On May 28, 2025 Nucleai, an AI-powered spatial biomarker and diagnostics company, reported it will showcase its expanded suite of solutions for antibody-drug conjugate (ADC) clinical trials at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, held this week from May 30-June 3 in Chicago, IL (Press release, Nucleai, MAY 28, 2025, View Source [SID1234653464]). Recent studies have demonstrated that AI-powered computational pathology and spatial biomarkers can predict ADC treatment response more accurately than standard pathological scores, enabling ADC developers to derisk their drug development programs by designing biomarker-informed clinical trials. Nucleai’s commercially available ADC suite of solutions unlocks unparalleled granularity for ADC developers, including high sensitivity for low levels of biomarker expression as well as detecting subcellular protein expression.

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At ASCO (Free ASCO Whitepaper), Nucleai will demo their OD-based quantitative biomarker scoring solution, which solves the challenges of manual visual scoring of immunohistochemistry (IHC) images by pathologists, which could lead to inconsistent results and an incomplete understanding of drug efficacy. The analysis suite also includes spatial biomarker scoring methods to model a drug’s potential bystander effect, with implications for patient stratification and trial design. In addition to these applications, biopharma partners developing ADC and immunotherapy combination therapy strategies can evaluate tumor immunogenicity and identify specific immune cell subsets in the tumor microenvironment using Nucleai’s multimodal capabilities, which combine IHC data with hematoxylin and eosin (H&E) stained biopsy slides.

Demand has continued to rise for AI-powered quantitative biomarker scoring, especially for ADC development, where the exact mechanism of action (MOA), treatment response, and resistance mechanisms have not been fully established. For example, in some studies, researchers have concluded that high levels of protein expression on the surface of tumor cells are correlated to patient outcomes, but in other studies, treatment response is correlated to higher expression of the protein in the cell’s cytoplasm. On the other hand, in some indications, there is no clear correlation between protein expression levels in the patient and their response to the drug. In addition to supporting drug development, clinicians are also in need of better biomarkers to help guide the sequence of treatment in indications like hormone receptor (HR)-positive breast cancer, where multiple ADCs with similar cytotoxic payloads have been approved in recent years.

Nucleai, which has pioneered the use of AI for spatial biomarker analysis, has been working with leading ADC developers to evaluate their trials with this expanded suite of capabilities. As an add-on to these capabilities, Nucleai will also unveil an AI-driven analysis studio that enables easier extraction of actionable MOA and biomarker insights from complex computational pathology and spatial biology data. With this advancement, biopharma partners now have faster access to actionable insights, which can be applied to clinical trials and companion diagnostics in the future.

The expanded ADC suite also includes a novel spatial proteomics dataset with over 200 tumor and normal samples, across 30 biomarkers and 3 indications to profile ADCs, bispecific antibody targets, the tumor immune microenvironment, and for credentialing potential combination therapy strategies.

"Biomarker exploration often stops at identifying correlations, but the promise of AI-based spatial biomarkers and diagnostics is to move beyond this limited understanding," said Avi Veidman, CEO and co-founder of Nucleai. "With this expanded suite of ADC solutions, researchers can shift from passive observation to active investigation with an interactive interface, helping to bridge the gap from correlation to causality. This approach enables our biopharma partners to accelerate development by deriving clinically meaningful insights from complex data."

Next week at ASCO (Free ASCO Whitepaper) (booth #IH02), the Nucleai team will be sharing specific applications of the ADC solutions suite with demos that cover target identification, credentialing of bispecific targets and combination strategies, OD-based quantitative biomarker scoring, and spatial scoring to model a drug’s potential bystander effect. The demos will show how Nucleai is reducing the burden on bioinformatics and pathology teams by providing intuitive tools for real-time interaction with data.

Poster Presentation: Biomarkers of Immunotherapy Response in Melanoma

Also at ASCO (Free ASCO Whitepaper), Nucleai’s AI-powered spatial biomarker technology combined with Lunaphore (a Bio-Techne brand)’s high-throughput, hyperplex COMET platform will be featured in a poster presentation in collaboration with Dr. Paolo A. Ascierto, Director of the Melanoma and Cancer Immunotherapy Unit at the National Cancer Institute in Naples.

