Duvelisib hydrate

Terzo remains on track for an interim data readout in early 2027, based on enrollment to date Achieved >30% annual growth in U.S. net sales of COPIKTRA™ through November BERKELEY HEIGHTS, N.J., Dec. 22, 2025 (GLOBE NEWSWIRE) -- Secura Bio, Inc. (www.securabio.com), an integrated pharmaceutical company maximizing commercial outcomes for oncology medicines, today provided a corporate update, including an update on the encouraging enrollment progress in its ongoing Phase 3 TERZO study of COPIKTRA (duvelisib) in adults with relapsed or refractory (R/R) nodal T-follicular helper cell lymphoma (nTFHL). The TERZO Phase 3 study of COPIKTRA (duvelisib) in patients with R/R nTFHL is a multicenter, open label, randomized controlled study of duvelisib versus investigator’s choice of gemcitabine or bendamustine. To date, the study has randomized 35 of the anticipated 124 patients and has activated 43 of the expected 45 sites across ten European countries. The Company initiated the study earlier this year, with the first patient dosed in June. “We are encouraged by the significant momentum in our Phase 3 TERZO trial, driven by the dedication of our investigators and strong interest from patients with R/R nTFHL,” said Dr. Christiane Langer, Senior Vice President of Clinical and Medical Affairs at Secura Bio. “Having achieved 25% patient accrual already, the study is advancing at the top end of our expectations and keeps us on track for an interim data readout in early 2027.” Additional 2025 Corporate Highlights: National Comprehensive Cancer Network® added duvelisib to Clinical Practice Guidelines in Cutaneous Lymphoma for Mycosis Fungoides / Sézary Syndrome (MFSS)Achieved >30% year-over-year annual growth in U.S. net sales of COPIKTRA year to date through NovemberStrengthened the management team with the addition of Christiane Langer, M.D., Senior Vice President of Clinical and Medical Affairs. Dr. Langer brings over 20 years of experience in clinical research and medical affairs having established deep expertise in hematology and oncology within corporate, commercial, and scientific communities.Expanded the company’s distribution territories and established patient access programs, including Puerto Rico, the European Union, United Kingdom and Israel Moved the company’s corporate headquarters to Berkley Heights, New Jersey from Nevada Executing a robust and active Business Development program and are currently evaluating commercial-stage hematology and oncology programs to expand the company’s commercial footprint Chip Romp, President and CEO of Secura Bio commented, “Secura Bio has made exceptional progress this year across each of our strategic areas including clinical development, commercial growth, and business development. We continue to see strong sales growth in the U.S. and importantly have expanded our reach into new territories such as Puerto Rico, the EU, UK, and Israel. We are well-positioned to advance our mission and are actively pursuing new commercial opportunities in hematology and oncology. These achievements reflect our commitment to delivering innovative therapies to patients worldwide and continuing to build Secura Bio into a world-class biopharmaceutical company with a diverse portfolio of oncology assets.” About TERZOThe Phase 3 TERZO study is a multicenter, open-label, randomized controlled study of duvelisib versus investigator’s choice of gemcitabine or bendamustine in patients with R/R nTFHL. Patients in the European Union (CT: 2024-516605-23-00) and the United Kingdom (NCT06522737) will be randomized on a 1:1 basis and receive treatment until progressive disease (PD) or unacceptable toxicity. The primary endpoint of the study is progression-free survival. Secondary endpoints include overall survival, objective response rate, complete response rate, duration of response, number of participants with adverse events, and quality of life. The company expects to enroll approximately 124 patients with interim data from the study anticipated in early-2027. About nodal T-Follicular Helper Cell LymphomaNodal T-follicular