Icon Genetics successfully completes Phase I clinical study with personalized vaccines for treatment of non-Hodgkin’s lymphoma

Icon Genet­ics GmbH (ICON) suc­cess­ful­ly com­plet­ed a Phase I clin­i­cal study on the safe­ty and immuno­genic­i­ty of per­son­al­ized vac­cines to treat patients with fol­lic­u­lar non-Hodgkin’s lym­phoma. The vac­cines, which con­sist of mon­o­clon­al anti­bod­ies derived from each patient’s own tumor and serve as dis­ease-spe­cif­ic mark­ers, were admin­is­tered to induce a tumor-spe­cif­ic immune reac­tion. The vac­cines were man­u­fac­tured in tobac­co plants using mag­nI­CON® tech­nol­o­gy in the facil­i­ty owned and oper­at­ed by ICON in Halle, Ger­many. Results of the 27-patient study demon­strat­ed the safe­ty, tol­er­a­bil­i­ty and tumor-spe­cif­ic immuno­genic­i­ty of the plant-made vac­cines. Can­cer patients receiv­ing ICON’s vac­cines did not exhib­it the types of side effects that are typ­i­cal­ly asso­ci­at­ed with more tra­di­tion­al approach­es for can­cer treat­ment. Thus, these vac­cines have the poten­tial of offer­ing patients improved qual­i­ty of life through­out their ther­a­peu­tic reg­i­men. While not designed to assess effi­ca­cy, the study eval­u­at­ed immune respons­es to vac­ci­na­tion. Of the patients eval­u­at­ed at study com­ple­tion, 73% were found to have mount­ed a tumor-spe­cif­ic immune response. The Phase I tri­al was spon­sored by Bay­er Inno­va­tion GmbH and con­duct­ed under US FDA IND at 3 clin­i­cal cen­ters in the Unit­ed States, with pri­ma­ry treat­ment at the Uni­ver­si­ty of Texas South­west­ern Med­ical Cen­ter and Bay­lor Med­ical Cen­ter, both in Dal­las, Texas, with local coor­di­na­tion and over­sight pro­vid­ed by DAVA Oncol­o­gy, LP.

The study was car­ried out in close coop­er­a­tion with the group of Pro­fes­sor Mau­r­izio Ben­dan­di (Uni­ver­si­ty of Navar­ra, Spain). Dr. Bendandi’s team had pre­vi­ous­ly suc­ceed­ed in a ground­break­ing study with hybrido­ma-pro­duced vac­cines that trig­gered an immune response to each patient’s tumor-spe­cif­ic idio­typ­ic anti­body (sur­face immunoglob­u­lin) in sub­jects who had pre­vi­ous­ly achieved com­plete remis­sion with chemother­a­py. ICON’s study was based on Dr. Bendandi’s work and that of oth­er lym­phoma researchers, but used plant-based tech­nol­o­gy to cus­tom-man­u­fac­ture the vac­cines more rapid­ly and effi­cient­ly than is pos­si­ble by oth­er approach­es.

Being the own­er of the lym­phoma vac­cines pro­gram upon com­ple­tion of the study, ICON plans to fur­ther devel­op the prod­uct in order to bring this promis­ing new treat­ment to mar­ket.

”Our study fol­lowed the orig­i­nal con­cept of per­son­al­ized can­cer vac­ci­na­tion devel­oped by Pro­fes­sor Ronald Levy at Stan­ford Uni­ver­si­ty. Its suc­cess­ful com­ple­tion brings the pow­er­ful con­cept of indi­vid­u­al­ized can­cer med­i­cines clos­er to patients,” said Yuri Gle­ba, CEO of ICON. ”Com­ple­tion of this pro­gram required res­o­lu­tion of mul­ti­ple tech­ni­cal and logis­ti­cal chal­lenges, includ­ing man­u­fac­ture, release and admin­is­tra­tion of 27 dif­fer­ent recom­bi­nant pro­teins in a sin­gle clin­i­cal tri­al. It was the first clin­i­cal test of the company’s mag­nI­CON® tech­nol­o­gy, which required the coor­di­nat­ed efforts of sev­er­al orga­ni­za­tions. Suc­cess would not have been pos­si­ble with­out the con­tri­bu­tions of the many ICON pro­fes­sion­als who par­tic­i­pat­ed in this project, the lead­er­ship and sup­port pro­vid­ed by Dr. John But­ler of Bay­er Inno­va­tion, plan­ning and ana­lyt­i­cal sup­port from Uni­ver­si­ty of Navar­ra (http://www.unav.edu), clin­i­cal coor­di­na­tion by DAVA Oncol­o­gy (http://www.davaonc.com), and the excel­lent prod­uct devel­op­ment and reg­u­la­to­ry sup­port pro­vid­ed by DT/Consulting Group (http://www.dt-cg.com), Bay­er Health­Care Phar­ma­ceu­ti­cals and CBR Inter­na­tion­al (http://www.cbrintl.com),” Dr. Gle­ba added.

