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Passage Bio, Inc. (NASDAQ: PASG) is a pioneering genetic medicines company dedicated to the development of transformative therapies for rare monogenic central nervous system (CNS) diseases. Leveraging cutting-edge gene therapy techniques, Passage Bio is advancing a robust pipeline aimed at addressing unmet medical needs in both pediatric and adult CNS disorders.
The company's key initiatives include the development of PBGM01 for infantile GM1 gangliosidosis, PBFT02 for frontotemporal dementia (FTD) caused by progranulin deficiency, and PBKR03 for infantile Krabbe disease. These therapies utilize proprietary adeno-associated virus (AAV) capsids to deliver functional genes directly to the brain and peripheral tissues, promising significant therapeutic benefits.
Passage Bio collaborates with leading institutions to bolster its research and development efforts. This includes a strategic research partnership with the University of Pennsylvania's Gene Therapy Program and a collaboration agreement with Catalent Maryland, Inc. Such alliances enhance Passage Bio's capacity to innovate and expedite the clinical development of its promising therapies.
Financially, Passage Bio is in a strong position, with a cash runway extending into the fourth quarter of 2025, allowing the company to diligently progress its clinical programs. Recent achievements include positive interim data from the Imagine-1 study, a Phase 1/2 clinical trial of PBGM01, demonstrating a favorable safety profile and initial evidence of efficacy in early and late infantile GM1 gangliosidosis.
Additionally, the company is making strides with PBFT02. Initial data from the upliFT-D clinical trial indicate promising safety and biomarker outcomes, showing elevated cerebrospinal fluid (CSF) progranulin levels. Such results underscore the potential of PBFT02 to address the underlying pathology of FTD and other neurodegenerative conditions.
Passage Bio is also committed to fostering the next generation of scientists through initiatives like the Tachi Yamada Scholarship program, which supports students in life sciences disciplines.
Passage Bio has announced the commencement of manufacturing operations for its gene therapy product candidates following the completion of a dedicated Current Good Manufacturing Practice (CGMP) suite at Catalent's facility in Maryland. This marks a significant milestone in advancing therapies for rare monogenic CNS disorders, enabling better supply chain control and scalability. The partnership with Catalent allows for efficient production and distribution, enhancing the potential for clinical and commercial success.
Passage Bio (Nasdaq: PASG) announces that CEO Bruce Goldsmith will participate in a fireside chat at the Piper Sandler 32nd Annual Healthcare Conference from December 1 to 3, 2020. This virtual event enables registered attendees to view the chat on-demand. A recording will be accessible for 30 days on the company's Investors & Media webpage. Passage Bio focuses on developing gene therapies for rare central nervous system disorders, collaborating with the University of Pennsylvania’s Gene Therapy Program to enhance its research and clinical pipeline.
Passage Bio has secured rights to innovative technology from the University of Pennsylvania’s Gene Therapy Program aimed at mitigating dorsal root ganglia (DRG) toxicity observed in gene therapy. This collaboration could enhance the safety of its gene therapy treatments for rare CNS disorders. Although safety studies have not indicated clinical manifestations of DRG toxicity, Passage Bio expresses optimism about integrating this new approach into its programs if it proves beneficial. The company anticipates initiating clinical trials for several programs in 2021.
Passage Bio (Nasdaq: PASG), a company specializing in genetic therapies for rare CNS disorders, will participate in two virtual investor conferences in November. The Guggenheim Virtual Healthcare Talks will take place on November 16, 2020, followed by the Stifel Virtual Healthcare Conference on November 18, 2020, where Passage Bio will present at 4:00 p.m. ET. The company is committed to developing innovative gene therapies in collaboration with the University of Pennsylvania's Gene Therapy Program.
Passage Bio (NASDAQ: PASG) reported its third-quarter financial results as of September 30, 2020, showing cash equivalents of $335.7 million, up from $158.9 million in December 2019. The company is advancing three Phase 1/2 clinical trials for GM1, FTD-GRN, and Krabbe disease, with the first patient dosing for PBGM01 expected in Q1 2021 and safety data anticipated mid-2021. Additionally, PBGM01 received Orphan Drug Designation from the European Commission. R&D expenses surged to $20.8 million, while the net loss reached $28.5 million, or $0.63 per share, reflecting increased operational investments.
Passage Bio (NASDAQ: PASG) partners with Invitae to enhance genetic testing for GM1 gangliosidosis. This collaboration offers free genetic testing and counseling through Invitae’s Detect LSDs program, promoting early diagnosis and access to clinical trials. The initiative aims to support patients, especially infants, as GM1's severe form has a life expectancy of only 2-4 years. Passage Bio plans to initiate its Phase 1/2 trial for PBGM01 shortly, positioning the partnership as crucial for early intervention and treatment.
Passage Bio (NASDAQ: PASG) announced a conference call and live webcast scheduled for 8:30 a.m. ET on November 10, 2020, to discuss its Q3 2020 financial results and recent business highlights. The call can be accessed by dialing 833-528-0605 (domestic) or 830-221-9711 (international) with conference ID 8478507. The archived webcast will be available for 30 days post-event. The company focuses on gene therapies for rare CNS disorders and collaborates with the University of Pennsylvania’s Gene Therapy Program.
Passage Bio (NASDAQ: PASG) announced that the FDA has granted Orphan Drug and Rare Pediatric Disease designations to PBKR03 for treating Krabbe disease. This designation highlights the urgent need for treatments in this area, as Krabbe disease currently has no approved therapies. The company aims to start a Phase 1/2 clinical trial for PBKR03 in the first half of 2021. In addition to potential market exclusivity and assistance from the FDA, the RPD designation could provide a priority review voucher for future applications.
Passage Bio (NASDAQ: PASG) announced that the European Commission granted orphan drug designation for PBGM01, its lead gene therapy for GM1 gangliosidosis, a rare CNS disorder. Previously, PBGM01 received similar designations from the FDA. This designation allows Passage Bio to gain 10-year market exclusivity upon marketing approval and provides regulatory support. The company plans to initiate a Phase 1/2 trial by early 2021, assessing safety and biomarker data by mid-2021. GM1 is severe, particularly in infants, leading to rapid neurodegeneration and limited life expectancy.
Passage Bio announced positive preclinical results for its gene therapy PBGM01, aimed at treating GM1 gangliosidosis, a severe genetic disorder affecting infants. The study from the University of Pennsylvania demonstrated that a single injection of an optimized adeno-associated virus (AAV) improved β-galactosidase activity in the brain, reduced harmful lysosomal storage lesions, and enhanced survival rates in treated mice. The company anticipates starting a Phase 1/2 clinical trial late in 2020 or early 2021, aiming to address the critical need for disease-modifying therapies for GM1.
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