Af­ter a bust with knee pain drug and 3 Covid-19 flops, Am­pio lays off staff; An­ti­body start­up nabs sec­ond deal in two weeks

Since at least April 2015, Am­pio Phar­ma­ceu­ti­cals has reeled from one Phase III fail af­ter an­oth­er for its knee os­teoarthri­tis drug, known as Am­pi­on.

The is­sue has on­ly es­ca­lat­ed in re­cent months with a tri­fec­ta of hur­dles that are now send­ing the pen­ny stock biotech $AMPE in­to a down­ward spi­ral, with 10 of 18 em­ploy­ees be­ing laid off Tues­day, ac­cord­ing to an SEC fil­ing. Am­pio had $28.8 mil­lion at the end of March, enough to get in­to the sec­ond half of next year.

To re­cap: the FDA said an­oth­er Phase III tri­al did not pro­vide suf­fi­cient da­ta for a path to mar­ket; the com­pa­ny en­list­ed an in­de­pen­dent com­mit­tee to re­view unau­tho­rized use of Am­pi­on out­side of clin­i­cal tri­als; and the biotech launched a strate­gic re­view to find its way out of fi­nan­cial doom.

There’s al­so a trio of clin­i­cal tri­als eval­u­at­ing Am­pi­on for Covid-19, for acute res­pi­ra­to­ry dis­tress syn­drome re­lat­ed to Covid-19 and for long Covid that all found no clin­i­cal­ly mean­ing­ful treat­ment ef­fects. Long Covid has tripped up PureTech Health and Ax­cel­la, the lat­ter of which re­port­ed Phase IIa re­sults on Tues­day, say­ing it will move to­ward a Phase III de­spite flunk­ing the pri­ma­ry end­point.

Mul­ti­ple biotechs have been be­fud­dled by drug R&D for knee pain, in­clud­ing Bios­plice (for­mer­ly Sa­mumed) and Cen­trex­ion, helmed by ex-Pfiz­er CEO Jeff Kindler. — Kyle LaHu­cik

Lan­dos will head in­to PhII with ul­cer­a­tive col­i­tis drug 

Lan­dos Bio­phar­ma said da­ta from its Phase Ib study of an ul­cer­a­tive col­i­tis drug give it the con­fi­dence to move in­to a Phase II clin­i­cal tri­al.

The New York biotech will take the once-dai­ly oral drug, known as NX-13, in­to a proof of con­cept study af­ter show­ing it was well tol­er­at­ed across mul­ti­ple dos­es af­ter four weeks. The pen­ny stock $LABP rose near­ly 15% short­ly af­ter the open­ing bell Wednes­day.

The NL­RX1 ag­o­nist was test­ed at 250mg im­me­di­ate re­lease, 500mg im­me­di­ate re­lease and 500mg mod­i­fied re­lease. Each arm con­tained 11 pa­tients, and an­oth­er five were giv­en place­bo.

“While the study was short­er in du­ra­tion than stan­dard in­duc­tion tri­als and not pow­ered for ef­fi­ca­cy, there was an in­di­ca­tion of promis­ing sig­nals of clin­i­cal im­prove­ment as soon as two weeks in pa­tients’ symp­toms and four weeks by en­doscopy in ex­plorato­ry end­points,” CEO and pres­i­dent Gre­go­ry Oakes said in a state­ment. — Kyle LaHu­cik

Fol­low­ing Covid-19 an­ti­body ap­proval, Ab­Cellera wins sec­ond deal in two weeks

Fol­low­ing its Eli Lil­ly an­ti­body deal, Ab­Cellera has been on the up. To­day, At­las Ven­tures an­nounced that it tapped the an­ti­body dis­cov­ery biotech in a col­lab­o­ra­tion for three drug tar­gets. The de­tails on the col­lab­o­ra­tion are sparse, but the an­ti­bod­ies will be de­vel­oped by an At­las stealth com­pa­ny.

Ab­Cellera will re­ceive an undis­closed amount in re­search pay­ments and could get paid for down­stream mile­stones as well.

Pre­vi­ous­ly, Ab­Cellera col­lab­o­rat­ed with Eli Lil­ly to de­vel­op a Covid-19 an­ti­body, bebtelovimab, which was ap­proved by the FDA ear­li­er this year. For that part­ner­ship, the two com­pa­nies got a $720 mil­lion deal to sup­ply 600,000 dos­es of the drug, bebtelovimab, to the US gov­ern­ment.

And just last week, Ab­Cellera inked a deal with Ver­sant on an­oth­er stealth part­ner­ship with min­i­mal de­tails. Ab­Cellera had pre­vi­ous­ly col­lab­o­rat­ed with a num­ber of Ver­sant’s stealth com­pa­nies. — Lei Lei Wu

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.

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 148,300+ biopharma pros reading Endpoints daily — and it's free.

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 148,300+ biopharma pros reading Endpoints daily — and it's free.

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.

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 148,300+ 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 148,300+ 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.”

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 148,300+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 148,300+ biopharma pros reading Endpoints daily — and it's free.