Mayo Clin­ic launch­es clin­i­cal an­a­lyt­ics plat­form with nfer­ence; WuXi buys Ger­man plant from Bay­er

Mayo Clin­ic is open­ing up its sprawl­ing clin­i­cal data­base to nfer­ence, the Cam­bridge, MA-based AI start­up it’s long part­nered with and re­cent­ly backed in a $60 mil­lion round. The project aims to dig­i­tize 25 mil­lion tis­sue slides with­in the next 2 to 2.5 years, Fierce­Biotech re­port­ed, in ad­di­tion to an­no­tat­ing, link­ing and tag­ging writ­ten physi­cian notes. Af­ter sort­ing through the da­ta, nfer­ence will use the plat­form to iden­ti­fy new tar­gets and bio­mark­ers as well as ap­ply it in clin­i­cal tri­al re­cruit­ment and re­al-world ev­i­dence gen­er­a­tion.

Cypri­um Ther­a­peu­tics, one of the star­tups in­cu­bat­ed by Fortress Biotech, has been grant­ed rare pe­di­atric dis­ease des­ig­na­tion by the FDA for cop­per his­tid­i­nate, al­so re­ferred to as CUTX-101, for the treat­ment of Menkes dis­ease. The drug — which is de­signed to boost blood and brain cop­per lev­els — has al­so gained or­phan and fast track sta­tus.

→ In an ex­pan­sion of its glob­al foot­print, WuXi Bi­o­log­ics has ac­quired a drug prod­uct man­u­fac­tur­ing plant from Bay­er. The fa­cil­i­ty, lo­cat­ed in Lev­erkusen, Ger­many, will al­so serve as a back-up pro­duc­tion site for Bay­er’s Ko­val­try, a he­mo­phil­ia A treat­ment, once WuXi takes over.

→ South Ko­rea’s Cell­tri­on has plans to build a new plant in Chi­na to man­u­fac­ture its biosim­i­lars as it ad­vances a Rem­i­cade copy­cat in the coun­try. Chair­man Jung-jin Seo said at the JP Mor­gan con­fer­ence that the fa­cil­i­ty will have a pro­duc­tion ca­pac­i­ty of 120,000 liters, ac­cord­ing to Yon­hap News Agency.

No­var­tis, J&J, Eli Lil­ly, Pfiz­er and GSK are join­ing the Gates Foun­da­tion on a phil­an­thropic com­mu­ni­ty-based pri­ma­ry health­care ini­tia­tive in six African coun­tries led by two char­i­ties. The drug­mak­ers will “con­tribute dis­ease-spe­cif­ic ex­per­tise and ex­pe­ri­ence in the dis­cov­ery and de­vel­op­ment of new tools, which will sup­ple­ment the com­mu­ni­ty health work­er mod­els.” They would al­so each con­tribute $1.5 mil­lion to the project.

Tar­get­ing a Po­ten­tial Vul­ner­a­bil­i­ty of Cer­tain Can­cers with DNA Dam­age Re­sponse

Every individual’s DNA is unique, and because of this, every patient responds differently to disease and treatment. It is astonishing how four tiny building blocks of our DNA – A, T, C, G – dictate our health, disease, and how we age.

The tricky thing about DNA is that it is constantly exposed to damage by sources such as ultraviolet light, certain chemicals, toxins, and even natural biochemical processes inside our cells.¹ If ignored, DNA damage will accumulate in replicating cells, giving rise to mutations that can lead to premature aging, cancer, and other diseases.

Fol­low biotechs go­ing pub­lic with the End­points News IPO Track­er

The Endpoints News team is continuing to track IPO filings for 2021, and we’ve designed a new tracker page for the effort.

Check it out here: Biopharma IPOs 2021 from Endpoints News

You’ll be able to find all the biotechs that have filed and priced so far this year, sortable by quarter and listed by newest first. As of the time of publishing on Feb. 25, there have already been 16 biotechs debuting on Nasdaq so far this year, with an additional four having filed their S-1 paperwork.

Steve Cutler, Icon CEO (Icon)

In the biggest CRO takeover in years, Icon doles out $12B for PRA Health Sci­ences to fo­cus on de­cen­tral­ized clin­i­cal work

Contract research M&A had a healthy run in recent years before recently petering out. But with the market ripe for a big buyout and the Covid-19 pandemic emphasizing the importance of decentralized trials, Wednesday saw a tectonic shift in the CRO world.

