On May 19, 2026 Myosin Therapeutics, a clinical stage biotechnology company developing innovative therapies for oncology, reported that the first patient has been dosed in its Phase 1/2 STAR-GBM study. The trial is designed to assess safety, tolerability, pharmacokinetics, and preliminary signals of clinical activity with longitudinal imaging in adults with newly diagnosed glioblastoma (GBM). With support from the National Cancer Institute (NCI/NIH), the trial is being conducted in collaboration with the Mayo Clinic across its Minnesota, Florida, and Arizona campuses.

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MT-125 is a first-in-class inhibitor of non-muscle myosin II (NMII), designed to disrupt the physical mechanics of tumor cells to induce tumor cell collapse and death through non-redundant mechanisms distinct from any existing therapy.

"This marks the transition of MT-125 from a strong mechanistic and preclinical foundation into clinical testing in patients with one of the most aggressive cancers," said Courtney Miller, PhD, Chief Executive Officer of Myosin Therapeutics. "Our research shows that targeting the mechanical dependencies of tumor cells represents a fundamentally different approach to cancer treatment, and this study is designed to test that hypothesis directly in patients with glioblastoma."

"MT-125 introduces a novel therapeutic strategy that is distinct from conventional cytotoxic and targeted approaches," said Karen Smith, MD, PhD, MBA, LLM, Chief Medical Officer of Myosin Therapeutics. "Partnering with Mayo Clinic allows us to efficiently evaluate both safety and early biological activity in a patient population with significant unmet need."

MT-125 has received Orphan Drug Designation for malignant gliomas and Fast Track Designation for glioblastoma, supporting an accelerated regulatory pathway. In addition to GBM, MT-125 is being developed for other treatment-resistant cancers, including acute myeloid leukemia and pancreatic cancer. Additional information on the STAR GBM study is available at clinicaltrials.gov (NCT07185880).

The STAR-GBM trial is supported by the National Cancer Institute and by a syndicate of life sciences investors and philanthropic organizations.

(Press release, Myosin Therapeutics, MAY 19, 2026, View Source [SID1234665877])

On May 19, 2026 Matter Bio reported the submission of its first Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for Lm-LLO-TT, the company’s lead therapeutic candidate, for a first-in-human Phase 1/2a clinical trial in patients with pancreatic ductal adenocarcinoma (PDAC).

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If the IND is cleared by the FDA, the Phase 1/2a study is expected to evaluate the safety, tolerability, dose optimization, and preliminary anti-tumor activity of Lm-LLO-TT in patients with PDAC, one of the deadliest and most treatment-resistant solid tumors.

"Submitting our first IND for Lm-LLO-TT is a landmark achievement for Matter Bio and the beginning of our transition into a clinical-stage company," said Chris Bradley, Chief Executive Officer of Matter Bio. "We believe this program represents a differentiated and potentially transformative approach for pancreatic cancer, a disease where patients urgently need better options. Our team has worked with urgency and discipline to bring this therapy to the clinic, and we are excited to take this next step."

Lm-LLO-TT is Matter Bio’s attenuated Listeria monocytogenes-based immunotherapy candidate, designed to stimulate tumor-directed memory immune responses in difficult-to-treat cancers. The company is advancing the program in PDAC, where current treatment options remain limited and patient outcomes remain poor.

"Lm-LLO-TT was created to mobilize the immune system in a way that could meaningfully change how we treat difficult solid tumors such as pancreatic cancer," said Claudia Gravekamp, PhD, inventor of Lm-LLO-TT. "The promise of this platform lies in its potential to both engage memory immune mechanisms and target a tumor environment that has remained resistant to many existing approaches. Seeing this program reach IND submission is deeply meaningful and brings us closer to evaluating its potential in patients."

The IND submission represents a major milestone for Matter Bio as the company moves from preclinical development toward clinical evaluation of its lead oncology program. Matter Bio expects to provide additional updates following completion of the FDA’s review of the IND.

(Press release, Matter Bio, MAY 19, 2026, View Source [SID1234665876])

On May 19, 2026 MEKanistic Therapeutics, a biotechnology company developing first-in-class precision medicines designed to overcome cancer resistance mechanisms, reported that the U.S. Food and Drug Administration has cleared the Investigational New Drug application for MTX-531, the company’s lead oncology candidate.

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With the IND now in effect, MEKanistic may proceed with its planned Phase 1 clinical study of MTX-531, subject to standard study start-up activities.

MTX-531 is a potential first-in-class small molecule designed to selectively inhibit PI3K and EGFR, two signaling pathways implicated in tumor growth, survival and adaptive resistance.

