On October 23, 2023 Chimeric Therapeutics (ASX:CHM, "Chimeric" or the "Company"), an Australian leader in cell therapy, reported positive clinical data for CLTX CAR T in heavily pretreated, late stage, recurrent Glioblastoma patients in the Phase 1A trial, conducted at City of Hope, one of the largest cancer research and treatment organizations in the United States (Press release, Chimeric Therapeutics, OCT 23, 2023, View Source [SID1234636406]). The information provided herein is based on preliminary study data. The trial remains ongoing and will continue to be monitored and evaluated.
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Patients treated in the Phase 1A trial were heavily pretreated, on average receiving CLTX CAR T as 4th line therapy (range 3-5th line). Historical trials in recurrent GBM have generally been limited to patients treated in 2nd line.
Patients treated across all 4 dose levels of the trial achieved a 55% Disease Control Rate, exceeding expectations and historical disease control rates of 20-37% for patients treated in 2nd line.
~9.9, 95% CI [5.8, NA] months median survival was demonstrated for patients that achieved disease control, with one patient exceeding 18 months survival, two patients exceeding 14 months survival and with 3 patients remaining alive and in follow up. Survival expectations for patients after first line therapy are generally ~7 months.
The interim results suggest that CLTX CAR T was generally well tolerated, with no dose limiting toxicities (DLT’s), no Cytokine Release Syndrome (CRS) and no Tumor Lysis Syndrome (TLS). Grade 3 events were generally manageable and most often attributed to disease progression.
"The CLTX CAR T dose escalation preliminary data are truly encouraging and have exceeded our expectations, particularly given that the patients enrolled were heavily pretreated and very late stage," said Jennifer Chow, CEO and Managing Director of Chimeric Therapeutics.
"Historical therapies for recurrent Glioblastoma have generally been studied in patients with a median of 1 prior line of therapy. In contrast, the CLTX CAR T study enrolled patients with a median of 3 prior lines of therapy. The disease control rate of 55% is beyond that observed in patients treated with 2nd line therapy in historical clinical trials. Most exciting to us though, is that despite the advanced nature of the patients studied, CLTX CAR T demonstrated median survival of ~10 months for those that achieved disease control, with two patients demonstrating survival beyond 14 months. These data strongly demonstrate the potential utility of CLTX CAR T for patients with recurrent GBM."
Chimeric has now advanced development of CLTX CAR T to a Phase 1B clinical trial currently open for enrollment at the Sarah Cannon Transplant & Cellular Therapy Program at St. David’s South Austin Medical Center in Austin, Texas. The trial is being conducted under a US IND and is a two-part clinical trial (NCT04214392).
Part A of the trial will enroll 3-6 clinical trial participants at 440 X 106 CHM 1101 cells, the highest dose tested in the Phase 1A clinical trial at City of Hope. Based on the safety and efficacy demonstrated in the interim results of the Phase 1A City of Hope clinical trial, Chimeric will advance development of CLTX CAR T to Part B of the trial, an expansion cohort designed to confirm the recommended Phase 2 dose and administration schedule. Part B of the trial will enroll 12-26 additional patients.
"The preliminary data from the Phase 1A trial of CLTX CAR T reinforce our confidence in CLTX CAR T cell therapy," said Dr Jason Litten, Chief Medical Officer of Chimeric Therapeutics. "The safety profile and potential survival benefit demonstrated in these difficult-to-treat patients inspire us to advance clinical development of CLTX CAR T cell therapy. We are actively enrolling patients in our Phase 1B dose confirmation trial and now look forward to advancing our study to a dose expansion cohort in 2024".
Upon successful completion of the dose expansion cohort, Chimeric intends to design and initiate a registrational trial, in alignment with regulatory guidance and feedback. The City of Hope Phase 1A study enrolled clinical trial participants with MMP2+ recurrent or progressive GBM across four dose levels. Behnam Badie, M.D., City of Hope Chief of Division of Neurosurgery, is the trial’s principal investigator. The trial is being conducted at City of Hope’s Los Angeles campus.
Chimeric Therapeutics has licensed the exclusive global rights to intellectual property covering the chlorotoxin CAR-T cells from City of Hope, one of the largest cancer research and treatment organizations in the United States.
INVESTOR WEBINAR – 11am AEDT TODAY
Chimeric is pleased to host a webinar regarding today’s announcement, with all shareholders and interested parties welcome to attend. Chimeric’s CEO and Managing Director Jennifer Chow and Chimeric’s Chief Medical Officer, Dr Jason Litten will host the session and provide further discussion and context around the CLTX CAR T data.
An opportunity to ask questions will also be provided. When: 11am AEDT, Monday 23 October 2023
Register at: View Source Upon registering attendees will receive an email containing information about joining the webinar.
A recording will be available at the above link soon after the conclusion of the live session, with the replay to also be made available via Chimeric’s website and social media channels.
Questions can be sent in advance of the webinar to [email protected]