Core Insights - HCW Biologics Inc. will present research data on three lead drug candidates utilizing its TRBC platform technology at the 40th Annual Meeting of the Society for Immunotherapy of Cancer from November 5 to 9, 2025 [1][2] Company Overview - HCW Biologics Inc. is a clinical-stage biopharmaceutical company focused on developing innovative immunotherapies targeting chronic inflammation and related diseases, aiming to improve healthspan and quality of life [3] - The company's lead product candidate, HCW9302, was developed using the legacy TOBI platform, while the new TRBC platform allows for the creation of various classes of immunotherapeutic compounds [3] TRBC Platform Details - The TRBC platform enables the development 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 [2][3] - Over 50 molecules have been constructed using the TRBC platform, with ongoing preclinical evaluations based on promising data [3] Upcoming Presentations - The company will showcase three posters at the conference: - **Poster 1**: A novel multi-functional bispecific T-cell engager molecule for cancer therapy (Class III TRBC Compound) on November 7, 2025 [2] - **Poster 2**: A novel tetra-specific pembrolizumab-based immunotherapeutic (Class II TRBC Compound) on November 8, 2025 [2] - **Poster 3**: Enhancing immune cell expansion and checkpoint inhibitor synergy using HCW11-006 (Class I TRBC Compound) on November 8, 2025 [2]

Core Insights - HCW Biologics has announced advancements in its second-generation T-Cell Engager (TCE) program, which aims to improve manufacturability, safety, and efficacy in treating solid tumors compared to first-generation TCEs [2][3] Company Overview - HCW Biologics Inc. is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies to combat age-related diseases linked to chronic inflammation [5] - The company’s lead product candidate, HCW9302, was developed using the legacy TOBI platform, while the new TRBC platform allows for the creation of various immunotherapeutic compounds [5] T-Cell Engager Program - The second-generation TCE program is based on TRBC technology and has shown a positive safety profile in recent non-human primate studies [3] - The new TCEs are designed to address challenges faced by first-generation TCEs, including complex manufacturing, tolerability, and efficacy in solid tumors [3] Research and Development - HCW Biologics has developed over 50 molecules using the TRBC platform, with ongoing preclinical evaluations for selected candidates based on promising data [5] - The TRBC platform enables the development of multiple classes of immunotherapeutics, targeting various diseases including cancer and autoimmune conditions [5]

Core Insights - HCW Biologics congratulates Wugen on its $115 million equity financing led by Fidelity Management & Research Company, indicating strong institutional support for Wugen's development of CAR-T cell therapies [1][3] - HCW Biologics holds a minority equity interest in Wugen, which has generated $16.2 million in revenue from a license agreement since its inception [2] Company Overview: HCW Biologics - HCW Biologics is a clinical-stage biopharmaceutical company focused on developing immunotherapies targeting chronic inflammation and age-related diseases [3] - The company’s lead product candidate, HCW9302, is developed using the TOBI™ platform, and it has also created the TRBC platform for constructing various immunotherapeutics [3] - HCW Biologics has over 50 molecules in development using the TRBC platform, with ongoing preclinical evaluations [3] Company Overview: Wugen - Wugen is a pivotal-stage biotechnology company specializing in off-the-shelf cell therapies derived from healthy donor cells, aimed at treating hematologic malignancies [4] - The company utilizes a proprietary CAR-T platform to address unmet medical needs and has optimized its US-based manufacturing for scalability and rapid deployment [4]

Core Insights - HCW Biologics Inc. is advancing its lead product candidate HCW11-040, a second-generation pembrolizumab-based immunotherapeutic, into late IND-enabling studies for the treatment of solid tumors [1][4] - The company has discovered a unique combination of cytokines that can expand Progenitor Exhausted T (TPEX) cells without causing a cytokine storm, which is a significant advancement in immunotherapy [2][3] Group 1: Product Development - HCW11-040 is a multi-functional fusion protein that combines pembrolizumab with interleukin (IL)-7, IL-15, and TGF-β receptor components, aimed at enhancing the immune response against cancer [2] - Preclinical studies indicate that HCW11-040 outperforms pembrolizumab monotherapy in immune-cell activation, tumor infiltration, and cytotoxicity against cancer cells [3] - The company plans to conduct high-expression manufacturing cell bank creation, chemistry manufacture control process development, and preclinical Good Laboratory Practice toxicology studies for HCW11-040 [4] Group 2: Company Overview - HCW Biologics is focused on developing novel immunotherapies to treat diseases associated with chronic inflammation, particularly age-related diseases [5] - The company utilizes its proprietary TRBC drug discovery platform to create a range of immunotherapeutics, including multi-functional immune cell stimulators and second-generation immune checkpoint inhibitors [6] - HCW Biologics has developed over 50 molecules using the TRBC platform, with ongoing preclinical evaluations for selected candidates based on promising data [6]

