Secura Bio Announces Final Patient Enrolled in the COPIKTRA® (duvelisib) (PRIMO) Study in Relapsed and Refractory Peripheral T-cell Lymphoma

Secura Bio, Inc. (Secura Bio) – (www.securabio.com), an integrated pharmaceutical company dedicated to the worldwide development and commercialization of impactful oncology therapies, today announced that it completed enrollment on February 1, 2022, in the PRIMO study. PRIMO is evaluating COPIKTRA for the treatment of adult patients with relapsed or refractory (r/r) Peripheral T-cell Lymphoma (PTCL) and has enrolled a total of 157 patients.

COPIKTRA is an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta and gamma pathways, which are involved in the proliferation and sustenance of malignant cells. COPIKTRA monotherapy has received Fast Track status for the treatment of PTCL patients who have received at least one prior therapy. Additionally, COPIKTRA has received an Orphan Drug Designation for use in the treatment of T-cell lymphomas. Treatment of T-cell lymphomas is a disease category for which COPIKTRA is not currently indicated.

The PRIMO study is a global, multi-center, open-label, parallel cohort, Phase 2 study. In the dose optimization portion of the study, 33 patients were randomized to receive COPIKTRA 25mg twice daily (Cohort 1) or COPIKTRA 75mg twice daily continuously (Cohort 2) until progressive disease (PD) or unacceptable toxicity. Based on the dose optimization results, an expansion group of 124 patients was added in which COPIKTRA is dosed at 75mg twice daily for two cycles, followed by 25mg twice daily, until PD or unacceptable toxicity. The primary endpoint of the expansion phase of the study is overall response rate (ORR; complete response [CR] + partial response) as determined by an independent review committee (IRC). Secondary endpoints include additional efficacy measures including duration of response (DOR), progression free survival, pharmacokinetics, and safety.

An interim analysis of the first 78 patients in the expansion phase, with a minimum follow-up of 6 months, was reported in December 2021 at the 63^rd Annual Meeting of the American Society of Hematology (ASH) in Atlanta, Georgia. The study is ongoing and is expected to have enough events for the primary endpoint analysis later in 2022.

Interim results included an ORR by IRC assessment of 50% (39/78 pts) and a CR rate of 32.1% (25/78), with a median DOR of 233 days (range, 1-420+). Patients had a median of 3 (range, 1-7) prior therapeutic regimens and included the following PTCL subtypes: PTCL NOS (53.8%), ALCL (14.1%), AITL (26.0%) and Other (0.5%). Eighteen percent of patients remain on therapy; 47.4% discontinued due to PD, 6.4% discontinued for stem cell transplant, and 19.2% discontinued due to unacceptable toxicity.

Overall, the safety profile was consistent with that seen in previous studies. In this analysis the most frequent > Grade 3 adverse events seen were neutropenia (21.8%), ALT/AST increased (24.4%/ 21.8%), rash (7.7%), lymphocyte count decreased (7.7%), and sepsis (6.4%). ALT and/or AST elevations were the most common treatment-emergent AEs leading to treatment discontinuations (N=12, 15.4%).

Shortly following the presentation of these data at ASH, COPIKTRA was included in the National Comprehensive Cancer Network^® T-Cell Lymphoma Guidelines^® (Version 1.2022, 12/22/21) as a Category 2A designated option for the treatment of all subtypes of r/r PTCL.

“Secura Bio is dedicated to the development of COPIKTRA for the treatment of T-cell malignancies because these patients often have limited therapeutic options and generally poor outcomes. In addition to the treatment of r/r PTCL patients, we are exploring a wide range of development options for T-cell malignancies, including earlier line use as a single-agent or in combinations with other mechanisms of action.” Said Dr. David Cohan, Chief Medical Officer of Secura Bio.

“Secura Bio in the last few months has sharpened its overall development focus to a very great extent on the potential of COPIKTRA in the treatment of T-cell malignancies. We believe that this patient population has the potential to benefit greatly based on these actions.” Said Joseph M. Limber, President and CEO of Secura Bio.