{"success":true,"data":{"pressRelease":{"id":"165449","rtpr_id":"nGNX8BWTrk-20261009","ticker":"HCWB","exchange":"NASDAQ","all_tickers":["HCWB"],"title":"HCW Biologics Maintains Momentum Toward Completion of IND Application for Clinical Study to Evaluate Lead T-Cell Engager in Solid Tumors","author":"Globe Newswire","published_at":"2026-10-09T13:00:00.703Z","article_body":"Communication with FDA at recent Type B meeting provided clear guidance for\nnext steps to prepare IND application to support first-in-human clinical study\nin cancer \n\nHCW11-018b is Company’s lead candidate in its second-generation T-Cell\nEngager Program constructed using proprietary non-FC based TRBC platform\ntechnology\n\nManufacturing of cGMP material for clinical trials is underway\n\nIND application remains on track to be filed in 1H 2027\n\nMIRAMAR, Fla., Oct. 09, 2026 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (the\n“Company” or “HCW Biologics”) (NASDAQ: HCWB), a U.S.-based\nclinical-stage biopharmaceutical company focused on developing novel fusion\nimmunotherapeutics to treat autoimmune diseases, cancer, and\nsenescence-associated dysplasia, maintains momentum toward filing an IND\napplication to evaluate HCW11-018b, the lead product candidate in its\nsecond-generation, non-Fc-based T-Cell Engager Program, in the treatment of\nsolid tumors. The Company’s T-Cell Engager Program is derived from its\nproprietary drug discovery and development TRBC platform, which features a\nprotein-based scaffold that allows for the construction of tetravalent\nmolecules.\n\nT-Cell Engagers, particularly bispecific T-Cell Engagers (“BiTEs”), are\npromising cancer immunotherapies for hematologic malignancies. However, their\nsuccess against solid tumors has been limited because the immunosuppressive\ntumor microenvironments and physical barriers can reduce their effectiveness\nand impede infiltration by cancer-fighting immune cells.\n\nHCW11-018b incorporates the core features of a BiTE while adding components\nthat alleviate immunosuppression and promote activation and tumor infiltration\nof cancer-fighting cells. The BiTE component of HCW11-018b contains an\nanti-CD3 single-chain antibody and an antibody domain that targets human\nTissue Factor (“TF”), which is overexpressed in a wide spectrum of solid\ntumors. In addition, the molecule includes soluble IL-15, an IL-15 receptor α\n(“IL-15Rα”) domain, and a TGF-β receptor II (“TGFβRII”) domain\ntrap. The result is a compound that targets TF-positive tumor cells, engages\nCD3 on T cells, incorporates IL-15/IL-15Rα activity, and uses a soluble\nTGFβRII domain as a TGF-β trap to reduce immunosuppression.\n\nTargeting TGF-β has emerged as a promising strategy in cancer therapy.\nBesides its direct effects on cancer cells, TGF-β pro-tumorigenic activity\nincludes its immunosuppression effects on CD8(+) and NK cells, induction of\nregulatory T cells, and hindrance of effector-cell infiltration into the\ntumors by modulating monocytes and macrophages in the tumor microenvironment.\nThe Company included IL-15 because it is an attractive immune-stimulatory\ncytokine that supports CD8(+) T-cell and NK cell survival, proliferation, and\ncytotoxic functions without inducing the activation cell death phenomenon\nmediated by IL-2.\n\nDr. Hing C. Wong, the Company’s Founder and Chief Executive Officer, stated,\n“Tissue factor has been shown to be highly expressed by various solid\ntumors. Cancers that hijack the body’s TF are very difficult-to-treat\ncancers. They use TF to avoid immune-cells that would attack them, use\nextracellular matrix interactions to promote the growth of cancer, increase\nchances for metastasis, and build resistance to standard-of-care therapies.”