Orbus Therapeutics Announces First Patient Enrolled in Phase 1 Clinical Study in Newly Diagnosed Glioblastoma

- The Phase 1 Study will Evaluate Eflornithine in Combination with Temozolomide -

 

 

PALO ALTO, Calif., September 6, 2023 – Orbus Therapeutics Inc., a private, late-stage biopharmaceutical company focused on the development and commercialization of therapies that treat rare diseases, announced today that the first patient has been enrolled in its Phase 1b study combining temozolomide and eflornithine in patients newly diagnosed with glioblastoma.

 

Orbus Therapeutics is currently conducting a Phase 3 clinical trial, referred to as the STELLAR study, to evaluate its eflornithine oral solution in patients with anaplastic astrocytoma whose cancer has recurred following radiation and adjuvant temozolomide chemotherapy. The initiation of this Phase 1b study is part of Orbus’ ongoing efforts to develop a new treatment option for patients with malignant glioma.

 

"While we are evaluating the combination of eflornithine and lomustine in the ongoing randomized Phase 3 STELLAR study to improve overall survival in patients with 2nd line or recurrent anaplastic astrocytoma, we are very excited to start this new study of eflornithine combined with temozolomide in patients with newly diagnosed glioblastoma,” said Bob Myers, Co-Founder and Chief Executive Officer of Orbus Therapeutics. 

 

“This is an important trial evaluating the safety of eflornithine combined with temozolomide after surgery and radiation in patients with newly diagnosed glioblastoma,” said Howard Colman, MD, PhD, FAAN,  the Jon M. Huntsman Presidential Chair in Neuro-Oncology at the Huntsman Cancer Institute at the University of Utah. “The results of this trial will provide important information on the dosing combination of eflornithine with temozolomide, in patients with newly diagnosed glioblastoma, and will build on the progress of the ongoing Phase 3 trial in patients with recurrent anaplastic astrocytoma. Temozolomide is the current standard of care in patients with newly diagnosed glioblastoma.“

 

The Phase 1b study is an open-label, single arm, dose-limiting toxicity clinical trial that will include approximately 8 leading neuro-oncology clinical trial centers in the United States. The trial is designed to evaluate the safety and pharmacokinetics of eflornithine in combination with temozolomide in patients with newly diagnosed glioblastoma who have completed surgery and irradiation.

 

The Company plans to enroll up to 60 subjects into the Phase 1b study. Participants in the study will be assigned into cohorts according to a standard “3 + 3” dose escalation design. The primary endpoints are the assessment of dose-limiting toxicity and adverse events. Secondary endpoints include progression free survival (PFS), objective response rate (ORR) and pharmacokinetics.

 

For more information about the trial, including enrolling centers, please visit

www.clinicaltrials.gov (NCT05879367).

 

About Eflornithine

Eflornithine is a novel cytostatic agent that irreversibly inhibits ornithine decarboxylase, a key enzyme in mammalian polyamine biosynthesis that is up-regulated in certain types of cancer.

 

Eflornithine has been granted Orphan Drug Designation and Breakthrough Therapy Designation for the treatment of patients with anaplastic glioma by the U.S. Food and Drug Administration (FDA), and has also been granted Orphan Medicinal Product status for the treatment of glioma by the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA).

 

About Orbus Therapeutics

Orbus Therapeutics Inc. is a late-stage, private biopharmaceutical company that is dedicated to developing products that treat rare diseases for which there are few, if any, effective therapies. The Company’s lead product candidate, eflornithine, is being evaluated in a pivotal Phase 3 clinical trial in patients with recurrent anaplastic astrocytoma, a rare form of central nervous system cancer. For more information, please visit the Company's website at http://www.orbustherapeutics.com.

 

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Source: Orbus Therapeutics, Inc.

 

Investor Contact:         

Jason Levin, COO   
jason.levin@orbustherapeutics.com     
650.656.9440                                                                                                                           

Media Contact:

Kelli Perkins
kelli@redhousecomms.com
310.625.3248

Orbus Therapeutics Enters Exclusive License Agreement for Intellectual Property Related to Treatment of Rare Pediatric Syndrome with Eflornithine

- Eflornithine method for use patent from Michigan State University/Corewell Health® relates to treating patients with rare Bachmann-Bupp Syndrome -

PALO ALTO, Calif., Jan. 10, 2023 – Orbus Therapeutics Inc., a private, late-stage biopharmaceutical company focused on the development and commercialization of therapies that treat rare diseases, announced an exclusive license agreement with Michigan State University (MSU) and Helen DeVos Children’s Hospital (HDVCH), part of Corewell Health® (formerly Spectrum Health), that grants Orbus exclusive rights to intellectual property related to the method of use of eflornithine in the treatment of a novel pediatric condition known as Bachmann-Bupp Syndrome (BABS).

