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ACM Biolabs Reports Favorable Safety Signals and Early Pharmacodynamics from Intramuscular Administration of ACM-CpG in Patients with Advanced Solid Tumors

On October 22, 2025 ACM Biolabs, a clinical-stage biotechnology company developing next-generation nanoparticle-based immunotherapies, reported encouraging early clinical findings from its ongoing Phase 1 study of ACM-CpG, a TLR9 agonist formulated with ACM’s proprietary polymersome platform through a strategic collaboration with the National Cancer Centre Singapore (NCCS).

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Preclinical experiments show that the ACM nanoparticle formulation fundamentally alters CpG’s mechanism of action, enabling myeloid modulation through comprehensive TLR9 engagement in immunologically "cold" tumors. The ongoing Phase 1 trial (NCT06587295)[i] is enrolling patients with advanced solid tumors at NCCS to assess the safety, tolerability, and pharmacodynamic effects of ACM-CpG.

Early clinical data indicate that these preclinical findings are translating into humans. In patients with advanced solid tumors, intramuscular administration of ACM-CpG – at weekly or biweekly doses as low as 0.25mg CpG – has demonstrated robust systemic immune activation as evidenced through immune biomarker data. The therapy shows a highly favorable safety and tolerability profile and to date, no dose-limiting toxicities have been observed.

"TLR9 has long been recognized as a validated immunologic target, but its therapeutic potential has been limited by delivery and safety limitations," said Dr. Madhavan Nallani, CEO of ACM Biolabs. "Our intramuscular nanoparticle delivery enables systemic immune activation with an excellent safety profile, creating opportunities not only for combination approaches but also for targeted monotherapy in patient populations with few treatment options. Over time, this platform can also support additional routes of administration allowing us to tailor treatment strategies to diverse tumor settings and address significant unmet medical needs."

"The safety profile and clear pharmacodynamic activity we have observed so far are very encouraging, with two out of the three patients enrolled at the 0.25mg dose level having ongoing disease control for eight months with monotherapy alone." said Dr. Amit Jain, Senior Consultant, Division of Medical Oncology, National Cancer Centre Singapore. "We look forward to exploring ways to optimize its delivery and maximize its therapeutic potential for patients with advanced cancers."

The collaboration is supported in part by funding from Singapore’s Industry Alignment Fund – Pre-Positioning (IAF-PP), which fosters strategic collaborations between industry and research institutes. This study is evaluating ACM-CpG in patients with advanced head and neck, lung, bladder, and kidney cancers and is designed to establish proof of mechanism to support global clinical development.

(Press release, ACM Biolabs, OCT 22, 2025, View Source [SID1234656908])

SkylineDx Publishes Landmark MERLIN_001 Trial in JAMA Surgery Validating the Predictive Power of the Merlin CP-GEP Test in Melanoma

On October 22, 2025 SkylineDx reported that results from its landmark MERLIN_001 trial, the largest prospective evaluation of a genomic test in cutaneous melanoma, have been published in the October 2025 issue of JAMA Surgery, the most cited surgery journal in the world. The study demonstrates that the Merlin CP-GEP Test stratified T1-T3 melanomas with clearly distinct risk levels for sentinel node metastasis: patients with a High-Risk result had a three-fold higher rate of sentinel node metastasis compared to those with a Low-Risk result (23.8% vs. 7.1%) overall.

The MERLIN_001 trial enrolled 1,761 patients across leading U.S. academic cancer centers including the Mayo Clinic, University of Louisville, University of Michigan, Huntsman Cancer Institute, University of Kentucky, Emory University, Duke University, Memorial Sloan Kettering Cancer Center, and Moffitt Cancer Center.

"This study represents a major step forward in evaluating personalized melanoma care," said Vernon Sondak, MD, MERLIN_001 Principal Investigator and chair of the Cutaneous Oncology Department at Moffitt Cancer Center in Tampa, Florida. "Studying the Merlin CP-GEP Test’s ability to distinguish patients’ risk of sentinel node metastasis with a rigor and precision no other test or nomogram can match. Our results show that the test adds a level of accuracy above current clinical factors alone, even when factors like mitotic rate and histologic subtype are taken into account, and this kind of knowledge ultimately allows patients and surgeons to make better decisions about when sentinel node biopsy should be part of the management of clinically localized melanoma. In appropriately selected patients, this test can add value for shared decision-making."

