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 Coherus BioSciences, Inc. ("the Company"; Nasdaq: CHRS) reported positive results from a randomized, open-label, crossover study assessing the pharmacokinetic (PK) and pharmacodynamic (PD) bioequivalence of UDENYCA (pegfilgrastim-cbqv) administered via a proprietary on-body injector (OBI) device compared to the currently marketed UDENYCA pre-filled syringe (PFS)(Press release, Coherus Biosciences, OCT 5, 2021, View Source [SID1234590818]). The study met all PK bioequivalence primary endpoints as well as the key secondary pharmacodynamic endpoint of ANC (absolute neutrophil count). No new safety signals were observed. The study enrolled 189 subjects randomized 1:1 to receive one of two treatment sequences of UDENYCA: OBI followed by PFS, or the reverse, with a treatment interval of 6 to 8 weeks.

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Coherus plans a 2022 submission to the United States Food and Drug Administration (FDA) of a prior approval supplement to seek marketing authorization for the UDENYCA OBI and anticipates a standard 10-month review period. Coherus expects commercial launch of the UDENYCA OBI directly post approval.

"UDENYCA quickly became the top-selling pre-filled syringe pegfilgrastim in the U.S. within months of launch in 2019, establishing Coherus as a trusted partner to oncologists and demonstrating the power of biosimilar competition to expand patient access to an important cancer medicine," said Denny Lanfear, CEO of Coherus. "With our OBI program progress, we are excited by the potential to offer to providers and patients a new on-body injector presentation of UDENYCA, if approved, and to compete directly with Neulasta Onpro, which retains more than 50% share of the overall pegfilgrastim market."

An FDA-approved UDENYCA OBI would offer providers a highly desired alternative to the originator’s on-body pegfilgrastim delivery system and eliminate the need for patients to return to a hospital or other clinical setting the day after chemotherapy to receive UDENYCA.

About UDENYCA
UDENYCA is the #1 prescribed pegfilgrastim pre-filled syringe in the United States.
UDENYCA is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

Limitations of Use: UDENYCA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

Contraindications: Patients with a history of serious allergic reactions to pegfilgrastim products or filgrastim products. Reactions have included anaphylaxis.

Warnings and Precautions:
Fatal splenic rupture: Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture.
Acute respiratory distress syndrome (ARDS):
Evaluate patients who develop fever, lung infiltrates, or respiratory distress. Discontinue UDENYCA in patients with ARDS.
Serious allergic reactions, including anaphylaxis:
The majority of reported events occurred upon initial exposure. Allergic reactions, including anaphylaxis, can recur within days after the discontinuation of initial anti-allergic treatment. Permanently discontinue UDENYCA in patients with serious allergic reactions.
Sickle cell crises: Severe and sometimes fatal crises have occurred. Discontinue UDENYCA if sickle cell crisis occurs.
Glomerulonephritis: The diagnoses were based upon azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy. Generally, events resolved after dose reduction or discontinuation. Evaluate and consider dose-reduction or interruption of UDENYCA if causality is likely.
Leukocytosis: White blood cell (WBC) counts of 100 x 109/L or greater have been observed in patients receiving pegfilgrastim products. Monitoring of complete blood count (CBC) during UDENYCA therapy is recommended.
Thrombocytopenia: Thrombocytopenia has been reported in patients receiving pegfilgrastim. Monitor platelet counts.
Capillary Leak Syndrome: Has been reported after G-CSF administration, including pegfilgrastim products, and is characterized by hypotension, hypoalbuminemia, edema, and hemoconcentration. Episodes vary in frequency, severity and may be life-threatening if treatment is delayed. If symptoms develop, closely monitor and give standard symptomatic treatment, which may include a need for intensive care.
Potential for Tumor Growth Stimulatory Effects on Malignant Cells: The possibility that pegfilgrastim products act as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which pegfilgrastim products are not approved, cannot be excluded.
Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) in Patients with Breast and Lung Cancer: MDS and AML have been associated with the use of pegfilgrastim in conjunction with chemotherapy and/or radiotherapy in patients with breast and lung cancer. Monitor patients for sign and symptoms of MDS/AML in these settings.
Aortitis: Has been reported in patients receiving pegfilgrastim products, occurring as early as the first week after start of therapy. Manifestations may include generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers (e.g., c-reactive protein and white blood cell count). Consider aortitis when signs and symptoms develop without known etiology. Discontinue UDENYCA if aortitis is suspected.
Nuclear Imaging: Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone imaging changes. Consider when interpreting bone imaging results.

Adverse Reactions: Most common adverse reactions (≥ 5% difference in incidence compared to placebo) are bone pain and pain in extremity.

On October 5, 2021 Himalaya Therapeutics of Shanghai has submitted four INDs in China for two Conditionally Active Biologics, each one aimed at two solid tumor cancer indications(Press release, Himalaya Therapeutics, OCT 5, 2021, View Source [SID1234590817]). The company describes itself as a global clinical-stage biotech developing drugs that have more selective targeting for greater safety and efficacy. It also works to be more cost-efficient with highly predictable manufacturing compared to traditional antibodies. Himalaya, a majority owned subsidiary of San Diego’s BioAtla, develops BioAtla’s products in China.

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On October 5, 2021 NovoCodex Pharma reported positive interim data from a China trial of its lead drug in patients with HER2+ metastatic gastric / gastroesophageal junction (GEJ) cancer(Press release, NovoCodex Biopharmaceuticals, OCT 5, 2021, View Source [SID1234590815]). ARX788 is an antibody-drug conjugate composed of an EGFR antibody targeting EGFR2 and HER2, joined to a apoptosis molecule. The candidate showed a tolerable safety profile and promising efficacy data. NovoCodex acquired China rights to ARX788 from Ambrx, a San Diego biotech. NovoCodex is a majority owned subsidiary of Zhejiang Medicine.

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On October 5, 2021 CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, reported that management will host a virtual event on October 12, 2021 at 4:30 p.m. ET to highlight clinical data from its ongoing Phase 1 CARBON trial assessing the safety and efficacy of CTX110, its wholly-owned allogeneic chimeric antigen receptor T cell (CAR-T) investigational therapy targeting CD19, for the treatment of relapsed or refractory B-cell malignancies(Press release, CRISPR Therapeutics, OCT 5, 2021, View Source [SID1234590813]).

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Conference Call and Webcast
To access the conference call, please dial +1 (866) 952-8559 (domestic) or +1 (785) 424-1743 (international) and reference the conference ID "CRISPR."

A live webcast of the event will be available on the "Events & Presentations" page in the Investors section of the Company’s website at View Source A webcast replay will be available on the CRISPR Therapeutics website after the event and will be archived for 14 days.

About CTX110
CTX110, a wholly owned program of CRISPR Therapeutics, is a healthy donor-derived gene-edited allogeneic CAR-T investigational therapy targeting Cluster of Differentiation 19, or CD19. CTX110 is being investigated in the ongoing CARBON trial.

About CARBON
The ongoing Phase 1 single-arm, multi-center, open label clinical trial, CARBON, is designed to assess the safety and efficacy of several dose levels of CTX110 for the treatment of relapsed or refractory B-cell malignancies.