HCW Biologics receives FDA IND clearance to begin a Phase 1 trial of HCW9302 for alopecia areata treatment.
Quiver AI Summary
HCW Biologics Inc. has announced the FDA's approval of its Investigational New Drug Application to begin a Phase 1 clinical trial for HCW9302, a new immunotherapy targeting alopecia areata, an autoimmune disease that causes significant hair loss without any currently approved curative treatments. HCW9302 is a first-in-kind interleukin 2 fusion protein designed to activate regulatory T cells, potentially reducing inflammation and improving patient quality of life. The trial aims to determine a safe dosage for increasing Treg cell activity and could pave the way for future studies in other autoimmune and inflammatory conditions. Dr. Hing C. Wong, the company's CEO, emphasized the importance of this milestone for developing new treatments that address quality-of-life issues associated with autoimmune diseases.
Potential Positives
- HCW Biologics Inc. received FDA clearance for its IND application, allowing it to initiate a first-in-human clinical trial for its lead drug candidate, HCW9302.
- HCW9302 targets alopecia areata, a prevalent autoimmune disease with currently no FDA-approved curative treatments, potentially addressing a significant unmet medical need.
- The drug candidate is based on the proprietary TOBI platform technology, which may offer a novel approach to treating autoimmune diseases by activating and expanding regulatory T cells.
- The successful advancement of HCW9302 could lead to further clinical development for additional autoimmune and inflammatory conditions, increasing the company's therapeutic portfolio and market potential.
Potential Negatives
- The press release contains forward-looking statements that emphasize the inherent risks and uncertainties associated with the clinical trial, including potential inability to enroll patients, adverse effects, and the possibility of the FDA placing the study on clinical hold.
- Despite the clearance to initiate a clinical trial, there is no guarantee of the efficacy or safety of HCW9302, as it is still in early clinical development stages, potentially raising concerns for investors about long-term viability.
- The mention of existing off-label treatments with "dangerous side effects" may cast a negative light on the competitive landscape and the necessity of HCW9302, implying that it must overcome significant expectations to prove its value and safety.
FAQ
What is HCW9302 and its purpose?
HCW9302 is an injectable interleukin 2 fusion protein developed to treat moderate-to-severe alopecia areata.
What clearance did HCW Biologics receive from the FDA?
HCW Biologics received FDA clearance for its Investigational New Drug Application to begin a Phase 1 clinical trial for HCW9302.
How does HCW9302 work in treating autoimmune diseases?
HCW9302 activates and expands regulatory T cells to suppress unwanted immune and inflammatory responses.
What is alopecia areata and its impact?
Alopecia areata is an autoimmune disease causing hair loss, affecting quality of life for millions worldwide.
What are the next steps following the Phase 1 trial?
If successful, HCW Biologics plans to rapidly expand clinical trials for HCW9302 in other autoimmune conditions.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
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Full Release
MIRAMAR, Fla., Feb. 03, 2025 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (“HCWB” or the “Company”) (NASDAQ: HCWB), a U.S.-based clinical-stage biopharmaceutical company focused on discovering and developing innovative immunotherapies to extend healthspan by targeting the link between chronic inflammation and disease, 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. Alopecia areata causes sudden hair loss and can have a significant negative impact on patients’ quality of life and psychological health. HCW9302 is an injectable, first-in-kind interleukin 2 (“IL-2”) fusion protein complex constructed using the Company’s proprietary TOBI platform technology. Its mechanism of action involves binding to IL-2αβγ receptors predominantly expressed on regulatory T (“T
reg
”) cells, thereby activating and expanding T
reg
cells that can suppress unwanted immune and inflammatory responses.
Chronic inflammation is believed to be a significant contributing factor in many diseases and conditions including those that have a major impact on quality-of-life but are not life-threatening. In multiple relevant preclinical models, HCW9302 has shown efficacy in treating autoimmune diseases at well-tolerated dose levels by activating and expanding T
reg
cells through subcutaneous injections. Protein-based therapies, whether as direct inhibitors or immunomodulatory agents, have revolutionized the management of autoimmune and inflammatory conditions. The Company believes that HCW9302, with its subcutaneous injectable approach, has the potential to activate and expand T
reg
cells in patients, reducing inflammation, while minimizing the risk of broad immunosuppression.
