CEO Stephen Yoder (Pieris)

Pieris fi­nal­ly vaults FDA hold on next-gen sol­id tu­mor hunter, clear­ing the path for mid-stage tri­al

Fi­nal­ly freed from the re­straints of a par­tial FDA clin­i­cal hold on its lead HER2-pos­i­tive sol­id tu­mor can­di­date, Pieris Phar­ma­ceu­ti­cals is now rac­ing to­ward Phase II.

The FDA slapped a par­tial hold on Pieris’ PRS-343 back in Ju­ly, re­strict­ing the biotech from en­rolling new pa­tients in a Phase I tri­al. While Pieris was al­lowed to con­tin­ue dos­ing pa­tients who were al­ready en­rolled, the agency re­quest­ed they con­duct an ad­di­tion­al “in-use and com­pat­i­bil­i­ty study” be­fore re­cruit­ing any more.

PRS-343 con­sists of a 4-1BB-tar­get­ing An­ti­calin pro­tein and a HER2-tar­get­ing an­ti­body. It’s a frozen for­mu­la­tion that’s re­moved from a freez­er and pre­pared for IV in­fu­sion at the tri­al site, CEO Stephen Yo­der said.

“There was a re­quest from FDA to test the mol­e­cule, the drug prod­uct, un­der var­i­ous con­di­tions in­clud­ing stress con­di­tions to show that it has a very ro­bust sta­bil­i­ty pro­file, giv­en the vari­abil­i­ty that can hap­pen in the dif­fer­ent clin­i­cal sites,” Yo­der told End­points. 

At the time, the biotech had en­rolled pa­tients in the two high­est-dose co­horts — 8 mg/kg and 18 mg/kg — and in com­bi­na­tion stud­ies with Tecen­triq un­der a drug sup­ply agree­ment with Roche.

At vir­tu­al ES­MO 2020, Pieris said the drug showed a “durable clin­i­cal ben­e­fit in the ac­tive dose co­horts, in­clud­ing a con­firmed com­plete re­sponse, in heav­i­ly pre-treat­ed pa­tients across mul­ti­ple HER2-pos­i­tive tu­mor types” in Phase I monother­a­py and Tecen­triq com­bi­na­tion stud­ies.

As of a Ju­ly 27 cut­off date, re­searchers not­ed a con­firmed com­plete re­sponse at the 18mg/kg dose lev­el and three par­tial re­spons­es in the 8 mg/kg lev­el (out of 33 evalu­able pa­tients), ac­cord­ing to the ES­MO da­ta. And in the ate­zolizum­ab com­bi­na­tion tri­al, four out of 29 evalu­able pa­tients achieved a con­firmed par­tial re­sponse at ac­tive dose lev­els.

“We’re sat­is­fied that we have da­ta for our rec­om­mend­ed Phase II dose and we’re now re­al­ly fo­cused on mo­bi­liz­ing for Phase II ini­ti­a­tion,” Yo­der said on Wednes­day, adding that the study is ex­pect­ed to launch this year.

Pieris $PIRS has worked for years on en­gi­neer­ing pro­teins that are lighter and more ver­sa­tile than an­ti­bod­ies, so that they can work where an­ti­bod­ies find their en­try barred. On Wednes­day, their stock was up 1.5%, pric­ing in at $2.71 per share.

“What sets our ap­proach apart from even oth­er im­muno-on­col­o­gy agents such as the check­point in­hibitors is that we are ag­o­niz­ing po­tent­ly in the tu­mor mi­croen­vi­ron­ment tu­mor-spe­cif­ic T cells by tar­get­ing 4-1BB,” Yo­der said. “What that does is it im­proves the meta­bol­ic fit­ness of T cells, and it caus­es al­so their pro­lif­er­a­tion.”

“You don’t just re­ac­ti­vate T cells, but you ex­pand them, and you can po­ten­tial­ly give them a lot more longevi­ty and more dura­bil­i­ty,” he added.

