Pieris slammed with FDA hold; Bio­gen adds PhIV for Spin­raza

→ Boston-based Pieris $PIRS has been forced to hit the brakes on a slate of Phase I stud­ies for its 4-1BB/HER2 fu­sion pro­tein drug PRS-343 af­ter the FDA hit the com­pa­ny with a par­tial hold. The biotech can con­tin­ue to dose pa­tients al­ready in the stud­ies, but can’t add pa­tients un­til af­ter it con­ducts “an ad­di­tion­al in-use and com­pat­i­bil­i­ty study of PRS-343 with var­i­ous in­fu­sion ma­te­ri­als un­der spe­cif­ic con­di­tions to con­firm suit­abil­i­ty of PRS-343 for ad­min­is­tra­tion in clin­i­cal set­tings.” The biotech says no ad­verse events were cit­ed and still plans to launch their Phase II pro­gram for the drug lat­er this year — pro­vid­ed the FDA can be sat­is­fied.  “We al­so re­main on track to present com­pre­hen­sive da­ta from both the monother­a­py and ate­zolizum­ab com­bi­na­tion phase 1 stud­ies at a med­ical con­fer­ence lat­er this year,” says CEO Stephen Yo­der. Their stock was down about 6% in morn­ing trad­ing Tues­day.

Bio­gen wants to see ex­act­ly what ben­e­fits its big SMA block­buster Spin­raza can have on pa­tients who don’t re­spond suf­fi­cient­ly well to No­var­tis’ gene ther­a­py ri­val Zol­gens­ma. The big biotech says the Phase IV study was in­spired by the sto­ries of some pa­tients who went on Spin­raza af­ter the gene ther­a­py failed to prove a once-and-done treat­ment. “Avail­able da­ta now show that some pa­tients in the long-term study of Zol­gens­ma have moved on to treat­ment with Spin­raza. We be­lieve that, for cer­tain pa­tients, mo­tor neu­rons may be in­suf­fi­cient­ly treat­ed by this gene ther­a­py, and we plan to ini­ti­ate this study to un­der­stand the ex­tent to which Spin­raza may po­ten­tial­ly im­prove out­comes,” said Ma­ha Rad­hakr­ish­nan, the CMO at Bio­gen.

→ Myokar­dia is jump­ing on board Ful­crum‘s dis­cov­ery plat­form in search of new drugs to treat ge­net­ic car­diomy­opathies. The deal starts with a pay­ment of $12.5 mil­lion, with a lit­tle more than $300 mil­lion on the ta­ble for the first drug and up to $150 mil­lion more for each ad­di­tion­al pro­gram. “We have been im­pressed by Ful­crum’s abil­i­ty to dis­cov­er new bi­ol­o­gy around ge­net­ic mus­cle dis­or­ders,” not­ed Myokar­dia CSO Robert Mc­Dow­ell.

→ UPMC En­ter­pris­es, Cas­din Cap­i­tal and Dol­by Fam­i­ly Ven­tures have stepped up with an ex­tra $20 mil­lion to add to Cere­vance‘s lat­est round, bring­ing the to­tal to $65 mil­lion. Fore­site Cap­i­tal al­so chipped in some ex­tra cash on the round, which al­ready in­clud­ed GV (for­mer­ly Google Ven­tures), Bill Gates, Take­da Ven­tures, Inc., the De­men­tia Dis­cov­ery Fund and Light­stone Ven­tures. The biotech is work­ing on a pipeline of drugs aimed at a range of CNS dis­eases.

→ Ger­many’s Tubu­lis has raised €10.7 mil­lion in Se­ries A cash to back its work on an­ti­body-drug con­ju­gates. Bio­Med­Part­ners and High-Tech Grün­der­fonds co-led the launch round, with con­tri­bu­tions from some in­di­vid­ual in­vestors, the founders as well as Sev­en­ture Part­ners, co­par­i­on, Bay­ern Kap­i­tal, and Oc­ci­dent. “Tubu­lis’ ob­jec­tive is to use our dual plat­form ap­proach to gen­er­ate unique­ly matched and dis­ease-spe­cif­ic AD­Cs that com­bine se­lec­tive an­ti­bod­ies with ef­fec­tive pay­loads,” said Do­minik Schu­mach­er, CEO and co-founder of Tubu­lis.

→ In more emerg­ing-from-stealth news, Bethes­da, MD-based Gain Ther­a­peu­tics re­ports that the com­pa­ny bagged a $10 mil­lion Se­ries B for their work tar­get­ing “nov­el al­losteric bind­ing sites on en­zymes for the treat­ment of rare ge­net­ic and CNS dis­eases.” They’re set­ting up 2 IND-en­abling stud­ies for their lead pro­grams. “Our pro­pri­etary and patent­ed plat­form of­fers the abil­i­ty to dis­cov­er and val­i­date pre­vi­ous­ly uniden­ti­fied non-clas­si­cal bind­ing sites on en­zymes that can be reg­u­lat­ed by our nov­el first-in-class drug can­di­dates to re­store (or gain) en­zyme func­tion in rare and dev­as­tat­ing ge­net­ic dis­eases,” said Khalid Is­lam, the founder and chair­man of Gain.

→ A col­lab­o­ra­tion in­volv­ing phar­ma gi­ants and a trio of tech trans­fer of­fices at top UK uni­ver­si­ties has out-li­censed a gene ther­a­py to Deer­field, which plans to hand it to re­searchers at their new­ly launched Cure build­ing in the heart of New York City. The pro­gram was ini­tial­ly de­vel­oped at Uni­ver­si­ty Col­lege Lon­don, which is part of the Apol­lo Ther­a­peu­tics al­liance.

→ There has been a slew of terms set for this week’s biotech IPOs. The on­col­o­gy biotech iTeos plans to raise around $151 mil­lion by pric­ing shares at $16 to $18. Re­nais­sance Cap­i­tal is al­so track­ing a $75 mil­lion IPO from In­ozyme. An­nex­on, mean­while, is scout­ing for $150 mil­lion to back its work in de­gen­er­a­tive dis­eases.

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.

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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.”

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.

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.

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Marisol Peron, Genmab SVP of communications and corporate affairs

Gen­mab launch­es cor­po­rate cam­paign am­pli­fy­ing its ‘knock your socks off’ an­ti­bod­ies

Genmab often talks about its “knock-your-socks-off” antibodies — and now the term is getting its own logo and corporate campaign.

The teal and purple logo for the acronym KYSO — Genmab pronounces it “ky-so” — debuts on Wednesday and comes on the heels of Genmab’s newly announced 2030 vision. That aspiration aims to expand Genmab’s drug development beyond oncology to include other serious diseases, while also doubling down on its own drug development.

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Joel Dudley, new partner at Innovation Endeavors (Bosch Health Campus)

For­mer Google CEO’s VC is mak­ing a big­ger push in­to the biotech world, hir­ing promi­nent Ther­a­nos skep­tic

Venture capital firm Innovation Endeavors has mainly had its focus on investments across the tech space, but it has been slowly turning its attention to the biotech world. Now, a new partner is coming into the fold showing that its interest in biotech is likely to grow further.

The Silicon Valley-based company, which is headed up by former Google CEO Eric Schmidt, has brought on Joel Dudley as a partner. According to Dudley’s LinkedIn page, he is joining Innovation Endeavors after serving as the chief science officer of biotech startup Tempus Labs since 2020.

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