Adenosquamous Carcinoma

NCI Activated as Clinical Site for Phase 1b/2 Clinical Trial to Evaluate HCW9218 in Advanced Pancreatic CancerMIRAMAR, Fla., Dec. 08, 2022 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (the “Company” or “HCW Biologics”) (NASDAQ: HCWB), a clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen health span by disrupting the link between inflammation and age-related diseases, today announced that under a Cooperative Research and Development Agreement (CRADA), the National Cancer Institute (NCI) and HCW Biologics Inc. (HCW Biologics) will collaborate to perform a Phase 1b/2 clinical study to evaluate the safety and tolerability of HCW Biologics’ proprietary agent, HCW9218, in patients with advanced/metastatic pancreatic cancer. The CRADA is entitled, “A Phase 1b/2 Study of HCW9218, a Bifunctional TGF- β Antagonist/IL-15 Protein Complex, for Advanced Pancreatic Cancer.” The Principal Investigator at NCI is Christine Alewine, M.D., Ph.D. Dr. Alewine is a Lasker Clinical Research Scholar at the National Institutes of Health in the Laboratory of Molecular Biology. Her research focuses on identifying new treatments for pancreatic cancer including pancreatic adenocarcinoma, adenosquamous carcinoma, and acinar cell carcinoma. Dr. Alewine is board certified in internal medicine and medical oncology. About the Center for Cancer Research at the National Cancer Institute:The Center for Cancer Research (CCR), NCI’s specialized internal cancer center, has a robust clinical research program, the largest at the National Institutes of Health. Their physician‐scientists conduct clinical trials that explore unique and understudied questions in cancer research and treatment. CCR collaborates extensively with partners in industry, non‐governmental organizations and academia to conduct clinical trials. As a federally funded entity, a fundamental goal is for CCR to publicize its research activities to the general public. About the Phase 1b/2 Clinical Trial to Evaluate HCW9218 in Advanced Pancreatic CancerSee, “HCW9218 for Advanced Pancreatic Cancer,” at Clinicaltrials.gov Identifier: NCT05304936. About Advanced Pancreatic Cancer:Pancreatic cancer is the third leading cause of cancer death in the United States. The disease accounts for approximately 3% of all cancers. This disease is most frequently diagnosed among people aged 65–74. In 2022, there will be an estimated 62,210 new cases of pancreatic cancer and 49,830 deaths in the U.S. Incidence rates of pancreatic cancer have gone up by around 1% each year since 2000. Worldwide, an estimated 495,773 people were diagnosed with pancreatic cancer in 2020. Because survival is poor, the population distribution of people who die of pancreatic cancer is similar to that of people who are diagnosed with the disease. In part because it is difficult to detect early, the average survival time from pancreatic cancer is low. About HCW Biologics: HCW Biologics is a clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen healthspan by disrupting the link between chronic, low-grade inflammation, and age-related diseases, such as cancer, cardiovascular diseases, diabetes, neurodegenerative diseases, and autoimmune diseases. The Company has combined deep understanding of disease-related immunology with its expertise in advanced protein engineering to develop the TOBI™ (Tissue factOr-Based fusIon) discovery platform. The Company uses its TOBITM discovery platform to generate designer, novel multi-functional fusion molecules with immunotherapeutic properties. The invention of HCW Biologics’ two lead molecules, HCW9218 and HCW9302, was made via the TOBI™ discovery platform. The Masonic Cancer Center, University of Minnesota, has initiated a Phase 1 clinical trial to evaluate HCW9218 in chemo-refractory/chemo-resistant solid tumors that have progressed after prior chemotherapies (Clinicaltrials.gov: NCT05322408). The Company is also enrolling patients in a Company-sponsored Phase 1b/2 clinical trial to evaluate HCW9218 in chemo-refractory/chemo-resistant advanced pancreatic cancer (Clinicaltrials.gov: NCT05304936). The Company’s lead molecule for its regulatory T cell expansion program, HCW9302, is currently undergoing IND-enabling studies for an autoimmune indication. 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, without limitation, statements regarding HCW9218 being a new category of cancer treatment capable of modifying factors related to drug resistance and disease recurrence; the ability of HCW9218 to treat cancer; and the ability of HCW9218 to neutralize TGF-β and the Company’s ability to provide an early human data readout. 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 Company’s Quarterly Report on Form 10-Q filed with the United States Securities and Exchange Commission (the “SEC”) on November 7, 2022 and in other filings filed from time to time with the SEC. Forward-looking statements contained in this press release are made as of this date, and the Company undertakes no duty to update such information except as required under applicable law. Company Contact:Rebecca ByamCFOHCW Biologics Inc.rebeccabyam@hcwbiologics.com