Key Findings

Across the study population, the Merlin CP-GEP Test stratified melanomas into two distinct risk groups: High-Risk patients had greater than a three-fold likelihood of SLN metastasis (23.8%) compared to Low-Risk patients (7.1%). Overall, 37.0% of patients were Low-Risk while 63.0% were High-Risk. Importantly, the test was successful in 97.7% of submitted samples.
In patients aged 65 and older, where comorbidities can be more prevalent, the test identified 57.9% as High-Risk, with a positive SLNB rate of 20.3%, versus a 6.6% positive SLNB rate for Low-Risk cases.
In head and neck melanomas, where SLNB can be technically difficult and can carry higher morbidity, the Merlin CP-GEP test identified High-Risk cases with a 26.7% SLN rate and Low-Risk cases with a 4.9% SLN (five-fold risk increase in the High-Risk vs. the Low-Risk groups).
Across all ages and primary sites, cases with clinical Stage IB melanoma were classified as Low-Risk 49.3% of the time, with a 6.5% positive SLNB rate, compared with an 18.3% rate for High-Risk cases.
The MERLIN_001 trial results published in JAMA Surgery can be found here: View Source

About the Merlin CP-GEP Test

CP-GEP is a non-invasive prediction model for cutaneous melanoma patients and is the only commercially available GEP test that combines clinicopathologic (CP) variables with gene expression profiling (GEP) into a single integrated algorithm. This CP-GEP model is also the only GEP test that provides a binary stratification of all patients based on being High or Low Risk for metastasis and thereby assigns them to the appropriate surgical action categories as listed in evidence-based cancer treatment, prevention, and screening guidelines. The advanced CP-GEP model was developed by Mayo Clinic and SkylineDx and is the latest commercially launched GEP test, which has been clinically validated in multiple studies on a global basis. The test has been launched in the United States and Europe as Merlin. SkylineDx collaborates with diagnostic service providers globally to bring this test to market and increase patient access. More information (including references) may be obtained at www.falconprogram.com and www.merlinmelanomatest.com.

(Press release, SkylineDx, OCT 22, 2025, View Source [SID1234656907])

Accent Therapeutics Presents New Preclinical Data on Lead Clinical Programs ATX-295 and ATX-559 at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics

On October 22, 2025 Accent Therapeutics, a clinical-stage biopharmaceutical company pioneering a new class of small molecule precision cancer therapies, reported new preclinical data on its two lead programs: the novel KIF18A inhibitor, ATX-295, and the first-in-class DHX9 inhibitor, ATX-559. The company will share the data, which highlight the potential to target key tumor vulnerabilities for selective cancer cell death, at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) (the "Triple Meeting"), being held October 22-26, 2025, in Boston, Massachusetts.

"The data presented for our KIF18A and DHX9 programs continue to validate the success of our biomarker-driven strategy against challenging, genetically diverse cancers," said Serena Silver, Ph.D., Chief Scientific Officer of Accent Therapeutics. "By precisely targeting the vulnerabilities created by genomic instability, we are excited about the potential of ATX-295 and ATX-559 to address significant unmet needs for patients."

In the presentation entitled "Addressing Novel Oncology Targets for Tumors with Genomic Instability," (Concurrent Session 9, October 25th at 4:45 PM ET) Dr. Silver will discuss the promise of ATX-295 and ATX-559 as precision cancer therapeutics that exploit the genomic instability of cancer cells to effect cancer-selective growth inhibition in vitro and in vivo. She will highlight the potential for KIF18A inhibition by ATX-295 in cancers with high levels of chromosomal instability (CIN) such as ovarian and triple negative breast cancer, and for DHX9 inhibition by ATX-559 in multiple tumor types with high levels of replication stress including dMMR/MSI-H and BRCA alterations.

Additional Poster Presentations
ATX-295 (KIF18A Inhibitor)

Title: Activity of the Novel KIF18A Inhibitor, ATX-295, is Enriched in Whole Genome Doubled Ovarian and TNBC Preclinical Models
Summary: Inhibition of KIF18A by ATX-295 is a compelling strategy for chromosomally unstable cancers, supported by new data identifying whole genome doubling (WGD) as a strong predictive biomarker for tumors such as ovarian cancer and TNBC. This biomarker-driven approach was validated in preclinical models where ATX-295 induced dose-dependent tumor regression in WGD-positive models.
Session Details: October 24th, Session B, 12:30-4:00 PM ET
ATX-559 (DHX9 Inhibitor)

Title: ATX-559, a First-in-Class, Clinical-Stage DHX9 Inhibitor, as a Targeted Therapeutic for Molecularly Defined Tumors with Genomic Instability and Replicative Stress
Summary: Preclinical data show the first-in-class oral DHX9 inhibitor, ATX-559, increases replicative stress and DNA damage, leading to selective cell death in cancers with genomic instability. This activity led to robust, dose-dependent tumor regression in preclinical models with BRCA alterations and microsatellite instability-high (MSI-H).
Session Details: October 24th, Session B, 12:30-4:00 PM ET
About ATX-295
ATX-295 is a potential best-in-class inhibitor for KIF18A, a mitotic kinesin motor protein essential for cell division in select tumors with chromosomal instability. A subset of tumors with an abnormal number of chromosomes (aneuploid), such as those found in ovarian and triple-negative breast cancer (TNBC), are reliant on KIF18A. Treatment with a KIF18A inhibitor leads to rapid cell death in these chromosomally unstable cancer cells while leaving healthy cells with normal numbers of chromosomes unaffected. Accent retains full worldwide rights to the KIF18A program, including ATX-295, which is being evaluated in a Phase 1/2 clinical trial (NCT06799065).