helper cell lymphomas (nTFHL) comprise a group of aggressive non-Hodgkin lymphomas that share common genetic, clinical, and cell of origin features. This group of lymphomas originates from a type of white blood cell called a T-follicular helper cell. nTFHLs generally occur in people aged 60 and older and are slightly more common in males. nTFHLs most commonly present with widespread, enlarged, typically painless lymph nodes in the neck, armpit, and/or groin. There are currently no well-established standards of care for patients with relapsed or refractory disease. About Cutaneous T-Cell Lymphoma (CTCL)Cutaneous T-cell lymphoma (CTCL) is a rare group of non-Hodgkin lymphomas in which malignant T cells primarily involve the skin. The most common subtypes are mycosis fungoides (MF) and Sézary syndrome (SS). Patients may experience persistent patches or plaques, tumors, diffuse skin redness, and often debilitating pruritus; in more advanced disease, malignant cells can also be detected in the blood, lymph nodes, and other organs. CTCL is typically chronic and relapsing, and treatment is individualized based on stage and symptoms, often requiring multiple lines of therapy over time. About COPIKTRA (duvelisib)COPIKTRA is an oral inhibitor of phosphoinositide 3-kinase (PI3K) and the first US approved dual inhibitor of PI3K-delta and PI3K-gamma pathways, two enzymes known to help support the growth and survival of malignant cells. PI3K signaling may lead to the proliferation of malignant cells and is thought to play a role in the formation and maintenance of a supportive tumor microenvironment. COPIKTRA is indicated in the United States for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies. COPIKTRA is also being developed for the treatment of peripheral T-cell lymphoma (PTCL), for which it has received Fast Track status in the United States and is being investigated in combination with other agents through investigator-sponsored studies. Treatment of T-cell lymphomas is a disease category for which COPIKTRA is not currently indicated. For more information on COPIKTRA, please visit www.COPIKTRA.com. Information about duvelisib clinical trials can be found on www.clinicaltrials.gov. IMPORTANT SAFETY INFORMATION ABOUT COPIKTRA WARNING: FATAL AND SERIOUS TOXICITIES: INFECTIONS, DIARRHEA OR COLITIS, CUTANEOUS REACTIONS, and PNEUMONITIS See full prescribing information for complete boxed warning Treatment-related mortality occurred in 15% of COPIKTRA-treated patients.Fatal and/or serious infections occurred in 31%of COPIKTRA-treated patients. Monitor for signs and symptoms of infection. Withhold COPIKTRA if infection is suspected.Fatal and/or serious diarrhea or colitis occurred in 18% of COPIKTRA-treated patients. Monitor for the development of severe diarrhea or colitis. Withhold COPIKTRA.Fatal and/or serious cutaneous reactions occurred in 5% of COPIKTRA-treated patients. Withhold COPIKTRA.Fatal and/or serious pneumonitis occurred in 5% of COPIKTRA-treated patients. Monitor for pulmonary symptoms and interstitial infiltrates. Withhold COPIKTRA. INDICATIONS AND USAGECOPIKTRA is a kinase inhibitor indicated for the treatment of adult patients with:Relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies. Limitations of Use: COPIKTRA is not indicated or recommended for the treatment of any patients with CLL or SLL as initial or second line treatment due to an increased risk of treatment-related mortality. WARNINGS AND PRECAUTIONS Hepatotoxicity: Monitor hepatic function.Neutropenia: Monitor blood counts.Embryo-Fetal toxicity: COPIKTRA can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception. ADVERSE REACTIONSThe most common adverse reactions (≥20%) are diarrhea or colitis, neutropenia, rash, fatigue, pyrexia, cough, nausea, upper respiratory infection, pneumonia, musculoskeletal pain, and anemia. DRUG INTERACTIONS CYP3A4 inducers: Avoid co-administration with strong or moderate CYP3A4 inducers.CYP3A4 inhibitors: Monitor for COPIKTRA toxicities when co-administered with strong or moderate CYP3A4 inhibitors. Reduce COPIKTRA dose to 15 mg twice daily when co-administered with strong CYP3A4 inhibitors.CYP3A4 substrates: Monitor for signs of toxicities when co-administering COPIKTRA with sensitive CYP3A substrates. USE IN SPECIFIC POPULATIONSLactation: Advise women not to breastfeed. Please see complete Prescribing information, including boxed warning, at: www.copiktra.com. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088. About Secura Bio, Inc.Secura Bio is an integrated, commercial-stage pharmaceutical company dedicated to theworldwide development and commercialization of impactful oncology therapies for physicians andtheir patients. For more information on Secura Bio, please visit https://www.securabio.com/. Investor ContactWill BrownChief Financial OfficerPhone: 619-986-1364ir@securabio.com Media ContactKit RodopheleTen Bridge CommunicationsPhone: 617-999-9620krodophele@tenbridgecommunications.com

BERKELEY HEIGHTS, N.J., Dec. 17, 2025 (GLOBE NEWSWIRE) -- Secura Bio, Inc. (www.securabio.com), an integrated pharmaceutical company maximizing commercial outcomes for oncology medicines, today announced that duvelisib (COPIKTRA®) was added by the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) as a NCCN Category 2A treatment option for mycosis fungoides / Sézary Syndrome (MFSS). “We are very pleased to see COPIKTRA (duvelisib) added as a treatment option in the NCCN Guidelines for patients with CTCL (MFSS). We appreciate NCCN’s recognition of evidence showing COPIKTRA, as an oral dual PI3K inhibitor, to be a clinically important option in the treatment of T cell lymphomas,” said Dr. Christiane Langer, Senior Vice President, Head of Clinical & Medical Affairs at Secura Bio. “COPIKTRA is approved by the U.S. Food and Drug Administration for patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (r/r CLL/SLL). The NCCN Guidelines also recommend COPIKTRA for relapsed/refractory peripheral T-cell lymphoma (PTCL). Currently we are advancing a Phase 3 trial (TERZO) evaluating COPIKTRA in patients with relapsed/refractory nodal T-cell lymphoma with a T follicular helper (TFH) phenotype. We look forward to building the clinical evidence that further defines COPIKTRA’s role across T-cell lymphomas where successful treatment options have proven challenging.” The recommendation to add COPIKTRA (duvelisib) to the NCCN Guidelines is based on the broad body of evidence and uniform consensus (>85% support of the NCCN Panel) that intervention is appropriate. The updated NCCN Guidelines including recommended dosing are available at www.nccn.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. About Mycosis fungoides and Sezary syndrome (MFSS)Mycosis fungoides and Sézary syndrome are the two most common types of cutaneous T cell lymphoma, a type of non-Hodgkin lymphoma, characterized by malignant T cells in the blood. Mycosis fungoides is characterized by red skin lesions that can progress through various stages, including patches, plaques, and tumors. Sézary Syndrome is a leukemic variant of mycosis fungoides characterized by erythroderma, generalized lymphadenopathy, and the presence of malignant T cells in the blood. About Peripheral T-cell LymphomaPeripheral T-cell lymphoma (PTCL) is a rare, aggressive type of non-Hodgkin lymphoma that develops in mature white blood cells that circulate through the bloodstream and lymphatic system. PTCL accounts for between 10-15% of all non-Hodgkin lymphomas and generally affects people aged 60 years and older. Although there are many different subtypes of PTCL, they often present with widespread, enlarged, typically painless lymph nodes in the neck, armpit, and/or groin. There are currently no well-established standards of care for patients with relapsed or refractory disease. About nodal T-Follicular Helper Cell LymphomaNodal T-follicular helper cell lymphomas (nTFHL) comprise a group of aggressive non-Hodgkin lymphomas that share common genetic, clinical, and cell of origin features. This group of lymphomas originates from a type of white blood cell called a T-follicular helper cell. nTFHLs generally occur in people aged 60 and older and are slightly