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Nucleai to Showcase Expanded Suite of ADC Biomarker Scoring Solutions at ASCO 2025

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.

U.S. FDA Accepts New Drug Application Under Priority Review for sevabertinib (BAY 2927088) in HER2-Mutant Non-Small Cell Lung Cancer

On May 28, 2025 Bayer reported that the U.S. Food and Drug Administration (FDA) has accepted the company’s new drug application (NDA) and granted Priority Review designation for the investigational compound sevabertinib (BAY 2927088), an oral, small molecule, tyrosine kinase inhibitor (TKI), for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumors have activating human epidermal growth factor receptors 2 (HER2) (ERBB2) mutations and who have received a prior systemic therapy (Press release, Bayer, MAY 28, 2025, View Source [SID1234653463]).

"Patients with HER2-mutant NSCLC are predominantly women, may be of younger age and non-smokers. The FDA’s decision to grant Priority Review designation to our application for sevabertinib is a significant milestone that supports our ongoing efforts to develop healthcare solutions that help people living with lung cancer," said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer. "If approved, sevabertinib will provide an additional treatment option for previously treated patients with advanced NSCLC harboring a HER2-activating mutation."

The NDA for sevabertinib is based on positive results from the ongoing Phase I/II SOHO-01 trial. Results from patients with advanced NSCLC harboring a HER2-activating mutation, who experienced disease progression after ≥1 systemic therapies for advanced disease and were naïve to HER2-targeted therapy.1

The FDA grants Priority Review designation for the evaluation of medicines that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment, prevention, or diagnosis of a serious condition.2

In 2024, the FDA granted sevabertinib Breakthrough Therapy designation for the treatment of adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 (ERBB2) mutations, and who have received a prior systemic therapy. The Breakthrough Therapy designation was supported by preliminary clinical evidence from the SOHO-01 trial. The FDA grants Breakthrough Therapy designation for the evaluation of investigational medicines that are intended to treat a serious condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).3

About sevabertinib (BAY 2927088)4
Sevabertinib is an investigational agent and has not been approved by any health authority for use in any country, for any indication. It is currently being evaluated as a potential new targeted treatment option for patients with NSCLC harboring human epidermal growth factor receptors 2 (HER2) activating mutations. Sevabertinib is also being studied in patients with metastatic or unresectable solid tumors harboring HER2-activating mutations. Sevabertinib is an oral, reversible tyrosine kinase inhibitor (TKI) that potently inhibits mutant HER2, including HER2 exon 20 insertions and HER2 point mutations, as well as epidermal growth factor receptors (EGFR), with high selectivity for mutant vs wild-type EGFR. Investigational agent sevabertinib is derived from Bayer’s strategic research alliance with the Broad Institute of MIT and Harvard in Cambridge, MA, USA.

About Non-Small Cell Lung Cancer (NSCLC)
Lung cancer is the leading cause of cancer-related deaths in the U.S.5 Non-Small Cell Lung Cancer (NSCLC) is the most common type of lung cancer, accounting for more than 85% of cases.4 Activating HER2 mutations are found in 2% to 4% of advanced NSCLC.6 80% of people diagnosed with NSCLC have already progressed to advanced stages, which makes it more difficult to treat.7 Patients with HER2-mutant NSCLC currently face limited targeted therapies.

CARsgen’s Satri-cel Granted Priority Review by the NMPA

On May 28, 2025 CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, reported that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted Priority Review to satricabtagene autoleucel ("satri-cel", CT041)(an autologous CAR T-cell product candidate against protein Claudin18.2), for the treatment of Claudin18.2-positive advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJA) in patients who have failed at least two prior lines of therapy (Press release, Carsgen Therapeutics, MAY 28, 2025, View Source [SID1234653462]).

About Satri-cel

Satri-cel is an autologous CAR T-cell product candidate against the protein Claudin18.2 that has the potential to be the first-in-class globally. Satri-cel targets the treatment of Claudin18.2-positive solid tumors with a primary focus on G/GEJA and pancreatic cancer (PC). Initiated trials include investigator-initiated trials (CT041-CG4006, NCT03874897), a confirmatory Phase II clinical trial for advanced G/GEJA in China (CT041-ST-01, NCT04581473), a Phase Ib clinical trial for PC adjuvant therapy in China (CT041-ST-05, NCT05911217), an investigator-initiated trial for satri-cel be used as consolidation treatment following adjuvant therapy in patients with resected G/GEJA (CT041-CG4010, NCT06857786), and a Phase 1b/2 clinical trial for advanced gastric or pancreatic adenocarcinoma in North America (CT041-ST-02, NCT04404595). Satri-cel has been granted Breakthrough Therapy Designation by the CDE of China’s NMPA for the treatment of Claudin18.2-positive advanced G/GEJA in patients who have failed at least two prior lines of therapy in March 2025. Satri-cel was granted Regenerative Medicine Advanced Therapy designation by U.S. FDA for the treatment of advanced G/GEJA with Claudin18.2-positive tumors in January 2022. Satri-cel received Orphan Drug designation from the U.S. FDA in September 2020 for the treatment of G/GEJA.

