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.

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; 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.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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Yong Dai, Frontera Therapeutics CEO

Scoop: Lit­tle-known Or­biMed-backed biotech clos­es $160M round to start gene ther­a­py tri­al

Frontera Therapeutics, a China and US biotech, has closed a $160 million Series B and received regulatory clearance to test its first gene therapy stateside, Endpoints News has learned.

Led by the largest shareholder, OrbiMed, the biotech has secured $195 million total since its September 2019 founding, according to an email reviewed by Endpoints. The lead AAV gene therapy program is for an undisclosed rare eye disease, according to the source.

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De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

Spanish Prime Minister Pédro Sanchez and European Commission President Ursula von der Leyen (AP Photo/Geert Vanden Wijngaert)

EU to launch vac­cine de­vel­op­ment and man­u­fac­tur­ing part­ner­ship with Latin Amer­i­can and Caribbean coun­tries

While European companies, including BioNTech, are focused on increasing vaccine access to African countries by setting up vaccine manufacturing facilities, the European Union is looking westward to Latin America and the Caribbean.

Speaking at a press conference with Spanish Prime Minister Pédro Sanchez, EU Commission president Ursula von der Leyen said that the EU is launching a new initiative for vaccines and medicines manufacturing in Latin America, to get drugs to Latin America and the Caribbean faster.

Matt Kapusta, uniQure CEO

In trou­bled Hunt­ing­ton’s space, uniQure’s gene ther­a­py shows ear­ly promise

In randomized clinical trial data from a small number of patients, Dutch biotech uniQure shared that its gene therapy for Huntington’s disease seems to reduce the amount of the mutant protein responsible for the disease over the course of a year.

In seven patients with early-stage Huntington’s — four who got the treatment and three who got a placebo — mutant huntingtin protein levels in the cerebrospinal fluid decreased by an average of just over 50% in patients who got the gene therapy compared to around a 17% drop in patients who got the placebo after a year.

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DEM BioPharma CEO David Donabedian (L) and executive chair Jan Skvarka

Long­wood sets an­oth­er 'don't eat me' biotech in­to gear with help of for­mer Tril­li­um CEO Jan Skvar­ka

Jonathan Weissman and team are out with a cancer-fighting biotech riding the appetite for those so-called “don’t eat me” and “eat me” signals.

The scientific co-founder — alongside fellow Whitehead Institute colleague Kipp Weiskopf and Stanford biologist Michael Bassik — has launched DEM BioPharma with incubator Longwood Fund and a crop of other investors.

In all, the nascent, 10-employee biotech has $70 million to bankroll hematology- and solid tumor-based programs, including a lead asset that could enter human trials in two to three years, CEO David Donabedian told Endpoints News.

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