Dr. Vic­tor Klimyuk, ICON’s COO, elab­o­rat­ed: ”This study was piv­otal for ICON because not only did we con­firm the safe­ty and immuno­genic­i­ty of plant-pro­duced vac­cines, we also estab­lished a com­plete­ly scal­able man­u­fac­tur­ing process. The tech­noe­co­nom­ic advan­tages of our approach to pro­duc­ing indi­vid­u­al­ized prod­ucts are strik­ing­ly supe­ri­or to con­ven­tion­al meth­ods used to pro­duce bio­phar­ma­ceu­ti­cals. We have found that the mag­nI­CON® man­u­fac­tur­ing plat­form is very well-suit­ed for high-through­put pro­cess­ing of mul­ti­ple small batch­es con­tain­ing dif­fer­ent mol­e­c­u­lar com­po­si­tions, as exem­pli­fied by the idio­typ­ic lym­phoma vac­cines employed in this study.”

About idio­type vac­ci­na­tion
Idio­type vac­ci­na­tion is a new type of ther­a­py that has not yet been giv­en reg­u­la­to­ry approval. It is referred to as active immunother­a­py and, unlike most oth­er bio­log­i­cal ther­a­pies, is spe­cif­ic to the indi­vid­ual patient. This means that each patient is treat­ed with a prod­uct tai­lored to his or her spe­cif­ic needs. The vac­cine con­sists of an anti­body — an immunoglob­u­lin — which is present only on the dis­eased lym­pho­cytes and not on healthy lym­pho­cytes or oth­er cells in the body. This pro­tein is known as an ”idio­type.” The goal is to pro­duce an indi­vid­ual drug prod­uct for each patient and admin­is­ter it as a vac­cine. The objec­tive of the new ther­a­py is to acti­vate the patient’s immune sys­tem, enabling the malig­nant cells to be tar­get­ed and destroyed by the body’s own defense sys­tem with min­i­mal side effects.

About non-Hodgkin’s lym­phoma
Non-Hodgkin’s lym­phoma is a type of malig­nant dis­ease that occurs with­in the lym­phat­ic sys­tem, and it is the fifth most com­mon cause of death due to can­cer after breast, prostate, lung, and colon can­cer. It orig­i­nates from lym­pho­cytes, a type of white blood cells. There are two main types of lym­pho­cytes: B lym­pho­cytes and T lym­pho­cytes (also called B-cells and T-cells). Non-Hodgkin’s lym­phoma can be divid­ed into two gen­er­al clin­i­cal cat­e­gories: indo­lent lym­phomas, the most com­mon forms of which include fol­lic­u­lar lym­phomas which tend to grow rel­a­tive­ly slow­ly; and aggres­sive lym­phomas, which include dif­fuse large B-cell lym­phomas (DLBCL), which grow more rapid­ly. The over­all preva­lence of NHL in the Euro­pean Union is approx­i­mate­ly 230,000, with an annu­al inci­dence of about 70,000 new cas­es. Fol­lic­u­lar lym­phoma is one of the most com­mon types of indo­lent NHL, account­ing for 25–30 per­cent of all NHL lym­phomas. It is a type of can­cer that can be treat­ed in the short-term but is per­sis­tent and ulti­mate­ly dif­fi­cult to cure.

About Icon Genet­ics GmbH
ICON is a whol­ly owned sub­sidiary of Nomad Bio­science GmbH, Munich, Ger­many. The Com­pa­ny dis­cov­ers and devel­ops new bio­phar­ma­ceu­ti­cals and high-val­ue pro­tein prod­ucts using green plants as pro­duc­tion hosts. ICON offers new plant man­u­fac­tur­ing tech­nolo­gies that address speed, yield, pre­ci­sion, expres­sion con­trol and safe­ty of prod­uct man­u­fac­tur­ing in plants. ICON oper­ates its own cGMP-com­pli­ant man­u­fac­tur­ing facil­i­ty in Halle, Ger­many. ICON’s own pipeline includes sev­er­al ‘bio­bet­ter’ anti-can­cer anti­bod­ies (pre-clin­i­cal stage) and vac­cines.