Kexing Biopharm’s GB18 project received clearance of IND application from NMPA and FDA

On May 28, 2025 Kexing Biopharm (688136.SH) reported that the National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application for its independently developed innovative product, GB18. Moreover, GB18 has previously received the clearance from U.S. Food and Drug Administration (FDA) for IND application on May 21st (Press release, Kexing Biopharm, MAY 28, 2025, View Source [SID1234653461]).

GB18 is an innovative biologic product developed for the treatment of cancer cachexia, a complication with a prevalence up to 40% to 70% among cancer patients. Currently, no specific biological therapies are available to address the condition, presenting vast market potential. Featuring a unique nanobody-Fc fusion molecular structure, the product demonstrates enhanced stability, bettered bioavailability, and significantly improved performance in inhibiting disease-associated signaling pathways.

Benchmarking against globally leading pipelines with the same target (GDF-15) and indication, Kexing Biopharm’s GB18 features a special nanobody-Fc fusion structure (VHH-Fc), with the patents granted or applied for the molecule globally already. Last October, a research article of GB18’s preclinical study was published in the renowned international academic journal mAbs, which demonstrated that GB18 effectively alleviated weight loss in cancer cachexia models, showing superior weight recovery and improved muscle fibers in both quantity and size compared to the comparator.

In cancer cachexia, the expression level of GDF-15 is significantly elevated, which is closely associated with tumor progression and the severity of cachexia. Therefore, targeting GDF-15 has emerged as a new strategy in addressing the clinical challenge of cancer cachexia. This recent FDA IND approval marks a significant milestone in the Company’s globalization of innovative products.

Approximately millions advanced cancer patients annually in the world are suffering from cachexia. There is a significant unmet clinical need for the indication of cancer cachexia.Kexing Biopharm will remain steadfast in its mission to deliver "Precise Products, Predictable Effects, and Health Protection", with a focus on product quality and a commitment to scientific innovation, and improve the lives of patients worldwide.

AKTIS ONCOLOGY INITIATES PHASE 1B CLINICAL TRIAL OF ITS NECTIN-4-TARGETING RADIOPHARMACEUTICAL PRODUCT CANDIDATE, AKY-1189, ACROSS MULTIPLE TUMOR TYPES

On May 28, 2025 Aktis Oncology, Inc., an oncology company focused on unlocking the breakthrough potential of targeted radiopharmaceuticals for patient populations not addressed by existing platform technologies, reported that it has initiated clinical development of AKY-1189 in its Phase 1b clinical trial for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC), triple negative breast cancer (TNBC) and potentially other Nectin-4 expressing tumors (Press release, Aktis Oncology, MAY 28, 2025, View Source [SID1234653460]).

Nectin-4 is a cell-surface protein highly expressed in several solid tumors with limited expression in normal tissues, making it an attractive target for precision oncology therapies. NECTINIUM-2 is a Phase 1b clinical trial that will enroll mUC patients during dose escalation, followed by dedicated expansion cohorts in mUC, TNBC and other Nectin-4 expressing tumors, including but not limited to lung, colorectal and cervical cancers. The trial is expected to enroll approximately 150 patients and patients will receive up to six doses of [225Ac]Ac-AKY-1189. The multi-center study is being conducted in the U.S.

"Advancing the first product candidate from our proprietary miniprotein radioconjugate platform into Phase 1b clinical development in the U.S. is an important milestone for Aktis," said Akos Czibere, MD, PhD, Chief Medical Officer of Aktis Oncology. "Data presented to date demonstrates AKY-1189’s substantial tumor uptake in patients with various Nectin-4-expressing tumor types with limited exposure to normal tissue, suggesting potential for a wide therapeutic window in addressing high unmet need patient populations."

Data presented in an oral plenary session at the 2024 EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics demonstrated that AKY-1189 has a promising biodistribution profile with significant tumor uptake in patients with mUC, metastatic breast cancer, non-small cell lung cancer carcinoma, colorectal cancer and cervical cancer. These data marked the first report of a Nectin-4 targeted radiopharmaceutical candidate to demonstrate significant tumor uptake in patients and support the progression of AKY-1189 into therapeutic clinical studies, potentially offering a new treatment option for patients with these challenging solid tumor types.

"Radiopharmaceutical therapy targeting Nectin-4 is a highly attractive strategy, enabling the targeted delivery of radiation directly to tumor cells. Building on the success of Nectin-4-directed antibody-drug conjugates, this approach combines imaging with therapeutic innovation to potentially personalize treatment for advanced urothelial cancer and other solid tumors. The NECTINIUM-2 trial, evaluating the safety and efficacy of the Nectin-4 radiopharmaceutical, [225Ac]Ac-AKY-1189, is a key step forward in advancing this concept," said Matthew Galsky, M.D., co-director of the Center of Excellence for Bladder Cancer at The Tisch Cancer Institute at Mount Sinai Hospital in New York.