On June 2, 2025 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported the presentation of new clinical results from the PREDICT DNA and SCANDARE studies highlighting the capabilities of its ultrasensitive NeXT Personal circulating tumor DNA (ctDNA) blood test for monitoring and predicting neoadjuvant therapy (NAT) response in triple negative breast cancer (TNBC), one of the most aggressive types of breast cancer (Press release, Personalis, JUN 2, 2025, View Source [SID1234653652]).

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"Many triple negative breast cancer patients receive neoadjuvant therapy prior to surgery as standard of care. The data from these two studies independently suggest that an ultrasensitive ctDNA assay like NeXT Personal could help these patients better understand their risk of relapse, with the potential to help inform the need for additional therapy," said Richard Chen, MD, Chief Medical Officer and Executive Vice President, R&D at Personalis. "We believe this data, once published, can form the basis for seeking reimbursement coverage for neoadjuvant therapy monitoring in breast cancer. We are excited to continue to work with leading collaborators to expand the data around the use of NeXT Personal in breast cancer with the goal of helping breast cancer patients optimize their care."

Results from the PREDICT DNA study were presented yesterday by Dr. Natasha Hunter, MD, University of Washington, at the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2025 Annual Meeting in Chicago in an oral presentation titled "Circulating tumor DNA, pathologic response after neoadjuvant therapy, and survival: First results from TBCRC 040 (the PREDICT DNA trial)."

"The PREDICT DNA study prospectively evaluated ctDNA in early-stage patients with HER2-positive and triple negative breast cancer. The trial was initiated a decade ago and accrued 228 patients across 22 sites in the United States, and was statistically designed and powered for analysis of ctDNA to predict for pathologic complete response (pCR), and whether ctDNA could be a prognostic test to identify patients at high vs. very low risk for recurrence," said Dr. Ben Park, MD PhD, Vanderbilt-Ingram Cancer Center. "We partnered with Personalis because of their technology’s ultrasensitive detection of ctDNA down to 1 to 3 parts per million. Our results demonstrate that patients who ‘clear’ their ctDNA after upfront chemotherapy have excellent outcomes that mirror those with pCR, identifying a group of patients who, despite having residual disease at the time of surgery, will be at extremely low risk for recurrence. Conversely, those with detectable ctDNA after upfront chemotherapy are at a much higher risk of recurrence, and serial ctDNA measurements after surgery can help identify patients who may benefit from either escalation or de-escalation of therapies. We are truly excited by these results as they will allow us to more precisely risk-stratify patients with breast cancer in future trials and clinical practice."

Key findings included:

ctDNA status after completion of NAT (post-NAT) was highly prognostic for relapse-free survival (RFS).
Patients with ctDNA detected post-NAT were ~10 times more likely to relapse than patients who were ctDNA negative.
Detection of ctDNA post-NAT was more predictive of recurrence than pCR.
Patients who did not have detectable post-NAT ctDNA had excellent outcomes regardless of pathologic response.
Preliminary analyses indicate that patients who had post-surgical ctDNA detected were >85 times more likely to experience disease recurrence.
48% of post-NAT ctDNA detections were <100 PPM, highlighting the importance of NeXT Personal’s ultrasensitive performance.
Overall, the results suggest that ultrasensitive ctDNA detection in patients with TNBC after completion of NAT and prior to surgery may be used as a prognostic marker, independent of pCR, to guide clinical decision making for additional adjuvant therapies.
Dr. Luc Cabel, MD, PhD, Institut Curie, Paris, presented results from a second study titled "Ultrasensitive circulating tumor DNA (ctDNA) detection for prognostication in triple-negative breast cancer (TNBC) post-neoadjuvant chemotherapy (NAC)." This study included 86 patients with early stage (Stage I-III) TNBC receiving neoadjuvant therapy. Key findings included:

ctDNA was detected in 100% (84/84) of pretreatment baseline plasma samples.
The majority of ctDNA detections during NAT (51%) and post-NAT (55%) were in the ultrasensitive range below 100 PPM of ctDNA.
Post-NAT ctDNA status was highly prognostic. Patients with ctDNA detected post-NAT were ~36 times more likely to have a distant relapse than patients who tested negative.
For patients who were non-pCR, ctDNA negative patients were 93% less likely to relapse than ctDNA positive patients.
ctDNA status can be combined with pCR status to assess patient distant relapse risk following NAT.
Said François-Clément Bidard, MD, PhD, one of the Institut Curie lead investigators on the study, "Our results uncover the clinical need for ultrasensitive MRD testing, and pave the way for ctDNA-based adjuvant therapy decisions in early triple negative breast cancer."

On June 2, 2025 Enterome SA, a clinical-stage company developing first-in-class OncoMimics immunotherapies to treat cancer, reported it will present positive data from its Phase 1/2 clinical study with EO2463, its lead clinical program, as monotherapy and in combination with lenalidomide and/or rituximab to treat indolent Non-Hodgkin lymphoma (iNHL) at the International Conference on Malignant Lymphoma (ICML) in Lugano on June 21, 2025 (Press release, Enterome, JUN 2, 2025, View Source [SID1234653605]).

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As indicated by the data generated by Enterome’s ongoing SIDNEY study, EO2463 has the potential to become a frontline therapy in iNHL, either as monotherapy or in combination regimens, across all patient groups suffering from the disease, including in watch-and-wait settings, first-line therapy, and in relapsed/refractory settings.

The title of the peer-reviewed presentation is "EO2463 (EO) peptide immunotherapy in combination with lenalidomide (L) and rituximab (R) in patients (pts) with follicular (FL) and marginal zone lymphoma (MZL)", and will be presented by Dr Jose Caetano (JC) Villasboas Bisneto, principal study investigator at the Mayo Clinic in Rochester, MN, USA.

"We look forward to sharing these interim Phase 2 data, which suggest to us that our lead OncoMimics immunotherapeutic candidate EO2463 could have broad potential to benefit patients suffering from multiple clinical presentations of Follicular Lymphoma. Later this month, Dr Villasboas will present interim data obtained more specifically in iNHL patients with relapsed/refractory disease," said Pierre Bélichard, Chief Executive Officer of Enterome.

"Just this past weekend we presented positive Phase 1/2 data from the AUDREY trial in metastatic colorectal cancer with our second-most advanced OncoMimics immunotherapeutic candidate, EO4010, at ASCO (Free ASCO Whitepaper). OncoMimics represent a new therapeutic modality that has tremendous potential for cancer treatment."

Separately, Enterome recently held a positive Type-C meeting with the FDA, outlining a clear regulatory path to marketing approval for EO2463 in iNHL after constructive discussion with the regulator.

In addition, this week, Enterome will participate at the Jefferies Global Healthcare Conference in New York ( June 3 to 5). Pierre Bélichard and Chief Financial Officer Christelle Dumoussaud will meet with investors and industry partners during the event.

SIDNEY is a 12-month open label study that aims to assess safety, tolerability, immunogenicity, and preliminary efficacy of EO2463 monotherapy and combination therapy in some 48 patients with follicular lymphoma and marginal zone lymphoma. The study is comprised of four cohorts: 1) relapsed/refractory iNHL patients, who received EO2463 monotherapy for 6 weeks, followed by combination with lenalidomide plus rituximab for 16 weeks; 2) EO2463 monotherapy in newly diagnosed untreated stage III/IV iNHL classified as "watch and wait"; 3) EO2463 monotherapy followed by combination with rituximab in newly diagnosed previously untreated stage III/IV iNHL patients classified with low tumor burden in need of therapy; 4) relapsed/refractory iNHL patients, having received at least one prior treatment. EO2463 and lenalidomide are given in combination from treatment inception with addition of rituximab at week 19.

