HCW9302 / HCW Biologics - LARVOL DELTA

HCW Biologics…announced the first patient was dosed at The Ohio State University Wexner Medical Center for the Company-sponsored, multi-center first-in-human clinical trial to evaluate HCW9302 in patients with alopecia areata (NCT07049328) (GlobeNewswire) - "The Phase 1 multi-center dose-escalation study of HCW9302is designed to treat up to 30 patients with alopecia areata....Depending on the results of this study, multi-dose studies of HCW9302 in expanded cohorts of patients with alopecia areata and in patients with other inflammatory dermatological conditions are expected to be initiated."

First-in-human • Trial status • Alopecia • Immunology

Research and development (R&D) expenses (GlobeNewswire) - "R&D expenses in the nine months ended September 30, 2024 were comparatively higher than the same period in 2025 due to expenses incurred for the manufacture of a high-expressing line of HCW9101, an element needed in the manufacture of HCW9302, the Company’s clinical-stage molecule."

Commercial • Alopecia

HCW Biologics Reports Third Quarter 2025 Business Highlights... (GlobeNewswire) - "The Company has successfully opened two clinical sites that are actively screening patients to participate in a first-in-human Phase 1 dose escalation clinical trial to evaluate one of its lead drug candidates, HCW9302, in patients with alopecia areata. The Company expects to dose the first patient in this clinical trial in the fourth quarter of 2025."

Trial status • Alopecia

HCW9302 (Interleukin-2 Fusion Protein) for Alopecia Areata (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: HCW Biologics | Not yet recruiting ➔ Recruiting

Enrollment open • Alopecia • Dermatology • Immunology

IL-2: HCW9302 (Interleukin-2 Fusion Protein) for Alopecia Areata (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: HCW Biologics

New P1 trial • Alopecia • Dermatology • Immunology

Treg-targeted therapies restrain disease in a murine model of alopecia areata (SID 2025) - "HCW9302 is a recombinant fusion protein containing two human IL-2 domains fused to a soluble human tissue factor domain...Overall, our findings suggest that Tregs play a protective role towards the hair follicle, and their enhancement is effective at restraining disease. Our data provides translational support for the use of IL-2 fusion proteins as a therapeutic strategy for patients with AA."

Preclinical • Alopecia • Immunology • CD8 • IL2

A humanized IL-2 fusion protein enhances T regulatory cells in vivo and restrains disease in a murine model of Alopecia Areata (IMMUNOLOGY 2025) - "HCW9302 is a recombinant fusion protein containing two human IL-2 domains fused to a soluble human tissue factor domain...We also noted a significant reduction in the number of Teff found infiltrating the skin and a recovery of skin Tregs to outnumber Teff 4:1. Overall, our findings suggest that Treg enhancement is effective at restraining disease and provides translational insight for the use of IL-2 fusion proteins as a therapeutic strategy for patients with AA.Keywords: Cells T Cells; Diseases Autoimmunity; Tissues Skin"

Preclinical • Alopecia • Immunology • CD8 • IL2 • NKG2D

HCW Biologics Granted FDA Clearance to Evaluate One of the Company’s Lead Product Candidates in a First-In-Human Phase 1 Clinical Trial (GlobeNewswire) - "HCW Biologics Inc...today announced that it has received clearance of its Investigational New Drug Application ('IND') from the U.S. Food and Drug Administration ('FDA') to initiate a first-in-human Phase 1 dose escalation clinical trial to evaluate one of its lead drug candidates, HCW9302, in patients with moderate-to-severe alopecia areata, a common autoimmune disease in humans that currently has no curative FDA approved treatments."

IND • Alopecia

HCW Biologics Reports Second Quarter 2024 Financial Results and Business Highlights (GlobeNewswire) - "Business Highlights...Going forward, the Company retains ownership and control of the TOBI platform and TOBI-based molecules, with no restrictions under the Settlement Agreement on its ability to use the TOBI platform for protein-fusion molecules for non-oncology indications. The Company may pursue the clinical development of treatments for cancer indications based on HCW9302, HCW9206 and HCW9201. Further, HCW Biologics retains ownership of the Wugen license and shares of Wugen common stock transferred to the Company as the upfront licensing fee from Wugen for granting the Wugen license...R&D expenses for the quarter ended June 30, 2023 and 2024 were $1.6 million and $2.0 million, respectively...Manufacturing costs increased in three- and six-month periods ended June 30, 2024 because the Company was replenishing its supply of a high-expressing cell line of HCW9101."

Commercial • Licensing / partnership • Hematological Malignancies • Immunology • Oncology • Solid Tumor

HCW Biologics Reports First Quarter 2024 Financial Results and Business Highlights (GlobeNewswire) - "We are preparing an IND application to evaluate our IL-2 based product candidate designed to activate and expand Treg cells, HCW9302, in an autoimmune disease, which we plan to submit in the third quarter of 2024....Preclinical expenses declined primarily due to a change in the preclinical activities in March 31, 2024 versus the comparable period one year earlier. In the three-month period ended March 31, 2023, preclinical costs were incurred for setup costs for toxicology studies and other IND-enabling studies to prepare an IND application to obtain permission from the FDA to evaluate HCW9302 in an autoimmune indication."

Commercial • IND • Immunology

HCW Biologics Reports Second Quarter 2023 Financial Results and Recent Business Highlights (GlobeNewswire) - "R&D expenses for the quarter ended June 30, 2022 and 2023 were $2.0 million and $1.6 million, respectively, a decrease of $353,216, or 18%. R&D expenses for the six months ended June 30, 2022 and 2023 were $3.8 million and $3.9 million, respectively, an increase of $112,921, or 3%. The change is primarily attributable to a decrease in preclinical expenses and manufacturing costs and an increase in costs associated with clinical trial activities. As of June 30, 2023, the Company anticipates it has the required supplies of its lead molecules, HCW9218 and HCW9302, in place to provide for planned clinical development activities for the next 24 months...In first half of 2023, IND-enabling activities focused on additional research studies required for the Company’s IND submission. The Company expects to submit an IND application for permission to conduct a clinical trial to evaluate HCW9302 in an autoimmune disorder by the end of 2023."

Commercial • IND • Oncology • Solid Tumor

A novel interleukin-2-based fusion molecule, HCW9302, differentially promotes regulatory T cell expansion to treat atherosclerosis in mice. (PubMed, Front Immunol) - "HCW9302 treatment also lessened inflammatory responses in the aorta. Thus, HCW9302 is a potential therapeutic agent to expand and activate Tregs for treatment of inflammatory and autoimmune diseases."

Journal • Preclinical • Atherosclerosis • Cardiovascular • Dyslipidemia • Immunology • Inflammation • APOE • CD4 • IL2