As­traZeneca push­es back OS read­out on MYS­TIC to H2; An­thera shares oblit­er­at­ed in re­peat PhI­II flop

→ The much-an­tic­i­pat­ed over­all sur­vival da­ta of As­traZeneca’s $AZN piv­otal lung can­cer tri­al will be de­liv­ered lat­er than ex­pect­ed, the UK drug­mak­er an­nounced this morn­ing. In­vestors will now have to wait un­til the sec­ond half of 2018 for the fi­nal analy­sis of Imfinzi’s im­pact on OS, in­stead of the first half. The re­sults from the MYS­TIC tri­al re­mains a ma­jor cat­a­lyst af­ter the check­point in­hibitor failed to meet the pri­ma­ry end­point of pro­gres­sion-free sur­vival (PFS), send­ing a shock wave to As­traZeneca’s stock prices last Ju­ly. The tri­al tests Imfinzi both as a monother­a­py and in com­bi­na­tion with treme­li­mum­ab against chemother­a­py in first-line non-small cell lung can­cer, an all-im­por­tant are­na in the bat­tle for check­point drug dom­i­nance.

If at first you don’t suc­ceed in biotech, maybe you should just cut your loss­es and move on. That les­son may be top of mind to­day for An­thera $ANTH af­ter re­searchers re­port­ed that its lead drug Sollpu­ra failed a re­peat Phase III study for cas­es of ex­ocrine pan­cre­at­ic in­suf­fi­cien­cy caused by cys­tic fi­bro­sis. The biotech had al­ready felt the sting of in­vestor dis­sat­is­fac­tion when an ear­li­er Phase III al­so failed. This time sci­en­tists had hoped that more agres­sive dos­ing would fix the prob­lem. It didn’t. An­thera’s shares were evis­cer­at­ed, drop­ping 82% and leav­ing the stock deep in pen­ny stock ter­ri­to­ry.

Malvern, PA-based Realm Ther­a­peu­tics says that their Phase II study of a new ther­a­py for al­ler­gic con­junc­tivi­tis failed, forc­ing the biotech to dump the drug. PR013 was a top­i­cal oph­thalmic so­lu­tion. Realm’s shares (AIM: $RLM) took a dive on the news.

→  Ox­ford Uni­ver­si­ty spin­out OxSy­Bio stepped out to­day with a £10 mil­lion ($13.9 mil­lion) Se­ries A round, join­ing the in­creas­ing­ly crowd­ed space of “tis­sue bio­print­ing” star­tups. This one is de­vel­op­ing a 3D print­er tech­nol­o­gy that can print bi­o­log­i­cal ma­te­ri­als, with the ul­ti­mate goal of mak­ing ther­a­peu­tic tis­sues for pa­tients. This is not un­like the goals of San Diego’s more ma­ture Organo­vo, or the rel­a­tive new­com­er Ste­moniX. OxSy­Bio was found­ed back in 2014 on re­search con­duct­ed in the lab of Pro­fes­sor Ha­gan Bay­ley, the found­ing aca­d­e­m­ic be­hind Ox­ford Nanopore Tech­nolo­gies. The new fi­nanc­ing round was led by Wood­ford In­vest­ment Man­age­ment along­side new and ex­ist­ing back­ers, ac­cord­ing to a com­pa­ny state­ment.


With ad­di­tion­al re­port­ing by Brit­tany Meil­ing and Am­ber Tong.

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.

Roivant par­lays a $450M chunk of eq­ui­ty in biotech buy­out, grab­bing a com­pu­ta­tion­al group to dri­ve dis­cov­ery work

New Roivant CEO Matt Gline has crafted an all-equity upfront deal to buy out a Boston-based biotech that has been toiling for several years now at building a supercomputing-based computational platform to design new drugs. And he’s adding it to the Erector set of science operations that are being built up to support their network of biotech subsidiaries with an eye to growing the pipeline in a play to create a new kind of pharma company.

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Mark Mal­lon charts post-Iron­wood course by tak­ing CEO job at NeoGe­nomics; Glax­o­SmithK­line vet Feng Ren joins In­sil­i­co as CSO

Mark Mallon steps aside at Ironwood on March 12 after close to two years at the helm, and he already has a new change of scenery squared away. Beginning April 19, Mallon takes charge as CEO of cancer-focused genetic test maker NeoGenomics out of Fort Myers, FL while his predecessor, Douglas VanOort, is retiring after 12 years as NeoGenomics’ chairman and CEO.

It’s a fresh start for Mallon after what will amount to a tumultuous 23 months as Ironwood’s chief executive. Last year was marked by trial failures that spelled double trouble, leaving the Ironwood cupboard bare: first, a Linzess reformulation for irritable bowel syndrome with diarrhea (IBS-D) in May, and then the drug IW-3718 for persistent acid reflux in September. After IW-3718’s discontinuation, Ironwood chopped its staff by 35%. On Feb. 8, Mallon announced his departure at Ironwood, with president Tom McCourt getting bumped up to interim CEO.

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.

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.

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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.

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Covid-19 roundup: Mer­ck­'s $356M sup­ply deal on hold as FDA asks for more da­ta; FDA ap­proves Pfiz­er/BioN­Tech vac­cine stor­age at stan­dard freez­er temps

Merck is pushing back plans to supply the US government with a Covid-19 drug after the FDA asked for more data to support an emergency use authorization.

The antibody, MK-7110, had looked promising in a Phase III study conducted by OncoImmune before Merck came along and bought the biotech for $425 million. At the interim analysis, investigators looked at data from 203 patients and concluded that a single dose of the drug cut the risk of death or respiratory failure by more than 50% among severe patients. And those taking the drug had a 60% higher chance of improvement in clinical status compared to placebo.

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CEO Fred Aslan (Artiva)

NK cell ther­a­py play­er Arti­va makes some more noise, pulling in $120M Se­ries B less than a month af­ter Mer­ck deal

Not even one month after Big Pharma took notice of Artiva when Merck signed a collaboration worth nearly $2 billion in milestones, the off-the-shelf NK cell biotech already has its next big fundraise.

Artiva returns from the venture well Friday with a $120 million Series B round, money they will use to get their first program into the clinic and to file INDs for another two candidates. The raise marks the latest development in a rapidly expanding footprint for Artiva, which, in addition to the Merck deal last month, has now raised almost $200 million since its Series A last June.

Fatty liver conceptual image, 3D illustration showing fatty liver silhouette made from micrograph of liver steatosis (Shutterstock)

The path to NASH: un­der­stand­ing the role of se­vere obe­si­ty in a com­plex, mul­ti-sys­tem dis­ease

Biotech Voices is a collection of exclusive opinion editorials from some of the leading voices in biopharma on the biggest industry questions today. Think you have a voice that should be heard? Reach out to senior editors Kyle Blankenship and Amber Tong.

We often think a person’s transition from a healthy to a diseased state is binary. But that’s often not the case. In reality, the onset of a disease is not something that occurs overnight, and the majority lie on a continuum that is impacted by a multitude of factors. Some of these factors are in a patient’s control. Others are not.

This is the case in nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH), two of the most complex diseases that “live” on this proverbial continuum. The clinical onset of NAFLD — and ultimately NASH — is a complex process that is closely related to obesity, insulin resistance and impaired adipose tissue metabolism.