Orbus Therapeutics Appoints Jason Levin, Co-founder and COO to President

PALO ALTO, Calif., Feb. 27, 2025 – Orbus Therapeutics, Inc., a private, late-stage biopharmaceutical company focused on the development and commercialization of eflornithine to treat malignant glioma, announced that co-founder and current Chief Operating Officer (COO) Jason Levin will become President. Bob Myers, co-founder and Orbus’s President and CEO since 2012, will be stepping down from the role as a day-to-day executive in order to pursue other opportunities in the industry.

“Bob has been instrumental in building Orbus as CEO, including securing funding that enabled us to complete the Phase 3 STELLAR study of eflornithine that demonstrated a clinically meaningful improvement in PFS and OS for the subgroup of patients with grade 3 astrocytoma,” said Mr. Levin. “We believe that the results from the STELLAR study represent a major step forward in advancing the standard of care for patients with these difficult diagnoses, and we could not have done it without Bob’s determination and strong leadership.”

“The Board remains committed to the company’s mission and this team’s ongoing efforts to find a path forward to bring eflornithine to patients with grade 3 astrocytoma,” said Patrick Enright, Orbus Therapeutics Board Member and Managing Director at Longitude Capital. “The Board of Directors greatly appreciates Bob’s many years of hard work and major contributions to the progress that Orbus has demonstrated, and wishes him great success in his next endeavor.”

Mr. Levin brings extensive executive experience to Orbus Therapeutics. Prior to co-founding Orbus, he was Chief Business Officer at Sorbent Therapeutics and BrainCells. Previous to those roles he was Vice President, Corporate Development at Jazz Pharmaceuticals, having started there in 2003 after working in business development at ALZA Corporation, a Johnson & Johnson company. With more than 30 years of experience in the life sciences industry, he has a strong track record in the operational and strategic aspects of entrepreneurial biopharma companies.

About Eflornithine

Eflornithine is a novel cytostatic agent that irreversibly inhibits ornithine decarboxylase, a key enzyme in mammalian polyamine biosynthesis that is upregulated 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, recently completed the STELLAR study, a Phase 3 clinical trial in patients with recurrent anaplastic astrocytoma, a rare form of central nervous system cancer. The primary efficacy endpoint, overall survival (OS) in the STELLAR study was not statistically significant, however, a clinically meaningful improvement in OS and PFS was seen in a defined subgroup of patients with grade 3 astrocytoma. The known side effect profile of eflornithine combined with lomustine was consistent with data from earlier studies and showed no unexpected safety signals. For more information, please visit the Company's website at http://www.orbustherapeutics.com.

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Source: Orbus Therapeutics, Inc.

Contact Information:

Jason Levin, President

jason.levin@orbustherapeutics.com

650.656.9440 

Media:

Kelli Perkins

kelli@redhousecomms.com

310.625.3248 

Eflornithine and Lomustine Combination Shows Clinically Meaningful Improvements in Overall Survival (OS) and Progression Free Survival (PFS) in Patients with Recurrent Astrocytoma IDH Mutant Grade 3

– OS and PFS Study endpoints met in large subgroup of patients with recurrent astrocytoma, IDH mutant grade 3 as defined by the 2021 WHO CNS Tumor Classification in Orbus Therapeutics’ Phase 3 STELLAR study –

– Eflornithine was previously granted Orphan Designation and Breakthrough Therapy Designation by U.S. Food and Drug Administration (FDA) –

PALO ALTO, Calif., Nov. 22, 2024 – Orbus Therapeutics, Inc., a private pharmaceutical company, today announced that the combination of eflornithine and lomustine achieved a clinically meaningful improvement in overall survival (OS) and progression free survival (PFS) compared to lomustine as a single agent for those patients with grade 3 IDH mutant astrocytoma who have progressed after irradiation and adjuvant temozolomide treatment.  This patient subpopulation represented the majority of patients enrolled in the Phase 3 STELLAR clinical trial.  The results were presented at the Society for Neuro-Oncology Annual Meeting held in Houston, Texas.

“For patients with recurrent grade 3 astrocytoma, a rare and fatal disease, there are very few available treatment options.  The last FDA approval of a chemotherapeutic agent for these patients was 25 years ago,” said Bob Myers, Chief Executive Officer, Orbus.  “We are impressed by these results, which would not have been attainable without the dedication and participation of patients, investigators, and study staff who made major contributions to the conduct of this study.”

The STELLAR study (NCT02796261) was 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 study enrolled a total of 343 patients and, importantly, it included a large subset (n=194) of grade 3 IDH mutant astrocytoma patients, as defined by World Health Organization (WHO) specified molecular markers. More than 105 leading clinical trial centers in eight countries in North America and Europe participated in the study.

·       The primary efficacy endpoint, overall survival (OS) in the intention-to-treat population of 343 patients had a hazard ratio (HR) = 0.94 and was not statistically significant.

·       In the 194 patients with recurrent grade 3 IDH mutant astrocytoma, clinically meaningful improvements in both OS and PFS were observed.

·       Median OS in the eflornithine + lomustine arm was 34.9 months compared to 23.5 months in the lomustine alone arm with HR = 0.64 (log rank p = 0.016).

·       PFS showed a correlating benefit with median PFS of 15.8 months in the eflornithine + lomustine arm and 7.2 months in the lomustine alone arm with HR = 0.58 (log rank p = 0.015).

·       The combination of eflornithine and lomustine was generally well-tolerated. The known side effect profile of eflornithine combined with lomustine was consistent with data from earlier studies and showed no unexpected safety signals.  The most common Grade 3+ treatment emergent adverse events of relevance were related to myelosuppression and hearing impairment. Similarly, the proportion of patients with Grade 3+ hematology parameters and those with Grade 3 + clinical chemistry parameters were as expected.

“The subset results for the patients with recurrent grade 3 astrocytoma in the STELLAR study represent the first positive outcome to show significant increases in overall survival and progression free survival in a very difficult-to-treat form of malignant glioma,” 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.  “These findings from the STELLAR study are very impressive and provide caregivers and patients with hope for a new treatment option for this fatal disease.”

About Eflornithine

Eflornithine is a novel cytostatic agent that irreversibly inhibits ornithine decarboxylase, a key enzyme in mammalian polyamine biosynthesis that is upregulated 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.

Contact Information:

Jason Levin

jason.levin@orbustherapeutics.com

650.656.9440   

Media:

Kelli Perkins

kelli@redhousecomms.com

310.625.3248

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

Orbus Therapeutics Announces Positive Outcome of Pre-Planned Interim Futility Analysis for Phase 3 Eflornithine STELLAR Study

Orbus Therapeutics Receives U.S. Patent for Eflornithine Formulations

Orbus Therapeutics Expands Series A Financing to $71 Million to Support Ongoing STELLAR Phase 3 Study in Rare Brain Cancer