MIRAMAR, Fla., Dec. 08, 2022 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (the “Company” or “HCW Biologics”) (NASDAQ: HCWB), a clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen health span by disrupting the link between inflammation and age-related diseases, today announced that under a Cooperative Research and Development Agreement (CRADA), the National Cancer Institute (NCI) and HCW Biologics Inc. (HCW Biologics) will collaborate to perform a Phase 1b/2 clinical study to evaluate the safety and tolerability of HCW Biologics’ proprietary agent, HCW9218, in patients with advanced/metastatic pancreatic cancer. The CRADA is entitled, “A Phase 1b/2 Study of HCW9218, a Bifunctional TGF- β Antagonist/IL-15 Protein Complex, for Advanced Pancreatic Cancer.” The Principal Investigator at NCI is Christine Alewine, M.D., Ph.D. Dr. Alewine is a Lasker Clinical Research Scholar at the National Institutes of Health in the Laboratory of Molecular Biology. Her research focuses on identifying new treatments for pancreatic cancer including pancreatic adenocarcinoma, adenosquamous carcinoma, and acinar cell carcinoma. Dr. Alewine is board certified in internal medicine and medical oncology. About the Center for Cancer Research at the National Cancer Institute: The Center for Cancer Research (CCR), NCI’s specialized internal cancer center, has a robust clinical research program, the largest at the National Institutes of Health. Their physician‐scientists conduct clinical trials that explore unique and understudied questions in cancer research and treatment. CCR collaborates extensively with partners in industry, non‐governmental organizations and academia to conduct clinical trials. As a federally funded entity, a fundamental goal is for CCR to publicize its research activities to the general public. About the Phase 1b/2 Clinical Trial to Evaluate HCW9218 in Advanced Pancreatic Cancer See, “HCW9218 for Advanced Pancreatic Cancer,” at Clinicaltrials.gov Identifier: NCT05304936. About Advanced Pancreatic Cancer: Pancreatic cancer is the third leading cause of cancer death in the United States. The disease accounts for approximately 3% of all cancers. This disease is most frequently diagnosed among people aged 65–74. In 2022, there will be an estimated 62,210 new cases of pancreatic cancer and 49,830 deaths in the U.S. Incidence rates of pancreatic cancer have gone up by around 1% each year since 2000. Worldwide, an estimated 495,773 people were diagnosed with pancreatic cancer in 2020. Because survival is poor, the population distribution of people who die of pancreatic cancer is similar to that of people who are diagnosed with the disease. In part because it is difficult to detect early, the average survival time from pancreatic cancer is low. About HCW Biologics: HCW Biologics is a clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen healthspan by disrupting the link between chronic, low-grade inflammation, and age-related diseases, such as cancer, cardiovascular diseases, diabetes, neurodegenerative diseases, and autoimmune diseases. The Company has combined deep understanding of disease-related immunology with its expertise in advanced protein engineering to develop the TOBI™ (Tissue factOr-Based fusIon) discovery platform. The Company uses its TOBITM discovery platform to generate designer, novel multi-functional fusion molecules with immunotherapeutic properties. The invention of HCW Biologics’ two lead molecules, HCW9218 and HCW9302, was made via the TOBI™ discovery platform. The Masonic Cancer Center, University of Minnesota, has initiated a Phase 1 clinical trial to evaluate HCW9218 in chemo-refractory/chemo-resistant solid tumors that have progressed after prior chemotherapies (Clinicaltrials.gov: NCT05322408). The Company is also enrolling patients in a Company-sponsored Phase 1b/2 clinical trial to evaluate HCW9218 in chemo-refractory/chemo-resistant advanced pancreatic cancer (Clinicaltrials.gov: NCT05304936). The Company’s lead molecule for its regulatory T cell expansion program, HCW9302, is currently undergoing IND-enabling studies for an autoimmune indication. 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, without limitation, statements regarding HCW9218 being a new category of cancer treatment capable of modifying factors related to drug resistance and disease recurrence; the ability of HCW9218 to treat cancer; and the ability of HCW9218 to neutralize TGF-β and the Company’s ability to provide an early human data readout. 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 Company’s Quarterly Report on Form 10-Q filed with the United States Securities and Exchange Commission (the “SEC”) on November 7, 2022 and in other filings filed from time to time with the SEC. Forward-looking statements contained in this press release are made as of this date, and the Company undertakes no duty to update such information except as required under applicable law. Company Contact: Rebecca Byam CFO HCW Biologics Inc. rebeccabyam@hcwbiologics.com

