Bel­gium's liv­er-fo­cused stem cell ther­a­py de­vel­op­er Promethera rais­es $44M+ in lat­est round

Bet­ting on its stem cell ther­a­py for end-stage liv­er dis­ease, Bel­gium-based Promethera Bio­sciences has got €39.7 mil­lion (about $44.4 mil­lion) in the bank to de­vel­op the drug as an al­ter­na­tive to of­ten hard-to-pro­cure trans­plants.

Es­tab­lished in 2009, Promethera’s lead drug is an ex­per­i­men­tal stem cell ther­a­py called He­paStem for pa­tients with a dead­ly syn­drome called acute-on-chron­ic liv­er fail­ure, or ACLF, for whom trans­plants are the on­ly ex­ist­ing res­cue treat­ment. De­rived from hu­man liv­ers, the ther­a­py is for­mu­lat­ed us­ing mes­enchy­mal stem cells (MSCs) re­plete with liv­er mark­ers and liv­er fea­tures. At the In­ter­na­tion­al Liv­er Con­gress last month, Promethera pre­sent­ed da­ta from an on­go­ing dose-es­ca­la­tion Phase IIa study, which showed the treat­ment is safe and sug­gest­ed “trends in ef­fi­ca­cy.”

“The hope is to de­vel­op the tech­nol­o­gy as an al­ter­na­tive to liv­er trans­plan­ta­tion in ACLF pa­tients — not all of them are get­ting trans­plants be­cause a lot of the pa­tients are al­co­holics,” com­pa­ny chief John Tchelin­ger­ian said in an in­ter­view with End­points News.

John Tchelin­ger­ian

“Our cells have these nat­ur­al fea­tures — they are com­ing from the liv­er and go­ing back in­to the liv­er — af­ter their in­tra­venous ad­min­is­tra­tion in pa­tients. They are pro­duc­ing high­ly po­tent fac­tors that are nec­es­sary for liv­er bal­ance and liv­er main­te­nance…these fac­tors are tai­lored to act specif­i­cal­ly on liv­er cells and re­pair the le­sion or act against the in­flam­ma­tion oc­cur­ring in the liv­er.”

In 2016, Promethera ac­quired the as­sets of Durham-based Cynotet, who had over a decade of ex­pe­ri­ence deal­ing with US-based or­gan pro­cure­ment or­ga­ni­za­tions (OPOs). This es­tab­lished in­fra­struc­ture makes Promethera the sec­ond port of call for the OPOs — if the liv­er is non-trans­plantable, Tchelin­ger­ian said.

Once the do­na­tion is pro­cured — the liv­er is processed at a GMP-com­pli­ant US Promethera fa­cil­i­ty, which pro­duces a liv­er cell sus­pen­sion that is en­riched with he­pa­to­cytes — this con­sti­tutes the start­ing ma­te­ri­als to pro­duce He­paStem.  This sus­pen­sion is put in­to sealed bags, frozen and shipped to the com­pa­ny’s Bel­gium fac­to­ry, where He­paStem is then for­mu­lat­ed and cryo-pre­served, he ex­plained. “The process takes about two months — to pro­duce a batch of bil­lions of stem cells from a sin­gle bag that con­tains a few hun­dred mil­lions cells. We have many runs per year. From one liv­er to­day — we can treat about 300 to 350 pa­tients suf­fer­ing from ACLF.”

“We’re the op­po­site of the CAR-Ts — who went from bench to pa­tient very quick­ly show­ing ef­fi­ca­cy…we have done the re­verse, I think that’s a very good way to bring our prod­ucts to the max­i­mum num­ber of pa­tients world­wide, be­cause we con­trol the full val­ue chain from the donor to the end prod­uct.”

No­var­tis’ $NVS pi­o­neer­ing CAR-T ther­a­py Kym­ri­ah was ap­proved amidst great fan­fare in 2017, but sales have suf­fered due to man­u­fac­tur­ing is­sues. In the fourth quar­ter, the drug gen­er­at­ed a pal­try $28 mil­lion. How­ev­er, No­var­tis is do­ing its best to shore up man­u­fac­tur­ing, hav­ing bought cell and gene ther­a­py man­u­fac­tur­er Cell­for­Cure.

Promethera’s on­go­ing He­paStem Phase IIa will be com­plet­ed this sum­mer — and if the pos­i­tive find­ings are con­firmed, that da­ta will pro­vide the ground to launch a Phase IIb tri­al. That study is ex­pect­ed to kick off by the end of 2019, with about 200+ pa­tients and should take 2.5 years to com­plete.

Mean­while, Promethera in­tends to ini­ti­ate a NASH tri­al in very late-stage pa­tients some­time this year and will make a de­ci­sion on whether to pur­sue He­paStem in less-se­vere pa­tients, based on the re­sults of oth­er NASH read­outs ex­pect­ed this year.

So far, the com­pa­ny has raised rough­ly €110 mil­lion — in­clud­ing the Tues­day se­ries D raise, which was co-led by new Japan­ese in­vestors Itochu and Shin­sei Cap­i­tal Part­ners.

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.

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.

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.

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.