We are a
Who we are
We are investors in top tier biotherapeutic and digital health entrepreneurs who focus on helping patients and transforming the healthcare system.
What we do
We act similarly to institutional venture capitalists; we have the ability to lead, co-lead, or seed companies. We partner with management on their boards and make equity investments.
Our raison d'être
We provide a low-cost, self-sustaining vehicle enabling our parent company to engage with the early stage innovation ecosystem when companies are too risky or early to in-license or acquire.
We love to meet entrepreneurs and hear about what they are doing. Feel free to reach out to us…
Valérie joined Sanofi Ventures in 2020. She previously worked for 30 years in positions of increased responsibility across a number of departments within the Sanofi Group including R&D, Legal and Strategy & Business Development.
Valérie holds a Baccalaureate in Economic & Social Sciences and a B.T.S. in Bilingual Management Assistant. She loves travelling, sports, visiting museums and pop music.
Laia joined Sanofi Ventures in 2018 with a background in biotech investing primarily in Europe. Prior to Sanofi, Laia served as Investment Director for Ysios Capital where she led investments and served on the Boards for OxThera, Minoryx Therapeutics and Inbiomotion, and as an observer for AM-Pharma. Earlier in her career, Laia was part of the European New Business Development team of Janssen-Cilag, a pharmaceutical company of the Johnson & Johnson group, where she assessed commercial and scientific licensing-in opportunities. Previously she worked as a researcher in the UK in companies such as Spirogen (now AstraZeneca), Medivir and UCB-Celltech.
Laia currently serves on the Board of Directors for Muna Therapeutics, OMass Therapeutics and Therini Bio, and is a board observer for Nodthera. Previous investments and board roles include Lava Therapeutics (LVTX).
Laia graduated in Chemistry from the University of Barcelona, where she also completed a Master in Science and a Ph.D. with honors. Laia holds an M.B.A. from Cambridge Judge Business School, University of Cambridge, where she focused on biotechnology, healthcare and finance.
Cris joined Sanofi Ventures in 2020 with a 15+ year track record of building and launching emerging technologies, startups and innovation platforms for some of the largest organizations in the world. Prior to Sanofi, Cris was a founding team member of J&J Innovation and Global Head of Digital Innovation since 2013. He held primary digital and data responsibilities, driving strategy and external tech collaborations throughout J&J’s Innovation Centers, JLABS incubators and JJDC corporate ventures across the Pharmaceutical, Consumer and Medical Device businesses.
Previously, Cris led emerging technology programs within research informatics at Novartis Institutes for BioMedical Research for six years. With entrepreneurial DNA, Cris is well recognized for his role in the innovation economy since Co-Founding one of the largest startup venture pitch accelerators in the U.S called Ultra Light Startups, accelerating hundreds of companies in Boston, New York City and Silicon Valley, with several large-scale acquisitions by major tech companies. Cris was named a 40 under 40 Innovator by the Boston Business Journal in 2015, and Top 40 Healthcare Transformer by MM&M Magazine in 2019.
Cris currently serves on the boards of Medisafe, Nucleai, Click Therapeutics, Omada Health, and Aetion. He is also on the advisory boards of the American Telemedicine Association, SXSW Health, and the Boston University SPH Innovation Hub.
Cris holds a M.Sc. in Computer Information Systems from Boston University and a B.S. in Business Administration from Suffolk University.
Chris joined Sanofi Ventures in 2017 with a background in life science and healthcare consulting. He previously spent three years as a management consultant at L.E.K. consulting where his work focused on corporate strategy, due diligence, commercial launch planning and asset valuation across the pharmaceutical, biotech, R&D and API manufacturing sectors.
Chris currently serves on the Board of Directors for i2O Therapeutics and Minervax.
Prior to a postdoctoral fellowship at Harvard University, Chris earned a Ph.D. in Chemistry from the University of North Carolina at Chapel Hill as well as a B.S. in both Biology and Chemistry from Roger Williams University.
Jason joined Sanofi Ventures in 2014 with a background in early-stage biotech investing and transactions. Prior to Sanofi, Jason was the Director of Corporate Development at Translate Bio (fka RaNA Therapeutics), a company co-founded by his previous firm Atlas Venture. While at Atlas, Jason was an Associate in the Life Sciences group. Previously, he was a Flagship Ventures Entrepreneurial Fellow, and consulted for the technology transfer company at the University of Cambridge while performing his doctoral research. Before his time at Cambridge, Jason was an analyst at JSB Partners LP, an investment banking firm, focusing on advisory and business development activities in the life sciences space.