Enterome has previously presented interim data from the study at major international conferences held by the European Hematology Association (EHA) (Free EHA Whitepaper), the American Society of Hematology (ASH) (Free ASH Whitepaper), and the American Society for Cancer and Oncology.

EO2463 is an innovative, off-the-shelf immunotherapy candidate that combines four synthetic OncoMimic peptides. These non-self, microbial-derived peptides correspond to CD8 HLA-A2 epitopes that exhibit molecular mimicry with the B lymphocyte-specific lineage markers CD20, CD22, CD37, and CD268 (BAFF receptor). EO2463 also includes the helper peptide (CD4+ epitope) universal cancer peptide 2 (UCP2).

The unique ability of EO2463 immunotherapy to selectively target multiple B cell markers enables the destruction of malignant B lymphocytes. By ensuring broad target coverage across malignant B cells, this novel approach aims to simultaneously improve safety and maximize efficacy, reducing the tumor cells’ capacity to develop immune-resistance mechanisms such as antigen escape.

On June 2, 2025 QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported the expansion of its oncology diagnostics portfolio with two strategic partnerships to advance the use of minimal residual disease (MRD) testing in clinical trials to support pharma co-development projects for companion diagnostics (Press release, Qiagen, JUN 2, 2025, View Source [SID1234653621]). The new collaborations with Tracer Biotechnologies and Foresight Diagnostics expand QIAGEN’s reach in MRD testing and cover solid tumors and hematological cancers.

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Minimal residual disease (MRD) testing is becoming a cornerstone of oncology by enabling early detection of cancer recurrence and guiding timely adjustments to therapy from a blood sample. These new partnerships support the growing demand for decentralized, non-invasive tools that advance precision medicine and help deliver more personalized care.

"These new partnerships represent an important step in strengthening QIAGEN’s leadership in oncology by aiming to bring innovative MRD technologies into clinical practice," said Jonathan Arnold, Vice President, Head of Precision Partnering Diagnostics at QIAGEN. "We want to in particular strengthen our scalable, cost-effective solutions based on our QIAcuity digital PCR system and enable laboratories and healthcare providers worldwide to use MRD insights for guiding personalized treatment decisions for cancer patients."

Under the new collaborations:

Tracer Biotechnologies, a developer of blood-based molecular diagnostics for cancer, is working with QIAGEN to create companion diagnostics for MRD testing in solid tumors. These assays, designed for use on QIAGEN’s QIAcuity digital PCR platform, are designed to enable the use of minimally invasive blood samples to monitor residual disease with high sensitivity. The approach offers a cost-efficient and quick way to support decentralized implementation in clinical laboratories with results comparable to those generated using next-generation sequencing technologies.
"Partnering with QIAGEN enables Tracer to bring our solid tumor MRD expertise to a broader market using a robust digital PCR platform in QIAcuity," said Mark Kaganovich, CEO, Tracer Biotechnologies. "With QIAcuity’s sensitivity and scalability, we can deliver high-quality companion diagnostics that integrate seamlessly into clinical workflows and offer new options to oncologists and patients."

Foresight Diagnostics and QIAGEN are creating a kit-based version of the Foresight CLARITY assay, a circulating tumor DNA (ctDNA)-based NGS test for certain types of lymphoma. Transitioning the assay from a CLIA central laboratory service to an in-lab kit is designed to allow for broader clinical access and supports pharmaceutical-sponsored trials with companion diagnostic applications.
"We are excited to partner with QIAGEN to accelerate the development of a kit-based version of our CLARITY assay and expand our ability to support pharmaceutical companies in developing companion diagnostics and IVD solutions globally," said Jake Chabon, CEO of Foresight Diagnostics. "By combining our leading MRD technology with QIAGEN’s global infrastructure and expertise, we are well-positioned to deliver a diagnostic kit that has the potential to enable personalized treatment strategies for lymphoma patients worldwide."

