Bayer starts clinical Phase I study with personalized vaccine from tobacco plants Idiotype vaccination in the treatment of non-Hodgkin’s lymphoma

Lev­erkusen, Jan­u­ary 28, 2010 — The trans­fer into clin­i­cal devel­op­ment of a patient-spe­cif­ic vac­cine rep­re­sents a mile­stone for Bay­er Inno­va­tion GmbH. Fol­low­ing approval of the Phase I study by the FDA (Food & Drug Admin­is­tra­tion) in the Unit­ed States, the vac­cine is now being test­ed in human sub­jects. This is the first time that pro­teins obtained from tobac­co plants using mag­nI­CON® tech­nol­o­gy under­go clin­i­cal test­ing. The patient-spe­cif­ic vac­cines pro­duced in the pilot plant oper­at­ed by the Bay­er-sub­sidiary Icon Genet­ics in Halle, Ger­many, are intend­ed for the treat­ment of non-Hodgkin’s lym­phoma (NHL), a type of can­cer affect­ing lym­pho­cytes. The objec­tive of the 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.

”This per­son­al­ized vac­cine is being devel­oped with the aim of keep­ing patients who have respond­ed well to chemother­a­py in com­plete remis­sion.” explains Dr. Detlef Woll­we­ber, head of Bay­er Inno­va­tion GmbH. ”In oth­er words, it should pre­vent a recur­rence of the tumor. The ini­ti­a­tion of this clin­i­cal tri­al also demon­strates that our mag­nI­CON® tech­nol­o­gy is suit­able for man­u­fac­tur­ing pro­teins for poten­tial phar­ma­ceu­ti­cal appli­ca­tions.”

The mag­nI­CON® tech­nol­o­gy is a new process for the rapid pro­duc­tion of high yields of recom­bi­nant pro­teins such as bio­phar­ma­ceu­ti­cals in tobac­co plants. The plant is not genet­i­cal­ly mod­i­fied: The blue­print for the required prod­uct is insert­ed tem­porar­i­ly into the plant using a species of Agrobac­teri­um and dis­trib­uted through­out the plant cells. The pro­tein is sub­se­quent­ly be extract­ed from the plant’s leaves in a very pure form. The process can also be car­ried out in a large-scale closed facil­i­ty.

”The goal of can­cer ther­a­py in the future will be to tai­lor treat­ment to the indi­vid­ual patient as far as pos­si­ble,” says John But­ler-Ran­so­hoff, Project Man­ag­er for Plant-made Phar­ma­ceu­ti­cals at Bay­er. ”Hema­to­log­i­cal tumors such as B-cell lym­phomas are a good start­ing point for the fur­ther devel­op­ment of per­son­al­ized med­i­cine because the idio­typ­ic anti­bod­ies formed by the lym­phomas are high­ly spe­cif­ic tumor mark­ers.”

Sci­en­tists have been try­ing to trig­ger an immune response to this type of patient-spe­cif­ic idio­typ­ic anti­body (sur­face immunoglob­u­lins) since the 1990s in the hope of sub­stan­tial­ly delay­ing the recur­rence of the tumor. In 2006 a team of researchers work­ing with Pro­fes­sor Mau­r­izio Ben­dan­di at the Uni­ver­si­ty of Navar­ra (Spain), suc­ceed­ed in this objec­tive in a ground­break­ing research study involv­ing patients who had pre­vi­ous­ly achieved com­plete remis­sion with chemother­a­py. Bayer’s new Phase I study is car­ried out in close coop­er­a­tion with Ben­dan­di.

