CHM 2101 / Chimeric Therap, University of Pennsylvania - LARVOL DELTA

Chimeric Therapeutics…is pleased to announce it has been granted Orphan Drug Designation from the US Food and Drug Administration (FDA) for CHM CDH17 in the treatment of Gastric Cancer (Chimeric Therapeutics Press Release) - "The Phase 1/2 trial (NCT06055439) of CHM CDH17 is a two-stage study designed to determine a recommended Phase 2 dose and evaluate its safety and objective response rate in patients with advanced colorectal cancer, gastric cancer, and gastrointestinal NETs....The Phase 1 portion of this study is expected to enrol up to 15 patients and lead to dose selection and expansion with indication-specific Phase 2 cohorts."

Orphan drug • Trial status • Colorectal Cancer • Gastric Cancer • Gastrointestinal Neuroendocrine Tumor

CHM CDH17 RECEIVES FDA FAST TRACK (Chimeric Therapeutics Press Release) - "Chimeric Therapeutics...is pleased to announce that the US Food and Drug Administration (FDA) has granted CHM CDH17 Fast Track Designation. CHM CDH17 was granted Fast Track Designation based on the FDA’s assessment of CHM-CDH17’s potential to improve outcomes for patients with gastroenteropancreatic neuroendocrine tumours (GEP-NETs) who have progressed beyond at least one prior line of therapy in the advanced or metastatic setting....The ongoing Phase 1/2 trial (NCT06055439) is a two-stage study designed to determine a recommended Phase 2 dose of CHM CDH17 and evaluate its safety and objective response rate in patients with advanced colorectal cancer, gastric cancer, and intestinal neuroendocrine tumours (NETs)....The Phase 1 portion of this study is expected to enrol up to 15 patients and lead to dose selection and expansion with indication-specific Phase 2 cohorts."

Fast track • Trial status • Neuroendocrine Tumor

Chimeric announces US patent allowed for CHM CDH17 technology (BiotechDispatch) - "The allowed patent application 17/050,299, entitled 'Compositions and Methods for Retrieving Tumour-related Antibodies and Antigens', provides intellectual property protection for Chimeric's CHM CDH17 CAR-T therapy, which targets CDH17, a protein highly expressed on gastrointestinal cancer cells associated with poor prognosis and metastasis...The company said the allowed patent is expected to provide protection until at least 2039..The technology is currently in a first-in-human Phase 1/2 clinical trial at leading US cancer centres, including the Sarah Cannon Research Institute, the University of Pennsylvania, and UChicago Medicine."

Patent • Colorectal Cancer • Gastric Cancer • Neuroendocrine Tumor

A phase 1/2 study to evaluate CHM-2101, an autologous cadherin 17 (CDH17) chimeric antigen receptor (CAR) T cell therapy for the treatment of relapsed or refractory gastrointestinal cancers. (ASCO-GI 2025) - P1/2 | "In preparation for receiving CDH17 CAR T-cells, subjects receive 3-days of lymphodepleting intravenous (IV) chemotherapy (fludarabine and cyclophosphamide). This is an ongoing first-in-human multi-center clinical trial of CHM CDH17, a CDH17 directed autologous CAR T-cell product candidate, enrolling subjects with advanced GI cancers that express CDH17. Expression of CDH17 in selected gastrointestinal cancer indications.*Expression of total tumors tested for CDH17 by immunohistochemistry (CHM data on file)."

IO biomarker • P1/2 data • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CDH17

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

UNIVERSITY OF PENNSYLVANIA JOINS CHM CDH17 PHASE 1/2 CLINICAL TRIAL (Chimeric Therapeutics Press Release) - "himeric Therapeutics...is pleased to announce that University of Pennsylvania (Penn) is open to enrol patients in the Phase 1/2 multi-centre clinical trial for CHM CDH17 cell therapy...The Phase 1/2 trial (NCT06055439) is a two-stage study designed to determine a recommended Phase 2 dose of CHM CDH17 and evaluate its safety and objective response rate in patients with advanced colorectal cancer, gastric cancer, and intestinal neuroendocrine tumours....Additional clinical trial sites are anticipated to open to enrolment in the second half of 2024." "

Enrollment status • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor

Chimeric says Phase 1/2 CHM CDH17 CAR-T GMP manufacturing complete (BiotechDispatch) - "...Chimeric Therapeutics...has announced the completion of Good Manufacturing Practice (GMP) manufacturing to enable the treatment of the first clinical participant in the CHM CDH17 CAR-T trial...The cells of the trial participants were collected at Sarah Cannon Cancer Centre in Nashville, Tennessee, and transported to the contract manufacturing site...The company said that following GMP manufacturing, the CHM CDH17 CAR-T cells passed specification testing and quality Assurance review and are in transit back to the clinical trial site for infusion...The Phase 1/2 trial (NCT06055439) is a two-stage study designed to determine a recommended Phase 2 dose of CHM CDH17 and evaluate its safety and objective response rate in participants with advanced colorectal, gastric, and intestinal neuroendocrine tumours....The company said additional clinical trial sites are anticipated to open in the second half of 2024."

Commercial • Trial status • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Neuroendocrine Tumor • 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

Chimeric Therapeutics says first patient enrolled in cell therapy trial (BiotechDispatch) - "Australian cell therapy company Chimeric Therapeutics has announced that the first patients have been enrolled in the new clinical trial of its CHM CDH17 in patients with different forms of cancer...The Phase 1/2 trial is a two-stage study designed to determine a recommended Phase 2 dose of CHM CDH17 and evaluate its safety and objective response rate in patients with advanced colorectal cancer, gastric cancer, and intestinal neuroendocrine tumours....CHM CDH17 is a first-in-class, third-generation CDH17 CAR-T discovered at the University of Pennsylvania's cell therapy centre."

