CHM 1101 / Chimeric Therap, City of Hope - LARVOL DELTA

Chimeric Antigen Receptor (CAR) T Cells With a Chlorotoxin Tumor-Targeting Domain for the Treatment of MMP2+ Recurrent or Progressive Glioblastoma (clinicaltrials.gov) - P1 | N=19 | Active, not recruiting | Sponsor: City of Hope Medical Center | Trial completion date: Aug 2025 ➔ Jun 2026 | Trial primary completion date: Aug 2025 ➔ Jun 2026

Trial completion date • Trial primary completion date • Brain Cancer • Glioblastoma • Glioma • High Grade Glioma • Oncology • Solid Tumor • MMP2

Chlorotoxin-directed CAR T cell therapy for recurrent glioblastoma: Interim clinical experience demonstrating feasibility and safety. (PubMed, Cell Rep Med) - P1 | "Here, we report interim clinical experience of a phase 1 trial evaluating intracavity/intratumoral (ICT) delivery of CLTX-CAR T cells in four patients with MMP-2-expressing recurrent GBM (NCT04214392), with the primary objectives of feasibility and safety...Human anti-CAR antibody assays do not detect humoral immunogenicity against the CLTX-CAR. These observations support further clinical evaluation of CLTX-CAR therapy."

Journal • Brain Cancer • Glioblastoma • Glioma • Oncology • Solid Tumor • MMP2

Chimeric Antigen Receptor (CAR) T Cells With a Chlorotoxin Tumor-Targeting Domain for the Treatment of MMP2+ Recurrent or Progressive Glioblastoma (clinicaltrials.gov) - P1 | N=19 | Active, not recruiting | Sponsor: City of Hope Medical Center | Recruiting ➔ Active, not recruiting | N=36 ➔ 19

Enrollment change • Enrollment closed • Brain Cancer • Glioblastoma • Glioma • High Grade Glioma • Oncology • Solid Tumor • MMP2

Chimeric Antigen Receptor (CAR) T Cells With a Chlorotoxin Tumor-Targeting Domain for the Treatment of MMP2+ Recurrent or Progressive Glioblastoma (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: City of Hope Medical Center | Trial primary completion date: Sep 2024 ➔ Aug 2025

Trial primary completion date • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Malignant Glioma • Oncology • Solid Tumor • MMP2

Chimeric Therapeutics (ASX:CHM) Announces AU$5Mn Placement to Advance Cancer Trials (Kalkine Media) - "The company has secured commitments from a range of institutional, sophisticated and professional investors. The funds raised will primarily support Chimeric’s clinical trial programs...The issue price is set at AU$0.008 (0.8 cents) per new fully paid ordinary share...Proceeds from the placement will primarily support Chimeric’s clinical trial pipeline and cell therapy portfolio, including: CHM CDH17 CAR-T Program...in a Phase 1/2 trial for various cancers...CHM CLTX Program: A novel CAR T therapy currently in a Phase 1b clinical trial for glioblastoma...CORE NK Platform: A Phase 1B clinical trial assessing NK cells combined with Vactosertib in patients with advanced colorectal and blood cancers, following a successful Phase 1A trial....Funding will also cover general working capital and capital-raising costs."

Financing • Brain Cancer • CNS Tumor • Colorectal Cancer • Gastrointestinal Cancer • Glioblastoma • Glioma • Hematological Malignancies • Oncology • Solid Tumor

CHIMERIC PARTNERING WITH CELL THERAPIES AUSTRALIA (Chimeric Therapeutics Press Release) - "Chimeric Therapeutics...is pleased to announce a collaboration with Cell Therapies Pty Ltd to explore the potential to manufacture Chimeric’s CAR T assets in Australia...CTPL’s facilities are co-located with the Peter MacCallum Cancer Centre in Melbourne’s Parkville Precinct and are Australia’s only biomedical manufacturing facility where CAR T-cells and other 'living' cancer therapies can be made at a commercial scale....Chimeric currently has four Phase 1/1b trials open across the United States and is exploring the addition of new sites in Australia."

Licensing / partnership • Oncology • Solid Tumor

CAR T Cells in Patients With MMP2+ Recurrent or Progressive Glioblastoma (clinicaltrials.gov) - P1 | N=42 | Active, not recruiting | Sponsor: Chimeric Therapeutics | Recruiting ➔ Active, not recruiting | Trial primary completion date: Oct 2024 ➔ Oct 2025

CAR T-Cell Therapy • Enrollment closed • Trial primary completion date • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • MMP2

Chimeric Therapeutics highlights key cell therapy targets in treatment of various cancers (Small Caps) - "Chimeric Therapeutics...has reported strong progress for the 12 months to end December and highlighted key cell therapy targets for the coming year...Chimeric achieved multiple milestones in the advancement of the CHM 1101 clinical program to treat recurrent and progressive glioblastoma...The company plans to advance to a dose expansion cohort this year and anticipates milestones including US Food and Drug Administration clearance and early clinical data from the cohort...CHM 2101 submission....This year, the trial will be initiated at leading US institutions and Chimeric expects to provide a clinical update on patients treated at the initial dose level prior to year end."

