On June 19, 2025 Amplia Therapeutics Limited (ASX: ATX), ("Amplia" or the "Company"), reported further data from the ongoing ACCENT trial investigating the Company’s best-in-class FAK inhibitor narmafotinib in advanced pancreatic cancer (Press release, Amplia Therapeutics, JUN 19, 2025, View Source [SID1234653983]). A second patient of the 55 patients enrolled in the trial has recorded a confirmed complete response (CR). This finding follows the announcement earlier this week1 of a separate patient who achieved a pathological CR in the trial.

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A confirmed complete response is a formal designation of response where there is a complete disappearance of all tumour lesions that is maintained for >2 months. This is a rare outcome in advanced pancreatic cancer where the disease has spread to other parts of the body. For example, the seminal study demonstrating efficacy of the chemotherapies gemcitabine and Abraxane in advanced pancreatic cancer reported only one (1) CR out of 431 patients.

Amplia CEO and MD Dr Chris Burns commented: "To see a second complete response in the ACCENT trial is really wonderful news, particularly given how rare these are observed in advanced pancreatic cancer. Along with the pathological CR announced earlier in the week, this outcome further demonstrates the promising activity narmafotinib, on top of standard-of-care, is showing in pancreatic cancer."

This ASX announcement was approved and authorised for release by the Board of Amplia Therapeutics.

About Narmafotinib

Narmafotinib (AMP945) is the company’s best-in-class inhibitor of the protein FAK, a protein over-expressed in pancreatic cancer and a drug target gaining increasing attention for its role in solid tumours. The drug, which is a highly potent and selective inhibitor of FAK, has shown promising data in a range of preclinical cancer studies.

About the ACCENT Trial

The ACCENT trial is entitled ‘A Phase 1b/2a, Multicentre, Open Label Study of the Pharmacokinetics, Safety and Efficacy of AMP945 in Combination with Nab-paclitaxel and Gemcitabine in Pancreatic Cancer Patients’.

The trial is a single-arm open label study conducted in two stages. The first stage (Phase 1b), completed in November 2023, determined an optimal dose of narmafotinib (AMP945) by assessing the safety, tolerability, pharmacokinetics and preliminary efficacy when dosed in combination with gemcitabine and Abraxane in first-line patients with advanced pancreatic cancer.

The second stage (Phase 2a) of the trial is designed to assess efficacy in combination with gemcitabine and Abraxane. The primary endpoints are Objective Response Rate (ORR) and Duration on Trial (DOT) with secondary endpoints being Progression Free Survival (PFS) and Overall Survival (OS). Safety and tolerability will continue to be assessed.

The trial is being conducted at seven sites in Australia and five sites in South Korea.

More information about the ACCENT trial can be found via the ACCENT trial site, the Amplia Therapeutics website and at ClinicalTrials.gov under the identifier NCT05355298.

On June 18, 2025 Akari Therapeutics, Plc (Nasdaq: AKTX), an oncology biotechnology company developing novel immuno-oncology payload antibody drug conjugates (ADCs) for the treatment of cancer, reported the Intellectual Property India (IPI) has issued Patent No. 562,919 titled,"Thailanstatin Analogs" (Press release, Akari Therapeutics, JUN 19, 2025, View Source [SID1234654005]).

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The issued patent covers claims for the Company’s potent immuno-oncology PH1 payload, proprietary non-cleavable and cleavable linkers and ADC technology which has applications across various cancer targets.

"We believe our innovative ADC payload PH1 has the potential to provide therapies that disrupt cellular function, trigger cancer cell death and most importantly, enhance the immune system to fight cancer beyond the cells targeted by the ADC molecule. The issuance of this patent further strengthens our global intellectual property estate and importantly, provides additional patent protection around our CMC manufacturing activities for this PH1payload and related analogs. Importantly, as cancer rates and diagnosis continue to rise significantly in India, we believe the need for innovative cancer therapies continue to increase. We are pleased to bolster our intellectual property portfolio to include this key market for future opportunities to potentially help cancer patients with our immuno-oncology ADCs," commented Abizer Gaslightwala, President and CEO of Akari Therapeutics.

The issued India patent is a divisional patent of the Company’s R&D toxin portfolio on PH1 and builds on the portfolio of previously issued patents (Patent No. US 10,815,246 B2, Patent No. US 10,301,319 B2 and Patent No. US 11,691,982 B2). Grant Patent right for PCT/US2018/051721 family was issued by China National Intellectual Property Administration in August 2023, and in Israel in September 2023. Corresponding foreign patent applications are pending and currently undergoing examination in Patent Cooperation Treaty ("PCT")countries – Brazil, Canada, member states of the European Patent Organisation ("EPO"), Hong Kong, Japan, New Zealand, Singapore, & South Africa.