"IND clearance marks an important milestone for MEKanistic and advances MTX-531 into the clinic," said Danny Cunagin, chief executive officer of MEKanistic Therapeutics. "We believe MTX-531’s differentiated dual-targeting approach has the potential to address meaningful unmet needs in oncology, provide new options for cancer patients and support a new treatment approach for hard-to-treat cancers."

The Phase 1 study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of MTX-531 in patients with advanced solid tumors characterized by dysregulated EGFR and/or PI3K signaling, including head and neck and endometrial cancers and other tumor types in which these pathways are implicated. The study will include dose-escalation with expansion cohorts at multiple U.S. sites, with first-patient dosing anticipated in the third quarter of 2026.

Preclinical findings published in Nature Cancer in 2024 demonstrated potent inhibition of EGFR and PI3K, durable tumor regressions and a differentiated tolerability profile. IND-enabling toxicology studies were supported through the National Cancer Institute’s Experimental Therapeutics, or NExT, Program.

About MTX-531

MTX-531 is a dual inhibitor of PI3K and EGFR designed to block key signaling pathways involved in tumor progression and adaptive resistance.

(Press release, Mekanistic Therapeutics, MAY 19, 2026, View Source [SID1234665875])

On May 19, 2026 Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative positron emission tomography (PET) radiopharmaceuticals, reported that nine abstracts featuring the latest data on its growing portfolio and pipeline will be presented at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2026 Annual Meeting, held from May 30–June 2, in Los Angeles, CA. The presentations will showcase expanding clinical and preclinical evidence supporting novel PET imaging agents designed to improve prostate cancer detection, including findings from an intra-patient, head-to-head comparator study of POSLUMA (flotufolastat F 18) and piflufolastat F 18.

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Across multiple studies, POSLUMA demonstrated strong performance in detecting biochemical recurrence following radical prostatectomy, particularly at low prostate-specific antigen (PSA) levels where conventional imaging remains limited. Additional data from a prospective clinical study underscores the potential utility of Axumin (fluciclovine F 18) in patients with negative or inconclusive prostate-specific membrane antigen (PSMA) PET scans, supporting continued innovation in prostate cancer imaging.

"PET radiopharmaceuticals can transform uncertainty into precision by providing clinicians with early insights to identify clinically meaningful answers when decisions cannot wait," said Marco Campione, President and CEO of Blue Earth Diagnostics. "The data presented at SNMMI showcase our commitment to advancing nuclear medicine and enhancing patient outcomes through cutting-edge molecular imaging solutions, which facilitate precise, timely, and confident clinical decision-making."

Blue Earth Diagnostics invites attendees of the 2026 SNMMI Annual Meeting to participate in the Satellite Symposium titled, "Precision in PSMA: Why Agent Selection Matters More Than Ever" on Sunday, May 31, from 11:15 AM to 12:15 PM PT in Petree Hall C. Additionally, please visit the Bracco | Blue Earth Diagnostics Exhibit Booth #1823. For complete details on the sessions and a list of scientific presentations, please check the SNMMI online program.

POSLUMA (flotufolastat F 18)
DATE: Sunday, May 31, 2026
Title: Intra-patient Contemporaneous Comparator Study of the Qualitative Assessment of Urinary Radioactivity of 18F-Piflufolastat and 18F Flotufolastat PET/CT in Patients with Low PSA Biochemical Recurrence of Prostate Cancer After Radical Prostatectomy
Presenter: Phillip H. Kuo, MD, Kuo Radiology LLC
Session Type: Poster presentation
Session Time: 5:30 – 6:15 PM CT
Abstract ID.: 261637

DATE: Sunday, May 31, 2026
Title: Intra-patient Contemporaneous Comparator Study of Normal-Organ Distribution of PSMA-Targeting PET Radiopharmaceuticals, 18F-Piflufolastat and 18F-Flotufolastat, in Patients with Low PSA Biochemical Recurrence of Prostate Cancer after Radical Prostatectomy
Presenter: Phillip H. Kuo, MD, Kuo Radiology LLC
Session Type: Poster presentation
Session Time: 5:30 – 6:15 PM CT
Abstract ID.: 261643

DATE: Sunday, May 31, 2026
Title: Positive Predictive Value of 18F-Flotufolastat PET in Patients with Biochemical Recurrence of Prostate Cancer: Radio-Guided Salvage Surgery and Histological Validation
Presenter: Daniel Sasse, Technical University of Munich, School of Medicine, Klinikum rechts der Isar, Department of Nuclear Medicine München, Germany
Session Type: Poster presentation
Session Time: 5:30 – 6:15 PM CT
Abstract ID.: 202066

DATE: Sunday, May 31, 2026
Title: Intraindividual Comparison of Unspecific Bone Uptake Between 18F-Flotufolastat and 18F-PSMA-1007 PET/CT in Patients with Prostate Cancer
Presenter: Daniel Sasse, Technical University of Munich, School of Medicine, Klinikum rechts der Isar, Department of Nuclear Medicine München, Germany
Session Type: Poster presentation
Session Time: 5:30 – 6:15 PM CT
Abstract ID.: 261004

