InnoCare Announces Approval of Orelabrutinib in Australia

On May 27, 2026 InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on cancer and autoimmune diseases, reported that orelabrutinib (HIBRUKA) has been approved by the Therapeutic Goods Administration (TGA) in Australia, offering a new treatment option for patients with Mantle Cell Lymphoma (R/R MCL) in the region.

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Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare said, "The approval of orelabrutinib in Australia marks another important milestone in InnoCare’s global footprint and brings a new treatment option to patients with lymphoma in the region. Beyond oncology, we are also advancing global clinical trials of orelabrutinib in autoimmune diseases."

MCL is a distinct subtype of B-cell non-Hodgkin’s lymphoma (NHL). It is an aggressive and currently incurable disease with rising incidence rate. Patients are often diagnosed at an advanced stage with limited treatment options and poor prognosis.

Orelabrutinib is a novel Bruton’s tyrosine kinase (BTK) inhibitor developed by InnoCare for the treatment of cancers and autoimmune diseases. With its high target selectivity, it minimizes off-target effects, thereby improving both safety and efficacy.

Orelabrutinib has been approved in Singapore for the treatment of patients with R/R MCL and R/R MZL (marginal zone lymphoma). In China, Orelabrutinib has been approved for the treatment of four lymphoma indications, all of which have been included in China’s National Reimbursement Drug List.

(Press release, InnoCare Pharma, MAY 27, 2026, View Source [SID1234666135])

Sapreme Development B.V. to become Sapreme Therapeutics B.V.

On May 27, 2026 Sapreme Development reported as company continues to evolve, it is excited to announce that effective June 1st, 2026, Sapreme Development B.V. will become Sapreme Therapeutics B.V.

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Over the past years, our focus has progressed from platform technology toward the development of a growing portfolio of therapeutic programs.

Our new name reflects that evolution and our future as a therapeutics-focused biotech company.

This is a name change only, and we look forward to continuing this journey together with our partners, collaborators, and broader network.

(Press release, Sapreme Technologies, MAY 27, 2026, View Source [SID1234666088])

ViroMissile IDOV-Safe Phase 1 Data to Be Presented at the 2026 ASCO Annual Meeting

On May 27, 2026 ViroMissile, Inc., a cancer immunotherapy company pioneering the IDOV (Intravenously Deliverable Oncolytic Virus) platform, reported the presentation of clinical data from an investigator-initiated Phase I study of IDOV-Safe, the company’s first clinical-stage oncolytic virus, at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, Illinois.

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The poster, titled "Intravenous oncolytic virus IDOV-Safe in pMMR/MSS metastatic colorectal cancer" (Abstract #3536), will be presented on Saturday, May 30th, at Poster Board 290 by Tong Xie, MD, of Peking University Cancer Hospital & Institute in Beijing, China. The study’s principal investigator is Lin Shen, MD, of the same institution.

"These findings validate a core hypothesis underlying our IDOV platform that systemic delivery of an oncolytic virus can prime immune responses even in tumors historically considered immune-cold," said Nanhai George Chen, PhD, Founder and Chief Executive Officer of ViroMissile. "Achieving a 30-46% response rate in pMMR/MSS metastatic colorectal cancer, a setting where checkpoint inhibitors have largely fallen short, represents an encouraging signal that warrants further investigation. We look forward to advancing this approach into our contemplated registrational Phase 2 study."

The data are from a study evaluating IDOV-Safe in combination with fruquintinib, a VEGF inhibitor, and toripalimab, a PD-1 inhibitor, in patients (n=55) with proficient mismatch repair/microsatellite stable (pMMR/MSS) metastatic colorectal cancer (mCRC). Patients with mCRC historically have limited treatment options and poor response to checkpoint inhibitor-based immunotherapy. The poster highlights results from a key expansion cohort (n=20) where treatment with IDOV-Safe demonstrated an objective response rate (ORR) of 30.0% and a disease control rate (DCR) of 70.0%, with a median progression-free survival (PFS) of 8.7 months. In patients without liver metastases, ORR reached 46.2% and median PFS extended to 10.8 months.

