CEO Sonny Hsiao (Acepodia)

Tai­wan's Ace­po­dia clos­es Se­ries B with the promise of con­ju­gat­ing an­ti­bod­ies and off-the-shelf NK cells

What if re­searchers could take the an­ti­body-drug con­ju­gate mod­el and ap­ply it to off-the-shelf NK cell ther­a­py? For the Tai­wan-based biotech Ace­po­dia, that’s the $47 mil­lion ques­tion.

Ace­po­dia closed its Se­ries B round Tues­day morn­ing, hop­ing to build up­on CEO Son­ny Hsiao’s work from when he was a bi­ol­o­gist at UC Berke­ley. The biotech plans to use the funds to ad­vance its lead pro­gram through the end of a Phase I tri­al and launch a Phase II study, as well as to get two oth­er can­di­dates in­to the clin­ic.

Fol­low­ing a $10 mil­lion Se­ries A, Ace­po­dia has now raised $57 mil­lion to date.

The biotech’s core tech­nol­o­gy comes from Hsiao’s lab re­search at Berke­ley, where he dis­cov­ered a way to con­ju­gate an­ti­bod­ies with NK cells in a sim­i­lar fash­ion to the ADC ap­proach with small mol­e­cule or check­point in­hibitors. And as if tak­ing a cue from that mod­el, Ace­po­dia calls its plat­form “an­ti­body cell con­ju­ga­tion,” or ACC.

While most NK cell ther­a­pies are al­ready ad­min­is­tered in con­junc­tion with an­ti­bod­ies, Hsiao says Ace­po­dia’s tech al­lows for a more tar­get­ed treat­ment. Nor­mal­ly, the an­ti­bod­ies and NK cells are ad­min­is­tered sep­a­rate­ly, mak­ing for less po­tent ef­fi­ca­cy, Hsiao told End­points News.

But by con­ju­gat­ing the two, the can­cer-tar­get­ing an­ti­bod­ies are less like­ly to dif­fuse through­out the body. Hsiao likened the an­ti­bod­ies used in his plat­form to track­ing de­vices, hunt­ing down tu­mor cells as they evade the body’s nat­ur­al de­fens­es.

“We can put hun­dreds of thou­sands of them, of these very good track­ing de­vices, on the NK cells for the NK cells to rec­og­nize and kill the tu­mor cells,” Hsiao said.

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 your typ­i­cal ADC.

Ace­po­dia’s lead pro­gram is called ACE1702, and it’s cur­rent­ly un­der­go­ing a Phase I study tar­get­ing HER2-ex­press­ing sol­id tu­mors. As with any ini­tial clin­i­cal tri­al, Ace­po­dia is eval­u­at­ing the safe­ty and tol­er­a­bil­i­ty of the pro­gram and is en­rolling be­tween 12 and 24 pa­tients. The first pa­tient was dosed with ACE1702 last Au­gust, with topline da­ta ex­pect­ed at ES­MO this sum­mer.

Should the Phase I re­turn pos­i­tive re­sults when it’s fin­ished, Ace­po­dia plans to prep a Phase II for ear­ly 2022.

Hsiao high­light­ed the ver­sa­til­i­ty of the plat­form, not­ing that HER2 is ex­pressed in sev­er­al dif­fer­ent can­cer types. And the pro­grams com­ing up be­hind ACE1702 will tar­get CD20 and CD70, re­spec­tive­ly, with ini­tial in­di­ca­tions planned for a va­ri­ety of liq­uid and sol­id tu­mors, he said. Ace­po­dia ex­pects to sub­mit an IND for the CD20 can­di­date in the sec­ond half of this year.

Be­yond that, the biotech is al­ready set­ting the wheels in mo­tion to kick off its crossover round fund­ing. The Se­ries B gives Ace­po­dia enough run­way for 12 to 18 months to launch these tri­als, but fu­ture fund­ing is ex­pect­ed to help the com­pa­ny ex­pand its pipeline even fur­ther.

And af­ter that, could Ace­po­dia see it­self jump­ing to Nas­daq with an IPO? It’s “def­i­nite­ly an op­tion for us to keep in mind,” Hsiao said.

Tues­day’s round was sup­port­ed by new in­vestors Ridge­back Cap­i­tal, 8VC, and DEF­TA Part­ners, and the Tai­wan-based in­sti­tu­tion­al in­vestor-CDIB Cap­i­tal Health­care. Ace­po­dia’s Se­ries A in­vestors al­so par­tic­i­pat­ed in the fund­ing.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Christian Itin, Autolus CEO (UKBIO19)

Au­to­lus tips its hand, bags $220M as CAR-T show­down with Gilead looms

The first batch of pivotal data on Autolus Therapeutics’ CAR-T is in, and execs are ready to plot a path to market.

With an overall remission rate of 70% at the interim analysis featuring 50 patients, the results set the stage for a BLA filing by the end of 2023, said CEO Christian Itin.

