Chimeric Announces Launch of New Phase 1B Glioblastoma Clinical Trial

• New CHM 1101 (CLXT CAR T) multi-center clinical trial activated at Sarah Cannon Research Institute (SCRI) in Austin, Texas
• Enrolment now open to patients with recurrent and/or progressive glioblastoma multiforme (GBM), the most common and most deadly primary brain cancer

SYDNEY, Australia, June 04, 2023 (GLOBE NEWSWIRE) — Chimeric Therapeutics (ASX:CHM, “Chimeric” or the “Company”), the only clinical stage cell therapy company on the ASX, 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. (ClinicalTrials.gov Identifier: NCT05627323)

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.

“We are very excited to be activating the first site in our CHM 1101 Phase 1B clinical trial as it marks a new chapter in the development of CHM 1101,” said Jennifer Chow, CEO and Managing Director of Chimeric Therapeutics. “This multi-center trial will enable us to more rapidly advance the development of CHM 1101 with recruitment across multiple clinical trial sites and also prepare us to accelerate the next phase of development if supported by the clinical results.”

This Phase 1B trial, being conducted under a US IND, is a two-part clinical trial designed to determine a recommended Phase 2 dose and administration schedule. Part A of the trial will enroll 3-6 patients at the highest dose tested in the ongoing clinical trial at City of Hope Cancer Centre.

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.

Upon successful completion of the Part B dose expansion cohort, the Company intends to design and initiate a registration trial, in collaboration with global regulatory feedback.

“We’re very pleased to be building upon the City of Hope investigator-initiated trial and advancing CHM 1101 to a multi-center clinical trial. GBM continues to represent an important unmet medical need and the early clinical results from the City of Hope trial provide support that CHM 1101 may improve outcomes for GBM patients,” said Jason B Litten MD, Chief Medical Officer, Chimeric Therapeutics.

CHM 1101 demonstrated safety with ~70% disease stability in the initial two dose cohorts in the City of Hope Phase 1A investigator-initiated clinical trial.

Additional details on the CHM Phase 1B trial design and objectives were presented on June 3 at the American Society of Clinical Oncology (ASCO) annual meeting as part of the Central Nervous System Tumors section as abstract TPS2086/Poster 440a, “Phase 1B multicenter study to evaluate CHM 1101 in patients with recurrent or progressive glioblastoma”.

About CHM 1101:

CHM 1101 (CLTX CAR T) is a first-in-class CAR T therapy that has the potential to address the high unmet medical need of patients with recurrent or progressive glioblastoma. Research to develop the intellectual property covering this CAR T cell therapy took place at City of Hope.

CHM 1101 cells uniquely utilize chlorotoxin (CLTX), a peptide component of scorpion venom, as the tumour-targeting component of the chimeric antigen receptor (CAR). CHM 1101 CAR T cells have been shown in preclinical models to bind more broadly and specifically to GBM cells than other targeting domains like EGFR, HER-2 or IL-13.

In preclinical models, CHM 1101 cells also demonstrated potent antitumor activity against glioblastoma while not exhibiting any off-tumor recognition of normal human cells and tissues, indicating a potentially optimal safety and efficacy profile.

CHM 1101 is currently being studied in a Phase 1B clinical trial in recurrent / progressive glioblastoma. Initial positive data from the investigator-initiated Phase 1A trial has been presented on patients treated in the first two dose levels of the trial.

ABOUT CHIMERIC THERAPEUTICS

Chimeric Therapeutics, a clinical stage cell therapy company and an Australian leader in cell therapy, is focused on bringing the promise of cell therapy to life for more patients with cancer. We believe that cellular therapies have the promise to cure cancer, not just delay disease progression.

To bring that promise to life for more patients, Chimeric’s world-class team of cell therapy pioneers and experts is focused on the discovery, development, and commercialization of the most innovative and promising cell therapies.

Chimeric currently has a diversified portfolio that includes first-in-class autologous CAR T cell therapies and best-in-class allogeneic NK cell therapies. Chimeric assets are being developed across multiple different disease areas in oncology with 3 current clinical programs and plans to open additional clinical programs in 2023.

CHM 1101 (CLTX CAR T) is a novel and promising CAR T therapy developed for the treatment of patients with solid tumours. CHM 1101 is currently being studied in a Phase 1B clinical trial in recurrent / progressive glioblastoma. Initial positive data from the investigator-initiated Phase 1A trial has been presented on patients treated in the first two dose levels of the trial.

CHM 2101 (CDH17 CAR T) is a first-in-class, 3rd generation CDH17 CAR T invented at the world-renowned cell therapy centre, the University of Pennsylvania. Preclinical evidence for CHM 2101 was published in March 2022 in Nature Cancer demonstrating complete eradication of tumors in 7 types of cancer. CHM 2101 (CDH17 CAR T) is currently in preclinical development with a planned Phase 1A clinical trial in gastrointestinal and neuroendocrine tumours.

CHM 0201 (CORE-NK platform) is a potentially best-in-class, clinically validated NK cell platform. Data from the complete Phase 1A clinical trial was published in March 2022, demonstrating safety and efficacy in blood cancers and solid tumours. Based on the promising activity signal demonstrated in that trial, an additional Phase 1B clinical trial investigating CHM 0201 in combination with IL2 and Vactosertib is now underway. From the CHM 0201 platform, Chimeric has initiated development of new next generation NK and CAR NK assets.

Authorised on behalf of the Chimeric Therapeutics board of directors by Chairman Paul Hopper.

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