On March 4, 2026 Adela, Inc., an innovator in blood testing for molecular residual disease (MRD) monitoring and early cancer detection through a proprietary genome-wide methylome enrichment technology, reported the publication of clinical validation results in npj Precision Oncology for use of its test to monitor response to immunotherapy in patients with advanced solid tumors.

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The study demonstrated that changes in methylated circulating tumor DNA (ctDNA) measured prior to treatment initiation and before cycle 3 of therapy were strongly associated with objective response and clinical benefit. These findings validated the test’s potential to support clinical decision-making regarding continuation or discontinuation of immunotherapy early in a course of treatment.

In patients with advanced cancer receiving immunotherapy, there is a critical unmet need for sensitive, rapid turnaround tools to monitor treatment response during early treatment cycles, as using conventional imaging alone can lead to delayed recognition of non-response and missed opportunities to alter treatment. Most emerging molecular options for response monitoring require tumor tissue, which is often not available in patients with advanced cancer. A tissue-free option offers broader accessibility.

The validation study analyzed banked samples from 64 patients with advanced head & neck, breast, ovarian, melanoma, or other solid tumors who received pembrolizumab at Princess Margaret Cancer Centre, University Health Network as part of the INSPIRE Study (NCT026344369). Blood samples were collected pre-treatment and prior to every three treatment cycles starting at cycle 3 of treatment.

Compared to those with an increase in methylated ctDNA, patients with a decrease in methylated ctDNA between pre-treatment and pre-cycle 3 were more likely to achieve:

Objective response (odds ratio [OR]=31.77, 95% CI: 3.71–4173.19, P=0.0003)
Clinical benefit (OR=15.55, 95% CI: 3.31–151.52, P=0.0002)
A decrease in methylated ctDNA was also associated with significantly better:

Progression-free survival (hazard ratio [HR]=0.27, 95% CI: 0.14–0.50, P<0.0001)
Overall survival (HR=0.49, 95% CI: 0.27–0.86, P=0.01).
"The study supports the use of the test for response monitoring and the early identification of patients who are not responding to immunotherapy and could benefit from a different treatment approach. The test may thus be a useful tool to support clinical decisions regarding therapy continuation or discontinuation to optimize patient outcomes, and perhaps avoid unnecessary toxicity," said Enrique Sanz-Garcia, MD, Medical Oncologist and Clinician Investigator at Princess Margaret Cancer Centre, University Health Network.

Adela’s test has also been clinically validated for surveilling for recurrence in head and neck cancer, with results published in the Annals of Oncology.

"We are pleased to announce the publication of the clinical validation of a second application of our genome-wide methylation-based platform," said Anne-Renee Hartman, MD, Chief Medical Officer at Adela. "Because our approach captures biologically relevant information across the entire methylome, it removes the need for disease-specific panels and supports broad use across solid tumors and diverse clinical settings."

Adela’s test is currently available for use in monitoring immunotherapy response by biopharmaceutical companies and other investigators, including for biomarker discovery and drug development. Adela plans to commercialize the test later this year for use in patients with solid tumors treated with immunotherapy to monitor response and help guide treatment decision-making.

(Press release, Adela, MAR 4, 2026, View Source [SID1234663264])

On March 4, 2026 Creatv Bio, a Division of Creatv MicroTech, Inc. ("Creatv") reported the initiation of a collaboration with CytoDyn Inc. of Vancouver, Washington ("CytoDyn") to provide its’ LifeTracDx liquid biopsy test to support a Phase 2 study evaluating CytoDyn’s leronlimab in combination with TAS-102 and Bevacizumab in previously treated patients with relapsed/refractory metastatic Colorectal Cancer (mCRC).

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CytoDyn’s Phase 2 study in mCRC (NCT06699836), now underway, is enrolling 60 participants who will be tested with the LifeTracDx blood test at multiple-time points over the course of the trial. Collected under the study protocol as an exploratory biomarker, Creatv Bio’s LifeTracDx Blood Test will be used to evaluate numeric increases in PD-L1 expression across the patient population. The study’s primary endpoint is objective response rate (ORR), defined as the proportion of patients achieving a confirmed complete or partial response per RECIST v1.1, evaluating the efficacy of leronlimab in combination with trifluridine and tipiracil plus bevacizumab in patients with CCR5-positive, refractory, microsatellite-stable metastatic colorectal cancer (mCRC) over a 12-month treatment period.

LifeTracDx uses both circulating tumor cells (CTCs) and Cancer Associated Macrophage-Like (CAML) cells, which are macrophages that engulf tumor cells, as sensitive and accurate markers for real-time monitoring of tumor response to all forms of treatment and provides pharmacokinetic changes of both CCR5 and PD-L1 from the tumor microenvironment.

In prior studies, leronlimab induced PD-L1 expression on CTCs and CAMLS in 88% of metastatic breast cancer patients treated at doses above 525 mg/week, reinforcing the proposed ability of CCR5 blockade to convert "cold" tumors into "hot," PD-L1–positive tumors. In addition, changes observed in circulating atypical CAMLs further support leronlimab’s role in remodeling the tumor immune microenvironment and enhancing responsiveness to checkpoint blockade.

Creatv Bio has demonstrated that monitoring the expressions of PD-L1 using the LifeTracDx blood test at baseline, followed by sequential sampling after induction of therapy, may identify patients who have upregulated PD-L1 expression in their tumors.

(Press release, CytoDyn, MAR 4, 2026, View Source [SID1234663263])

On March 4, 2026 Fapon Biopharma reported that Dr. Kaiqing Zhang, Ph.D., Associate Director of Business/Corporate Development, will deliver a company presentation at the 19th Annual European Life Sciences CEO Forum, taking place March 4–5 at the Hilton Zurich Airport Hotel.

