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 IpiNovyx Bio, a biopharmaceutical company developing a platform of best-in-class immunoproteasome modulating therapeutics to transform treatment of autoimmune and inflammatory diseases, reported the closing of a $10 million seed financing round (Press release, IpiNovyx Bio, OCT 5, 2021, View Source [SID1234656418]). The financing was led by Viva BioInnovator (a Viva Biotech division) and also included participation from Lilly, Opaleye Management, Orange Grove Bio and Alexandria Venture Investments. Proceeds from the financing will support the company’s continued advancement of its lead drug candidates toward first-in-human clinical studies, including submission of the company’s first investigational new drug (IND) application.

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IpiNovyx Bio’s drug development candidates have emerged from the company’s proprietary technology platform, which enables the creation of novel, highly-selective and reversible immunoproteasome inhibitors. These innovative small molecule inhibitors are designed to selectively target the immunoproteasome and modulate specific immune cell types that are associated with autoimmune and inflammatory diseases. Importantly, preclinical research suggests the compounds may possess a favorable toxicity profile as compared to immunosuppressive therapies based on their ability to inhibit immune responses without killing immune cells. Additionally, the inhibitory activity of the company’s drug candidates is reversible, further reducing the potential for toxicity. This promising therapeutic profile positions the development candidates as potential steroid-sparing therapeutics for patients with a range of autoimmune diseases, as well as long-term therapies for autoimmune and inflammatory diseases, many of which are lacking effective therapeutic options.

IpiNovyx was founded by Orange Grove Bio, a preclinically-focused capital allocation and asset development biotech firm, alongside scientific founders Gang Lin, Ph.D. and Carl Nathan, M.D. of Weill Cornell Medicine, and Franck Barrat, Ph.D., of Hospital for Special Surgery (HSS) Research Institute.

"Patients suffering from autoimmune and inflammatory diseases are faced with limited treatment options and most therapies that are available are non-selective and carry significant toxicity concerns. This lack of appealing therapeutic options is largely due to the heterogeneity of these diseases, which makes addressing their fundamental pathophysiology challenging," said Dr. Nathan, chairman of the Department of Microbiology and Immunology and the R.A. Rees Pritchett Professor of Microbiology at Weill Cornell Medicine. "We believe that a strategy of specifically and selectively targeting the immunoproteasome offers the opportunity to overcome these challenges, allowing for the development of highly-selective, broad-acting and reversible immunoregulatory therapies that carry significantly reduced potential for toxicity. We are eager to continue our research in this area and work to advance these best-in-class immunoproteasome inhibitors into human clinical trials."

"Orange Grove Bio is dedicated to partnering with world-class researchers to advance the most promising drug development technologies emerging from leading academic institutions. We believe that IpiNovyx’s scientific founders and their unique approach to developing best-in-class immunoproteasome inhibitors are the ideal fit for this model," said Marc Appel, co-founder and chief executive officer of IpiNovyx and chief executive officer of Orange Grove Bio. "This seed funding will enable the company to rapidly progress through preclinical studies and into the clinic with the goal of delivering life changing therapies to patients suffering from autoimmune and inflammatory diseases."

The immunoproteasome possesses several key attributes that position it as a promising therapeutic target for complex inflammatory diseases. First, inflammatory disease relevant stimuli rapidly induce the immunoproteasome, which then supports the activity of immune cell functions including growth, differentiation, cytokine release and signaling. This induced activity is exacerbated by both the high prevalence of the immunoproteasome in multiple immune cell types that are linked to immunopathology and the fact that its abundance increases further in those cells undergoing activation. Supporting the value of this therapeutic target are preclinical study results in multiple in vivo and in vitro inflammatory disease models that have demonstrated efficacy for modestly selective inhibition of the immunoproteasome.

The fundamental technology being advanced by IpiNovyx is based on pioneering science conducted in the Nathan and Lin laboratories at Weill Cornell Medicine in collaboration with the Barrat lab at HSS, with prior support provided by Weill Cornell Medicine’s de-risking program, the Daedalus Fund for Innovation, which operates under the auspices of Weill Cornell Medicine Enterprise Innovation. An important component of this work was also developed through the efforts of the Tri-Institutional Therapeutics Discovery Institute, a unique program that provides a dedicated medicinal chemistry platform to generate novel chemical and molecular entities on behalf of its academic collaborators, with a view toward advancing early-stage therapeutic candidates into new treatments for patients. The technology is also in-licensed through an agreement with Cornell University’s Center for Technology Licensing (CTL).

"Weill Cornell Medicine’s robust innovation ecosystem works together to bring our faculty’s cutting-edge research to market for the benefit of patients by providing institutional support at critical junctures," said Dr. John Leonard, senior associate dean for innovation and initiatives at Weill Cornell Medicine. "IpiNovyx Bio, a company based on the fundamental work of Drs. Lin and Nathan, serves as an example of innovation meeting collaboration at the frontiers of science, and we look forward to the treatment advances this technology may one day offer for autoimmune and inflammatory diseases."

Weill Cornell Medicine Enterprise Innovation accelerates the best of biomedical innovation to market, translating groundbreaking research into transformational care. Enterprise Innovation provides a bridge between academic researchers and industry stakeholders, brokering engagements and alliances, engaging with and educating faculty about biotech commercialization and business development—which includes patenting and licensing, as well as designing dedicated research alliances —and providing a full suite of entrepreneurial programming, education, mentoring, and other resources.