Sonny Hsiao, Acepodia CEO

Ace­po­dia un­corks a very ear­ly win for its an­ti­body-nat­ur­al killer cell con­ju­gates in HER2 tu­mors

Can the an­ti­body-drug con­ju­gate mod­el be ap­plied to an off-the-shelf NK cell ther­a­py? Ace­po­dia un­corked pre­lim­i­nary Phase I da­ta at #ES­MO21 that sug­gest the an­swer may be yes.

Pri­vate biotech Ace­po­dia’s lead “an­ti­body cell con­ju­ga­tion” (ACC) can­di­date ACE1702 was well-tol­er­at­ed in sev­en pa­tients with ad­vanced HER2 tu­mors who re­ceived low­er dos­es of the drug, CEO Son­ny Hsiao an­nounced ear­ly Thurs­day. The pa­tients who re­ceived the first four dose lev­els showed no signs of cy­tokine re­lease syn­drome, neu­ro­tox­i­c­i­ty or graft ver­sus host dis­ease — and one of them achieved a con­firmed par­tial re­sponse; not earth-shat­ter­ing, but a pos­i­tive sign.

“We didn’t ex­pect to see the re­sult on the ef­fi­ca­cy,” Hsiao told End­points News ahead of ES­MO. More than a decade af­ter the dis­cov­ery of the com­pa­ny’s ACC tech­nol­o­gy, Hsiao said the read­out “re­flects the hard work of our in­ter­na­tion­al teams as we con­tin­ue to gain mo­men­tum.”

The da­ta could al­so spell good news for JW Ther­a­peu­tics, which plunked down an undis­closed amount last sum­mer to de­vel­op and com­mer­cial­ize the can­di­date in main­land Chi­na, Hong Kong and Macau.

Ace­po­dia’s core tech­nol­o­gy traces back to Hsiao’s re­search at Berke­ley, where he dis­cov­ered a way to con­ju­gate an­ti­bod­ies with NK cells in a sim­i­lar fash­ion to AD­Cs. 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 ear­li­er this year.

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 the typ­i­cal ADC.

“It’s a mild chem­i­cal con­ju­ga­tion re­ac­tion to link the an­ti­body, which means we don’t need ge­net­ic en­gi­neer­ing,” the CEO said on Wednes­day. “Our ACC will ac­tu­al­ly be more stream­lined, quick­er and eas­i­er to man­u­fac­ture, and that will al­so re­flect the low pro­duc­tion cost,” com­pared to oth­er cell ther­a­pies, he added.

The Phase I tri­al is ex­pect­ed to in­clude about 16 pa­tients to­tal, count­ing pa­tients who were giv­en high­er dos­es. Hsiao says da­ta on those pa­tients won’t be ready un­til Q2 of next year. Af­ter find­ing the max­i­mum tol­er­at­ed dose, the CEO ex­pects to ex­pand the study by ap­prox­i­mate­ly nine to 12 pa­tients be­fore leap­ing in­to a Phase II test.

The Alame­da, CA-based biotech hooked a $47 mil­lion Se­ries B round back in March, bring­ing its to­tal raise up to $57 mil­lion. The two pro­grams com­ing up be­hind ACE1702 will tar­get CD20 and PD-L1, re­spec­tive­ly, with plans to launch the CD20 pro­gram in­to the clin­ic next year. An IND for the PD-L1 pro­gram will like­ly fol­low in the sec­ond half of next year, Hsiao said.

IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

Tom Barnes, Orna Therapeutics CEO

UP­DAT­ED: 'We have failed to fail': Mer­ck gam­bles $250M cash on a next-gen ap­proach to mR­NA — af­ter punt­ing its big al­liance with Mod­er­na

Merck went in deep on its collaboration with Moderna on new mRNA programs, and dropped them all over time, including their RSV partnership. But after writing off what turned out as one of the most successful infectious disease players in the business, Merck is coming in this morning with a new preclinical alliance — this time embracing a biotech that hopes to eventually outdo the famously successful mRNA in a new run at vaccines and therapeutics.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 148,200+ biopharma pros reading Endpoints daily — and it's free.

Bayer's first DTC ad campaign for chronic kidney disease drug Kerendia spells out its benefits

Bay­er aims to sim­pli­fy the com­plex­i­ties of CKD with an ABC-themed ad cam­paign

Do you know the ABCs of CKD in T2D? Bayer’s first ad campaign for Kerendia tackles the complexity of chronic kidney disease with a play on the acronym (CKD) and its connection to type 2 diabetes (T2D).

