On May 26, 2026 Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported the publication of two investigator-initiated trials-in-progress abstracts on May 21, 2026. These abstracts will be presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago. The abstracts highlight ongoing clinical investigations evaluating the use of Delcath’s percutaneous hepatic perfusion (PHP) with melphalan using the HEPZATO KIT Hepatic Delivery System (HDS) in metastatic melanoma involving the liver — a common and difficult-to-treat site of disease progression.

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One abstract, titled "Phase 2 sequential treatment of percutaneous hepatic perfusion with melphalan/hepatic delivery system followed by tebentafusp in the treatment of metastatic uveal melanoma," describes an investigator-initiated Phase 2 trial evaluating sequential treatment with HEPZATO followed by tebentafusp in patients with metastatic uveal melanoma (mUM) who are HLA-A*02:01 positive and have isolated or liver-dominant metastases. The study is designed to assess progression-free survival and additional measures including safety, objective response, overall survival, and biomarker analyses. The study opened for enrollment in November 2025.

A second abstract, titled "Phase 1b/2 trial of melphalan-percutaneous hepatic perfusion (PHP) therapy and nivolumab/relatlimab in patients with metastatic melanoma and liver metastasis," outlines a single-center Phase 1b/2 study evaluating HEPZATO in combination with nivolumab/relatlimab as a first-line treatment approach for patients with metastatic non-uveal melanoma involving the liver. The trial is intended to assess safety, tolerability, and preliminary efficacy, with secondary objectives including disease control rate, progression-free survival, overall survival, duration of response, and tumor reduction. The study opened for enrollment in January 2026.

The abstract on sequential PHP followed by tebentafusp in mUM (Abstract TPS9605) and the abstract on PHP plus nivolumab/relatlimab in metastatic melanoma with liver metastasis (Abstract TPS9600) will be presented as posters at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting. Specific session details will be available on the ASCO (Free ASCO Whitepaper) website.

"We believe the publication of these two ASCO (Free ASCO Whitepaper) abstracts underscores the growing clinical interest in HEPZATO’s potential across multiple metastatic melanoma settings with liver involvement," said Gerard Michel, Chief Executive Officer of Delcath Systems. "These investigator-initiated trials will provide important insights into combining or sequencing liver-directed therapy with modern systemic treatments in patients with challenging disease. We remain committed to supporting such research to advance therapeutic options for patients with liver cancers and metastases."

(Press release, Delcath Systems, MAY 26, 2026, View Source [SID1234666050])

On May 26, 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 progress on its prospective observational case-control study designed to train and validate a blood test for multi-cancer early detection (MCED) at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting from May 29-June 2, 2026.

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The CAMPERR study (NCT05366881) is enrolling 6,300 participants at 15 sites with nationwide representation across the US. Approximately 98% of participants have been enrolled to date, and enrollment is expected to be complete by the end of 2026.

"CAMPERR is one of the most comprehensive prospective observational MCED studies conducted to date," said Anne-Renee Hartman, MD, Co-Founder and Chief Medical Officer at Adela. "The study’s scale, demographic diversity, and scientific rigor provide high confidence that a lab developed test (LDT) for MCED trained and validated with CAMPERR samples will be highly generalizable, performing reliably across a broad and diverse population."

CAMPERR is enrolling 2,400 participants with newly diagnosed, untreated cancer or cancer recurrence across 20 pre-selected cancer types, with blood collected prior to treatment initiation. Together, these 20 cancer types represent 93% of annual cancer incidence and 88% of annual cancer deaths in the United States. An additional 3,900 cancer-free control participants have been enrolled. A subset of participants with Stage I–III lung cancer will undergo additional blood draws and longitudinal follow-up, enabling training and validation of a test for MRD-based recurrence detection.

Adela’s genome-wide methylome enrichment platform is unique from other methylation-based MCED tests because it utilizes a high-affinity enrichment process, enabling capture and preservation of more genomic material for sequencing compared to other platforms that use enzymatic or chemical treatment (bisulfite conversion).

"The methylome carries one of the richest cancer signals in the blood, particularly for detecting early-stage disease and identifying cancer signal of origin," said Daniel De Carvalho, PhD, Co-Founder and Chief Scientific Officer at Adela. "Adela’s genome-wide methylome enrichment platform is designed to capture that signal while preserving the integrity of cfDNA, rather than relying on chemical conversion methods that can degrade limited blood-derived DNA. This allows us to access a broad, biologically informative view of cancer-associated methylation from a blood draw, with the potential to improve sensitivity, in particular for early stage and low-shedding cancers, when tumor-derived DNA is present at very low levels in the blood."

