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.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Dave Lennon, former president of Novartis Gene Therapies

Zol­gens­ma patent spat brews be­tween No­var­tis and Re­genxbio as top No­var­tis gene ther­a­py ex­ec de­parts

Regenxbio, a small licensor of gene therapy viral vectors spun out from the University of Pennsylvania, is now finding itself in the middle of some major league patent fights.

In addition to a patent suit with Sarepta Therapeutics from last September, Novartis, is now trying to push its smaller partner out of the way. The Swiss biopharma licensed Regenxbio’s AAV9 vector for its $2.1 million spinal muscular atrophy therapy Zolgensma.

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Rafaèle Tordjman (Jeito Capital)

Con­ti­nu­ity and di­ver­si­ty: Rafaèle Tord­j­man's women-led VC firm tops out first fund at $630M

For a first-time fund, Jeito Capital talks a lot about continuity.

Rafaèle Tordjman had spotlighted that concept ever since she started building the firm in 2018, promising to go the extra mile(s) with biotech entrepreneurs while pushing them to reach patients faster.

Coincidentally, the lack of continuity was one of the sore spots listed in a report about the European healthcare sector published that same year by the European Investment Bank — whose fund is one of the LPs, alongside the American pension fund Teacher Retirement System of Texas and Singapore’s Temasek, to help Jeito close its first fund at $630 million (€534 million). As previously reported, Sanofi had chimed in €50 million, marking its first investment in a French life sciences fund.

FDA hands ac­cel­er­at­ed nod to Seagen, Gen­mab's so­lo ADC in cer­vi­cal can­cer, but com­bo stud­ies look even more promis­ing

Biopharma’s resident antibody-drug conjugate expert Seagen has scored a clutch of oncology approvals in recent years, finding gold in what are known as “third-gen” ADCs. Now, another of their partnered conjugates is ready for prime time.

The FDA on Monday handed an accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv, or “TV”) in second-line patients with recurrent or metastatic cervical cancer who previously progressed after chemotherapy rather than PD-(L)1 systemic therapy, the companies said in a release.

The biggest ques­tions fac­ing gene ther­a­py, the XLMTM com­mu­ni­ty, and Astel­las af­ter fourth pa­tient death

After three patients died last year in an Astellas gene therapy trial, the company halted the study and began figuring out how to safely get the program back on track. They would, executives eventually explained, cut the dose by more than half and institute a battery of other measures to try to prevent the same thing from happening again.

Then tragically, Astellas announced this week that the first patient to receive the new regimen had died, just weeks after administration.

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Time for round 2: Il­lu­mi­na-backed VC snags $325M for its next fund

Illumina Ventures closed off its second investment fund with a total commitment of $325 million, offering fresh fuel to back a slate of startups that have already included a smorgasbord of companies, covering everything from diagnostics to biotech drug development and genomics.

Fund II brings the total investment under Illumina Ventures’ oversight to $560 million, which has been focused on early-stage companies. And it has a transatlantic portfolio that includes SQZ, Twist and Encoded Therapeutics.

Volker Wagner (L) and Jeff Legos

As Bay­er, No­var­tis stack up their ra­dio­phar­ma­ceu­ti­cal da­ta at #ES­MO21, a key de­bate takes shape

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

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