The clin­i­cal tri­al pro­duced results that de-risk the devel­op­ment of Kan­vas Bio’s lead immuno-oncol­o­gy drug.

PRINCE­TON, NJ – Novem­ber 7, 2024 – Kan­vas Bio­sciences, a full-stack spa­tial biol­o­gy com­pa­ny, today announced results from a clin­i­cal tri­al of fecal micro­bio­ta trans­plan­ta­tion (FMT) and anti-PD‑1 re-induc­tion in microsatel­lite insta­bil­i­ty-high (MSI‑H) refrac­to­ry can­cers. Pre­sent­ed at the third annu­al Soci­ety for Immunother­a­py of Can­cer (SITC) meet­ing, the tri­al data show that FMT enabled a response to rein­tro­duced anti-PD‑1 in patients with anti-PD‑1 refrac­to­ry, MSI‑H can­cers, and sug­gest that the gut micro­bio­me affects anti-tumoral immu­ni­ty in a tumor-agnos­tic manner. 

“The strains in our lead drug can­di­date, KAN-001, were iso­lat­ed from the same donor who pro­vid­ed FMT mate­r­i­al for this clin­i­cal tri­al. All strains present in KAN-001 were deliv­ered to tri­al par­tic­i­pants via FMT, where most if not all suc­cess­ful­ly engraft­ed,” said Dr. Kyle Jaco­by, Vice Pres­i­dent of Clin­i­cal Research at Kan­vas Bio. ​“This sig­nif­i­cant­ly de-risks the clin­i­cal devel­op­ment of KAN-001, which seeks to improve out­comes for can­cer patients who have been resis­tant to immune check­point inhibitors (ICIs) like anti-PD‑1. With this tri­al data, Kan­vas Bio is in the unique posi­tion of hav­ing pos­i­tive human immuno-oncol­o­gy data on the safe­ty, effi­ca­cy and engraft­ment of the strains that com­prise our drug can­di­date before ini­ti­at­ing our own clin­i­cal tri­al for KAN-001.” 

Par­tic­i­pants in the tri­al includ­ed 10 patients with col­orec­tal can­cer, two with small bow­el ade­no­car­ci­no­mas, one with pan­cre­at­ic ade­no­car­ci­no­ma, one with endome­tri­al ade­no­car­ci­no­ma and one with a pineal brain tumor. Each par­tic­i­pant under­went FMT via colonoscopy, receiv­ing an FMT from a metasta­t­ic MSI‑H col­orec­tal can­cer patient who achieved a com­plete response (CR) on anti-PD‑1 ther­a­py. Result high­lights include:

• Three out of 15 (20%) par­tic­i­pants respond­ed to treat­ment, includ­ing one col­orec­tal can­cer patient who achieved an ongo­ing CR >2 years. 
• Engraft­ment was remark­ably high, with sig­nif­i­cant lev­els of donor strains in the major­i­ty of participants.
• No inci­dents of ICI-induced col­i­tis occurred. 

“The gut micro­bio­me has pre­vi­ous­ly been asso­ci­at­ed with response to anti-PD‑1 ther­a­py, but the mech­a­nisms that impact its effect on anti-tumoral immu­ni­ty have been unclear,” said Dr. Erez Baruch, pre­sent­ing author and Med­ical Oncol­o­gy Fel­low at The Uni­ver­si­ty of Texas MD Ander­son Can­cer Cen­ter. ​“Our tri­al results demon­strate that FMT enables a response to rein­tro­duced anti-PD‑1 in patients with anti-PD‑1 refrac­to­ry, MSI‑H can­cers.” Baruch is pre­sent­ing these data as abstract #1266 at SITC on Novem­ber 9 at the George R. Brown Con­ven­tion Cen­ter in Hous­ton, TX. 

Kan­vas Bio plans to request a pre-Inves­ti­ga­tion­al New Drug meet­ing with the FDA for KAN-001 in Jan­u­ary 2025, with the goal of begin­ning a clin­i­cal tri­al for the drug as soon as pos­si­ble. For more infor­ma­tion on the company’s ther­a­peu­tic pipeline, or to inquire about part­ner­ship oppor­tu­ni­ties, vis­it www​.kan​vas​bio​.com or speak with the team in-per­son at SITC’s annu­al meet­ing in Hous­ton Novem­ber 6 — 10. To access the full clin­i­cal tri­al results, see the poster here.

About Kan­vas Biosciences

Kan­vas Bio­sciences is a spa­tial biol­o­gy com­pa­ny build­ing the world’s first micro­bio­me drug screen­ing, dis­cov­ery and man­u­fac­tur­ing plat­form to accel­er­ate the devel­op­ment of next gen­er­a­tion live bio­ther­a­peu­tics. With an unpar­al­leled abil­i­ty to spa­tial­ly map the micro­bio­me and pro­file host gene expres­sion, and man­u­fac­ture com­plex con­sor­tia con­tain­ing hun­dreds of mem­bers that can restore micro­bio­me health, the com­pa­ny is unique­ly posi­tioned to devel­op nov­el ther­a­peu­tics that can sig­nif­i­cant­ly improve the lives of all patients liv­ing with micro­bio­me-asso­ci­at­ed dis­eases. Kan­vas Bio­sciences’ tech­nol­o­gy was ini­tial­ly devel­oped at Cor­nell Uni­ver­si­ty and exclu­sive­ly licensed. The com­pa­ny’s notable investors include DCVC, Lions Cap­i­tal LLC, FemHealth Ven­tures, Germin8, Ki Tua Fund, Pan­gaea Ven­tures, Triple Impact Cap­i­tal and Uncom­mon Denom­i­na­tor. Kan­vas Bio­sciences is head­quar­tered in Prince­ton, NJ. For more infor­ma­tion, vis­it www​.kan​vas​bio​.com or fol­low the com­pa­ny on LinkedIn.