On October 5, 2021 NBTS reported that it can be hard to keep track of new brain tumor clinical trial opportunities opening across the United States, especially as we continue to navigate the public health crisis created by the coronavirus (COVID-19)(Press release, National Brain Tumor Society, OCT 5, 2021, View Source [SID1234590821]). There are many clinical trials actively enrolling patients, and this report provides a summary of the studies that have recently opened or started for primary brain tumor patients. To learn more about each trial, and to contact the party responsible for enrolling patients.

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ONC206 for newly diagnosed or recurrent diffuse midline gliomas and other recurrent malignant brain tumors (PNOC 023)
This phase I trial studies the effects and best dose of the drug ONC206 alone or in combination with radiation therapy in treating patients with diffuse midline gliomas that are newly diagnosed or have come back (recurrent) or in other recurrent primary malignant brain tumors.
A comprehensive evaluation of tumor oxygenation, metabolism, and blood supply of high-grade glioma using dynamic FAZA PET and multiparametric MR
This is a pilot trial evaluating the use of several advanced medical imaging techniques to study high-grade glioma tumors.
Multimodality MRI and liquid biopsy in GBM
This is a non-therapeutic pilot trial that will evaluate imaging methods and liquid biopsy techniques to study glioblastoma.
Simultaneous multinuclear metabolic MRI in newly diagnosed or recurrent glioma
This clinical trial develops and tests a novel multinuclear metabolic magnetic resonance imaging (MRI) sequence in patients with glioma that is newly diagnosed or has come back (recurrent). This trial aims to develop new diagnostic imaging technology that may bridge gaps between early detection and diagnosis, prognosis, and treatment in brain cancer.
Study of PBI-200 in subjects with NTRK fusion-positive solid tumors
This is a first-in-human, phase I/II trial of the drug PBI-200 in subjects with NTRK fusion-positive advanced or metastatic solid tumors, including brain tumors.
PEACH TRIAL: Precision medicine and adoptive cellular therapy
This phase I study will evaluate the safety, feasibility, and maximum tolerated dose (MTD) of treating children with newly diagnosed DIPG or recurrent neuroblastoma with molecular targeted therapy in combination with adoptive cell therapy.
Study of DSP-0390 in patients with recurrent high-grade glioma
This phase I study will evaluate the safety and efficacy of the investigational treatment DSP-0390 in patients with recurrent high-grade glioma.
Combination intraventricular chemotherapy pilot study: 5-Azacytidine (5-AZA) and trastuzumab infusions into the fourth ventricle or resection cavity in children and adults with recurrent or residual posterior fossa ependymoma
The purpose of this early phase I study is to establish the safety and tolerability of simultaneous infusions of 5-Azacytidine and trastuzumab into the fourth ventricle of the brain or resection cavity in patients with recurrent posterior fossa ependymoma and to assess the antitumor activity of simultaneous infusions of 5-Azacytidine and trastuzumab into the fourth ventricle of the brain or resection cavity in patients based upon imaging studies and lumbar cerebrospinal fluid (CSF) cytology.
A study of BPM31510 with Vitamin K1 in subjects with newly diagnosed glioblastoma
This is a phase II therapeutic study that will assess the effects of combining the drug BPM31510 with standard of care treatments for subjects with newly diagnosed glioblastoma.
177Lu-DTPA-omburtamab radioimmunotherapy for recurrent or refractory medulloblastoma
Children and adolescents diagnosed with medulloblastoma and with recurrent or refractory to frontline therapy will be treated with 177Lu-DTPA-omburtamab in this phase I/II trial.
Testing the addition of the immunotherapy drugs tocilizumab and atezolizumab to radiation therapy for recurrent glioblastoma
This phase II trial studies the best dose and effect of tocilizumab in combination with atezolizumab and stereotactic radiation therapy in treating glioblastoma patients whose tumor has come back after initial treatment (recurrent).

On October 5, 2021 CytRx Corporation (OTCQB: CYTR) ("CytRx" or the "Company"), a specialized biopharmaceutical company focused on research and development for the oncology and neurodegenerative disease categories, reported that Steven A. Kriegsman, Chairman and Chief Executive Officer of CytRx, is scheduled to present at the Virtual LD Micro Main Event XIV, which is being held from October 12-14, 2021 (Press release, CytRx, OCT 5, 2021, View Source [SID1234590844]).

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Mr. Kriegsman’s virtual presentation will be available for on-demand viewing throughout the conference. Interested parties can view the presentation here.

As a reminder, CytRx joined the LD Micro Index in 2021.

On October 5, 2021 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported pre-clinical data from ONCT-534, an androgen receptor N-terminal-domain-binding small molecule degrader, was accepted for virtual poster presentation at the AACR (Free AACR Whitepaper)-NCI-EORTC Virtual AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) on October 7-10, 2021(Press release, Oncternal Therapeutics, OCT 5, 2021, View Source [SID1234590822]). Oncternal has conducted a series of preclinical studies in collaboration with the Center for Cancer Research at the University of Tennessee Health Science Center.

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The ONCT-534 data will be presented as a late-breaking abstract selected for virtual poster presentations and will be available for on-demand viewing in the AACR (Free AACR Whitepaper)-NCI-EORTC platform on October 7, 2021, at 9 a.m. ET.

Abstract Title: Androgen Receptor (AR) N-Terminus-Domain-Binding Small Molecule Degraders for the Treatment of AR Splice Variant-Positive Castration-Resistant Prostate Cancer
Abstract Number: LBA016
"Despite relatively recent advances in treating CRPC, 5-year overall survival remains low, and patients are in need of more effective treatment options" said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. "In preclinical research, ONCT-534 has demonstrated anti-tumor activity in a series of studies and might have the potential to address significant unmet needs related to important tumor resistance mechanisms, including those involving expression of the AR splice variant AR-V7."

