Ze­ta­gen Fights Breast Can­cer Where it Lives…

Ze­ta­gen Ther­a­peu­tics, found­ed 2015, pri­vate clin­i­cal-stage bio­phar­ma­ceu­ti­cal com­pa­ny de­vel­ops first-of-its-kind tar­get­ed ther­a­pies for pri­ma­ry and metasta­t­ic breast can­cer.   The lo­core­gion­al ad­min­is­tra­tion of their drugs puts the pa­tient first, min­i­miz­ing off-tar­get side ef­fects of chemother­a­peu­tics, res­o­lu­tion of painful metasta­t­ic le­sions, re­duc­ing de­pen­den­cy on opi­oid med­ica­tions, pre­serv­ing pal­lia­tive ra­dio­ther­a­py, while in­creas­ing sur­vival rates.

Ze­ta­gen’s three nov­el drugs, Ze­taMet™ (Ze­ta-BC-003), for the treat­ment of metasta­t­ic breast can­cer to bone,  Ze­ta­Mast™ (Ze­ta-MBC-005) for breast can­cer liv­er metas­tases (BCLM), and (NEW) Ze­taPrime™ (Ze­ta-PBC-007) for the treat­ment of pri­ma­ry HR+ breast can­cer, all with in­spir­ing re­sults.

Ze­ta­gen’s lead drug can­di­date, Ze­taMet™  (Ze­ta-BC-003)

Ze­taMet™ is a ground­break­ing mol­e­c­u­lar path­way drug, tar­gets metasta­t­ic breast can­cer in bone, ceas­ing lyt­ic ac­tiv­i­ty, in­hibits pain, and re­gen­er­ates new bone all via lo­core­gion­al ad­min­is­tra­tion, 30-minute out­pa­tient pro­ce­dure, with­out sys­temic lim­i­ta­tion, min­i­miz­ing skele­tal re­lat­ed events (SRE) while in­creas­ing sur­vival rates.

Un­met need– Ze­ta­gen fo­cus­es on the 690,000 pa­tients in the Unit­ed States,  liv­ing with metasta­t­ic bone can­cers. [1] The me­di­an sur­vival rate of bone metas­tases is 9 months and 4.8 months if the pa­tient has a SRE.

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Pre­clin­i­cal Ze­taMet™ (Ze­ta-BC-003) Tri­al Da­ta sub­stan­ti­ates “mouse to man” out­comes with same con­cen­tra­tion.

Ze­taMet™ award­ed 2x FDA Break­through Des­ig­na­tions, has treat­ed 8x Com­pas­sion­ate Use pa­tients in the US and Cana­da.  Ze­ta­gen pub­lished clin­i­cal re­sults in mul­ti­ple peer-re­viewed jour­nals sub­stan­ti­at­ing ef­fi­ca­cy claims with the same con­cen­tra­tion from “mouse to man” of Ze­taMet™ (Ze­ta-BC-003).  Note, these pa­tients had failed con­ven­tion­al ther­a­pies, e.g., chemother­a­peu­tics, sur­gi­cal in­ter­ven­tion, and ra­di­a­tion be­fore treat­ed with Ze­taMet™ (Ze­ta-BC-003).

One case re­port, en­ti­tled Treat­ing Bone Metas­tases with Lo­cal Ther­a­py in Breast Can­cer Pa­tient Re­sult­ed in De­crease Pain and Pre­vent­ed Frac­ture, demon­strat­ed Ze­taMet™ (Ze­ta-BC-003) sig­nif­i­cant­ly re­duced pain (4-fold), re­sult­ing in re­duced pre­scribed mor­phine 250mg per day down to 60mg, res­o­lu­tion of 7 spinal le­sions in < 9 months, pre­ven­tion of SRE with pa­tient mon­i­tored for 36-months demon­strat­ing com­plete re­mis­sion.  View pub­li­ca­tion via open ac­cess:  https://www.fu­turemed­i­cine.com/doi/10.2217/pmt-2023-0069

Ze­ta­gen suc­cess­ful­ly com­plet­ed en­roll­ment of phase IIa clin­i­cal tri­al for the treat­ment of metasta­t­ic breast can­cer to the spine, Uni­ver­si­ty of British Co­lum­bia, ini­tial re­sults avail­able up­on re­quest Mon­day, June 2^nd and full study re­sults No­vem­ber 2025.

Ze­ta­gen’s sec­ond drug can­di­date, Ze­ta­Mast™ (Ze­ta-MBC-005)

Ze­ta­Mast™ is a pro­pri­etary drug-elut­ing hy­dro­gel car­ri­er de­signed for lo­core­gion­al ad­min­is­tra­tion,  con­trolled re­lease of small mol­e­cules in treat­ment of mul­ti­fo­cal, un­re­sectable, liv­er metas­tases from breast can­cer with po­ten­tial to in­crease sur­vival rates.

Ze­ta­gen com­plet­ed pre­clin­i­cal stud­ies, drug elu­tion re­fine­ment, tox­i­c­i­ty test­ing and dose op­ti­miza­tion study, re­sults pub­lished in peer-re­view jour­nal PLOS-One.

Ze­ta­Mast™ (Ze­ta-MBC-005)  dose op­ti­miza­tion study, uti­liz­ing TNBC cells im­plant­ed in the liv­er of mice, per­formed at Charles Riv­er Labs (CRL) com­pared to pos­i­tive con­trol Dox­oru­bicin demon­strat­ed two Ze­ta­Mast™ (Ze­ta-MBC-005) con­cen­tra­tions achieved su­pe­ri­or re­sults in tu­mor bur­den man­age­ment, 3.9x in­crease in sur­vival rate, and no soft tis­sue metas­tases to lung or brain.

