On December 6, 2024 Treovir, Inc. reported the opening of a Phase 2 trial testing G207, an oncolytic HSV immunotherapy, in pediatric brain tumor patients (Press release, Treovir, DEC 4, 2024, View Source [SID1234648855]).

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G207 is being evaluated for efficacy in a single-arm Phase 2 study of 30 pediatric patients with high grade gliomas at first recurrence, a uniformly fatal form of pediatric brain tumors with no currently approved therapies. The Phase 2 trial will evaluate efficacy (overall survival) and confirm safety of G207, an oncolytic HSV virus. The trial is being conducted in collaboration with the Pediatric Brain Tumor Consortium, a National Cancer Institute (NCI)-supported consortium comprising 15 pediatric cancer centers, and is currently enrolling patients at Memorial Sloan Kettering Cancer Center and The University of Texas MD Anderson Cancer Center. NCI is part of the National Institutes of Health. Treovir anticipates that additional US and Canadian sites will open for enrollment in late 2024 and 2025. ClinicalTrials.gov ID NCT04482933; PBTC 061 www.pbtc.org

"With the opening of the Phase 2 study Treovir expects to expand on the positive data obtained from the Phase 1 study in pediatric patients completed in 2021" stated Michael Christini, CEO of Treovir. "There are no approved therapies for pediatric glioma and we anticipate that Phase 2 data will ultimately be used in support of a BLA filing for market approval of G207 offering a treatment option for patients in this critically underserved therapeutic area."

On December 4, 2024 Delta-Fly Pharma reported that as a result of consultation with the PMDA on December 3rd, 2024, the Phase II/III clinical trial of DFP-17729 in combination with TS-1 versus TS-1 alone in patients with pancreatic cancer after third-line treatment was approved (Press release, Delta-Fly Pharma, DEC 4, 2024, View Source [SID1234648815]).

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In a Phase I/II study of DFP-17729 in combination with TS-1 in patients with end-stage pancreatic cancer, no significant difference was observed against the control treatment (TS-1 or gemcitabine), but stratified analysis showed that when patients in the third-line or later treatment were treated for more than 6 weeks, DFP-17729 in combination with TS-1 showed a predominant median overall survival (mOS) prolongation (9.0 months vs. 6.1 months) and a significant correlation was also observed between urinary alkalinization and mOS in pancreatic cancer patients treated with DFP-17729, as key proof of concept. We had presented these results at the ESMO (Free ESMO Whitepaper) Gastrointestinal Cancers Congress 2024 and the 55 Annual Meeting of the Japan Pancreas Society, where much attention was paid to the presentation.

DFP-17729 is a novel approach to neutralize the acidic cancer microenvironment, and several patents on related inventions have been granted in major countries around the world, and its potential of efficacy has been published in peer-reviewed journals.

We will first identify DFP-17729 as a treatment for refractory pancreatic cancer, for which effective treatment is not yet available, and then seek to expand the indication to other types of cancer through partnership with major global pharmaceutical companies.

On December 4, 2024 Plus Therapeutics, Inc. (Nasdaq: PSTV) ("Plus" or the "Company"), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, reported that it will present data at the 2024 San Antonio Breast Cancer Symposium, December 10-13, 2024 in San Antonio, Texas (Press release, Plus Therapeutics, DEC 4, 2024, View Source [SID1234648798]).

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Presentation:

Title Rhenium (186Re) obisbemeda (rhenium nanoliposome,186RNL) for the treatment of leptomeningeal metastases (LM): Update on Phase 1 dose escalation (Abstract Number: SESS-2271, Presentation ID: PS14-01)

Presenter Andrew Brenner, M.D., Ph.D., Professor and Kolitz / Zachry Endowed Chair Neuro-Oncology Research; Co-Leader, Experimental and Developmental Therapeutics Program, University of Texas Health, Science Center at San Antonio

Date/Time Friday, 13 December 2024 7:30-8:30 a.m. CST

Location Stars at Night Ballroom 3-4, Henry B. Gonzalez Convention Center

About Leptomeningeal Metastases (LM)

LM is a rare complication of cancer in which the primary cancer spreads to the cerebrospinal fluid (CSF) and leptomeninges surrounding the brain and spinal cord. All malignancies originating from solid tumors, primary brain tumors, or hematological malignancies have this LM complication potential with breast cancer as the most common cancer linked to LM, with 3-5% of breast cancer patients developing LM. Additionally, lung cancer, GI cancers and melanoma can also spread to the CSF and result in LM. LM occurs in approximately 5% of people with cancer and is usually terminal with 1-year and 2-year survival of just 7% and 3%, respectively. The incidence of LM is on the rise, partly because cancer patients are living longer and partly because many standard chemotherapies cannot reach sufficient concentrations in the spinal fluid to kill the tumor cells, yet there are no FDA-approved therapies specifically for LM patients, who often succumb to this complication within weeks to several months, if untreated.

