Intro­duc­ing the Next Drug Can­di­date in Kan­vas Bio’s Immuno-Oncol­o­gy Pro­gram: KAN-003

Introducing the Next Drug Candidate in Kanvas Bio's Immuno-Oncology Program: KAN-003

Immune check­point inhibitors (ICIs) are a type of immunother­a­py that can help fight a vari­ety of can­cers, includ­ing malig­nant melanoma, non-small cell lung can­cer, clas­si­cal Hodgkin lym­phoma, head and neck squa­mous cell car­ci­no­ma, urothe­lial car­ci­no­ma, and renal cell car­ci­no­ma. ICIs block check­point pro­teins from bind­ing with their part­ners, which pre­vents the ​"off" sig­nal from being sent to T cells and allows T cells to kill can­cer cells. The trou­ble is that not all patients respond to ICI treat­ment. Only 20 - 40% of patients respond to ICI ther­a­py, although for those who do, it's a miracle.

For patients whose can­cers don't respond to ICI treat­ment, there's anoth­er glim­mer of hope: inter­ven­ing with a fecal micro­bio­ta trans­plant (FMT). FMTs involve trans­fer­ring a micro­bial ecosys­tem from a healthy indi­vid­ual into anoth­er per­son, often by colonoscopy. Recent stud­ies have shown that after a FMT trans­fer, some patients with ICI-refrac­to­ry can­cers can be con­vert­ed to ICI respon­ders, with the change in micro­bial ecosys­tem unlock­ing the patient's T cells so their immune sys­tem can tar­get the can­cer. It's an amaz­ing exam­ple of how our health depends on a bal­anced inter­ac­tion between our immune sys­tem and the microbes in our gut.

While FMTs have played an impor­tant role in fight­ing dis­ease, there are clear draw­backs, as our Chief Devel­op­ment Offi­cer recent­ly artic­u­lat­ed in Med­C­i­ty News. FMT treat­ments are not com­mer­cial­ly scal­able, risk the trans­fer of pathogens, and in most cas­es pro­vide only a sin­gle dose. To evolve beyond FMTs, at Kan­vas we're uti­liz­ing our pro­pri­etary spa­tial biol­o­gy plat­form com­bined with AI and machine learn­ing to reveal new insights into com­plex host-micro­bio­me inter­ac­tions. These insights are being put to work via our Anaer­o­bic Co-cul­ture Tech­nol­o­gy (ACT) cul­ti­va­tion plat­form, which can improve upon the effec­tive­ness of FMTs by being used to dis­cov­er and devel­op nov­el, live bio­ther­a­peu­tic prod­ucts, which act in a syn­er­gis­tic and com­ple­men­tary man­ner to exist­ing ther­a­pies while pro­vid­ing a safe method for tar­get­ing under­ly­ing dis­ease process­es with greater effi­ca­cy. This is why we're excit­ed to share our newest drug can­di­date in our Immuno-oncol­o­gy Pro­gram: KAN-003.

KAN-003 seeks to improve out­comes for patients with ICI-naïve cancers.

KAN-003 will be a con­sis­tent dose reg­i­men that can­cer patients can take just before and with ICI treat­ment. Ear­li­er treat­ment may gen­er­ate an ear­li­er response and the chance to sta­bi­lize or send can­cers into remis­sion for ICI-naïve patients. Our goal with KAN-003 is to dra­mat­i­cal­ly increase the per­cent­age of patients who respond to ICI ther­a­py across all ICI-approved can­cer types. As we've learned time and again, there's no sin­gle cure for can­cer, but every can­cer patient deserves safe and effec­tive options.

We pre­vi­ous­ly revealed that our lead drug can­di­date in our Immuno-oncol­o­gy Pro­gram, KAN-001, is demon­strat­ing sig­nif­i­cant poten­tial to improve out­comes for patients with ICI-refrac­to­ry can­cers. Both KAN-001 and KAN-003 are cur­rent­ly under­go­ing pre­clin­i­cal stud­ies in col­lab­o­ra­tion with The Uni­ver­si­ty of Texas MD Ander­son Can­cer Cen­ter and the institution's Plat­form for Inno­v­a­tive Micro­bio­me and Trans­la­tion­al Research (PRIME-TR). And while KAN-003 is dif­fer­ent from KAN-001 in terms of donor source and the micro­bial ecosys­tem, both of these drug can­di­dates have the poten­tial to trans­form Immuno-oncol­o­gy and patient lives.

Our lead drug can­di­date informs the design of KAN-003.

There isn't like­ly to be a one-size-fits-all solu­tion for com­plex micro­bio­me ther­a­py, so KAN-003 and KAN-001 are based on dif­fer­en­ti­at­ed design prin­ci­ples - each with the chance to con­vert sub-pop­u­la­tions to ICI response. Our spa­tial biol­o­gy plat­form, metage­nomics and metabolomics analy­sis pipelines will assess the mea­sure­ment of drug mate­r­i­al (PK) and the host response (PD) using tech­nolo­gies that didn't even exist a cou­ple of years ago. As we grow our imag­ing data­base, AI tools will help to increase our pre­ci­sion and under­stand­ing of how to cus­tomize micro­bio­me ther­a­pies to each patient. Our man­u­fac­tur­ing strate­gies are iden­ti­cal, so from in vivo sig­nal to drug prod­uct, both KAN-001 and KAN-003 will fol­low the same path. This approach will allow us to syn­er­gize our learn­ings and scale to drug pro­duc­tion quickly.

As we pre­pare an IND fil­ing, we wel­come addi­tion­al clin­i­cal partners.

We val­ue our ongo­ing part­ner­ships with The Uni­ver­si­ty of Texas MD Ander­son Can­cer Cen­ter and the institution's Plat­form for Inno­v­a­tive Micro­bio­me and Trans­la­tion­al Research (PRIME-TR), and the Uni­ver­si­ty of Mon­tréal Hos­pi­tal Research Cen­tre (CRCHUM), because they share our long-term vision. We believe that the com­plex inter­ac­tion of the gut micro­bio­me with human health can be unlocked with a series of dis­crete, solv­able steps.

FMT treat­ments have revealed what's pos­si­ble for micro­bio­me-based ther­a­peu­tics, but to real­ize the poten­tial of our safe and scal­able drug can­di­dates KAN-001 and KAN-003, we're active­ly seek­ing addi­tion­al part­ners who are inter­est­ed in sup­port­ing rig­or­ous clin­i­cal stud­ies over the next few years. We're cur­rent­ly prepar­ing a pre-Inves­ti­ga­tion­al New Drug (IND) fil­ing for KAN-003 for Q3 of 2025, so please reach out to us direct­ly if you're inter­est­ed in learn­ing more.