On November 30, 2021 Chimeric Therapeutics (ASX:CHM, "Chimeric" or the "Company"), a clinical-stage cell therapy company and the ASX leader in cell therapy, reported that it has entered into an exclusive option to license agreement with Case Western Reserve University (CWRU) for a Clinically validated, Off the shelf, Robust, Enhanced Natural Killer (CORE-NK) cell platform – a platform technology that provides the optimal foundation for the development of multiple next generation NK and CAR-NK products (Press release, Chimeric Therapeutics, NOV 30, 2021, View Source [SID1234596312]).

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Natural killer (NK) cells have innate safety features and the natural ability to target and destroy cancer cells through both indirect and direct mechanisms. The challenge with natural killer (NK) cells is that they are not naturally abundant or active enough to overcome cancer.

Dr. David Wald, a leading expert in immuno-oncology at Case Western Reserve University in Ohio, USA designed and developed the CORE-NK platform, enhancing the natural anti-cancer properties of NK cells to be robust and active enough to overcome cancer.

The CORE-NK platform utilizes a foundation of healthy donor NK cells, activating and expanding them to establish an enhanced, off the shelf NK cell platform that can provide an abundant supply of highly active NK cells. Preclinical data on the CORE-NK platform was published in the prestigious family of Nature publications in 2019.

In May 2018 a phase 1 clinical trial was initiated at the Case Comprehensive Cancer Center to study the CORE-NK platform in patients with both solid tumours and blood cancers. The phase 1 clinical trial of the CORE-NK platform was completed in June 2021 with clinical data expected in 2022. The trial examined the safety, bioactivity and efficacy of the CORE-NK platform cells at 3 dose levels in patients with both blood cancers and solid tumours.

With the clinical validation from the phase 1 trial complete, the CORE-NK platform provides the ideal off the shelf platform for the development of next generation NK and CAR-NK products.

Chimeric intends to begin a research collaboration with CWRU to further enhance and engineer the CORE-NK platform cells to develop a next generation CORE-NK platform and three initial CAR-NK products.

"The clinical experience we’ve had with the CORE-NK platform gives us tremendous confidence in the development path for optimized NK and CAR NK products. We look forward to working in close collaboration with Chimeric to bring forward the next generation of NK and CAR NK products to the clinic," said Dr. Wald, MD, PhD, Associate Professor of Pathology Case Western Reserve University School of Medicine and Member, Immune Oncology Program, Case Comprehensive Cancer Center, Associate Director for Basic Research, University Hospitals, Wesley Center for Immunotherapy.

The next generation CORE-NK platform will be developed with enhanced activation and expansion features with plans to study it as a combination therapy in blood cancers.

Three initial CAR-NK products will be developed using the next generation CORE-NK platform as a backbone leveraging Chimeric’s existing pipeline of chimeric antigen receptors (CARs); a CLTX CAR-NK (CHM 1301), a CDH17 CAR-NK (CHM 2301) and a currently undisclosed target CAR-NK (CHM 3301).

Chimeric will also explore additional opportunities to further leverage the CORE-NK platform to develop additional NK and CAR NK products through internal development and/or partnerships with other biotech and pharmaceutical companies.

This strategic agreement is transformative for Chimeric propelling the company forward as the Australian leader in cell therapy and as an emerging global cell therapy company with a robust and advanced portfolio of innovative autologous (personalized) and allogeneic (off the shelf) NK and T cell assets.

"The CORE-NK platform is truly transformative for Chimeric. It provides us with a platform technology that triples our current portfolio by enabling us to accelerate the development of multiple new, off the shelf, NK cell assets that work in perfect synergy with our existing pipeline. We could not be more excited to be bringing the CORE-NK platform into our portfolio and to be working in collaboration with Dr. Wald and the expert team at CWRU. Their clinical trial experience with the CORE-NK platform and their expertise in the development of NK cells will catapult our development forward," said Jennifer Chow, CEO Chimeric Therapeutics.

Under the terms of the option agreement, Chimeric has the exclusive right to license the CORE-NK platform for development and commercialization in cancer. Chimeric intends to rapidly move to complete full licensing of the platform and expects to pay CWRU development milestones and industry standard royalty payments based on commercial net sales. Upfront fees associated with the option agreement will be funded entirely from existing cash reserves.

The area of natural killer cells has seen widespread investment and partnership interest with numerous large transactions involving companies such as Merck, Takeda, Janssen and Kite.

Investor webinar

Chimeric Therapeutics CEO and Managing Director Jennifer Chow will hold an investor webinar today, Wednesday 1 December 2021, at 11am AEDT to elaborate on this announcement and take questions.

Click the link below to register:
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After registering, you will receive a confirmation email about how to join the webinar. A recording of the webinar will be available at the same link shortly after the conclusion of the session.