- Chimeric Therapeutics made significant progress during the June quarter, which involved the completion of the first patient cohort in the CLTX CAR T Phase 1 clinical trial and commencement of second dose cohort.
- The oncology firm also onboarded Dr Li Ren, a senior CAR T therapy executive from Bristol-Myers Squibb, as the VP of Technical Operations.
- Chimeric concluded the June quarter in a strong financial position to support CLTX CAR T development and build a cell therapy pipeline.
Clinical-stage cell therapy company Chimeric Therapeutics Limited (ASX:CHM) has provided a summary of its activities for the June 2021 quarter (period ended 30 June 2021). The Company successfully completed the first cohort of its Phase 1 CLTX trial and commenced the second cohort during the period. Moreover, Chimeric ended the quarter in a strong financial position with the ability to support CLTX CAR T development and build a cell therapy pipeline in the future.
The illustration below indicates the key highlights from the quarter:
Chimeric makes crucial progress in Phase 1 CLTX trial
In late March, Chimeric Therapeutics announced that all patients in the first patient cohort of the Phase 1 CLTX trial had been dosed. More significantly, all the patients dosed in the first patient cohort had progressed beyond the 28-day follow-up period without experiencing any dose-limiting toxicities.
The cohort 1 safety milestone for all patients enabled the Company to advance the clinical trial to the second dosing level, which is underway currently. In this level, cells are administered by dual route of administration- intratumoral (ICT) and intracranial intraventricular (ICV)- at a total dose of 88 x 106 CAR T cells. There is no FDA-mandated stagger for dose administration in the second cohort.
Source: CHM Presentation (18 March 2021)
Initiation of second dose cohort for CLTX CAR T
In May 2021, CHM disclosed that the first trial participants in the second dose cohort of the Phase 1 CLTX trial had received dosing. With the dose administration of the first patient in the second cohort, CHM introduced dual, ICT and ICV, administration of CLTX CAR T cells.
ASCO Abstract Acceptance
During the quarter, the American Society of Clinical Oncology (ASCO) chose the first CLTX CAR T abstract for presentation at the 2021 ASCO Annual Meeting. The abstract was presented by Dr Christine Brown in the ‘Trials in Progress: Developmental Therapeutics—Immunotherapy’ section. It highlighted the Phase 1 trial design and objectives for CLTX CAR T, a first and potentially best-in-class CAR T cell therapy with the potential to address the high unmet medical need in recurrent or progressive glioblastoma.
Key official roped in
Chimeric Therapeutics announced the appointment of Dr Li Ren as VP, Technical Operations in late June 2021. Dr Ren has over 20 years of extensive experience in the development and advancement of cell therapy drug candidates, from the preclinical stage through to commercialisation.
During her career, she has headed the process and analytical development of several allogeneic and autologous cell therapy products, including CAR T cells, mesenchymal-like stem cells, NK cells, and TCR cells.
Dr Ren joined CHM from Bristol-Myers Squibb (BMS), where she recently supervised the technology transfers of Juno cell therapy pipeline products to BMS’ manufacturing facilities.
Notably, Chimeric Therapeutics had AU$22.4 million in cash and equivalents as of 30 June 2021, sufficient to support CLTX CAR T development and build cell therapy pipeline.
On 29 July 2021, CHM shares were trading at AU$0.325 (at 10:30 AM AEST).