For­bion leads $62.5M round for neu­ro start­up as ex-Te­va R&D chief takes con­trol; CSL Behring inks gene ther­a­py pact in im­munol­o­gy

For­bion has led a $62.5 mil­lion round for Prile­nia Ther­a­peu­tics to fund two late-stage tri­als in Hunt­ing­ton’s dis­ease and amy­otroph­ic lat­er­al scle­ro­sis. Michael Hay­den, the for­mer Te­va R&D chief who’s been serv­ing as chair­man, will now take over as CEO to over­see the pro­gram for pri­do­pi­dine, which ag­o­nizes the sig­ma-1 re­cep­tor (S1R). Morn­ing­side and Sec­toral As­set Man­age­ment al­so joined, as did Tal­is­man Cap­i­tal Part­ners and Gen­works 2.

→ Aus­tralia’s CSL Behring is team­ing up with Seat­tle Chil­dren’s Re­search In­sti­tute to de­vel­op stem cell gene ther­a­pies for rare pri­ma­ry im­mun­od­e­fi­cien­cy dis­eases, start­ing with Wiskott-Aldrich Syn­drome and X-linked Agam­ma­glob­u­line­mia. They are among 400 pri­ma­ry im­mun­od­e­fi­cien­cy dis­eases, in which the hu­man im­mune sys­tem is dys­func­tion­al. “Ex­pand­ing our gene ther­a­py port­fo­lio in­to an area of im­munol­o­gy well known to CSL ex­em­pli­fies how we are strate­gi­cal­ly grow­ing our ca­pa­bil­i­ties in this strate­gic sci­en­tif­ic plat­form and are col­lab­o­rat­ing with world class in­sti­tu­tions to ac­cess in­no­va­tion with the po­ten­tial to vast­ly im­prove pa­tients’ lives,” not­ed CSL R&D chief Bill Mez­zan­otte.

Hy­loris Phar­ma­ceu­ti­cals, a Bel­gian com­pa­ny ded­i­cat­ed to re­for­mu­lat­ing well-known drugs, is look­ing to tap the pub­lic mar­ket by list­ing on Eu­ronext Brus­sels. “The IPO is ex­pect­ed to pro­vide us with the re­sources need­ed to fi­nance the de­vel­op­ment of our ex­ist­ing port­fo­lio of prod­uct can­di­dates, as well as es­tab­lish a com­mer­cial in­fra­struc­ture in the Unit­ed States for our IV Car­dio­vas­cu­lar port­fo­lio (ex­cl. So­talol IV, which is com­mer­cial­ized through a part­ner), where we will fo­cus on ad­dress­ing pre­scribers in a cost-ef­fi­cient man­ner by con­cen­trat­ing on spe­cial­ized care fa­cil­i­ties such as hos­pi­tals,” CEO Sti­jn Van Rompay said in a state­ment.

GHO Cap­i­tal has put the $1 bil­lion-plus fund it closed at the end of last year to use, buy­ing X-Chem from an af­fil­i­ate of The Car­lyle Group and Hell­man & Fried­man. The com­pa­ny spe­cial­izes in DNA-En­cod­ed Li­brary (DEL)-based dis­cov­ery ser­vices and has li­censed over 70 re­search pro­grams to bio­phar­ma part­ners over the years. Matt Clark, a co-founder and the cur­rent SVP of chem­istry, will re­place Rick Wag­n­er as CEO.

→ Dublin-based Avec­tas has en­list­ed Scott Si­mon’s lab at UC Davis to char­ac­ter­ize cells en­gi­neered on its plat­form, with the goal of in­form­ing the de­vel­op­ment of next-gen cell ther­a­pies. “A ma­jor fo­cus of our group is to un­der­stand how chem­i­cal and me­chan­i­cal forces act­ing on im­mune cells en­able them to lo­cal­ize at sites of in­flam­ma­tion,” Si­mon said in a state­ment. “The part­ner­ship with Avec­tas will help us eval­u­ate how these same forces play a role to de­liv­er­ing mR­NA and pro­teins to im­mune cells and there­by ex­tend their ther­a­peu­tic ap­pli­ca­tions.”