Jason’s active investments include Abcuro, Amathus Therapeutics, Escient Pharmaceuticals, Expansion Therapeutics, Glycomine, Q32 Bio, ReCode Therapeutics, Rome Therapeutics and Navitor Pharmaceuticals. Previous investments include Icosavax (NASDAQ: ICVX), Kymera Therapeutics (NASDAQ: KYMR), Ovid Therapeutics (NASDAQ: OVID) Science 37 (NASDAQ: SNCE) and Lysosomal Therapeutics Inc. Jason also serves as the Vice Chair of the Board of Trustees of the Buckingham Browne and Nichols school and the Board of Directors of The Magdalene College Foundation.
Jason graduated with honors from Bowdoin College, and holds a Ph.D. from the University of Cambridge.
Paulina joined Sanofi Ventures in 2022 with a background in early stage biotech investing and company building. Prior to joining Sanofi, Paulina was a Principal on the investment team at Omega Funds where she served as the board director or observer for Scorpion Therapeutics, Arrakis Therapeutics, IFM, and additionally led or co-led Omega’s investments in Theseus (NASDAQ: THRX), Ikena (NASDAQ: IKNA), Synthekine and Vanqua Bio.
Previous to Omega Funds, Paulina began her career with Polaris Partners. Paulina served on the boards of Kala Pharmaceuticals (NASDAQ: KALA), Neuronetics (NASDAQ: STIM) and Lyra Therapeutics (NASDAQ: LYRA), Microchips Biotech (acquired by Dare Biosciences), Arsenal Medical and CAMP4 Therapeutics, where she was the founding CEO. Paulina completed her postdoctoral fellowship in Robert Langer’s lab in the Chemical Engineering department at the Massachusetts Institute of Technology. During her time at MIT, Paulina founded the MIT Postdoctoral Association and served as its President. Paulina also served on the MIT Intellectual Property Committee. Paulina completed her PhD in Molecular Medicine from the Wake Forest University School of Medicine. Paulina graduated magna cum laude from East Carolina University with a quadruple major in biochemistry, neuroscience, biology and chemistry. Paulina attended East Carolina University on a full athletic scholarship and served as the captain of the women’s varsity tennis team.
Meg joined Sanofi Ventures in 2021 with a background in biotech investing and business development. She previously worked as Director of Business Development at Vertex Pharmaceuticals, where she was part of the External Innovation team. Prior to Vertex, Meg worked at RA Capital, a crossover investment fund, where her areas of focus included rare diseases, genetic therapies, and neuroscience.
Meg currently serves on the Board of Directors for Veralox.
Meg holds a Ph.D. in Neuroscience from Massachusetts Institute of Technology and a B.S. with Honors in Neuroscience from The Pennsylvania State University. She currently sits on the Steering Committee of the New England Venture Network.
Camille joined Sanofi Ventures in 2021. She previously worked for three years in Sanofi’s Business Development team as Director in Transactions, where she led several deals to execution, including digital partnerships with Abbott Diabetes Care and Biocorp.
Camille began her career as a consultant at L.E.K. Consulting, where she focused on strategic due diligences for private equity funds and corporates. She then joined Sanofi as an internal consultant where she provided organizational and strategic support to senior leaders of the group.
Camille holds a Master’s degree in Finance and Corporate Strategy and a Bachelor’s Degree in Social Sciences from Sciences Po in Paris.
Over the last decade, Alba has worked with some of the world's largest organizations in their digital transformation, enabling them to create new growth engines, by investing into, and partnering with the startup ecosystem.
Prior to Sanofi, Alba was the Global Head of Innovation Strategy for Venture Capital firm 500 Global, one of the most active early-stage investors in the world, where she was responsible for the firm's end-to-end enterprise deal making. Previously, Alba was a senior management consultant with Deloitte Venture Support, serving as an advisor to Japan’s largest enterprises, helping them source, diligence, invest in, and partner with startups.
Alba holds a Ph.D. in Innovation and Technology Management by the University of Tokyo and an M.Sc. in Biotechnology from the Polytechnical University of Valencia.
OMass Therapeutics is a biotechnology company discovering medicines against highly-validated target ecosystems, such as membrane proteins or intracellular complexes. The company’s unique OdyssION™ technology platform comprises novel biochemistry techniques, next-generation native mass spectrometry, and custom chemistry. This allows OMass to interrogate not just the target, but also the interaction of the target with its native ecosystem, separate from the confounding complexity of the cell. The result is cell-system fidelity with cell-free precision. OMass is advancing a pipeline of small molecule therapeutics in rare diseases and immunological conditions, therapeutics that target solute carriers, complex-bound proteins, and GPCRs.
