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])

BioLineRx Reports First Quarter 2026 Financial Results and Provides Corporate Update

On May 27, 2026 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, reported its unaudited financial results for the quarter ended March 31, 2026, and provided a corporate update.

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"Since our last quarterly update, we achieved a significant milestone for our company and for the GLIX1 development program with the dosing of the first patient in our Phase 1/2a clinical trial of GLIX1 in glioblastoma," stated Philip Serlin, Chief Executive Officer of BioLineRx. "We are also very encouraged by compelling new pre-clinical data showing that GLIX1 demonstrated robust dose-dependent tumor-growth inhibition and survival benefit in orthotopic cell-derived xenograft (CDX) GBM models. Furthermore, in a newly completed subcutaneous TMZ-resistant patient-derived xenograft (PDX) GBM model, GLIX1 demonstrated a robust anti-tumor effect while no effect was observed with TMZ, highlighting the potential to address the very high unmet need in GBM."

"In the coming days, we look forward to engaging with the broader oncology community at this year’s ASCO (Free ASCO Whitepaper) meeting with two abstracts featuring GLIX1. The abstracts highlight its novel mechanism of action and provide strong rationale for the development of GLIX1 in GBM as well as in other cancers. They also highlight that in safety studies in animals GLIX1 was safe up to the highest feasible doses tested, supporting the combination with other anti-cancer agents. Furthermore, the abstracts highlight the compelling mechanistic rationale for combining GLIX1 with PARP inhibitors supported by synergistic effect in cell lines across diverse cancers including from tumor types typically less responsive to PARP inhibition."

Financial Updates

With $17.4 million on its balance sheet as of March 31, 2026, BioLineRx is maintaining its cash runway guidance into the first half of 2027.
Development Updates
GLIX1

Phase 1/2a clinical trial of GLIX1 in glioblastoma and other cancers initiated in March 2026.
The first patient was dosed at NYU Langone Health under the supervision of Dr. Alexandra Miller, Chief of Neuro-Oncology & Co-Director of Brain and Spine Tumor Center, Perlmutter Cancer Center.
Two additional leading cancer centers are participating in the study: Northwestern University, led by Dr. Roger Stupp and Dr. Ditte Primdahl; and Moffit Cancer Center, led by Dr. Patrick Grogan. Additional sites may be added to the study at a later date.
The Phase 1 part of the trial is expected to recruit up to 30 patients with recurrent and progressive GBM and other high-grade gliomas. The objective is to establish a maximum tolerated dose (MTD) and/or a recommended dose based on safety, PK/PD and preliminary efficacy.
The Phase 2a expansion part of the trial is planned to include additional indications, including newly diagnosed GBM, as well as select cancers, with GLIX1 as monotherapy or in combination with standard of care (including in combination with PARP inhibitors). These cohorts are expected to identify preliminary efficacy, PD assessments and dose optimization data, serving as the basis for a rapid and effective advanced clinical development plan.
Announced new GLIX1 data demonstrating potent anti-tumor effect in GBM across multiple in-vivo studies, including a temozolomide (TMZ)-resistant patient-derived xenograft model
Announced two abstracts on GLIX1 that were selected for publication during the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which is scheduled for May 29-June 2, in Chicago, IL.
Pre-clinical activities in support of clinical development for GLIX1 in additional cancer indications, including in combination with PARP inhibitors, are ongoing.
Motixafortide
Pancreatic Ductal Adenocarcinoma (mPDAC)

Enrollment is continuing in the CheMo4METPANC Phase 2b clinical trial, which is being led by Columbia University, and supported by both Regeneron and BioLineRx. The trial is evaluating motixafortide in combination with the PD-1 inhibitor cemiplimab and standard chemotherapy (gemcitabine and nab-paclitaxel).
A prespecified interim/futility analysis is planned when 40% of progression-free survival (PFS) events are observed, which the Company continues to anticipate will occur in 2026.
APHEXDA Performance Update

APHEXDA sales for the first quarter of 2026 were $2.7 million, which provided royalty revenues to the company of $0.5 million.
Financial Results for the Quarter ended March 31, 2026