DATE: Sunday, May 31, 2026
Title: Real-world Detection Efficacy of ¹⁸F-Flotufolastat PET/CT
Presenter: Daniel Sasse, Technical University of Munich, School of Medicine, Klinikum rechts der Isar, Department of Nuclear Medicine München, Germany
Session Type: Poster presentation
Session Time: 5:30 – 6:15 PM CT
Abstract ID.: 262312

DATE: Sunday, May 31, 2026
Title: Tracking Changes in PSMA-PET During Initial Therapy for Metastatic Hormone-sensitive Prostate Cancer (mHSPC): Initial Results from PSMATrack
Presenter: Heather Jacene, MD, Dana-Farber Cancer Institute, Boston, Massachusetts
Session Type: Poster presentation
Session Time: 5:30 – 6:15 PM CT
Abstract ID.: 262165

Axumin (fluciclovine F 18)
DATE: Sunday, May 31, 2026
Title: The REFINE Study – A Prospective Clinical Trial: Uncovering Prostate Cancer Biochemical Recurrence with 18F-Fluciclovine After Negative PSMA PET
Presenter: Theo Lorenzini, Technical University of Munich, School of Medicine, TUM Klinikum rechts der Isar, Department of Nuclear Medicine Munich, Germany
Session Type: Oral presentation
Session Time: 1:20 – 1:30 PM PT
Abstract ID.: 262074

DATE: Tuesday, June 2, 2026
Title: Imaging Heterogeneity in Neuroendocrine Prostate Cancer on Paired PSMA and F18-Fluciclovine PET/CT
Presenter: Heather Jacene, MD, Dana-Farber Cancer Institute, Boston, Massachusetts
Session Type: Poster presentation
Session Time: 11:30 – 12:15 pm PT
Abstract ID.: 261277

64Cu-rhPSMA-7.3/Pipeline
DATE: Tuesday, June 2, 2026
Title: 64Cu-rhPSMA-7.3 for Imaging Prostate Cancer: A Preclinical Proof of Concept Study
Presenter: George Pope
Session Type: Poster presentation
Session Time: 11:30 – 12:15 PM CT
Abstract ID.: 261612

(Press release, Blue Earth Diagnostics, MAY 19, 2026, View Source [SID1234665874])

On May 19, 2026 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing targeted radiotherapeutics for central nervous system (CNS) cancers, reported that it has signed an agreement to enter into a strategic partnership with Ephemeral Technologies ("Ephemeral") to deliver a unique AI execution platform for CNS oncology. The AI execution platform is designed to integrate, organize, and derive actionable intelligence from longitudinal therapeutic, diagnostic and bioinformatic data sets generated across Plus’ CNS oncology technology programs.

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"Plus is building a CNS oncology platform to integrate across our therapeutics, diagnostics and bioinformatics data sets," said Marc Hedrick, M.D., Plus Therapeutics President and Chief Executive Officer. "Our partnership with Ephemeral and its expertise in deploying artificial intelligence brings industry-proven engineering and advanced AI capabilities to the most challenging area of oncology. This partnership is intended to help further position Plus as a leader in CNS oncology and accomplish our mission of improving survival for patients with the most devastating cancers."

Ephemeral was founded by the former co-heads of Palantir Technologies’ U.S. healthcare business. Ephemeral was launched to bring AI solutions to life sciences to accelerate drug development.

Plus and Ephemeral believe the combination of multi-modal, longitudinal data with generative AI reasoning and agentic workflows will create both near- and long-term value for shareholders. Beginning in 2026, Plus anticipates tangible improvements in both laboratory and clinical operating efficiency and workflows. Beyond 2026, Plus intends to increasingly use artificial intelligence for fully integrated operational workflows, operational decision support, translational and treatment response analytics, patient stratification, precision oncology initiatives, pharmaceutical collaborations and real-world evidence initiatives.

"Ephemeral was founded to help companies like Plus align AI to real scientific and operational execution to more quickly deliver better medicines to patients," said Drew Goldstein, Ephemeral Co-Founder and Co-Chief Executive Officer. "Plus’ unique positioning and data sets in CNS oncology represents an ideal opportunity for Ephemeral, and we are proud to leverage our technology to support Plus’ mission to help patients with CNS cancers."

Under the agreement, Plus Therapeutics and Ephemeral will assess and implement AI-enabled data infrastructure to support the integration, organization, and analysis of complex CNS oncology data sets generated through the Company’s therapeutic and diagnostic workflows. No financial terms of the agreement were disclosed.

(Press release, Plus Therapeutics, MAY 19, 2026, View Source [SID1234665872])