Veracyte Announces Eight Abstracts Highlighting Performance and Clinical Utility of Its Decipher and MRD Tests in Urologic Cancers To Be Presented at EAU25

On March 19, 2025 Veracyte, Inc. (Nasdaq: VCYT), a leading cancer diagnostics company, reported that multiple abstracts will be presented at the 40th Annual European Association of Urology Congress (EAU25) demonstrating the clinical performance and utility of its Decipher tests in prostate and bladder cancer (Press release, Veracyte, MAR 19, 2025, View Source [SID1234651263]). Additionally, independent performance data supporting the company’s minimal residual disease (MRD) testing platform for muscle-invasive bladder cancer will be unveiled from a large, multicenter trial. The EAU25 meeting is taking place March 21-24 at IFEMA Madrid in Spain.

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"These new data reinforce the impact our Decipher tests are having on patient care in prostate and bladder cancers and how our whole-transcriptome approach is enabling us to partner with researchers to fuel new insights into the underlying biology of these diseases," said Philip Febbo, M.D., Veracyte’s chief scientific officer and chief medical officer. "We are similarly deploying a whole-genome approach with our MRD testing platform and are excited to see data from the TOMBOLA trial at EAU25 that reinforce the strong performance of our MRD platform for muscle-invasive bladder cancer. We plan to launch a test for this indication next year."

The following Decipher- and MRD-focused abstracts will be presented at EAU25:

PROSTATE CANCER:

Title:

Transcriptomic profiling of the tumor immune microenvironment reveals prognostic markers in mCRPC patients treated with LuPSMA therapy​

Presenter:

Analena Handke, M.D., Ruhr University Bochum, Bochum, Germany

Format:

Poster (#P195)

Date/Time:

Saturday, March 22, 11:30-12:00 CET

Location:

Green Area, EGPT 2

Title:

Transcriptomic expression patterns in very high risk Decipher >0.85​

Presenter:

Nicole Handa, M.D., Northwestern University, Chicago, Ill.

Format:

Oral (#A0587)

Date/Time:

Sunday, March 23, 15:30-16:10 CET

Location:

Purple Area, Room 1

BLADDER CANCER:

Title:

Discrepancy between clinical and pathological stage after radical cystectomy: Results from a nation-wide prospective cohort study

Presenter:

Joep J. de Jong, M.D., Erasmus University Medical Center, Rotterdam, The Netherlands

Format:

Oral (#A0122)

Date/Time:

Friday, March 21, 16:15-16:40 CET

Location:

Pink Area, N103

Title:

A non-coding RNA based classifier for favorable outcomes in clinically organ confined bladder cancer

Presenter:

Joep J. de Jong, M.D., Erasmus University Medical Center, Rotterdam, The Netherlands

Format:

Oral (#A0504)

Date/Time:

Sunday, March 23, 14:35-15:15 CET

Location:

Pink Area, N101

Title:

Molecular characterization of residual muscle-invasive bladder cancer identifies a scar-like genomic profile with favorable prognosis after neoadjuvant chemo and immunotherapy

Presenter:

Joep J. de Jong, M.D., Erasmus University Medical Center, Rotterdam, The Netherlands

Format:

Oral (#A0508)

Date/Time:

Sunday, March 23, 14:35-15:15 CET

Location:

Pink Area, N101

Title:

Gene expression signatures of immune infiltration portend differential response to sequential Intravesical Gemcitabine and Docetaxel versus Bacillus Calmette-Guerin in High-Risk Non-Muscle-Invasive Bladder Cancer

Presenter:

Joep J. de Jong, M.D., Erasmus University Medical Center, Rotterdam, The Netherlands

Format:

Oral (#A0674)

Date/Time:

Sunday, March 23, 17:15-17:50 CET

Location:

Pink Area, N101

Title:

The Estrogen Response Pathway as a Putative Predictive Biomarker of Neoadjuvant Pembrolizumab benefit in Patients with Muscle-Invasive Bladder Carcinoma (MIBC)

Presenter:

Joep J. de Jong, M.D., Erasmus University Medical Center, Rotterdam, The Netherlands

Format:

Poster (#P598)

Date/Time:

Monday, March 24, 13:10-14:00 CET

Location:

Green Area, EGPT 1

MRD:

Title:

Comparison of ctDNA detection methods for monitoring minimal residual disease in patients with bladder cancer: Insights from the TOMBOLA trial

Presenter:

Iver Nordentoft, Ph.D., Aarhus University, Aarhus, Denmark

Format:

Oral (#A0162)

Date/Time:

Saturday, March 22, 10:32-11:15 CET

Location:

Purple Area, Room 1​

About Decipher Prostate

The Decipher Prostate Genomic Classifier is a 22-gene test, developed using RNA whole-transcriptome analysis and machine learning, that helps inform treatment decisions for patients with prostate cancer. The test is performed on biopsy or surgically resected samples and provides an accurate risk of developing metastasis with standard treatment. Armed with this information, physicians can better personalize their patients’ care and may recommend less-intensive options for those at lower risk or earlier, more-intensive treatment for those at higher risk of metastasis. The Decipher Prostate test’s performance and clinical utility has been demonstrated in over 85 studies involving more than 200,000 patients. It is the only gene expression test to achieve "Level IB" evidence status and inclusion in the risk-stratification table in the most recent NCCN Guidelines* for prostate cancer. More information about the Decipher Prostate test can be found here.

