Chimeric Therapeutics reports early success in frontline cell therapy for AML in ADVENT-AML Phase 1B trial

What Is Chimeric Therapeutics’ ADVENT-AML Trial and Why Does It Matter?

Chimeric Therapeutics Limited (ASX:CHM), a clinical-stage biotechnology company based in Australia, has reported promising interim results from its ADVENT-AML Phase 1B clinical trial. This trial is evaluating the use of its allogeneic CORE-NK cell therapy platform in combination with standard treatments for Acute Myeloid Leukemia (AML). Conducted at the prestigious MD Anderson Cancer Center in Texas, the trial marks the first time a cell therapy has been deployed in a frontline setting for AML patients ineligible for chemotherapy or stem cell transplantation.

The latest update shows that two out of three patients treated under the new regimen achieved CRi, or Complete Response with incomplete blood count recovery. The third patient exhibited stable disease. These findings, although preliminary, represent an important proof-of-concept for using CORE-NK cells in newly diagnosed, older, or comorbid AML patients. The synergy between natural killer cells and standard drugs like azacitidine and venetoclax could potentially reshape the treatment paradigm for this challenging cancer subset.

How Is the ADVENT-AML Trial Designed and Who Qualifies?

The ADVENT-AML trial (NCT05834244) is being executed in two stages: dose escalation and dose expansion. It aims to recruit a total of 20 patients who are newly diagnosed with AML but deemed unfit for intensive treatments like allogeneic stem-cell transplants. This demographic typically includes older adults or those with significant comorbidities, where traditional therapies present high risk.

The eligibility framework is built on recent classification standards for AML and MDS/AML, specifically those with between 10% to 19% myeloblasts. Patients must be at least 75 years of age, or 18 and older with comorbidities such as reduced ejection fraction, impaired pulmonary function, or controlled heart disease. They also need to meet liver and kidney function thresholds to ensure safety during treatment. Exclusion criteria are stringent, covering prior exposure to specific drugs, active CNS pathology, certain genetic abnormalities, and any ongoing infections or uncontrolled comorbidities that may interfere with treatment or outcomes.

Importantly, the trial involves the use of cryopreserved, off-the-shelf NK cells manufactured at Case Western Reserve University. This feature eliminates the time delays and logistical complexities often associated with autologous therapies, providing patients with more immediate access to treatment. The trial also mandates rigorous contraception and informed consent protocols, reflecting the regulatory requirements around cellular immunotherapies.

What Have the Early Results Shown?

The first three patients treated in the frontline cohort have provided encouraging signs of clinical activity. Two achieved CRi, indicating a major reduction in leukemic burden with partial recovery of normal blood counts. The third patient demonstrated stable disease, meaning that their cancer has not progressed but has also not significantly regressed.

While full conclusions will require additional data, these outcomes are a meaningful signal in the context of early-stage trials for a high-risk patient group. Achieving CRi at this stage supports the hypothesis that NK cells can enhance the efficacy of existing AML therapies. Importantly, no serious safety events were observed in this cohort, further underscoring the feasibility of using CORE-NK in combination with azacitidine and venetoclax.

The absence of toxicity red flags is particularly notable given the frailty of the patient population being treated. Tolerability remains a key consideration for any treatment introduced into frontline care for elderly AML patients, many of whom are ineligible for stem cell transplant or chemotherapy due to organ function limitations.

What Makes CHM’s CORE-NK Platform Unique?

CORE-NK represents a novel, clinically validated, off-the-shelf natural killer (NK) cell therapy platform developed by Chimeric Therapeutics. Unlike autologous CAR-T therapies, which require harvesting and engineering a patient’s own T-cells, CORE-NK is derived from healthy donors and can be mass-produced and cryopreserved. This allogeneic feature gives CORE-NK a significant logistical and commercial advantage in terms of scalability, cost, and time-to-treatment.

The platform was previously validated in a Phase 1A trial where it showed promising safety and efficacy across a variety of blood cancers and solid tumors. Building on that foundation, Chimeric has since launched additional Phase 1B studies to explore CORE-NK’s use in combination with other treatments — the ADVENT-AML trial being one of the most ambitious.

