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PredicineCARE™

Moreover, CNB decreased below the limit of quantification during treatment and increased above the limit at progression. In conclusion, longitudinal CSF cfDNA can feasibly be obtained via CSF access devices in patients with gliomas during their disease course toward evaluating candidate monitoring biomarkers.

Urine testing identifies additional NMIBC pts who may respond to erdafitinib, which is especially valuable when the parallel tissue sample submitted does not return a result. Findings support urine testing for pt selection in the recently initiated phase 3 study (MoonRISe-1, NCT06319820).

The utDNA and uCNB analyses in this study demonstrated high sensitivity and specificity, offering promising non-invasive diagnostic options for UC. These methods also have the potential to facilitate personalized therapy, improving patient management in urothelial carcinoma.

Plasma samples were collected after aromatase inhibitor treatment and before starting Fulvestrant... The ultra-sensitive ctDNA NGS assay outperformed standard liquid biopsy assays in detecting low-frequency mutations and those from samples with low tumor fractions in HR-positive, HER2-negative breast cancer. Its superior detection may help identify patients suitable for targeted therapies like PIK3CA and ESR1 inhibitors, improving early detection of treatment resistance and disease monitoring for more effective personalized treatment strategies.

P2; N=35 --> 0 | Recruiting --> Withdrawn

"Predicine, Inc...announced today that it will present data from 9 ctDNA studies at ASCO 2024, spotlighting the clinical utility of Predicine’s genomic and epigenomic liquid biopsy solutions for patient selection, disease monitoring, and drug resistance mechanism studies. The forthcoming data represents significant potential for the practical application of Predicine’s cutting-edge liquid biopsy technology in personalized cancer care, clinical trials, and Companion Diagnostic (CDx) development."

In this ongoing investigation, 46 patients with advanced HR-positive, HER2-negative breast cancer were enrolled, and plasma samples were collected subsequent to first-line aromatase inhibitor (AI) treatment and before the initiation of second-line treatment with fulvestrant... The ultra-sensitive ctDNA NGS assay demonstrated superior detection of low-frequency mutations in HR-positive, HER2-negative breast cancer, significantly outperforming standard liquid biopsy assays. This enhanced sensitivity may offer profound implications for identifying more diagnostically positive patients who may benefit from targeted therapy such as PIK3CA and ESR1 inhibitors. This ultra-sensitive ctDNA assay will also enable early detection of treatment resistance and refined disease monitoring, potentially guiding more effective personalized therapies.

This study confirms that urine-based NGS liquid biopsy is a promising method for identifying molecular markers in MIBC patients undergoing bladder preservation therapy. Furthermore, the reduction in ctDNA tumor fractions may associate with effective treatment and the possibility of disease eradication.

Longitudinal CSF cfDNA can feasibly be obtained via CSF access devices in patients with gliomas during their disease course. Ongoing studies will evaluate hypotheses generated in this case series regarding how longitudinal CSF cfDNA could be utilized to sensitively detect changes in disease burden.

"Predicine, Inc...announced the release of its innovative PredicineCARE™ NGS Kit. This offering presents a research-use-only (RUO) next-generation sequencing (NGS) kit packaged for genomic profiling across various cancers, enabling tumor profiling."

"Predicine, Inc...today announced a collaboration with Apollomics, Inc. This collaboration aims to advance the development of PredicineCARE, a blood cell-free DNA (cfDNA) next-generation sequencing (NGS) assay, to identify non-small cell lung cancer (NSCLC) patients who may benefit from targeted therapy."

"Predicine...announced today that it will present data from 15 ctDNA studies at AACR 2024, spotlighting the clinical utility of Predicine’s genomic and epigenomic liquid biopsy solutions for patient selection, disease monitoring, and disease mechanism studies."

This study reveals the extensive mutational landscape in advanced colorectal cancer patients through liquid biopsy. Distinct prevalence patterns in certain genes between the U.S. and China cohorts offer novel biomarkers for clinical diagnosis and provide insights for targeted therapy mechanism studies.

This study offers insights into the genomic landscape of advanced breast cancer subtypes through liquid biopsy. The observed prevalence of PIK3CA mutations supports the potential efficacy of PI3K inhibitors across these diverse types of breast cancer, laying the groundwork for personalized therapeutic strategies and biomarker identification for prognosis and targeted therapies.

