Chimeric Therapeutics Hits Dose Level 2, Secures FDA Fast Track, Raises $6.6M
Chimeric Therapeutics has advanced its CHM CDH17 CAR-T program with dose escalation and FDA Fast Track status, alongside promising early results in AML trials and a successful $6.6 million capital raise.
- Dose escalation to level 2 in CHM CDH17 Phase 1/2 trial
- FDA grants Fast Track Designation for GEP-NET treatment
- Fourth US clinical site activated at Emory Winship Cancer Institute
- Early encouraging results from ADVENT-AML Phase 1B trial
- Successful $6.6 million placement and $2.5 million R&D tax incentive facility
Clinical Progress Accelerates
Chimeric Therapeutics (ASX – CHM) has reported a productive quarter ending 30 June 2025, marked by significant clinical and regulatory milestones. The company’s lead CHM CDH17 CAR-T cell therapy program has progressed to dose level 2 in its Phase 1/2 trial, following a safe and well-tolerated initial dose. Notably, the US Food and Drug Administration (FDA) granted Fast Track Designation for CHM CDH17 targeting gastroenteropancreatic neuroendocrine tumours (GEP-NETs), underscoring the therapy’s potential to address a serious unmet medical need.
The Phase 1/2 study, which includes patients with colorectal cancer, gastric cancer, and intestinal neuroendocrine tumours, has now expanded its US footprint with the activation of a fourth clinical site at the Emory Winship Cancer Institute in Atlanta. This addition enhances patient recruitment capabilities and strengthens the trial’s presence within a leading cancer research network.
Translational Data and Early Clinical Signals
Translational data from the initial dose cohort demonstrated persistence of CAR-T cells up to 28 days in all treated patients, with two patients showing persistence for as long as six months. These biological signals correlate with clinical observations of stable disease in some participants, providing encouraging evidence of the therapy’s activity and durability.
In parallel, Chimeric’s ADVENT-AML Phase 1B trial at MD Anderson Cancer Center reported promising early outcomes. Two of the first three patients treated with the company’s proprietary CORE-NK cell therapy in combination with standard care achieved complete remission with incomplete blood count recovery, while the third maintained stable disease. This trial is pioneering the integration of cell therapy in frontline acute myeloid leukemia treatment, particularly for elderly or unfit patients.
Corporate and Financial Developments
On the corporate front, Chimeric appointed Professor Miles Prince AM, a distinguished haematologist and cell therapy expert, to its board as a Non-Executive Director. His extensive clinical and research experience is expected to bolster the company’s strategic direction and clinical development efforts.
Financially, the company successfully raised $6.6 million through a two-tranche placement, supported by institutional and sophisticated investors, including a US-based family office. This capital injection, complemented by a $2.5 million non-dilutive financing facility secured against the anticipated FY25 Research and Development Tax Incentive, has strengthened Chimeric’s balance sheet. The company reported a cash position of $5.76 million at quarter-end, with ongoing prudent cost management aimed at extending its operational runway.
Looking Ahead
Chimeric’s clinical programs are advancing steadily, with the CHM CDH17 trial continuing dose escalation and patient recruitment, and the ADVENT-AML trial progressing through its dose expansion phase. The FDA Fast Track status is expected to facilitate more frequent regulatory interactions and potentially expedite development timelines. Meanwhile, the company’s financial strategy appears focused on balancing aggressive clinical advancement with sustainable cash management.
Bottom Line?
Chimeric’s clinical momentum and strengthened finances position it well for upcoming data readouts and regulatory milestones, but investors should watch cash runway and trial recruitment closely.
Questions in the middle?
- Will the Phase 1/2 CHM CDH17 trial maintain its safety profile at higher dose levels?
- How quickly can patient recruitment accelerate across the expanded US clinical sites?
- What impact will option exercises from the recent placement have on shareholder dilution?
