Philo­gen who? A low pro­file but phar­ma-con­nect­ed Ital­ian-Swiss hy­brid steps out with $68M for a fi­nal push over the PhI­II fin­ish line

Philo­gen is one of the best con­nect­ed late-stage biotechs you’ve prob­a­bly nev­er heard of. 

Found­ed by three broth­ers — the busi­ness­man and com­pa­ny CEO Duc­cio Neri and his two sci­en­tist sib­lings, Dario and Gio­van­ni — way back in 1996, Philo­gen has been build­ing up its ex­per­tise in armed an­ti­bod­ies over the past 23 years. It’s struck mul­ti­ple de­vel­op­ment pacts with a whole range of phar­ma gi­ants, oc­ca­sion­al­ly rather ca­su­al­ly and briefly not­ing them in ab­bre­vi­at­ed re­leas­es — like the three it an­nounced in Jan­u­ary with No­var­tis, J&J and Cel­gene, shorn of any specifics.

Dario Neri

Philo­gen spe­cial­izes in arm­ing an­ti­bod­ies, with a fo­cus on im­muno­cy­tokines — link­ing cy­tokines for tar­get­ed de­liv­ery to spur lo­cal and sys­temic im­mune re­spons­es. The Ner­is say those pacts with top in­dus­try play­ers have kept the pri­vate com­pa­ny prof­itable — and large­ly out of the eye of IPO-fo­cused ven­ture groups — for the past 20 years. But to­day, with two in-house ther­a­pies in Phase III de­vel­op­ment, they’re step­ping out with a €62 mil­lion ($68 mil­lion) raise aimed at tak­ing the biotech over the top of late-stage tri­als and in­to the mar­ket.

“We have worked for many years on the an­ti­body de­liv­ery of many pay­loads and cer­tain­ly cy­tokines are very spe­cial for us,” Dario Neri tells me over the phone, em­pha­siz­ing that the biotech has de­vel­oped con­sid­er­able ex­per­tise in the use of both an­ti­bod­ies and lig­ands. Dario worked in Gre­go­ry Win­ter’s lab in Cam­bridge, UK af­ter his post-doc, then re­turned to ETH Zurich, where he is a pro­fes­sor of chem­istry and ap­plied bio­sciences. A co-founder and head of the sci­ence ad­vi­so­ry board at Philo­gen, he an­chors the biotech’s work in Switzer­land, a bio­phar­ma hotbed, which is co­or­di­nat­ed with the home base ac­tiv­i­ties in Siena, Italy, south of Flo­rence.

These im­muno­cy­tokines are fu­sion pro­teins, chem­i­cal­ly cou­pling the cy­tokine to their de­liv­ery ve­hi­cle. And some of its part­ners — like Pfiz­er — have come back to build a slate of part­nered ef­forts.

“We have dif­fer­ent types of col­lab­o­ra­tions,” says Dario Neri cheer­ful­ly, “some pub­lic and some not. Pfiz­er has signed up for a few.” Servi­er and Boehringer In­gel­heim have al­so lined up for deals.

“Our mod­el is in­no­vat­ing tar­get­ing,” he adds, lo­cal­ized at the site of dis­ease.

Gio­van­ni Neri

You can see that in their own so­lo work, tai­lored to some care­ful­ly de­fined tar­gets. Daro­mun, the lead drug, com­bines a pair of their im­muno­cy­tokines — The IL2 fu­sion pro­tein Dar­leukin and the TNF fu­sion pro­tein Fi­bro­mun — for the in­trale­sion­al treat­ment of Stage III B and C melanoma pa­tients who are try­ing to fight off pro­gres­sion to Stage IV, where their prospects of sur­vival are grim. In the late-stage work, re­searchers are com­par­ing the neoad­ju­vant use of the drug fol­lowed by surgery against surgery alone — the stan­dard of care — for an end­point fo­cused on re­cur­rence free sur­vival, with over­all sur­vival as a sec­ondary end­point.

Fi­bro­mun gained an or­phan drug des­ig­na­tion in Jan­u­ary from the FDA for soft tis­sue sar­co­ma.

Work­ing with its part­ners, Philo­gen has built up a staff of 110 who have cre­at­ed an in­te­grat­ed R&D group work­ing from dis­cov­ery to late stage tri­als, with their own man­u­fac­tur­ing wing. “We val­ue that very much,” says Dario Neri. “We know our prod­ucts best,” and by build­ing up their own ex­per­tise they’re able to move more re­li­ably than any com­pa­ny that re­quires a CMO for the work.