MRD testing offers a highly sensitive way to monitor treatment response, identify patients at risk of relapse before symptoms appear and inform decisions on therapy usage. It is also emerging as a surrogate endpoint in clinical trials, accelerating drug development and regulatory review.

QIAGEN’s MRD portfolio spans sample technologies and testing platforms that support workflows from sample to insight. This includes the QIAsymphony system for automated sample preparation, with the new generation QIAsymphony Connect upgraded version being prepared for launch in late 2025, along with PAXgene blood collection tubes for stabilized blood draws. QIAGEN also offers an extensive range of kits for use on the QIAcuity family of digital PCR instruments as well as the QIAseq targeted gene panels for use on third-party NGS systems. Complementing these solutions is the portfolio of QIAGEN Digital Insights solutions that offer integrated bioinformatics for comprehensive NGS data analysis and interpretation to enable comprehensive MRD results.

On June 2, 2025 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, reported updated Phase 1 study results of IBI343, a novel anti-CLDN18.2 ADC, for the treatment of advanced pancreatic cancer at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Innovent Biologics, JUN 2, 2025, View Source [SID1234653637]).

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With extended follow-up and more mature data on progression-free survival (PFS) and overall survival (OS), IBI343 has demonstrated promising therapeutic efficacy in patients with CLDN18.2-positive advanced pancreatic cancer. These encouraging results suggest the potential of IBI343 in this challenging-to-treat malignancy. Supported by these robust clinical findings, IBI343 has been granted Breakthrough Therapy Designation (BTD) by China’s National Medical Products Administration (NMPA). Concurrently, the Phase 1 clinical trial of IBI343 is also being conducted in the United States, where the drug candidate has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA).

Pancreatic cancer is one of the most aggressive malignancies worldwide. Most patients are diagnosed in the middle and late stages and often develop resistance to standard chemotherapy, resulting in a 5-year survival rate of less than 10%1. According to the GLOBOCAN 2022 statistics2, there are approximately 510,000 new cases and 467,000 deaths globally from pancreatic cancer each year, with China accounting for 120,000 new cases and 110,000 deaths annually.

This Phase 1/1b study is a multi-regional, dose escalation and expansion clinical trial (NCT05458219). Preliminary data were presented at ASCO (Free ASCO Whitepaper) 2025 and ESMO (Free ESMO Whitepaper) Asia 2024 and the updated results from the study’s dose-expansion cohort were presented at the 2025 ASCO (Free ASCO Whitepaper) as follows:

As of March 14, 2025, a total of 83 patients with pancreatic cancer had received at least one dose of IBI343 with a median follow-up time of 11.1 months.
As the data cutoff date, in patients with CLDN18.2 1+2+3+≥60% expression treated at the 6mg/kg dose (N=44), the confirmed overall objective response rate (cORR) was 22.7% and the disease control rate (DCR) was 81.8%. The median progression-free survival (mPFS) was 5.4 months, and the median overall survival (mOS) was 9.1 months. Among them, 17 patients had received only one line of prior treatment, achieving a mPFS of 5.4 months and a mOS of 12.1 months; and 18 patients had received two lines of prior treatment, the mPFS was 5.3 months and the mOS was 9.1 months.
The updated safety results demonstrated the favorable safety profile of IBI343 with a consistently low rate of gastrointestinal toxicity and no new safety signals. 98.8% of the patients experienced treatment-emergent adverse events (TEAEs), with the most common TEAEs being anemia, neutrophil count decreased, and white blood cell count decreased. Notably, no ≥ grade 3 nausea and vomiting occurred.
Professor Xianjun Yu from Fudan University Cancer Hospital, said, "Pancreatic cancer is one of the most malignant tumors of the digestive tract. Most patients are already in the advanced stage when diagnosed, and the 5-year survival rate is only about 10%1. Currently, chemotherapy is still the main first- and second-line treatment for advanced pancreatic cancer. The clinical options for second-line treatment are particularly limited, with a chemotherapy response rate of only 6-16%, median progression free survival of 2 to 5 months, and a median survival of approximately 6 to 9 months3, representing an urgent clinical need. With longer follow-up, the mature PFS and OS data from the latest IBI343 update demonstrate promising therapeutic potential, suggesting a breakthrough in this difficult-to-treat malignancy."

