Secura Bio Announces NCCN® Duvelisib (COPIKTRA®) Update to Clinical Practice Guidelines in Oncology for Cutaneous T-Cell Lymphoma (CTCL), Including Mycosis Fungoides and Sézary Syndrome

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 Lymphoma
Peripheral 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 Lymphoma
Nodal 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 USAGE
COPIKTRA 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 REACTIONS
The 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 POPULATIONS
Lactation: 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/.

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