About Decipher Bladder

The Decipher Bladder Genomic Classifier is a 219-gene test, developed using RNA whole-transcriptome analysis and machine learning, that is designed for use in patients following bladder cancer diagnosis who face questions regarding treatment intensity. The test classifies bladder tumors into five molecular subtypes, each having distinct tumor biology and potential clinical implications. This information can help physicians and their patients better understand the degree of benefit that would likely be gained from neoadjuvant chemotherapy and/or the likelihood of harboring non-organ-confined disease at time of surgery, respectively.

Xenetic Biosciences, Inc. Reports Full Year 2024 Financial Results

On March 19, 2025 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing innovative immuno-oncology technologies addressing difficult to treat cancers, reported its financial results for the year ended December 31, 2024 (Press release, Xenetic Biosciences, MAR 19, 2025, View Source [SID1234651264]).

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Recent Highlights

Extended its collaborations with the University of Virginia and Scripps Research through 2025;

Entered into a Clinical Trial Services Agreement with PeriNess Ltd. to manage investigator initiated exploratory studies of DNase I in combination with chemotherapy and immunotherapy platforms for the treatment of pancreatic carcinoma, colorectal cancer and other locally advanced or metastatic solid tumors; and

Continued pursuit of other strategic collaborations to advance the Company’s technology.

"Over the course of 2024, our team made notable advancements across multiple fronts. We continued to establish and present a growing body of preclinical data that supports the use of our DNase-based technology across several cancer indications. Additionally, we continued to engage institutional partners to drive our development strategies forward including investigator-initiated studies and partnering on various other efforts. Leveraging these relationships allows us to advance our technology toward the clinic while utilizing our resources efficiently and minimizing our internal investment. Looking ahead to 2025, we are executing on our initiatives as we progress toward an IND and Phase 1 clinical trial and look forward to an exciting year," commented James Parslow, Interim Chief Executive Officer and Chief Financial Officer of Xenetic.

Xenetic continues to advance its DNase-based technology towards Phase 1 clinical development for the treatment of pancreatic carcinoma and other locally advanced or metastatic solid tumors. Preliminary preclinical studies evaluating the combinations of DNase I with chemotherapy and DNase I with immuno-therapies in colorectal cancer models as well as CAR-T therapy have been completed.

Summary of Financial Results for Fiscal Year 2024

Net loss for the year ended December 31, 2024 was approximately $4.0 million. Research and development expenses for the year ended December 31, 2024 decreased by approximately $0.2 million, or 5.9%, to $3.3 million from $3.5 million in the prior year period. This decrease was primarily due to decreased spending in connection with the Company’s DNase process development efforts. Royalty payments received from the Company’s sublicense with Takeda Pharmaceuticals Co. Ltd in the year ended December 31, 2024 were approximately $2.5 million, relatively flat with that of the year ended December 31, 2023. General and administrative expenses for the year ended December 31, 2024 were $3.4 million, decreasing by approximately $0.1 million, or 4.1%, compared to the prior year. The decrease was primarily due to a reduction in legal and accounting costs during the year ended December 31, 2024 compared to the prior year. These decreases were substantially offset by certain severance and benefits expensed in connection with a separation agreement entered into during the second quarter of 2024.

The Company ended the year with approximately $6.2 million of cash.

Actinium Pharmaceuticals to Host Investor KOL Call with Dr. Ehab Atallah of the Medical College of Wisconsin and Provide a Pipeline Update Highlighting Revamped Clinical Programs and Expanded Market Opportunities for Actimab-A and Iomab-ACT with Clinical Data in 2H:2025

On March 19, 2025 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a pioneer in the development of targeted radiotherapies, reported that it will host a KOL call that will feature Dr. Ehab Atallah, Professor of Medicine at the Medical College of Wisconsin and principal investigator of the Actimab-A + CLAG-M combination trial in patients with relapsed/refractory acute myeloid leukemia (r/r AML) (Press release, Actinium Pharmaceuticals, MAR 19, 2025, View Source [SID1234651266]). Dr. Atallah will discuss Actimab-A clinical results to date including recently published long-term survival outcomes and the planned pivotal Phase 2/3 clinical trial in r/r AML and trials to be conducted under Actinium’s cooperative research and development agreement (CRADA) with the National Cancer Institute (NCI). In addition, Actinium will provide a pipeline update to highlight 3 separate potential multi-billion-dollar blockbuster market opportunities for its targeted radiotherapies including the following:

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Actimab-A as a mutation agnostic, backbone therapy for myeloid malignancies including AML and myelodysplastic syndromes (MDS) across multiple treatment settings
Actimab-A as a pan solid tumor therapy in combination with PD-1 inhibitors including KEYTRUDA and OPDIVO by depleting myeloid derived suppressor cells (MDSCs)
Iomab-ACT as a universal targeted conditioning agent to increase patients access to cell & gene therapies and improve patient outcomes
To register for the KOL Call & Pipeline Update please use the following link:

View Source

Sandesh Seth, Actinium’s Chairman and CEO, said, "We have made significant progress across our pipeline in the first quarter of 2025 achieving several important milestones. We are excited to highlight the large multi-billion-dollar market opportunities for Actimab-A in myeloid malignancies and now solid tumors, as well as cell and gene therapy conditioning with Iomab-ACT. With cash runway into 2027, we are in an excellent position to advance our programs, and we are excited to deliver validating data in the second half of 2025."

Theriva™ Biologics to Present at the 2025 NeauxCancer Conference

On March 19, 2025 Theriva Biologics (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, reported that the Company’s Management will be attending and presenting at the Cancer Advocacy Group of Louisiana (CAGLA) NeauxCancer 2025 Conference being held March 27th-29th, 2025 at The Roosevelt New Orleans Hotel in New Orleans, LA (Press release, Theriva Biologics, MAR 19, 2025, View Source [SID1234651267]).

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A company presentation will take place during the conference’s Innovation track on Friday, March 28th at 9:00am. NeauxCancer conference’s Innovation track spotlights the most promising emerging biotech and healthcare companies advancing detection, treatment, and cures across critical oncology areas.

Theriva’s management team will be available for one-on-one meetings during the conference, interested investors should contact Theriva’s investor relations representative as below.

Immutep to Present Pivotal TACTI-004 Trial in Progress Poster at the
European Lung Cancer Congress 2025

On March 19, 2025 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a late-stage immunotherapy company targeting cancer and autoimmune diseases, reported an upcoming poster presentation for the pivotal TACTI-004 Phase III trial (Press release, Immutep, MAR 19, 2025, View Source [SID1234651268]). The poster will be presented at the European Lung Cancer Congress (ELCC) 2025, taking place in Paris, France, from 26-29 March 2025.

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The Trial in Progress poster includes an overview and study design of the TACTI-004 Phase III evaluating the Company’s MHC Class II agonist, eftilagimod alfa (efti) in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 KEYTRUDA (pembrolizumab) and chemotherapy as first line therapy for patients with advanced or metastatic non-small cell lung cancer (1L NSCLC). The global trial will enrol approximately 750 patients regardless of PD-L1 expression and with non-squamous or squamous tumours at over 150 clinical sites in over 25 countries.

Immutep CSO, Frédéric Triebel, M.D., Ph.D, said, "We look forward to engaging with physicians in the lung cancer community at the ELCC conference to discuss our TACTI-004 Phase III study that is actively recruiting patients. Efti in combination with KEYTRUDA may change the treatment paradigm for patients with advanced or metastatic non-small cell lung cancer, irrespective of their PD-L1 expression, and we hope to see this registrational trial confirm the promising safety and efficacy achieved to date."

Details for the poster presentation:
Title: TACTI-004: a double-blinded, randomized phase 3 trial in patients with advanced/metastatic non-small cell cancer receiving eftilagimod alfa (MHC class II agonist) in combination with pembrolizumab (P) and chemotherapy (C) versus placebo + P + C
Presentation number: 131TiP
Presenter: Margarita Majem, MD, PhD, Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau
Session Date and Time: 26 March 2025, 13:50 CET

The poster will be available on the Posters & Publications section of Immutep’s website following the presentation.

About Eftilagimod Alpha (efti)
Efti is Immutep’s proprietary soluble LAG-3 protein and MHC Class II agonist that stimulates both innate and adaptive immunity for the treatment of cancer. As a first-in-class antigen presenting cell (APC) activator, efti binds to MHC (major histocompatibility complex) Class II molecules on APC leading to activation and proliferation of CD8+ cytotoxic T cells, CD4+ helper T cells, dendritic cells, NK cells, and monocytes. It also upregulates the expression of key biological molecules like IFN-ƴ and CXCL10 that further boost the immune system’s ability to fight cancer.

Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and metastatic breast cancer. Its favourable safety profile enables various combinations, including with anti-PD-[L]1 immunotherapy and/or chemotherapy. Efti has received Fast Track designation in first line HNSCC and in first line NSCLC from the United States Food and Drug Administration (FDA).