Nucleai is committed to bringing the power of spatial biology to reality by providing pharmaceutical companies and clinicians with AI-powered image analysis applications. Nucleai's platform enhances drug development, supports treatment decisions and improves patient lives.
Nucleai's image analysis and biomarker discovery technology leverages real-world pathology, clinical and molecular datasets to better understand cancer biology, optimize patient stratification and improve patient care.
ReCode Therapeutics is an integrated genetic medicines company developing disease-modifying therapeutics using its powerful LNP delivery technology to target organs and tissues beyond the liver.
Collaboration will focus on co-development of unique datasets to understand health in everyday life
January 10, 2022 06:00 AM Eastern Standard Time
SAN MATEO, Calif.--(BUSINESS WIRE)--Evidation, the company creating new ways to measure and improve health in everyday life, is expanding its decade-long collaboration with Sanofi to build upon their joint real-world data initiatives. This new phase will focus on the co-development of unique datasets to develop and validate new measures of health and wellness.
Evidation’s collaboration with Sanofi has delivered groundbreaking results to date, with over 20 studies conducted across 10 therapeutic areas, including diabetes and Type 2 Inflammation, more than 500,000 patients reached, and four studies published. This continued collaboration will further the work Evidation and Sanofi have pioneered to translate person-generated health data into quantified clinical and economic outcomes, a key priority for both companies.
“After nearly a decade of working with Sanofi, we are proud to expand this collaboration agreement to advance the role that real-world data and analysis can play in better understanding health and disease,” said Christine Lemke, Evidation co-founder and co-CEO. “Sanofi has led the way in garnering insights from real-world data in R&D and we’re excited to advance our work together into its next decade."
Sanofi and Evidation announced a prior expansion of their work together in 2017, in addition to Sanofi’s investment in Evidation in the same year.
“Real-world evidence is critical to help us better understand the patient’s health and wellness journey outside of traditional healthcare visits,” said Arnaud Robert, Executive Vice President, Chief Digital Officer, Sanofi. “Through our expanded collaboration with Evidation, we can further our ambition to transform the practice of medicine by connecting more closely with patients and citizens, expanding our geographic capabilities, and increasing diversity to better represent the global population.”
This announcement comes as biopharmaceutical companies, regulators, and payers are working to develop new guidelines on how real-world data should be incorporated into the development and approval of therapeutics. Evidation and Sanofi will continue to contribute to this conversation through similar industry-leading research.
The Evidation network is made up of more than 4.4 million individuals across all 50 states, representing 9 out of every 10 U.S. ZIP codes, allowing organizations like Sanofi access to a highly engaged, diverse population and privacy-conscious research platform.
Evidation measures health in everyday life and enables anyone to participate in ground-breaking research and health programs. Built upon a foundation of user privacy and control over permissioned health data, Evidation’s platform is trusted by millions of individuals—generating data with unprecedented speed, scale, and rigor. We partner with leading healthcare companies to understand health and disease outside the clinic walls. Guided by our mission to enable and empower everyone to participate in better health outcomes, Evidation is working to bring people individualized, proactive, and accessible healthcare—faster. Founded in 2012, Evidation is headquartered in California with additional offices around the globe. To learn more, visit evidation.com, or follow us on Twitter @evidation.
Partnership to create new treatment delivery options for people facing serious diseases
BOSTON, MA—February 10, 2021—i2O Therapeutics, developers of a platform for oral delivery of traditionally injectable biological drugs, announced today a research collaboration with Sanofi to investigate the oral delivery of Sanofi's Nanobody®-based medicines, which are currently administered through intravenous or subcutaneous injections.
Nanobodies - proprietary therapeutic proteins based on camelid derived immunoglobulin single variable domains - have potential uses in the treatment of a range of serious and life-threatening diseases and are being developed in many therapeutic areas including inflammation, hematology, immuno-oncology, oncology and rare diseases. The research collaboration between i2O Therapeutics and Sanofi will explore a new oral route of administering nanobodies.
“Our mission at i2O Therapeutics is to develop safe and effective oral formulations of therapies traditionally limited to injections and we are excited to partner with Sanofi to advance this mission,” said Ravi Srinivasan, co-founder and director of i2O Therapeutics.
