Life Biosciences and Forge Biologics Announce cGMP Manufacturing Partnership to Advance Development of Novel Gene Therapies for Aging- Related Diseases
Forge to provide cGMP manufacturing and development services for Life Biosciences’ novel adeno-associated virus (AAV) gene therapy platform for aging-related diseases, including in ophthalmic indications
BOSTON AND COLUMBUS, Ohio, May 8, 2023 – Life Biosciences (“Life Bio”), a biotechnology company advancing innovative cellular rejuvenation technologies to reverse diseases of aging and injury and ultimately restore health for patients, and Forge Biologics (“Forge”), a genetic medicines manufacturing organization, today announced a manufacturing partnership to help advance Life Bio’s partial epigenetic reprogramming platform to address aging-related diseases, including its lead program targeting ophthalmic indications.
“Life Bio is an emerging leader in the development of novel therapies for aging-related diseases, and we are thrilled to serve as their cGMP manufacturing partner to help advance the manufacturing of AAV for their innovative cellular rejuvenation technology, which has the potential to benefit millions of aging patients worldwide,” said Timothy J. Miller, Ph.D., CEO, President, and Co-Founder of Forge.
Through this partnership, Forge will provide adeno-associated virus (AAV) process development, toxicology, cGMP manufacturing, and analytical services to Life Bio. The company will utilize Forge’s platform processes including its proprietary HEK293 suspension Ignition Cells™ and pEMBR™ adenovirus helper plasmid. All development and AAV manufacturing activities will occur at the Hearth, Forge’s 200,000 square foot gene therapy facility in Columbus, Ohio.
“We are delighted to be working with the Forge team, whose expertise in gene therapy manufacturing is unmatched,” said Jerry McLaughlin, Chief Executive Officer of Life Biosciences. “We believe we’re on the cusp of revolutionizing medicine with our cellular rejuvenation capabilities across a range of aging-related diseases, including ophthalmic disorders that involve retinal ganglion cell dysfunction. We are confident our partnership with Forge will have a tremendous impact on our ability to enhance the speed and quality with which we can manufacture our therapeutic candidates as we progress toward the first human clinical trials and continue to develop treatments to reverse diseases of aging by restoring cells to a more youthful state.”
About Life Biosciences
Life Biosciences is a biotechnology company advancing innovative cellular rejuvenation platforms to reverse diseases of aging and injury and ultimately restore health for patients. The company is focusing on two platforms targeting key mechanisms underlying aging biology, epigenetic reprogramming and chaperone-mediated autophagy, to restore cells to a more youthful state. Therapies developed within these platforms have the potential to prevent, treat, and/or reverse multiple aging-related diseases. For more information, please visit lifebiosciences.com or follow us on Twitter and LinkedIn.
About Forge Biologics
Forge Biologics is a hybrid gene therapy contract manufacturing and clinical-stage therapeutics development company. Forge’s mission is to enable access to life-changing gene therapies and help bring them from idea to reality. Forge’s 200,000 square foot facility utilizes 20 cGMP suites in Columbus, Ohio, the Hearth, to serve as its headquarters. The Hearth is a custom-designed cGMP facility dedicated to AAV manufacturing and hosts scalable, end-to-end manufacturing services. Offerings include process and analytical development, plasmid DNA manufacturing, viral vector manufacturing, final fill, as well as regulatory consulting support to accelerate gene therapy programs from preclinical through clinical and commercial stage manufacturing. By taking a patients-first approach, Forge aims to accelerate the timelines of these transformative medicines for those who need them the most. To learn more, visit www.forgebiologics.com.
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Life Biosciences Presents Groundbreaking Data at ARVO Demonstrating Restoration of Visual Function in Nonhuman Primates
Data in a nonhuman primate model of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) demonstrates the ability to restore visual function after delivery of a novel gene therapy
BOSTON, April 23, 2023 — Life Biosciences, a biotechnology company advancing innovative cellular rejuvenation technologies to reverse diseases of aging and injury and ultimately restore health for patients, today announced preclinical data in nonhuman primates (NHP) for its novel gene therapy candidate which uses a partial epigenetic reprogramming approach to restore visual function.