Leveraging its innovative payload platform, the Company is advancing a pipeline of potentially first-in-class, best-in-class ADC candidates across a wide range of cancer tumor targets. These initial candidates have shown significant tumor-killing activity in preclinical models with the ability to robustly activate the immune system to drive durable, and sustained outcomes.

On June 18, 2025 FUJIFILM Healthcare Americas Corporation, a leading provider of diagnostic and enterprise imaging solutions, reported that use of its AFP-L3 and DCP in vitro diagnostic tests is being evaluated in the National Liver Cancer Screening Trial (known as TRACER), a study funded by the National Cancer Institute, part of the National Institute of Health (Press release, Fujifilm, JUN 18, 2025, View Source [SID1234653998]). The multi-center study compares liver cancer screening strategies in patients with cirrhosis or chronic hepatitis B.

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Hepatocellular cancer (HCC) is the third leading cause of cancer-related mortality worldwide and the most rapidly growing cause of cancer deaths in the U.S.1 HCC mortality continues to escalate due to the increased prevalence of chronic liver diseases, inadequate diagnostic precision in the early stages of disease, and historical lack of effective systemic therapies for late-stage HCC. Surveillance of high-risk patients is typically conducted via liver ultrasound in combination with serum alpha-fetoprotein (AFP) serum testing. However, ultrasound sensitivity can be compromised by the severity and underlying cause of liver disease, and serum AFP levels can be affected by hepatic inflammation, patient characteristics, and hereditary and other non-hepatic disorders,2 among other factors, compromising early-stage HCC diagnostic accuracy.

The use of serum biomarkers such as AFP-L3 and des-gamma-carboxyprothrombin (DCP) in surveillance can significantly improve early diagnosis capabilities, and the GALAD score3 – derived from Gender, Age, AFP-L3, AFP and DCP – has shown promise as a more accurate model for screening and early detection of HCC in at-risk patients in recent studies, including the HCC Early Detection Strategy (HEDS) Study conducted through the EDRN (View Source). FUJIFILM Healthcare Americas Corporation In Vitro Diagnostics division offers FDA-cleared AFP-L3 and DCP biomarker tests that are utilized as an aid in HCC risk assessment in conjunction with other laboratory findings, imaging studies, and clinical assessment.

The GALAD model continues to be studied in the TRACER study. The Phase IV prospective validation study, which began enrollment in January 2024 and is being conducted in the U.S., will enroll 5,500 at-risk patients across 15 sites that will be randomly assigned semi-annual screening with ultrasound ± AFP arm (the standard of care) or semi-annual screening via the GALAD model. Patients will be actively recruited over a 3-year period, with assessment of the data at year 5.5; the primary aim is a reduction in the proportion of late-stage HCC diagnosis. The TRACER study will measure secondary outcomes of interest including psychological and financial harms utilizing validated patient surveys.

"We are pleased that the TRACER study is evaluating the use of Fujifilm’s biomarker tests as a potential way to improve effectiveness in HCC screening in at-risk patients," said Henry (Hidetoshi) Izawa, president and chief executive officer, FUJIFILM Healthcare Americas Corporation. "HCC is often diagnosed at an advanced stage, with limited treatment options. Our hope is that this study will further underscore the benefits of HCC-specific blood tests in the detection of early-stage HCC, and patients will benefit from earlier diagnosis and treatment options."

The use of the Fujifilm’s biomarkers in the GALAD model is a novel concept and for research use only.
TRACER is supported by a grant within the Early Detection Research Network, a program of the National Cancer Institute, National Institutes of Health.

On June 18, 2025 CEL-SCI Corporation (NYSE American: CVM) reported the U.S. Food and Drug Administration’s (FDA) approval of Merck’s KEYTRUDA (pembrolizumab), an anti-PD-1 therapy, for the treatment of adult patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1) as determined by an FDA-approved test (Press release, Cel-Sci, JUN 18, 2025, View Source [SID1234653997]). Merck’s application was granted the FDA’s priority review on February 25, 2025, and regulatory approval was granted on June 13, 2025, based on interim results from Keytruda’s Phase 3 KEYNOTE-689 trial.

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Last week the FDA approved Keytruda as a perioperative (before and after surgery) treatment for resectable locally advanced head and neck cancer patients whose tumors express PD-L1 at a positive level. In Merck’s Phase 3 KEYNOTE-689 trial, Keytruda reduced the risk of recurrence and progression by 30%, compared with standard of care, in patients whose tumors expressed PD-L1 (CPS ≥1). The study did not show an improvement in overall survival. Patients with low to zero levels of PD-L1 did not benefit from Keytruda.