Un­met Need…Ze­ta­gen fo­cus­es on the 150,000 BCLM pa­tients which have a 12-month me­di­an sur­vival rate with no cu­ra­tive treat­ment op­tions.

“Pa­tients with metas­tases to the liv­er can ben­e­fit from lo­cal ther­a­pies to the liv­er in terms of symp­toms, but it does not seem to im­pact on oth­er ar­eas of dis­ease or pro­long sur­vival.  Ze­ta­MAST™ is an in­no­v­a­tive ap­proach that al­so pro­duces a sys­temic bi­o­log­i­cal ef­fect in pre­clin­i­cal mod­els and holds the po­ten­tial to im­prove out­comes for this sit­u­a­tion,” stat­ed De­ba­sish Tri­pa­thy, MD, Emer­i­tus Pro­fes­sor, Chair­man, De­part­ment of Breast Med­ical On­col­o­gy, The Uni­ver­si­ty of Texas MD An­der­son Can­cer Cen­ter, Hous­ton, TX.

“These in-vi­vo re­sults are promis­ing and I look for­ward to see­ing Ze­ta­MAST™ (Ze­ta-MBC-005) move in­to Phase 1b clin­i­cal tri­als and pos­si­bly ben­e­fit those pa­tients af­flict­ed with metasta­t­ic breast can­cer in the liv­er.,” stat­ed Bryan S. Mar­gulies, MS, Ph.D., CSO of Ze­ta­gen.

Ze­ta­gen has sub­mit­ted a pre-IND to FDA and now prepar­ing for a phase 1b study Q1-2026.

Ze­ta­gen’s third drug can­di­date, Ze­taPrime™ (Ze­ta-PBC-007)

Ze­taPrime™ is a neo-ad­ju­vant treat­ment en­gi­neered for lo­core­gion­al ad­min­is­tra­tion fol­low­ing di­ag­no­sis. Uti­liz­ing pro­pri­etary hy­dro­gel-like lipid car­ri­er, for­mu­la­tion en­ables con­trolled re­lease of two small mol­e­cules—one be­ing nov­el mol­e­c­u­lar en­ti­ty and or the abil­i­ty to de­liv­er a CDK4 or CDK4/6 pro­tein in­hibitor. De­signed for sol­u­bil­i­ty with­in adi­pose tis­sue, ap­proach tar­gets pri­ma­ry breast can­cer, aim­ing to mit­i­gate off-tar­get ef­fects, re­duce ne­ces­si­ty for lumpec­tomies and mas­tec­tomies, de­crease ra­di­a­tion ex­po­sure, and en­hance pa­tient sur­vival.

Ze­ta­gen com­plet­ed pre-clin­i­cal in-vi­vo test­ing at CRL with a pos­i­tive con­trol of Ta­mox­ifen, showed Ze­taPrime™ (Ze­ta-PBC-007) su­pe­ri­or re­sults in sup­pres­sion, cell death, and over­all tu­mor bur­den.

Ze­ta­gen will com­plete for­mu­la­tion re­fine­ment with CRL-UK and plans to ex­e­cute a dose op­ti­miza­tion study with pos­i­tive con­trol CDK 4 or CDK 4/6 pro­tein in­hibitor in Q3.

Ze­ta­gen has a ro­bust & strate­gic IP port­fo­lio, 66 is­sued patents, with mul­ti­ple “Com­po­si­tion-of-Mat­ter” is­suances.

“We pri­or­i­tize the pa­tient in every stage of our drug de­vel­op­ment,” said Joe C. Loy, Chief Ex­ec­u­tive Of­fi­cer. “Rec­og­niz­ing their needs, we are com­mit­ted to mak­ing a mean­ing­ful im­pact and ex­plor­ing in­no­v­a­tive so­lu­tions for a bet­ter fu­ture.”

For­ward-Look­ing State­ments

This post con­tains cer­tain for­ward-look­ing state­ments with the mean­ing of Sec­tion 27A of the Se­cu­ri­ties Act of 1933 and Sec­tion 21E of the Se­cu­ri­ties Ex­change Act of 1934 and Pri­vate Se­cu­ri­ties Lit­i­ga­tion Re­form Act, as amend­ed, in­clud­ing those re­lat­ing to the Com­pa­ny’s prod­uct de­vel­op­ment, clin­i­cal and reg­u­la­to­ry time­lines, mar­ket op­por­tu­ni­ty, com­pet­i­tive po­si­tion, pos­si­ble or as­sumed fu­ture re­sults of op­er­a­tions, busi­ness strate­gies, po­ten­tial growth op­por­tu­ni­ties and oth­er state­ments that are pre­dic­tive in na­ture. These for­ward-look­ing state­ments are based on cur­rent ex­pec­ta­tions, es­ti­mates, fore­casts and pro­jec­tions about the in­dus­try and mar­kets in which we op­er­ate and man­age­ment’s cur­rent be­liefs and as­sump­tions.

Source: Ze­ta­gen Ther­a­peu­tics, Inc.

In­vestor In­quiries:

Ze­ta­gen Ther­a­peu­tics, Inc.

Email: In­vestor­Re­la­tions@ze­ta­gen.com