Gilead-part­nered Vi­en­na-based im­munother­a­py com­pa­ny Hookipa makes Nas­daq de­but with down­sized $84M IPO

Gilead-part­nered im­munother­a­py de­vel­op­er Hookipa has been work­ing on tech­nol­o­gy us­ing are­navirus­es — a fam­i­ly of virus­es typ­i­cal­ly host­ed by ro­dents — to tur­bocharge the hu­man im­mune sys­tem to fight in­fec­tious dis­eases and can­cers. The Vi­en­na-based com­pa­ny on Wednes­day priced a down­sized IPO at the low end of its range at $14, rais­ing gross pro­ceeds of $84 mil­lion.

Co-found­ed by Rolf Zinker­nagel — who was award­ed the 1996 No­bel Prize in Phys­i­ol­o­gy or Med­i­cine for his are­navirus-based work — the com­pa­ny will be­gin trad­ing un­der the tick­er sym­bol “HOOK” on Thurs­day.

Rolf Zinker­nagel

Hookipa’s tech plat­form is based on en­gi­neer­ing are­navirus­es to car­ry and de­liv­er dis­ease-spe­cif­ic pro­teins (anti­gens) di­rect­ly in­to pa­tients to den­drit­ic cells. The im­mune sys­tem de­tects these anti­gens and shores up its de­fens­es to tar­get them, killing any cell that ex­press­es them and by in­ac­ti­vat­ing in­fec­tious in­trud­ers.

On Wednes­day, the com­pa­ny said it had sold 6 mil­lion shares of com­mon stock (down from the 6.7 mil­lion it had filed for) at low end of its range ($14-$16) at $14/share to shep­herd its pipeline of drugs through clin­i­cal de­vel­op­ment. The funds will be used to take its lead ex­per­i­men­tal drug, HB-101, for the pre­ven­tion of cy­tomegalovirus in­fec­tions through com­ple­tion of the on­go­ing Phase II clin­i­cal tri­al; to ad­vance HB-201 and HB-202, its lead on­col­o­gy drugs for can­cers caused by hu­man pa­pil­lo­ma virus in­to and through com­ple­tion of Phase I clin­i­cal tri­als; as well as to ad­vance its prostate can­cer drug HB-301, in­to and through a Phase I study.

Last year, Hookipa joined forces with Gilead to de­vel­op im­munother­a­pies for the he­pati­tis B virus and HIV. Un­der the deal, Gilead forked over $10 mil­lion up­front, and Hookipa is el­i­gi­ble to re­ceive mile­stone pay­ments of up to $400 mil­lion, in ad­di­tion to tiered roy­al­ties on po­ten­tial net sales.

UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

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The 2021 top 100 bio­phar­ma in­vestors: As the pan­dem­ic hit and IPOs boomed, VCs swung in­to ac­tion like nev­er be­fore

The global pandemic may have roiled economies, killed hundreds of thousands and throttled entire industries, but the only effect it had on biopharma venture investing was to help turbocharge the field to giddy new heights.

Below you’ll find the new top 100 venture investors in the industry, ranked by the number of deals they were publicly involved in, as tracked by DealForma chief Chris Dokomajilar. The numbers master then calculated the estimated amount of money they put into each deal — divvying up the cash by the number of players — to indicate how they managed their syndicates.

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Antoine Papiernik, Sofinnova managing director (Business Wire)

Sofinno­va Part­ners stays fo­cused on late-stage deals with a new, $540M crossover fund

One of Europe’s most high-profile biopharma investors is getting $540 million to invest in new crossover deals for late-stage companies.

The Paris-based VC says the fresh Sofinnova Crossover Fund raise positions them as the “largest crossover investor in Europe dedicated to late-stage biopharma and medtech investments.”

They got a leg up in France after winning a special “Tibi” designation from the French government, giving them access to a pool of €6 billion that helped them gain an edge with institutional investors. Since they were founded close to 50 years ago, the venture group has backed more than 500 companies and currently has more than €2 billion under management.

Hal Barron, Endpoints UKBIO19

GSK, Vir's hopes for a Covid-19 an­ti­body fall flat in NIH 'mas­ter pro­to­col' with no ben­e­fit in hos­pi­tal­ized pa­tients

GlaxoSmithKline and Vir Biotechnology were hopeful that one of their partnered antibodies would carve out a win after getting the invite to a major NIH study in hospitalized Covid-19 patients. But just like Eli Lilly, the pair’s drug couldn’t hit the mark, and now they’ll be left to take a hard look at the game plan.

The NIH has shut down enrollment for GSK and Vir’s antibody VIR-7831 in its late-stage ACTIV-3 trial after the drug showed negligible effect in achieving sustained recovery in hospitalized Covid-19 patients, the partners said Wednesday.

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As Brain­Storm con­tin­ues to tout ‘clear sig­nal’ on ALS drug, the FDA of­fers a rare pub­lic slap­down on the da­ta

A little more than a week after BrainStorm acknowledged that regulators at the FDA had informed them that the biotech needed more data before it could expect to gain an approval for its ALS treatment NurOwn — while still touting a “clear signal” of efficacy and not ruling out an application — the agency has decided to clarify the record in a most unusual statement.

The FDA statement amounts to a straight slap own, offering a different set of efficacy numbers from the company’s public presentation last November and ruling out any chance of statistical significance.

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In­tro­duc­ing End­points FDA+, our new pre­mi­um week­ly reg­u­la­to­ry news re­port led by Zachary Bren­nan

CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means.

Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society.

Presage teams with Mer­ck on its Phase 0 test­ing; Kem­Pharm AD­HD drug wins ap­proval in chil­dren aged 6 and up

Seattle-based Presage Biosciences, which approaches drug development through its microdosing platform, has some new partnerships and cash to come with them.

Presage closed a $13 million financing round Tuesday, aiming to expand its network of clinical trial sites and advance development of its microdosing injection devices. They also closed partnership deals with Merck and Maverick Therapeutics.

The financing included $7 million from new investors, including the LabCorp Venture Fund, Bristol Myers Squibb, and InHarv Partners. An additional $6 million convertible note from Takeda Ventures will convert to equity.

Eli Lil­ly claims suc­cess in a new JAK in­di­ca­tion: hair loss

Over the last decade, drugmakers have proven JAK inhibitors can treat a smattering of immune-related diseases ranging from rheumatoid arthritis to Covid-19. Now Eli Lilly has pulled out a new one.

Lilly and its biotech partner Incyte announced Wednesday that their JAK inhibitor baricitinib effectively regrew patients’ hair in a Phase III trial for alopecia areata, an autoimmune condition that can cause sudden, severe and patchy hair loss. Lilly didn’t break down the results from the 546-patient trial, but the primary endpoint was improvement on a standard score for alopecia symptoms.

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CEO David Campbell (Janux)

Fresh off $1B+ Mer­ck deal, Janux locks down first pri­vate fundraise for its T cell en­gagers

Janux Therapeutics had kept a relatively low profile since being founded back in 2017 but burst onto the scene late last year when Merck plunked down more than $1 billion in promised milestones for its T cell engagers. Now, less than three months later, the small biotech has clinched its first round of private funding led by some prominent backers.

As it prepares its first programs for INDs, Janux completed a $56 million Series A on Wednesday morning, with Jay Lichter’s Avalon Ventures joining forces with new investors OrbiMed and RA Capital Management to fund the company. Janux will use the cash to primarily advance its T cell engagers targeting PSMA and TROP2, which are expected to hit the clinic in the first and second quarters of 2022, respectively.