Prof­itable doesn’t mean earn­ing big mon­ey — Neri puts 2018 prof­its at €10 mil­lion. But com­pared to the av­er­age pre-rev­enue biotech con­sum­ing tens of mil­lions, if not hun­dreds of mil­lions of dol­lars, it’s a whole oth­er world. Now they’d like more of the bio­phar­ma world to take note as they close in on a goal they’ve had in sight for close to a quar­ter of a cen­tu­ry.

Lat­er, maybe, they can see if the third time is the charm for an IPO, which they tried and failed at in both 2008 — bad tim­ing for the mar­ket — and 2011, pulling the last one af­ter Bay­er pulled out of a deal. These broth­ers don’t give up eas­i­ly.

UP­DAT­ED: Clay Sie­gall’s $614M wa­ger on tu­ca­tinib pays off with solid­ly pos­i­tive piv­otal da­ta and a date with the FDA

Back at the beginning of 2018, Clay Siegall snagged a cancer drug called tucatinib with a $614 million cash deal to buy Cascadian. It paid off today with a solid set of mid-stage data for HER2 positive breast cancer that will in turn serve as the pivotal win Siegall needs to seek an accelerated approval in the push for a new triplet therapy.

And if all the cards keep falling in its favor, they’ll move from 1 drug on the market to 3 in 2020, which is shaping up as a landmark year as Seattle Genetics prepares for its 23rd anniversary on July 15.

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UP­DAT­ED: The FDA sets a reg­u­la­to­ry speed record, pro­vid­ing a snap OK for Ver­tex's break­through triplet for cys­tic fi­bro­sis

The FDA has approved Vertex’s new triplet for cystic fibrosis at a record-setting speed.

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IM­brave150: Roche’s reg­u­la­to­ry crew plans a glob­al roll­out of Tecen­triq com­bo for liv­er can­cer as PhI­II scores a hit

Just weeks after Bristol-Myers Squibb defended its failed pivotal study pitting Opdivo against Nexavar in liver cancer, Roche says it’s beat the frontline challenge with a combination of their PD-L1 Tecentriq with Avastin. And now they’re rolling their regulatory teams in the US, Europe and China in search of a new approval — badly needed to boost a trailing franchise effort.
Given their breakthrough and Big Pharma status as well as the use of two approved drugs, FDA approval may well prove to be something of a formality. And the Chinese have been clear that they want new drugs for liver cancer, where lethal disease rates are particularly high.
Researchers at their big biotech sub, Genentech, say that the combo beat Bayer’s Nexavar on both progression-free survival as well as overall survival — the first advance in this field in more than a decade. We won’t get the breakdown in months of life gained, but it’s a big win for Roche, which has lagged far, far behind Keytruda and Opdivo, the dominant PD-1s that have captured the bulk of the checkpoint market so far.
Researchers recruited hepatocellular carcinoma — the most common form of liver cancer — patients for the IMbrave150 study who weren’t eligible for surgery ahead of any systemic treatment of the disease.
Roche has a fairly low bar to beat, with modest survival benefit for Nexavar, approved for this indication 12 years ago. But they also plan to offer a combo therapy that could have significantly less toxicity, offering patients a much easier treatment regimen.
Cowen’s Steven Scala recently sized up the importance of IMbrave150, noting:

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That $335M JV Bay­er set up on CRISPR/Cas9? They’re let­ting the biotech part­ner car­ry on

Bayer committed $300 million to set up a joint venture on CRISPR/Cas9 tech with CRISPR Therapeutics $CRSP. But they’re handing off control now to the smaller biotech while retaining a couple of opt-ins for programs nearing an IND.

Bayer $BAY made much of the fact that they were going all-in on gene editing when they did their deal 3 years ago with CRISPR Therapeutics, which pitched $35 million in on their end. This was the cornerstone of their plan to set up new JVs that could make some serious leap forwards in hot new R&D spaces. Now CRISPR will have full management control of Casebia as they pursue programs in hemophilia, ophthalmology and autoimmune diseases.
Samarth Kulkarni, the CEO at CRISPR, made it sound like a natural progression.