This approach has been shown to reverse aging, improve vision, and extend lifespan in mice, but whether epigenetic reprogramming would work in primates was not known. Today, researchers at Life Bio and academic researchers, including Dr. Bruce Ksander and Dr. David Sinclair, reported that Life Bio’s therapy significantly restored visual function in an NHP model of non-arteritic anterior ischemic optic neuropathy (NAION), a disorder similar to a stroke of the eye that is characterized by painless yet sudden loss of vision. The data, presented at the Association for Research in Vision and Ophthalmology (ARVO) 2023 conference in New Orleans, LA, represents an important step forward toward enabling human clinical trials to potentially treat a variety of ophthalmic disorders and other diseases of aging.
Life Bio’s lead platform reprograms the epigenome of older animals to resemble that of younger animals via expression of three Yamanaka factors, Oct4, Sox2, and Klf4, collectively known as OSK. The approach partially reprograms cells to resemble a more youthful state while retaining their original cellular identity. Previous data from Life Bio and academic researchers, which were also presented at ARVO 2023, have shown that treatment with OSK reverses retinal aging and restores vision in old mice in a mouse model of glaucoma. Now, with the data presented today at ARVO, the company has demonstrated restoration of visual function and increased nerve axon survival in an NHP model that mimics human NAION deficits in retinal ganglion cells. Key data highlights include the following:
- Laser-induced damage to the eyes of NHPs showed a reduction in the key ophthalmic measures that are typically seen in humans with NAION, including pattern electroretinogram (pERG) signals, optical coherence tomography (OCT), retinal nerve fiber layer (RNFL) thickness, and number of surviving optic nerve axons.
- NHPs received an intravitreal (in-eye) injection of doxycycline-inducible OSK viruses or vehicle one day after laser damage. Doxycycline was administered systemically until the end of the study.
- When eyes were treated with OSK after laser damage, OSK significantly restored pERG responses compared to controls, consistent with restoration of vision.
- OSK also significantly improved the number of healthy axon bundles compared to controls.
“NAION is the most common cause of acute optic neuropathy in people over 50, but currently has no effective treatment. The data we are presenting here show, for the very first time, that treatment with OSK can lead to significant recovery in affected visual function in an NHP model of NAION, the gold standard translational model. That potential unlocks new opportunities for cellular rejuvenation, not just in NAION but in other ophthalmic diseases that occur as a result of retinal ganglion cell dysfunction as we age,” said Bruce Ksander, PhD, Associate Professor of Ophthalmology and Co-Director of the Ocular Oncology Center of Excellence at Harvard Medical School, and lead presenter of the study at the ARVO conference.
Sharon Rosenzweig-Lipson, PhD, Chief Scientific Officer of Life Bio, added, “We are delighted to present this truly groundbreaking data, which further validate Life Bio’s innovative approach to cellular rejuvenation. This approach has implications far beyond NAION and even the vision field, and we are pleased to share data that support the continued development of our scientific platform to address diseases of aging and restore human health.”
Life Bio is advancing its cellular rejuvenation capabilities across a range of aging-related diseases, including additional ophthalmic and neurodegenerative indications. The data being presented at ARVO builds on previous findings from Dr. David Sinclair’s and Dr. Bruce Ksander’s labs at Harvard Medical School showing that OSK can reverse aging in mice.
Dr. Sinclair, Co-Founder of Life Bio, Member of the company’s Board of Directors, Professor in the Department of Genetics and Co-Director of the Paul F. Glenn Center for Biology of Aging Research at Harvard Medical School, and coauthor on the study, said, “Demonstrating rejuvenation in nonhuman primates is a major step forward in advancing cellular rejuvenation as a way of treating both common and rare diseases in the eye and potentially other tissues. What we’ve learned in NHPs has important ramifications for research on reversing aging and is likely to be highly translational to humans. This data moves us an important step closer to the first clinical trials of how cellular rejuvenation technology could treat aging-related diseases.”
