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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), a genetic medicines company, will participate in the virtual 2020 Cell & Gene Meeting on the Mesa from October 12-16, 2020. COO Jill M. Quigley will provide an overview of the company during the conference's presentations segment. CTO Alex Fotopoulos will join a panel discussion on biotherapeutics development. This event features over 120 presentations and 20 sessions on cell and gene therapy advancements. More details can be found at www.meetingonthemesa.com.
Passage Bio (NASDAQ: PASG) announced participation in two virtual investor conferences on September 25, 2020. The first is the Jefferies 2020 Virtual Gene Therapy/Editing Summit, set for October 2, 2020, at 11 a.m. ET. The second is the Chardan 4th Annual Genetic Medicines Conference, scheduled for October 5, 2020, at 1 p.m. ET. Live webcasts will be available on Passage Bio's website, with replays for 30 days post-event. The company focuses on developing therapies for rare, monogenic CNS disorders and has a portfolio of six product candidates.
Data from a study conducted by the University of Pennsylvania demonstrates that Passage Bio's gene therapy, PBFT02, significantly reverses the pathology of frontotemporal dementia caused by granulin mutations. The study, published in Annals of Clinical and Translational Neurology, shows a single injection of an AAV-GRN vector notably increases progranulin levels in the CSF, with PBFT02 achieving over 50-fold higher levels. The therapy is well tolerated, and the company plans to initiate a Phase 1/2 trial in 2021 to further investigate its efficacy for patients with GRN-related dementia.
Passage Bio (Nasdaq: PASG) reported its Q2 2020 financial results with a strong cash position of $353 million, expected to fund operations into 2023. The company is currently on clinical hold from the FDA for its PBGM01 Phase 1/2 trial due to additional device review, aiming to dose the first patient by early 2021. R&D expenses rose to $19.9 million compared to $6.3 million in Q2 2019, and the net loss increased to $27.2 million from $13.4 million. The company anticipates initial safety data in 1H2021 and continues to progress in expanding its gene therapy collaborations.
Passage Bio (NASDAQ: PASG) announced a conference call on August 13, 2020, to discuss its second quarter 2020 financial results and recent business developments. The call will start at 8:30 a.m. ET, with participation details provided for domestic and international callers. The company focuses on genetic therapies for rare central nervous system disorders, collaborating with the University of Pennsylvania for research and development. Passage Bio currently has a portfolio of six product candidates addressing conditions such as GM1 gangliosidosis and Krabbe disease.
Passage Bio has officially been added to the Russell 2000® Index as of market close on June 26, 2020. This index tracks small-cap stocks in the U.S. equity market, reflecting about 10% of the Russell 3000® Index’s market capitalization. Passage Bio specializes in genetic medicines for rare, monogenic CNS disorders, and partners with the University of Pennsylvania for research and development. Its portfolio includes six product candidates targeting GM1 gangliosidosis, frontotemporal dementia, and Krabbe disease.
Passage Bio (NASDAQ: PASG) announced participation in the Goldman Sachs 41st Annual Global Healthcare Conference on June 11, 2020, at 11:20am ET. The event will be a fireside chat, and a live audio webcast can be accessed through the company's website. A replay will be available for 30 days post-event. Passage Bio focuses on developing therapies for rare, monogenic central nervous system disorders and has a collaboration with the University of Pennsylvania. Their portfolio includes six product candidates targeting conditions like GM1 gangliosidosis and Krabbe disease.
Passage Bio (NASDAQ: PASG) has received FDA's Rare Pediatric Disease (RPD) designation for its gene therapy PBGM01, aimed at treating infantile GM1 gangliosidosis, a severe CNS disorder. This designation reflects the urgent need for therapies for this rare condition. PBGM01 has also gained Orphan Drug designation, reinforcing its significance. The company plans to start a Phase 1/2 trial of PBGM01 in Q4 2020, with initial safety data expected by mid-2021. GM1 gangliosidosis, caused by GLB1 gene mutations, severely impacts infants, leading to shortened life expectancy.
Preclinical data from the University of Pennsylvania's Gene Therapy Program highlights the efficacy of a single injection of AAVhu68 delivering the GALC gene in animal models of Krabbe disease. The study revealed normalization of GALC enzyme activity, improved nerve conduction, and enhanced brain health in treated mice and dogs. The data suggests PBKR03 could be a major breakthrough for infantile Krabbe disease, aiming for IND submission later this year. The findings indicate significant potential for this gene therapy to restore myelination and nerve functions, ultimately increasing survival rates.
Passage Bio (NASDAQ: PASG) has expanded its collaboration with the Gene Therapy Program (GTP) at the University of Pennsylvania. This includes licensing an additional five programs, extending the collaboration to 2025, and committing $5 million annually for research funding. The agreement grants Passage exclusive rights to technologies developed during this partnership for their gene therapy products. This move is expected to enhance Passage's pipeline and expertise in creating transformative therapies for rare CNS disorders.
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