On March 19, 2025 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it launched "LUNSUMIO for intravenous infusion 1 mg" and "LUNSUMIO for intravenous infusion 30 mg" (generic name: mosunetuzumab (genetical recombination)) (hereafter, LUNSUMIO), antineoplastic agent / anti-CD20/CD3 humanized bispecific antibody for the treatment of patients with relapsed or refractory follicular lymphoma who have received two or more prior standard therapies (Press release, Chugai, MAR 19, 2025, View Source [SID1234651225]). LUNSUMIO had been approved by the Ministry of Health, Labour and Welfare (MHLW) on December 27, 2024 and was listed on the national health insurance (NHI) reimbursement price list today.

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"Relapsed or refractory follicular lymphoma is a difficult-to-cure disease that repeatedly relapses, and therefore there was a need for new treatment options. LUNSUMIO is expected to provide durable remission with monotherapy, and with a predetermined treatment duration based on each patient’s response to therapy, which can help reduce the burden of treatment on patients. We will strive to promote proper use in order to deliver new value to patients, their families, and healthcare professionals," said Chugai’s President and CEO, Dr. Osamu Okuda.

This approval is based on the results of a Japanese Phase I study with an expansion cohort (FLMOON-1 study) conducted in patients with relapsed or refractory follicular lymphoma who had received two or more prior standard therapies, as well as an overseas Phase I/II clinical trial conducted by Roche in the same patient population. In both studies, the efficacy and safety of this drug were evaluated as a monotherapy. Furthermore, four-year follow-up data from the overseas Phase I/II clinical trial was presented at the 66th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper).

Approval Information

Product name: "LUNSUMIO for intravenous infusion 1 mg" and "LUNSUMIO for intravenous infusion 30 mg"

Generic name: mosunetuzumab (genetical recombination)

Indications: relapsed or refractory follicular lymphoma

Precautions concerning indications:

Treatment with this drug should be targeted at patients who have failed to respond to or have relapsed after two or more standard therapies, including an anti-CD20 monoclonal antibody product.
This drug should be administered to patients diagnosed with Grade 1-3A by a pathologist with sufficient experience.
Dosage and administration:
For adults, the usual dosage of mosunetuzumab (genetically modified) is administered as an intravenous infusion in 21-day cycles as follows:
Cycle 1: 1 mg on Day 1, 2 mg on Day 8, and 60 mg on Day 15
Cycle 2: 60 mg on Day 1
Cycles 3-8: 30 mg on Day 1 of each cycle
After 8 cycles, treatment should be discontinued for patients who achieve a complete response. For patients with stable disease or partial response, treatment may be continued for up to a total of 17 cycles.

Date of approval: December 27, 2024

Date of NHI reimbursement price listing: March 19, 2025

Date of launch: March 19, 2025

Drug price:
LUNSUMIO for intravenous infusion 1 mg　　JPY 83,717 / bottle
LUNSUMIO for intravenous infusion 30 mg　 JPY 2,393,055 / bottle

Reference

Chugai Obtains Regulatory Approval for "LUNSUMIO for Intravenous Infusion" for Relapsed or Refractory Follicular Lymphoma in Japan (Press release December 27, 2024)
View Source

About LUNSUMIO

LUNSUMIO is a CD20/CD3 T cell-engaging bispecific antibody designed to target CD20 on B cells and CD3 on T cells. LUNSUMIO is expected to activate the immune system through cytotoxic T cells and have antitumor effects on CD20 expressing tumor cells. LUNSUMIO has been approved in 61 countries worldwide. LUNSUMIO is currently being developed for the treatment of follicular lymphoma (second-line treatment and previously untreated) and relapsed or refractory aggressive B-cell non-Hodgkin’s lymphoma.

About follicular lymphoma

Follicular lymphoma is a type of lymphoma that occurs when B lymphocytes, a type of white blood cell, become cancerous. At diagnosis, 70-85% of patients reach an advanced stage1. Generally, the progression is slow, and chemotherapy is initially effective, but recurrences occur repeatedly in many cases. Repeated recurrences can make it difficult for existing treatments to be effective, and new highly effective treatments are needed. In Japan, approximately 9,000 people reportedly become afflicted with follicular lymphoma each year.

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 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 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 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."