“i2O’s ionic liquid platform opens new opportunities to orally deliver biologics, and nanobodies represent an exciting application of this platform,” said Samir Mitragotri, co-founder of i2O Therapeutics.
i2O Therapeutics announced seed funding in April 2020, which was led by Sanofi Ventures, the corporate venture capital arm of Sanofi, and JDRF T1D Fund. The company also announced a strategic investment from Colorcon Ventures, the corporate venture capital fund of Colorcon, Inc. in December 2020.
About i2O Therapeutics
i2O Therapeutics is a biotechnology company developing safe and effective oral formulations of therapies traditionally limited to injections. Using an innovative ionic liquid technology, this platform leverages the benefits of protecting the drug cargo while also transiently enhancing permeation across the epithelial lining when administered orally. i2O is focused on creating the next generation of oral peptide and protein-based therapies. Visit us at www.i2OBio.com.
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
- Kymera to receive $150 million upfront with more than $2 billion in potential milestones plus royalty payments
- Kymera to retain option during clinical development to participate equally in US cost and profit sharing
CAMBRIDGE, Mass. (July 9, 2020) – Kymera Therapeutics Inc. today announced the company has entered into a multi-program strategic collaboration with Sanofi (NASDQ: SNY) to develop and commercialize first-in-class protein degrader therapies targeting IRAK4 in patients with immune-inflammatory diseases. The companies will also partner on a second earlier stage program. Kymera will receive $150 million in cash upfront and may receive more than $2 billion in potential development, regulatory and sales milestones, as well as significant royalty payments. Kymera retains the option to participate in US development and commercialization for both programs. This includes the ability to participate equally in the costs, profits and losses after opt-in, and to co-promote partnered products in the US.
“This is an important collaboration for both companies and for the field of targeted protein degradation,” said Nello Mainolfi, Ph.D., co-founder, President and CEO of Kymera Therapeutics. “Kymera is becoming a fully integrated biotechnology company advancing a pipeline of novel therapies with the potential to transform treatment paradigms. We are excited to partner with Sanofi, an organization with world-class drug development and commercialization capabilities, to ensure maximal patient impact from two of our programs across multiple disease indications, while enabling Kymera to invest in key strategic areas to realize the broad potential of protein degrader therapies.”
Under terms of the collaboration, Sanofi will make an upfront payment of $150 million in cash to Kymera for global rights to develop its small molecule IRAK4 protein degraders in inflammation and immunology indications, and a second earlier stage undisclosed program. IRAK4 is believed to play a key role in multiple immune-inflammatory diseases, including hidradenitis suppurativa, atopic dermatitis and rheumatoid arthritis. Kymera will advance the IRAK4 program through Phase 1 clinical trials; Sanofi will assume clinical development and commercialization responsibilities thereafter. Sanofi will lead all clinical development activities for the second program. Kymera will have the option to participate in the development of both programs in the US during clinical development. Kymera will retain global rights to its IRAK4 program in oncology indications.
IRAK4 is a key protein involved in inflammation mediated by the activation of toll-like receptors (TLRs) and IL-1 receptors (IL-1Rs). While TLR and IL-1R signaling via IRAK4 is involved in the normal immune response, aberrant activation of these pathways is the underlying cause of multiple immune-inflammatory conditions. In pre-clinical studies, Kymera has shown oral daily administration of an IRAK4 degrader can lead to complete knockdown of IRAK4 in skin and immune cells in higher species and is well tolerated. Data presented at the most recent annual meetings of the American College of Rheumatology and the European Hidradenitis Suppurativa Foundation showed potent anti- inflammatory activity in both in vitro and in vivo preclinical models."
“Targeted protein degrada on is an exci ng modality. Kymera has developed an incredible drug discovery engine producing protein degraders with compelling and dieren ated pharmacology against targets that, to date, have not been op mally addressed with other therapeu c modali es,” said John Reed, Global Head of Research & Development at Sano. “We are excited to partner with the Kymera team to advance a new genera on of rst-in-class therapies with the poten al to eliminate underlying drivers of disease.”
Aquilo Partners, L.P. acted as Financial advisor to Kymera on this transac on.
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About Kymera Therapeutics
Kymera Therapeutics is a biotechnology company pioneering a transformative new approach to treating previously untreatable diseases. The company is advancing the field of targeted protein degradation, accessing the body’s innate protein recycling machinery to degrade dysregulated, disease-causing proteins. Kymera’s Pegasus targeted protein degradation platform harnesses the body’s natural protein recycling machinery to degrade disease-causing proteins, with a focus on un-drugged nodes in validated pathways currently inaccessible with conventional therapeutics.