Kerendia was approved last year as the first and only non-steroidal mineralocorticoid receptor antagonist to treat CKD in people with type 2 diabetes.

In the TV commercial launched this week, A is for awareness, B is for belief and C is for cardiovascular, explained in the ad as awareness of the connection between type 2 and kidney disease, belief that something can be done about it, and cardiovascular events that may be reduced with treatment.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 148,200+ biopharma pros reading Endpoints daily — and it's free.

James Mock, incoming CFO at Moderna

Mod­er­na taps new CFO from PerkinElmer af­ter for­mer one-day CFO oust­ed

When Moderna hired a new CFO last year,  it didn’t expect to see him gone after only one day. Today the biotech named his — likely much more vetted — replacement.

The mRNA company put out word early Wednesday that after the untimely departure of then brand-new CFO Jorge Gomez, it has now found a replacement in James Mock, the soon-to-be former CFO at diagnostics and analytics company PerkinElmer.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 148,200+ biopharma pros reading Endpoints daily — and it's free.

Etleva Kadilli, director of UNICEF’s supply division

GSK lands first-ever UNICEF con­tract for malar­ia vac­cine worth $170M

GSK has landed a new first from UNICEF the first-ever contract for malaria vaccines, worth up to $170 million for 18 million vaccine doses distributed over the next three years.

The vaccine, known as Mosquirix or RTS,S, won WHO’s backing last October after a controversial start, but UNICEF said these doses will potentially save thousands of lives every year.

“We hope this is just the beginning,” Etleva Kadilli, director of UNICEF’s supply division, said. “Continued innovation is needed to develop new and next-generation vaccines to increase available supply, and enable a healthier vaccine market. This is a giant step forward in our collective efforts to save children’s lives and reduce the burden of malaria as part of wider malaria prevention and control programmes.”

Kate Haviland, Blueprint Medicines CEO

Blue­print met all its end­points in bid for ex­pand­ed Ay­vak­it la­bel — but stock trends low­er any­way

Blueprint Medicines announced this morning that the second part of its study on Ayvakit in non-advanced systemic mastocytosis (SM) — a rare disease in which a type of white blood cells known as mast cells builds up — met all endpoints, but the biopharma left key questions unanswered.

In 212 patients, with 141 in the treatment arm and 71 in the control arm, patients who got Ayvakit saw an average 15.6-point decrease in their symptom scores compared to a 9.2-point decrease in the placebo arm at 24 weeks. In an extension study, those on Ayvakit saw their symptom scores drop by 20.2 points by week 48.

Paul Perreault, CSL Behring CEO

CSL CEO Paul Per­reault de­ter­mined to grow plas­ma col­lec­tion af­ter full-year sales dip

As the ink dries on CSL’s $11.7 billion Vifor buyout, the company posted a dip in profits, due in part to a drop in plasma donations amid the pandemic.

However, CEO Paul Perreault assured investors and analysts on the full-year call that the team has left “no stone unturned” when assessing options to grow plasma volumes. The chief executive also spelled out positive results for the company’s monoclonal antibody garadacimab in hereditary angioedema (HAE), though he isn’t revealing the exact numbers just yet.

Paul Hudson, Sanofi CEO (Eric Piermont/AFP via Getty Images)

Up­dat­ed: Hit by an­oth­er PhI­II flop, Sanofi culls breast can­cer drug — sound­ing alarm for the class

Sanofi is officially giving up on its oral SERD.

The French drugmaker put out word Wednesday morning that it will discontinue the global development program of amcenestrant, the selective estrogen receptor degrader once billed as a top late-stage prospect. Having already failed a Phase II monotherapy test earlier this year, a combo with the drug also missed the bar in a second trial for breast cancer, triggering the decision to drop the whole program.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 148,200+ biopharma pros reading Endpoints daily — and it's free.

Joe Jonas (Photo by Anthony Behar/Sipa USA)(Sipa via AP Images)

So­lo Jonas broth­er car­ries Merz's new tune in Botox ri­val cam­paign

As the lyrics of his band’s 2019 pop-rock single suggest, Joe Jonas is only human — and that means even he gets frown lines. The 33-year-old singer-songwriter is Merz’s newest celebrity brand partner for its Botox rival Xeomin, as medical aesthetics brands target a younger audience.

Merz kicked off its “Beauty on Your Terms” campaign on Tuesday, featuring the Jonas brother in a video ad for its double-filtered anti-wrinkle injection Xeomin.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 148,200+ biopharma pros reading Endpoints daily — and it's free.