- Resilience to manufacture BridgeBio’s lead investigational gene therapy treatments, BBP-631 and BBP-812
- Partnership provides an innovative, capital efficient, sustainable model for BridgeBio to develop, test and deliver transformative medicines for patients more quickly
PALO ALTO, CA and SAN DIEGO, CA, USA I October 03, 2023 IBridgeBio Pharma, Inc. (BridgeBio), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, and National Resilience, Inc. (Resilience), a technology-focused biomanufacturing company dedicated to broadening access to complex medicines, today announced a strategic collaboration to manufacture and advance BBP-812, an investigational adeno-associated virus (AAV) 9 gene therapy for Canavan disease, and BBP-631, an investigational AAV 5 gene therapy for congenital adrenal hyperplasia (CAH).
The two companies have developed a novel manufacturing and aligned incentive business model to drive these gene therapies forward with an emphasis on sustainability and capital-efficiency. Under the terms of the collaboration, BridgeBio will transfer its manufacturing process for its lead AAV-based gene therapy candidates to Resilience’s network of gene therapy sites. As part of an innovative cost and risk-sharing framework, Resilience will provide in-kind manufacturing services and will receive future development and approval milestones and low-to-mid single digit royalties on BBP-631 and BBP-812. Resilience will support the ongoing clinical development manufacturing needs and will serve as the primary commercial manufacturer for both programs if successful.
“Our partnership with BridgeBio seeks to accelerate development of innovative therapeutic options for patients in need,” said Rahul Singhvi, Sc.D., Chief Executive Officer of Resilience. “We are pleased to partner with a gene therapy and rare disease leader, and we are inspired by their passion to deliver medicines to patients.”
Beyond BBP-812 and BBP-631, Resilience will also be the primary manufacturer for future clinical projects across BridgeBio’s gene therapy portfolio. The agreement will reduce manufacturing uncertainty for these programs and is expected to help BridgeBio expedite development of gene therapies going forward.
“Manufacturing is the most critical and costly aspect of developing gene therapy for patients with a serious unmet need. We conduct process development, analytical development and optimization in our own labs, and with this partnership we can now hand these programs off to one of the most trusted partners in the industry for scale up and commercial manufacturing. This allows us to accelerate the development of our gene therapy portfolio in a capital-efficient and sustainable way with the hope of providing medicines more quickly,” said Eric David, M.D., J.D., chief executive officer of BridgeBio Gene Therapy.
“We appreciate the opportunity to collaborate with the experienced and knowledgeable team at Resilience on the manufacturing of our gene therapies. We hope this expedites our path to benefiting as many patients as possible, as soon as possible,” said Neil Kumar, Ph.D., founder and CEO of BridgeBio.
About BridgeBio Pharma, Inc.
BridgeBio Pharma, Inc. is a commercial-stage biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. BridgeBio’s pipeline of development programs ranges from early science to advanced clinical trials. BridgeBio was founded in 2015 and its team of experienced drug discoverers, developers and innovators are committed to applying advances in genetic medicine to help patients as quickly as possible. For more information visit bridgebio.com and follow us on LinkedIn and Twitter.
About BBP-812
BBP-812 is an investigational AAV9 gene therapy for Canavan disease. Using AAV gene therapy, BridgeBio seeks to deliver functional copies of the ASPA gene throughout the body and into the brain, potentially correcting the disease at its source. Preclinical proof-of-concept results have shown the approach restores survival and normal motor function in Canavan disease models. BBP-812 was granted Fast Track Designation, Rare Pediatric Drug Designation, and Orphan Drug Designation by the U.S. Food and Drug Administration. BBP-812 was also granted Orphan Drug Designation by the European Medicines Agency.
About BBP-631
BBP-631 is an AAV5 gene therapy developed to treat CAH due to 21-hydroxylase deficiency at its source. BBP-631 is designed to deliver a functional copy of the 21-hydroxylase gene and has been shown through multiple preclinical studies to result in efficient and persistent delivery to the adrenal gland, where hormones are naturally made. If successful, BBP-631 may restore the body’s hormone and steroid balance by enabling people with CAH to naturally make their own cortisol and aldosterone. It could also allow for people with CAH to eliminate or significantly reduce their daily glucocorticoid or mineralocorticoid doses, which is the current standard of care for patients.
About Resilience
Resilience is a technology-focused biomanufacturing company dedicated to broadening access to complex medicines. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the treatments of today and tomorrow can be made quickly, safely, and at scale. By continuously advancing the science of biopharmaceutical manufacturing and development, Resilience seeks to free its partners to focus on the discoveries that improve patients’ lives and protect biopharmaceutical supply chains against future disruptions. For more information, visit https://resilience.com/ and follow us on social media: @IncResilience on Twitter and Resilience on LinkedIn.