\n\nDr. Wong continued, “With our non-Fc based T-Cell Engager program derived\nfrom the TRBC platform technology, we have created a second-generation T-Cell\nEngager, HCW11-018b. HCW11-018b has demonstrated that the addition of\nTGFβ-trap and IL-15 components onto a BiTE domain can overcome the\ndeficiencies of BiTE alone for solid tumor therapy. We are pleased with the\nclear regulatory guidance provided by the FDA at our recent Type B meeting\nregarding the preparation of an IND application for a first-in-human clinical\nstudy of HCW11-018b in cancer. This guidance enables us to maintain our\nmomentum toward achieving our target to file the IND application in the 1H\n2027.”\n\nAbout HCW Biologics:\n\nHCW Biologics Inc. (the “Company”) (NASDAQ: HCWB) is a clinical-stage\nbiopharmaceutical company developing transformative fusion immunotherapeutics\nto treat diseases promoted by chronic inflammation, including autoimmune\ndiseases, cancer, and senescence-associated dysplasia. HCW Biologics is the\nleader in creation of multi-valent immunotherapeutics with a unique\nprotein-based scaffold, without the antibody Fc domain. The Company’s\nimmunotherapeutics represent a new class of drugs that it believes have the\npotential to fundamentally change the treatment of proinflammatory and\nsenescence-associated diseases and conditions that are promoted by chronic\ninflammation —and in doing so, improve patients’ quality of life and\npossibly extend longevity. A key aspect of the Company’s clinical\ndevelopment and financing strategy is to focus on its business development\nprograms, including its commercial-ready reagents to be used in the production\nof immunotherapeutics for cancer and infectious diseases. To date, the Company\nhas entered into two licensing agreements in which it has licensed exclusive,\nworldwide rights for some of its proprietary molecules. See the Company\nPipeline at https://hcwbiologics.com/pipeline/\n\nForward Looking Statements:\n\nStatements in this press release contain “forward-looking statements” that\nare subject to substantial risks and uncertainties. These statements are made\nunder the “safe harbor” provisions of the U.S. Private Securities\nLitigation Reform Act of 1995. Forward-looking statements contained in this\npress release may be identified by the use of words such as “anticipate,”\n“expect,” “believe,” “will,” “may,” “should,”\n“estimate,” “project,” “outlook,” “forecast” or other similar\nwords and include, the ability and efficacy of HCW11-018b for the treatment of\nsolid tumors; the ability of HCW11-018b and its components to alleviate\nimmunosuppression and promote activation and tumor infiltration of\ncancer-fighting cells; the ability of HCW11-018b to overcome the deficiencies\nof other BiTEs against solid tumors; the ability of the Company to timely file\nthe IND for HCW11-018b trial by 1H 2027; and the probability of receiving a\nfavorable result from the submission of the IND for HCW11-018b based upon FDA\nType B meeting response. Forward-looking statements are based on the\nCompany’s current expectations and are subject to inherent uncertainties,\nrisks and assumptions that are difficult to predict. Further, certain\nforward-looking statements are based on assumptions as to future events that\nmay not prove to be accurate. Factors that could cause actual results to\ndiffer include, but are not limited to, the risks and uncertainties that are\ndescribed in the section titled “Risk Factors” in the annual report on\nForm 10-K filed with the United States Securities and Exchange Commission (the\n“SEC”) on March 31, 2026 and in other filings filed from time to time with\nthe SEC.\n\nCompany Contact:\n\nPeter Rhode, Ph.D.\nChief Scientific Officer and VP Clinical Affairs\nHCW Biologics Inc.\nPeterRhode@hcwbiologics.com \n\nThis press release was published by a CLEAR® Verified individual.