Eli Lil­ly teams with Pieris on HER2+ tu­mors; Op­di­vo + Yer­voy best chemo in mesothe­lioma

De­spite the FDA putting a par­tial clin­i­cal hold on its lead pro­gram on­ly a few weeks ago, Boston-based Pieris Phar­ma­ceu­ti­cals is plow­ing for­ward with a new col­lab­o­ra­tion.

Pieris will work with Eli Lil­ly to fur­ther ad­vance stud­ies on PRS-343, a 4-1BB/HER2 bis­pe­cif­ic for HER2-pos­i­tive tu­mors, in com­bi­na­tion with the lat­ter’s ra­mu­cirum­ab and pa­cli­tax­el for the sec­ond-line treat­ment of pa­tients with HER2-pos­i­tive gas­tric can­cer in a sin­gle-arm, Phase II study.

At the time of the hold, reg­u­la­tors de­ter­mined that the biotech could con­tin­ue dos­ing pa­tients al­ready in the stud­ies, but couldn’t add pa­tients un­til af­ter it con­duct­ed “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 FDA did not cite any ad­verse ef­fects and the Phase II is still on track for lat­er this year should the hold be lift­ed.

Un­der the terms of the new agree­ment, Eli Lil­ly will sup­ply the ad­di­tion­al com­pounds and col­lab­o­rate on da­ta while Pieris pre­pares to ini­ti­ate Phase II. — Max Gel­man

Op­di­vo + Yer­voy > Chemo

A com­bi­na­tion of Op­di­vo and Yer­voy has proven more ef­fec­tive than chemother­a­py as a first-line treat­ment for a form of mesothe­lioma in a Phase III study of 600 pa­tients. In the study, one of nu­mer­ous, Bris­tol My­ers Squibb is run­ning to test whether the two forms of check­point in­hibitors can be com­ple­men­tary, 40.8% of pa­tients with un­re­sectable ma­lig­nant pleur­al mesothe­lioma who re­ceived the im­munother­a­py cock­tail sur­vived for two years, com­pared with 27% of pa­tients on the chemother­a­py arm.

Just over 30% of pa­tients in both arms of the tri­al ex­pe­ri­enced grade 3 or grade 4 ad­verse events, but pa­tients were twice as like­ly to drop out as a re­sult in the com­bi­na­tion arm: 15%, com­pared with 7.4%.

Re­sults were pre­sent­ed Sat­ur­day at the In­ter­na­tion­al As­so­ci­a­tion for the Study of Lung Can­cer Vir­tu­al Pres­i­den­tial Sym­po­sium. — Ja­son Mast

Xcov­ery’s ALK in­hibitor out-runs Xalko­ri

In a Phase III tri­al an­nounced Fri­day, pa­tients giv­en Hong Kong-based Xcov­ery’s lead ALK in­hibitor re­spond­ed for twice as long as pa­tients giv­en Pfiz­er’s Xalko­ri. ALK-pos­i­tive non-small cell lung can­cer pa­tients giv­en Xcov­ery’s en­sar­tinib had a pro­gres­sion-free sur­vival time of 25.8 months, com­pared to 12.7 months for the pa­tients on Xalko­ri. The re­sponse rate was al­so high­er for en­sar­tinib, 75% com­pared to 67%.

The re­sults are a pos­i­tive sign for Xcov­ery but they are not nec­es­sar­i­ly sur­pris­ing: Xalko­ri was the first ALK-in­hibitor ap­proved in 2011, but since then, oth­er in­hibitors have come out and proven far more durable. Late last year, Take­da’s Alun­brig showed a sim­i­lar rate of pro­gres­sion-free sur­vival.  — Ja­son Mast

Vi­va Biotech buys up 80% of Langhua Phar­ma­ceu­ti­cal for $367M+

Just a week and a half af­ter sign­ing a deal with Mass­a­chu­setts-based Har­bour Bio­Med to help in­cu­bate new star­tups, Vi­va Biotech has con­tin­ued its march with a new ac­qui­si­tion.

The Chi­nese com­pa­ny — a half-in­cu­ba­tor, half-drug dis­cov­ery busi­ness — an­nounced the pur­chase of 80% of Langhua Phar­ma­ceu­ti­cal for about $367 mil­lion. With the ac­qui­si­tion, Vi­va ex­pects to ex­pand its R&D ca­pa­bil­i­ties and be­gin of­fer­ing CD­MO ser­vices.

“We have steady con­fi­dence to­wards the busi­ness prospects and po­ten­tial fu­ture growth of Langhua Phar­ma­ceu­ti­cal,” Vi­va Biotech CEO Chen (Ch­eney) Mao said in a state­ment.

Vi­va of­fers both “eq­ui­ty for ser­vice” and “cash for ser­vice” mod­els to US and Chi­nese bio­phar­mas look­ing for out­sourc­ing ser­vices. — Max Gel­man

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.”

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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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.

Blaise Coleman, Endo International CEO

En­do files for Chap­ter 11 as it looks to fin­ish off its opi­oid lit­i­ga­tion

Irish drugmaker Endo International is entering into bankruptcy as it faces the weight of serious litigation related to its involvement in the opioid epidemic in the US.

The company has filed Chapter 11 proceedings in the US Bankruptcy Court for the Southern District of New York, with the company expected to file recognition proceedings in Canada, the UK and Australia. The company’s bankruptcy filing showed the company had assets and liabilities in the range of $1 billion to $10 billion.

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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