"We are delighted to enter into this agreement with Orbus Therapeutics,” said Anupam Jhingran, Technology Manager with MSU Technologies, the technology transfer office of MSU. “We believe that Orbus Therapeutics' unique strength in developing new treatment options in the rare disease space and their current clinical development of eflornithine makes them the ideal partner to move this effort forward."

Orbus Therapeutics is currently conducting a Phase 3 clinical trial, referred to as the STELLAR study, to evaluate its eflornithine oral solution in patients with anaplastic astrocytoma whose cancer has recurred following radiation and adjuvant temozolomide chemotherapy. The company plans to expand its activities to include development and future commercialization of its eflornithine oral solution in BABS in parallel with its ongoing efforts in malignant glioma.

“These children face significant neurological and development hurdles as a result of this gain-of-function mutation,” said Bob Myers, Chief Executive Officer of Orbus. “We have been very impressed by the results of the ongoing work at MSU and HDVCH, and the positive impact that has been seen in the development of these children following treatment with eflornithine.”

About BABS

BABS is a newly recognized autosomal dominant genetic disorder caused by a heterozygous de novo variant in the ornithine decarboxylase 1 (ODC1) gene identified by Drs. André Bachmann, Caleb Bupp and Surender Rajasekaran. ODC1 produces an enzyme that is integral in putrescine biosynthesis, which is involved in cell division. BABS is a rare condition, where a gain-of-function mutation in ODC1 causes an increase in ODC expression and levels of putrescine in patients, that leads to disabling neurodevelopmental deficits. Researchers at MSU and HDVCH have shown that oral delivery of eflornithine improves physical coordination, attention and interaction in patients with BABS.

About Eflornithine

Eflornithine is a novel cytostatic agent that irreversibly inhibits ornithine decarboxylase, a key enzyme in mammalian polyamine biosynthesis that is up-regulated in certain types of cancer

Eflornithine has been granted Orphan Drug Designation and Breakthrough Therapy Designation for the treatment of patients with anaplastic glioma by the U.S. Food and Drug Administration (FDA), and has also been granted Orphan Medicinal Product status for the treatment of glioma by the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA).

About Orbus Therapeutics

Orbus Therapeutics Inc. is a late-stage, private biopharmaceutical company that is dedicated to developing products that treat rare diseases for which there are few, if any, effective therapies. The Company’s lead product candidate, eflornithine, is being evaluated in a pivotal Phase 3 clinical trial in patients with recurrent anaplastic astrocytoma, a rare form of central nervous system cancer. For more information, please visit the Company's website at

http://www.orbustherapeutics.com

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Source: Orbus Therapeutics, Inc.

Investor Contact:
Jason Levin, COO
jason.levin@orbustherapeutics.com
650.656.9440

Media Contact:
Kelli Perkins
kelli@redhousecomms.com
310.625.3248

Orbus Therapeutics’ Phase 3 Eflornithine STELLAR Study Reaches Full Patient Enrollment

- Phase 3 STELLAR trial evaluating eflornithine in patients with recurrent anaplastic astrocytoma –

- Pre-specified interim analysis to test for superiority expected to occur in 2022 -

PALO ALTO, Calif., January 19, 2022 – Orbus Therapeutics Inc., a private, late-stage biopharmaceutical company focused on the development and commercialization of therapies that treat rare diseases, today announced that patient enrollment of its Phase 3 STELLAR clinical study of eflornithine in patients with recurrent anaplastic astrocytoma is complete. The STELLAR study completed full enrollment with a total of 343 patients.

“We are delighted to announce that we have completed enrollment of patients in the STELLAR study.  The STELLAR study is the largest randomized Phase 3 study that has been conducted in this patient population,” said Bob Myers, co-founder and CEO. “This achievement represents an important milestone for our company toward our goal of bringing this new potential therapy to patients with recurrent anaplastic astrocytoma, a rare and fatal disease. We look forward to conducting an interim analysis for superiority in 2022.”

 About the STELLAR study
The STELLAR study, a Phase 3, Randomized, Open-Label Study To Evaluate the Efficacy and Safety of Eflornithine and Lomustine Compared to Lomustine Alone in Patients with Anaplastic Astrocytoma That Progress/Recur After Irradiation and Adjuvant Temozolomide Chemotherapy, started in late 2016 and has involved more than 85 leading clinical trial centers in eight countries in North America and Europe. The trial is designed to evaluate the efficacy and safety of eflornithine in combination with lomustine compared to lomustine alone in patients with anaplastic astrocytoma that recurs after surgery, irradiation and adjuvant temozolomide chemotherapy.

The primary efficacy endpoint in the STELLAR study is the duration of overall survival (OS). Secondary pre-specified efficacy endpoints include OS in isocitrate dehydrogenase (IDH) mutant and wild type sub-populations, progression free survival (PFS) and objective response rate (ORR). Find more information about the STELLAR study here.