Icon, the Dublin-based CRO, will acquire PRA Health Sciences for $12 billion in a move that will shake up the highest rungs of a fragmented market. The merger would combine the 5th- and 6th-largest CROs by 2020 revenue, according to Icon, and the merger will set the newco up to be the second-largest global CRO behind only IQVIA.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,000+ biopharma pros reading Endpoints daily — and it's free.

Tom Barnes (Orna)

The mR­NA era is here. MPM be­lieves the fu­ture be­longs to oR­NA — and Big Phar­ma wants a seat at the ta­ble

If the ultra-fast clinical development of Covid-19 vaccines opened the world’s eyes to the promises of messenger RNA, the subsequent delays in supply offered a crash course on the ultra-complex process of producing them. Even before the formulation and fill-finish steps, mRNA is the precious end product from an arduous journey involving enzyme-aided transcription, modification and purification.

For Bristol Myers Squibb, Novartis Institutes for Biomedical Research, Gilead’s Kite and Astellas, it’s time to rethink the way therapeutic RNA is engineered.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,000+ biopharma pros reading Endpoints daily — and it's free.

Xen­cor, UCLA to part­ner for new ther­a­peu­tic an­ti­bod­ies; Schrödinger ex­pands part­ner­ship with Google Cloud

Seeking to build on the 20 clinical-stage drug candidates already in its pipeline, California oncology and autoimmune disease-focused biotech Xencor announced on Thursday a partnership with nearby UCLA and the university’s Technology Development Group.

The two will collaborate to develop novel therapeutic antibodies, pairing novel targets proposed by scientists at UCLA with Xencor’s XmAb technology platforms that engineer monoclonal antibodies to create new protein structures. No financial terms of the agreement were disclosed, but any selected drug candidates resulting from the partnership will use a framework of “predefined terms to enter sponsored research agreements and potential license agreements,” the organizations said.

S&P ex­pects steady ero­sion in Big Phar­ma's cred­it pro­file in 2021 as new M&A deals roll in — but don't un­der­es­ti­mate their un­der­ly­ing strength

S&P Global has taken a look at the dominant forces shaping the pharma market and come to the conclusion that there will be more downgrades than upgrades in 2021 — the 8th straight year of steady decline.

But it’s not all bad news. Some things are looking up, and there’s still plenty of money to be made in an industry that enjoys a 30% to 40% profit margin, once you factor in steep R&D expenses.

Tal Zaks, Moderna CMO (AP Photo/Rodrique Ngowi, via still image from video)

CMO Tal Zaks bids Mod­er­na a sur­prise adieu as biotech projects $18.4B in rev­enue, plots post-Covid ex­pan­sion

How do you exit a company after six years in style? Developing one of the most lucrative and life-saving products in pharma history is probably not the worst way to go.

Tal Zaks, Moderna’s CMO since 2015, will leave the mRNA biotech in September, the biotech disclosed in their annual report this morning. The company has already retained the recruitment firm Russell Reynolds to find a replacement.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,000+ biopharma pros reading Endpoints daily — and it's free.

Ken Frazier, Merck CEO (Bess Adler/Bloomberg via Getty Images)

UP­DAT­ED: Mer­ck takes a swing at the IL-2 puz­zle­box with a $1.85B play for buzzy Pan­dion and its au­toim­mune hope­fuls

When Roger Perlmutter bid farewell to Merck late last year, the drugmaker perhaps best known now for sales giant Keytruda signaled its intent to take a swing at early-stage novelty with the appointment of discovery head Dean Li. Now, Merck is signing a decent-sized check to bring an IL-2 moonshot into the fold.

Merck will shell out roughly $1.85 billion for Pandion Pharmaceuticals, a biotech hoping to gin up regulatory T cells (Tregs) to treat a range of autoimmune disorders, the drugmaker said Thursday.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,000+ biopharma pros reading Endpoints daily — and it's free.

Glax­o­SmithK­line re­thinks strat­e­gy for Covid-19 an­ti­body — not the Vir ones — af­ter tri­al flop. Is there hope in high-risk pa­tients?

In the search for a better Covid-19 therapeutic, GlaxoSmithKline and Vir have partnered up on two antibodies they hope have a chance. GSK is also testing its own in-house antibody, and early results may have shut the door on its widespread use.

A combination of GSK’s monoclonal antibody otilimab plus standard of care couldn’t best standard of care alone in preventing death and respiratory failure in hospitalized Covid-19 patients after 28 days, according to data from the Phase IIa OSCAR study unveiled Thursday.