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:

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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."

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.

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.

On March 19, 2025 Tvardi Therapeutics, Inc. ("Tvardi"), a clinical-stage biopharmaceutical company developing novel STAT3 inhibitors for fibrosis-driven diseases, reported that results from the first-in-human Phase 1 study of TTI-101 in patients with advanced solid tumors have been published in the journal Clinical Cancer Research (Press release, Tvardi Therapeutics, MAR 19, 2025, View Source [SID1234651262]).

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Imran Alibhai, Ph.D., Chief Executive Officer of Tvardi Therapeutics, stated, "The positive results of this Phase 1 study speak to the potential broad clinical utility of our lead candidate, TTI-101, across a range of fibrosis-driven diseases in which STAT3-mediated proliferation is implicated. Perhaps most notable, in addition to its biological activity in advanced treatment-refractory hepatocellular carcinoma, was a pharmacodynamic reduction of TTI-101’s target, activated STAT3, within paired tumor biopsies. We believe these findings provide very strong rationale for our ongoing Phase 2 studies in IPF and liver cancer."

The publication, titled, "Phase 1 Trial of TTI-101, a First-in-Class Oral Inhibitor of STAT3, in Patients with Advanced Solid Tumors," describes a Phase 1 study in which patients, who received a median of three prior systemic therapies, were treated with TTI-101 monotherapy orally twice daily (NCT03195699). By targeting both intrinsic tumorigenesis and extrinsic immune suppression, TTI-101 showed promising antitumor activity across tumor types, particularly in patients with hepatocellular carcinoma who were refractory to immune checkpoint inhibitors and anti-angiogenic agents.

TTI-101 showed dose-linear pharmacokinetics and, at the recommended Phase 2 dose, the trough exposure levels were above the IC90 for STAT3-induced growth. No dose-limiting toxicities or treatment-related adverse events greater than grade 3 were observed. Pharmacodynamic analysis demonstrated TTI-101 decreased levels of phosphotyrosine (pY) STAT3 within paired tumor biopsies.

On March 19, 2025 Sonnet BioTherapeutics Holdings, Inc. (the "Company" or "Sonnet") (NASDAQ: SONN), a clinical-stage company developing targeted immunotherapeutic drugs, reported that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance to the Company for a second patent in the IL-18 variant protein field which discloses the amino acid sequence of its variant human IL-18BPR protein (Press release, Sonnet BioTherapeutics, MAR 19, 2025, View Source [SID1234651261]). The allowed patent claims cover variant human IL-18 (hIL-18) proteins, including but not limited to hIL-18 proteins having amino acid substitutions at the following positions: Y1W, Y1K, M51Y, M51S, M60W, S105E, and D110Y, relative to human wildtype IL-18. Additionally, the Company announced the release of a Virtual Investor "What This Means" segment to discuss the allowed patent, which is now available here.

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"I believe that Sonnet has become of one of the few companies that hold proprietary rights to IL-18BPR which could be a highly valuable cytokine for cancer patients. This patent covers the composition of matter of the amino acid sequence of our human IL-18BPR variant protein which bolsters our intellectual property position and provides further validation to our approach that when IL-18BPR is synergistically combined with IL-12, we believe we will have the potential to develop an important therapeutic asset for oncology and cell-based therapy. Additionally, we feel that this patent enables us to explore opportunities for IL-18BPR to be licensed independent of our FHAB platform. We continue to believe that novel bifunctional molecules such as SON-1411, when combined with our proprietary FHAB platform, have the potential to demonstrate improved tumor targeting, extended half-life and an enhanced therapeutic window," said Pankaj Mohan, Ph.D., Sonnet Founder and Chief Executive Officer.

Sonnet previously reported the generation of two novel drug candidates, SON-1411 (IL18BPR-FHAB-IL12) and SON-1400 (IL18BPR-FHAB), each containing a variant version of recombinant human interleukin-18 (IL-18BPR). SON-1411 is a proprietary bifunctional fusion protein consisting of IL-18BPR combined with single-chain wild-type IL-12, linked to Sonnet’s Fully Human Albumin Binding (FHAB) platform while SON-1400 is a monofunctional fusion protein comprising the same IL-18BPR domain linked to the FHAB. FHAB extends the half-life and biological activity of linked molecules by binding native albumin in the serum and targets the tumor microenvironment (TME) through high affinity binding to glycoprotein 60 (gp60) and the Secreted Protein Acidic and Rich in Cysteine (SPARC).

"SON-1411 (IL18BPR-FHAB-IL12) is a bifunctional combination of IL-12 and the FHAB domain with a human variant of human interleukin-18 ("IL-18BPR"), which was modified to resist an inhibitory interaction with IL-18 binding protein (IL-18BP). IL-18 is involved in activating both innate and adaptive immune responses; however, IL-18 clinical therapies have been hampered by a lack of efficacy due to the inhibitory activity of the IL-18BP," commented John Cini, Ph.D., Sonnet Chief Scientific Officer.

About SON-1411

SON-1411 is a candidate immunotherapeutic recombinant drug that is closely related to and will replace SON-1410, which links an unmodified single-chain human IL18 and an unmodified IL-12 with the albumin-binding domain of the single-chain antibody fragment A10m3. The only difference between SON-1410 and SON-1411 is that in the latter, the IL-18 domain has been modified via mutagenesis to retain wildtype binding to the IL-18 receptor (IL-18 Rc) while inhibiting or abolishing binding to the IL-18 binding protein (IL-18 BP). The A10m3 scFv was selected to bind both at normal pH, as well as at the acidic pH that is typically found in the TME. The FHAB technology targets tumor and lymphatic tissue, providing a mechanism for dose sparing and an opportunity to improve the safety and efficacy profile of IL-18 and IL-12, as well as a variety of potent immunomodulators that can be added using the platform. Interleukin-12 can orchestrate a robust immune response to many cancers and pathogens. Given the types of proteins induced in the TME, such as SPARC and gp60, several types of cancer such as non-small cell lung cancer, melanoma, head and neck cancer, sarcoma, and some gynecological cancers are particularly relevant for this approach. SON-1411 is designed to deliver IL-18BPR and IL-12 to local tumor tissue, turning ‘cold’ tumors ‘hot’ by stimulating IFNγ, which activates innate and adaptive immune cell responses and increases the production of Programed Death Ligand 1 (PD-L1) on tumor cells.