No­vo-backed Galec­to Biotech scores €79 mil­lion in Se­ries C fund­ing

Galec­to Biotech has closed a €79 mil­lion Se­ries C fund­ing round that will help ad­vance the de­vel­op­ment of its lead galectin-3 in­hibitor for id­io­path­ic pul­monary fi­bro­sis (IPF).

Hans Scham­bye

The Copen­hagen-based com­pa­ny, which is de­vel­op­ing so-called galectin mod­u­la­tors for a pletho­ra of dis­eases in­clud­ing fi­bro­sis and can­cer, is the brain­child of two sci­en­tists from the Uni­ver­si­ty of Lund in Swe­den. The com­pa­ny, led by founder and CEO Hans Scham­bye, was orig­i­nal­ly fund­ed via the pre-seed grant pro­gram of the No­vo Nordisk $NVO Foun­da­tion in 2010. Even­tu­al­ly, the ear­ly-stage in­vest­ment arm of No­vo Nordisk Foun­da­tion owned No­vo Hold­ings — No­vo Seeds — led the first seed in­vest­ment round in 2011.

As part of this Se­ries C fund­ing round, No­vo Seeds has in­vest­ed €12.5 mil­lion, in­clud­ing a con­vert­ible loan, mak­ing it Galec­to’s largest share­hold­er. In ad­di­tion, the round of fi­nanc­ing was co-led by Ys­ios Cap­i­tal and Or­biMed, and in­clud­ed ex­ist­ing in­vestors M Ven­tures and Sun­stone Cap­i­tal. New in­vestors in­to the com­pa­ny in­clud­ed Bris­tol My­ers-Squibb $BMY, HBM Health­care In­vest­ments, Mav­er­ick Ven­tures and Sev­en­ture Part­ners.

The fi­nanc­ing will al­so en­able the clin­i­cal in­ves­ti­ga­tion of two ad­di­tion­al galectin mod­u­la­tors de­signed to treat fi­brot­ic dis­eases of oth­er or­gans, such as the liv­er and eye, Galec­to said. Galectin-3 is a pro­tein which binds to car­bo­hy­drate struc­tures, and plays a cen­tral role in fi­bro­sis. By in­hibit­ing the pro­tein’s bind­ing abil­i­ty, this class of drugs aim to treat dis­eases that ex­hib­it galentin-3 ex­pres­sion such as IPF, a chron­ic, pro­gres­sive lung dis­ease char­ac­ter­ized by the scar­ring of lung tis­sue.

If the Phase II/III study is suc­cess­ful, this da­ta could po­ten­tial­ly be used for a mar­ket­ing fil­ing, Scham­bye told End­points News, not­ing that the com­pa­ny’s mod­el in­cludes plans to ac­com­mo­date an ad­di­tion­al late-stage study if nec­es­sary. Galec­to is not dis­clos­ing its val­u­a­tion at the mo­ment, he said, adding that the com­pa­ny is not averse to part­ner­ships, M&A or an IPO in the fu­ture al­though it is equipped to take TD139 across the fin­ish line on its own.

In 2014, Bris­tol-My­ers signed an op­tion to li­cense Galec­to’s IPF drug TD139 fol­low­ing the re­sults of its Phase Ib/IIa da­ta, but did not ex­er­cise that op­tion.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Fangliang Zhang (Imaginechina via AP Images)

The big mon­ey: Poised to make drug R&D his­to­ry, a Chi­na biotech un­veils uni­corn rac­ing am­bi­tions in a bid to raise $350M-plus on Nas­daq

Almost exactly three years after Shanghai-based Legend came out of nowhere to steal the show at ASCO with jaw-dropping data on their BCMA-targeted CAR-T for multiple myeloma, the little player with Big Pharma connections is taking a giant step toward making it big on Wall Street. And this time they want to seal the deal on a global rep after staking out a unicorn valuation in what’s turned out to be a bull market for biotech IPOs — in the middle of a pandemic.

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Gilead re­leas­es an­oth­er round of murky remde­sivir re­sults

A month after the NIH declared the first trial on remdesivir in Covid-19 a success, Gilead is out with new results on their antiviral. But although the study met one of its primary endpoints, the data are likely to only add to a growing debate over how effective the drug actually is.