→ Ire­land’s Shorla Phar­ma has closed its Se­ries A at $8.3 mil­lion to ad­vance a slate of drugs for rare, or­phan and pe­di­atric can­cers. Ser­o­ba Life Sci­ences led the round, which fea­tured oth­er lo­cal in­vestors as well as fam­i­ly of­fices in Cana­da.

Chris­t­ian Anger­may­er, founder of the men­tal health and psy­che­delics biotech ATAI, is try­ing to bring the Aus­tralian biotech Bio­nom­ics and its PTSD drug back from the near-dead. Bio­nom­ic’s stock flat­lined to $0.04 af­ter the drug’s fail­ure in a Phase II tri­al, but the com­pa­ny, which has al­so part­nered with Mer­ck on Alzheimer’s, has since re­for­mu­lat­ed the drug, and Anger­may­er is bet­ting it might now work. His firm Ape­iron put down $5 mil­lion and un­der­wrote $15 mil­lion in fund­ing to put the com­pound back in­to tri­als.

Regeneron CEO Leonard Schleifer speaks at a meeting with President Donald Trump, members of the Coronavirus Task Force, and pharmaceutical executives in the Cabinet Room of the White House (AP Photo/Andrew Harnik)

OWS shifts spot­light to drugs to fight Covid-19, hand­ing Re­gen­eron $450M to be­gin large scale man­u­fac­tur­ing in the US

The US government is on a spending spree. And after committing billions to vaccines defense operations are now doling out more of the big bucks through Operation Warp Speed to back a rapid flip of a drug into the market to stop Covid-19 from ravaging patients — possibly inside of 2 months.

The beneficiary this morning is Regeneron, the big biotech engaged in a frenzied race to develop an antibody cocktail called REGN-COV2 that just started a late-stage program to prove its worth in fighting the virus. BARDA and the Department of Defense are awarding Regeneron a $450 million contract to cover bulk delivery of the cocktail starting as early as late summer, with money added for fill/finish and storage activities.

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Andrew Kruegel, Kures president and co-founder (Columbia Tech Ventures via Vimeo)

Af­ter psilo­cy­bin and ke­t­a­mine, a new biotech comes along de­vel­op­ing a drug Scott Got­tlieb fought

Andrew Kruegel was six years into his chemistry work at Columbia University, when, one day in August 2016, he learned he might have only 30 days before the government made him destroy his research.

Kruegel had been studying kratom, a leaf long used in Southeast Asia as a stimulant or for pain. It had opioid-like properties, he found, but seemed to offer pain relief without the addictive potential or respiratory side effects of traditional opioids — a riddle that might help illuminate how human opioid receptors work.

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UP­DAT­ED: Bio­gen shares spike as ex­ecs com­plete a de­layed pitch for their con­tro­ver­sial Alzheimer's drug — the next move be­longs to the FDA

Biogen is stepping out onto the high wire today, reporting that the team working on the controversial Alzheimer’s drug aducanumab has now completed their submission to the FDA. And they want the agency to bless it with a priority review that would cut the agency’s decision-making time to a mere 6 months.

The news drove a 10% spike in Biogen’s stock $BIIB ahead of the bell.

Part of that spike can be attributed to a relief rally. Biogen execs rattled backers and a host of analysts earlier in the year when they unexpectedly delayed their filing to the third quarter. That delay provoked all manner of speculation after CEO Michel Vounatsos and R&D chief Al Sandrock failed to persuade influential observers that the pandemic and other factors had slowed the timeline for filing. Actually making the pitch at least satisfies skeptics that the FDA was not likely pushing back as Biogen was pushing in. From the start, Biogen execs claimed that they were doing everything in cooperation with the FDA, saying that regulators had signaled their interest in reviewing the submission.