Enrollment open • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor

CHIMERIC ANNOUNCES OPENING OF CHM CDH17 PHASE 1/2 TRIAL (Listcorp) - "Chimeric Therapeutics...is pleased to announce activation of the Phase 1/2 multi-centre clinical trial for its CHM CDH17 CAR T cell therapy (CHM 2101)...The trial is now open for enrolment at SCRI Oncology Partners in Nashville, Tennessee, a world-class cancer centre with expertise in executing first-in-human trials, developing new cancer medicines and delivering complex cell and gene therapies for patients...The Phase 1/2 trial (NCT06055439), being conducted under a US IND, is a two-stage study designed to determine a recommended Phase 2 dose of CHM CDH17 (CHM 2101) and evaluate its safety and objective response rate in patients with advanced colorectal cancer, gastric cancer, and intestinal neuroendocrine tumours....Additional clinical trial sites are anticipated to open in the second half of 2024."

Enrollment open • Trial status • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor

A Phase 1/2 Study to Evaluate CHM-2101, an Autologous Cadherin 17 Chimeric Antigen Receptor (CAR) T Cell Therapy (clinicaltrials.gov) - P1/2 | N=135 | Recruiting | Sponsor: Chimeric Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Colorectal Adenocarcinoma • Colorectal Cancer • Endocrine Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Neuroendocrine Tumor • Oncology • Solid Tumor • CDH17

Chimeric Therapeutics receives ethics approval for CHM CDH17 gastrointestinal cancer trial (Small Caps) - "Chimeric Therapeutics...has received ethics approval for the initiation of a multi-site Phase 1/2 clinical trial of CHM CDH17 in patients with advanced gastrointestinal cancers...The trial is designed to build upon pre-clinical studies that showed the therapy was able to eradicate established tumours in seven cancer models with no toxicity to normal tissues...Chief operating officer Rebecca McQualter said the approval represents a significant milestone in advancing the program toward study initiation under US Food and Drug Administration regulations....planned Phase 1A trial on gastrointestinal and neuroendocrine tumours planned for this year."

Trial status • Gastrointestinal Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor

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

A Phase 1/2 Study to Evaluate CHM-2101, an Autologous Cadherin 17 Chimeric Antigen Receptor (CAR) T Cell Therapy (clinicaltrials.gov) - P1/2 | N=135 | Not yet recruiting | Sponsor: Chimeric Therapeutics | Trial completion date: Aug 2024 ➔ Jun 2027 | Initiation date: Feb 2024 ➔ Jun 2024 | Trial primary completion date: Aug 2024 ➔ Jun 2026

Trial completion date • Trial initiation date • Trial primary completion date • Colorectal Adenocarcinoma • Colorectal Cancer • Endocrine Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Neuroendocrine Tumor • Oncology • Solid Tumor • CDH17

CHIMERIC THERAPEUTICS ANNOUNCES FDA CLEARANCE OF IND APPLICATION FOR CHM 2101, A NOVEL CDH17 CAR T CELL THERAPY FOR ADVANCED GASTROINTESTINAL CANCERS (PRNewswire) - "himeric Therapeutics...announced today that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application of CHM 2101, Chimeric's first in class CDH17 CAR T cell therapy for gastrointestinal cancers. The company plans to investigate CHM 2101 in a multi center, open label Phase 1A/B clinical trial for patients with advanced Colorectal Cancer, Gastric Cancer and Neuroendocrine Tumours....With the FDA IND clearance Chimeric will now begin the initiation of a phase 1 /2 multi-site clinical trial in patients with advanced Colorectal Cancer, Gastric Cancer and Neuroendocrine Tumours. The study is planned to begin patient enrollment in 2024."

IND • Trial status • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor

A Phase 1/2 Study to Evaluate CHM-2101, an Autologous Cadherin 17 Chimeric Antigen Receptor (CAR) T Cell Therapy (clinicaltrials.gov) - P1/2 | N=135 | Not yet recruiting | Sponsor: Chimeric Therapeutics

New P1/2 trial • Colorectal Adenocarcinoma • Colorectal Cancer • Endocrine Cancer • Gastric Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Neuroendocrine Tumor • Oncology • Solid Tumor • CDH17

Chimeric Therapeutics: Positive Response to CHM 2101 Plan (Mirage News) - "Clinical-stage cell therapy company Chimeric Therapeutics...says that it has successfully completed a pre-Investigational New Drug (pre-IND) meeting with the US FDA and has received 'positive feedback' on the development plan for CHM 2101. The company described this as a significant milestone towards an IND application and Phase 1 clinical trial for CHM 2101....Chimeric said it is focused on advancing CHM 2101 towards a phase 1A clinical trial in gastrointestinal and neuroendocrine tumours."

FDA event • Gastrointestinal Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor

Chimeric Therapeutics completes CHM 2101 viral vector manufacturing ahead of Phase 1A clinical program (Proactiveinvestors) - "Chimeric Therapeutics Ltd...has passed a key milestone in advancing the CHM 2101 CAR T cell therapy with completion of manufacturing and quality release for the viral vector....'Securing vector supply for the CHM 2101 Phase 1A clinical trial marks a significant milestone for advancing CHM 2101 towards the clinic and patients that need novel therapies to treat advanced gastrointestinal and neuroendocrine tumours'."

Commercial • Gastric Cancer • Gastrointestinal Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor

"#Chimeric takes Initial Regulatory Step towards #IND for #CHM2101 $CHM https://t.co/jzr0M2OKIl" (@1stOncology)