Chimeric Therapeutics has dosed the first three patients in its Phase 1/2 CHM CDH17 CAR-T trial targeting gastrointestinal cancers, alongside advancing its AML and NK cell therapy programs. The company also secured $5 million in funding and appointed Dr Rebecca McQualter as CEO.
- First three patients dosed in Phase 1/2 CHM CDH17 CAR-T trial for GI cancers
- Phase 1B ADVENT-AML trial expanded to include newly diagnosed AML patients
- Complete response observed in AML patient treated with CHM CORE-NK + Vactosertib
- Successful $5 million capital raise completed to support clinical programs
- Dr Rebecca McQualter appointed as new Chief Executive Officer
Clinical Milestones Achieved in CAR-T and NK Cell Therapies
Chimeric Therapeutics (ASX:CHM) has marked a significant step forward in its clinical development pipeline with the dosing of the first three patients in its Phase 1/2 trial of CHM CDH17, a novel CAR-T cell therapy targeting gastrointestinal (GI) cancers. This trial, conducted at leading US cancer centers including Sarah Cannon Research Institute and the University of Pennsylvania, aims to establish a recommended Phase 2 dose and evaluate safety and efficacy in advanced colorectal, gastric, and neuroendocrine tumors.
The CHM CDH17 therapy is a third-generation CAR-T product designed to target CDH17, a protein linked to poor prognosis and metastasis in common GI cancers. The dosing milestone follows successful manufacturing runs and sets the stage for further patient enrolment, with up to 15 participants expected by the end of fiscal 2025.
Expansion of AML Trial and Encouraging Early Results
Parallel to the CAR-T program, Chimeric’s Phase 1B ADVENT-AML trial investigating the CHM CORE-NK platform has progressed to include newly diagnosed acute myeloid leukemia (AML) patients who are elderly or ineligible for intensive therapies. This expansion comes after a dose-finding phase demonstrated safety and tolerability of the CORE-NK cells combined with standard treatments Azacitidine and Venetoclax.
Notably, the trial reported a complete response in an AML patient treated with the combination of CHM CORE-NK and Vactosertib, a TGF-beta receptor inhibitor, just 28 days after treatment initiation. This promising outcome, observed at the UH Seidman Cancer Center, underscores the potential of the off-the-shelf NK cell therapy to improve outcomes in difficult-to-treat blood cancers.
Capital Raise and Leadership Transition Support Growth
To underpin these clinical advancements, Chimeric Therapeutics successfully completed a $5 million two-tranche placement at $0.008 per share, issuing approximately 625 million new shares along with options. The funds are earmarked primarily for progressing the CHM CDH17 CAR-T trial, as well as supporting ongoing Phase 1B trials of the CORE-NK platform and the CHM CLTX CAR-T therapy for glioblastoma.
In a strategic leadership move, Dr Rebecca McQualter was appointed Chief Executive Officer in November 2024. Dr McQualter brings extensive experience from senior roles at Novartis, Amgen, and GlaxoSmithKline, alongside a PhD in Cell Therapy and Regenerative Medicine from Monash University. Her appointment signals a renewed focus on clinical execution and commercialisation pathways.
Financial Position and Outlook
Chimeric ended the quarter with $5.07 million in cash and cash equivalents, bolstered by the capital raise and a $4.17 million R&D tax incentive refund. Operating cash outflows remained modest at $0.11 million, reflecting prudent cost management amid ongoing clinical activities. The company’s cash runway extends for approximately 45 quarters at current burn rates, providing a solid financial foundation for its near-term objectives.
With multiple clinical programs advancing and a strengthened leadership team, Chimeric Therapeutics is well positioned to deliver on its promise of innovative cell therapies for cancer patients. Investors will be watching closely for interim clinical data from the CHM CDH17 trial and further efficacy signals from the AML and glioblastoma programs.
Bottom Line?
Chimeric’s clinical progress and fresh capital set the stage for pivotal data readouts that could reshape its growth trajectory.
Questions in the middle?
- When can investors expect interim efficacy data from the CHM CDH17 Phase 1/2 trial?
- How will Dr McQualter’s leadership influence Chimeric’s commercial strategy and partnerships?
- What are the next steps for the CHM CLTX CAR-T glioblastoma program following positive early data?