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.

Aduhelm OK 'bit­ter­sweet' for ALS ad­vo­cates; Con­trast­ing Covid-19 vac­cine read­outs; GSK joins TIG­IT bat­tle; 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.

With the busiest days of June now behind us, we’re starting to think seriously about the second half of the year. In August, we have scheduled a special report where Endpoints will compile a list of the 20 most influential R&D executives in biopharma. Know a luminary who should definitely be included? Nominate them now.

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In­side Track: Be­hind the Scenes of a Ma­jor Biotech SPAC

Dr. David Hung and Michelle Doig are no strangers to the SPAC phenomenon. As Founder and CEO of Nuvation Bio, a biotech company tackling some of the greatest unmet needs in oncology, Dr. Hung recently took the company public in one of this year’s biggest SPAC related deals. And as Partner at Omega Funds, Doig not only led and syndicated Nuvation Bio’s Series A, but is now also President of the newly formed, Omega-sponsored, Omega Alpha SPAC (Nasdaq: OMEG; oversubscribed $138m IPO priced January 6, 2021).

Who are the lu­mi­nar­ies dri­ving the biggest ad­vances in bio­phar­ma R&D? End­points News is ask­ing for your nom­i­na­tions for a spe­cial re­port

In biopharma, driving a drug to market is the ultimate goal — but none of that happens without a strong research and development program. At the most successful companies, those R&D efforts are spearheaded by true innovators in the field who are always looking for that next novel mechanism of action or breakthrough safety profile.

Now, Endpoints News is asking you to tell us who those guiding lights are.

Bris­tol My­ers breaks the bank on Ei­sai's fo­late re­cep­tor ADC drug, lay­ing out more than $3B+ for rights

For years, innovation in oncology has been a crapshoot with Big Pharma — the whales at the table — dropping the big bucks for the key to the next generation of tumor fighters. Bristol Myers Squibb hasn’t exactly made a name for being an innovator in the space, but that doesn’t mean it won’t splash in when it sees a potential winner.

Now, with a massive check in hand, the drugmaker is willing to put its intuition to the test.

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Michael Chambers (L) and John Ballantyne

Dana­her strikes deal to buy boom­ing next-gen man­u­fac­tur­er Alde­vron for $9.6B

Life sciences conglomerate Danaher Corp. $DHR has struck a deal to buy the fast-growing Aldevron, one of the world’s top manufacturers of hotly sought-after plasmid DNA, mRNA and recombinant proteins for the burgeoning world of vaccine and drugmakers pushing some game-changing technologies.

Buyout talks set the stage for Danaher to settle on a $9.6 billion cash pact to acquire the private Fargo, ND-based company — a key supplier for a disruptive new Covid vaccine as well as a host of gene and cell therapy and CRISPR gene editing players — founded by Michael Chambers and CSO John Ballantyne as a crew of 2 back in 1998.

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Christian Hogg, Hutchmed CEO

Hutchmed files for $600M+ IPO in Hong Kong as lead on­col­o­gy drug su­r­u­fa­tinib awaits FDA's good graces

In oncology, a flush of Chinese-developed drugs has the biopharma industry rethinking the poles of power in R&D as the blossoming nation continues to make a name for itself and pick up bundles of cash in the process. Now, as its lead drug faces a pivotal FDA review, the company formerly known as Chi-Med is planting its flag on home soil with a massive public offering.

Hutchmed — recently renamed from Chi-Med, or Hutchison China MediTech — will look to raise $603 million as part of a Hong Kong IPO that serves as a homecoming of sorts for the Chinese-based oncology player, which has listed on Nasdaq since 2016.

Michel Sade­lain puts his name and new cell en­gi­neer­ing tech be­hind 'ag­nos­tic' CAR-T start­up chas­ing epi­ge­net­ic anti­gens

It felt natural for Alain Maiore and Sebastian Amigorena to bring in Michel Sadelain as a co-founder of Mnemo Therapeutics. A CAR-T pioneer, Sadelain had been involved as an advisor since the early days — enthusiastic about Amigorena’s work in a genetic knockout that could enhance T cell memory and a new class of potential targets he’s discovered — and could introduce some well-known technologies to the toolbox. So they got the initial cash from Sofinnova Partners to plant roots in Paris and New York in early 2019; within a few months, they began to see more clearly just what the antigen discovery platform might unlock.

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FDA's con­tro­ver­sial Aduhelm de­ci­sion leaves ALS pa­tients feel­ing spurned

The FDA’s controversial approval of Biogen’s Aduhelm drug for Alzheimer’s disease has been met with fierce resistance from all corners of the biopharma industry, but few seem to be as upset with the decision as ALS patients and advocacy groups.

For all that’s already been written and discussed about the agency’s announcement, from the drug’s exorbitantly high price of $56,000 per year to criticism over lowered standards, ALS patients see something more. ALS patients and associations say they largely regarded Aduhelm’s approval as a bittersweet double standard: happy that those with Alzheimer’s have a new drug available, but questioning how the FDA evaluated Biogen’s drug compared to the experimental programs being studied for their own disease.

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Spring reg­u­la­to­ry agen­da: What’s com­ing soon-ish from the FDA

The FDA’s lack of a permanent commissioner does not seem to be halting its progress to propose and finalize dozens of new regulations, with the latest batch covering everything from adverse event reporting to supplemental application submissions to annual reports for INDs.

Overall, FDA expects to release more than 40 new proposed regulations and finalize another 24 in the coming months and years.

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