more common in males. nTFHLs most commonly present with widespread, enlarged, typically painless lymph nodes in the neck, armpit, and/or groin, in addition to rashes, B-symptoms, and immune dysregulation. There are currently no well-established standards of care for patients with relapsed or refractory disease. About COPIKTRA (duvelisib)COPIKTRA is an oral inhibitor of phosphoinositide 3-kinase (PI3K) and the first US approved dual inhibitor of PI3K-delta and PI3K-gamma pathways, two enzymes known to help support the growth and survival of malignant cells. PI3K signaling may lead to the proliferation of malignant cells and is thought to play a role in the formation and maintenance of a supportive tumor microenvironment. COPIKTRA is indicated in the United States for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies. COPIKTRA is also being developed for the treatment of peripheral T-cell lymphoma (PTCL), for which it has received Fast Track status in the United States and is being investigated in combination with other agents through investigator-sponsored studies. Treatment of T-cell lymphomas is a disease category for which COPIKTRA is not currently indicated. For more information on COPIKTRA, please visit www.COPIKTRA.com. Information about duvelisib clinical trials can be found on www.clinicaltrials.gov. IMPORTANT SAFETY INFORMATION ABOUT COPIKTRA WARNING: FATAL AND SERIOUS TOXICITIES: INFECTIONS, DIARRHEA OR COLITIS, CUTANEOUS REACTIONS, and PNEUMONITIS See full prescribing information for complete boxed warning Treatment-related mortality occurred in 15% of COPIKTRA-treated patients.Fatal and/or serious infections occurred in 31%of COPIKTRA-treated patients. Monitor for signs and symptoms of infection. Withhold COPIKTRA if infection is suspected.Fatal and/or serious diarrhea or colitis occurred in 18% of COPIKTRA-treated patients. Monitor for the development of severe diarrhea or colitis. Withhold COPIKTRA.Fatal and/or serious cutaneous reactions occurred in 5% of COPIKTRA-treated patients. Withhold COPIKTRA.Fatal and/or serious pneumonitis occurred in 5% of COPIKTRA-treated patients. Monitor for pulmonary symptoms and interstitial infiltrates. Withhold COPIKTRA. INDICATIONS AND USAGECOPIKTRA is a kinase inhibitor indicated for the treatment of adult patients with:Relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies. Limitations of Use: COPIKTRA is not indicated or recommended for the treatment of any patients with CLL or SLL as initial or second line treatment due to an increased risk of treatment-related mortality. WARNINGS AND PRECAUTIONS Hepatotoxicity: Monitor hepatic function.Neutropenia: Monitor blood counts.Embryo-Fetal toxicity: COPIKTRA can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception. ADVERSE REACTIONSThe most common adverse reactions (≥20%) are diarrhea or colitis, neutropenia, rash, fatigue, pyrexia, cough, nausea, upper respiratory infection, pneumonia, musculoskeletal pain, and anemia. DRUG INTERACTIONS CYP3A4 inducers: Avoid co-administration with strong or moderate CYP3A4 inducers.CYP3A4 inhibitors: Monitor for COPIKTRA toxicities when co-administered with strong or moderate CYP3A4 inhibitors. Reduce COPIKTRA dose to 15 mg twice daily when co-administered with strong CYP3A4 inhibitors.CYP3A4 substrates: Monitor for signs of toxicities when co-administering COPIKTRA with sensitive CYP3A substrates. USE IN SPECIFIC POPULATIONSLactation: Advise women not to breastfeed. Please see complete Prescribing information, including boxed warning, at: www.copiktra.com. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088. About Secura Bio, Inc.Secura Bio is an integrated, commercial-stage pharmaceutical company dedicated to the worldwide development and commercialization of impactful oncology therapies for physicians and their patients. For more information on Secura Bio, please visit https://www.securabio.com/. Investor ContactWill BrownChief Financial OfficerPhone: 619-986-1364ir@securabio.com Media ContactKit RodopheleTen Bridge CommunicationsPhone: 617-999-9620krodophele@tenbridgecommunications.com