Tem­pest Ther­a­peu­tics jumps on­to Nas­daq in merg­er with strug­gling Mil­len­do Ther­a­peu­tics; Bio­haven hits $100M mile­stone as it gears up for a late-stage study in mi­graine pa­tients

Less than a month af­ter land­ing a Big Phar­ma part­ner on one of its lead on­col­o­gy pro­grams, Tem­pest Ther­a­peu­tics is back­flip­ping on­to Nas­daq through a re­verse merg­er with Mil­len­do Ther­a­peu­tics.

Back in Jan­u­ary, Mil­len­do shut down the sole re­main­ing ear­ly-stage study for its NK3R an­tag­o­nist MLE-301 — just nine months af­ter pulling the plug on a piv­otal study for its lead drug liv­o­le­tide. The biotech planned some deep cuts for the re­main­ing staff, while look­ing for a sale or merg­er.

In sup­port of the merg­er, Tem­pest se­cured com­mit­ments from a slate of in­vestors for a $30 mil­lion PIPE fi­nanc­ing, in­clud­ing Ver­sant Ven­tures, Rock Springs Cap­i­tal, F-Prime Cap­i­tal, Monashee In­vest­ment Man­age­ment, Quan Cap­i­tal, Lyfe Cap­i­tal, Maven In­vest­ment Part­ners US, Lil­ly Asia Ven­tures and Eight Roads Ven­tures, the com­pa­ny said on Mon­day. Over­all, the deal should ex­tend the com­pa­ny’s cash run­way through ear­ly 2023, ac­cord­ing to a state­ment.

Tom Duben­sky

Ear­li­er this month, the com­pa­ny inked a deal with Roche to study its TPST-1120 in com­bi­na­tion with Tecen­triq and Avastin in pre­vi­ous­ly un­treat­ed pa­tients with ad­vanced he­pa­to­cel­lu­lar car­ci­no­ma (HCC). The com­pa­ny al­so has TPST-1495, which is in a Phase Ia/Ib dose and sched­ule op­ti­miza­tion study in pa­tients with ad­vanced sol­id tu­mors, specif­i­cal­ly known prostaglandin-dri­ven tu­mors like col­orec­tal can­cer, lung ade­no­car­ci­no­ma and urothe­lial can­cer.

“The tran­si­tion of Tem­pest to a pub­lic com­pa­ny en­hances our abil­i­ty to fund these po­ten­tial­ly im­por­tant prod­uct can­di­dates, as well as con­sid­er ad­di­tion­al pro­grams with ex­cit­ing new tar­gets,” CEO Tom Duben­sky said in a state­ment.

The merg­er is ex­pect­ed to close in the first half of this year, with Mil­len­do stock­hold­ers ex­pect­ed to own ap­prox­i­mate­ly 18.5% of the com­bined com­pa­ny and pre-merg­er Tem­pest stock­hold­ers to hold 81.5%.

Bio­haven hits $100M mile­stone as it gears up for a late-stage study in mi­graine pa­tients

Bio­haven has of­fi­cial­ly launched a Phase II/III tri­al for its oral mi­graine drug, trig­ger­ing a $100 mil­lion pay­off from Roy­al­ty Phar­ma.

Back in Au­gust, Bio­haven added near­ly $1 bil­lion to its bal­ance sheet through a pair of cre­ative agree­ments with Roy­al­ty Phar­ma and the in­vest­ment firm Sixth Street to bol­ster the com­mer­cial launch of its new mi­graine drug, Nurtec. As part of an agree­ment with Roy­al­ty, Bio­haven was promised up to $250 mil­lion to ad­vance its za­veg­epant in mi­graine and oth­er CGRP-me­di­at­ed dis­eases. Bio­haven had al­ready pock­et­ed $150 mil­lion, and will now re­ceive the last $100 mil­lion as it en­rolls the first pa­tient in the Phase II/III study. In to­tal, Bio­haven is look­ing for 2,900 mi­graine pa­tients to test the ef­fi­ca­cy and safe­ty of 100 mg and 200 mg dos­es of oral za­veg­epant.

“Our suc­cess­ful, mul­ti-year part­ner­ship with Bio­haven to sup­port both the reg­u­la­to­ry ap­proval and com­mer­cial­iza­tion of Nurtec as well as pipeline de­vel­op­ment is an ex­cel­lent ex­am­ple of how Roy­al­ty Phar­ma can be a col­lab­o­ra­tive part­ner to in­no­v­a­tive bio­phar­ma com­pa­nies,” Roy­al­ty CSO and co-head of re­search and in­vest­ments Jim Red­doch said in a state­ment.

An in­tranasal for­mu­la­tion of za­veg­epant, for­mer­ly known as vazegepant, achieved su­pe­ri­or ef­fi­ca­cy to place­bo in a Phase II/III study, the com­pa­ny said.

Sim­cere promis­es near­ly $300M for the rights to a for­mer Genen­tech can­di­date

There’s a new glioblas­toma can­di­date in Greater Chi­na.

Sim­cere Phar­ma­ceu­ti­cal Group is putting down $11 mil­lion up­front and up to $281 in mile­stones for the de­vel­op­ment and com­mer­cial­iza­tion rights to Kazia Ther­a­peu­tics’ pax­al­is­ib — a PI3K in­hibitor li­censed from Genen­tech back in 2016. The can­di­date en­tered a piv­otal study ear­li­er this year, and is in sev­en ad­di­tion­al stud­ies for oth­er brain can­cers.

“The need for new ther­a­pies in brain can­cer is sig­nif­i­cant in Chi­na, and we share Kazia’s com­mit­ment to bring­ing for­ward new treat­ment op­tions for pa­tients,” Sim­cere se­nior VP Ren­hong Tang said in a state­ment.