\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/5689edc3-6997-43a0-a20c-b34dc5f99b0f)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNX8BWTrk-20261009","title":"HCW Biologics Maintains Momentum Toward Completion of IND Application for Clinical Study to Evaluate Lead T-Cell Engager in Solid Tumors","author":"Globe Newswire","ticker":"HCWB","created":"2026-10-09T13:00:00.703Z","tickers":["HCWB"],"exchange":"NASDAQ","article_body":"Communication with FDA at recent Type B meeting provided clear guidance for\nnext steps to prepare IND application to support first-in-human clinical study\nin cancer \n\nHCW11-018b is Company’s lead candidate in its second-generation T-Cell\nEngager Program constructed using proprietary non-FC based TRBC platform\ntechnology\n\nManufacturing of cGMP material for clinical trials is underway\n\nIND application remains on track to be filed in 1H 2027\n\nMIRAMAR, Fla., Oct. 09, 2026 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (the\n“Company” or “HCW Biologics”) (NASDAQ: HCWB), a U.S.-based\nclinical-stage biopharmaceutical company focused on developing novel fusion\nimmunotherapeutics to treat autoimmune diseases, cancer, and\nsenescence-associated dysplasia, maintains momentum toward filing an IND\napplication to evaluate HCW11-018b, the lead product candidate in its\nsecond-generation, non-Fc-based T-Cell Engager Program, in the treatment of\nsolid tumors. The Company’s T-Cell Engager Program is derived from its\nproprietary drug discovery and development TRBC platform, which features a\nprotein-based scaffold that allows for the construction of tetravalent\nmolecules.\n\nT-Cell Engagers, particularly bispecific T-Cell Engagers (“BiTEs”), are\npromising cancer immunotherapies for hematologic malignancies. However, their\nsuccess against solid tumors has been limited because the immunosuppressive\ntumor microenvironments and physical barriers can reduce their effectiveness\nand impede infiltration by cancer-fighting immune cells.\n\nHCW11-018b incorporates the core features of a BiTE while adding components\nthat alleviate immunosuppression and promote activation and tumor infiltration\nof cancer-fighting cells. The BiTE component of HCW11-018b contains an\nanti-CD3 single-chain antibody and an antibody domain that targets human\nTissue Factor (“TF”), which is overexpressed in a wide spectrum of solid\ntumors. In addition, the molecule includes soluble IL-15, an IL-15 receptor α\n(“IL-15Rα”) domain, and a TGF-β receptor II (“TGFβRII”) domain\ntrap. The result is a compound that targets TF-positive tumor cells, engages\nCD3 on T cells, incorporates IL-15/IL-15Rα activity, and uses a soluble\nTGFβRII domain as a TGF-β trap to reduce immunosuppression.\n\nTargeting TGF-β has emerged as a promising strategy in cancer therapy.\nBesides its direct effects on cancer cells, TGF-β pro-tumorigenic activity\nincludes its immunosuppression effects on CD8(+) and NK cells, induction of\nregulatory T cells, and hindrance of effector-cell infiltration into the\ntumors by modulating monocytes and macrophages in the tumor microenvironment.\nThe Company included IL-15 because it is an attractive immune-stimulatory\ncytokine that supports CD8(+) T-cell and NK cell survival, proliferation, and\ncytotoxic functions without inducing the activation cell death phenomenon\nmediated by IL-2.\n\nDr. Hing C. Wong, the Company’s Founder and Chief Executive Officer, stated,\n“Tissue factor has been shown to be highly expressed by various solid\ntumors. Cancers that hijack the body’s TF are very difficult-to-treat\ncancers. They use TF to avoid immune-cells that would attack them, use\nextracellular matrix interactions to promote the growth of cancer, increase\nchances for metastasis, and build resistance to standard-of-care therapies.”