About Life Biosciences
Life Biosciences is a biotechnology company advancing innovative cellular rejuvenation platforms to reverse diseases of aging and injury and ultimately restore health for patients. The company is focusing on two platforms targeting key mechanisms underlying aging biology, epigenetic reprogramming and chaperone-mediated autophagy, to restore cells to a more youthful state. Therapies developed within these platforms have the potential to prevent, treat, and/or reverse multiple aging-related diseases. For more information, please visit lifebiosciences.com or follow us on Twitter and LinkedIn.
About OSK
Life Bio’s lead platform, OSK, was invented in the lab of Professor David Sinclair, AO, PhD, Co-Founder of Life Bio, Member of the company’s Board of Directors, and Professor in the Department of Genetics and Co-Director of the Paul F. Glenn Center for Biology of Aging Research at Harvard Medical School. The partial reprogramming technology was in-licensed by Life Bio from Harvard University. The technology was based on Dr. Sinclair’s Information Theory of Aging and works by reprogramming the epigenome of older animals to resemble that of younger animals via expression of three Yamanaka factors, Oct4, Sox2, and Klf4, collectively known as OSK. The approach partially reprograms cells to resemble a more youthful state while retaining their original cellular identity.
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Life Biosciences Appoints Sharon Rosenzweig-Lipson, PhD as Chief Scientific Officer
Dr. Rosenzweig-Lipson brings decades of experience in R&D strategy and clinical development as Life Biosciences advances therapeutics that target the biology of aging
BOSTON, February 13, 2023 – Life Biosciences, a pioneering life sciences company developing therapeutics that target the biology of aging, today announced the appointment of Sharon Rosenzweig-Lipson, PhD as Chief Scientific Officer. At Life Biosciences, she will be responsible for leading the company’s scientific research and development efforts built on the epigenetic reprogramming science of Dr. David Sinclair and the chaperone-mediated autophagy discoveries of Dr. Ana Maria Cuervo.
“Dr. Rosenzweig-Lipson brings great scientific and strategic leadership to Life Biosciences,” said Jerry McLaughlin, Chief Executive Officer at Life Biosciences. “Sharon has been serving as a consultant to Life since early 2021 and has helped to create strong processes to accelerate our drug discovery and development. Her impressive background and accomplishments in both preclinical and clinical development will continue to be invaluable to us as we progress our therapies toward the clinic. It is a pleasure to officially welcome her to the team.”
“I am thrilled to be joining Life Biosciences to revolutionize the treatment of a wide-range of age-related disorders,” said Dr. Rosenzweig-Lipson. “I look forward to collaborating with the strong mission-driven team at Life Biosciences and its outstanding scientific collaborators.”
Dr. Rosenzweig-Lipson holds significant expertise in screening strategies, in vivo models, translation, and clinical development strategy with more than three decades of experience developing compounds for psychiatric and neurologic indications in the pharmaceutical industry and in biotech. Her career in big pharma includes American Cyanamid, American Home Products, Wyeth, and Pfizer. Most recently, as head of R&D, Dr. Rosenzweig-Lipson led the clinical development of AgeneBio’s lead asset through Phase 2B trials as well as the company’s preclinical development programs. Dr. Rosenzweig-Lipson earned her BA in the biological basis of behavior from the University of Pennsylvania and her PhD in behavioral neuroscience from Harvard University.
About Life Biosciences
Life Biosciences is a private biotechnology company dedicated to discovering and developing novel therapies to improve the lives of people as they age. The company is focusing on two platforms targeting key mechanisms underlying aging biology: epigenetic reprogramming to restore cellular function to a more youthful state and chaperone-mediated autophagy to reverse the age-related decline in the body’s ability to recycle unwanted proteins. Therapies developed within these platforms have the potential to prevent, treat, and/or reverse multiple aging-related diseases. For more information, please visit www.lifebiosciences.com.
