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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]).

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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.

Whitehawk Therapeutics to Present at the Jefferies 2025 Global Healthcare Conference

On May 28, 2025 Whitehawk Therapeutics, Inc. (Nasdaq: WHWK), an oncology therapeutics company applying advanced technologies to established tumor biology to efficiently deliver improved ADC cancer treatments, reported its presentation at the Jefferies 2025 Global Healthcare Conference, taking place June 3-5, 2025, in New York City, NY (Press release, Whitehawk Therapeutics, MAY 28, 2025, View Source [SID1234653459]). Dave Lennon, PhD, President and CEO, will present a company overview on Wednesday, June 4, 2025, from 2:00-2:30 PM ET.

A live webcast of the fireside chat can be accessed by visiting the Whitehawk Therapeutics IR website and will be available for replay for approximately 30 days following the event.

Illumina expands clinical oncology portfolio unlocking new standard of care and access to precision therapies

On May 28, 2025 Illumina Inc. (NASDAQ: ILMN) reported an expanded clinical oncology portfolio, unlocking the next new solutions to advance precision oncology and improve the standard of care (Press release, Illumina, MAY 28, 2025, View Source [SID1234653458]). The company’s broad range of clinical offerings will accelerate access to precision oncology for more patients with cancer. Illumina tumor profiling and in vitro diagnostic (IVD) solutions will be on display at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago.

"Access to tumor profiling is essential to deliver on the promise of precision cancer care," said Everett Cunningham, chief commercial officer of Illumina. "With our growing portfolio of distributable clinical solutions, we are unlocking the next new standard of care for clinicians and their patients. With TSO Comprehensive and Pillar oncoReveal CDx, more labs can perform tumor profiling in-house, allowing oncologists to rapidly understand the genomic drivers of disease, and match their patients to the best possible therapies."

Illumina TruSight (TSO) Comprehensive is the first and only FDA-approved test offering a distributable comprehensive genomic profiling IVD kit with pan-cancer CDx claims, evaluating both DNA and RNA. This enables clinicians to rapidly match cancer patients with targeted therapies using comprehensive tumor profiling. Illumina customers across the US — in community oncology care practices, regional hospitals and health systems, and academic medical centers — are integrating TSO Comprehensive into their clinical practice. This month, UofL Health – UofL Hospital became the first Illumina customer to begin offering the test to patients.

"We are excited to bring TSO Comprehensive to our patient and provider community. Access to an in-house comprehensive tumor profiling solution will allow our care teams to deliver faster precision therapy decisions for our patients," said Mustafa Al-Kawaaz, MD, assistant professor and director of Hematology, Cytogenetics and Molecular Pathology in the Department of Pathology and Laboratory Medicine at the University of Louisville School of Medicine.

TSO Comprehensive is now covered under Medicare plans by the Centers for Medicare & Medicaid Services (CMS), as well as most commercial health plans.

Illumina continues to pursue expanded biomarker indications and CDx claims for TSO Comprehensive in the US. Also announced today, the IVD kit has now received regulatory approval in Japan.

Illumina expands partnership with Pillar Biosciences to boost access to clinical diagnostics

Expanding its IVD portfolio, Illumina is partnering with Pillar Biosciences to offer Pillar oncoReveal CDx to Illumina customers beginning this summer. The oncoReveal CDx IVD kit is used for the detection of genetic variations in 22 genes and is intended for previously diagnosed patients with solid tumors. In April, Pillar announced that oncoReveal CDx received nationwide Medicare coverage by the CMS.

‘With over 66 million people in the US covered by Medicare, reimbursement of oncoReveal CDx will help ensure that highly accurate, actionable, and reimbursable next-generation sequencing testing is available to clinical laboratories and biopharmaceutical companies," said Brian Wright, chief marketing officer of Pillar Biosciences. "In turn, this enables faster treatment decisions and improved outcomes for everyone, everywhere."

Learn more about Illumina at ASCO (Free ASCO Whitepaper) and visit us at Booth 33101.