Editas Medicine and Shoreline Biosciences Enter into Definitive Agreement for Shoreline to Acquire Editas’ iNK Cell Franchise and Related Gene Editing Technologies

  • Shoreline to obtain an exclusive license to SLEEK knock-in technology for iPSC-derived NK cells, an exclusive license to SLEEK for iPSC-derived macrophages in oncology and  a non-exclusive license for AsCas12a
  • Shoreline to acquire Editas Medicine’s iNK cell franchise, including EDIT-202 and certain related manufacturing technologies
  • Economics to Editas Medicine to include upfront payment, and development and commercial milestone and royalty payments

CAMBRIDGE, Mass. And SAN DIEGO, Jan. 19, 2023 – Editas Medicine, Inc. (Nasdaq: EDIT), a clinical-stage genome editing company, today announced that it has entered into a definitive agreement with Shoreline Biosciences (Shoreline) for Shoreline to license Editas Medicine’s proprietary SLEEK (SeLection by Essential-gene Exon Knock-in) and AsCas12a gene editing technologies and acquire Editas Medicine’s preclinical gene edited induced pluripotent stem cell (iPSC) derived natural killer cell (iNK) programs and related manufacturing technologies.

Shoreline Biosciences is a private biopharmaceutical company developing next-generation cellular immunotherapies based on iPSCs utilizing proprietary iNK and macrophage (iMACs) platforms.

Under the terms of the agreement, Shoreline will obtain an exclusive license to Editas Medicine’s interest in SLEEK gene editing knock-in technology for use in Shoreline’s iNK platform and for oncology in its iMACs platform, and on a non-exclusive basis for iMACs in other indications. Shoreline will also receive a non-exclusive license for the use of Editas Medicine’s engineered AsCas12a enzyme.

As part of the transaction, Shoreline will acquire EDIT-202, Editas Medicine’s preclinical multiplexed edited iNK cell medicine for the potential treatment of solid tumors, as well as an additional iNK program under development and certain related manufacturing technologies. The acquisition of the Company’s wholly owned oncology assets by Shoreline is part of Editas Medicine’s strategic portfolio reprioritization, including its focus on the development of in vivo gene edited medicines.

“The acquisition of our allogeneic iNK franchise by Shoreline is highly aligned with our strategic portfolio reprioritization, as it allows us to sharpen our efforts on advancing current clinical stage trials and focus our resources on in vivo fit-for-purpose therapeutic construction and development.” said Gilmore O’Neill, M.B., M.M.Sc., President and Chief Executive Officer, Editas Medicine. “Shoreline is a leader in developing next generation iNK and macrophage cell therapies, and we believe they are the right company to move these assets toward clinical applications.”

“Our goal is to win the war on cancer, and through this agreement with Editas, we have strategically enhanced our ability to execute upon our mission.  The addition of Editas Medicine’s novel gene editing SLEEK technology, combined with the use of a high efficiency and high fidelity proprietary CRISPR enzyme, and the other assets from Editas Medicine’s iNK franchise, strengthens our portfolio and ability to create next generation immunotherapies for patients with cancer,” said Kleanthis G. Xanthopoulos, Ph.D., Shoreline’s Chairman and CEO, Shoreline Biosciences. “We look forward to advancing our pipeline towards the clinic, including these new assets and technologies from Editas.”

Shoreline will pay Editas Medicine an upfront payment at the close of the transaction. Additionally, Editas Medicine is eligible to receive future development and commercial milestone and royalty payments for each of the iNK programs and for future programs engineered with the gene editing technologies. Evercore Group LLC served as financial advisor to Editas Medicine on the transaction.

About Editas Medicine

As a clinical-stage genome editing company, Editas Medicine is focused on translating the power and potential of the CRISPR/Cas9 and CRISPR/Cas12a genome editing systems into a robust pipeline of treatments for people living with serious diseases around the world. Editas Medicine aims to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for a broad class of diseases. Editas Medicine is the exclusive licensee of Broad Institute and Harvard University’s Cas9 patent estates and Broad Institute’s Cas12a patent estate for human medicines. For the latest information and scientific presentations, please visit www.editasmedicine.com.

About Shoreline Biosciences

Shoreline Biosciences is a biopharmaceutical company developing next-generation cellular immunotherapies based on induced pluripotent stem cells (iPSCs) utilizing its proprietary iPSC-derived natural killer (iNK) cell and macrophage (iMACs) platforms. The company’s cellular design technologies are built on a deep understanding of iPSC differentiation, immune cell biology and genetic engineering that enable the development of specific effector cell types, including iNK cells and iMACs as allogeneic “off-the-shelf” cellular immunotherapies designed for durability, scalability, safety, and efficacy. Shoreline is advancing a pipeline of programs towards the clinic, on its own and with its strategic partners, Kite, a Gilead Company, and BeiGene, a global pharmaceutical company. Shoreline Biosciences is headquartered in San Diego, CA. 