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Life Biosciences CEO Jerry McLaughlin to Speak at Roadmap to Healthy Longevity International Summit
BOSTON, February 9, 2023 — Life Biosciences, a pioneering biotech company developing therapeutics that target the biology of aging, today announced that Jerry McLaughlin, Chief Executive Officer, will speak at the Roadmap to Healthy Longevity: Enabling Healthier, Longer Lives in the GCC conference February 19, 2023, in Riyadh, Saudi Arabia. McLaughlin will participate on a panel entitled “Meet the Healthy Longevity Innovators.”
“Our scientific team at Life Biosciences is at the cutting edge of developing novel therapies based on exciting advances in age-related science,” said McLaughlin. “I’m proud to speak at this important international conference to discuss developments in the bourgeoning healthspan space that are rooted in innovative science as well as to share more about Life’s scientific progress to date and its robust pipeline.”
About the Conference
Jointly organized by the US National Academy of Medicine (NAM), Hevolution Foundation, and the King Abdullah International Medical Research Center (KAIMRC), the event will gather leaders from across the longevity ecosystem to discuss the state of longevity and healthy lifespan in the Gulf Region and an envisioned world with healthy longevity by 2050.
About Life Biosciences
Life Biosciences is a private biotechnology company dedicated to discovering and developing novel therapies to improve the lives of people as they age. The company is focusing on two platforms targeting key mechanisms underlying aging biology: epigenetic reprogramming to restore cellular function to a more youthful state and chaperone-mediated autophagy to reverse the age-related decline in the body’s ability to recycle unwanted proteins. Therapies developed within these platforms have the potential to prevent, treat, and/or reverse multiple aging-related diseases. For more information, please visit www.lifebiosciences.com.
Life Biosciences to Present at Longevity Leaders World Congress 2022
BOSTON, April 14, 2022 — Life Biosciences, a pioneering life sciences company developing therapeutics that target the biology of aging, today announced that Jerry McLaughlin, Chief Executive Officer, will speak at the fourth annual Longevity Leaders World Congress being held on April 26-27, 2022, in London, UK.
Mr. McLaughlin will deliver a presentation on April 26 at 11:10 BST titled, “Targeting Mechanisms Underlying the Biology of Aging to Treat and Reverse Disease.”
“Life Biosciences is truly at the forefront of developing novel therapies based on exciting advances in age-related science,” says Mr. McLaughlin. “I’m delighted to have the opportunity to share more about our work and progress here at Life Biosciences and discuss ways to work with pioneers in the field to move our industry forward.”
The Longevity Leaders World Congress, hosted by LSX, brings the world’s most prominent regenerative medicine and longevity scientists together, presenting the new research, responsible drug development, novel therapies, and commercialization to target age-related diseases. Those interested in attending the conference may register here.
About Life Biosciences
Life Biosciences is a private biotechnology company dedicated to discovering and developing novel therapies to improve the lives of people as they age. The company is focusing on three platforms targeting key mechanisms underlying aging biology: mitochondrial uncoupling, chaperone-mediated autophagy, and epigenetic reprogramming. Therapies developed within each platform have the potential to prevent, treat, and/or reverse multiple aging-related diseases. For more information, please visit www.lifebiosciences.com.
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Life Biosciences, Leading Developer of Therapeutics for Aging-Related Diseases, Completes $82 Million Series C Financing Round
Announces Bill Sullivan as Chief Financial Officer
BOSTON, Jan. 5, 2022 — Life Biosciences, a pioneering life sciences company developing therapeutics that target the biology of aging, today announced the completion of a Series C financing of $82 million led by Alpha Wave Ventures. Senior management and founders invested in the Series C financing alongside longevity-oriented funds, seasoned investors, and experienced biotechnology scientists/entrepreneurs. Since its founding, Life Biosciences has raised over $158 million.