Approval based on a Phase 3 trial that demonstrated significant survival benefit in patients with recurrent or metastatic cervical cancer, with Libtayo reducing the risk of death by 31% compared to chemotherapy during the study Libtayo now approved to treat four cancer types in the European Union TARRYTOWN, NY, USA I November 22, 2022 I Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN ) today announced that the European Commission (EC) approved Libtayo ® (cemiplimab) as monotherapy for the treatment of adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy. "Despite recent advancements in the prevention and treatment of cervical cancer, there remain limited options for people with recurrent or metastatic cases," said Israel Lowy, M.D., Ph.D., Senior Vice President, Translational and Clinical Sciences, Oncology at Regeneron. "Libtayo was the first PD-1 inhibitor to demonstrate significant improvements in survival compared to chemotherapy in a Phase 3 trial. With this fourth approval from the European Commission, Libtayo can now be extended to appropriate patients in the European Union with advanced cervical cancer, irrespective of their PD-L1 status or histology." The EC approval in advanced cervical cancer is based on data from the global Phase 3 EMPOWER-Cervical 1 trial, which was conducted with the GOG Foundation, Inc. (GOG), the European Network for Gynaecological Oncological Trial groups (ENGOT) and NRG Oncology-Japan. The trial evaluated Libtayo in comparison to an investigator's choice of chemotherapy and enrolled 608 patients across 14 countries, irrespective of PD-L1 expression status or histology. In March 2021, the trial was stopped early based on the highly significant effect of Libtayo on overall survival (OS) among squamous cell carcinoma (SCC) patients following a unanimous recommendation by the Independent Data Monitoring Committee. "Consistent with our mission to bring the best treatments to patients across Europe living with gynaecological cancers, we are proud to have been a part of the landmark ENGOT-cx9/GEICO/EMPOWER Cervical-1 trial for Libtayo," said Professor Ignace Vergote, investigator and gynecologist oncologist at University Hospitals Leuven in Belgium, and Vice-Chair of the Trial Steering Committee. "Libtayo is an important advancement for patients with recurrent or metastatic cervical cancer whose disease has progressed following platinum-based chemotherapy and could offer a new standard of care in this setting. We are grateful to those who participated in the trial and to our partners at Regeneron, ENGOT, the GOG Foundation and NRG Oncology-Japan without whom this approval would not have been possible." Cervical cancer is the fourth leading cause of cancer death in women worldwide and is most frequently diagnosed between the ages of 35 and 44. Approximately 600,000 new cases of cervical cancer and 350,000 deaths from cervical cancer occur worldwide each year. Almost all cases are caused by human papillomavirus (HPV) infection, with approximately 80% classified as squamous cell carcinoma (SCC; arising from cells lining the external portion of the cervix) and the remainder largely adenocarcinomas (arising from glandular cells lining the internal portion of the cervix). Cervical cancer is often curable when detected early and effectively managed, but treatment options are more limited in advanced stages. In addition to today's approval, Libtayo is approved in the European Union (EU) for the treatment of certain patients with advanced basal cell carcinoma (BCC), advanced cutaneous squamous cell carcinoma (CSCC) and advanced non-small cell lung cancer (NSCLC). About the Phase 3 Trial EMPOWER-Cervical 1 was an open-label, multi-center Phase 3 trial that investigated Libtayo monotherapy versus an investigator's choice of commonly used chemotherapy in patients with recurrent or metastatic cervical cancer who had progressed on platinum-based chemotherapy. Patients (median age: 51 years) were randomized to receive Libtayo (350 mg every three weeks) or chemotherapy (pemetrexed, vinorelbine, topotecan, irinotecan or gemcitabine). The primary endpoint for the trial was OS, analyzed first among patients with SCC, then in the total population. Patients were allowed to enroll regardless of PD-L1 expression status, with 78% of patients having SCC and 22% having adenocarcinoma or adenosquamous carcinoma. The trial included women from 14 countries: Australia, Belgium, Brazil, Canada, Greece, Italy, Japan, Poland, Russia, South