Subsequently, CSF cfDNA decreased during chemoradiation and adjuvant treatment and increased at recurrence, even in patients co-enrolled in immunotherapy trials for IL-7 agonists and pembrolizumab... Analysis of cfDNA throughout a patient's disease course, encompassing resection and treatment with standard-of-care and experimental therapies, may aid in disease monitoring and treatment response. Further evaluation in a larger patient cohort is needed to determine the sensitivity of changes in mutations, CNB, and cfDNA quantity for glioma disease burden.

This study unveils the mutational landscape of advanced NSCLC through liquid biopsy. Unique prevalence patterns between U.S. and China cohorts suggest novel biomarkers for clinical diagnosis and provide insights for targeted therapy mechanism studies.

"Predicine...announced a collaboration with Janssen Pharmaceutica NV (Janssen), a Johnson & Johnson company. This collaboration focuses on the development of the PredicineCARE™ urine cell-free DNA (cfDNA) next-generation sequencing (NGS) assay as a companion diagnostic to identify patients who may benefit from targeted therapy....PredicineCARE™ is a comprehensive, state-of-the-art NGS assay that interrogates point mutations/indels, fusions, amplifications, and gene deletions in key cancer-associated genes using cfDNA in urine."

Implementing a urine-based assay expands the molecular testing methods to identify additional patients that may respond to erdafitinib. Results justify further study. Clinical trial information: NCT05316155.

Of the 42 pts with a treatment recommendation, 23 pts (56%) have received an on-label treatment, 19 with a PARP inhibitor and 4 with pembrolizumab... In this prospective study, 38% of pts with mCRPC were identified to have variants with an on-label treatment recommendation, highlighting the value of comprehensive testing to identify a relatively high number of these pts. In pts with both cfDNA and tissue testing, cfDNA alone detected 68% of these pts, emphasizing the value of cfDNA as a complement or alternative to tissue testing. Repeat cfDNA testing in a cohort of pts detected a new on-label variant in almost half of the pts tested, emphasizing the potential value of serial testing with tumor progression.

There is a paucity of treatment options for patients with stage IV RCC post anti-PD1 and anti-VEGF therapies. Novel therapies on this clinical scenario are needed. On this abstract we showed radiographic and pharmacodynamic data on patients with RCC who achieved a clinical partial response by RECIST on the phase I clinical trial TPST1120-001.

This assay was then adopted for longitudinal sequencing of 57 serial plasmas from 6 patients with HER2+ gastroesophageal adenocarcinomas (GEC) who underwent combined treatments (capecitabine, oxaliplatin, bevacizumab and trastuzumab) at different time points (baseline, response, and progression). This study demonstrated the promise and clinical utility of the ultra-sensitive cfDNA molecular profiling at 100,000X sequencing depth in treatment selection, therapy monitoring, and drug resistance studies.

This study elucidated the comprehensive mutational landscape of advanced gastrointestinal cancer through liquid biopsy, thereby contributing novel biomarkers for clinical diagnosis and facilitating targeted therapy mechanism investigations.

P2; Not yet recruiting --> Recruiting

"Predicine...announce its participation in the European Society for Medical Oncology (ESMO) 2023 Congress in Madrid, Spain. The company will present six compelling poster studies, unveiling the future of liquid biopsy solutions...These poster presentations will shine a spotlight on Predicine’s groundbreaking liquid biopsy innovations, including PredicineBEACON™, a revolutionary solution for personalized and actionable minimal residual disease (MRD) analysis."

P2; Trial completion date: May 2028 --> Sep 2028 | Initiation date: May 2023 --> Sep 2023 | Trial primary completion date: May 2026 --> Sep 2026

These data emphasise that the BRCA genes, in particular BRCA2, are key prognostic biomarkers in mCRPC. The clinical utility of BRCA2 as a marker of poor outcomes may, at least in cfDNA assays, be independent of the zygosity state detected. Enrichment of actionable genomic alterations in cfDNA from BRCA-deficient mCRPC may support rational co-targeting strategies in future clinical trials.

Conclusions The results of this study confirm the validity of utilizing a utDNA assay to detect molecular recurrence in early-stage bladder cancer patients who have undergone TURBT treatment, which can be instrumental in facilitating early detection of tumor recurrence and guiding treatment decisions. These findings underscore the enormous potential of urine-based NGS assays for urothelial cancer detection and disease surveillance.

