On May 26, 2026 Citius Oncology, Inc. ("Citius Oncology") (Nasdaq: CTOR), an oncology‑focused biopharmaceutical company and majority‑owned subsidiary of Citius Pharmaceuticals, Inc. ("Citius Pharma") (Nasdaq: CTXR), reported that University of Pittsburgh Medical Center’s investigator-initiated trial evaluating LYMPHIR (denileukin diftitox-cxdl) in combination with the PD-1 immune checkpoint inhibitor pembrolizumab (KEYTRUDA) has been selected for poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO) (Free ASCO Whitepaper), taking place May 29 – June 2, 2026, in Chicago, Illinois.

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The abstract, submitted by investigators at the University of Pittsburgh Medical Center, was selected for presentation from more than 8,500 submissions reviewed by the ASCO (Free ASCO Whitepaper) Scientific Program Committee. The full abstract was made available on May 21, 2026, via the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) website.

"We are pleased to see this investigator-sponsored study selected for presentation at ASCO (Free ASCO Whitepaper), reflecting continued clinical interest in denileukin diftitox-cxdl across multiple tumor types," said Leonard Mazur, Chairman and Chief Executive Officer of Citius Oncology. "We look forward to engaging with the clinical oncology community to discuss the encouraging topline Phase 1 data evaluating Treg cell suppression in combination with checkpoint inhibitors."

Abstract Details:

Abstract Number: 2564
Title: Depletion of T-regulatory cells by denileukin diftitox-cxdl (E7777) in combination with pembrolizumab in relapsed/refractory (r/r) gynecologic malignancies: Phase 1 study results
Session Type: Poster Session – Developmental Therapeutics—Immunotherapy
Poster Board: 354
Date and Time: May 30, 2026, 1:30 PM-4:30 PM CDT
The Phase 1 study evaluated the safety, tolerability, and preliminary activity of denileukin diftitox-cxdl in combination with pembrolizumab in patients with relapsed or refractory gynecologic malignancies.

The ASCO (Free ASCO Whitepaper) Annual Meeting is one of the world’s largest and most influential oncology conferences, bringing together an estimated 35,000 oncology professionals from around the globe. The meeting serves as a premier forum for the presentation of cutting-edge cancer research, with abstracts selected through a highly competitive peer-review process.

About the Study

This open‑label, dose‑escalation, investigator‑initiated Phase 1 study (NCT05200559), led by Dr. Alexander B Olawaiye at UPMC Magee‑Women’s Hospital, enrolled patients with recurrent or metastatic solid tumors who had received at least one prior line of therapy. LYMPHIR was administered intravenously on Days 1–3 of each 21‑day cycle at escalating doses (3, 6, 9, and 12 mcg/kg), along with pembrolizumab (200 mg IV) on Day 1. Patients who completed eight cycles of combination therapy were continued on pembrolizumab monotherapy until disease progression.

The use of LYMPHIR in this study was investigational and outside of its FDA-approved indication. The Phase 1 study was not designed or powered to evaluate clinical efficacy, and no conclusions can be drawn regarding comparative effectiveness or long-term outcomes.

About Gynecologic Cancers

Recurrent or metastatic ovarian and endometrial cancers are two of the most common gynecologic malignancies in the United States. Endometrial cancer is the most frequently diagnosed gynecologic cancer, with an estimated 70,000 new endometrial cancer cases expected in the United States in 20261, while ovarian cancer remains the deadliest with approximately 12,700 deaths per year (51.6%) and approximately 20,000 new diagnoses each year in the United States2. These cancers are often detected at advanced stages, and although many patients initially respond to platinum‑based chemotherapy, most experience relapse and develop resistance. Survival rates in the recurrent setting remain poor, and responses to current immunotherapies such as PD‑1 inhibitors are limited, highlighting a significant unmet need for novel treatment approaches. LYMPHIR’s transient depletion of regulatory T‑cells may enhance anti‑tumor immune responses and help overcome immunotherapy resistance in these difficult‑to‑treat tumors.

About LYMPHIR (denileukin diftitox‑cxdl)

LYMPHIR is a targeted immune therapy for relapsed or refractory cutaneous T-cell lymphoma (CTCL) indicated for use in Stage I-III disease after at least one prior systemic therapy. It is a recombinant fusion protein that combines the IL-2 receptor binding domain with diphtheria toxin (DT) fragments. The agent specifically binds to IL-2 receptors on the cell surface, causing diphtheria toxin fragments that have entered cells to inhibit protein synthesis. After uptake into the cell, the DT fragment is cleaved and the free DT fragments inhibit protein synthesis, resulting in cell death. Denileukin diftitox-cxdl demonstrated the ability to deplete immunosuppressive regulatory T lymphocytes (Tregs) and antitumor activity through a direct cytocidal action on IL-2R-expressing tumors.

