Lead­ing the Next CAR T Rev­o­lu­tion in Can­cer

David Chang, M.D., Ph.D
Pres­i­dent, Chief Ex­ec­u­tive Of­fi­cer and Co-Founder of Al­lo­gene Ther­a­peu­tics

One of the great­est ac­com­plish­ments for a sci­en­tist in their life­time is ad­vanc­ing a new med­i­cine that helps pa­tients. There’s some­thing in­com­pa­ra­ble in know­ing that you’ve played a part in ex­pand­ing the fu­ture of sci­en­tif­ic dis­cov­ery, in know­ing that some­thing once seem­ing­ly im­pos­si­ble is now a re­al­i­ty, and, most im­por­tant­ly, in know­ing that you’ve cre­at­ed some­thing that can help a fel­low hu­man be­ing.

The dan­ger lies in be­liev­ing one new ad­vance­ment is enough. As a med­ical on­col­o­gist, re­search sci­en­tist and biotech­nol­o­gy ex­ec­u­tive, I be­lieve we must nev­er rest or grow com­pla­cent. In my case specif­i­cal­ly, that means pro­gress­ing new ther­a­pies be­yond pre­vi­ous ac­com­plish­ments and break­throughs made with the team at Kite Phar­ma.

Our work in cell ther­a­py is far from done, as long as can­cer con­tin­ues to be a lead­ing cause of mor­bid­i­ty and mor­tal­i­ty, and pa­tients con­tin­ue to suf­fer. I be­lieve we are on the cusp of the next rev­o­lu­tion in can­cer ther­a­py – one built on the amaz­ing foun­da­tion of au­tol­o­gous CAR T cell ther­a­py. One that has the po­ten­tial to make this type of ther­a­py avail­able to more peo­ple more quick­ly. My goal is to move CAR T in­to the fast lane with al­lo­gene­ic.

Be­gin­ning the Rev­o­lu­tion

At Kite, we had an am­bi­tious goal of cur­ing can­cer through the de­vel­op­ment of ground­break­ing cell ther­a­pies. We knew our lead pro­gram had the po­ten­tial to change the par­a­digm of can­cer treat­ment, but in the be­gin­ning, very few out­side of Kite be­lieved it was pos­si­ble.

But we per­sist­ed and spear­head­ed the clin­i­cal de­vel­op­ment of Yescar­ta^® (axi­cab­ta­gene ciloleu­cel), the first au­tol­o­gous CAR T cell ther­a­py to be ap­proved by the U.S. Food and Drug Ad­min­is­tra­tion (FDA) for the treat­ment of adults with re­lapsed or re­frac­to­ry large B-cell lym­phoma, a form of non-Hodgkin lym­phoma (NHL).

Con­tin­u­ing the Rev­o­lu­tion

Au­tol­o­gous CAR T ther­a­py in­volves tak­ing a pa­tient’s own T cells and ge­net­i­cal­ly en­gi­neer­ing them to rec­og­nize and kill can­cer cells. This ther­a­py has pro­duced re­mark­able re­spons­es in some pa­tients for whom all oth­er treat­ments stopped work­ing, but as can be the case with the first prod­uct from a new modal­i­ty, they come with cer­tain lim­i­ta­tions. One in par­tic­u­lar is the source of the T cells from which an in­di­vid­u­al­ized ther­a­py is pro­duced.

This means that man­u­fac­tur­ing and de­liv­er­ing a CAR T ther­a­py can on­ly hap­pen af­ter the cells have been tak­en from the pa­tient.  The wait of two to four weeks for pa­tients, who al­ready have failed mul­ti­ple lines of ther­a­py, can be sig­nif­i­cant par­tic­u­lar­ly for pa­tients with ag­gres­sive can­cer.  Ad­di­tion­al­ly, some pa­tients may not have enough T cells to ex­pand and en­gi­neer.

