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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) announced positive interim results from the Imagine-1 Phase 1/2 trial of PBGM01, a gene therapy for GM1 gangliosidosis. Data presented showed that PBGM01 was well-tolerated and exhibited a favorable safety profile without serious adverse events. Both patients in Cohort 1 demonstrated significant developmental improvements, particularly in motor and language skills. MRI results indicated increased brain volume in patient 1, while biomarker data confirmed functional gene expression. The trial continues with additional cohorts, and interim data from Cohorts 2 and 3 is expected in 2H22.
Passage Bio (NASDAQ: PASG) announced the dosing of its first patient in Cohort 2 and the completion of Cohort 3 in the Imagine-1 clinical trial for GM1 gangliosidosis. The GALax-C trial for infantile Krabbe disease has also initiated dosing. The company submitted an IND for PBML04 targeting metachromatic leukodystrophy and aims to extend its cash runway into Q2 2024 through strategic prioritization and a workforce reduction. Financial results for Q1 2022 reported a net loss of $42.8 million, with cash reserves of $267.1 million, sufficient to support ongoing operations into 2024.
Passage Bio (NASDAQ: PASG) will host a conference call on May 16, 2022, at 8:30 a.m. ET to discuss its first quarter 2022 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 6960234. A live audio webcast will also be available on the company's investor website, with an archived version to follow. Passage Bio is focused on developing gene therapies for central nervous system disorders, with ongoing clinical programs targeting GM1 gangliosidosis, Krabbe disease, and frontotemporal dementia.
Passage Bio (NASDAQ: PASG) announced it will present additional clinical and biomarker data from the Imagine-1 study for GM1 gangliosidosis at the ASGCT 25th Annual Meeting on May 18, 2022, in Washington, D.C. The late-breaker oral presentation will feature interim safety, biomarker, and efficacy data for PBGM01, a therapy for both early and late-onset types of the disorder. Additionally, researchers from the University of Pennsylvania will present preclinical data supporting Passage Bio’s programs, including a study on PBML04 for metachromatic leukodystrophy.
Passage Bio (NASDAQ: PASG) announced that it will present additional clinical data from Cohort 1 of the Imagine-1 study for GM1 gangliosidosis at the ASGCT Annual Meeting from May 16-19, 2022, in Washington D.C. The late-breaker oral presentation will showcase interim safety and efficacy data, scheduled for May 18, 2022. Additionally, the University of Pennsylvania will present preclinical data supporting Passage Bio's Investigational New Drug application for Metachromatic leukodystrophy (MLD), also on May 18, 2022.
Passage Bio (Nasdaq: PASG) has granted inducement awards to new employees, issuing options to purchase 18,100 shares of common stock. The options feature an exercise price of $2.61 per share, corresponding to the shares' closing price on April 18, 2022. The vesting schedule includes 25% on the one-year anniversary and the remainder in monthly installments over three years. This move aligns with Nasdaq Listing Rule 5635(c)(4), emphasizing the company’s commitment to attracting top talent while focusing on developing transformative genetic therapies for central nervous system disorders.
Passage Bio (Nasdaq: PASG) has published significant preclinical results supporting the development of its gene therapy PBKR03 for infantile Krabbe disease, a severe pediatric condition. The studies, in collaboration with the University of Pennsylvania, demonstrated marked safety improvements and positive effects on disease progression in animal models, with no dose-limiting toxicities observed. Passage Bio is now enrolling patients for the GALax-C clinical trial, aiming to evaluate the potential of PBKR03 to effectively treat this rare disease.
Passage Bio (NASDAQ: PASG) has announced its participation in three upcoming virtual investor conferences. The events include the Guggenheim 3rd Annual Genomic Medicines & Rare Disease Day on March 31, 2022, at 9:00 a.m. ET, the 21st Annual Needham Virtual Healthcare Conference on April 13, 2022, at 2:15 p.m. ET, and the Chardan Genetic Medicines and Cell Therapy Manufacturing Summit on April 26, 2022, at 11:30 a.m. ET. Live webcasts will be available on their website, with replays for 30 days post-event.
Passage Bio (Nasdaq: PASG) announced a strategic restructuring to extend its cash runway by reducing its workforce by 13% and focusing on key R&D programs. The company is advancing three clinical trials for GM1 gangliosidosis, Krabbe disease, and frontotemporal dementia. The estimated cash runway is now extended into Q2 2024. Key leadership changes include the retirement of Chief Research and Development Officer Eliseo O. Salinas, effective March 18, 2022, with Mark Forman continuing to lead the trials. Upcoming milestones include patient dosing and IND submissions in 2022.
Passage Bio has initiated dosing in its global Phase 1/2 clinical trial, GALax-C, for PBKR03, a gene therapy for early infantile Krabbe disease. The first patient has received the treatment, with interim safety and biomarker data expected by the end of 2022. PBKR03, using a proprietary AAV capsid, aims to treat both central nervous and peripheral nervous symptoms. The FDA has granted it Fast Track and Orphan Drug designations, highlighting the urgent medical need as there are currently no approved treatments for Krabbe disease.
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