Dr. Hing C. Wong, Founder and CEO of HCW Biologics, commented, “The FDA’s clearance to initiate our first-in-human clinical trial for HCW9302 brings us one step closer to advancing a potentially transformative immunotherapeutic treatment of autoimmune diseases. This trial is a milestone for our Company, and the beginning of clinical development of treatments for quality-of-life indications. While not life-threatening, alopecia areata has no cure. Existing off-label treatments may provide some relief of symptoms, but there are often dangerous side effects. For those who suffer from this disease, it can negatively impact their quality-of-life.” Dr. Wong continued, “The goal of this initial trial is to establish the safe dose of HCW9302 that effectively increases T
reg
cells activity in patients. Once we achieve this objective, we will rapidly expand clinical development of HCW9302 in Phase 2 studies in patients with other autoimmune diseases and inflammatory conditions, including other dermatological conditions, graft rejection, arthrosclerosis, diabetes, and neurodegenerative diseases where HCW9302 has been shown to have activity in relevant animal models.”
About Alopecia Areata:
Alopecia areata (“AA”) is one of the most prevalent autoimmune diseases in the world, affecting approximately 1 in 1,000 people, with a lifetime incidence of 2% worldwide, or 160 million people. According to the
National Alopecia Areata Foundation (NAAF)
, about 7 million people in the United States have alopecia areata. The condition primarily affects individuals under the age of 30, occurring at similar rates in both males and females. AA is characterized by hair loss in localized areas, the entire scalp, or, in some cases, the whole body. It occurs when the immune system mistakenly attacks hair follicles, leading to hair loss without causing permanent damage to the follicles. Patients often experience recurring episodes of hair loss throughout their lives. Existing treatments, such as corticosteroids, immunotherapy, Janus kinase inhibitors, and topical solutions, focus on managing the severity and duration of episodes of hair loss. However, these therapies primarily address symptoms rather than providing a cure or consistent, long-term hair regrowth. Currently, there is no cure for alopecia areata.
About HCW Biologics:
HCW Biologics Inc. (NASDAQ: HCWB) is a clinical-stage biopharmaceutical company developing proprietary immunotherapies to treat diseases promoted by chronic inflammation, especially age-related and senescence-associated diseases. The Company’s immunotherapeutics represent a new class of drug that it believes have the potential to fundamentally change the treatment of cancer and many other diseases and conditions that are promoted by chronic inflammation — and in doing so, improve patients’ quality of life and possibly extend longevity. Chronic inflammation, including inflammaging, is believed to be a significant contributing factor to the cause for senescence-associated diseases and conditions that diminish healthspan, including many types of cancer, autoimmune diseases, and neurodegenerative diseases, as well as indications that impact quality-of-life that are not life-threatening. The Company’s lead product candidate, HCW9302, was developed using the Company’s legacy TOBI™ (Tissue factOr-Based fusIon) platform. The Company has created another drug discovery technology, the TRBC platform, which is not based on Tissue Factor. The TRBC platform has the capability to construct immunotherapeutics that not only activate and target immune responses but are also equipped with receptors that specifically target cancerous or infected cells. This platform is such a versatile scaffold that it enables the creation of multiple classes of immunotherapeutic compounds: Class I: Multi-Functional Immune Cell Stimulators; Class II: Second-Generation Immune Checkpoint Inhibitors; Class III: Multi-Specific Targeting Fusions and Enhanced Immune Cell Engagers. These novel immunotherapeutics can be used to treat a wide range of disease indications, including oncology, autoimmune diseases, and improving quality of life conditions. The Company has constructed over 30 molecules using the TRBC platform, including HCW11-002, HCW11-018 and HCW11-027. Further preclinical evaluation studies are currently being conducted for these three molecules the Company has selected based on promising early data. The Company has two licensing programs in which it has licensed exclusive rights for some of its proprietary molecules. See the Company Pipeline at
https://hcwbiologics.com/pipeline/
.
Forward Looking Statements:
Statements in this press release contain “forward-looking statements” that are subject to substantial risks and uncertainties. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “expect,” “believe,” “will,” “may,” “should,” “estimate,” “project,” “outlook,” “forecast” or other similar words and include, the Company’s ability to develop new immunotherapeutic treatments for auto-immune indications; the Company’s ability to enter into agreements with clinical sites to participate in the study; the successful initiation of a clinical trial; the Company’s ability to enroll the required number of patients for the study; that the clinical study will proceed with no adverse effects to any patients participating in the trial; that the study will not be put on a clinical hold by the FDA for any reason; and that the clinical study will reach its endpoints successfully; the efficacy of HCW9302 for autoimmune conditions; and the ability of HCW9302 to activate and regulate T
reg
cells in patients. Forward-looking statements are based on the Company’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, but are not limited to, the risks and uncertainties that are described in the section titled “Risk Factors” in the annual report on Form 10-K/A filed with the United States Securities and Exchange Commission (the “SEC”) on May 15, 2024, the latest Form 10-Q filed with the SEC on November 14, 2024, and in other filings filed from time to time with the SEC.
Company Contact:
Peter Rhode, PhD.
Vice President of Clinical Operations and Chief Scientific Officer
HCW Biologics Inc.
peterrhode@hcwbiologics.com
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