The poster, titled "Application of a novel multiplex imaging-based immunotherapy panel and AI-powered analysis solution for predictive spatial biomarker identification on immunotherapy-treated melanoma patients," will be presented on Sunday, June 1 from 9:00 AM – 12:00 PM CDT in Hall A – Posters and Exhibits.

For more information, visit nucleai.ai/asco2025.

On May 28, 2025 Bristol Myers Squibb (NYSE: BMY) reported that the company will participate in the Goldman Sachs 46th Annual Global Healthcare Conference on Wednesday, June 11, 2025 (Press release, Bristol-Myers Squibb, MAY 28, 2025, View Source [SID1234653432]).

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The company will take part in a fireside chat beginning at 10:00 a.m. ET.

Investors and the general public are invited to listen to the session by visiting View Source An archived edition of the session will be available following its conclusion.

On May 28, 2025 Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a commercial stage biotechnology company focused on hematologic disorders and cancer, reported that Raul Rodriguez, the company’s president and CEO, will present a company overview at the Jefferies Global Healthcare Conference on Wednesday, June 4, 2025 at 12:50 p.m. ET in New York, NY (Press release, Rigel, MAY 28, 2025, View Source [SID1234653449]).

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To access the live webcast or archived recording, visit the Investor Relations section of the company’s website at www.rigel.com. Please connect to Rigel’s website prior to the start of the live webcast to allow for any software downloads.

On May 28, 2025 Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President and COO: Toichi Takino; "Ono"), reported that the results from the open label Phase 2 PROSPECT Study of tirabrutinib is to be presented at the 2025 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting (Press release, Ono, MAY 28, 2025, View Source [SID1234653465]). Patients in the U.S. with relapsed or refractory primary central nervous system lymphoma (R/R PCNSL) who received oral tirabrutinib as a monotherapy achieved an overall response rate (ORR) of 67%.2

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Tirabrutinib is a highly selective irreversible, second generation Bruton’s tyrosine kinase inhibitor discovered by Ono in Japan. In March 2023, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to investigational tirabrutinib for the treatment of PCNSL.3

"PCNSL is a rare and aggressive extranodal non-Hodgkin lymphoma with historically poor survival rates and no approved treatments in the U.S.," said Tracy Batchelor, MD, MPH, Mass General Brigham Chair of Neurology and Coordinating Investigator for the PROSPECT study. "The PROSPECT Study data show tirabrutinib provided a promising response rate in patients with R/R PCNSL, supporting its role as a potentially effective treatment option for patients living with this devastating disease."

Study Results
In the PROSPECT Study, 48 patients with R/R PCNSL received oral tirabrutinib as a monotherapy once daily.2,4 The primary endpoint was ORR, and secondary endpoints included duration of response (DOR), time to response (TTR), and safety.2,4

After a median follow-up of 11.5 months, ORR was 67%, with a complete response rate of 44%.2 Median DOR was 9.3 months, and median TTR was 1.0 months.2 Exploratory endpoints included median overall survival, which was not reached, and median progression-free survival, which was 6.0 months.2

Tirabrutinib demonstrated a generally favorable safety profile.2 At data cutoff, 13 patients (27%) remained on tirabrutinib treatment.2 The main reasons for discontinuation were disease progression (54.2%) and death (8.3%); one patient discontinued due to an adverse event (AE).2 Incidence of grade ≥3 treatment-emergent adverse events (TEAEs) was 56.3%.2 Any-grade treatment-related TEAEs were experienced by 75.0%, and most frequently included anemia (18.8%), rash maculo-papular (16.7%), fatigue (14.6%), neutrophil count decreased (14.6%), lymphocyte count decreased (14.6%), pruritus (14.6%), and rash (14.6%).2 Two patients died of TEAEs, which were considered unrelated to study treatment. 2

"We are deeply grateful to the study investigators and the patients who participated in this study for making this important research possible," said Thomas Lechner, MSc. Ph.D., VP, Medical Affairs, ONO PHARMA USA INC. "Tirabrutinib is approved for relapsed or recurring PCNSL in Japan, Taiwan, and South Korea and our hope is to bring this potential treatment to those living with this hard-to-treat disease in the U.S as soon as possible."

PROSPECT Study data will be included in a regulatory submission to the FDA in the near future.