De­spite the par­tial clin­i­cal hold, Eli Lil­ly struck a col­lab­o­ra­tion deal with Pieris in Au­gust to fur­ther ad­vance PRS-343 stud­ies in com­bi­na­tion with its Cyra­mza and chemother­a­py pa­cli­tax­el for the sec­ond-line treat­ment of pa­tients with HER2-pos­i­tive gas­tric can­cer. Lil­ly agreed to sup­ply the ad­di­tion­al com­pounds and col­lab­o­rate on da­ta while Pieris pre­pared to ini­ti­ate Phase II.

That isn’t Pieris’ first Big Phar­ma pact. Back in 2017, As­traZeneca com­mit­ted up to $57.5 mil­lion to seed an R&D pact with Pieris, which was charged with tak­ing PRS-060 — an An­ti­calin against in­ter­leukin-4 re­cep­tor al­pha — in­to a Phase I asth­ma tri­al. And be­fore that, it inked a deal to work with Servi­er for PRS-332 and four more im­muno-on­col­o­gy pro­grams.

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.

Martin Landray, Protas CEO (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Those big bil­lion-dol­lar PhI­II stud­ies? Mar­tin Lan­dray says they can be done for a tiny frac­tion of the cost

Martin Landray knows what controversy in clinical drug development feels like, from first-hand experience.

Landray was the chief architect of RECOVERY, a study that pitted a variety of drugs against Covid-19. And he offered some landmark data that would help push dexamethasone out into broader use as a cheap treatment, while helping ice hydroxy’s reputation as a clear misfire.

“Lots of people told us we shouldn’t use it,” Landray says about dexamethasone and Covid-19. “It was dangerous. We shouldn’t even do a trial. They also cared about hydroxychloroquine and lots of people said we shouldn’t do a trial because it must be used. I’ve got the letters from both sets of people.”

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Geoffrey Porges, new Schrödinger CFO

Long­time an­a­lyst Ge­of­frey Porges de­parts SVB to lead fi­nances at a drug dis­cov­ery shop

Geoffrey Porges has ended his two-decade run as a biotech analyst, as the former SVB Securities vice chair began as CFO of Schrödinger on Thursday.

The long-running analyst, who previously headed up vaccines marketing at Merck before the turn of the millennium, will lead the financial operations of the 700-employee company as Schrödinger broadens its focus from a drug discovery partner to also building out an in-house pipeline, with clinical trial No. 1 set to begin next quarter.

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FDA ap­proves one of the prici­est new treat­ments of all time — blue­bird's gene ther­a­py for be­ta tha­lassemia

The FDA on Wednesday approved the first gene therapy for a chronic condition — bluebird bio’s new Zynteglo (beti-cel) as a potentially curative treatment for those with transfusion-dependent thalassemia.

The thumbs-up from the FDA follows a unanimous adcomm vote in June, with outside experts pointing to extraordinary efficacy, with 89% of subjects with TDT who received beti-cel having achieved transfusion independence.

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James Sabry, Roche global head of pharma partnering

Roche, Genen­tech plunk down $60M up­front to part­ner with Chi­nese phar­ma on PRO­TAC-based prostate can­cer drug

Roche and Genentech are always on the hunt for deals, and on Thursday they found their newest partner.

The pair will team up with the Chinese pharma company Jemincare to push forward a new program for prostate cancer, the companies announced. Roche is ponying up $60 million upfront to get its hands on the candidate and promising up to $590 million in biobucks, plus royalties, down the line.

In return, Genentech will get a worldwide license to develop the program, known as JMKX002992, and bring it to market.

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Andrew Hopkins, Exscientia CEO

Ex­sci­en­tia ter­mi­nates Bay­er pact half a year ear­ly, col­lect­ing small por­tion of €240M promised

Bayer and Exscientia are winding down their three-year collaboration, leaving the big German pharma to take the AI-designed compounds born out of the pact further.

London-based Exscientia revealed in its Q2 update that the partners have “mutually agreed to end” their collaboration, which kicked off in early 2020, after recently achieving a drug discovery milestone. In an SEC filing, Exscientia said it terminated the pact on May 30, about six months early.

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.

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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.

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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.”