Kymera is accelerating drug discovery with an unmatched ability to target and degrade the most intractable of proteins, and advance new treatment options for patients. For more information, visit www.kymeratx.com.
Sanofi is dedicated to supporting people through their health challenges. We are a global pharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Sanofi, empowering life. For more information, visit www.sanofi.com.
PARIS and NEW YORK – November 20, 2019 - Sanofi announced today an enterprise- wide collaboration with health care technology company Aetion that will integrate Sanofi’s real-world data platform, DARWIN, with the Aetion Evidence Platform® with the objective of advancing more efficient use of real-world evidence (RWE), facilitating regulatory-grade studies with deep transparency, and unlocking access to new real-world data.
Both companies have invested in RWE platforms, recognizing the pressing need for accurate, fast, and cost-effective research and the important role RWE could play in meeting this need. Sanofi’s DARWIN compiles and analyzes de-identified data from hundreds of millions of patients across disease states, while Aetion’s platform analyzes real-world data to produce transparent, rapid, and scientifically validated answers about the effectiveness, safety, and value of drugs. By combining these platforms, Sanofi is seeking to elevate its capabilities in conducting regulatory-grade analytics, opening new doors for the development and application of medical treatments.
“Today marks another important step in Sanofi’s digital transformation,” said Bernard Hamelin, MD, MSc, MBA, Global Head of Medical Evidence Generation, Sanofi. “By integrating these platforms, we strive to make faster, more informed decisions with the potential to lead to first-in-class and best-in-class treatments that could change the practice of medicine.”
Real-world evidence offers a view of clinical practice outside of the experimental setting, providing an opportunity to inform clinical trial development and supplement trial data with evidence of actual product use in the health care system.
“Our work with Sanofi further validates the value and potential for real-world evidence in drug development,” said Carolyn Magill, Chief Executive Officer of Aetion. “Our companies share a common goal of using the best available data to get the right treatment to the right patient as quickly and efficiently as possible.”
This collaboration between Sanofi and Aetion demonstrates leadership during a critical time. Real-world evidence is expected to play a key role in transforming the health care ecosystem, with the U.S. Food and Drug Administration (FDA) recently prioritizing efforts to incorporate RWE as a companion to clinical trial data to aid in regulatory decision making. The FDA will release its draft RWE guidance before the end of 2020.
Aetion is a health care technology company that delivers real-world evidence for life sciences companies, payers, at-risk providers, and regulatory agencies. The Aetion Evidence Platform analyzes data from the real world to produce transparent, rapid, and scientifically validated answers on treatments, costs, and outcomes. Founded by Harvard Medical School faculty with decades of experience in epidemiology and health outcomes research, Aetion informs health care's most critical decisions — what works best, for whom, and when — to guide treatment development, commercialization, and payment innovation into health care's modern era. Aetion is based in New York City, and backed by investors including New Enterprise Associates (NEA), Flare Capital Partners, Lakestar, Town Hall Ventures, McKesson Ventures, Sanofi Ventures, Amgen Ventures, UCB, and Horizon Health Services, Inc. Learn more at aetion.com, and follow us at @aetioninc.
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
Sanofi, Empowering Life
Sanofi Media Relations Contact
Tel.: +33 (0)1 53 77 46 46
Aetion Media Relations Contact
Sanofi Investor Relations Contact
Tel.: +33 (0)1 53 77 45 45
Sanofi Forward-Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward- looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi’s ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic conditions, the impact of cost containment initiatives and subsequent changes thereto, the average number of shares outstanding as well as those discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2018. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any
forward-looking information or statements.
Without clinical trials, new medicine may never make it from the research lab to patients in need. These carefully designed studies can provide important data that include proper dosage, benefit to patients, and potential side effects.
There is a growing challenge, however, in finding appropriate participants, especially for treatments that target highly specific conditions affecting narrower patient populations. Right now, there are more than 40,000 clinical studies recruiting patients in the U.S. alone, with some requiring thousands of participants, each of whom must meet precise criteria to join. So it’s not surprising that 80% of these important studies are delayed due to recruitment problems, according to a study by the Center for Information and Study on Clinical Research Participation (CISCRP).
Unfortunately, those delays mean it can take longer for innovative new medicines to be studied and approved, leaving patients to wait years for new treatment options. To tackle this growing problem, Sanofi is taking a digital approach to clinical trials, partnering with Science 37, a clinical research services and technology company based in California.