At the ASCO (Free ASCO Whitepaper) Annual Meeting, Adela is also presenting data using an updated classifier for recurrence detection for head & neck squamous cell carcinoma. Adela previously reported clinical validation results for head & neck cancer in Annals of Oncology.

Adela’s test for MRD is currently available to select providers and institutions for use to monitor for recurrence in head & neck cancer. Adela plans to expand commercialization of the test later this year for use in patients with solid tumors treated with immunotherapy to monitor response and help guide treatment decision-making. The test is also broadly available for use by biopharmaceutical companies and other investigators for recurrence monitoring and immunotherapy response monitoring, including for biomarker discovery and drug development.

Presentation Details

Abstract 6084: Evaluation of a tissue-free genome-wide methylome enrichment assay for detecting molecular residual disease (MRD) in patients with head and neck squamous cell carcinoma (HNSCC).

Dr. Geoffrey Liu1

Hall A, Poster Board: 541

Saturday, May 30, 2026: 1:30 PM-4:30 PM CDT

Abstract TPS10628: CAMPERR: A multicenter, prospective, observational study to evaluate a cfDNA-based genome-wide methylation enrichment assay for multicancer early detection (MCED), identification of molecular residual disease, and relapse prognostication.

Dr. Gregory Idos2

Hall A, Poster Board: 589a

Monday, June 1, 2026: 1:30 PM-4:30 PM CDT

(Press release, Adela, MAY 26, 2026, View Source [SID1234666066])

On May 26, 2026 Bionano Genomics, Inc. (Nasdaq: BNGO) reported publication of a peer-reviewed study in Modern Pathology showing that optical genome mapping (OGM) detected genomic abnormalities in 97.8% of T-cell acute lymphoblastic leukemia (T-ALL) cases — nearly double the 55% detection rate achieved by conventional cytogenetic analysis. Conducted by researchers at The University of Texas MD Anderson Cancer Center and Johns Hopkins University School of Medicine and representing one of the most comprehensive genomic analyses of T-ALL to date, the study underscores OGM’s potential to transform how this aggressive blood cancer is studied and understood.

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T-ALL is an aggressive form of pediatric and adult leukemia driven by a wide variety of complex genetic changes, many of which are too subtle or structurally complex to be detected by traditional methods. The disease is notoriously difficult to characterize fully, limiting the ability of researchers to study its biology, classify subtypes, and develop targeted therapies.

The 91-subject study compared OGM head-to-head against conventional karyotyping and next-generation sequencing (NGS) — the standard tools for evaluating T-ALL. Where karyotyping identified abnormalities in just 55% of cases, OGM found them in 97.8% of cases, and provided additional genomic insights beyond standard methods in approximately 70% of the cases — all from OGM’s single workflow.

Key Highlights:

91 cases: of T-ALL cases analyzed across three platforms — OGM, conventional karyotyping, and NGS — making this study the largest OGM study of T-ALL conducted to date.
High success rate for finding abnormalities: OGM identified chromosomal abnormalities in 97.8% of cases, compared to 55% by conventional karyotyping — a dramatic improvement in detection for a disease where missed findings can leave the biology incompletely understood.
Broader picture in 70% of cases: OGM delivered clinically relevant genomic information beyond karyotyping in approximately 70% of cases, uncovering abnormalities that standard methods missed — all without requiring additional testing.
24 known + 21 novel gene fusions identified: OGM detected gene rearrangements in 80% of cases, including 24 known recurrent fusions and 21 newly identified fusions, pointing to potential new targets for T-ALL research.
Comprehensive sequence variant and copy number profiling: OGM identified copy number changes in 93% of cases. NGS detected sequence variants in 92% of cases. The gene most frequently found to harbor variants was NOTCH1 (57% of cases).
Disease subtypes decoded: OGM uncovered distinct genomic patterns across T-ALL subtypes, supporting more precise biological classification of this heterogeneous disease.
OGM can streamline workflows for T-ALL. T-ALL presents particular challenges for standard genomic analysis: samples often yield poor-quality material for karyotyping, and many of the most biologically important genetic changes are subtle, small-scale, or driven by rearrangements in non-coding regions of the genome. Conventional approaches typically require multiple sequential analyses to piece together a complete picture — a process that is time-consuming, costly, and incomplete. OGM can address these limitations with a genome-wide approach that captures the full landscape of genetic variation in a single workflow.

