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.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

The End­points 11: They've got mad mon­ey and huge am­bi­tions. It's time to go big or go home

These days, selecting a group of private biotechs for the Endpoints 11 spotlight begins with a sprint to get ahead of IPOs and the M&A teams at Big Pharma. I’ve had a couple of faceplants earlier this year, watching some of the biotechs on my short list choose a quick leap onto Nasdaq or into the arms of a buyer.

Vividion, you would have been a great pick for the Endpoints 11. I’m sorry I missed you.

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Dave Lennon, former president of Novartis Gene Therapies

So what hap­pened with No­var­tis Gene Ther­a­pies? Here's your an­swer

Over the last couple of days it’s become clear that the gene therapy division at Novartis has quietly undergone a major reorganization. We learned on Monday that Dave Lennon, who had pursued a high-profile role as president of the unit with 1,500 people, had left the pharma giant to take over as CEO of a startup.

Like a lot of the majors, Novartis is an open highway for head hunters, or anyone looking to staff a startup. So that was news but not completely unexpected.

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Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

Maureen Hillenmeyer, Hexagon Bio CEO

Hexa­gon Bio rais­es $61M to con­tin­ue ef­forts to turn fun­gi in­to drugs

A year after raising a $47 million launch round, the fungi-loving drug hunters at Hexagon Bio have more than doubled their coffers.

Hexagon announced today that it raised another $61 million for its efforts to design cancer and infectious disease drugs based on insights mined from the DNA in millions of species of fungi. The new financing brings Hexagon’s committed funding to over $108 million.

FDA+ roundup: Bs­U­FA III ready for show­time, court tells FDA to re-work com­pound­ing plan, new guid­ance up­dates and more

The FDA has now spelled out what exactly will be included in the third iteration of Biosimilar User Fee Act (BsUFA) from 2023 through 2027, which similarly to the prescription drug deal, sets fees that industry has to pay for submitting applications, in exchange for firm timelines that the agency must meet.

This latest deal includes several sweeteners for the biosimilar industry, which has yet to make great strides in the US market, with shorter review timelines for safety labeling updates and updates to add or remove an indication that does not contain efficacy data.

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Joshua Liang, Clover Biopharmaceuticals CEO

With world still in sore need of dos­es, Clover says its Covid-19 vac­cine is 67% ef­fec­tive in Phase III

With concerns about the Delta variant rising and much of the world still in desperate need of vaccine doses, a Chinese biotech announced Wednesday that a new shot has shown positive results in a large trial against Covid-19, including new variants.

Clover Biopharmaceuticals announced Wednesday that its vaccine candidate showed 79% efficacy against the Delta variant in a Phase II/III trial dubbed Spectra, and 67% effective against Covid-19 overall.

Jean Bennett (Brent N. Clarke/Invision/AP Images)

Lux­tur­na in­ven­tor Jean Ben­nett starts a new gene ther­a­py com­pa­ny to tack­le rare dis­eases left be­hind by phar­ma, VCs

A few years ago Jean Bennett found herself in a surprising place for a woman who invented the first gene therapy ever approved in the United States: No one, it seemed, wanted her work.

Bennett, who designed and co-developed Luxturna, approved in 2018 for a rare form of blindness, had kept building new gene therapies for eye diseases at her University of Pennsylvania lab. But although the results in animals looked promising, pharma companies and investors kept turning down the pedigreed ophthalmology professor.

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