Lund, Sweden (Press Release) – Active Biotech (NASDAQ STOCKHOLM: ACTI) to­day an­nounces that the first patient has been dosed in the phase 1b/2a clin­i­cal study of tas­quini­mod for treat­ment of re­lapsed or re­frac­tory mul­ti­ple myeloma. The study, which is planned to recruit up to 54 patients, will estab­lish a max­i­mum tol­er­ated dose of tas­quini­mod as single agent and then in­ves­ti­gate tas­quini­mod in com­bi­na­tion with a stan­dard mul­ti­ple myeloma oral regi­men of ix­az­o­mib, lena­lido­mide, and dexa­meth­a­sone (IRd). For both single agent tas­quini­mod and the com­bi­na­tion of tas­quini­mod and IRd, exploratory ex­pan­sion cohorts will be en­rolled to char­ac­ter­ize the anti-myeloma ac­­tiv­ity of each regi­men.

The pri­mary objective of the study is to estab­lish the optimal dose and treat­ment schedule of tas­quini­mod when used as a single agent and in com­bi­na­tion with IRd. Key sec­ond­ary end­points in­clude pre­lim­i­nary antimyeloma ac­­tiv­ity using the re­sponse criteria of the Inter­na­tional Myeloma Work­ing Group.

The study is con­ducted in an academic part­ner­ship with the Abramson Cancer Center of the Uni­ver­sity of Pennsylvania, with Dr. Dan Vogl as prin­ci­pal in­ves­ti­ga­tor. Detailed in­for­ma­tion about the study is avail­able on clin­i­caltrials.gov (NCT04405167).

"We are ex­cited to have ini­ti­ated this trial based on compelling pre­clin­i­cal data showing that tas­quini­mod can block tumor-sustaining signals from the bone mar­row micro­en­vi­ron­ment. We hope that tas­quini­mod shows ef­fi­cacy for patients with re­lapsed or re­frac­tory myeloma, who need addi­tional treat­ment op­tions," says Dr. Dan Vogl, Prin­ci­pal In­ves­ti­ga­tor.

“We are very pleased to have reached the mile­stone of first patient dosed in this study, un­der­taken in col­lab­o­ration with the Abramson Cancer Center, Uni­ver­sity of Pennsylvania. Due to ex­cit­ing and com­pre­hen­sive pre­clin­i­cal data devel­oped in col­lab­o­ration with the the Wistar In­sti­tute in Philadelphia there is clear po­ten­tial for an im­por­tant role of tas­quini­mod both as mono­therapy and in com­bi­na­tion with stan­dard mul­ti­ple myeloma ther­apy. We look for­ward to fol­low­ing the progress of this study,” says Helén Tuvesson, CEO, Active Biotech AB.

About tas­quini­mod

Tasquinimod is an oral immuno­modu­la­tory and anti-angiogenic inves­ti­ga­tional treat­ment, that affects the tumor's ability to grow and metastasize. Tasquinimod is devel­oped as a new immuno­modu­la­tory treat­ment for mul­ti­ple myeloma. Tasquinimod has pre­vi­ously been studied as an anti-cancer agent in patients with solid can­cers, in­clud­ing a phase 3 ran­dom­ized trial in patients with metastatic prostate can­cer. The tol­er­a­bil­ity of tas­quini­mod is well-characterized based on these pre­vi­ous ex­peri­ences. Tasquinimod has dem­onstrated a clear thera­peutic po­ten­tial in pre­clin­i­cal models of mul­ti­ple myeloma, when used as a single agent and in com­bi­na­tion with stan­dard mul­ti­ple myeloma ther­apy.

About mul­ti­ple myeloma

Multiple myeloma is an incurable blood can­cer in which ab­nor­mal plasma cells in the bone mar­row grow un­con­trol­lably while other blood forming cells such as white and red blood cells and blood plate­lets are sup­pressed. This leads to anemia, in­fec­tions, destruction of bone tissue and progressive loss of renal function. Despite new treat­ments have greatly im­proved sur­vival of mul­ti­ple myeloma patients, the bio­logical heterogeneity of the dis­ease and the emergence of drug re­sis­tance is a major chal­lenge, and the med­i­cal need of inno­va­tive treat­ment modalities re­mains high. In 2017, 81000 new cases of mul­ti­ple myeloma were diag­nosed in the eight major mar­kets. The global sales of drugs for mul­ti­ple myeloma totaled USD 16 billion in 2017 and sales are ex­pected to in­crease 48% by 2026 (ref Global Data 2019).

About Active Biotech

Active Biotech AB (publ) (NASDAQ Stockholm: ACTI) is a bio­technol­ogy com­pany with focus on can­cer and auto­immune/inflammatory dis­eases. Naptumomab, an immuno­therapy licensed to NeoTX Thera­peutics Ltd., is in clin­i­cal phase 1b/2 de­vel­op­ment for treat­ment of solid tumors, NCT03983954. Tasquinimod, an oral immunomodulator, is in clin­i­cal de­vel­op­ment for treat­ment of mul­ti­ple myeloma, NCT04405167. Laquinimod, an immunomodulator, is eval­u­ated as a po­ten­tial treat­ment of the eye disorders wet AMD and uveitis and the in­flam­ma­tory bowels dis­ease, Crohn’s dis­ease. Please visit www.activebiotech.com for more in­for­ma­tion.

This in­for­ma­tion is in­for­ma­tion that Active Biotech AB is obliged to make pub­lic pur­su­ant to the EU Market Abuse Regulation. This in­for­ma­tion was sub­mitted for pub­li­ca­tion at 08.30 a.m. CET on August 3, 2020.

Source: Active Biotech.