Core Insights - Premarket trading is showing notable activity with significant price movements indicating potential trading opportunities before the market opens [1] Premarket Gainers - Vestand Inc. (VSTD) is up 96% at $2.53 - GlucoTrack, Inc. (GCTK) is up 86% at $9.09 - HCW Biologics Inc. (HCWB) is up 71% at $5.68 - Millennium Group International Holdings Limited (MGIH) is up 31% at $2.87 - IBEX Limited (IBEX) is up 27% at $38.74 - BGSF, Inc. (BGSF) is up 27% at $8.19 - Apimeds Pharmaceuticals US, Inc (APUS) is up 23% at $2.40 - Asset Entities Inc. (ASST) is up 16% at $10.39 - HUB Cyber Security Ltd. (HUBC) is up 10% at $2.71 - BioNexus Gene Lab Corp. (BGLC) is up 9% at $4.70 [3] Premarket Losers - Rent the Runway, Inc. (RENT) is down 21% at $6.17 - XTI Aerospace, Inc. (XTIA) is down 19% at $1.64 - RH (RH) is down 9% at $206.00 - Frequency Electronics, Inc. (FEIM) is down 9% at $30.96 - Global Mofy AI Limited (GMM) is down 9% at $1.99 - Jeffs' Brands Ltd (JFBR) is down 8% at $4.33 - Kindly MD, Inc. (NAKA) is down 8% at $3.60 - Empro Group Inc. (EMPG) is down 7% at $12.38 - Rezolve AI PLC (RZLV) is down 6% at $6.32 - NLS Pharmaceutics AG (NLSP) is down 5% at $2.03 [4]

Group 1 - HCW Biologics Inc. shares surged 102.72% to $6.73 in after-hours trading following the announcement of successful development of second-generation T-cell engagers targeting solid tumors [1] - The company has developed new T-cell engagers targeting tissue factor for treating pancreatic cancer and glioblastoma using its TRBC platform technology [2] - The advancement aims to address major issues with earlier T-cell engagers, including manufacturing difficulties, safety concerns, and weak results against solid tumors [3] Group 2 - HCW Biologics reported 100% survival rates in tumor-bearing mice models for its lead candidate, while untreated mice showed zero survival [4] - Non-human primate studies indicated that the treatment was well-tolerated at efficacious dose levels without inducing cytokine release syndrome [4] - The CEO stated that preclinical studies show potential for significant tumor shrinkage with the second-generation T-cell engagers [5] Group 3 - The company plans to collaborate with financially robust corporations for development, aiming to capitalize on a market where T-cell engagers generate billions in annual sales [5] - Over the past year, HCW Biologics experienced significant stock fluctuations, peaking at $49.60 on November 18, 2024, and recently dropping to $3.32 [6] - The stock has averaged 3.06 million shares traded daily over the year, reflecting a loss of 85.46% [6]

Core Insights - HCW Biologics has developed second-generation T-cell engagers (TCEs) targeting solid tumors, particularly pancreatic cancer and glioblastoma, using its proprietary TRBC platform technology [2][4] - The company has demonstrated that its lead TCE candidate is well tolerated in non-human primates at doses significantly higher than the efficacious dose, with no evidence of overt toxicity or cytokine release syndrome [5][6] - The TCEs are designed to address challenges faced by first-generation TCEs, including antigen selection, efficacy for solid tumors, and complex manufacturing processes, positioning the company for potential high-value corporate partnerships [4][7] Company Overview - HCW Biologics Inc. is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies to treat diseases associated with chronic inflammation and age-related conditions [8] - The company has created over 50 molecules using its TRBC platform, which allows for the construction of various classes of immunotherapeutic compounds targeting oncology and autoimmune diseases [8] Market Context - T-cell engagers have transformed cancer immunotherapy since the approval of Amgen's BLINCYTO in 2014, with eight TCEs currently approved for 11 indications, generating multi-billion-dollar annual sales [3] - The landscape of cancer therapy is evolving with numerous high-value partnerships between major pharmaceutical companies and biotech firms, driven by the potential of TCEs in oncology and autoimmune diseases [3]

Core Viewpoint - HCW Biologics (HCWB.US) experienced a nearly 70% surge in stock price, reaching $5.81, following the announcement of a second-generation immunotherapy drug based on Pembrolizumab targeting solid tumors, particularly pancreatic and ovarian cancers [1] Company Summary - HCW Biologics has developed a novel proprietary TRBC product discovery and development platform technology for its new immunotherapy drug [1] - The company highlighted that immune checkpoint inhibitors (ICIs), introduced in cancer treatment since 2011, are considered groundbreaking therapies but have shown a lack of immune cell co-stimulation activity, which diminishes their anti-tumor efficacy [1]

Group 1 - HCW Biologics experienced a nearly 70% surge in stock price, reaching $5.81, following the announcement of a second-generation immunotherapy drug based on Pembrolizumab targeting solid tumors, particularly pancreatic and ovarian cancers [1] - The company utilizes a novel proprietary TRBC product discovery and development platform technology for its new drug [1] - Since the introduction of immune checkpoint inhibitors (ICIs) in cancer treatment in 2011, they have been recognized as breakthrough therapies, although the company noted that preclinical and clinical studies indicate ICIs lack co-stimulatory activity of immune cells, reducing their anti-tumor efficacy [1]

Core Viewpoint - HCW Biologics (HCWB.US) experienced a nearly 70% surge in stock price, reaching $5.81, following the announcement of a second-generation immunotherapy drug based on pembrolizumab targeting solid tumors, particularly pancreatic and ovarian cancers [1] Company Summary - The company has developed a novel proprietary TRBC product discovery and development platform technology for its new immunotherapy drug [1] - Since the introduction of immune checkpoint inhibitors (ICIs) in cancer treatment in 2011, they have been recognized as breakthrough therapies [1] - The company highlighted that preclinical and clinical studies indicate that ICIs lack co-stimulatory activity of immune cells, which diminishes their anti-tumor efficacy [1]