In 2021, reformulated denileukin diftitox received regulatory approval in Japan for the treatment of relapsed or refractory CTCL and peripheral T-cell lymphoma (PTCL). Subsequently, in 2021, Citius acquired an exclusive license with rights to develop and commercialize reformulated denileukin diftitox in all markets except for India, Japan and certain parts of Asia. LYMPHIR (denileukin diftitox-cxdl) was approved by the FDA and subsequently launched in the U.S. in December 2025.

(Press release, Citius Oncology, MAY 26, 2026, View Source [SID1234666068])

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])

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 Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, (together with its subsidiaries and/or affiliated companies, "Sun Pharma") reported the company will share updated results from the locally advanced cutaneous squamous cell carcinoma (laCSCC) expansion cohort from the pivotal CK-301-101 trial of UNLOXCYT (cosibelimab-ipdl) at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on May 31, 2026 in Chicago.

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In the investigator-reviewed data being presented at ASCO (Free ASCO Whitepaper), 64 patients with laCSCC received ≥1 dose of UNLOXCYT. The median age of patients in the cohort was 77 years old and 66% were male. This reflects the population commonly seen in clinical practice. Patients received a median of 29 doses over a median treatment duration of 60 weeks. The objective response rate was 50%, including 17 (27%) complete responses and 15 (23%) partial responses. Over a median follow-up of 31 months, responses were durable and the median duration of response was not yet reached.

"These data support clinically meaningful efficacy within this patient population. We observed a high rate of complete responses in patients with laCSCC, which is associated with long-term clinical outcomes. The durability of these responses, a primary therapeutic objective, was achieved alongside a manageable safety profile," said Rahul Ladwa, MBChB, BSc, FRACP, MPhil, Medical Oncologist at the Princess Alexandra Hospital and Greenslopes Private Hospital; Associate Professor, The University of Queensland, Australia; and presenting study co-author at ASCO (Free ASCO Whitepaper).

The safety profile was comparable to what was observed in an earlier analysis of a smaller cohort.

The most common adverse events (AEs) were anemia and diarrhea, recorded in 17 (27%) patients each.
Immune-related adverse reactions (irAEs) were observed in 22 (34%) patients.
Grade ≥3 irAEs occurred in 1 (2%) patient and were dermatologic in nature (maculo-papular and pruritic rashes) and considered treatment-related.
Treatment-emergent AEs (TEAEs) were reported in 61 (95%) patients and considered treatment-related in 50 (78%) patients; none were fatal.
Grade ≥3 TEAEs were reported in 26 (41%) patients and considered treatment-related in 7 (11%).
"The findings from this large cohort of patients are impressive from both an efficacy and tolerability perspective. Patients with laCSCC are older and have many comorbidities, so we need treatment options that are both efficacious and well tolerated, so patients remain on therapy and experience meaningful benefit," said Emily Ruiz, MD, MPH, Associate Professor of Dermatology, Harvard Medical School, Academic Director of the Micrographic Surgery Center at Brigham and Women’s Hospital; co-founder of Skin Cancer Champions; and study co-author. "Cosibelimab seems to work differently than other checkpoint inhibitors by restoring the adaptive immune response and engaging the innate immune system while preserving the PD-1/PD-L2 pathway. We believe this may explain the results we observe in these patients."

Poster Presentation Details

Title: Efficacy and safety of cosibelimab 800 mg every 2 weeks for locally advanced cutaneous squamous cell carcinoma: Updated follow-up from a pivotal study
Poster Session: Melanoma/Skin Cancers
Abstract Number: 9585
Poster Board Number: 301
Date and Time: May 31, 2026; 9:00am-12:00pm CDT
Presenter: Dr. Rahul Ladwa
"We’re looking forward to presenting these data at ASCO (Free ASCO Whitepaper)’s Annual Meeting later this month, highlighting pivotal results from the second largest ever reported prospective study of laCSCC patients treated with PD-(L)1 monotherapy, reinforcing our commitment to the skin cancer community," said Ahmad Naim, MD, Senior Vice President, North America Chief Medical Officer, Sun Pharma. "With a median duration of response not yet reached after more than two and a half years of follow-up, UNLOXCYT continues to demonstrate the kind of clinically meaningful efficacy with durable clinical responses and well-tolerated treatment option that patients with laCSCC need."