About Rhenium (186Re) obisbemeda

Rhenium (186Re) obisbemeda is a novel injectable radiotherapy specifically formulated to deliver direct targeted high dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. Rhenium (186Re) obisbemeda has the potential to reduce off target risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. Rhenium (186Re) obisbemeda is being evaluated for the treatment of recurrent glioblastoma and leptomeningeal metastases in the ReSPECT-GBM and ReSPECT-LM clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT).

On December 4, 2024 Matica Biotechnology (Matica Bio), a leading contract development and manufacturing organization (CDMO) specializing in viral vector development and manufacturing, reported a strategic partnerships with Treovir (Press release, Treovir, DEC 4, 2024, View Source [SID1234648816]). The collaboration aims to advance innovative therapies for pediatric patients with brain and other neurological cancers. Matica Bio will provide GMP manufacturing for clinical supplies.

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Treovir, a biotechnology company developing oncolytic immunotherapies, will partner with Matica Bio on its G207 HSV-based oncolytic therapy for treating glioblastoma and other brain tumors in children. The therapy is currently in Phase 2 clinical trials and could ultimately provide a treatment option for children in this critically underserved therapeutic area. "Finding a CDMO partner who truly understands our mission and works alongside us as an extension of our team is essential for successful drug development," said Michael Christini, CEO of Treovir. "We are collaborating with Matica Bio on process optimization and GMP clinical production for G207 and we look forward to advancing this promising therapy for pediatric brain tumors with Matica Bio playing a key role."

Matica Bio is committed to leveraging its expertise in gene therapy development and manufacturing to support the creation of treatment that address the unique challenges faced by children with rare diseases.

"We are thrilled to partner with Treovir in this important effort," said Paul Kim, CEO of Matica Bio. "Pediatric rare diseases represent an area of critical need, and Matica Bio is proud to contribute to the mission of improving the lives of these children. Our cutting-edge facilities and advanced manufacturing technologies provide the ideal foundation to help bring these life-changing therapies to market."

The collaboration reflects a shared commitment to addressing critical gaps in pediatric healthcare, ensuring that no child is left behind in the pursuit of better health outcomes.

On December 4, 2024 Oncoinvent ASA, a clinical stage company advancing alpha emitter therapy across a variety of solid cancers, reported that it has entered into an agreement with ARTBIO, a clinical-stage radiopharmaceutical company developing a new class of targeted alpha radioligand therapies (Press release, Oncoinvent, DEC 4, 2024, https://www.oncoinvent.com/press-release/oncoinvent-announces-agreement-with-artbio-to-collaborate-on-radiopharma-laboratory-facilities/?utm_source=mailpoet&utm_medium=email&utm_source_platform=mailpoet [SID1234648799]). As part of the agreement, ARTBIO will rent space and equipment, acquire access to some of Oncoinvent’s radioprotection expertise and analytical services, and purchase select R&D equipment. The agreement between Oncoinvent and ARTBIO shows a joint commitment to maximizing resource utilization and operational efficiency in a field which is constrained by a limited supply of these specialized facilities worldwide.

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"We are excited to partner with ARTBIO on the combined exploitation of our radiopharmaceutical laboratory facilities and analytical services," said Oystein Soug, Chief Executive Officer of Oncoinvent. "Our state-of-the-art laboratory and equipment represent years of expertise and significant investment in radiopharmaceutical development, making them invaluable resources. This agreement allows us to optimize our facility usage, leveraging our advanced capabilities and capacity."

"Oncoinvent has built up significant expertise in the area of alpha based radiopharmaceuticals R&D and production, offering a considerable opportunity for joint laboratory facility utilization," said Emanuele Ostuni, Chief Executive Officer of ARTBIO. "We see this partnership as a key collaboration that further strengthens the greater Oslo radiopharmaceutical hub."