The focus of the cur­rent­ly start­ed first clin­i­cal study in vol­un­teers who have NHL is on the safe­ty, tol­er­a­bil­i­ty and — to the extent that this can be deter­mined from lab­o­ra­to­ry tests — immuno­log­i­cal effects of the vac­cine. In this study, 20 patients will each be giv­en six sub­cu­ta­neous injec­tions of the per­son­al­ized vac­cine over a six-month peri­od. The humoral and cel­lu­lar immune respons­es in these patients will sub­se­quent­ly be char­ac­ter­ized in Bendandi’s lab­o­ra­to­ry at the Uni­ver­si­ty of Navar­ra. If the results of this study are suf­fi­cient­ly pos­i­tive and promis­ing, an appli­ca­tion will be made to car­ry out a Phase III study for reg­is­tra­tion pur­pos­es. The Phase I clin­i­cal study which has just start­ed is being per­formed at the renowned Uni­ver­si­ty of Texas South­west­ern Med­ical Cen­ter in Dal­las (Unit­ed States). The study is being coor­di­nat­ed local­ly by DAVA Oncol­o­gy.

About idio­type vac­ci­na­tion
Idio­type vac­ci­na­tion is a new type of ther­a­py which 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 inten­tion 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.

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 which is long-last­ing and dif­fi­cult to treat.

About Bay­er Inno­va­tion GmbH
Bay­er Inno­va­tion GmbH (BIG), a whol­ly owned sub­sidiary of Bay­er AG, eval­u­ates and devel­ops new fields of busi­ness for the Bay­er Group that are relat­ed to Bayer’s core com­pe­ten­cies of health care, nutri­tion and inno­v­a­tive mate­ri­als and com­ple­ment its cur­rent key areas of inno­va­tion and busi­ness.

About DAVA Oncol­o­gy, LP
DAVA Oncol­o­gy is a Dal­las (Texas, USA) based oncol­o­gy drug devel­op­ment com­pa­ny focus­ing on accel­er­at­ing clin­i­cal tri­als. Its team of four full time med­ical oncol­o­gists allows DAVA Oncol­o­gy to con­duct high­ly com­plex, elab­o­rate tri­als in oncol­o­gy patients using a fixed cost mod­el. DAVA also pro­vides strate­gic con­sult­ing ser­vices as well as clin­i­cal devel­op­ment plan­ning ser­vices to both biotech­nol­o­gy and phar­ma­ceu­ti­cal com­pa­nies. For more infor­ma­tion, please go to

Bay­er: Sci­ence For A Bet­ter Life
Bay­er is a glob­al enter­prise with core com­pe­ten­cies in the fields of health care, nutri­tion and high-tech mate­ri­als. The company’s prod­ucts and ser­vices are designed to ben­e­fit peo­ple and improve their qual­i­ty of life. At the same time Bay­er cre­ates val­ue through inno­va­tion, growth and high earn­ing pow­er. The Group is com­mit­ted to the prin­ci­ples of sus­tain­able devel­op­ment and to its role as a social­ly and eth­i­cal­ly respon­si­ble cor­po­rate cit­i­zen. Econ­o­my, ecol­o­gy and social respon­si­bil­i­ty are cor­po­rate pol­i­cy objec­tives of equal rank. In fis­cal 2008, Bay­er employed 108,600 peo­ple and had sales of EUR 32.9 bil­lion. Cap­i­tal expen­di­tures amount­ed to EUR 2.0 bil­lion, R&D expens­es to EUR 2.7 bil­lion. For more infor­ma­tion, go to

For­ward-Look­ing State­ments
This release may con­tain for­ward-look­ing state­ments based on cur­rent assump­tions and fore­casts made by Bay­er Group or sub­group man­age­ment. Var­i­ous known and unknown risks, uncer­tain­ties and oth­er fac­tors could lead to mate­r­i­al dif­fer­ences between the actu­al future results, finan­cial sit­u­a­tion, devel­op­ment or per­for­mance of the com­pa­ny and the esti­mates giv­en here. These fac­tors include those dis­cussed in Bayer’s pub­lic reports which are avail­able on the Bay­er web­site at The com­pa­ny assumes no lia­bil­i­ty what­so­ev­er to update these for­ward-look­ing state­ments or to con­form them to future events or devel­op­ments.