Chimeric Therapeutics : CORE NK Platform Phase 1 Clinical Data Presentation

ersonal use only

THE ASX LEADER IN CELL THERAPY

THE CORE-NK PLATFORM

PHASE 1 CLINICAL DATA

MONDAY MARCH 7, 2022

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CORE-NK PLATFORM (CHM 0201)

Clinically Validated, Off the Shelf, Robust, Enhanced, Natural Killer Cell Platform

▪ A universal, off the shelf, natural killer cell platform technology

ersonal use

CORE-NK Cell

• Developed by Dr. David Wald, a clinical scientist at Case Western Reserve University
• Specifically designed to overcome the hurdles often associated with NK cell development, including the ability to produce large numbers of highly active universal donor NK cells that maintain their activity once they're in the body.
• Chimeric exclusive option with a planned licensing and research collaboration with Case Western
• Platform enables near-term development Chimeric therapies for solid tumors and blood cancers

David

WALD, MD, PhD

Associate Professor, Department

of Pathology, School of Medicine Member, Immune Oncology Program, Case Comprehensive Cancer Center, Associate Director for Basic Research, University Hospitals, Wesley Center for Immunotherapy

1.

CORE-NKPlatform

Positive Phase 1A Clinical Data

only	COMPELLING EFFICACY IN BLOOD	DEMONSTRATED
CANCERS	SAFETY
100% Disease Control Rate (DCR) achieved in	Positive safety profile established with
no Graft versus Host Disease (GvHD),
blood cancer patients (n=3)
Cytokine Release Syndrome or Dose
use	100+ day durability in 2 out of 3 patients	Limiting Toxicities
Durable Complete Response (CR) achieved with
	15+ month ongoing response	ESTABLISHED EXPANSION AND PERSISTENCE
ersonal		Proven robust expansion of universal
PROMISING EFFICACY IN SOLID TUMORS	donor NK cells

Demonstrated 4-week persistence without

33% Disease Control Rate (DCR) achieved in	exogenous cytokine support
solid tumor patients (n=6)
Otegbeye et al. A Phase I study to determine maximum tolerated dose of ex vivo expanded natural killer cells derived from unrelated, HLA-disparate adult donors. Transplantation and Cellular Therapy, 2022, ISSN 2666-6367,https://doi.org/10.1016/j.jtct.2022.02.008	2.

CORE-NK PLATFORM

PHASE 1A TRIAL DESIGN

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The trial was designed to establish the safety of CORE-NK universal donor NK cells while assessing cell

expansion, persistence and anti-tumor activity.

ersonal use

PATIENT ELIGIBILITY

BLOOD CANCERS

Acute Myeloid Leukemia

Myelodysplastic Syndromes

Acute Lymphoblastic Leukemia

Chronic Myeloid Leukemia

Chronic Lymphocytic Leukemia

Myeloproliferative Syndromes

Non-Hodgkin Lymphoma

Hodgkin Lymphoma

SOLID TUMORS

Adenocarcinoma of the Rectum

Rhabdomyosarcoma

Soft Tissue Sarcoma

Ewing's Sarcoma

Colon Cancer

PRIMARY OBJECTIVE:

To demonstrate that escalating doses of the CORE-NK platform could be infused without inducing GvHD or other significant toxicities

SECONDARY OBJECTIVE:

To examine if the lymphocyte depleting regimen would prevent immediate rejection of the HLA-mismatched NK cell product allowing for demonstrable anti-tumor effect

Study Initiation: May 2018

Primary Study Completion: June 2021

3.

CORE-NK PLATFORM

PHASE 1A TRIAL DESIGN

only	PHASE 1 DOSE ESCALATION
	Dosing:
use	9 patients : 3 Blood Cancers / 6 Solid Tumors
Day -	Day	Day	Day	Day
	7	0	14	28	100
ersonal
Initiation of	NK Cell	NK Cell	Disease	Disease
	Lympho-	Infusion	Infusion	Assessment	Assessment
	depletion	#1	#2

4.