"This publication further strengthens the growing body of evidence supporting OGM as a powerful tool for resolving the genomic complexity of challenging childhood and adult blood cancers like T-ALL, 50% of which remain unsolved by legacy methods, such as, karyotyping. This study, as one of the first and largest of its kind in T-ALL, demonstrates the complementarity that OGM and NGS can provide and shows how OGM can be particularly well-suited to T-ALL’s unique challenges — including poor sample quality, subtle rearrangements, and a wide range of genomic targets — capturing recurrent and novel alterations in a single pass that would otherwise require multiple sequential tests," said Alka Chaubey, PhD, FACMG, chief medical officer of Bionano. Dr. Chaubey continued, "the ability to uncover subtle and complex rearrangements in diseases like T-ALL can give researchers a far more complete picture of the biology — and reinforces why comprehensive structural variant analysis matters in blood cancer research."

(Press release, BioNano International Singapore Pte, MAY 26, 2026, View Source [SID1234666083])

On May 26, 2026 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that its research collaborators’ abstract was published at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The abstract details positive clinical data from studies of predictive biomarkers in patients receiving its lead drug candidate, Reqorsa Gene Therapy (quaratusugene ozeplasmid), for the treatment of lung cancer.

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"This clinical validation, derived from patients in our Acclaim clinical trials, substantiates earlier preclinical evidence revealing that Non-Small Cell Lung Cancer (NSCLC) patients receiving REQORSA who exhibit high Trop-2 levels and low PTEN levels experience prolonged Progression Free Survival (PFS), underscoring the critical role these biomarkers play in predicting treatment efficacy and advancing our understanding of this novel gene therapy," said Ryan Confer, President and Chief Executive Officer at Genprex. "These findings represent a substantial leap forward for personalized medicine in lung cancer, allowing for a targeted approach to potentially improve treatment outcomes and optimize resource allocation within the therapeutic landscape."

The featured Genprex-supported abstract at ASCO (Free ASCO Whitepaper) 2026:

Title: "Predictive biomarkers for PFS in patients receiving quaratusugene ozeplasmid"

Abstract Number: e15184

Quaratusugene ozeplasmid is a gene therapy that delivers a plasmid coding for the TUSC2 tumor suppressor gene to lung cancer cells, as >80% of lung cancers have been shown to have decreased or absent TUSC2 protein. TUSC2 protein levels have not correlated with PFS, presumably because of the complexities of TUSC2 protein regulation. Preclinical studies have identified higher levels of Trop-2 protein in organoids and lower levels of PTEN protein in lung cancer cell lines as correlating with response (AACR 2026). Tumor tissue from patients in clinical trials with quaratusugene ozeplasmid were evaluated for Trop-2 and PTEN protein expression.

Monoclonal antibodies against Trop-2 (BSB148 from BioSB) and PTEN (138G6 from Cell Signaling Technology) were used for immunohistochemistry in paraffin sections from archival tumor samples in patients enrolled in three clinical trials with quaratusugene ozeplasmid and results expressed as H-scores. H-scores were calculated by evaluating diaminobenzidine staining intensity using the formula [1 × (% cells 1+) + 2 × (% cells 2+) + 3 × (% cells 3+)].

Data on Trop-2 and PTEN protein expression and data on PFS were available from 18 patients enrolled in clinical trials with quaratusugene ozeplasmid.

Six patients with NSCLC were enrolled in the Acclaim-1 trial in combination with osimertinib.
One patient was enrolled in the Acclaim-2 trial in combination with pembrolizumab.
Eleven patients with small cell lung cancer (SCLC) were enrolled in the Acclaim-3 trial in combination with atezolizumab.
In patients with NSCLC, Trop-2 H-scores above 100 correlated with prolonged PFS (p=0.05), and PTEN H-scores below 100 correlated with prolonged PFS (p=0.03).
In patients with SCLC, Trop-2 H-scores were universally low, and thus non-evaluable. PTEN H-scores in patients with SCLC did not correlate with prolonged PFS (p=0.53).
Following up on preclinical cell line and organoid models indicating that Trop-2 and PTEN protein expression correlated with response, levels of Trop-2 and PTEN protein were evaluated in patients treated with quaratusugene ozeplasmid. In conclusion, both Trop-2 H-scores above 100 and PTEN H-scores below 100 correlated with longer PFS in patients with NSCLC, but not in patients with SCLC.

Beyond the ASCO (Free ASCO Whitepaper) 2026 Abstract:

Following the clinical studies outlined above, Genprex completed additional analysis to evaluate the relationship between NSCLCs with high intensity staining (3+) and PFS. NSCLCs with 3+ Trop-2 staining had a strong relationship with PFS that was just outside the bounds for significance (p=0.053) and those with 3+ PTEN staining exhibited a trend for a negative relationship with PFS that was not statistically significant (p=0.309). These results are consistent with the H-score analysis regarding a strong positive relationship between Trop-2 expression and PFS. High (3+) Trop-2 expression will be investigated further as a potential biomarker for REQORSA.