Leveraging mobile technology and telemedicine capabilities, this new approach will allow Sanofi to develop “site-less” or decentralized clinical trials that are more patient friendly: easier for them to access, and eliminating many of the common impediments to participation. Using digital technologies to streamline finding and retaining participants for the entire length of a study has the potential to reduce the time required for a typical trial by at least 30%, according to Science 37.
“After years invested in the lab on an innovative treatment, the clinical trials are where we finally obtain and analyze the relevant data that will let us understand how well a new treatment will benefit patients,” said Lionel Bascles, Global Head of Clinical Sciences and Operations of Sanofi. “With digital clinical trials we can get and analyze the data on how a new medicine works in the real world a lot sooner, which means patients get the medicines they need sooner.”
Going digital also eliminates a number of other hurdles to patient participation, including the most significant: geography.
Most people are eager to participate in relevant trials – 87% of patients want to do so, the CISCRP study found. Yet, 70% of potential participants live more than two hours away from the nearest study center. Because most clinical trials require patients to travel to those centers for regular tests and observations, sometimes several times each week for the duration of the trial, this distance is another challenge to patient access.
Science 37’s approach allows patients to be monitored and report to researchers via an Apple iPhone equipped with the company’s NORA® technology. Qualified study participants are provided with the phone, a data plan and any other sensors or connected devices needed for the trial, along with the medicines being researched. Participants can reach study staff at any time via the mobile device, while also remaining under the care of their local health care professionals. Mobile nurses are also sent to the participant’s home to provide services like blood draws when needed, and nearby hospitals or clinics are engaged for scans or other tests that require specialized equipment.
The patient’s data are sent securely to researchers who can immediately access information that would otherwise have to be collected by medical personnel through face-to-face interactions at study centers. This platform can also remind patients to take their study medications at the proper time, and let researchers know if participants are adhering to the study requirements.
“Our decentralized clinical trial model addresses critical shortcomings of traditional clinical trials, such as enrolling and retaining appropriate patients. Whether you live near a major research institution, or in a remote area, we make participation possible,” said Noah Craft, CEO of Science 37. “By utilizing a patient’s home in lieu of a physical trial site, we remove the burden of travel for those too sick or remote and provide access to qualified individuals who want to volunteer for a study but cannot because of geographic limitations.”
The Science 37 platform will also help engage patients who would normally not participate in clinical trials, “so our data will much more closely track the diversity of the population,” Bascles said. “In addition to reducing the burden for patients, decentralized clinical trials are far more likely to keep patients engaged for the full length of the trial, increasing the relevance and the acceptability of the data by regulators.”
Sanofi’s agreement with Science 37 covers use of its Metasite™ model and NORA technology across the U.S. with plans to expand internationally in the future. By eliminating months of searching for patients and long travel time to study sites, virtual clinical trials could reduce total trial time by as much as two years.
Partnering with Science 37 is the most recent strengthening of the relationship with Sanofi, which began last October when Sanofi’s venture capital fund, Sanofi-Genzyme BioVentures, made a minority investment in Science 37.
“Science 37 has a great track record, and they are smart and forward-thinking about developing the science around clinical trials that leverage digital technologies,” said Heather Bell, Global Head of Digital and Analytics for Sanofi. “As part of the scope of our digital strategy, we have expanded the scope of the venture fund to include digital investments, and Science 37 was our first investment since that change and we’re very excited about it.”
SEATTLE and SOUTH SAN FRANCISCO – October 16, 2014 Immune Design Corp. (NASDAQ: IMDZ), a clinical-stage immunotherapy company, today announced that it has entered into a broad collaboration for the development of a herpes simplex virus (HSV) immune therapy with Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT: SAN and NYSE: SNY).
Sanofi Pasteur and Immune Design will each contribute product candidates to the collaboration: Sanofi Pasteur will contribute HSV-529, a clinical-stage replication-defective HSV vaccine product candidate, and Immune Design will contribute G103, its preclinical trivalent vaccine product candidate. The collaboration will explore the potential of various combinations of agents, including leveraging Immune Design’s GLAASTM platform, with the goal to select the best potential immune therapy for patients.
The two companies will develop the products jointly through Phase 2 clinical trials, at which point Sanofi Pasteur intends to continue development of the most promising candidate and be responsible for commercialization. Sanofi Pasteur will bear the costs of all preclinical and clinical development, with Immune Design providing a specific formulation of GLA from the GLAAS platform at its cost through Phase 2 studies. Immune Design will be eligible to receive future milestone and royalty payments on any product developed from the collaboration; other financial terms of the agreement have not been disclosed.