In contrast to the results of the KEYNOTE-689, CEL-SCI’s Phase 3 study showed that Multikine* treated patients whose tumors expressed low (Tumor Proportion Score [TPS <10]) to zero PD-L1, had their risk of death reduced by 66% (hazard ratio 0.34, 95% CI [0.18, 0.65], p=0.0012) and extended the 5-year overall survival to 73% compared to 45% in the standard of care, log rank p=0.0015. About 70% of the patients in CEL-SCI’s Phase 3 study had low to zero levels of PD-L1.

"It is encouraging for CEL-SCI that Merck’s Keytruda application received the FDA’s priority review and that marketing approval was given based on a Phase 3 study’s first pre-specified interim analysis. CEL-SCI has received the FDA’s go-ahead for a confirmatory Registration Study with 212 patients based on results from the completed Multikine Phase 3 study in head and neck cancer patients. The patients in the Phase 3 study that benefited from Multikine pre-surgery treatment showed an almost 4-year median overall survival advantage over control, and pre-surgery tumor responses to Multikine predicted survival benefit. The Keytruda approval based on pre-specified interim results strongly implies that Multikine has the potential for accelerated regulatory approval based on favorable post-surgical tumor responses," stated CEL-SCI’s CEO, Geert Kersten.

On June 18, 2025 GeneCentric Therapeutics, a company making precision medicine more precise through gene expression, reported the initial closing of an $8.0 million Series C financing (Press release, GeneCentric Therapeutics, JUN 18, 2025, View Source [SID1234653996]). The proceeds will be used to launch and commercialize GeneCentric’s GenomicsNext, the first integrated platform for comprehensive liquid biopsy testing that simultaneously provides thousands of gene expression measurements and high-fidelity DNA variant detection from circulating tumor DNA (ctDNA) in one sample. This novel gene expression platform will accelerate the growth of GeneCentric’s pipeline of predictive response signatures for oncology therapeutics development.

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The funding round was led by Hatteras Venture Partners, with current participation from existing investors IAG Capital Partners, Alexandria Venture Investments, and Labcorp. The financing is expected to provide a cash runway for GeneCentric through 2026.

"While we see many new liquid biopsy companies seeking funding, GeneCentric has the most compelling opportunity we have identified," said Clay Thorp, General Partner, Hatteras Ventures Partners. "GenomicsNext has the potential to become the ‘decoder ring’ for translating a broad array of tissue-based biomarkers into liquid biopsy formats. This could transform how patients are identified and how disease and treatments are monitored."

"With a single blood sample from a cancer patient, our GenomicsNext liquid biopsy platform can determine the gene expression of drug target genes, molecular subtypes, and predictive gene signatures, in addition to mutations and fusions," said Mike Milburn, PhD, President and CEO of GeneCentric Therapeutics. "We believe our unique fragmentomics technology will become the best-in-class application for yielding greater insights and biomarker coverage from liquid biopsies to better aid diagnosis and treatment selection for patients. We are grateful for the enthusiasm and support of our investors and expect to make the GenomicsNext platform commercially available as a powerful research tool for biopharmaceutical companies in 2025."

About GenomicsNext

While liquid biopsy enables the diagnosis or analysis of tumors using a blood or fluid sample rather than a tissue biopsy, it currently focuses on measuring mutations in genes and not their expression. This narrow focus limits its utility, because important measures including molecular subtypes and common biomarkers for targeted therapy, such as HER2 or antibody-drug conjugates, are not measured by most assays, potentially delaying diagnosis and administration of life-saving oncology therapeutics.

Building on over a decade of expertise with gene expression, GeneCentric developed ExpressCT, a breakthrough technology that measures gene expression using information embedded in ctDNA, to provide a more complete liquid biopsy solution for precision oncology. The company will apply this technology through GenomicsNext, its integrated platform for comprehensive liquid biopsy testing. Once launched, the platform will simultaneously provide high-fidelity DNA variants and gene expression information.

"We’ve known that gene expression is a powerful diagnostic adjunct to traditional DNA alterations, but unlike tumor tissue profiling today, gene expression measurement is largely missing from liquid biopsy assays," said Kirk Beebe, PhD, Chief Scientific Officer of GeneCentric. "The GenomicsNext platform delivers a dramatic step change in the diagnostic utility of ctDNA-based liquid biopsies by ushering in this dimension."