\n\nDr. Wong continued, “With our non-Fc based T-Cell Engager program derived\nfrom the TRBC platform technology, we have created a second-generation T-Cell\nEngager, HCW11-018b. HCW11-018b has demonstrated that the addition of\nTGFβ-trap and IL-15 components onto a BiTE domain can overcome the\ndeficiencies of BiTE alone for solid tumor therapy. We are pleased with the\nclear regulatory guidance provided by the FDA at our recent Type B meeting\nregarding the preparation of an IND application for a first-in-human clinical\nstudy of HCW11-018b in cancer. This guidance enables us to maintain our\nmomentum toward achieving our target to file the IND application in the 1H\n2027.”\n\nAbout HCW Biologics:\n\nHCW Biologics Inc. (the “Company”) (NASDAQ: HCWB) is a clinical-stage\nbiopharmaceutical company developing transformative fusion immunotherapeutics\nto treat diseases promoted by chronic inflammation, including autoimmune\ndiseases, cancer, and senescence-associated dysplasia. HCW Biologics is the\nleader in creation of multi-valent immunotherapeutics with a unique\nprotein-based scaffold, without the antibody Fc domain. The Company’s\nimmunotherapeutics represent a new class of drugs that it believes have the\npotential to fundamentally change the treatment of proinflammatory and\nsenescence-associated diseases and conditions that are promoted by chronic\ninflammation —and in doing so, improve patients’ quality of life and\npossibly extend longevity. A key aspect of the Company’s clinical\ndevelopment and financing strategy is to focus on its business development\nprograms, including its commercial-ready reagents to be used in the production\nof immunotherapeutics for cancer and infectious diseases. To date, the Company\nhas entered into two licensing agreements in which it has licensed exclusive,\nworldwide rights for some of its proprietary molecules. See the Company\nPipeline at https://hcwbiologics.com/pipeline/\n\nForward Looking Statements:\n\nStatements in this press release contain “forward-looking statements” that\nare subject to substantial risks and uncertainties. These statements are made\nunder the “safe harbor” provisions of the U.S. Private Securities\nLitigation Reform Act of 1995. Forward-looking statements contained in this\npress release may be identified by the use of words such as “anticipate,”\n“expect,” “believe,” “will,” “may,” “should,”\n“estimate,” “project,” “outlook,” “forecast” or other similar\nwords and include, the ability and efficacy of HCW11-018b for the treatment of\nsolid tumors; the ability of HCW11-018b and its components to alleviate\nimmunosuppression and promote activation and tumor infiltration of\ncancer-fighting cells; the ability of HCW11-018b to overcome the deficiencies\nof other BiTEs against solid tumors; the ability of the Company to timely file\nthe IND for HCW11-018b trial by 1H 2027; and the probability of receiving a\nfavorable result from the submission of the IND for HCW11-018b based upon FDA\nType B meeting response. Forward-looking statements are based on the\nCompany’s current expectations and are subject to inherent uncertainties,\nrisks and assumptions that are difficult to predict. Further, certain\nforward-looking statements are based on assumptions as to future events that\nmay not prove to be accurate. Factors that could cause actual results to\ndiffer include, but are not limited to, the risks and uncertainties that are\ndescribed in the section titled “Risk Factors” in the annual report on\nForm 10-K filed with the United States Securities and Exchange Commission (the\n“SEC”) on March 31, 2026 and in other filings filed from time to time with\nthe SEC.\n\nCompany Contact:\n\nPeter Rhode, Ph.D.\nChief Scientific Officer and VP Clinical Affairs\nHCW Biologics Inc.\nPeterRhode@hcwbiologics.com \n\nThis press release was published by a CLEAR® Verified individual.