About Anaplastic Glioma and Anaplastic Astrocytoma
Several brain tumor types are grouped together under the name glioma which originates in the glial cells that surround and support neurons in the brain. In the United States, greater than 2,000 new cases of anaplastic glioma, one of three grades of malignant glioma, are diagnosed each year. Despite treatment with surgery, radiation and chemotherapy, median survival for people with anaplastic glioma is just over three years. Anaplastic astrocytoma is the largest subset of anaplastic glioma, and represents approximately 75 percent of anaplastic glioma patients. Anaplastic astrocytomas typically require aggressive treatment and, due to tentacle-like projections that grow into surrounding tissue, are difficult to completely remove during surgery. It is estimated that there are more than 1,500 new anaplastic astrocytoma cases diagnosed in the United States each year. The prevalence of diffuse and anaplastic astrocytoma in the United States is estimated to be just over 23,000 people.

About Eflornithine
Eflornithine is a novel cytostatic agent that irreversibly inhibits ornithine decarboxylase, a key enzyme in mammalian polyamine biosynthesis that is up-regulated in certain types of cancer. In controlled, randomized and single arm clinical studies, eflornithine has shown an increase in overall survival of patients with newly diagnosed or recurrent anaplastic astrocytoma.

Eflornithine has been granted Orphan Drug Designation and Breakthrough Therapy Designation for the treatment of patients with anaplastic glioma by the U.S. Food and Drug Administration (FDA), and has also been granted Orphan Medicinal Product status for the treatment of glioma by the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA).

About Orbus Therapeutics
Orbus Therapeutics Inc. is a late-stage, private biopharmaceutical company that is dedicated to developing products that treat rare diseases for which there are few, if any, effective therapies. The Company’s lead product candidate, eflornithine, is being evaluated in a pivotal Phase 3 clinical trial in patients with recurrent anaplastic astrocytoma, a rare form of central nervous system cancer. For more information, please visit the Company's website at http://www.orbustherapeutics.com

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Source: Orbus Therapeutics, Inc.

 Investor Contact:                                                                 
Jason Levin, COO                                                          
jason.levin@orbustherapeutics.com                       
650.656.9440                      

Media Contact:     
Kelli Perkins
kelli@redhousecomms.com                                         
310.625.3248

 

Orbus Therapeutics Granted European Patent for Method of Use for Eflornithine

- Patent relates to method for use of eflornithine to treat cancers, including gliomas -

PALO ALTO, Calif., Sep. 28, 2021 – Orbus Therapeutics Inc., a private, late-stage biopharmaceutical company focused on the development and commercialization of therapies that treat rare diseases, announced that it has been granted patent No. 3432872 entitled “Compositions and Methods for Use of Eflornithine and Derivatives and Analogs thereof to Treat Cancers, Including Gliomas,” by the European Patent Office (EPO).

The patent, which was granted on August 25, 2021 and is being validated in 15 European countries including Germany, France, Spain, the United Kingdom and Italy, covers eflornithine or a pharmaceutically acceptable salt thereof in a method for the treatment of temozolomide-recurrent anaplastic astrocytoma.

Orbus is currently evaluating eflornithine in an ongoing Phase 3 clinical trial, the STELLAR study, in patients with anaplastic astrocytoma whose cancer has recurred following radiation and adjuvant chemotherapy.

About Eflornithine

Eflornithine is a novel cytostatic agent that irreversibly inhibits ornithine decarboxylase, a key enzyme in mammalian polyamine biosynthesis that is up-regulated in certain types of cancer

Eflornithine has been granted Orphan Drug Designation and Breakthrough Therapy Designation for the treatment of patients with anaplastic glioma by the U.S. Food and Drug Administration (FDA), and has also been granted Orphan Medicinal Product status for the treatment of glioma by the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA).

About Orbus Therapeutics

Orbus Therapeutics Inc. is a late-stage, private biopharmaceutical company that is dedicated to developing products that treat rare diseases for which there are few, if any, effective therapies. The Company’s lead product candidate, eflornithine, is being evaluated in a pivotal Phase 3 clinical trial in patients with recurrent anaplastic astrocytoma, a rare form of central nervous system cancer. For more information, please visit the Company's website at http://www.orbustherapeutics.com

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Source: Orbus Therapeutics, Inc.

Investor Contact: Jason Levin, COO, jason.levin@orbustherapeutics.com, 650.656.9440

Media Contact: Denise Powell, denise@redhousecomms.com, 510.703.9491

COVID-19 Update

During this challenging time of global pandemic, we wanted to reach out to let you know that the entire team at Orbus Therapeutics is fully committed to the ongoing STELLAR Study and most importantly, protecting the safety of patients. In collaboration with our clinical sites that remain open, we are working to make sure that the STELLAR Study patients are getting the best possible medical care.

We stand with you throughout this difficult time of social distancing and want to thank you for your unwavering support and commitment to the STELLAR Study.

Please check with your clinical sites for any special accommodations that may be available. In addition, you can visit www.stellarstudy.com for news and updates.