Perhaps more importantly — given that Autolus’ drug, obe-cel, is going after an indication that Gilead’s Tecartus is already approved for — the biotech highlighted “encouraging safety data” in the trial, with a low percentage of patients experiencing severe immune responses.

Dipal Doshi, Entrada Therapeutics CEO

Ver­tex just found the next big ‘trans­for­ma­tive’ thing for the pipeline — at a biotech just down the street

Back in the summer of 2019, when I was covering Vertex’s executive chairman Jeff Leiden’s plans for the pipeline, I picked up on a distinct focus on myotonic dystrophy Type I, or DM1 — one of what Leiden called “two diseases (with DMD) we’re interested in and we continue to look for those assets.”

Today, Leiden’s successor at the helm of Vertex, CEO Reshma Kewalramani, is plunking down $250 million in cash to go the extra mile on DM1. The lion’s share of that is for the upfront, with a small reserve for equity in a deal that lines Vertex up with a neighbor in Seaport that has been rather quietly going at both of Vertex’s early disease targets with preclinical assets.

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WIB22: Am­ber Salz­man had few op­tions when her son was di­ag­nosed with a rare ge­net­ic dis­ease. So she cre­at­ed a bet­ter one

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

Amber Salzman’s life changed on a cold, damp day in Paris over tiny plastic cups of lukewarm tea.

She was meeting with Patrick Aubourg, a French neurologist studying adrenoleukodystrophy, or ALD, a rare genetic condition that causes rapid neurological decline in young boys. It’s a sinister disease that often leads to disability or death within just a few years. Salzman’s nephew was diagnosed at just 6 or 7 years old, and died at the age of 12.

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Ahead of ad­comm, FDA rais­es un­cer­tain­ties on ben­e­fit-risk pro­file of Cy­to­ki­net­ic­s' po­ten­tial heart drug

The FDA’s Cardiovascular and Renal Drugs Advisory Committee will meet next Tuesday to discuss whether Cytokinetics’ potential heart drug can safely reduce the risk of cardiovascular death and heart failure in patients with symptomatic chronic heart failure with reduced ejection fraction.

The drug, known as omecamtiv mecarbil and in development for more than 15 years, has seen mixed results, with a first Phase III readout from November 2020 hitting the primary endpoint of reducing the odds of hospitalization or other urgent care for heart failure by 8%. But it also missed a key secondary endpoint analysts had pegged as key to breaking into the market.

Nashville-based CD­MO nets a $65M Se­ries B to ex­pand fa­cil­i­ty and ca­pa­bil­i­ties

Another $65 million is music to the ears of the team at August Bioservices, a contract manufacturer in Nashville.

The company announced the Series B round last week, which will fund equipment in a new building expected to open in 2023, according to CEO Jenn Adams. It was led by Oak HC/FT, the same firm that led August’s Series A round in July 2020.

August Bioservices, a producer of materials such as prefilled syringes, IV bags and vials, was formed back in 2020 after the acquisition of PMI BioPharma Solutions, also based in Nashville. Adams said the goal was to build a business that could “address the scarcity of supply relative to sterile injectable manufacturing based in the US” and provide a broad range of manufacturing services.

Ab­b­Vie slapped with age dis­crim­i­na­tion law­suit, fol­low­ing oth­er phar­mas

Add AbbVie to the list of pharma companies currently facing age discrimination allegations.

Pennsylvania resident Thomas Hesch filed suit against AbbVie on Wednesday, accusing the company of passing him over for promotions in favor of younger candidates.

Despite 30 years of pharma experience, “Hesch has consistently seen younger, less qualified employees promoted over him,” the complaint states.

Rami Elghandour, Arcellx CEO

Up­dat­ed: Gilead, Ar­cel­lx team up on an­ti-BC­MA CAR-T as biotech touts a 100% re­sponse rate at #ASH22

Gilead and Kite are plunking down big cash to get into the anti-BCMA CAR-T game.

The pair will shell out $225 million in cash upfront and $100 million in equity to Arcellx, Kite announced Friday morning, to develop the biotech’s lead CAR-T program together. Kite will handle commercialization and co-development with Arcellx, and profits in the US will be split 50-50.

Concurrent with the deal, Arcellx revealed its latest cut of data for the program known as CART-ddBCMA, ahead of a full presentation at this weekend’s ASH conference — a 100% response rate among patients getting the therapy. Investors jumped at the dual announcements, sending Arcellx shares $ACLX up more than 25% in Friday’s morning session.

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WIB22: Lead­ing NK cell re­searcher re­flects on roots in Iran, the UK and Texas

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

In a small but widely-cited 11-person study published in NEJM in 2020, seven patients saw signs of their cancer completely go away after getting a new therapy made from natural killer cells. The study was one of the earliest to provide clinical proof that the experimental treatment method had promise.

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