SOURCE: Resilience
Post Views: 279
- Resilience to manufacture BridgeBio’s lead investigational gene therapy treatments, BBP-631 and BBP-812
- Partnership provides an innovative, capital efficient, sustainable model for BridgeBio to develop, test and deliver transformative medicines for patients more quickly
PALO ALTO, CA and SAN DIEGO, CA, USA I October 03, 2023 IBridgeBio Pharma, Inc. (BridgeBio), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, and National Resilience, Inc. (Resilience), a technology-focused biomanufacturing company dedicated to broadening access to complex medicines, today announced a strategic collaboration to manufacture and advance BBP-812, an investigational adeno-associated virus (AAV) 9 gene therapy for Canavan disease, and BBP-631, an investigational AAV 5 gene therapy for congenital adrenal hyperplasia (CAH).
The two companies have developed a novel manufacturing and aligned incentive business model to drive these gene therapies forward with an emphasis on sustainability and capital-efficiency. Under the terms of the collaboration, BridgeBio will transfer its manufacturing process for its lead AAV-based gene therapy candidates to Resilience’s network of gene therapy sites. As part of an innovative cost and risk-sharing framework, Resilience will provide in-kind manufacturing services and will receive future development and approval milestones and low-to-mid single digit royalties on BBP-631 and BBP-812. Resilience will support the ongoing clinical development manufacturing needs and will serve as the primary commercial manufacturer for both programs if successful.
“Our partnership with BridgeBio seeks to accelerate development of innovative therapeutic options for patients in need,” said Rahul Singhvi, Sc.D., Chief Executive Officer of Resilience. “We are pleased to partner with a gene therapy and rare disease leader, and we are inspired by their passion to deliver medicines to patients.”
Beyond BBP-812 and BBP-631, Resilience will also be the primary manufacturer for future clinical projects across BridgeBio’s gene therapy portfolio. The agreement will reduce manufacturing uncertainty for these programs and is expected to help BridgeBio expedite development of gene therapies going forward.
“Manufacturing is the most critical and costly aspect of developing gene therapy for patients with a serious unmet need. We conduct process development, analytical development and optimization in our own labs, and with this partnership we can now hand these programs off to one of the most trusted partners in the industry for scale up and commercial manufacturing. This allows us to accelerate the development of our gene therapy portfolio in a capital-efficient and sustainable way with the hope of providing medicines more quickly,” said Eric David, M.D., J.D., chief executive officer of BridgeBio Gene Therapy.
“We appreciate the opportunity to collaborate with the experienced and knowledgeable team at Resilience on the manufacturing of our gene therapies. We hope this expedites our path to benefiting as many patients as possible, as soon as possible,” said Neil Kumar, Ph.D., founder and CEO of BridgeBio.
About BridgeBio Pharma, Inc.
BridgeBio Pharma, Inc. is a commercial-stage biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. BridgeBio’s pipeline of development programs ranges from early science to advanced clinical trials. BridgeBio was founded in 2015 and its team of experienced drug discoverers, developers and innovators are committed to applying advances in genetic medicine to help patients as quickly as possible. For more information visit bridgebio.com and follow us on LinkedIn and Twitter.
About BBP-812
BBP-812 is an investigational AAV9 gene therapy for Canavan disease. Using AAV gene therapy, BridgeBio seeks to deliver functional copies of the ASPA gene throughout the body and into the brain, potentially correcting the disease at its source. Preclinical proof-of-concept results have shown the approach restores survival and normal motor function in Canavan disease models. BBP-812 was granted Fast Track Designation, Rare Pediatric Drug Designation, and Orphan Drug Designation by the U.S. Food and Drug Administration. BBP-812 was also granted Orphan Drug Designation by the European Medicines Agency.
About BBP-631
BBP-631 is an AAV5 gene therapy developed to treat CAH due to 21-hydroxylase deficiency at its source. BBP-631 is designed to deliver a functional copy of the 21-hydroxylase gene and has been shown through multiple preclinical studies to result in efficient and persistent delivery to the adrenal gland, where hormones are naturally made. If successful, BBP-631 may restore the body’s hormone and steroid balance by enabling people with CAH to naturally make their own cortisol and aldosterone. It could also allow for people with CAH to eliminate or significantly reduce their daily glucocorticoid or mineralocorticoid doses, which is the current standard of care for patients.
About Resilience
Resilience is a technology-focused biomanufacturing company dedicated to broadening access to complex medicines. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the treatments of today and tomorrow can be made quickly, safely, and at scale. By continuously advancing the science of biopharmaceutical manufacturing and development, Resilience seeks to free its partners to focus on the discoveries that improve patients’ lives and protect biopharmaceutical supply chains against future disruptions. For more information, visit https://resilience.com/ and follow us on social media: @IncResilience on Twitter and Resilience on LinkedIn.
SOURCE: Resilience
Post Views: 279
