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Vincere Biosciences is tackling the challenge of age-related decline, starting with enhancement of mitophagy, a mechanism known to decline with age contributing to Parkinson’s disease and cardiorenal failure.
Vincere Biosciences is developing small molecules that increase mitophagy, which could potentially lead to the first medicines capable of slowing or halting the progression of Parkinson's and other age-related diseases. By improving mitophagy, Vincere Biosciences strives to offer new, effective treatments for these conditions where currently only symptomatic treatments exist.
The mitophagy process has emerged as a significant focal point in medical research due to its involvement in numerous diseases and as a hallmark of aging. In response to this growing body of evidence, there is an increasing interest in developing small molecules that can specifically target and activate the mitophagy process. With Parkinson’s disease affecting 10 million patients worldwide, followed by the potential to address every human if the intervention successfully slows aging, the market potential ranges from large to limitless. Demand for this space is evidenced by the recent acquisition of Mitokinin by Abbvie for their preclinical PINK1 activators, and by formation of Pretzel Therapeutics and Capacity Bio by Arch and RA capital respectively. Each of the top 10 pharma companies have some level of mitophagy R&D work ongoing providing a robust environment for anticipated partnering activities in the near future.
There is no other company in the world with a similar blend of neuroscience, molecular biology, medicinal chemistry, and artificial intelligence expertise. Vincere blends these disciplines to efficiently develop novel interventions from idea to IND, as demonstrated by highly selective USP30 inhibitors that are staged to enter the clinic, unparalleled parkin activators, and a growing pipeline of undisclosed targets & molecules that have emerged from a patented (U.S. Patent No. 9,805,159) and proprietary data-driven discovery platform.
Company Milestones
Scientific and Clinical
The company was formed with confidence that increasing mitophagy would have broad clinical value, most notably for Parkinson’s disease, and with discovery programs targeting activation of Parkin and inhibition of USP30 as strategies. Within the first year their medicinal chemistry campaign yielded our first patent filing for USP30 inhibitors, with that patent now having been issued by the USPTO. Since those initial discoveries, they have synthesized and characterized over 800 USP30 inhibitor molecules to optimize two series of assets targeting CNS and cardiorenal pharmacokinetic profiles and indication with molecules demonstrating mitophagy increase in the brain, and accelerated recovery in multiple acute kidney injury models. We are now completing IND-enabling studies on the cardiorenal development candidate and anticipate initiating phase 1 safety trials within 12-18 months.
Business
Industry Partnerships
- 2023: Investment from Deawoong Pharmaceutical & HanAll Biopharma
- 2020: Golden Ticket Award from Bristol Meyer Squibb (BMS)
- 2019: Accepted into Johnson & Johnson JLABs incubator Grant Funding
- 2023: Grant Funding from National Institute for Neurological Disorders and Stroke (NINDS) to advance Parkinson's disease research
- 2022: Grant funding from National institute of Aging (NIA) to for cardiac and longevity indications
- 2022: Grant funding from Michael J. Fox Foundation (MJFF) to accelerate USP30 inhibitor program
- 2020: Grant Funding from the National Institute for Neurological Disorders and Stroke (NINDS) for the development of small molecule inhibitors USP30
- 2019: Grant funding from Michael J. Fox Foundation (MJFF) to accelerate Parkin activator program Awards:
- 2023: Finalist for a “Start Up of the Year” Biotech Week Boston (BWB) Award
- 2020: Top 10 finalist (from 1300 applications) for the Entrepreneurship World Cup – US East Coast Division
- 2020: Winner of the Johnson & Johnson (J&J) Innovation Pitch Challenge
Financial Overview
Vincere Biosciences has received $6M in investments: and $2.7M in grants. They are currently seeking $5 million in H1 2024. They will seek commercialization in 1-2 years with no further dilution (license to large pharma) OR $30M to support Phase 1/1b trial and pipeline expansion before commercialization/IPO.
Intellectual Property
- Allowed and published US application US-2022/0315531, also published under PCT WO 2021/050992 and accompanied by 10 other national stage applications with protection extending to at least 2039.
- Published PCT WO 2022/192562 accompanied by 11 national stage applications with protection extending to at least 2042.
Product Development and Regulatory Strategy
Vincere Biosciences’ approach to product development and regulatory strategy for small molecule therapeutics and their technology platform is multifaceted and dynamic. It commences with an intense focus on pre-clinical R&D, employing AI to refine drug discovery and enhance our understanding of targeted diseases. Recognizing the importance of collaboration, they actively seek strategic partnerships with academic institutions, industry leaders, and research organizations, pooling expertise and resources.
A cornerstone of their strategy is robust Intellectual Property (IP) management, including the acquisition of patents and effective management of existing IP assets, essential for safeguarding their innovations. Navigating the complexities of the global regulatory landscape, especially compliance with FDA and EMA guidelines, is a critical component of their strategy, and guides their current preclinical studies.
They envision their clinical trials to be robust and ethnically diverse, leveraging their technology platform to optimize patient selection and monitoring and applying advanced data management systems to upholding data integrity, security, and compliance with regulatory standards. Continuous market analysis and engagement with various investor, healthcare and patient stakeholders will allow them to adapt swiftly evolving market needs. Lastly, post-market surveillance is conducted with rigor to ensure ongoing product performance, compliance with regulatory standards, and responsiveness to market feedback and developments.
Commercialization Strategy
Their commercialization strategy includes partnering with pharmaceutical companies who can license their small molecule and technology platform assets to take into the clinic at or near the IND stage. This allows them to leverage their patented innovations to expedite the delivery of effective treatments, enhancing therapeutic options for various serious health conditions. Additionally, their aim for the commercialization of their AI technology platform is to advance partnerships, enhance diagnostics, educate healthcare professionals, secure insurance coverage, and expand research to improve treatment for disease.
Company Details
Cambridge, MA
Industry: Therapeutics
Management Team:
- Spring Behrouz, Ph.D., CEO & Co-founder
- Andy Lee, COO & Co-founder
Point of Contact:
Anahit Campbell
campbell@vincerebio.com
(502) 552-5574
SBIR