Regeneron to assume full development and commercialization rights for 2seventy bio’s preclinical and clinical stage cell therapy pipeline
TARRYTOWN, N.Y., Jan. 30, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the formation of Regeneron Cell Medicines based on an agreement with 2seventy bio, Inc. to acquire full development and commercialization rights to its pipeline of investigational novel immune cell therapies, along with its discovery and clinical manufacturing capabilities. 2seventy bio employees who support the acquired programs will join Regeneron Cell Medicines, a newly formed research & development (R&D) unit to advance cell therapies and combination approaches in oncology and immunology.
“Regeneron and 2seventy share a relentless commitment to push the boundaries of science in pursuit of therapies that can improve people’s lives. Our expertise in antibody technologies and emerging genetics capabilities, combined with 2seventy’s cell therapy platforms, presents a significant opportunity to address cancer and other serious diseases in new and impactful ways,” said George D. Yancopoulos, M.D., Ph.D., Board Co-Chair, Co-Founder, President and Chief Scientific Officer of Regeneron. "By integrating 2seventy’s pipeline of cell therapies and their talented team, we are complementing our own expertise and portfolio of innovative immuno-oncology treatments, which will allow for potentially transformative combinations that can really make a difference in patients’ lives.”
In 2018, Regeneron and bluebird bio (which subsequently spun out 2seventy bio in 2021) entered into an agreement to leverage their complementary technologies to discover novel cell therapy approaches to address cancer. Under the original agreement, Regeneron had the right to opt-in to a co-development/co-commercialization arrangement for collaboration targets. Under the terms of the new agreement, Regeneron will acquire full development and commercialization rights of 2seventy bio’s preclinical and clinical stage pipeline and will assume ongoing program, infrastructure and personnel costs related to these programs. There will be an upfront payment of $5 million and a single milestone payment from Regeneron to 2seventy bio for the first major market approval of the first approved product. Regeneron will pay 2seventy bio a low single-digit percent royalty on revenues generated by the products. The transaction is expected to close in the first half of 2024 subject to certain closing conditions including SEC-filings required by 2seventy bio and landlord consent of the sublease agreements.
To realize the full potential of these programs and capabilities, Regeneron Cell Medicines has been created to advance the next generation of cell therapies and explore combinations with Regeneron’s proprietary antibodies and bispecifics. An estimated 150 employees from 2seventy bio will transition to Regeneron to continue their work on cell therapy programs and will remain located in Cambridge, MA and Seattle, WA. Philip Gregory, D.Phil., currently the Chief Scientific Officer of 2seventy bio, will be appointed Senior Vice President and Head of Regeneron Cell Medicines upon closing of the transaction.
“Being part of Regeneron not only supercharges our ability to execute on our current portfolio of CAR T and T cell receptor programs but also creates unique opportunities for the combination of cell-based medicines with antibodies and other Regeneron biologics. Moreover, we can immediately build upon the strength of our longstanding relationship and our shared innovation-focused and science-driven approach to create new medicines for patients in need,” said Philip Gregory, D.Phil., who, as noted above, will be appointed Senior Vice President, Head of Regeneron Cell Medicines. “We are excited to join an organization with decades of proven scientific innovation and the resources and visionary mindset to make Regeneron Cell Medicines a success.”
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led for over 35 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous FDA-approved treatments and product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, hematologic conditions, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune®, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center®, which is conducting one of the largest genetics sequencing efforts in the world.
For more information, please visit www.Regeneron.com or follow @Regeneron on LinkedIn.
Regeneron Forward-Looking Statements and Use of Digital Media
This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and actual events or results may differ materially from these forward-looking statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, Regeneron’s agreement with 2seventy bio, Inc. (“2seventy bio”) as discussed in this press release to acquire full development and commercialization rights to 2seventy bio’s pipeline of investigational novel immune cell therapies and its discovery and clinical manufacturing capabilities (the “Acquisition”); the likelihood and timing of the closing of the Acquisition, including the possibility that various closing conditions for the Acquisition may not be satisfied or waived; risks related to Regeneron’s ability to realize the anticipated benefits of the Acquisition, including the possibility that the expected benefits from the Acquisition will not be realized or will not be realized within the expected time period; significant transaction costs and unknown liabilities; the risk of litigation and/or regulatory actions related to the Acquisition; the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Products”) and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Product Candidates”) and research and clinical programs now underway or planned, including without limitation the cell therapies and combination approaches in oncology and immunology to be advanced by Regeneron Cell Medicines, a newly formed R&D unit in connection with Acquisition; uncertainty of the utilization, market acceptance, and commercial success of Regeneron’s Products and Regeneron’s Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary) on any of the foregoing; the ability of Regeneron’s collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron’s Products and Regeneron’s Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates; safety issues resulting from the administration of Regeneron’s Products and Regeneron’s Product Candidates in patients, including serious complications or side effects in connection with the use of Regeneron’s Products and Regeneron’s Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron’s ability to continue to develop or commercialize Regeneron’s Products and Regeneron’s Product Candidates; ongoing regulatory obligations and oversight impacting Regeneron’s Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement of Regeneron’s Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron’s Products and Regeneron’s Product Candidates; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regeneron’s agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable) to be cancelled or terminated; the impact of public health outbreaks, epidemics, or pandemics (such as the COVID-19 pandemic) on Regeneron’s business; and risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA® (aflibercept) Injection), other litigation and other proceedings and government investigations relating to the Company and/or its operations, the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron’s business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron’s filings with the U.S. Securities and Exchange Commission. Any forward-looking statements are made based on management’s current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.
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Tina Parisi Tuttle, Regeneron
Tel: +1 973-975-9357
Vesna Tosic, Regeneron
Tel: +1 914-847-5443
Source: Regeneron Pharmaceuticals, Inc.