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.

Albert Bourla (Photo by Steven Ferdman/Getty Images)

UP­DAT­ED: Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

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Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

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Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

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A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

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Brian Thomas, Metagenomi CEO

Gen 2: Berke­ley spin­out lands $175M megaround to keep it on the cut­ting edge of the boom­ing gene-edit­ing field

The big bucks keep pumping into the gene-editing field.

This morning Metagenomi, allied with one of the biggest names in the mRNA field with a company DNA that includes the ubiquitous Jennifer Doudna, is showing off a $175 million B round that will pay for a rapid swelling of its staff in pursuit of some of the cutting-edge tech that keeps this field in the spotlight. And they’re aligning themselves with some major industry players with an eye on the clinic while getting behind some startups to help expand the work into new fields.

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Roy Baynes, Merck

FDA bats back Mer­ck’s ‘pipeline in a prod­uct,’ de­mands more ef­fi­ca­cy da­ta

Despite some heavy blowback from analysts, Merck execs maintained an upbeat attitude about the market potential of its chronic cough drug gefapixant. But the confidence may be fading somewhat today as Merck puts out news that the FDA is handing back its application with a CRL.

Dubbed by Merck’s development chief Roy Baynes as a “pipeline in a product” with a variety of potential uses, Merck had fielded positive late-stage data demonstrating the drug’s ability to combat chronic cough. The drug dramatically reduced chronic cough in Phase III, but so did placebo, leaving Merck’s research team with a marginal success on the p-value side of the equation.

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Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.

Not cheap­er by the dozen: Bris­tol My­ers be­comes the 12th phar­ma com­pa­ny to re­strict 340B sales

Bristol Myers Squibb recently joined 11 of its peer pharma companies in limiting how many contract pharmacies can access certain drugs discounted by a federal program known as 340B.

Bristol Myers is just the latest in a series of high-profile pharma companies moving in their own direction as the Biden administration’s Health Resources and Services Administration struggles to rein in the drug discount program for the neediest Americans.

Joaquin Duato, J&J CEO (Photo by Charles Sykes/Invision/AP)

New J&J CEO Joaquin Du­a­to promis­es an ag­gres­sive M&A hunt in quest to grow phar­ma sales

Joaquin Duato stepped away from the sideline and directly into the spotlight on Tuesday, delivering his first quarterly review for J&J as its newly-tapped CEO after an 11-year run in senior posts. And he had some mixed financial news to deliver today while laying claim to a string of blockbuster drugs in the making and outlining an appetite for small and medium-sized M&A deals.

Duato also didn’t exactly shun large buyouts when asked about the future of the company’s medtech business — where they look to be in either the top or number 2 position in every segment they’re in — even though the bar for getting those deals done is so much higher.

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