UNLOXCYT (cosibelimab-ipdl) is indicated for the treatment of adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation. The recommended dosage of UNLOXCYT is 1,200 mg as an intravenous infusion over 60 minutes every 3 weeks.

UNLOXCYT (cosibelimab-ipdl) was approved at 1,200 mg Q3W because PK/PD modeling showed it provides similar overall exposure and PD-L1 receptor coverage as the trial regimen of 800 mg Q2W. Since checkpoint inhibitors have flat exposure-response curves, they have been utilized with more convenient dosing schedules if equivalent efficacy and safety are maintained. The safety analyses included patients who received both 800 mg Q2W and 1,200 mg Q3W.

About Cutaneous Squamous Cell Carcinoma
Cutaneous squamous cell carcinoma (CSCC) is among the most common skin cancers worldwide. While early stages are treatable, an estimated 40,000 US patients each year progress to advanced disease, resulting in nearly 15,000 deaths.

Important risk factors for CSCC include chronic ultraviolet radiation exposure and immunosuppressive conditions. In addition to being life threatening, CSCC causes significant functional morbidities and cosmetic deformities due to tumors that commonly arise in the head and neck region and that invade blood vessels, nerves, and vital organs such as the eye or ear.

(Press release, Sun Pharma, MAY 26, 2026, https://www.prnewswire.com/news-releases/at-the-asco-2026-annual-meeting-sun-pharma-to-present-pivotal-long-term-follow-up-data-on-unloxcyt-cosibelimab-ipdl-302781880.html [SID1234666065])

On May 26, 2026 Mercy BioAnalytics, Inc., a pioneer in blood-based early cancer detection, reported that it will present two abstracts at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting highlighting results from studies using biospecimens from the National Lung Screening Trial (NLST) repository.

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The NLST was an NCI-sponsored randomized controlled trial that demonstrated a significant mortality benefit associated with annual low-dose CT-based screening. NLST established a biospecimen repository for the purpose of enabling the validation of early detection lung cancer biomarkers that might augment or replace low-dose CT (LDCT).1 To date, nearly 900 requests for NLST data or biospecimens have been approved.2 To our knowledge, Mercy’s ASCO (Free ASCO Whitepaper) presentation will be the first use of blood specimens from NLST subjects for preliminary validation of early detection lung cancer biomarkers. This work represents an important milestone in advancing blood-based approaches for lung cancer screening and lung nodule triage in elevated-risk subjects.

The first study reports results from a blinded evaluation of a novel blood-based lung cancer screening assay in elevated-risk subjects from the NLST. In this dataset, the blood-based screening assay showed similar sensitivity to low-dose CT across two annual screening encounters and detected lung cancers that were missed by low-dose CT, supporting further evaluation of the assay for lung cancer screening in the elevated-risk population.

The second study reports results from a blinded evaluation of a novel blood-based pulmonary nodule triage assay in elevated-risk subjects from the NLST. Six percent of LDCT-screened subjects in NLST were scored as 3 or 4A using the Lung-RADS framework. Despite a 4% prevalence of cancer in this population, immediate diagnostic workup is not recommended. Mercy’s blood-based assay exhibited 43% sensitivity for the detection of lung cancer in these subjects, supporting further evaluation as a reflex approach for LDCT-detected pulmonary nodules.

"The results of the National Lung Screening Trial documenting a 20% decrease in lung cancer mortality with low-dose CT has led to practice changing recommendations with screening now recommended in high-risk groups. Mercy’s encouraging preliminary results are exactly why the NCI set up the NLST biospecimen repository: to enable validation of promising blood biomarkers. A blood test like Mercy’s could increase lung cancer screening uptake and make evaluation of pulmonary nodules more precise, potentially leading to more lives saved," said Dr. Christine Berg, M.D. the now retired NCI lead investigator on the NLST. "I am excited about these results. I have the good fortune to serve on the Clinical Advisory Board at Mercy and observed the meticulous care with which this work was done."

These results support further evaluation which is now underway of Mercy’s blood-based approaches to lung cancer screening and risk stratification of LDCT-detected pulmonary nodules.

Mercy is continuing to advance blood-based approaches designed to expand access to earlier detection and improve decision-making in lung cancer screening and follow-up.

Presentation details for the two accepted abstracts will be available through the ASCO (Free ASCO Whitepaper) Annual Meeting program and Mercy’s communications channels as the meeting approaches.

(Press release, Mercy BioAnalytics, MAY 26, 2026, View Source [SID1234666064])