Lund, Sweden (Press Release) – Active Biotech (Nasdaq Stockholm: ACTI) to­day provides a status up­date in the proj­ects fol­low­ing the new direction com­mu­ni­cated in early Feb­ru­ary. This abbre­vi­ated up­date is provided as a midterm replacement of the Capital Markets Day pre­vi­ously an­nounced for May 19, which we now instead are planning to host during Q4 this year subject to the status of Covid-19. Despite the Covid-19 pandemic, most ac­­tiv­i­ties in our proj­ects have proceeded ac­cord­ing to plan and, so far, no proj­ect timelines have been sig­nif­i­cantly affected.

The Phase 1b/2 study with naptumomab in com­bi­na­tion with the checkpoint in­hib­i­tor durvalumab in patients with ad­vanced solid tumors aims to estab­lish the max­i­mum tolerated dose of the com­bi­na­tion before ad­vanc­ing to a larger cohort ex­pan­sion phase in the United States. The study is en­rolling ac­cord­ing to plan and we look for­ward to reviewing results from the dose escalation phase of this trial later this year.

In the tasquinimod project, which is directed to­wards mul­ti­ple myeloma, the final preparations to start the first clin­i­cal study with tasquinimod in this in­di­ca­tion are underway. The study, which is planned to recruit up to 54 patients, will estab­lish a max­i­mum tolerated dose of tasquinimod alone, then in­ves­ti­gate tasquinimod in com­bi­na­tion with a standard mul­ti­ple myeloma oral regi­men of ix­az­o­mib, lena­lido­mide, and dexa­meth­a­sone. For both single agent tasquinimod and the com­bi­na­tion with the standard oral treat­ments, exploratory ex­pan­sion cohorts will be en­rolled to preliminarily char­ac­ter­ize the anti-myeloma ac­­tiv­ity of each regi­men. The Covid-19 pandemic has slowed down trial initiation pro­ce­dures during April and May, but our ad­vanced preparations enable us to main­tain the target of first patient recruited into the study during the third quarter of this year, as pre­vi­ously com­mu­ni­cated. More detailed in­for­ma­tion about the study is avail­able on clin­i­caltrials.gov (NCT04405167).

New pre­clin­i­cal data on the effects of tasquinimod in ex­per­i­men­tal models of mul­ti­ple myeloma, will be pre­sented at the Virtual edition of the Euro­pean He­ma­tol­ogy Asso­ci­a­tion Meeting – EHA, in June 11-22. Data to be pre­sented in­clude effects of tasquinimod alone and in com­bi­na­tion with treat­ments from the com­pound classes that will be used in the upcoming clin­i­cal study, i.e. immuno­modu­la­tory drugs (IMiDs)and pro­te­a­some in­hib­i­tors (PIs). This work has been com­pleted in col­lab­o­ration with Dr Yulia Nefedova and her team at the Wistar In­sti­tute, Philadelphia, US. The data will be made avail­able through activebiotech.com in con­nec­tion with the pre­sen­ta­tion.

In the laquinimod project, which now is directed into a project focused to­wards sys­temic treat­ment of Crohn’s dis­ease, and a proj­ect focused to­wards topical de­vel­op­ment of a new treat­ment for the eye dis­eases uveitis and wet AMD, progress has also been realized. We have entered into an agree­ment with Leukocare AG, who has ex­per­tise in for­mu­la­tion de­vel­op­ment to sup­port our work in ad­vanc­ing a topical for­mu­la­tion. In parallel we have identified part­ners to fur­ther ex­pand our pre­clin­i­cal data of laquinimod in ad­vanced pre-clinical models of the eye-disorders in focus. In Crohn’s dis­ease we are eval­u­ating and compiling the doc­u­mentation from the pre­vi­ous clin­i­cal phase 2a study results prior to a regu­la­tory advice pro­ce­dure with the FDA and EMA.

An abstract reporting on the effects of laquinimod in an ex­per­i­men­tal model of the blinding dis­ease uveitis, ac­cepted for pre­sen­ta­tion at the scientific meeting The American Asso­ci­a­tion of Immunology, was recently pub­lished in the Journal of Immunology (J Immunol May 1, 2020, 204 (1 Supplement) 150.18). This study, per­formed by a re­search team at the National Eye In­sti­tute at the National In­sti­tute of Health in the US, dem­onstrated that laquinimod com­pletely prevented dis­ease de­vel­op­ment and in­hib­ited pro-inflammatory processes in a mouse model of auto­immune uveitis. The abstract is avail­able for downloading through www.activebiotech.com.

“I am very pleased with the progress we have achieved across our de­vel­op­ment proj­ects since our new re­search focus was an­nounced back in Feb­ru­ary this year. I now look for­ward to taking the next step with tasquinimod and start­ing the first clin­i­cal trial in mul­ti­ple myeloma” says Helena Eriksson, Chief Scientific Officer at Active Biotech.

At the Annual General Meeting of Active Biotech held on May 19, 2020, the Board was fur­ther strengthened with the new Board members, Dr. Elaine Sullivan, Dr. Aleksandar Danilovski and Dr. Axel Glasmacher. All of the new Board members have broad inter­na­tional sector competences and extensive scientific insights in the areas that Active Biotech now is focusing on. Aleksandar brings ex­per­tise especially within the CMC and regu­la­tory field. Axel will con­trib­ute with deep med­i­cal, clin­i­cal de­vel­op­ment and regu­la­tory ex­per­tise spe­cif­i­cally in the field of he­ma­tol­ogy, while Elaine, com­ple­ments the Board with her broad ex­peri­ences from roles within science leadership, business de­vel­op­ment and Executive man­age­ment. All Board members will work alongside the Active Biotech team to sup­port execution of the new direction.

“We welcome Elaine, Aleksandar and Axel to Active Biotech, they will be an im­por­tant com­ple­ment to the Board and to the Active Biotech team. Together we will form a strong lineup to ad­vance the proj­ects ac­cord­ing to our new direction” says Helén Tuvesson, CEO of 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 immunomodulator, is in de­vel­op­ment for treat­ment of mul­ti­ple myeloma. 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, through the agency of the contact person set out above, at 08.30 a.m. CET on June 3, 2020.

Source: Active Biotech.