Can the an­ti­body-drug con­ju­gate mod­el be ap­plied to an off-the-shelf NK cell ther­a­py? Ace­po­dia un­corked pre­lim­i­nary Phase I da­ta at #ES­MO21 that sug­gest the an­swer may be yes.

Pri­vate biotech Ace­po­dia’s lead “an­ti­body cell con­ju­ga­tion” (ACC) can­di­date ACE1702 was well-tol­er­at­ed in sev­en pa­tients with ad­vanced HER2 tu­mors who re­ceived low­er dos­es of the drug, CEO Son­ny Hsiao an­nounced ear­ly Thurs­day. The pa­tients who re­ceived the first four dose lev­els showed no signs of cy­tokine re­lease syn­drome, neu­ro­tox­i­c­i­ty or graft ver­sus host dis­ease — and one of them achieved a con­firmed par­tial re­sponse; not earth-shat­ter­ing, but a pos­i­tive sign.

“We didn’t ex­pect to see the re­sult on the ef­fi­ca­cy,” Hsiao told End­points News ahead of ES­MO. More than a decade af­ter the dis­cov­ery of the com­pa­ny’s ACC tech­nol­o­gy, Hsiao said the read­out “re­flects the hard work of our in­ter­na­tion­al teams as we con­tin­ue to gain mo­men­tum.”

The da­ta could al­so spell good news for JW Ther­a­peu­tics, which plunked down an undis­closed amount last sum­mer to de­vel­op and com­mer­cial­ize the can­di­date in main­land Chi­na, Hong Kong and Macau.

Ace­po­dia’s core tech­nol­o­gy traces back to Hsiao’s re­search at Berke­ley, where he dis­cov­ered a way to con­ju­gate an­ti­bod­ies with NK cells in a sim­i­lar fash­ion to AD­Cs. While most NK cell ther­a­pies are al­ready ad­min­is­tered in con­junc­tion with an­ti­bod­ies, they’re usu­al­ly giv­en sep­a­rate­ly, mak­ing for less po­ten­cy, Ace­po­dia be­lieves. By con­ju­gat­ing the two, the can­cer-tar­get­ing an­ti­bod­ies are less like­ly to dif­fuse through­out the body, Hsiao told End­points ear­li­er this year.

The ACCs al­so help ac­ti­vate the en­tire im­mune sys­tem to fight the tu­mor, Hsiao added, as con­ju­gat­ing the NK cells di­rect­ly pro­vides for an en­hanced im­mune re­sponse com­pared to cur­rent NK cell ther­a­pies or the typ­i­cal ADC.

“It’s a mild chem­i­cal con­ju­ga­tion re­ac­tion to link the an­ti­body, which means we don’t need ge­net­ic en­gi­neer­ing,” the CEO said on Wednes­day. “Our ACC will ac­tu­al­ly be more stream­lined, quick­er and eas­i­er to man­u­fac­ture, and that will al­so re­flect the low pro­duc­tion cost,” com­pared to oth­er cell ther­a­pies, he added.

The Phase I tri­al is ex­pect­ed to in­clude about 16 pa­tients to­tal, count­ing pa­tients who were giv­en high­er dos­es. Hsiao says da­ta on those pa­tients won’t be ready un­til Q2 of next year. Af­ter find­ing the max­i­mum tol­er­at­ed dose, the CEO ex­pects to ex­pand the study by ap­prox­i­mate­ly nine to 12 pa­tients be­fore leap­ing in­to a Phase II test.

The Alame­da, CA-based biotech hooked a $47 mil­lion Se­ries B round back in March, bring­ing its to­tal raise up to $57 mil­lion. The two pro­grams com­ing up be­hind ACE1702 will tar­get CD20 and PD-L1, re­spec­tive­ly, with plans to launch the CD20 pro­gram in­to the clin­ic next year. An IND for the PD-L1 pro­gram will like­ly fol­low in the sec­ond half of next year, Hsiao said.

89bio said its drug was better than placebo at lessening fibrosis without worsening nonalcoholic steatohepatitis, or NASH, in two of three dose groups.

The San Francisco biotech said it thinks the Phase IIb data pave the way for a potential Phase III, following in the footsteps of another biotech in its drug class, Akero Therapeutics. To fund a late-stage study, CEO Rohan Palekar told Endpoints News 89bio “would need to raise additional capital,” with the company having about $188 million at the end of last year.