It was time to change lanes and we were just get­ting start­ed. Be­liev­ing that re­cent ad­vances in sci­ence, tech­nol­o­gy and ge­net­ic en­gi­neer­ing had the po­ten­tial to ad­dress the chal­lenges of au­tol­o­gous CAR T ther­a­py, Arie Bellde­grun and I launched Al­lo­gene Ther­a­peu­tics in April 2018 with the goal of cre­at­ing “off-the-shelf” al­lo­gene­ic CAR T cell ther­a­pies. While we have to over­come chal­lenges to pro­gress­ing new ther­a­pies, we be­lieved in the po­ten­tial of these ther­a­pies for on de­mand use and man­u­fac­ture at scale. And be­cause al­lo­gene­ic CAR T ther­a­pies are cre­at­ed from T cells from healthy donors rather than from pa­tients them­selves, they have the po­ten­tial to over­come the lim­i­ta­tions of au­tol­o­gous ther­a­pies. At Al­lo­gene, we have cre­at­ed a ro­bust pipeline of in­ves­ti­ga­tion­al al­lo­gene­ic CAR T cell ther­a­pies in var­i­ous stages of de­vel­op­ment to treat both blood can­cers and the great­est chal­lenge of all, sol­id tu­mors.

The Fu­ture of Can­cer

Decades ago, a well-known com­put­er sci­en­tist said, “The best way to pre­dict the fu­ture is to in­vent it.” We know that the fu­ture is not de­pen­dent on a sin­gle in­ven­tion, but rather an on­go­ing, ever-build­ing process of in­no­va­tion that we each have the pow­er to pro­pel in new, cut­ting-edge ways.

That’s why I’m hope­ful for the fu­ture of can­cer. I be­lieve that al­lo­gene­ic CAR T ther­a­py rep­re­sents the fu­ture. This nascent field is mov­ing at light­ning speed, but our am­bi­tion is to catch light­en­ing in a bag.

We have made im­por­tant first steps to­ward es­tab­lish­ing al­lo­gene­ic CAR T cell ther­a­py as a vi­able plat­form. As we ap­proach our one-year an­niver­sary as a pub­lic com­pa­ny, our goals have not changed. We re­main 100% fo­cused and com­mit­ted to evolv­ing, re­fin­ing, pro­gress­ing and ad­vanc­ing the sci­ence of cell ther­a­py.  We must find bal­ance be­tween per­fec­tion­ism and prac­ti­cal­i­ty as we aim to bring the next rev­o­lu­tion in can­cer treat­ment to pa­tients in need.  And on a high­way filled with in­di­vid­u­als who are mo­ti­vat­ed by im­prov­ing pa­tient lives, we will con­tin­ue to build the body of re­search, we will con­tin­ue to progress new treat­ments, and we will not rest un­til can­cer has been cured.

Cau­tion­ary Note on For­ward-Look­ing State­ments|||This post­ing con­tains for­ward-look­ing state­ments for pur­pos­es of the safe har­bor pro­vi­sions of the Pri­vate Se­cu­ri­ties Lit­i­ga­tion Re­form Act of 1995. The post­ing may, in some cas­es, use terms such as “pre­dicts,” “be­lieves,” “po­ten­tial,” “pro­posed,” “con­tin­ue,” “es­ti­mates,” “an­tic­i­pates,” “ex­pects,” “plans,” “in­tends,” “may,” “could,” “might,” “will,” “should” or oth­er words that con­vey un­cer­tain­ty of fu­ture events or out­comes to iden­ti­fy these for­ward-look­ing state­ments. For­ward-look­ing state­ments in­clude state­ments re­gard­ing in­ten­tions, be­liefs, pro­jec­tions, out­look, analy­ses or cur­rent ex­pec­ta­tions con­cern­ing, among oth­er things: the abil­i­ty to ini­ti­ate and progress clin­i­cal tri­als of al­lo­gene­ic CAR T ther­a­pies, and the po­ten­tial ben­e­fits of al­lo­gene­ic CAR T ther­a­py. Var­i­ous fac­tors may cause dif­fer­ences be­tween Al­lo­gene’s ex­pec­ta­tions and ac­tu­al re­sults as dis­cussed in greater de­tail in Al­lo­gene’s fil­ings with the Se­cu­ri­ties and Ex­change Com­mis­sion (SEC), in­clud­ing with­out lim­i­ta­tion in its Form 10-Q for the quar­ter end­ed June 30, 2019. Any for­ward-look­ing state­ments that are made in this post­ing speak on­ly as of the date of this post­ing. Al­lo­gene as­sumes no oblig­a­tion to up­date the for­ward-look­ing state­ments whether as a re­sult of new in­for­ma­tion, fu­ture events or oth­er­wise, af­ter the date of this post­ing.