Study Design

The investigator-initiated Phase I trial treated a total 55 patients with pMMR/MSS mCRC across all cohorts. The study employed a triplet 3+3 dose-escalation design to assess dose-limiting toxicities (DLTs) and determine the maximum tolerated dose and the recommended expansion dose. Expansion cohorts assessed IDOV-Safe in combination with fruquintinib and with or without toripalimab across three combination strategies: sequential, early, and IO-free. Primary and secondary endpoints included safety, objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS).

Key findings

Safety
IDOV-Safe demonstrated a manageable safety profile across all dose levels
62% of patients experienced Grade 3 or higher treatment-related adverse events (TRAEs), with only one Grade 4 TRAE reported as a dose-limiting toxicity (DLT). The most common TRAEs were transient fever, thrombocytopenia, and neutropenia
No treatment-related deaths were observed
Efficacy/Tumor Response
In the sequential combination expansion cohort, which received IDOV-Safe at the higher dose level in combination with fruquintinib and toripalimab, the results demonstrated:
An objective response rate (ORR) of 30.0% was observed overall in the key expansion cohort
In patients without liver metastases, ORR reached 46.2% with a DCR of 84.7% and a median PFS of 10.8 months, compared to a median PFS of 3.7 months in patients with liver metastases
Median progression-free survival (PFS) was 8.7 months overall.
The poster will be available on the ViroMissile website after the conclusion of the session.

(Press release, ViroMissile, MAY 27, 2026, View Source [SID1234666104])

Solu Therapeutics Granted FDA Fast Track Designation for STX-0712 for Treatment of Chronic Myelomonocytic Leukemia

On May 27, 2026 Solu Therapeutics, a biotechnology company pioneering novel therapies to eliminate disease-driving cells in cancer, immunology, and other therapeutic areas, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to STX-0712, the company’s investigational therapy in development for the treatment of relapsed or refractory chronic myelomonocytic leukemia (CMML). CMML is an aggressive blood cancer with limited treatment options, particularly for patients whose disease has relapsed or become resistant to available therapies.

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Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The designation also enables more frequent interactions with the FDA throughout the development and review process.

"Fast Track designation for STX-0712 reinforces the significant need for new treatment options for people living with CMML," said Philip Vickers, President and CEO of Solu Therapeutics. "By directly depleting CCR2-positive malignant monocytes and bone marrow blasts that drive disease in CMML, STX-0712 has the potential to offer a highly specific and targeted approach. We look forward to continuing to work closely with the FDA as we advance through clinical development and work to bring this potential therapy to patients as quickly as possible."

In addition to CMML, Solu is also exploring the potential of STX-0712 in other hematologic malignancies, including acute myeloid leukemia (AML). STX-0712 is a CyTAC (Cytotoxicity Targeting Chimera) targeting the G-Protein Coupled Receptor CCR2, a selective marker expressed at high levels on malignant monocytes and bone marrow blasts, which are key drivers of disease in CMML, AML, and other hematologic cancers. By eliminating CCR2-positive cells, STX-0712 has the potential to offer a more targeted and effective treatment option with minimal effects on non-malignant cells.

The Phase 1, open-label, multicenter study evaluating STX-0712 as monotherapy in patients with relapsed or refractory CMML and AML is ongoing. It is planned that initial clinical data from this study will be submitted to a hematology conference later this year.

(Press release, Solu Therapeutics, MAY 27, 2026, View Source [SID1234666120])

Myriad Genetics Highlights Data Showing Broad Clinical Utility of Precise MRD Assay at 2026 ASCO Annual Meeting

On May 27, 2026 Myriad Genetics, Inc., (NASDAQ: MYGN), a leader in molecular diagnostic testing and precision medicine, reported it will share data demonstrating the utility of Myriad’s Precise MRD (molecular residual disease) test across diverse cancer types.

