Intellia and ONK Therapeutics Announce Collaboration to Advance Allogeneic CRISPR-Edited NK Cell Therapies for the Treatment of Patients with Cancer

- Collaboration combines Intellia’s genome editing platform with ONK’s optimized natural killer (NK) cell therapy platform

- Intellia grants ONK non-exclusive rights to its ex vivo genome editing and LNP delivery technologies and exclusive rights to certain guide RNAs for up to five allogeneic CRISPR-edited NK cell therapies

- ONK is responsible for the research, clinical development and commercialization of engineered NK cell therapies derived from collaboration

- Intellia to receive global co-development and co-commercialization options for up to two CRISPR-edited NK cell therapies with lead commercialization rights in the U.S.

CAMBRIDGE, Mass., and GALWAY, Ireland and SAN DIEGO, Calif., Feb. 15, 2022 – Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading genome editing company focused on developing curative therapies leveraging CRISPR-based technologies, and ONK Therapeutics Ltd., an innovative company dedicated to developing optimally engineered natural killer (NK) cell therapies to cure patients with cancer, today announced a licensing and collaboration agreement. NK cells are specialized, naturally occurring immune cells that play a critical role in immune activation against abnormal cells, including cancer cells. NK cells have gained significant attention in the field of cancer immunotherapy and various approaches are being explored to effectively develop and engineer NK cell-based cancer immunotherapy.

The agreement grants ONK a non-exclusive license to Intellia’s proprietary ex vivo CRISPR/Cas9-based genome editing platform and its lipid nanoparticle (LNP)-based delivery technologies to develop up to five allogeneic NK cell therapies. ONK will receive exclusive rights to certain Intellia guide RNAs (gRNAs) resulting from the collaboration for use in engineering those NK cell products. ONK will be responsible for preclinical and clinical development for the engineered NK cell therapies covered under the agreement. Intellia will be eligible to receive up to $184 million per product in development and commercial milestone payments, as well as up to mid-single digit royalties on potential future sales. In addition, the agreement grants Intellia options to co-develop and co-commercialize up to two products worldwide with rights to lead commercialization in the U.S. ONK retains lead commercialization rights ex-U.S. This co-development and co-commercialization option excludes ONK’s lead product ONKT-102, which is being developed for the treatment of patients with relapsed / refractory multiple myeloma, for which ONK retains sole rights. If Intellia chooses to exercise the co-development and co-commercialization option on an investigational product, in lieu of the potential royalties and milestones, Intellia will share 50 percent of any future profit and loss generated by the product.

“We look forward to working with ONK in the development of allogeneic NK cell therapies for patients with cancer. This collaboration, which combines Intellia’s industry-leading CRISPR technology platform and ONK’s expertise in NK cell technology, offers yet another powerful example of how we’re leveraging our strategic collaborations to address life-threatening diseases for patients in need,” said Intellia President and Chief Executive Officer John Leonard, M.D.  

“We believe combining Intellia’s ex vivo genome editing and LNP delivery platforms with our suite of proprietary NK cell gene edits has the potential to create optimally engineered NK cells with enhanced cytotoxicity, persistence and an improved metabolic profile that hold tremendous promise to advance the treatment of both hematologic malignancies and solid tumors. We are excited to partner with Intellia and are looking forward to a collaboration that allows us to continue to deliver against our strategy, as we evolve into a clinical-stage company,” said ONK Therapeutics Chief Executive Officer Chris Nowers.

About Intellia Therapeutics

Intellia Therapeutics, a leading clinical-stage genome editing company, is developing novel, potentially curative therapeutics leveraging CRISPR-based technologies. To fully realize the transformative potential of CRISPR-based technologies, Intellia is pursuing two primary approaches. The company’s in vivo programs use intravenously administered CRISPR as the therapy, in which proprietary delivery technology enables highly precise editing of disease-causing genes directly within specific target tissues. Intellia’s ex vivo programs use CRISPR to create the therapy by using engineered human cells to treat cancer and autoimmune diseases. Intellia’s deep scientific, technical and clinical development experience, along with its robust intellectual property portfolio, have enabled the company to take a leadership role in harnessing the full potential of genome editing to create new classes of genetic medicine. Learn more at intelliatx.com. Follow us on Twitter @intelliatx.

