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Updated 4th June 2025
Chimeric Therapeutics (ASX: CHM) has received fast-track designation from the US Food and Drug Administration (FDA) for lead candidate CHM CDH17 to treat gastroenteropancreatic neuroendocrine tumours (GEP-NETs).
The FDA based its designation on the drug’s potential to improve outcomes for patients who have progressed beyond at least one prior line of therapy in the advanced or metastatic setting.
What does fast-track mean? It will create a faster development pathway for CHM CDH17, giving Chimeric access to more frequent meetings with the FDA to discuss the drug’s development plan and eligibility for accelerated approval.
Read more here
Updated 31st August 2024 to provide additional details of Clincial Trial CDH17 and the addition of a new multi cancer trial which includes Neuroendocrine Neoplasms.
Original post published 26th October 2021
CAR-T – chimeric antigen receptor T-cell – therapy is specifically developed for each individual patient and involves reprogramming the patient’s own immune system cells which are then used to target their cancer, i.e. it’s an immunotherapy. It is a highly complex and potentially risky treatment, but it has been shown in trials to cure some patients, even those with quite advanced cancers and where other available treatments have failed.
The treatment involves several steps over a number of weeks. First the patient’s blood is taken and is sent off to the manufacturer’s laboratory. Here the patient’s blood is ‘trained’ to fight the cancer cells. The CAR-T blood is then transported back to the hospital and the patient is administered with the CAR-T to treat their condition.
It has not been deployed in clinical trials for Neuroendocrine Neoplasms but leading CAR-T company Chimeric recently announced the expansion of their pipeline with the exclusive licensing of CHM 2101, a novel, 3rd generation CDH17 CAR T invented at the University of Pennsylvania. CHM 2101 (CDH17 CAR T) is currently in preclinical development with a planned phase 1 clinical trial in 2022 in Neuroendocrine Tumours, Colorectal, Pancreatic and Gastric Cancer.
ANNOUNCEMENT: CHIMERIC ACHIEVES FIRST MILESTONE ON THE PATH TO CDH17 CAR T CLINICAL TRIAL
● Phase 1 plasmid manufacturing commenced
● Phase 1 clinical trial for neuroendocrine & colorectal tumors planned for 2022
● Positions Chimeric to have a minimum of two Phase 1 trials underway during 2022
Chimeric Therapeutics (ASX:CHM, “Chimeric”), a clinical-stage cell therapy company and the ASX leader in cell therapy, is pleased to announce the successful completion of the manufacturing for CHM 2101 research-grade plasmids, a critical first step in the development of CDH17 CAR T. Manufacturing of CAR T therapies is dependent upon plasmids and viral vectors that hold the genetic instructions for each specific CAR T product. Plasmids are small DNA molecules that carry genetic instructions and their successful manufacture marks an important early step for all CAR T therapies.
In collaboration with the University of Pennsylvania, all of the research-grade helper and transfer plasmids for the CDH17 CAR T have been completed and released. The achievement of this first step in CAR T manufacturing enables progression to research vector manufacturing, GMP plasmid and vector manufacturing and advancement of technical operations in readiness for the CDH17 CAR T phase 1 clinical trial.
Chimeric’s CEO and Managing Director Jennifer Chow said: “We are very pleased that we have been able to achieve this key first step so rapidly after licensing. This accomplishment speaks to the commitment and drive that the Chimeric and University of Pennsylvania teams share to move this important CAR T forward to Phase 1 clinical trials.”
In addition to commencing the CDH17 CAR T Phase 1 trial in 2022, Chimeric is also progressing its CLTX CAR T Phase 1 clinical trial in glioblastoma (brain cancer) at The City of Hope Cancer Centre in California, where patients are now receiving second dose levels.
Interest point. The UK NHS is already using CAR-T for treating relapsed or refractory B-cell acute lymphoblastic leukaemia (ALL) in people up to the age of 25 years. A second one has been approved for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after 2 or more systemic therapies. Read here.
A more in-depth summary of CAT-T tech is given here.
This is a Phase 1/2 open-label study to evaluate CHM-2101, an autologous CDH17 CAR T-cell therapy for the treatment of advanced gastrointestinal (GI) cancers that are relapsed or refractory to at least 1 standard treatment regimen in the metastatic or locally advanced setting. The study has 2 parts: Phase 1, Dose Escalation and Expansion, and Phase 2.
Potential participants will provide written consent and be screened for study eligibility prior to undergoing any screening procedures, including leukapheresis. Protocol-specified criteria must be met prior to the start of leukapheresis for collection of peripheral blood mononuclear cells (PBMCs). Eligible participants will undergo leukapheresis to collect PBMCs for product manufacturing, which comprises enrichment of T cells, lentiviral transduction, ex vivo expansion, and cryopreservation of the CHM-2101 cell product. Participants who have a leukapheresis or manufacturing failure may be permitted a second attempt at leukapheresis.
Bridging chemotherapy (treatment between the time of leukapheresis and first dose of lymphodepleting chemotherapy [LDC]) is permitted at the discretion of the investigator, if needed to maintain disease stability during CHM-2101 manufacturing time. Bridging chemotherapy is prohibited within the 2 weeks prior to leukapheresis and 2 weeks prior to planned CHM-2101 infusion.
Specific criteria to proceed should be reviewed prior to leukapheresis, LDC, and CHM-2101 infusion.
Participants will be followed in this study for 18 months or until disease progression.
Click the blue link below to see the clinical trials document:
A Phase 1/2 Study to Evaluate CHM-2101, an Autologous Cadherin 17 Chimeric Antigen Receptor (CAR) T Cell Therapy – Full Text View – ClinicalTrials.gov – (ClinicalTrials.gov ID: NCT06055439)
Update October 31st, 2023
Chimeric Therapeutics, an Australian leader in cell therapy, 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. 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 – see details of the trial below.
See announcement – click here
This article indicates the preclinical in vivo trials look promising. Potent suppression of neuroendocrine tumors and gastrointestinal cancers by CDH17CAR T cells without toxicity to normal tissues | Nature Cancer
Update 29th August 2024
First patient dosed. Read more here.
This is a phase 1 multiple cancer clinical trial taking place in UCLA California. The list includes Metastatic Malignant Solid Neoplasm (technically includes all Stage IV Neuroendocrine Neoplasms) but individual types mentioned below. Inclusion criteria indicates conditions must be ‘relapsed’ or ‘refractory’.
The list from clinical trials document.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided in the clinical trials document. It’s very important to check the trial inclusion and exclusion criteria before making any contact. If you need questions, the articles here is very useful Questions to Ask About Clinical Trials | Cancer.Net
The inclusion of any trial within this blog should not be taken as a recommendation by Ronny Allan.
Whenever I post about a trial or study, some people get excited without understanding that these new treatments and capabilities can very often take years to come to fruition and it’s also possible that clinical trials can be halted, or that national approval agencies will not approve the final product. Plus, not everyone will be eligible, so always check the exclusion and inclusion criteria in the relevant clinical trials document. Please bear that in mind when reading studies/clinical trials posted on RonnyAllan.NET
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