By focusing on allogeneic NK cells rather than autologous T-cells, Chimeric Therapeutics seeks to expand cell therapy access beyond the narrow cohorts currently served by CAR-T therapies. This approach could particularly benefit older patients or those from underserved health systems, where personalized cell therapy logistics are often infeasible.

How Does This Fit Into Chimeric’s Broader Oncology Pipeline?

Chimeric Therapeutics maintains a diversified pipeline that includes both autologous CAR-T and allogeneic NK cell therapies. In addition to CORE-NK, the company is developing CHM CDH17, a third-generation CAR-T platform for gastrointestinal and neuroendocrine cancers, which originated at the University of Pennsylvania. This therapy is now being evaluated in a Phase 1/2 trial following strong preclinical data published in Nature Cancer in 2022.

Another pipeline asset is CHM CLTX, a CAR-T therapy designed for patients with glioblastoma. Preliminary Phase 1A data released in 2023 indicated positive safety and activity signals, leading to advancement into Phase 1B studies.

These programs illustrate Chimeric’s multi-pronged strategy of developing both autologous and allogeneic approaches to address gaps in cancer treatment. The company’s emphasis on first-in-class and best-in-class therapies positions it well to generate differentiated outcomes across multiple oncology indications.

What Is the Institutional and Investor Sentiment Around CHM Stock?

Chimeric Therapeutics’ announcement on May 15, 2025, has sparked renewed interest in its stock, traded under the ticker ASX:CHM. Historically, the company’s share performance has followed a pattern common to early-stage biotech firms — highly sensitive to clinical milestones and capital events.

The announcement of early CRi responses, coupled with an acceptable safety profile, is likely to be viewed positively by institutional investors and clinical analysts. The MD Anderson Cancer Center’s involvement adds a layer of credibility and could attract further institutional interest, particularly from healthcare-focused funds and venture arms tracking innovation in immuno-oncology.

Buy/sell/hold sentiment remains cautiously optimistic. Investors are awaiting further data from the remaining patient cohort, expected later this year. Institutional flows have remained stable, though volume spikes may occur as key trial milestones are met. Retail sentiment, bolstered by the compelling narrative around off-the-shelf cancer therapies, also appears supportive but will depend heavily on the trajectory of future trial results.

What Are the Future Implications for AML Treatment?

If the outcomes observed in the initial cohort are replicated in the broader trial population, the ADVENT-AML study could mark a turning point in AML treatment. For decades, intensive chemotherapy and stem cell transplantation have formed the backbone of AML care. However, these modalities are not feasible for many elderly or unfit patients.

The integration of an allogeneic NK cell platform into frontline therapy opens up new possibilities for this underserved group. It also aligns with broader trends in immuno-oncology toward making cellular therapies faster, more accessible, and more adaptable across disease types.

Furthermore, success in AML could pave the way for regulatory filings in major markets such as the United States and Australia. Chimeric may also explore expanding CORE-NK into other hematologic malignancies, such as MDS or high-risk lymphomas. Market analysts estimate that the global AML therapeutics market could surpass USD 2.5 billion by 2030, and innovative therapies addressing unmet needs are expected to capture a sizable share of that growth.

What Should Stakeholders Watch for Next?

The company anticipates full enrollment in the ADVENT-AML trial by Q4 2025. Stakeholders should monitor upcoming data readouts, manufacturing developments related to the scale-up of CORE-NK, and potential collaborations or licensing discussions that may follow positive clinical milestones.

Additional trial results from Chimeric’s other programs — including CHM CDH17 and CHM CLTX — could further validate its technology platforms and contribute to an uptick in investor confidence. Analyst coverage is also likely to intensify as the company nears pivotal clinical inflection points.

With a strong scientific rationale, early efficacy signals, and scalable manufacturing in place, Chimeric Therapeutics is positioning itself as a disruptive force in the next wave of immuno-oncology. The next two quarters could be defining in determining whether the company transforms promising science into market-ready therapeutics.