Editas Medicine Forward-Looking Statements

This press release contains forward-looking statements and information within the meaning of The Private Securities Litigation Reform Act of 1995. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “target,” “should,” “would,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements in this press release include statements regarding the expected benefits of Editas Medicine’s transaction with Shoreline, including any future payments it may receive under the agreement and the impact on its strategic portfolio reprioritization. The Company may not actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various important factors, including: uncertainties inherent in the initiation and completion of preclinical studies and clinical trials, and clinical development of the Company’s product candidates; availability and timing of results from preclinical studies and clinical trials; whether interim results from a clinical trial will be predictive of the final results of the trial or the results of future trials; expectations for regulatory approvals to conduct trials or to market products and availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements. These and other risks are described in greater detail under the caption “Risk Factors” included in the Company’s most recent Annual Report on Form 10-K, which is on file with the Securities and Exchange Commission, as updated by the Company’s subsequent filings with the Securities and Exchange Commission, and in other filings that the Company may make with the Securities and Exchange Commission in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements, whether because of new information, future events or otherwise.

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Editas Medicine Contacts:

Media

Cristi Barnett

(617) 401-0113

cristi.barnett@editasmed.com

Investors

Ron Moldaver

(617) 401-9052

ir@editasmed.com

Shoreline Biosciences Contacts:

Investor Contact

Amy Conrad

Juniper Point

amy@juniper-point.com

858-366-3243

Media Contact

David Schull

Russo Partners

David.Schull@russopartnersllc.com 

212-845-4271

 

Shoreline Biosciences Announces Appointment of Cell Therapy Manufacturing Veteran Charles Calderaro III as Chief Technical Officer

SAN DIEGOOct. 24, 2022 / — Shoreline Biosciences, Inc. (Shoreline), a biopharmaceutical company developing next-generation cellular immunotherapies based on induced pluripotent stem cells (iPSCs) utilizing its proprietary iPSC-derived natural killer (iNK) cell and macrophage (iMACs) platforms, today announced the appointment of Charles Calderaro III as Chief Technical Officer. Mr. Calderaro brings three decades of manufacturing and engineering experience to Shoreline, with industry-leading expertise in building and optimizing technical and manufacturing infrastructures for cell therapy products.

“Chuck is a drug manufacturing expert, highlighted by the successful creation and implementation of end-to-end manufacturing and commercial operations for Kite, a Gilead company and a leading cell therapy company. I am thrilled to welcome him to Shoreline as Chief Technical Officer,” said Kleanthis G. Xanthopoulos, Ph.D., Shoreline’s Co-Founder, Chairman and CEO. “With Chuck’s expertise and our iPSC platforms, we are well positioned to implement our planned scalable manufacturing approach, designed to reduce the cost and complexity of manufacturing and enable the development of true ‘off-the-shelf’ products for use in outpatient settings. This could lead to a significant competitive advantage as we move our iNKs and iMACs towards the clinic.”

Prior to joining Shoreline, Mr. Calderaro served as Global Head of Technical Operations for Kite, a pioneer in cell therapy development, where he was responsible for leading all aspects of Kite’s technical operations, including process development, CMC regulatory, manufacturing, quality, supply chain, engineering, and end-to-end optimization of commercial and pipeline products. While at Kite, Mr. Calderaro oversaw the manufacturing of CAR-T cell therapy products at commercial scale. Prior to Kite, Mr. Calderaro was Senior Vice President, Global Manufacturing at BioMarin Pharmaceutical, where he was responsible for the strategic oversight and leadership of a diverse international manufacturing network, which utilizes small molecule, oligonucleotide, biotechnology, and gene therapy technologies to deliver an innovative portfolio of clinical and commercial products to patients. Before that, he spent fourteen years at Genentech in roles of increasing responsibility in product management, engineering, and manufacturing. Early in his career, Mr. Calderaro spent time at Alcon, a division of Novartis, and at Aventis Behring, spanning roles in manufacturing, validation, and biopharmaceutical operations. Mr. Calderaro received a Bachelor’s degree, Electrical Engineering from the University of Notre Dame, a Master’s Degree, Nuclear Engineering from the US Naval Nuclear Power School and a Master of Business Administration from Texan Christian University.

“It is clear that a major gating factor to increasing the number of cellular immunotherapies on the market is the lack of automation in the manufacturing process. Shoreline’s smart manufacturing system holds tremendous promise to create a novel, scalable, end-to-end process, that will optimize the product quality of iPSC-derived cell therapies,” added Mr. Calderaro. “The strength of the technology and the team created a compelling opportunity for me and I look forward to creating the manufacturing system of the future, with the goal of finally winning the war on cancer and delivering benefit to patients.”

About Shoreline Biosciences

Shoreline Biosciences is a biopharmaceutical company developing next-generation cellular immunotherapies based on induced pluripotent stem cells (iPSCs) utilizing its proprietary iPSC-derived natural killer (iNK) cell and macrophage (iMACs) platforms. The company’s cellular design technologies are built on a deep understanding of iPSC differentiation, immune cell biology and genetic engineering that enable the development of specific effector cell types, including iNK cells and iMACs as allogeneic “off-the-shelf” cellular immunotherapies designed for durability, scalability, safety, and efficacy. Shoreline is advancing a pipeline of programs towards the clinic, on its own and with its strategic partners, Kite, a Gilead Company, and BeiGene, a global pharmaceutical company. Shoreline Biosciences is headquartered in San Diego, CA.