“Instead of being limited to a single approach, the companies are joining forces and combining multiple cutting-edge technologies with the goal to develop the most effective and safe immunotherapy to address HSV infection, a significant unmet medical need,” said Carlos Paya, M.D., Ph.D., President and Chief Executive Officer of Immune Design. “With other clinical and preclinical GLAAS-based product candidates in development, both with partners and internally at Immune Design, I believe this new collaboration continues to demonstrate the productivity and broad applicability of this platform.”
About G103 and GLAAS
G103 is a trivalent vaccine candidate consisting of recombinantly-expressed viral proteins adjuvanted with a specific formulation from Immune Design’s GLAAS platform. The combination of a novel molecular toll-like receptor 4 (TLR4) agonist with rationally selected antigens is designed to boost pre-existing T cells and trigger a broad antibody response, allowing for prophylactic and therapeutic immunization.
The GLAAS platform works in vivo and is based on a small synthetic molecule called GLA, which stands for glucopyranosyl lipid adjuvant. GLA selectively binds to the TLR4 receptor and causes potent activation of dendritic cells (DCs) leading to the production of cytokines and chemokines that drive a Th1-type immune response. When GLA is accompanied by an antigen and injected into a patient, the combination is taken up by DCs and leads to the production and expansion of immune cells called CD4 T helper lymphocytes with a Th1 phenotype. These CD4 T cells play a key role in boosting pre-existing cytotoxic T cells that are specific to the same antigen; and providing help to other immune cells, including B lymphocytes that are the precursor to antibodies, and natural killer cells that are also important in the overall immune response. Immune Design believes that GLAAS- based product candidates have the potential to target multiple types of cancer, as well as infectious, allergic and autoimmune diseases. Product candidates leveraging GLAAS’ core technology have now
been evaluated in over 1000 subjects in Phase 1 and Phase 2 trials.
About Immune Design
Immune Design (NASDAQ: IMDZ) is a clinical-stage immunotherapy company employing next- generation in vivo approaches to enable the body’s immune system to fight disease. The company’s technologies are engineered to activate the immune system’s natural ability to create and/or expand antigen-specific cytotoxic T cells, while enhancing other immune effectors, to fight cancer and other chronic diseases. Immune Design’s three on-going immuno-oncology clinical programs are the product of its two synergistic discovery platforms: ZVexTMand GLAASTM, the fundamental technologies of which were licensed from the California Institute of Technology and the Infectious Disease Research Institute (IDRI), respectively. Immune Design has offices in Seattle and South San Francisco. For more information, visit www.immunedesign.com.
Immune Design Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend", “believe” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Immune Design’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements regarding efforts to develop products under the collaboration, the potential receipt of milestone and royalty payments and the potential to develop new therapeutics. Factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Immune Design’s filings with the U.S. Securities and Exchange Commission (the “SEC”), including the "Risk Factors" section of Immune Design’s Quarterly Report on Form 10-Q filed with the SEC on September 8, 2014 and in any subsequent filings with the SEC. Except as required by law, Immune Design assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.
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For Immune Design:
Media Contact Julie Rathbun
Investor Contact Robert H. Uhl
CAMBRIDGE, Mass. and SEATTLE and SOUTH SAN FRANCISCO, Calif., Aug. 7, 2014 (GLOBE NEWSWIRE) -- Sanofi
(EURONEXT:SAN) (NYSE:SNY) and Immune Design (Nasdaq:IMDZ), a clinical-stage immunotherapy company, today announced that they have entered into a licensing agreement for use of Immune Design's GLAASTM discovery platform to develop therapeutic agents to treat a selected food allergy.
The incidence of food allergies is increasing worldwide in both developed and undeveloped countries, and especially in children.1 Globally, experts believe 220-250 million people may suffer from food allergies.2,3 In the United States alone, as many as 15 million people have food allergies,4 with allergic reactions resulting in an emergency room visit every three minutes and averaging more than 200,000 emergency room visits per year.5
"This is an exciting time in the area of immunology research, and our relationship with Immune Design is a great example of how Sanofi has changed our approach to R&D," said Kurt Stoeckli, vice president and head of Global Bio Therapeutics Organization, Sanofi. "With this partnership, we are able to tap into breakthrough science that holds great potential to transform how food allergies are treated, and the lives of those people affected. This kind of innovation is central to our new approach."
Under terms of the agreement, Immune Design has granted Sanofi an exclusive license to discover, develop and commercialize products to treat a selected food allergy. The company has received an undisclosed upfront payment and will be eligible to receive development and commercialization milestones totaling US $168 million, as well as tiered royalties on sales of approved products.
