Kuur Therapeutics Announces Presentation of Phase 1 and Preclinical CAR-NKT Immunotherapy Data at ASGCT Meeting

May 15, 2020

HOUSTON – May 15, 2020 – Kuur Therapeutics, a leader in the development of off-the-shelf CAR-NKT cell immunotherapies for the treatment of hematological and solid tumor cancers, today announced that collaborators from the Baylor College of Medicine presented updated results from the ongoing GINAKIT2 phase 1 trial studying autologous CAR-NKT therapeutic candidate KUR-501 for the treatment of relapsed or refractory (R/R) high-risk neuroblastoma in children at the 23rd Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT). Baylor College of Medicine also presented preclinical data from the KUR-503 program studying GPC3-targeting CAR-NKTs for the treatment of hepatocellular carcinoma (HCC).

“We are pleased to report promising phase 1 results, demonstrating safety, favorable pharmacokinetics, and early evidence of clinical activity in the first two dose levels of the GINAKIT2 trial, as well as evidence of tumor homing, as predicted for CAR-NKT cells. These results highlight the promise of CAR-NKT cells in targeting difficult-to-treat solid tumors. With the recent initiation of the ANCHOR study of KUR-502 in CD19 positive hematological malignancies, we are looking forward to exploring the effects of allogeneic (off-the-shelf) CAR-NKT cells,” said Kurt Gunter, Kuur’s Chief Medical Officer. “In addition, the preclinical proof of concept data from our allogeneic program targeting GPC3 for the treatment of HCC confirm the activity of CAR-NKT cells in another solid tumor, as well as the importance of IL-15 in supporting in vivo expansion and persistence. We look forward to nominating a therapeutic candidate for this program later this year.”

Phase 1 GINAKIT2 Trial Data of KUR-501 Presented at ASGCT
The oral presentation titled, “Natural Killer T Cells Expressing a GD2-CAR and IL-15 for Children with Neuroblastoma – A First-In-Human Phase 1 Trial” described data from the first five patients enrolled in the phase 1 proof of concept GINAKIT2 study of KUR-501 in patients with high risk, relapsed/refractory neuroblastoma. Of the five patients enrolled to date, three patients have been treated at dose level 1 (3×106 CAR+iNKTs/m2) and two patients have been treated at dose level 2 (10×106 CAR+iNKTs/m2) following lymphodepletion.

Data from the study demonstrated that patient-derived CAR-NKT cells targeting GD2, an antigen expressed by almost all neuroblastomas, expanded post infusion and were able to localize to the site of neuroblastoma tumors. All five treated patients showed evidence of CAR-NKT expansion, peaking at three weeks post infusion, with expansion continued through week 4 in one patient. The products demonstrated a favorable safety and pharmacokinetic profile, and there was evidence of clinical activity, based on reductions of tumor volume in two patients, including one near complete response.

The trial is currently enrolling at the third dose level in the Phase 1 study, with treatment resuming shortly at Baylor College of Medicine, following coronavirus-related restrictions lifting.

Preclinical Results from Allogenic Program Targeting GPC3 in HCC
The oral presentation titled “Glypican-3-Specific CAR NKT Cells Armored with IL-15 Mediate Potent Anti-Tumor Response Against Hepatocellular Carcinoma” outlined the positive in vivo results from Kuur’s allogeneic program of KUR-503 targeting glypican-3 (GPC3) for the treatment of hepatocellular carcinoma.  KUR-503 consists of CAR-NKTs engineered to target GPC3 and to express IL-15, which is known to stimulate proliferation and increase survival of CAR-NKT cells in the tumor microenvironment.

CAR-NKT cells could be ideal candidates for the treatment of HCC, in part because most of these cancers naturally express factors that recruit NKT cells, and in part because NKT cells suppress HCC in preclinical models. HCC is the fourth most common cause of cancer-related deaths worldwide with a five-year survival rate of less than 20%, and currently no curative therapies exist for unresectable HCC.

About Kuur Therapeutics
Kuur Therapeutics is a clinical-stage biopharmaceutical company focused on the development of off-the-shelf CAR-NKT cell immunotherapies for the treatment of hematological and solid tumor cancers. The company’s revolutionary platform engineers CARs on invariant NKT cells (iNKTs), a subset of T lymphocytes, and is being created in partnership with Baylor College of Medicine and Texas Children’s Hospital. This innovative approach harnesses the innate tissue-homing properties of natural killer T cells, a specialized type of lymphocytes which eliminate tumor-supportive macrophages, activate anti-tumor NK and CD8 T cells, and do not induce graft versus host disease. These NKT cells are modified to express targeted chimeric antigen receptors, among other enhancements that stimulate proliferation, increase survival of NKT cells in the tumor microenvironment, and minimize immune-mediated adverse effects. Allogeneic cell therapy has the potential to be much faster and less expensive than patient-specific autologous products, and NKT cells offer several advantages over other cell types for allogeneic immunotherapy applications.

Investor Contact
Stephanie Ascher
Stern Investor Relations, Inc.

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