Dr. Hui Zhou, Senior Vice President of Innovent, said, "We are pleased to present an oral update on IBI343’s clinical data at this year’s ASCO (Free ASCO Whitepaper) conference. With the unique Fc-silent antibody design, stable linker and potent TOPO1i payload, IBI343 is the first ADC candidate to show encouraging efficacy and a favorable safety profile in the treatment of advanced pancreatic cancer. We hope to continue advancing the clinical trials of IBI343 for pancreatic cancer patients. Innovent will leverage its unique strengths in R&D innovation and clinical translation to develop a new generation of globally competitive oncology – focused innovative pipeline to benefit patients worldwide.."

About IBI343（Anti-CLDN18.2 ADC）

IBI343 is a recombinant human anti-CLDN18.2 monoclonal antibody-drug conjugate (ADC) developed by Innovent Biologics. IBI343 binds to the CLDN18.2-expressing tumor cells, the CLDN18.2 dependent ADC internalization will occur and the drug is released resulting in DNA damage and eventually apoptosis of the tumor cells. The freed drug can also diffuse across the plasma membrane to reach and kill the neighboring cells, resulting in "bystander killing effect".

As an innovative TOPO1i ADC, IBI343 has demonstrated tolerable safety and encouraging efficacy signals in Phase 1 clinical studies. The therapeutic potential of IBI343 is currently being explored in tumor types such as gastric and pancreatic cancer.

The Phase 3 trial of IBI343 for advanced gastric / gastroesophageal junction adenocarcinoma is now recruiting patients. The relevant indication has been included in China’s NMPA breakthrough therapy list.

IBI343’s Phase 1 trial for advanced pancreatic ductal adenocarcinoma is enrolling patients in an multi-regional study. This indication has received Fast Track designation from the FDA and been included in the NMPA’s BTD list.

On June 2, 2025 PanGIA Biotech, a leader in non-invasive cancer diagnostics, reported findings at the 2025 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) from a prospective, multi-center validation study evaluating its AI-powered, urine-based platform for early-stage prostate cancer detection (Press release, PanGIA Biotech, JUN 2, 2025, View Source [SID1234653653]).

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The study, Development and validation of an AI-enabled prediction of prostate cancer (PCa) using urine-based liquid biopsy (Abstract #3080), is the first to clinically validate PanGIA’s novel approach—pairing proprietary chemistry with machine learning to detect cancer-specific biosignatures from a single, non-invasive urine sample.

"This study confirms what we’ve believed from the start: there’s power in non-invasive, data-driven diagnostics," said Holly Magliochetti, CEO of PanGIA Biotech. "Our platform helps clinicians detect prostate cancer when intervention is most effective—without costly or invasive procedures."

Key findings presented included:

Study Cohort: 197 biopsy-confirmed prostate cancer patients and 84 healthy controls.

Classifier Performance: Achieved an F1 score of 0.843 with a recall of 0.967 in distinguishing cancer from non-cancer subjects.

Gleason Score Cohorts: Maintained high recall (>0.89) across Gleason scores 6 through 10, with F1 scores ranging from 0.799 to 0.838.

Non-Invasive Advantage: Demonstrated strong performance in detecting intermediate- and low-grade cancers, offering a less invasive alternative to traditional diagnostics.
Unlike invasive biopsies or blood-based tests that often miss early-stage cases, PanGIA’s approach analyzes urinary biosignatures using proprietary AI models—eliminating the need for sequencing and enabling cost-effective, globally scalable testing.

Previously published in The Analyst, a journal of the Royal Society of Chemistry¹, the PanGIA platform is designed for diverse healthcare environments and holds promise for broad global adoption.