About PCNSL
PCNSL is a rare and aggressive extra nodal non-Hodgkin lymphoma (NHL) that is confined to the brain parenchyma, spinal cord, eye, or leptomeninges, without systemic involvement. The annual incidence rate of PCNSL is approximately five cases per 1,000,000 people in the U.S. The rate can further increase among immunocompromised people aged 65 years and older. The signs and symptoms presented in patients with PCNSL vary depending on the neuroanatomical site of the lesion, and include cranial neuropathy, neuropsychiatric symptoms, symptoms associated with increased intracranial pressure, seizures, ocular symptoms, headache, dysmotility, cranial neuropathy, and radiculopathy. There are no therapeutic products approved for the treatment of PCNSL in the U.S., and data guiding therapeutic approaches are very limited. Despite recent progress resulting in the improvement of clinical outcomes in newly diagnosed patients with PCNSL after an induction treatment, approximately 20 to 30 percent of patients are refractory to the initial treatment, and up to 60 percent of patients will eventually relapse. To learn more about R/R PCNSL, please visit navigatingpcnsl.com.

About Tirabrutinib
Tirabrutinib, discovered and developed by Ono Pharmaceutical Co., Ltd., is a highly potent selective BTK inhibitor. Signaling through the B-cell receptor (BCR) regulates cellular proliferation and activation, and promotes survival, differentiation, and clonal expansion of B-cells. The BCR signaling pathway plays an important role in a number of B-cell malignancies. In Japan, tirabrutinib was approved in March 2020 for the treatment of relapsed or refractory PCNSL and launched under the tradename of Velexbru in May 2020. It was subsequently approved for the treatment of Waldenstrom macroglobulinemia and lymphoplasmacytic lymphoma in August 2020.Tirabrutinib was approved for the treatment of relapsed or refractory PCNSL in South Korea in November 2021 and in Taiwan in February 2022.

About the PROSPECT Study
The PROSPECT Study is a Phase 2 trial (NCT04947319) evaluating the safety and efficacy of an investigational oral medicine called tirabrutinib for the potential treatment of newly diagnosed or relapsed/refractory (R/R) primary central nervous system lymphoma (PCNSL), which is a type of cancer that either does not improve from treatment (refractory) or improves only for a limited time (relapsed). Current treatment options for R/R PCNSL are limited, and there are no medications specifically approved in the U.S. for the treatment of PCNSL. Learn more about the PROSPECT Study here: theprospectstudy.com.

On May 28, 2025 Invectys, Inc., a clinical-stage biotechnology company pioneering novel cancer immunotherapies, reported that MD Anderson Investigators Drs. Samer Srour and Aung Naing will present a Trial-in-Progress poster at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 30–June 3 in Chicago, Illinois (Press release, Invectys, MAY 28, 2025, View Source [SID1234653612]).

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The presentation will detail the ongoing Phase 1/2a clinical trial evaluating IVS-3001, Invectys’ first-in-human chimeric antigen receptor (CAR) T-cell therapy targeting HLA-G, a non-classical MHC class I molecule overexpressed in various solid tumors. HLA-G functions as a powerful immune checkpoint, enabling tumor cells to evade immune surveillance. By engineering CAR T cells to recognize and eliminate HLA-G–expressing cancer cells, IVS-3001 aims to restore the immune system’s ability to combat tumors.

Presentation Details:

Abstract Title: Safety and efficacy of HLA-G–targeted CAR T cells (IVS-3001) in patients with advanced HLA-G–positive solid tumors: Clinical trial in progress
Abstract Number: TPS2679
Session: Developmental Therapeutics—Immunotherapy
Session Type: Poster Session
Poster Board Number: 320b
Date and Time: Monday, June 2, 2025, 1:30 PM – 4:30 PM CDT
Location: McCormick Place Convention Center, Chicago, IL
The Phase 1/2a trial is designed to assess the safety, tolerability, and preliminary efficacy of IVS-3001 in patients with advanced solid tumors expressing HLA-G. The study also aims to evaluate the therapy’s pharmacokinetics and immunogenicity.

"We are excited to share our progress on IVS-3001 at ASCO (Free ASCO Whitepaper) 2025. Patients with solid tumors have profound unmet clinical need. HLA-G is an especially exciting target for cell therapy, as it is both a widely expressed tumor marker and a potent immune checkpoint. Thus, HLA-G directed therapies have the potential to treat a vast variety of solid tumors." said Dr. Jake Kushner, CEO of Invectys. "This study represents a key step forward in our mission to develop innovative immunotherapies that address unmet needs in oncology."