On­coSec signs on Dana-Far­ber as CAR-T part­ner; Do­va racks up an­oth­er Doptelet ap­proval

Dana-Far­ber is lend­ing a hand to lit­tle On­coSec’s nascent ef­fort to de­vel­op CAR-T ther­a­pies for sol­id tu­mor can­cers. The San Diego biotech has worked out an ex­clu­sive li­cens­ing deal with Wayne Maras­co — an ex­pert in an­ti­body en­gi­neer­ing — to ap­ply his method of link­ing two sin­gle-chain vari­able frag­ment (scFv) in a bis­pe­cif­ic CAR-T such that the T cells are on­ly ac­ti­vat­ed when both tar­gets are en­gaged, there­by lim­it­ing off-tu­mor tox­i­c­i­ty. On­coSec’s fi­nan­cial con­tri­bu­tion in the re­search, which in­volves test­ing the ex­per­i­men­tal treat­ment so­lo and in com­bi­na­tion with Ta­vo in triple-neg­a­tive breast can­cer, will be “mod­est” and spread over sev­er­al years, CEO Daniel O’Con­nor said.

→ Af­ter win­ning the FDA nod for low blood platelet count (throm­bo­cy­tope­nia) in adults with chron­ic liv­er dis­ease (CLD) who are sched­uled to un­der­go a med­ical or den­tal pro­ce­dure, the la­bel of Do­va Phar­ma­ceu­ti­cal’s Doptelet on Thurs­day was ex­pand­ed to in­clude pa­tients with chron­ic im­mune throm­bo­cy­tope­nia (ITP) who have had an in­suf­fi­cient re­sponse to a pre­vi­ous treat­ment. The com­pa­ny’s shares $DO­VA leapt about 27.5% to $13.50 in morn­ing trad­ing. The FDA’s en­dorse­ment comes about a week af­ter Eu­ro­pean reg­u­la­tors al­so backed the drug for use in se­vere throm­bo­cy­tope­nia in adult pa­tients with CLD who are sched­uled to un­der­go an in­va­sive pro­ce­dure. Mean­while, late-stage da­ta from a study eval­u­at­ing the drug’s use in chemother­a­py-in­duced throm­bo­cy­tope­nia are ex­pect­ed in the first half of 2020.

→ The re­cent­ly-pub­lic Ver­ri­ca Phar­ma­ceu­ti­cals$VR­CA ex­per­i­men­tal drug, VP-102, has cleared a mid-stage study in pa­tients with com­mon warts. The drug’s “ef­fi­ca­cy and tol­er­a­bil­i­ty has been fur­ther con­firmed with the pos­i­tive Phase II COVE-1 tri­al in com­mon warts, and is now de-risked in an ad­di­tion­al in­di­ca­tion. We be­lieve this pro­vides ad­di­tion­al (and not mod­eled) up­side for VR­CA as our val­u­a­tion tar­gets are based pure­ly on VP-102 in mol­lus­cum con­ta­gio­sum which re­mains on track for a po­ten­tial H2:2020 launch,” Cowen an­a­lysts wrote in a note. The com­pa­ny said it is on track to sub­mit an ap­pli­ca­tion to mar­ket the drug for pa­tients with mol­lus­cum con­ta­gio­sum — a vi­ral skin in­fec­tion some­times called wa­ter warts — lat­er this year.

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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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.

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.

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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With dust set­tled on ac­tivist at­tack, Lau­rence Coop­er leaves Zio­pharm to a new board

Laurence Cooper has done his part.

In the five years since he left a tenured position at Houston’s MD Anderson Cancer Center to become CEO of Boston-based Ziopharm, he’s steered the small-cap immunotherapy player through patient deaths in trials, clinical holds, short attacks and, most recently, an activist attack on the board.

So when the company has “fantastic news” like an IND clearance for a TCR T cell therapy program, he’s ready to pass on the baton.

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