Clarus spear­heads a big, $150M raise so Galera can flip the PhI­II card on its new drug to treat ra­di­a­tion ef­fects

Any­one look­ing for sol­id ev­i­dence of the kind of im­pact the new, flush fund­ing en­vi­ron­ment — along with a more ac­com­mo­dat­ing FDA — is hav­ing on biotech need look no fur­ther than Galera Ther­a­peu­tics this morn­ing.

Mel Sorensen

Armed with pos­i­tive Phase IIb da­ta for a new can­cer-re­lat­ed ther­a­py, the small, 18-per­son crew at Galera has pieced to­geth­er a whop­ping $150 mil­lion raise; $70 mil­lion in an am­bi­tious Se­ries C with an $80 mil­lion roy­al­ty deal com­ing from one of its biggest back­ers. And CEO Mel Sorensen says that com­bo gives the com­pa­ny all the mon­ey it needs to get through a piv­otal study in the next cou­ple of years that could put them on the thresh­old of a mar­ket­ing de­ci­sion from the FDA.

“This fund­ing al­lows us to get all the way through the process,” Sorensen tells me, “to turn over the Phase III card.”

The “beach­head” in­di­ca­tion for Malvern, PA-based Galera is se­vere oral mu­cosi­tis, a com­mon side ef­fect in pa­tients with head and neck can­cer. Their drug, GC4419, tar­gets the tox­ic ef­fect of ra­di­a­tion ther­a­py as su­per­ox­ide swift­ly builds up in pa­tients, af­flict­ing the sen­si­tive tis­sue in their mouths.

The FDA has helped con­sid­er­ably, giv­ing Galera a break­through drug des­ig­na­tion and get­ting the CEO’s thumbs up for help­ing with the tri­al de­sign and keep­ing things on a rel­a­tive­ly tight sched­ule. Sorensen ex­pects to get the piv­otal Phase III un­der­way in the up­com­ing quar­ter, and he adds that it will like­ly take ap­prox­i­mate­ly 18 to 24 months to com­plete once they are un­der­way.

Em­mett Cun­ning­ham

At one point not long ago, the idea of a small biotech com­pa­ny tack­ling Phase III with­out at least a ma­jor part­ner would have ter­ri­fied most in­vestors. But times have changed, and the lev­el of cash flow­ing through the in­dus­try in the last 2 years has reached an un­prece­dent­ed depth. In Galera’s case, that means push­ing through Phase III while al­so lay­ing the foun­da­tion for a com­mer­cial­iza­tion ef­fort that could re­quire 50 peo­ple. Along the way, Galera will al­so study new in­di­ca­tions for their drug to see how they can build the fran­chise. 

Pre­sum­ably, an IPO has been on the ta­ble, es­pe­cial­ly as the cur­rent wave of biotechs go­ing pub­lic is dom­i­nat­ed by pre­clin­i­cal com­pa­nies with­out any­thing like a Phase IIb da­ta set. Sorensen, though, sim­ply says the com­pa­ny is keep­ing all op­tions on the ta­ble, pre­fer­ring to fo­cus now on the big step ahead.

In this case, Clarus not on­ly led the round, the firm al­so sup­plied the roy­al­ty cash through an­oth­er spe­cial­ized fund it runs. 

Clarus is jump­ing in along­side oth­er new in­vestors: Adage Cap­i­tal Man­age­ment, HBM Health­care In­vest­ments, Nan Fung Life Sci­ences, RA Cap­i­tal, Rock Springs Cap­i­tal and Tekla Cap­i­tal Man­age­ment LLC. Ex­ist­ing in­vestors Cor­re­la­tion Ven­tures, Galera An­gels, New En­ter­prise As­so­ci­ates, No­var­tis Ven­ture Fund, No­vo Ven­tures and Sofinno­va Ven­tures al­so par­tic­i­pat­ed. And Clarus’ man­ag­ing di­rec­tor Em­mett Cun­ning­ham is jump­ing on the board.

Ryan Watts, Denali CEO

Bio­gen hands De­nali $1B-plus in cash, $1B-plus in mile­stones to part­ner on late-stage Parkin­son’s drug

Biogen is handing over more than a billion dollars cash to partner with the up-and-coming neurosciences crew at Denali on a new therapy for Parkinson’s. And the big biotech is ready to pile on more than a billion dollars more in milestones — if the alliance is a success.

For Biogen $BIIB, the move on Denali’s small molecule inhibitors of LRRK2 puts them in line to collaborate on a late-stage program for DNL151, which is scheduled to start next year.

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Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen scores a pri­or­i­ty re­view for its Alzheimer's drug ad­u­canum­ab, mov­ing one gi­ant leap for­ward in its con­tro­ver­sial quest

Biogen scored a big win at the FDA today as regulators accepted their application for the controversial Alzheimer’s drug aducanumab and gave it a priority review.

