21 days."

Clinical • Metastases • P1 data • Oncology • Solid Tumor • TPBG

Study of ASN004 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=19 | Completed | Sponsor: Kirilys Therapeutics Inc. | Active, not recruiting ➔ Completed | Trial completion date: Sep 2024 ➔ May 2024

Metastases • Trial completion • Trial completion date • Oncology • Renal Cell Carcinoma • Solid Tumor • TPBG

Study of ASN004 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=19 | Active, not recruiting | Sponsor: Kirilys Therapeutics Inc. | Recruiting ➔ Active, not recruiting | N=45 ➔ 19 | Trial completion date: Mar 2027 ➔ Sep 2024 | Trial primary completion date: Mar 2026 ➔ Jun 2024

Enrollment change • Enrollment closed • Metastases • Trial completion date • Trial primary completion date • Oncology • Renal Cell Carcinoma • Solid Tumor • TPBG

Study of ASN004 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=45 | Recruiting | Sponsor: Kirilys Therapeutics Inc. | Trial completion date: Mar 2026 ➔ Mar 2027 | Trial primary completion date: Mar 2025 ➔ Mar 2026

Metastases • Trial completion date • Trial primary completion date • Oncology • Renal Cell Carcinoma • Solid Tumor • TPBG

Study of ASN004 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=43 | Recruiting | Sponsor: Kirilys Therapeutics Inc. | Trial primary completion date: Mar 2024 ➔ Mar 2025

Metastases • Trial primary completion date • Oncology • Renal Cell Carcinoma • Solid Tumor

Study of ASN004 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=43 | Recruiting | Sponsor: Kirilys Therapeutics, Inc. | Trial completion date: Mar 2024 ➔ Mar 2026 | Trial primary completion date: Dec 2022 ➔ Mar 2024

Metastases • Trial completion date • Trial primary completion date • Breast Cancer • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma

Study of ASN004 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=43 | Recruiting | Sponsor: Asana BioSciences | Trial primary completion date: Apr 2023 ➔ Dec 2022

Trial primary completion date • Breast Cancer • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma

Study of ASN004 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=43 | Recruiting | Sponsor: Asana BioSciences | Not yet recruiting ➔ Recruiting | Trial completion date: Dec 2022 ➔ Dec 2023 | Trial primary completion date: Apr 2022 ➔ Apr 2023

Enrollment open • Trial completion date • Trial primary completion date • Breast Cancer • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma

Asana BioSciences Announces Dosing of First Patient in Phase 1 Trial of ASN004, a Novel 5T4-Antibody-Drug-Conjugate (Businesswire) - "Asana BioSciences...announced that the first patient has been dosed in a Phase 1 trial for ASN004, an antibody drug conjugate (ADC) targeting the 5T4 oncofetal antigen (trophoblast glycoprotein), that is expressed in a wide range of malignant tumors but shows very limited expression in normal tissues. Higher 5T4 expression is associated with worse clinical outcome in non-small cell lung, head and neck, gastric, pancreatic, colorectal, and ovarian cancers."

Trial status • Colon Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor

ASN004, a 5T4-targeting scFv-Fc antibody-drug conjugate with high drug-to-antibody ratio, induces complete and durable tumor regressions in preclinical models. (PubMed, Mol Cancer Ther) - "In head-to-head studies, superior activity of ASN004 was demonstrated against trastuzumab-DM1, in a low-5T4/high-HER2 expressing gastric tumor model, and 10-fold greater potency was found for ASN004 against the 5T4-targeted ADC PF-06263507 in a lung tumor model. In marmoset monkeys, ASN004 was well tolerated at doses up to 1.5 mg/kg Q3W iv, and showed dose-dependent exposure, linear pharmacokinetics, and markedly low exposure of free payload drug. Taken together, these findings identify ASN004 as a promising new ADC therapeutic for clinical evaluation in a broad range of solid tumor types."

Journal • Preclinical • Cervical Cancer • Gastric Cancer • Gastrointestinal Cancer • Lung Cancer • Oncology • Solid Tumor • HER-2 • TPBG

Study of ASN004 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=43; Not yet recruiting; Sponsor: Asana BioSciences; Trial completion date: Dec 2021 ➔ Dec 2022; Initiation date: Apr 2021 ➔ Aug 2021; Trial primary completion date: Apr 2021 ➔ Apr 2022

Clinical • Trial completion date • Trial initiation date • Trial primary completion date • Breast Cancer • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma

Study of ASN004 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=43; Not yet recruiting; Sponsor: Asana BioSciences; Initiation date: Sep 2020 ➔ Apr 2021; Trial primary completion date: Sep 2021 ➔ Apr 2021

Clinical • Trial initiation date • Trial primary completion date • Breast Cancer • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma

Study of ASN004 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=43; Not yet recruiting; Sponsor: Asana BioSciences

Clinical • New P1 trial • Breast Cancer • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma • Thoracic Cancer

ASN004, a novel 5T4-targeted Dolaflexin ADC, causes complete and durable tumor regression in a variety of tumor xenograft models (EORTC-NCI-AACR 2017) - "The broad, superior activity of ASN004 was demonstrated in a head-to-head study against trastuzumab-DM1, in a low-5T4/high-HER2 expressing tumor model. In summary, ASN004 has been established as a promising ADC therapeutic for multiple tumor types, encompassing a wide range of 5T4-expression levels. IND-enabling studies are ongoing in preparation for advancement to clinical development."

Gastric Cancer