"We look forward to additional studies using intensity staining to understand the correlation between Trop-2 expression and PFS, offering more concrete data for optimized patient selection," said Mark S. Berger, Chief Medical Officer at Genprex.

About Acclaim-1

The Acclaim-1 clinical trial is an open-label, multi-center Phase 1/2 clinical trial evaluating REQORSA in combination with AstraZeneca’s Tagrisso (osimertinib) in patients with late-stage NSCLC with activating epidermal growth factor receptor (EGFR) mutations whose disease progressed after treatment with Tagrisso or or Tagrisso-containing regimens. Acclaim-1 received Fast Track Designation by the U.S. Food and Drug Administration (FDA) for use of REQORSA in combination with TKI Tagrisso for the treatment of NSCLC patients with EGFR mutations whose tumors progressed after treatment with Tagrisso.

About Acclaim-3

The Acclaim-3 clinical trial is an open-label, multi-center Phase 1/2 clinical trial evaluating REQORSA in combination with Genentech, Inc.’s Tecentriq (atezolizumab) as maintenance therapy in patients with extensive stage small cell lung cancer (ES-SCLC) who did not develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment. Acclaim-3 received Fast Track Designation by the FDA for the Acclaim-3 treatment combination of REQORSA and Tecentriq as maintenance therapy in patients with ES-SCLC who did not develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment. The FDA also granted Orphan Drug Designation to REQORSA for the treatment of SCLC.

(Press release, Genprex, MAY 26, 2026, View Source [SID1234666051])

On May 26, 2026 Hoth Therapeutics, Inc. (NASDAQ: HOTH) ("Hoth" or the "Company"), a clinical-stage biopharmaceutical company, reported that the U.S. Patent and Trademark Office ("USPTO") has issued a Notice of Allowance for Hoth’s HT-KIT therapeutic.

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The allowed claims cover antisense oligomers of 25 to 50 linked nucleosides directed to splicing-relevant regions of the MS4A6A pre-mRNA, including intron 3, exon 4, and the intron 3/exon 4 junction, together with pharmaceutical compositions and methods for modulating MS4A6A mRNA splicing in cells or tissues. Hybridization of the disclosed oligomers is intended to reduce cell-surface expression of the high-affinity IgE receptor (FcεRI), a central driver of mast cell activation in allergic and inflammatory disease.

Strategic Importance

Foundational IP Position. Allowance establishes composition-of-matter coverage for the Company’s lead antisense oligomer (SEQ ID NO: 22), including modified, morpholino, and pharmaceutical composition embodiments, providing a defensible basis for the underlying chemistry of the platform.
Mechanistic Differentiation. By reducing surface expression of FcεRI via exon-skipping of MS4A6A pre-mRNA, the approach addresses a node upstream of histamine release and IgE-mediated degranulation, distinct from antihistamine, anti-IgE antibody, and small-molecule mast cell inhibitor approaches.
Broad Indication Coverage. Allowed method claims and related disclosures span asthma, atopic dermatitis, chronic rhinitis, allergic conjunctivitis, chronic sinusitis, anaphylaxis prevention, and mast cell–driven diseases including mastocytosis and mast cell tumors.
Reinforces HT-KIT. The allowed claims strengthen the intellectual property foundation underlying HT-KIT, the Company’s orphan drug–designated program for mast cell–driven disease.
Combination Optionality. The application as filed also describes combination approaches with antisense oligomers targeting FcεRIβ (MS4A2) pre-mRNA splicing, supporting future development of dual-target compositions.
Management Commentary

"This Notice of Allowance is a meaningful validation of the science underlying our mast cell platform and an important addition to the intellectual property foundation supporting HT-KIT," said Robb Knie, Chief Executive Officer of Hoth Therapeutics.

About HT-KIT

HT-KIT is Hoth Therapeutics’ orphan drug–designated program directed at mastocytosis and other mast cell–driven diseases. The program is built around antisense oligomer–mediated modulation of pre-mRNA splicing to reduce pathological mast cell signaling. Hoth expects to finalize its IND submission in 2026, followed by first-in-human studies.

Biotechnology Operations Continue Under Subsidiary Structure
The Company ‘s is exploring placing its biotechnology pipeline and therapeutic development programs under a separate, wholly owned subsidiary with dedicated management and operational resources. The restructuring is intended to preserve the value of the biotechnology portfolio for shareholders while enabling the parent company to pursue emerging opportunities in AI semiconductor infrastructure and advanced computing technologies.

(Press release, Hoth Therapeutics, MAY 26, 2026, View Source [SID1234666067])