The PDUFA date is March 7, 2021.

Significantly, Biogen says it did not use its priority review voucher to win special treatment at the FDA. The agency handed that out gratis.

That’s the ideal scenario Biogen was looking for as disappointed analysts wondered aloud about the delayed application earlier in the year.

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Bio­haven adds near­ly $1B in Nurtec deals with Roy­al­ty Phar­ma, Sixth Street

Biohaven just added nearly $1 billion to their balance sheet.

On Friday morning, the neuroscience biotech announced a pair of creative agreements with Royalty Pharma and the investment firm Sixth Street to bolster the commercial launch of their new migraine drug, Nurtec. Biohaven will sell a sliver of its royalties on Nurtec and 3% of the royalties on their experimental migraine drug zavegepant to Royalty Pharma as part of a larger agreeement that will pay $450 million. At the same time, the company announced they took out a $500 million loan from Sixth Street.

Ab­b­Vie set­tles in­sur­ance fraud suit, agrees to tweak nurse am­bas­sador pro­gram; CStone aims for NSCLC OK with pos­i­tive PhI­II da­ta

AbbVie has resolved a California lawsuit alleging insurance fraud in the promotion of its cash cow Humira, paying $24 million to settle things with the state’s insurance regulator.

The settlement comes almost four years after a whistleblower first reported AbbVie’s practice of deploying registered nurses to visit patients at home or call them by phone to ensure that Humira prescriptions are filled. AbbVie was also charged with providing illegal kickbacks to doctors in an attempt to encourage them to prescribe Humira for a range of anti-inflammatory diseases.

Per­cep­tive fields SPAC #3 as an­oth­er group of biotechs scoops up $364M in lat­est Nas­daq romp

There’s no sign that the windfall of cash dropping biotech’s way on Wall Street is abating. Three more biopharmas priced IPOs on Thursday and Friday morning, riding a historic boom with a $364 million payoff.

London-based biotech Freeline Therapeutics took home the lion’s share of the cash with $159 million after pricing 8,823,529 shares at $18 a pop. Checkmate Pharmaceuticals, of Cambridge, MA, raised $75 million with an offer of 5 million shares at $15 — right at the midpoint of its range. And Arya Sciences Acquisition Corp III, the third in a series from Perceptive, priced 13,000,000 shares at $10 per share.

Covid-19 roundup: Gates Foun­da­tion pours $150M in­to In­dia’s Serum In­sti­tute; Pfiz­er teams with Gilead on remde­sivir

By CEO and scion Adar Poonawalla’s estimation, the Serum Institute in India has already poured hundreds of millions of dollars into scaling up the unproven Covid-19 vaccine being developed by AstraZeneca and Oxford for use in low and middle income countries. It’s meant taking on a risk that other companies, including AstraZeneca, have mitigated with huge amounts of government funding.

Now, for the first time, Poonawalla is getting some outside help. The Gates Foundation has agreed to pay the institute $150 million to supply 100 million vaccines to India and other emerging economies next year, Reuters reported. That includes both the vaccine being developed by AstraZeneca and the one being developed by Novavax. Those vaccines will be available in 92 countries and be priced at $3 per dose.

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President Trump speaks with members of the media before boarding Marine One (AP Images)

'Oc­to­ber is com­ing,' and every­one still wants to know if a Covid-19 vac­cine will be whisked through the FDA ahead of the elec­tion

Right on the heels of a lengthy assurance from FDA commissioner Stephen Hahn that the agency will not rush through a quick approval for a Covid-19 vaccine, the President of the United States has some thoughts on timing he’d like to share.

In an exchange with Fox News’ Geraldo Rivera on Thursday, President Trump allowed that a vaccine could be ready to roll “sooner than the end of the year, could be much sooner.”

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UP­DAT­ED: No­vavax her­alds the lat­est pos­i­tive snap­shot of ear­ly-stage Covid-19 vac­cine — so why did its stock briefly crater?

High-flying Novavax $NVAX became the latest of the Covid-19 vaccine players to stake out a positive set of biomarker data from its early-stage look at its vaccine in humans.

Their adjuvanted Covid-19 vaccine was “well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera,” the company noted. According to the biotech:

All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease. Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional.

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Alex­ion cre­ates new post for chief di­ver­si­ty of­fi­cer; Bar­ry Greene step­ping down at Al­ny­lam, Yvonne Green­street named as suc­ces­sor

Alexion has carved out a new position for chief diversity officer and filled it with an inside promotion.

Uzair Qadeer will now be responsible for their “diversity, inclusion and belonging” strategy, looking to reshape the biotech’s corporate culture. A veteran of Deloitte and Bristol Myers Squibb, Qadeer was working on executive coaching and helping create the diversity program he now leads.