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The home run count: The $100M+ mega-round boom in biotech in­spired a $7.3B feed­ing fren­zy — so far this year

Over the last 6 months there’s been a blizzard of money piling up drifts of the green stuff through the biotech landscape. And the forecast calls for more cash windfalls ahead.

Even as a global pandemic has killed more than half a million people, blighted economies and divided nations over the proper response, it’s also helped ignite an unprecedented burst of big-time investing. And not just in Covid-19 deals, as we’ve looked at before.

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Nello Mainolfi (Kymera via YouTube)

Out to re­vive R&D, a resur­gent Sanofi pays $150M cash to part­ner up with a pi­o­neer­ing pro­tein degra­da­tion play­er

Frank Nestle was appointed Sanofi’s global head of immunology and inflammation research therapeutic area just days before dupilumab, the blockbuster-to-be IL-4 antibody, would be accepted for priority review. After four years of consolidating immunology expertise from multiple corners of the Sanofi family and recruiting new talents to build the discovery engine, he’s set eyes on a Phase I-ready program that he believes can grow into a Dupixent-sized franchise.

Atul Deshpande, Harbour BioMed chief strategy officer & head, US operations (Harbour BioMed)

An­oth­er biotech IPO set-up? Multi­na­tion­al biotech leaps from round to round, scoop­ing up cash at a blis­ter­ing pace

A short four months after announcing a $75 million haul in Series B+ fundraising, the multinational biotech Harbour BioMed pulled in another round of investments and eclipsed the nine-digit mark in the process.

Harbour completed its Series C financing, the company announced Thursday morning, raising $102.8 million and bringing its total investment sum to over $300 million since its founding in late 2016. The biotech plans to use the money to transition early-stage candidates from the discovery phase, fund candidates already in the clinic, and prep late-stage candidates for commercialization.

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Bio­phar­ma com­pa­nies pledge $1B to fund an­tibi­otics R&D as field shriv­els; Four biotechs hunt $797M+

→ As promised, a group of some 20 biopharma companies have pooled close to $1 billion to fund new research in antibiotics — a field that has been dying of late. Small margins and tiny markets have killed off a slate of players in the field and drove out most of the big organizations. Now Eli Lilly, Pfizer and others hope to foot the bill for a group of 2 to 4 new antibiotics in the next 10 years. Pfizer alone pledged $100 million for the industry effort. “With the AMR Action Fund, the pharmaceutical industry is investing nearly $1 billion to sustain an antibiotic pipeline that is on the verge of collapse, a potentially devastating situation that could affect millions of people around the world,” said David Ricks, Eli Lilly CEO and president of IFPMA.

Covid-19 roundup: CDC de­bat­ing who should get first avail­able vac­cines; EU in Gilead talks af­ter US gob­bled first remde­sivir dos­es

The federal government has now spent billions of dollars accelerating the development of a Covid-19 vaccine, and yet they’ve remained hush-hush on who, precisely, would actually get inoculated once the first doses are approved and available. Internally, though, they have been debating it.

The CDC and an advisory committee of outside health experts have been working since April to devise a ranking system that would determine who receives a vaccine and when, The New York Times reported. The question of who is first in line for inoculation is important because no matter how many doses developers can make or how quickly they can make them, doses will still come out in batches; 300 million inoculations will not appear overnight.

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For­bion spot­lights late-stage plays, carves out new €250M growth fund

Having staked its rep on picking out a mix of biotech investment opportunities across the “build,” “enable,” “growth” continuum, Forbion is launching its first fund dedicated to late-stage opportunities.

Forbion Growth Opportunities Fund’s first close brought in €185 million ($208 million). Existing investors Pantheon, KfW Capital and the European Investment Fund came on board, joined by new backers Eli Lilly, Horizon Therapeutics, Belgian Growth Fund and New Waves Investments.