Conclusions The present study unveils a comprehensive mutational landscape of non-muscle invasive bladder cancer (NMIBC) and muscle invasive bladder cancer (MIBC) utilizing urine samples from real-world patients. These results demonstrate the promising potential of urine-based next-generation sequencing (NGS) assays to identify tumor-derived variants for clinical diagnosis and targeted treatment.

Conclusions This study presents a comprehensive analysis of the mutational landscape of advanced HR+/HER2- breast cancer patients using liquid biopsy. Additionally, it compares the molecular profiles of patients with different clinical features receiving diverse treatments, thus identifying potential biomarkers for prognosis and targeted therapies.

This study demonstrates the feasibility of using urine ctDNA assay to detect molecular recurrence in early-stage bladder cancer patients treated by TURBT. This information can be used to improve patient outcomes by enabling early detection of tumor recurrence and guiding treatment decisions. The findings of this study highlight the promising potential of urine-based NGS assays for cancer detection and disease surveillance.

Randomization was 1:1 to giredestrant (30 mg PO daily) or PCET (fulvestrant/aromatase inhibitor). These data show that tumor response to single-agent ET is correlated with baseline ctDNA features and with tumor ER pathway activity. Interestingly, ER pathway activity was significantly lower in late-line tumors, except in ESR1m tumors. Overall, these results support the continued investigation of improved and personalized treatment options for pts with ER+, HER2– aBC.

P2; Trial completion date: Dec 2027 --> May 2028 | Trial primary completion date: Dec 2025 --> May 2026

UTUC tumor variants are detectable in the urine of treatment-naïve patients undergoing RNU for UTUC using both a panel-based approach and WGS. utDNA detection and dynamics may present an opportunity for personalized monitoring of UTUC.

"This study revealed the comprehensive mutational landscape of advanced NSCLC through liquid biopsy, providing novel biomarkers for clinical diagnosis and targeted therapy mechanism studies."

"The combination of CAPOX, trastuzumab and bevacizumab shows striking clinical activity comparable to novel triplet regimens that include PD1 blockade for HER2+ GEAs . Further evaluation of VEGF mAb in combination with chemoimmunotherapy and anti-PD1 regimens is warranted. Diagnostic ctDNA profiling identifies cases with high TF and alternative MAPK drivers who have worse outcomes."

"This study revealed the comprehensive mutational landscape of advanced breast cancer patients through liquid biopsy, providing novel biomarkers for clinical diagnosis and targeted therapy mechanism studies."

PredicineCARE has been CE-marked and received breakthrough device designation from FDA. A harmonized PredicineCARE assay is available in the US and China to support patient testing in the clinic, global clinical trials and CDx development.

Additionally, on top of a high proportion of AR alterations, BRCA-defective cancers were also enriched in a number of potentially actionable targets and neuroendocrine markers. Clinical trials that leverage rational co-targeting strategies will provide an opportunity to enhance the efficacy of PARPi in mCRPC.

TPST-1120 was well tolerated and showed signs of activity in a phase I trial as monotherapy and in combination with nivolumab (NCT03829436). TPST-1120 treated patients with PR demonstrated fatty acid oxidation perturbations and immune gene expression changes as potential biomarkers of clinical benefit. Increased frequencies of responding patients bearing PI3K pathway or IDH mutations may reveal populations likely to benefit from treatment with TPST-1120. 1.

Despite significant breakthroughs in targeted medicines (i.e., Erdafitinib, FGFR2/3 kinase inhibitor) and clinical care over the past decade, non-invasive molecular testing remains an unmet clinical need for the treatment of bladder cancer patients... High concordance between FGFR alterations detected with an FDA approved tissue CDx and urine cfDNA NGS assay demonstrates that the PredicineCARE urine cfDNA NGS assay may represent a novel, accurate, and non-invasive clinical application for molecular diagnostic testing to identify biomarkers in bladder cancer.

Prospective ctDNA and utDNA analysis using a targeted NGS panel is a feasible nonsurgical approach to prediction of muscle-invasive and non-organ-confined UTUC and has the potential for identification of upper tract urothelial cancer patients that may derive benefit from NAC.

Trial Registration TPST-1120 as Monotherapy and in Combination With Nivolumab in Subjects With Advanced Cancers (NCT03829436). Patients with PR demonstrated gene expression changes that implicate immune activation and alleviation of immune suppression as potential biomarkers of clinical benefit. Increased frequencies of responding patients bearing PI3K pathway or IDH mutations may reveal populations likely to benefit from treatment with TPST-1120.