FDA event • P1 data • P1/2 data • Trial status • CNS Tumor • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Glioblastoma • Glioma • Neuroendocrine Tumor • Oncology • Solid Tumor

Chimeric Antigen Receptor (CAR) T Cells With a Chlorotoxin Tumor-Targeting Domain for the Treatment of MMP2+ Recurrent or Progressive Glioblastoma (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: City of Hope Medical Center | Trial completion date: Aug 2026 ➔ Sep 2025 | Trial primary completion date: Aug 2026 ➔ Sep 2024

Trial completion date • Trial primary completion date • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor • MMP2

Chimeric Antigen Receptor (CAR) T Cells With a Chlorotoxin Tumor-Targeting Domain for the Treatment of MMP2+ Recurrent or Progressive Glioblastoma (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: City of Hope Medical Center | Trial completion date: Dec 2024 ➔ Aug 2026 | Trial primary completion date: Jan 2024 ➔ Aug 2026

Trial completion date • Trial primary completion date • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor • MMP2

CAR T Cells in Patients With MMP2+ Recurrent or Progressive Glioblastoma (clinicaltrials.gov) - P1 | N=42 | Recruiting | Sponsor: Chimeric Therapeutics

CAR T-Cell Therapy • Trial completion date • Trial primary completion date • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • MMP2

CAR T Cells in Patients With MMP2+ Recurrent or Progressive Glioblastoma (clinicaltrials.gov) - P1 | N=42 | Recruiting | Sponsor: Chimeric Therapeutics | Phase classification: P1b ➔ P1

CAR T-Cell Therapy • Phase classification • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • MMP2

Initial clinical experience with chlorotoxin-redirected CAR T cells for patients with recurrent glioblastoma (SITC 2023) - P1 | "Results Here we report clinical outcomes and correlative observations for four lead-in research participants, all of whom had a histopathological diagnosis of glioblastoma, idh wild type, grade 4, and who had received prior temozolomide as well as radiation and other treatments. Conclusions Phase 1 clinical observations to date confirm the feasibility and safety of CLTX-CAR T cell immunotherapy for patients with GBM. These studies will lead to determination of a maximum tolerated dose/maximum feasible dose."

CAR T-Cell Therapy • Clinical • IO biomarker • Late-breaking abstract • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • MMP2

Chimeric Therapeutics (ASX:CHM) completes dose escalation in phase 1A brain cancer trial (The Market Herald) - "Chimeric Therapeutics (CHM) has treated the third patient participating in its phase 1A dose escalation study at the City of Hope Hospital in California. This clinical trial involves the company’s novel drug candidate, CHM 1101, and marks the completion of the fourth and final cohort. The study focused on assessing safety and determining the maximum tolerated dose in patients with recurrent or progressive glioblastoma (GBM)....Upon successful completion of the second part of the dose expansion cohort, the company intends to design and initiate a registrational trial in accordance with regulatory guidance and feedback."

New trial • Trial status • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

CAR T Cells in Patients With MMP2+ Recurrent or Progressive Glioblastoma (clinicaltrials.gov) - P1b | N=42 | Recruiting | Sponsor: Chimeric Therapeutics | Not yet recruiting ➔ Recruiting | Initiation date: Feb 2023 ➔ Jun 2023

CAR T-Cell Therapy • Enrollment open • Trial initiation date • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • MMP2

Phase 1b multicenter study to evaluate CHM 1101 in patients with recurrent or progressive glioblastoma. (ASCO 2023) - P1b | "Recruitment is ongoing. Clinical trial information: NCT05627323."

Clinical • P1 data • Astrocytoma • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • MMP2

Chimeric Announces Launch of New Phase 1B Glioblastoma Clinical Trial (GlobeNewswire) - "Chimeric Therapeutics...is pleased to announce activation of a Phase 1B clinical trial in patients with recurrent and/ or progressive glioblastoma multiforme (GBM) to assess the safety and efficacy of CHM 1101, the company’s first in class CLTX CAR T cell therapy....The trial is now open for enrollment at the Sarah Cannon Transplant & Cellular Therapy Program at St. David’s South Austin Medical Center in Austin, Texas....In late 2023, Chimeric will assess the clinical safety and activity from the CHM 1101 clinical program. Based on a favorable review of the results of that assessment, Part B of the trial, a dose expansion cohort, will be opened to enroll 12 to 26 additional patients."

