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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 (NASDAQ: PASG) is set to announce its Q1 2021 financial results on May 5, 2021, during a conference call at 8:30 a.m. ET. The call will provide updates on recent business highlights in genetic medicines focused on rare CNS disorders. Interested parties can join the call by dialing 833-528-0605 (domestic) or 830-221-9111 (international). A live audio webcast will also be available on the company's investors page.
The company is partnered with the University of Pennsylvania for gene therapy innovations.
Passage Bio announced that the European Commission granted Orphan designation for its investigational gene therapy PBKR03, aimed at treating Krabbe disease, which currently has no approved therapies. The therapy, utilizing a proprietary AAV delivery method, is expected to begin a global Phase 1/2 trial, GALax-C, in the first half of 2021. This designation, along with previous FDA recognitions, emphasizes the urgency for effective treatments for this severe disease. Preclinical data indicate significant potential in improving myelination and clinical outcomes.
Passage Bio has progressed its PBGM01 gene therapy into clinical development, marking a significant milestone for the company. The first patient was dosed in the global Phase 1/2 Imagine-1 trial to treat infantile GM1 gangliosidosis, which affects approximately 0.5 to 1 in 100,000 live births. The trial aims to assess the safety, tolerability, and efficacy of PBGM01. Passage Bio anticipates releasing initial safety and biomarker data in mid-2021, with plans to open 10 clinical sites globally, enhancing its research capacity.
Passage Bio, a genetic medicines company focused on therapies for rare CNS disorders, announces participation in three virtual investor conferences. The events are scheduled for April 1, 13, and 26, 2021. The company aims to showcase its advancements in gene therapies and engage with investors. Webcasts of the events will be available on the company’s website, with replays for 30 days. Passage Bio collaborates with the University of Pennsylvania’s Gene Therapy Program to expedite its pipeline development. For more information, visit passagebio.com.
Passage Bio (Nasdaq: PASG) has appointed Eliseo O. Salinas, M.D., MSc, as its new chief research & development officer. Previously with Acadia Pharmaceuticals, Salinas brings over 30 years of experience in R&D leadership and expertise in neuroscience and rare diseases. His appointment aims to strengthen Passage Bio's pipeline and support its transition to a clinical-stage company with multiple assets. Salinas is expected to enhance the R&D team's capabilities to advance innovative gene therapies targeting rare CNS disorders, in collaboration with the University of Pennsylvania's Gene Therapy Program.
Passage Bio has received FDA Fast Track designation for its lead gene therapy candidates: PBGM01 for GM1 gangliosidosis, PBFT02 for frontotemporal dementia with granulin mutations, and PBKR03 for Krabbe disease. This designation will expedite their development and review processes. Clinical trials for PBGM01 will initiate in Q1 2021, followed by PBFT02 and PBKR03 in H1 2021. The company aims to meet urgent treatment needs for rare neurological diseases and has also secured various designations from regulatory agencies.
Passage Bio (NASDAQ: PASG) is advancing its clinical programs for rare CNS disorders, with three Phase 1/2 trials set to begin in H1 2021. The company has initiated patient recruitment for its PBGM01 trial for GM1 gangliosidosis and has cleared regulatory hurdles for PBKR03 (Krabbe disease) and PBFT02 (frontotemporal dementia). Following a public offering, the company strengthened its finances, raising $166M. As of December 31, 2020, cash reserves stood at $304.8M. Despite a net loss of $112.2M for 2020, Passage Bio is poised for development milestones and expanding its pipeline.
Passage Bio (NASDAQ: PASG) announced participation in two virtual investor conferences in March 2021. The first is the Barclay’s Global Healthcare Conference on March 10, at 4:10 p.m. ET, featuring a presentation format. The second event is the Stifel 3rd Annual CNS Day on March 31, at 10:00 a.m. ET, in a fireside chat format. Both events will be webcast live, with replays available for 30 days. Passage Bio focuses on gene therapies for rare central nervous system disorders, collaborating with the University of Pennsylvania's Gene Therapy Program.
Passage Bio (NASDAQ: PASG) announced a conference call on March 3, 2021, at 8:30 a.m. ET to discuss its fourth quarter and full-year 2020 financial results. This call will provide key insights into the company's recent business highlights. Investors can join via phone or through a live audio webcast. The call will be archived for 30 days. Based in Philadelphia, Passage Bio is focused on developing gene therapies for rare central nervous system disorders, collaborating with the University of Pennsylvania to further its preclinical work and enhance its pipeline.
Passage Bio (Nasdaq: PASG) has appointed Dr. Maxine Gowen to its board of directors, effective February 18, 2021. Dr. Gowen, CEO of Tamuro Bio, brings extensive leadership experience from her tenure at Trevena and GSK. Her expertise is expected to support Passage Bio's transition into a clinical development organization. Simultaneously, Dr. Stephen Squinto has resigned from his board position after significant contributions, including advancing the company’s pipeline and supporting its IPO. Passage Bio aims to develop transformative gene therapies for rare CNS disorders.
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