About ONCT-534

ONCT-534 (formerly GTx-534) is an investigational, potentially first-in-class androgen receptor (AR) N-terminal-domain-binding small molecule degrader, currently in preclinical development, that was originally discovered by the Center for Cancer Research at the University of Tennessee Health Science Center. Oncternal acquired rights to ONCT-534, which is part of what was previously known as the selective androgen receptor degrader (SARD) program, in Oncternal’s reverse merger with GTx, Inc. in 2019. ONCT-534 has demonstrated preclinical activity in prostate cancer tumor models resistant to approved AR-targeting therapies. Oncternal is currently evaluating strategic development options for ONCT-534 as a potential therapy for castration-resistant prostate cancer (CRPC), LAR-TNBC as well as AR-driven non-oncology indications.

Oncternal is currently seeking to amend the financial terms of a contingent value rights (CVR) agreement relating to the program, subject to approval of a majority in interest of the CVR holders. Among other things, the amendment would increase Oncternal’s share of proceeds from commercialization or other monetization of the program while limiting certain deductions in some cases to those costs incurred after the potential amendment becomes effective. Oncternal intends to provide a programmatic update on ONCT-534 on its earnings call planned for early November 2021.

On October 5, 2021 Aulos Bioscience, an immuno-oncology company working to revolutionize cancer care through a potentially best-in-class, computationally evolved IL-2 human antibody, reported the planned presentation of preclinical data on its lead investigational therapy, AU-007, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting (Press release, Aulos Bioscience, OCT 5, 2021, View Source [SID1234590845]). The SITC (Free SITC Whitepaper) meeting will run Nov. 10-14, 2021, in Washington D.C., as well as virtually.

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"We believe in the potential of our initial clinical candidate, AU-007, as a novel cancer treatment that could meaningfully impact the lives of patients with its highly differentiated approach to harnessing the power of IL-2 to eradicate solid tumors," said Aron Knickerbocker, Aulos Bioscience’s chief executive officer. "We look forward to presenting preclinical data at the SITC (Free SITC Whitepaper) Annual Meeting and to initiating clinical testing in patients with cancer by year end."
Abstract ID

Poster Number and Title

Presenting Author

14867

704: The computationally designed human antibody, AU-007, mediates human immune activation by endogenous IL-2, while uniquely breaking the IL-2 auto-inhibitory loop and preventing Treg expansion

Yanay Ofran, Ph.D.

Biolojic Design and Aulos Bioscience

The poster will be presented in the Poster Hall at the Walter E. Washington Convention Center in Washington, D.C. Saturday, Nov. 13, 2021. It will also be available as an ePoster on display on the SITC (Free SITC Whitepaper) 2021 virtual meeting platform from 7 a.m. EST on Friday, Nov. 12, 2021, until the virtual meeting platform is closed on Jan. 9, 2022.

About AU-007
AU-007 is a computationally evolved, human IgG1 monoclonal antibody that is highly selective to the CD25-binding portion of IL-2. With a mechanism of action unlike any other IL-2 therapeutic in development, AU-007 leverages the body’s own IL-2 to reinforce anti-tumor immune effects. This is achieved by preventing IL-2 secreted by T effector cells from binding to trimeric receptors on T regulatory cells while still allowing IL-2 to bind and expand effector cells. This prevents the negative feedback loop caused by other IL-2 based treatments and biases the immune system towards activation over suppression. AU-007 also prevents IL-2 from binding to trimeric receptors on vasculature and pulmonary endothelium, which may significantly reduce the vascular leak syndrome and pulmonary edema associated with high-dose IL-2 therapy.

On October 5, 2021 Almac Sciences, a member of the Almac Group, reported expanding collaborations with University College Dublin (UCD) for flow based-oxidation approaches through a co-founded PhD scholarship (Press release, Almac, OCT 5, 2021, View Source [SID1234590798]).

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Almac Sciences and Dr Marcus Baumann have an already well-established partnership through a Science Foundation Ireland (SFI) Industry Fellowship on the Continuous Biocatalysed Chemicals (CATCH) project which was publicised in 2020. Together the team has published six peer-reviewed papers focusing on the development of continuous flow approaches to demonstrate the synergies between technology platforms, such as flow chemistry and biocatalysis. Highlights include development of Curtius rearrangements under flow and demonstration of the synergies attainable with biocatalysis with a novel enzyme mediated purification strategy.

The new PhD scholarship is co-funded by Almac Sciences and the SFI Research Centre for Pharmaceuticals (SSPC) over the next 4 years and will investigate flow-based oxidation processes. This year’s student, Niamh Disney, will undertake industry placements within Almac, offering an immersive experience on which she will build key transferable skills and gain insight into critical decision-making for flow processes on an industrial scale.

Lead academic at UCD, Dr Marcus Baumann said "I am very excited to continue to work with Almac Sciences and publish further as we investigate novel oxidative approaches under continuous flow. It affords further extension of my research portfolio in industrially relevant fields."

This latest development demonstrates further Almac’s commitment to technology innovation as it continues to expand service offerings for the pharmaceutical, biotechnology, life sciences and fine chemical sectors following a £325,000 investment, specifically in flow capabilities.

Dr Megan Smyth, Technical Leader, Almac Sciences commented: "This PhD further intensifies our collaboration with the Baumann group at UCD and we look forward to working with Marcus and Niamh. Through close collaboration, and time with us at our state-of-the-art facilities, Niamh will gain a valuable insight into industrially relevant target transformations and I wish her every success with her studies."