Sonny Hsiao, Acepodia CEO

Can the an­ti­body-drug con­ju­gate mod­el work for NK cells? Ace­po­dia loads up with an­oth­er $109M to find out

Ace­po­dia chair­man and co-founder Patrick Yang called can­cer “the longest war Amer­i­ca (has) ever fought.” So when he met Son­ny Hsiao in 2016 and saw his “clever, very sim­ple, el­e­gant” ap­proach to bat­tling tu­mor cells, he was all in.

Four years and some very ear­ly pos­i­tive re­sults lat­er, Yang and Hsiao have racked up an­oth­er $109 mil­lion from in­vestors to see their “an­ti­body-cell con­ju­gates” through the clin­ic. And while Yang says this isn’t a crossover round, he ad­mit­ted that the com­pa­ny is “watch­ing the cap­i­tal cli­mate” and could pos­si­bly file for an IPO next year.

But for now, he says, the team at Ace­po­dia is laser-fo­cused on their pipeline.

Patrick Yang

The Alame­da, CA-based biotech’s plat­form traces back to Hsiao’s re­search at UC-Berke­ley, where he dis­cov­ered a way to con­ju­gate an­ti­bod­ies with NK cells in a sim­i­lar fash­ion to an­ti­body-drug con­ju­gates (AD­Cs). Hsiao — now CEO — calls this ap­proach “an­ti­body-cell con­ju­ga­tion,” or ACC for short.

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 News ear­li­er this year.

“It’s to­tal­ly dif­fer­ent from the CAR-T sci­en­tif­ic com­mu­ni­ty,” Yang said on Tues­day. “Some of the im­mune cells like NK cells, they’re just pa­trolling in the body with no spe­cif­ic ob­jec­tive, no tar­gets. If we arm it with a GPS guid­ed to the des­ti­na­tion, we could rad­i­cal­ly im­prove the treat­ment out­come.”

While au­tol­o­gous CAR-T ther­a­pies have shown great promise, they’re ex­pen­sive to make and they take too long, Yang said. That’s why his com­pa­ny is go­ing for an off-the-shelf ap­proach that doesn’t re­quire ge­net­ic en­gi­neer­ing.

“Our mis­sion state­ment is to bring a more pow­er­ful can­cer treat­ment that can be ac­ces­si­ble to all pa­tients, not just a small pop­u­la­tion of pa­tients who can af­ford it,” Hsiao said.

The team brought some pos­i­tive topline da­ta for their lead can­di­date, ACE1702, to this year’s ES­MO, show­ing the drug was well-tol­er­at­ed in eight pa­tients with ad­vanced HER2 tu­mors who re­ceived low­er dos­es. One pa­tient even achieved a con­firmed par­tial re­sponse — not earth-shat­ter­ing, but a pos­i­tive sign. Hsiao ex­pects to read out the full Phase I da­ta some­time in Q2 or Q3 2022. Then they’ll ex­tend the tri­al be­fore jump­ing in­to a piv­otal Phase II study.

“(At) Ace­po­dia, every day is Wednes­day,” Yang joked. “We kind of work around the clock.”

The ear­ly re­sults were al­so a pos­i­tive sign for JW Ther­a­peu­tics, which plunked down an undis­closed amount last sum­mer to de­vel­op and com­mer­cial­ize the can­di­date in main­land Chi­na, Hong Kong and Macau.

In ad­di­tion to see­ing ACE1702 through Phase I, the com­pa­ny is on track to sub­mit an IND for its sec­ond lead pro­gram this month — a gam­ma delta (γδ) T cell ther­a­py tar­get­ing CD20.

The Se­ries C round — led by Dig­i­tal Mo­bile Ven­ture with a hand from oth­er undis­closed in­vestors — will al­so help Hsiao ex­pand the team from 45 to 70 by the end of next year. Yang al­so hint­ed at po­ten­tial part­ner­ships com­ing in the next year or so.

“The tech­nol­o­gy that we have is a plat­form tech­nol­o­gy, and it takes a lot of hard work to trans­late the sci­ence in­to a prod­uct and get it com­mer­cial­ized,” Yang said. “And we could see that we have a roadmap to get there.”

Cor­rec­tion: The topline ES­MO da­ta was based on eight pa­tients, not sev­en.

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His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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No­var­tis re­ports two pa­tient deaths af­ter treat­ment with Zol­gens­ma

Two children with spinal muscular atrophy have died after receiving Novartis’ Zolgensma, a gene therapy designed as a one-time treatment for the rare fatal disease.

The deaths, which resulted from acute liver failure, occurred in Russia and Kazakhstan, Novartis confirmed in a statement to Endpoints News. Having notified health authorities across all the markets where Zolgensma is available, it will update the drug label “to specify that fatal acute liver failure has been reported,” a spokesperson wrote.

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House pass­es his­toric drug pric­ing re­forms, lin­ing up decades-in-the-mak­ing win for Biden and De­moc­rats

The US House of Representatives today voted along party lines (all Dems voted for it), 220-207 to pass new, wide-ranging legislation that will allow Medicare drug price negotiations for the first time ever, and cap seniors’ drug expenses to $2,000 per year and seniors’ insulin costs at $35 per month.

Setting up a major victory for President Joe Biden, representatives returned from their summer recess to pass the Inflation Reduction Act, even as many noted the bill would only modestly reduce inflation.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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