“Our three platforms are based on seminal research demonstrating that aging biology can be modified therapeutically. The Series C funding enables us to accelerate development of our innovative therapies for multiple aging-related conditions, and we expect to initiate first-in-human studies for our first drug candidate possibly as early as the end of 2022,” said Chief Executive Officer Jerry McLaughlin. “We appreciate the support of both our new and existing investors as we advance the company to its next stage of development. Life Biosciences’ experienced management team is committed to bringing potentially pioneering science to the service of humanity.”
Proceeds from the Series C financing will be used to accelerate research and development activities in the company’s three platforms that target fundamental biological mechanisms contributing to aging. The mitochondrial uncoupling platform is developing oral small molecules that are designed to increase metabolic rate and decrease fat accumulation in models of obesity and NASH. The chaperone-mediated autophagy (CMA) platform is developing oral small molecules that are designed to activate CMA and thereby remove unwanted proteins that accumulate during aging and contribute to multiple aging-related diseases including neurodegenerative diseases. The epigenetic reprogramming platform is developing therapies that are designed to induce the expression of three Yamanaka factors to reprogram the epigenome of cells to a younger state and thereby restore cellular function across a wide range of diseases such as glaucoma.
Commenting on the investment, Alpha Wave Global Chairman Rick Gerson added, “We are impressed by the groundbreaking science that has been published in leading and recently peer-reviewed journals like Nature and Cell by the company’s co-founder and director David Sinclair and other founder scientists such as Dr. Ana Maria Cuervo. Their foundational science could revolutionize how we develop therapies for aging-related conditions. We are excited to invest in this emerging field and believe that Life Biosciences’ experienced management team and exceptional science has the potential to unlock a new wave of therapies across their multiple platforms.”
In addition, Life Biosciences announces the appointment of Bill Sullivan as Chief Financial Officer. Bill brings more than 25 years of experience in corporate finance, strategic transactions, fundraising, and investor relations. He served as Chief Financial Officer and Treasurer at Applied Genetic Technologies Corporation, a publicly traded gene therapy company, where he led multiple financings and core business and finance functions. Prior to AGTC, he worked at Merrimack Pharmaceuticals, Inc. for ten years and held a variety of important leadership positions including Chief Financial Officer.
“It’s an honor to join the Life Biosciences team as the company pursues tremendous growth opportunities where aging biology has a clear link to disease pathogenesis,” said Mr. Sullivan. “I’m energized by both the people and strong science at the company and look forward to working together with the management team to drive the next phase of growth.”
“I couldn’t be more delighted by the progress made by the Life Biosciences’ team under Jerry’s leadership to sharpen its focus on developing therapeutics on a platform-oriented approach. In my opinion, Life Biosciences is on the cusp of revolutionizing medicine for aging-related diseases globally,” said Executive Chairman Dr. Mehmood Khan.
About Life Biosciences
Life Biosciences is a private biotechnology company dedicated to discovering and developing novel therapies to improve the lives of people as they age. The company is focusing on three platforms targeting key mechanisms underlying aging biology: mitochondrial uncoupling, chaperone-mediated autophagy, and epigenetic reprogramming. Therapies developed within each platform have the potential to prevent, treat, and/or reverse multiple aging-related diseases. For more information, please visit www.lifebiosciences.com.
About Alpha Wave Global
Alpha Wave is a global investment company with offices in New York, Miami, London, Abu Dhabi, Tel Aviv, and Bangalore. Its flagship global venture and growth fund, Alpha Wave Ventures, aims to invest in best-in-class venture and growth-stage companies and endeavors to be helpful long-term partners to the founders and management teams. Alpha Wave manages a variety of investment partnerships that cover a number of asset classes, themes, and geographies. For more information, please visit www.alphawaveglobal.com.
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