\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/5689edc3-6997-43a0-a20c-b34dc5f99b0f)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-10-09T13:00:00.779555962Z","server_sent_at_ms":1791550800779},"received_at":"2026-10-09T13:00:00.829Z","source_url":null},"analysis":{"id":"153844","press_release_id":"165449","analysis_json":{"industry":{"label":"Biotechnology","sector":"Health Care"},"redFlags":["first-in-human study still more than a year away; IND not yet filed","clinical-stage company with no approved products"],"eventType":"clinical_trial","narrative":"HCW Biologics remains on track to file an IND application in 1H 2027 for HCW11-018b, its lead second-generation T-Cell Engager targeting solid tumors.\n\nThe FDA provided clear guidance at a recent Type B meeting on preparing the IND for a first-in-human study, and cGMP manufacturing of clinical-trial material is already underway.\n\nHCW11-018b combines a BiTE targeting Tissue Factor with IL-15/IL-15Rα and a TGF-β trap, a design the company says addresses the limited efficacy of first-generation BiTEs against solid tumors.","sentiment":"bullish","agentHooks":{"shouldPost":true,"suggestedAngle":"FDA Type B feedback de-risks path to IND filing for lead T-Cell Engager in solid tumors by 1H 2027."},"keyFigures":{"drugName":"HCW11-018b","guidance":"IND application on track to be filed in 1H 2027","customDimensions":{"stage":"pre-IND, first-in-human study planned","ind_filing_target":"1H 2027"}},"quotedText":"We are pleased with the clear regulatory guidance provided by the FDA at our recent Type B meeting regarding the preparation of an IND application for a first-in-human clinical study of HCW11-018b in cancer.","namedEntities":{"people":[{"name":"Dr. Hing C. Wong","role":"Founder and CEO"},{"name":"Peter Rhode, Ph.D.","role":"Chief Scientific Officer and VP Clinical Affairs"}],"products":["HCW11-018b","TRBC platform","T-Cell Engager Program"],"companies":[{"name":"HCW Biologics Inc.","ticker":"HCWB","relationship":"filer"},{"name":"U.S. Food and Drug Administration","relationship":"regulator"}],"dollarAmounts":[]},"materialImpact":{"score":2,"reasoning":"Preclinical-stage progress update: FDA Type B meeting guidance received and IND filing on track for 1H 2027. No clinical data, no binary outcome; meaningful but routine milestone tracking for a clinical-stage micro-cap."},"tickerRelevance":{"others":[],"primary":"HCWB"},"globalImportance":22,"audienceRelevance":18,"eventTypeSecondary":["regulatory"],"importanceComponents":{"tickerTier":"micro-cap","eventGravity":"regulatory-pathway milestone, no data","preclinicalStage":true}},"event_type":"clinical_trial","event_type_secondary":["regulatory"],"sentiment":"bullish","material_impact_score":2,"narrative":"HCW Biologics remains on track to file an IND application in 1H 2027 for HCW11-018b, its lead second-generation T-Cell Engager targeting solid tumors.\n\nThe FDA provided clear guidance at a recent Type B meeting on preparing the IND for a first-in-human study, and cGMP manufacturing of clinical-trial material is already underway.\n\nHCW11-018b combines a BiTE targeting Tissue Factor with IL-15/IL-15Rα and a TGF-β trap, a design the company says addresses the limited efficacy of first-generation BiTEs against solid tumors.","key_figures":{"drugName":"HCW11-018b","guidance":"IND application on track to be filed in 1H 2027","customDimensions":{"stage":"pre-IND, first-in-human study planned","ind_filing_target":"1H 2027"}},"named_entities":{"people":[{"name":"Dr. Hing C. Wong","role":"Founder and CEO"},{"name":"Peter Rhode, Ph.D.","role":"Chief Scientific Officer and VP Clinical Affairs"}],"products":["HCW11-018b","TRBC platform","T-Cell Engager Program"],"companies":[{"name":"HCW Biologics Inc.","ticker":"HCWB","relationship":"filer"},{"name":"U.S. Food and Drug Administration","relationship":"regulator"}],"dollarAmounts":[]},"model_name":"glm-5.3-flashx","prompt_hash":"sha256:5c812bd9e28b810d","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-10-09T13:00:11.796Z","global_importance":22,"audience_relevance":18,"importance_components":{"tickerTier":"micro-cap","eventGravity":"regulatory-pathway milestone, no data","preclinicalStage":true}},"durationMs":5253,"modelName":"glm-5.3-flashx"}}