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In a presentation titled "Unlocking the Next Generation of TCEs: Fapon’s Human/Cyno Cross-Reactive CD3/TCR VHH Platform", Fapon Biopharma will showcase its proprietary CD3/TCR VHH-based T-cell engager (TCE) platform, an innovative approach designed to overcome developability and flexibility challenges associated with traditional multi-specific antibodies.

Built on fully human/cynomolgus cross-reactive single-domain antibodies (VHH), the platform enables a modular "plug-and-play" design with optimized activation kinetics and therapeutic index. This technology is uniquely positioned to power the next wave of therapeutics across two high-growth pillars:

Oncology: Precision T-cell redirection to eradicate solid and hematological tumors, engineered for optimized activation kinetics and a wider therapeutic index to minimize cytokine risk.

Autoimmune Diseases: Potent T-cell engagers designed for deep B-cell depletion, offering a functional "immune reset" for patients with refractory conditions.

The cornerstone of our technology is a series of cross-species CD3/TCR VHHs with different affinity binding to both human and cynomolgus monkeys. This dual reactivity significantly de-risks preclinical safety and accelerates translational timelines. The platform has already successfully completed evaluation demonstrating superior efficacy and safety as well as predictable PK/PD in mouse and NHP studies.

With superior CMC profiles and flexibility for multi-valent formatting, Fapon Biopharma is seeking strategic partners for co-development and licensing. For partnership inquiries, please contact us at [email protected] (USA, Europe and other regions) or [email protected] (Asia-Pacific)

(Press release, Fapon Biopharma, MAR 4, 2026, View Source [SID1234663262])

On March 4, 2026 Monteris Medical, the leader in minimally invasive neurosurgical technology with its NeuroBlate System, reported that a newly published randomized prospective study in the distinguished journal Nature Communications suggests that laser interstitial thermal therapy (LITT) using NeuroBlate may enhance the effectiveness of the immunotherapy drug pembrolizumab (Keytruda) for patients with recurrent high grade astrocytoma, including glioblastoma (GBM). The findings come from a Phase 1/randomized Phase 2b clinical trial (NCT02311582) led by investigators at Washington University, the University of Florida and the University of Southern California evaluating the combination of NeuroBlate LITT followed by pembrolizumab.

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High grade astrocytomas, including GBM, remain among the most aggressive and treatment resistant brain tumors. Immune checkpoint inhibitors, such as pembrolizumab, have historically shown limited benefit in this population due to multiple factors, including the impermeability of the blood-brain barrier (BBB) and tumor characteristics allowing for evasion of the body’s immune response.

This study suggests that thermal ablation – heat generated by laser energy – delivered by NeuroBlate induces BBB disruption and activates an immune response, thereby enhancing the therapeutic effect of pembrolizumab.

"What we’re seeing in this trial is that NeuroBlate may be doing more than cytoreducing the tumor – it appears to prime the immune system in ways that make pembrolizumab more effective at delivering real clinical benefit," said Dr. David Tran, lead author and division chief, neuro-oncology and co-director of the University of Southern California Brain Tumor Center in Los Angeles. "This opens the door to continue studying new treatment strategies for patients who currently have very limited options."

In the full study analysis, patients who received NeuroBlate followed by pembrolizumab demonstrated improved overall survival – more than three times – compared with those who received surgery or biopsy followed by the same therapy. The combined approach was also found to be safe and well-tolerated.

"Monteris has invested for more than a decade in pioneering the use of NeuroBlate for brain tumors and drug-resistant epilepsy, and we are proud that our technology continues to play a central role in advancing minimally invasive neurosurgery," said Martin J. Emerson, president and chief executive officer of Monteris Medical. "This new clinical evidence suggests that NeuroBlate may also serve as a powerful enabler of treatments like immunotherapy. We are honored to support the innovators and institutions pushing this field forward and, most importantly, to help bring new hope to patients and their families."

(Press release, Monteris Medical, MAR 4, 2026, View Source [SID1234663261])

On March 4, 2026 Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused biopharmaceutical company advancing breakthrough therapies for diseases, reported the deployment of the OpenAI API to support IND-enabling development of HT-KIT, its orphan-designated therapy targeting rare and aggressive KIT-driven cancers.

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The OpenAI-powered API platform has been integrated into the HT-KIT development workflow to support preclinical data analysis, molecular modeling of KIT-driven pathways, and preparation of regulatory documentation ahead of IND submission.

HT-KIT results below have shown success in rare cancers

Potent gene-level target suppression: HT-KIT achieved >80% reduction of KIT mRNA/protein across in-vitro systems and in vivo models of systemic mastocytosis and GIST.

Favorable tolerability in early studies: No dose-limiting toxicities observed in the reported preclinical work to date.

Rapid anti-tumor activity: In xenograft models, statistically significant tumor-volume reduction by Day 8 was observed, accompanied by apoptotic signaling consistent with KIT pathway knock-down.

Bioanalytical readiness: GLP-validated bioanalytical methods completed to support pharmacokinetic, biodistribution, and exposure-response analyses for IND.

HT-KIT is advancing toward Investigational New Drug (IND) submission and Phase 1 clinical evaluation.

HT-KIT has received Orphan Drug Designation and is designed to address cancers driven by KIT mutations, an area of significant unmet medical need.

"Hoth’s integration of OpenAI’s API supports execution of our IND-enabling strategy for HT-KIT as we advance toward Phase 1," said Robb Knie, Chief Executive Officer.

(Press release, Hoth Therapeutics, MAR 4, 2026, View Source [SID1234663260])