P1 data • Trial status • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor

Chimeric Therapeutics receives patent protection in India for CLTX CAR technology, allowance notice in Israel (Proactiveinvestors) - "Chimeric Therapeutics Ltd...is moving swiftly in the quest to expand its CLTX CAR intellectual property portfolio, with the receipt of a patent grant from India and a notice of allowance from Israel. The India patent covers certain applications of chimeric antigen receptor (CAR) technology using chlorotoxin (CLTX), including Chimeric’s clinical-stage CAR T asset CHM 1101 and pre-clinical stage CAR NK asset CHM 1301....The India patent has been granted under patent number IN 424963, while the Official Notification Prior to Acceptance from the Israel Patent Office is for application IL 258670. Chimeric Therapeutics, the only ASX-listed clinical stage cell therapy company, holds the exclusive worldwide licence to develop and commercialise IN 424963, IL 258670, and related patent applications filed in other global territories."

Patent • Oncology • Solid Tumor

Chimeric Therapeutics garners ethics approval for Phase 1B multi-site brain cancer study (Proactiveinvestors) - "Chimeric Therapeutics Ltd...has the ethics review board’s green light to initiate a multi-site Phase 1B clinical trial of CHM 1101 in patients with recurrent and/ or progressive glioblastoma multiforme (GBM)....'The two-part trial design also ensures that we are positioned to move rapidly into the dose expansion cohort upon a positive clinical assessment of the Phase 1 data at the end of 2023.' The company will present additional details of its CHM Phase 1B trial design and objectives at the American Society of Clinical Oncology (ASCO) annual meeting as part of the Central Nervous System Tumors section on June 3, 2023."

Clinical protocol • P1 data • Trial status • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

Chimeric’s (ASX:CHM) CHM 1101 GBM abstract selected for presentation at American Society of Clinical Oncology meeting (Kalkine Media) - "Australia's Chimeric Therapeutics...has announced that the abstract of one of its CAR T therapies would be a part of the presentation at the American Society of Clinical Oncology’s Annual Meeting 2023....In the latest development, CHM 1101 abstract would now be in the presentation at June 2023 event of the American Society of Clinical Oncology. The abstract highlights the therapy's clinical trial design and other aspects."

Clinical protocol • Brain Cancer • CNS Tumor • Glioblastoma • Oncology

Chimeric Antigen Receptor (CAR) T Cells With a Chlorotoxin Tumor-Targeting Domain for the Treatment of MMP2+ Recurrent or Progressive Glioblastoma (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: City of Hope Medical Center | Trial completion date: Dec 2023 ➔ Dec 2024

Trial completion date • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor • MMP2

Chimeric Therapeutics welcomes initiation of fourth dose cohort in CHM 1101 Phase 1 trial (Proactiveinvestors) - “Chimeric Therapeutics Ltd (ASX:CHM) welcomes initiation of the fourth dose cohort of City of Hope’s phase 1 clinical trial evaluating the safety and tolerability of Chimeric’s CHM 1101 (CLTX CAR T) cell therapy. The first patient in the fourth dose cohort in the phase 1 clinical trial in recurrent/progressive glioblastoma has received dosing at City of Hope Cancer Center in the US. This cohort will see patients treated at a total dose of 440 X 106 CHM 1101 (CLTX CAR T cells) through dual routes of intratumoral and intraventricular administration.”

Trial status • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor

Chimeric Antigen Receptor (CAR) T Cells With a Chlorotoxin Tumor-Targeting Domain for the Treatment of MMP2+ Recurrent or Progressive Glioblastoma (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: City of Hope Medical Center | Trial completion date: Feb 2023 ➔ Dec 2023 | Trial primary completion date: Feb 2023 ➔ Dec 2023

Trial completion date • Trial primary completion date • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor • MMP2

"#ChimericTherapeutics reported Follow Up Period Completed for 3rd Cohort in #CHM1101 Trial $CHM https://t.co/9cG4zDEyI5" (@1stOncology)

Chimeric Therapeutics completes dosing in third dose cohort of CHM 1101 Phase 1 clinical trial (Proactiveinvestors) - "Chimeric Therapeutics Ltd...welcomes the successful completion of the planned dosing of the third patient cohort in a Phase 1 dose-escalation study evaluating the safety and maximum tolerated dose of the company’s CHM 1101 (CLTX CAR T) cell therapy, in patients with recurrent or progressive glioblastoma....Once the final evaluable patient of this third dose cohort successfully completes the 28-dose-limiting toxicity (DLT) period, the study will be able to advance to the recruitment of patients at the fourth and final planned dose level of 440 X 106 CHM 1101 (CLTX CAR T) cells through dual routes of administration (intratumoral and intracranial intraventricular)."

Trial status • Brain Cancer • CNS Tumor • Glioblastoma • Oncology