In a Phase III trial, patients given a 5-day dose of remdesivir were 65% more likely to show “clinical improvement” compared to an arm given standard-of-care. The trial, though, gave little indication for whether the drug had an impact on key endpoints such as survival or time-to-recovery. And in a surprising twist, a 10-day dosing arm of remdesivir didn’t lead to a statistically significant improvement over standard of care.

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IPOs abound in the time of coro­n­avirus, as For­ma Ther­a­peu­tics pen­cils in $150M Nas­daq de­but

The IPO engine is thriving, never mind the rampage of the coronavirus crisis on R&D timelines.

On Friday, along with synthetic lethality-focused biotech Repare Therapeutics, another Bristol Myers partner Forma Therapeutics also unveiled its plans to vault on to the Nasdaq — penciling in a target of $150 million.

The Watertown, Massachusetts-based company — which poached senior Genentech executive Frank Lee to take over the reins last year after more than a decade under founder Steve Tregay — raised a plump $100 million late last year, while shepherding its sickle cell disease (SCD) drug through an early-stage trial.

Iterum's fu­ture looks un­cer­tain, af­ter lead an­tibi­ot­ic fails con­sec­u­tive piv­otal stud­ies

While the market for antibiotics remains in tatters — unlike many of its bankrupt (or at the brink of bankruptcy) peers — Iterum is suffering not because its antibiotic isn’t selling, but because the compound has now failed back-to-back late-stage studies.

The experimental drug, sulopenem, was designed to tackle drug-resistant infections with an outpatient focus (in addition to hospitals), to avert those reimbursement challenges that incentivize hospitals to prescribe cheaper, generic broad-spectrum antibiotics.

Len Schleifer (left) and George Yancopoulos, Regeneron (Vimeo)

Eyes on he­mo­phil­ia prize, Re­gen­eron adds a $100M wa­ger on joint de­vel­op­ment cam­paign with In­tel­lia

When George Yancopoulos first signed up Intellia to be its CRISPR/Cas9 partner on gene editing projects 4 years ago, the upstart smartly ramped up its IPO at the same time. Today, Regeneron $REGN is coming back in, adding $100 million in an upfront fee and equity to significantly boot up a whole roster of new development projects.

And they’re highlighting some clinical hemophilia research plans in the process.

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Covid-19 roundup: Did in­sid­ers cash in on pos­i­tive news re­port about Gilead be­fore pub­li­ca­tion?

A series of bullish trades on Gilead options just before the release of a favorable news story is raising questions among regulatory experts, Reuters reported.

On April 16, just hours before STAT published anecdotes from a Chicago hospital that served as one of the clinical sites to test Gilead’s remdesivir in Covid-19 patients, the California-based company’s shares were trading at around $75. Four large blocks of options were purchased for about $1.5 million each, betting that the stock would rise beyond that to as much as $87.5 by mid-August.

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Ver­sant-backed, Bris­tol My­ers-stamped Re­pare Ther­a­peu­tics guns for $100M IPO

With a Bristol Myers Squibb endorsement in tow, Versant-backed cancer drug developer Repare Therapeutics has set its sights on a Nasdaq debut.

On Friday, the Montreal-based company with operations in Cambridge, Massachusetts that is yet to enter the clinic, unveiled plans for a $100 million IPO, banking on its “synthetic lethality” platform.

The basic idea is to target the genetic basis of tumors, a common idea across precision oncology medicines. But instead of targeting the perpetrator mutation directly, the compound is designed to go after the other gene in the gene pair. The rationale is based on the decades-old genetic principle that indicates two mutations are lethal only when combined together.

Jean-Jacques Bienaimé, BioMarin chairman and CEO

Bio­Marin holds the line on bleeds with 4-year val­rox up­date on he­mo­phil­ia A — but what's this about an­oth­er de­cline in Fac­tor 8 lev­els?

BioMarin has posted some top-line results for their 4-year followup on the most advanced gene therapy for hemophilia A — extending its streak on keeping a handful of patients free of bleeds and off Factor VIII therapy, but likely stirring fresh worries over a continued drop in Factor VIII levels.

We just don’t know how big a drop.

We’ll see more data when the results are presented at the World Federation of Hemophilia in a couple of weeks. But in a statement out Sunday night, BioMarin $BMRN reported that none of the patients required Factor VIII treatment, adding:

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