J&J's block­buster Ste­lara wins US ap­proval for ul­cer­a­tive col­i­tis

J&J’s Stelara, which is set to be in the top ten list of blockbusters come 2025, is now cleared by the FDA for use in ulcerative colitis (UC), an inflammatory disease of the large intestine.

The biologic targets interleukin (IL)-12 and IL-23 cytokines, which are known to play a key role in inflammatory and immune responses. Stelara, which generated about $4.7 billion in the first nine months of 2019, is a key player in the crowded marketplace of drugs to treat autoimmune disorders such as psoriasis, rheumatoid arthritis and Crohn’s disease. AbbVie’s star therapy, Humira, continues to dominate, despite its looming patent cliff in the United States, while others including J&J’s $JNJ own anti-IL23 Tremfya, Lilly’s $LLY anti-IL-17 Taltz and AbbVie’s $ABBV recently approved anti-IL-23 antibody Skyrizi carve out a slice of market share.

Drug com­pa­nies reach $260M set­tle­ment just ahead of opi­oid tri­al; Oys­ter Point set terms for $85M IPO

→ Hours before the first federal opioid trial was set to begin, three drug distributors and an opioid manufacturer agreed to a $260 million agreement settlement, the Wall Street Journal was the first to report. The deal — which will see McKesson, Cardinal Health and AmerisourceBergen pay $215 million to Summit and Cuyahoga counties, and Teva deal out $35 million in cash and addiction treatments — does not resolve the pending, nationwide litigation that may result in a settlement worth upwards of $40 billion. Negotiators in that case, brought by 2,300 tribes, counties and cities nationwide and led by several states’ attorneys general, worked through much of Friday without success. Josh Stein, the attorney general for North Carolina, said they were trying to put together a $48 billion deal.

GSK of­floads two vac­cines in $1.1B deal as it works to re­vive the pipeline

GlaxoSmithKline is leaving the deep dark woods and its viruses behind.

GSK has agreed to divest its vaccines for rabies, RabAvert, and tick-born encephalitis vaccine, Encepur, to Bavarian Nordic, part of the company’s broader efforts to narrow its pipeline and focus on oncology and immunology.

The deal is worth up to nearly $1.1 billion, with a $336 million upfront payment. GSK acquired the vaccines from Novartis as part of an exchange for their late-stage oncology programs in 2015 under former chief Sir Andrew Witty.

Pfiz­er gets some en­cour­ag­ing PhI­II news on a fran­chise sav­ior, but is a dos­ing ad­van­tage worth the $295M up­front?

Close to 3 years after Opko tried to defend itself as shares tumbled on the news that its long-acting growth hormone had failed to outperform a placebo, the Pfizer partner $PFE is back. And this time they’re pitching Phase III data that demonstrate their drug is non-inferior — or maybe a tad better — than their well-known but fading standard in the field.
The comparator drug here is Genotropin, which earned a marginal $142 million for Pfizer last year — down 9% from the year before. Approved 24 years ago, biosimilars are now in development that Pfizer would like to stay out in front of. The market leader here is Norditropin, a growth hormone from Novo Nordisk that uses the same basic ingredient as Genotropin, which the Danish company sells with a kid-friendly self-injectable pen. That would also present some big competition if the new therapy from Opko/Pfizer makes it to the market.
The new data, says researchers, underscore that a weekly injection of somatrogon performed as well or slightly better than Genotropin (somatropin) in young children with growth hormone deficiency. Investigators tracked height velocity at 10.12 cm/year, edging out the older drug’s 9.78 cm/year. That 0.33 difference may not prove compelling to payers, though, who have been known to overlook dosing advantages in favor of lower costs.
That message may have weighed on the stock reaction this morning, with a 30%-plus hike $OPK giving way to more marginal gains.
Back in late 2016, Opko had to defend itself against a devastating Phase III setback as their initial late-stage trial failed against a sugar pill. Opko later blamed that setback on outliers in the study, though it wasn’t able to expunge the failure.

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As­traZeneca's Farx­i­ga scores FDA nod to cut risk of hos­pi­tal­iza­tion for heart fail­ure in di­a­bet­ics

While the FDA recently spurned an application to allow AstraZeneca’s blockbuster drug Farxiga for type 1 diabetes that cannot be controlled by insulin, citing safety concerns — the US regulator has endorsed the use of the SGLT2 treatment to reduce the risk of hospitalisation for heart failure in patients with type-2 diabetes and established cardiovascular disease or multiple CV risk factors.