"Our fourth agreement for the use of the GLAAS platform further demonstrates the broad applicability of this approach not only in cancer and infectious diseases, but now in allergic diseases as well," said Stephen Brady, chief business officer at Immune Design. "Due to the immune dysfunction leading to allergic diseases, GLAAS' mechanism of action is well suited to correct the imbalance, allowing for the potential of new therapeutics in the targeted indication that currently uses century-old technologies. We are pleased that Sanofi has decided to develop products for this often life-threatening and growing food allergy."
Under an existing collaborative research arrangement, Sanofi and Immune Design have generated a large set of preclinical data demonstrating that certain formulations within GLAAS, when given prophylactically or therapeutically, can shift the immune responses in a way that may result in significant protection and reduction from allergy symptoms.
Sanofi, an integrated global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, and consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi is listed in Paris (EURONEXT:SAN) and in New York (NYSE:SNY).
Immune Design's GLAAS platform works in vivo and is based on a small synthetic molecule called GLA, which stands for glucopyranosyl lipid adjuvant. GLA selectively binds to the TLR4 receptor and causes potent activation of dendritic cells (DCs) leading to the production of cytokines and chemokines that drive a Th1-type immune response. When GLA is accompanied by an antigen and injected into a patient, the combination is taken up by DCs and leads to the production and expansion of immune cells called CD4 T helper lymphocytes with a Th1 phenotype. These CD4 T cells play a key role in boosting pre- existing CTLs that are specific to the same antigen; and providing help to other immune cells, including B lymphocytes that are the precursor to antibodies, and natural killer cells that are also important in the overall immune response. Immune Design believes that GLAAS product candidates have the potential to target multiple types of cancer, as well as infectious, allergic and autoimmune diseases. GLAAS-based product candidates have now been evaluated in over 1000 subjects in Phase 1 and Phase 2 trials demonstrating an acceptable safety profile and efficacy.
About Immune Design
Immune Design (Nasdaq:IMDZ) is a clinical-stage immunotherapy company employing next-generation in vivo approaches to enable the body's immune system to fight disease. The company's technologies are engineered to activate the immune system's natural ability to create tumor-specific cytotoxic T cells, while enhancing other immune effectors, to fight cancer and other chronic diseases. Immune Design's three on-going Immuno-oncology clinical programs are the product of its two synergistic discovery platforms: DCVexTMand GLAASTM, the fundamental technologies of which were licensed from the California Institute of Technology and the Infectious Disease Research Institute, respectively. Immune Design has offices in Seattle, Washington and South San Francisco, California. For more information, visit www.immunedesign.com.
Sanofi Forward-Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, the Group's ability to benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of cost containment policies and subsequent changes thereto, the average number of shares outstanding as well as those discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2013. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
Immune Design Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend", "believe" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Immune Design's expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements regarding the receipt of milestone and royalty payments, the potential to develop new therapeutics and the potential of any future products to prevent and reduce allergy symptoms. Factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Immune Design's filings with the U.S. Securities and Exchange Commission, including the "Risk Factors" contained therein. Except as required by law, Immune Design assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.
- "Food Allergy - A Rising Global Health Problem," World Allergy Week 2013. 8-14 April 2013. http://www.worldallergy.org/UserFiles/file/WorldAllergyWeek2013final.pdf. Accessed online, July 28, 2014.
- Mills EN, Mackie AR, Burny P, Beyer K, Frewer L et al. "The prevalence, cost and basis of food allergy across Europe." Allergy 2007; 62:717-722.
- Fiocchi A, Sampson HA. "Food Allergy", Section 2.5, in WAO White Book on Allergy, Pawankar R, Canonica GW, Holgate ST, and Lockey RF, editors (Milwaukee, Wisconsin: World Allergy Organization, 2011), pp. 47-53.
- National Institute of Allergy and Infectious Diseases, National Institutes of Health. Report of the NIH Expert Panel on Food Allergy Research. 2006. Accessed online, July 25, 2014. http://www.niaid.nih.gov/topics/foodallergy/research/pages/reportfoodallergy.aspx
- 5. Clark S, Espinola J, Rudders SA, Banerji, A, Camargo CA. Frequency of US emergency department visits for food-
related acute allergic reactions. J Allergy ClinImmunol. 2011; 127(3):682-683.
Amy BA, Ph.D.
Sanofi Global R&D Communications
Rathbun Communications (Immune Design)