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Myriad will share evidence across six poster presentations showcasing the prognostic power of its ultrasensitive MRD assay. Several of the presentations report interim outcomes from the groundbreaking MONSTAR-SCREEN-3 study, led by Dr. Takayuki Yoshino, National Cancer Center Hospital East, Japan. "MONSTAR-SCREEN-3 has demonstrated exceptional performance of Precise MRD across more than a dozen indications," said Dr. Yoshino. "In our presentation, ’Prognostic Impact of MRD Positivity at Ultra-sensitive ctDNA Levels Using a WGS-based Personalized Assay: A Pan-Cancer Analysis from MONSTAR-SCREEN-3,’ we report 97% baseline detection, with 16% of samples detected in the ultrasensitive range. Importantly, patients who were ctDNA-positive at one month post-surgery had significantly worse disease-free survival compared to those who were ctDNA-negative, suggesting that post-surgical ctDNA positivity, including at ultrasensitive levels, is strongly prognostic for recurrence risk."

Other presentations focused on ovarian cancer, gastric cancer, head and neck cancer, and sarcoma also demonstrate the emerging clinical utility of ctDNA as a biomarker of recurrence and therapy response. "Our findings highlight the clear advantage of a whole-genome, personalized MRD approach in capturing clinically meaningful signals at the lowest ctDNA levels," said Dale Muzzey, PhD, Chief Scientific Officer, Myriad Genetics. "Detecting ctDNA at very low levels consistently across multiple tumor types demonstrates that sensitivity truly matters. Precise MRD may enable a new standard in which ultra-sensitive detection translates directly into earlier, more confident clinical decision-making."

Attendees can meet Dr. Muzzey at the Industry Expert Theater #1 on Sun., May 31 from 9:30 to 10:30 am CDT for an introduction to the Precise MRD Test. The session will cover assay technical details and the clinical evidence across multiple solid tumors, including breast and colorectal cancers, and explore the role of highly sensitive MRD detection in oncology.

Myriad Presentations
Poster 64, abstract 4081: Whole-Genome Sequencing-Based Ultra-sensitive ctDNA Molecular Residual Disease Assessment in Resectable Gastric Cancer: Results from MONSTAR-SCREEN-3
Poster Session: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
Sat., May 30, 9:00 am–12:00 pm CDT

Poster 181, abstract 3044: Prognostic Impact of Positivity at Ultra-sensitive ctDNA Levels Using a WGS-based Personalized Assay: A Pan-Cancer Analysis from MONSTAR-SCREEN-3
Poster Session: Developmental Therapeutics
Sat., May 30, 1:30-4:30 pm CDT

Poster 523, abstract 6066: Clinical Validation of Ultra-Sensitive WGS-based MRD Detection in Head and Neck Squamous Cell Carcinoma: Results from MONSTAR-SCREEN-3
Poster Session: Head and Neck Cancer
Sat., May 30, 1:30–4:30 pm CDT

Poster 270, abstract 5604: The Use of Circulating Tumor DNA to Stratify the Risk of Recurrence After Surgical Debulking in Epithelial Ovarian Cancer
Poster Session: Gynecologic Cancer
Mon., June 1, 9:00 am–12:00 pm CDT

Poster 334, abstract 11544: Ultra-Sensitive Whole-Genome Sequencing-Based Molecular Residual Disease Detection in Resectable Sarcoma in MONSTAR-SCREEN-3
Poster Session: Sarcoma
Mon., June 1, 1:30 – 4:30 pm CDT

Poster 501, abstract 10540: Association between physical activity and molecular residual disease clearance in postoperative cancer patients: The SCRUM-MONSTAR LIFELOG study
Poster Session: Prevention, Risk Reduction, and Genetics
Mon., June 1, 2026, 1:30pm – 4:30pm CDT

Conference Highlights
Myriad will welcome attendees to its booth (#25081) during exhibition hours. Myriad tests to be highlighted at the booth include:

Precise MRD (Molecular Residual Disease) Test is a tumor-informed assay that uses whole genome sequencing (WGS) to achieve ultra-sensitivity. This unique assay enables the custom selection of up to 1,000 targeted variants for deep analysis. It has impressive limits of detection and sensitivity.1 The test can be used to monitor circulating tumor DNA (ctDNA) levels throughout a patient’s clinical cancer care, starting immediately after diagnosis and continuing through treatment and surveillance.
MyRisk Hereditary Cancer Test with RiskScore combines genetics, clinical factors (Tyrer-Cuzick), and polygenic risk to uncover insights that gene testing alone may not provide, helping offer more information to support patient decisions in breast cancer risk assessment and management.
Prolaris + AI Prostate Cancer Prognostic Test is the first and only prostate cancer biomarker test to unite clinical-pathological features, an independent molecular score, and independent AI-powered digital pathology technology from Myriad’s partnership with PATHOMIQ AI.

The booth will also feature Myriad’s Biopharma services which are utilized for working in conjunction with Biopharma partners to advance drug development programs from biomarker discovery through CTA, CDx development, worldwide regulatory approval and global commercialization, including:

MyChoice CDx is the only FDA-approved homologous recombination deficiency (HRD) test specifically mentioned in ASCO (Free ASCO Whitepaper) guidelines for selecting patients with ovarian cancer who may benefit from PARP inhibitors.1 By determining comprehensive HRD status, the MyChoice CDx Test helps expand access to targeted therapy in both early and late-line settings.
MSK-ACCESS is a comprehensive liquid biopsy test developed by Memorial Sloan Kettering Cancer Center (MSK). The test offers noninvasive cancer genomic profiling and disease monitoring using cell-free DNA (cfDNA) obtained from blood and other body fluids. The test is currently available for use in conjunction with Myriad’s Pharma partnerships for CTA development and CDx utilizing Myriad’s partnership with SOPHiA GENETICS.
MSK-IMPACT is a solid tumor test for comprehensive genomic profiling (CGP) which delivers high-resolution profiling of complex biomarkers from DNA and RNA in a single, end-to-end workflow. The test is currently available for use in conjunction with Pharma partnerships for CTA development and CDx utilizing Myriad’s partnership with SOPHiA GENETICS.

Stop by Myriad booth #25081 to learn more or request a dedicated meeting at the show.

About the MONSTAR-SCREEN-3 Study
The MONSTAR-SCREEN-3 is a prospective multicenter study targeting more than 1,100 patients with solid tumors undergoing curative-intent treatment. Personalized panels were constructed using Precise MRD, incorporating up to 1,000 tumor-specific alterations identified through WGS of matched tumor tissue. Serial plasma samples were collected at baseline, post-neoadjuvant treatment (NAT) (when applicable), 1-month (1M) post-surgery, every 3 months in year 1, and every 6 months thereafter up to 2 years. Assay performance was evaluated across multiple cancer types for ctDNA detection and recurrence monitoring.

About Precise MRD
The Precise MRD test provides molecular insights across the cancer care continuum. After diagnosis, the test can help clinicians determine if adjuvant treatment is needed, or if cancer has recurred. Should cancer metastasize in a patient, Precise MRD can provide molecular insights showing whether treatment is working or if a patient’s ctDNA is increasing. For baseline tests, a personalized panel is developed based on a whole-genome sequencing profile of tumor tissue, and then the panel is used to measure the ctDNA level from an initial blood draw. For ongoing monitoring, the panel measures ctDNA levels from samples collected with a frequency based on where patients are in the treatment process. Clinicians will receive an easy-to-read report that shows whether ctDNA was detected or not. If ctDNA is detected, the concentration of ctDNA is reported, which allows clinicians to see historical results of the patient’s ctDNA concentration over time. Learn more at myriad.com/oncology/precise-mrd-test/.

(Press release, Myriad Genetics, MAY 27, 2026, View Source [SID1234666136])