Revenues for the three months ended March 31, 2026 were $0.5 million, an increase of $0.2 million, compared to revenues of $0.3 million for the three months ended March 31, 2025. The increase in revenues from 2025 to 2026 reflects an increase in royalties paid by Ayrmid from the commercialization of APHEXDA.
Cost of revenues for the three months ended March 31, 2026 was $0.1 million, compared to immaterial cost of revenues for the three months ended March 31, 2025. The cost of revenues reflects sub-license fees on royalties paid by Ayrmid from the commercialization of APHEXDA.
Research and development expenses for the three months ended March 31, 2026 were $2.5 million, an increase of $0.9 million, or 55.8%, compared to $1.6 million for the three months ended March 31, 2025. The increase resulted primarily from expenses related to the new GLIX1 project.
General and administrative expenses for the three months ended March 31, 2026 were $0.9 million, a decrease of $0.1 million, or 13.3%, compared to $1.0 million for the three months ended March 31, 2025. The decrease resulted primarily from a decrease in legal expenses, as well as a decrease in a number of other general and administrative expenses.
Net non-operating income amounted to $0.5 million for the three months ended March 31, 2026, compared to net non-operating income of $7.6 million for the three months ended March 31, 2025. Non-operating income for the periods primarily relates to non-cash fair-value adjustments of warrant liabilities, as a result of changes in the Company’s share price, offset by warrant offering expenses.
Net financial expenses for the three months ended March 31, 2026 were immaterial compared to net financial expenses of $0.1 million for the three months ended March 31, 2025. Net financial expenses for the periods primarily relate to interest paid on loans, partially offset by investment income earned on bank deposits.
Net loss for the quarter ended March 31, 2026 was $2.6 million, compared to net income of $5.1 million for the quarter ended March 31, 2025.
As of March 31, 2026, the Company had cash, cash equivalents, and short-term bank deposits of $17.4 million.
Conference Call and Webcast Information
To access the conference call, please dial +1-888-407-2553 from the U.S. or +972-3-918-0685 internationally. A live webcast and a replay of the call can be accessed through the event page on the Company’s website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast. The call replay will be available approximately two hours after completion of the live conference call. A dial-in replay of the call will be available until May 28, 2026; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.

(Press release, BioLineRx, MAY 27, 2026, View Source [SID1234666089])

Forlong Announces Completion of Phase I Clinical Studies of FL115 Monotherapy (IV): Disease Control for 3 Heavily-pretreated Patients with Advanced Solid Tumors over 12 Months

On May 27, 2026 Forlong Biotechnology, a clinical-stage biotech company focusing on developing transformative cytokine therapies for patients with severe unmet needs, reported that Phase I clinical studies of FL115, an IL-15 superagonist, as monotherapy via intravenous infusion in patients with advanced solid tumors have been completed, with durable treatment effects observed in 2 patients with confirmed partial response (cPR) and 1 patient with stable disease (SD).

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Phase I clinical studies of FL115 were conducted in US and China in parallel:

FL115-101 Study was conducted in US, with 11 patients treated. One patient with advanced cervical cancer and 4 prior therapies received the 1st dose in July 2024, and achieved SD. The patient was rolled off the study in Sept 2025, and continue to receive the FL115 treatment under a Single Patient IND Protocol/Treatment Plan. Data from this study will be presented at the upcoming 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Poster Board: 291; Session Type/Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology; Date and Time: May 30, 2026, 1:30 PM-4:30 PM CDT)

FL115-102 Study was conducted in China, with 23 patients treated. One patient with highly invasive NUT-NSCLC and 3 lines of prior therapies received the 1st dose of FL115 in Apr 2025, and achieved cPR. Another patient with lymphoepithelial carcinoma (parotid gland) and 4 lines of prior therapies received the 1st dose of FL115 in Jun 2025, and achieved cPR. Both patients have been rolled off the study respectively in March and May 2026, and continue to receive the FL115 under a Compassionate Treatment program. Data from this study was presented as a Late-breaking Abstract at 40th SITC (Free SITC Whitepaper) Annual Meeting.

FL115 (IV) is currently being investigated in combination with an anti-PD1 monoclonal antibody in a Phase 1b/2 clinical trial in patients with advanced solid tumors. Preclinical data regarding FL115 (Subcutaneous Injection) was presented at the 2026 AACR (Free AACR Whitepaper) Annual Meeting, and a Phase 1 clinical study will be initiated in 2H 2026 to evaluate FL115 (Subcutaneous Injection) in patients with advanced solid tumors. In parallel, FL115 (Intravesicale Delivery) is currently being investigated in combination with Bacillus Calmette-Guérin (BCG) in a Phase 2 clinical trial in patients with nonmuscle invasive bladder cancer (NMIBC).

"We deeply appreciate the commitment and support from the patients and their families," said Dong Wei, Ph.D., Chief Executive Officer of Forlong Biotechnology, "With favorable safety, preliminary efficacy and duration of response observed in Phase 1 clinical studies, FL115 continues to show its potential as Best-in-class IL-15 superagonist. We are advancing FL115 for multiple indications via different delivery routes, aiming to develop optimal treatment options for cancer patients in need."

About FL-115

FL115 is an engineered IL-15/IL15Rα-Fbody fusion protein, aiming to enhance anti-tumor immunity via IL-15-mediated signaling on NK and CD8+ T cells while minimizing complexity from Fc. FL115 has demonstrated significant anti-tumor activities as a monotherapy or as part of combination therapy in vivo, and can be manufactured by a robust and efficient process with excellent product stability. Clinically, FL115 has demonstrated favorable safety profile and preliminary clinical responses as a monotherapy, and has the best-in-class potential to synergize with current and emerging T cell-targeting immunotherapies through combination therapy to significantly improve the treatment outcome for patients. It is currently being investigated in combination with Bacillus Calmette-Guérin (BCG) in a Phase 2 clinical trial to evaluate safety and preliminary efficacy in patients with nonmuscle invasive bladder cancer (NMIBC) and in combination with an anti-PD1 monoclonal antibody in a Phase 1b/2 clinical trial to evaluate safety and preliminary efficacy in patients with advanced solid tumors.

(Press release, Forlong Biotechnology, MAY 27, 2026, View Source [SID1234666121])