Pipeline

HCW9218 Program

Our lead molecule, HCW9218, is an injectable, bifunctional fusion protein complex that innovatively combines a TGF-β receptor to neutralize a highly immunosuppressive cytokine secreted by tumors, and IL-15, a potent cytokine, to stimulate the natural killer (“NK”) cells and CD8+ T cell cytotoxicity. 

Phase 1 Clinical Trial to Evaluate HCW9218 in Solid Tumors (NCT05322408)

A single-center Investigator-sponsored Phase 1 clinical trial was initiated in May 2022 and patient enrollment, dosing and safety-evaluation period for this study were completed in February 2024. In this study, the Masonic Cancer Center, University of Minnesota (“UMN”) evaluated HCW9218 in patients with solid tumor cancers that progressed after at least two lines of standard-of-care treatment. Dr. Melissa A. Geller, M.D., M.S., Professor and Division Director of Gynecologic Oncology in the Department of Obstetrics, Gynecology and Women’s Health at UMN, serves as a Principal Investigator of this trial. At the time that the Phase 1 study was completed in February, over 66% of patients with ovarian cancer (4/6) showed evidence of stable disease after receiving HCW9218 at 0.5 mg/kg or greater. 

A total of 18 patients participated in this study by the end of February 2024, with at least one dose of HCW9218 administered to each participant. While two dose-limiting toxicities (“DLTs”) were experienced, neither of these events triggered stopping rules and the study established Recommended Phase 2 Dose (“RP2D”). The most frequent treatment-related adverse events (at least possibly related to the study medication) were injections site reactions (100% of patients), flu-like symptoms (87% of patients) and decreased lymphocyte counts (93% of patients), all of which are consistent with previous clinical experience with IL-15-based therapies.

This trial met its primary endpoints, including the Recommended Phase 2 Dose.  

Phase 2 Clinical Trial to Evaluate HCW9218 in Ovarian Cancer in Combination with a Neoadjuvant Chemotherapy (NCT05145569)

Based on the results of the UMN Phase 1 study, we entered into an agreement with University of Pittsburgh Medical Center (“UPMC”) to conduct an Investigator-sponsored Phase 2 clinical trial to evaluate HCW9218 in patients with metastatic advanced stage ovarian cancer in combination with neoadjuvant chemotherapy. Patient enrollment for this study is expected to begin in the first half of 2024. Designed as a randomized trial, the primary objectives of this study are to evaluate the safety and tolerability of HCW9218 with chemotherapy and the efficacy of the combined regimens in terms of complete pathologic response rate. In the arm of the study that relates to the evaluation of HCW9218, UPMC estimates approximately 33 patients will participate. The estimated duration of treatment is an average of 6–8 cycles of treatment (3–4 cycles prior to and after surgery), then maintenance therapy for 12 months, for a total of up to 20 months of treatment with HCW9218.

The Company expects the first patient will be dosed in this study in the second half of 2024.  

HCW9302 Program

Our lead molecule, HCW9302, is an injectable single-chain, IL-2-based fusion protein. Preclinical studies in mouse models have demonstrated the ability of HCW9302 to activate T_reg cells and reduce inflammation-related diseases, supporting the potential of HCW9302 to treat a wide variety of autoimmune and age-related diseases. The Company is in the process of completing IND-enabling activities required for an Investigational New Drug application (“IND”). We expect to submit an IND to the FDA in Q3 2024 for a Phase 1b/2 clinical trial to evaluate HCW9302 in an autoimmune indication.

HCW9206 Program

HCW9206 is a fusion protein complex created with the TOBI platform based on common gamma chain (γc) cytokines IL-7, IL-15 and IL-21, which are known to play important roles in NK cell and T cell homeostasis. We hold the rights to the injectable form of HCW9206, and ex vivo rights are licensed to Wugen. This molecule is designed to broadly activate the immune system to support expansion of NK cells and T cells ex vivo and in vivo. 

We are currently in the discovery stage of  HCW9206, which is to create an injectable immunotherapeutic.  We believe our preclinical testing of HCW9206 has demonstrated that this complex can support infused NK cells for a long duration and enable NK cells to sustain cytotoxicity against tumor cells. In addition, we are currently conducting preclinical studies to investigate use of HCW9206 to enhance vaccine efficacy in different vaccine models as well as to support CAR-T cells in vivo.

Other Programs

Part of the Company’s strategy is to license marketing rights and other rights that are outside of our core focus. We signed our first out-license in 2020 with Wugen Inc. for a worldwide exclusive license for limited rights for HCW9201 and HCW9206 to develop cell-based therapies for cancer treatments.  We retained all other rights, including injectable rights and manufacturing rights for these products.