About ONK Therapeutics

ONK Therapeutics is an innovative cell therapy company dedicated to developing the next generation of optimally engineered, off-the-shelf, natural killer (NK) cell therapies. With a growing pre-clinical pipeline targeting both hematological malignancies and solid tumors, ONK is advancing multiple cell therapy candidates towards the clinic, including its lead program, ONKT102, an optimized affinity CD38 CAR-NK product, intended for the treatment of patients with relapsed/ refractory multiple myeloma. Read about the pipeline here.

The company’s optimally engineered NK cell therapy platform utilizes a suite of proprietary gene edits and cell modification strategies to optimize cytotoxic potential, persistence and the metabolic health of NK cells, while reducing the potential for their exhaustion in the tumor microenvironment. These include CISH knockout (KO); the expression of high affinity, membrane bound, TNF-related apoptosis-inducing ligand variants (TRAILv) targeting DR5 or DR4; and the deletion of inhibitory receptors, including extracellular proteins for example CD96, and Siglec-7. Read about the platform here.

ONK Therapeutics is headquartered in the med-tech hub of Galway, Ireland, with a wholly owned US subsidiary, ONK Therapeutics, Inc. based at JLabs @ San Diego. Shareholders include Acorn Bioventures, Cormorant Asset Management, ALSHC (principally Seamus Mulligan), and Enterprise Ireland.

Learn more at www.onktherapeutics.com. Follow us on Twitter @ONKTherapeutics and LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding Intellia’s beliefs and expectations regarding: its strategy, business plans and focus; its ability to quickly and efficiently realize the scope and potential of its genome editing technology; its ability to maintain, expand and maximize its intellectual property portfolio and pipeline as well as accelerate clinical validation for its platform, including through its collaboration with ONK Therapeutics; the therapeutic value and development potential of CRISPR/Cas9 genome editing technologies and therapies; its ability to combine its CRISPR genome editing platform with ONK Therapeutics’ natural killer (NK) cell therapy platform to create successful therapeutic products; and the expected strategic benefits of any current or future collaborations, including the potential to generate revenue from such collaborations and related products, including products developed in collaboration with ONK Therapeutics.

Any forward-looking statements in this press release are based on management's current expectations and beliefs of future events, and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks related to Intellia’s ability to protect and maintain its intellectual property portfolio; risks related to Intellia’s relationship with third parties, including its licensors and licensees; risks related to the ability of Intellia’s licensors to protect and maintain their intellectual property position; uncertainties related to the authorization, initiation and conduct of studies and other development requirements for the new company’s product candidates; the risk that any one or more of the collaboration product candidates will not be successfully developed and commercialized; the risk that the results of preclinical studies or clinical studies will not be predictive of future results in connection with future studies; and the risk that Intellia’s collaboration with ONK Therapeutics or its other collaborations will not continue or will not be successful. These and other risks and uncertainties are described in greater detail in the section entitled “Risk Factors” in Intellia’s most recent annual report on Form 10-K and quarterly report on Form 10-Q filed with the SEC, as well as discussions of potential risks, uncertainties, and other important factors in Intellia’s other filings with the Securities and Exchange Commission. Any forward-looking statements contained in this press release represent Intellia’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Intellia explicitly disclaims any obligation to update any forward-looking statements, except as required by law.

Contacts:

For Intellia:

Investors:
Ian Karp
Senior Vice President, Investor Relations and Corporate Communications
+1-857-449-4175
ian.karp@intelliatx.com  

Lina Li
Director, Investor Relations
+1-857-706-1612
lina.li@intelliatx.com  

Media:
Matt Crenson
Ten Bridge Communications
+1-917-640-7930
media@intelliatx.com
mcrenson@tenbridgecommunications.com

For ONK:

International:
Sue Charles
Charles Consultants
+44 7968 726585
sue@charles-consultants.com

Ireland:
Ray Gordon
Gordon MRM
+353 87 2417373
ray@gordonmrm.ie