About ATX-559
ATX-559 is a first-in-class potent and selective inhibitor of DHX9, a DNA/RNA helicase that plays a critical role in tumors with high levels of replication stress. Such tumors include those with BRCA loss of function (breast, ovarian), mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) cancers (colorectal, endometrial, gastric), and others representing large patient populations with significant unmet medical need. DHX9 is a compelling oncology target as its inhibition exploits key tumor vulnerabilities related to replication, transcription, and the maintenance of genomic stability, resulting in cancer-specific cell death. Accent retains full worldwide rights to ATX-559, currently being evaluated in a Phase 1/2 clinical trial (NCT06625515), and the DHX9 program.

(Press release, Accent Therapeutics, OCT 22, 2025, View Source [SID1234656906])

Myosin Therapeutics Receives FDA Fast Track Designation for MT-125 in Glioblastoma

On October 22, 2025 Myosin Therapeutics, Inc., a clinical-stage biotechnology company developing first-in-class therapies that modulate molecular motor proteins, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to MT-125 for the treatment of glioblastoma (GBM).

Fast Track is an FDA program designed to facilitate development and expedite review of drugs that treat serious conditions and address unmet medical needs. This designation benefits patients and drug sponsors by enabling more frequent interactions with the FDA and providing eligibility for rolling review of a marketing application.

"Receiving Fast Track designation validates our conviction that MT-125 has the potential to offer an entirely novel treatment approach to patients with even the most aggressive forms of glioblastoma," said Dr. Courtney Miller, Chief Executive Officer of Myosin Therapeutics. "We are energized by the open communication with the FDA that the Fast Track offers because it will ensure we advance MT-125 as quickly as possible with our patient-centered approach."

MT-125 is a first-in-class dual inhibitor of non-muscle myosin IIA and IIB (NMIIA/IIB). It brings a completely new mechanism of action to a disease where decades of limited progress has built anticipation for genuine therapeutic innovation. By leveraging years of GBM biology research focused on targeting the cellular nanomotor proteins driving tumor cells, MT-125 enables simultaneous tackling of the proliferative and invasive phenotypes of this aggressive primary brain tumor, while improving the efficacy of radiation. A Phase 1/2 trial evaluating safety, pharmacokinetics, and preliminary activity is cleared to proceed (ClinicalTrials.gov: NCT07185880). FDA previously granted Orphan Drug Designation to MT-125 for malignant gliomas, including GBM.

(Press release, Myosin Therapeutics, OCT 22, 2025, View Source [SID1234656905])

Inhibrx To Host Webcast Presentation of Topline Results from its Registrational Trial of Ozekibart (INBRX-109) in Chondrosarcoma and to Provide Updates on Colorectal Cancer and Ewing Sarcoma Expansion Cohorts

On October 22, 2025 Inhibrx Biosciences, Inc. (Nasdaq: INBX) ("Inhibrx" or the "Company"), a clinical-stage biopharmaceutical company focused on developing therapeutics for oncology and rare diseases, reported that it will host a live webcast presentation on Thursday, October 23, 2025 at 1:30 p.m. Pacific Time to provide topline results from the registrational ChonDRAgon study investigating ozekibart (INBRX-109) as a single agent versus placebo in patients with advanced or metastatic, unresectable chondrosarcoma. The Company will also provide an update on the ongoing expansion trials investigating ozekibart in combination with FOLFIRI in late-line colorectal cancer and in combination with irinotecan and temozolomide in refractory Ewing sarcoma.

Investors may join via the web: View Source or may listen to the call by dialing (1-888-880-3330). Please refer to Inhibrx Biosciences, Inc. or the conference ID 9577647 when calling in. Following the webcast, the presentation may be accessed through a link on the investors section of Inhibrx’s website at View Source The webcast will be available for 60 days following the event. Following the presentation, Inhibrx will update its corporate presentation within the "Investors" section of its website at www.inhibrx.com.

About ozekibart (INBRX-109)
Ozekibart is a precision-engineered, tetravalent death receptor 5 (DR5) agonist antibody designed to exploit the tumor-biased cell death induced by DR5 activation. In January 2021, the FDA granted Fast Track designation to ozekibart for the treatment of patients with metastatic or unresectable conventional chondrosarcoma, and, in November 2021, the FDA granted orphan drug designation to ozekibart for chondrosarcoma.

In June 2021, Inhibrx initiated a randomized, blinded, placebo-controlled, registration-enabling Phase 2 trial of ozekibart in metastatic, unresectable conventional chondrosarcoma.

Additionally, in Phase 1/2 trials, Inhibrx is investigating ozekibart in colorectal cancer in combination with FOLFIRI and Ewing sarcoma in combination with irinotecan/temozolomide, as well as other tumor types.

(Press release, Inhibrx, OCT 22, 2025, View Source [SID1234656904])