Chimeric Therapeutics reports encouraging clinical progress in its CAR-T and NK cell therapy trials, alongside FDA orphan drug designation and a strategic funding boost to propel development.
- 75% disease control in CHM CDH17 CAR-T Phase 1/2 trial for gastrointestinal cancers
- FDA grants Orphan Drug Designation for CHM CDH17 in gastric cancer
- Additional complete responses achieved in CORE-NK Phase 1b AML trial
- $8.4 million raised via placement and convertible note to fund CHM CDH17 trial through Phase 1
- Strategic reset underway to reduce costs and sharpen clinical focus
Clinical Progress in CAR-T and NK Cell Therapies
Chimeric Therapeutics (ASX – CHM) has delivered a strong quarterly update, highlighting significant clinical milestones in its cell therapy pipeline. The company’s CHM CDH17 CAR-T Phase 1/2 trial targeting advanced gastrointestinal cancers reported a 75% disease control rate at 28 days among evaluable patients. Notably, at the higher dose level, all treated patients achieved stable disease, underscoring the therapy’s potential efficacy.
Adding to this momentum, one colorectal cancer patient has maintained stable disease for over 11 months following a single infusion, suggesting durable responses even at lower doses. This promising clinical activity is complemented by the US Food and Drug Administration granting Orphan Drug Designation for CHM CDH17 in gastric cancer, a regulatory milestone that offers market exclusivity and financial incentives, enhancing the program’s commercial appeal.
Advances in AML Treatment with CORE-NK
Chimeric’s CORE-NK Phase 1b ADVENT-AML study also reported encouraging results. In heavily pre-treated relapsed/refractory acute myeloid leukemia (AML) patients, the combination of CORE-NK with azacitidine and venetoclax demonstrated a strong safety profile and persistence of NK cells post-treatment. The frontline high-risk AML cohort showed a 57% clinical response rate, including two complete responses, reinforcing the potential of this immunotherapy approach.
However, the CHM CORE-NK + Vactosertib Phase 1b trial has been temporarily suspended due to supply chain issues unrelated to the drug combination, with expectations for a swift resolution.
Funding and Strategic Reset
To support its clinical ambitions, Chimeric Therapeutics secured $8.4 million through a $4.4 million placement and a $4 million convertible note. This capital injection fully funds the CHM CDH17 trial through Phase 1 and supports near-term clinical readouts. The placement attracted significant US institutional interest, including a $3 million commitment from a US-based family office.
Alongside funding, the company is undertaking a comprehensive strategic reset aimed at reducing its cost base and sharpening execution focus. This includes a targeted expense reduction program, organisational simplification, and prioritisation of capital allocation towards its highest-value clinical assets, all designed to extend cash runway and improve capital efficiency without compromising clinical progress.
Corporate Developments
In line with the strategic reset, Chimeric’s Chief Medical Officer, Dr Jason B. Litten, resigned. The company plans to streamline clinical oversight by engaging a contract CMO to maintain expertise while reducing costs. Additionally, a board refresh is underway, including the appointment of a new Chairperson to replace outgoing Executive Chairman Paul Hopper, signalling a new phase of governance aligned with the company’s evolving strategy.
Financially, Chimeric ended the quarter with $2.5 million in cash, bolstered by a $4.5 million R&D tax incentive refund. The company remains focused on prudent cash management and is actively exploring additional capital sources to sustain operations and clinical momentum.
Bottom Line?
With fresh capital and regulatory backing, Chimeric is poised to advance its cell therapy pipeline, but upcoming shareholder approvals and leadership changes will be key to watch.
Questions in the middle?
- How will the strategic reset impact the timeline and scope of Chimeric’s clinical trials?
- What are the prospects and timing for shareholder approval of the second tranche placement?
- How will the departure of the Chief Medical Officer affect clinical trial execution and regulatory engagement?