Korea, Spain, Taiwan, the UK and the U.S. Results from the trial demonstrated that those treated with Libtayo (n=304) compared to chemotherapy (n=304) experienced significant improvements in OS, progression-free survival (PFS) and objective response rate (ORR) including a: Safety was assessed in 1,281 patients with advanced solid malignancies who received Libtayo monotherapy in five clinical studies. The median duration of exposure to Libtayo was 28 weeks (range: 2 days to 144 weeks). Immune-mediated adverse reactions occurred in 21% of patients treated with Libtayo and led to permanent discontinuation in 4.6% of patients. The most common immune-mediated adverse reactions were hypothyroidism (6.8%), hyperthyroidism (3.0%), immune-mediated pneumonitis (2.6%), immune-mediated hepatitis (2.4%), immune-mediated colitis (2.0%) and immune-mediated skin adverse reactions (1.9%). Adverse events were serious in 32.4% of patients and led to permanent discontinuation in 9.4% of patients. The grade 3 or higher adverse events occurring in >1% of patients were anaemia (5.2%), hypertension (2.6%), fatigue (2.6%), urinary tract infection (2.3%), hepatitis (1.8%), musculoskeletal pain (1.8%), rash (1.6%) dyspnea (1.2%) and pneumonitis (1.1%). No new Libtayo safety signals were observed. Results from the trial were previously published in the New England Journal of Medicine . About Regeneron in Oncology At Regeneron, we're applying more than three decades of scientific innovation with the goal of developing paradigm-changing therapies for patients with cancer. Our oncology portfolio is built around two foundational approaches – our approved PD-1 inhibitor Libtayo and investigational bispecific antibodies – which are being evaluated both as monotherapies and in combination with emerging therapeutic modalities. Together, they provide us with unique combinatorial flexibility to develop potentially synergistic treatments for a wide range of solid tumors and blood cancers. If you are interested in learning more about our clinical trials, please contact us ( This email address is being protected from spambots. You need JavaScript enabled to view it. // or 844-734-6643) or visit our clinical trials website . About Libtayo Libtayo is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T cells and was invented using Regeneron's proprietary VelocImmune ® technology. By binding to PD-1, Libtayo has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation. In the U.S. and other countries, Libtayo is indicated in certain patients with advanced basal cell carcinoma (BCC), advanced cutaneous squamous cell carcinoma (CSCC) and advanced non-small cell lung cancer (NSCLC), as well as in advanced cervical cancer in the EU, Canada and Brazil. As of July 1, 2022, Libtayo is developed and marketed globally by Regeneron. In the U.S., the generic name for Libtayo in its approved indications is cemiplimab-rwlc, with rwlc as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the U.S. Food and Drug Administration (FDA). Outside of the U.S. the generic name of Libtayo in its approved indication is cemiplimab. The extensive clinical program for Libtayo is focused on difficult-to-treat cancers. Libtayo is currently being investigated in trials as a monotherapy, as well as in combination with either conventional or novel therapeutic approaches for other solid tumors and blood cancers. These potential uses are investigational, and their safety and efficacy have not been evaluated by any regulatory authority. U.S. FDA-approved Indications Libtayo is a prescription medicine used to treat: It is not known if Libtayo is safe and effective in children. About Regeneron's VelocImmune Technology Regeneron's VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron's co-Founder, President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite ® technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create approximately one in five of all original, FDA-approved or authorized fully human monoclonal antibodies. This includes REGEN-COV ® (casirivimab and imdevimab), Dupixent ® (dupilumab), Libtayo ® (cemiplimab-rwlc), Praluent ® (alirocumab), Kevzara ® (sarilumab), Evkeeza ® (evinacumab-dgnb) and Inmazeb ® (atoltivimab, maftivimab and odesivimab-ebgn). Please see full Prescribing Information , including Medication Guide . About Regeneron Regeneron is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led for nearly 35 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, hematologic conditions, infectious diseases and rare diseases. Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite technologies, such as VelocImmune , which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center ® , which is conducting one of the largest genetics sequencing efforts in the world. For more information, please visit www.Regeneron.com or follow @Regeneron on Twitter. SOURCE: Regeneron Pharmaceuticals