Pax­al­is­ib is dis­tin­guished by its abil­i­ty to cross the blood-brain bar­ri­er, which pre­vents many drugs from ful­ly af­fect­ing brain tis­sue, the com­pa­ny said.

Sim­cere’s up­front pay­ment in­cludes $7 mil­lion in cash and a $4 mil­lion eq­ui­ty in­vest­ment. In ad­di­tion to the $281 mil­lion in mile­stones for glioblas­toma, Kazia can snag more for oth­er in­di­ca­tions, ac­cord­ing to the deal. And Sim­cere will dole out com­mer­cial roy­al­ties in the “mid-teens.” Sim­cere can de­vel­op and mar­ket the drug in Main­land Chi­na, Hong Kong, Macau, and Tai­wan, while Kazia re­tains the rights every­where else.

Bob Bradway, Amgen CEO (Scott Eisen/Bloomberg via Getty Images)

Am­gen bel­lies back up to the M&A ta­ble for an­oth­er biotech buy­out, this time with a $2.5B deal for an­ti­body play­er

Five months after Amgen CEO Bob Bradway stepped up to the M&A table and acquired Five Prime for $1.9 billion, following up with the smaller Rodeo acquisition, he’s gone back in for another biotech buyout.

This time around, Amgen is paying $900 million cash while committing up to $1.6 billion in milestones to bag the privately held Teneobio, an antibody drug developer that has expertise in developing new bispecifics and multispecifics. In addition, Amgen cited Teneobio’s “T-cell engager platform, which expands on Amgen’s existing leadership position in bispecific T-cell engagers by providing a differentiated, but complementary, approach to Amgen’s current BiTE platform.”

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How one start­up fore­told the neu­ro­science re­nais­sance af­ter '50 years of shit­show'

In the past couple of years, something curious has happened: Pharma and VC dollars started gushing into neuroscience research.

Biogen’s controversial new Alzheimer’s drug Aduhelm has been approved on the basis of removing amyloid plaque from the brain, but the new neuro-focused pharma and biotechs have much loftier aims. Significantly curbing or even curing the most notorious disorders would prove the Holy Grail for a complex system that has tied the world’s best drug developers in knots for decades.

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Ryan Watts, Denali CEO

De­nali slips as a snap­shot of ear­ly da­ta rais­es some trou­bling ques­tions on its pi­o­neer­ing blood-brain bar­ri­er neu­ro work

Denali Therapeutics had drummed up considerable hype for their blood-brain barrier technology since launching over six years ago, hype that’s only intensified in the last 14 months following the publications of a pair of papers last spring and proof of concept data earlier this year. On Sunday, the South San Francisco-based biotech gave the biopharma world the next look at in-human data for its lead candidate in Hunter syndrome.

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Why is On­col­o­gy Drug De­vel­op­ment Re­search Late to the Dig­i­tal Bio­mark­ers Game?

During the recent Annual ASCO Meeting, thousands of cancer researchers and clinicians from across the globe joined together virtually to present and discuss the latest findings and breakthroughs in cancer research and care. There were more than 5000+ scientific abstracts presented during this event, yet only a handful involved the use of motion-tracking wearables to collect digital measures relating to activity, sleep, mobility, functional status, and/or quality of life. Although these results were a bit disappointing, they should come as no surprise to those of us in the wearable technology field.

Art Levinson (Calico)

Google-backed Cal­i­co dou­bles down on an­ti-ag­ing R&D pact with Ab­b­Vie as part­ners ante up $1B, start to de­tail drug tar­gets

Seven years after striking up a major R&D alliance, AbbVie and Google-backed anti-aging specialist Calico are doubling down on their work with a joint, $1 billion commitment to continuing their work together. And they’re also beginning to offer some details on where this project is taking them in the clinic.

According to their statement, each of the two players is putting up $500 million more to keep the labs humming.

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Mer­ck­'s wom­en's health spin­out snags mid-stage can­di­date for preterm birth; Keytru­da nails down TNBC ap­proval af­ter March CRL

Nearly two months after spinning out from Merck, women’s health business Organon has struck its first half-billion-dollar deal.

Organon $OGN has promised $25 million upfront and another $475 million in biobucks for worldwide rights to ebopiprant, ObsEva’s investigational treatment for preterm labor. Ebopiprant, a selective prostaglandin F2α (PGF2α) receptor antagonist, was originally licensed from Merck KGaA in 2015. The candidate works by reducing inflammation and uterine contractions.

Busi­ness­es and schools can man­date the use of Covid-19 vac­cines un­der EUAs, DOJ says

As public and private companies stare down the reality of the Delta variant, many are now requiring that their employees or students be vaccinated against Covid-19 prior to attending school or to returning or starting a new job. Claims that such mandates are illegal or cannot be used for vaccines under emergency use authorizations have now been dismissed.

Setting the record straight, the Department of Justice on Monday called the mandates legal in a new memo, even when used for people with vaccines that remain subject to EUAs.

Ugur Sahin, BioNTech CEO (Bernd von Jutrczenka/dpa via AP Images)

BioN­Tech is spear­head­ing an mR­NA vac­cine de­vel­op­ment pro­gram for malar­ia, with a tech trans­fer planned for Africa

Flush with the success of its mRNA Covid-19 vaccine, BioNTech is now gearing up for one of the biggest challenges in vaccine development — which comes without potential profit.

The German mRNA pioneer says it plans to work on a jab for malaria, then transfer the tech to the African continent, where it will work with partners on developing the manufacturing ops needed to make this and other vaccines.

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No­var­tis reshuf­fles its wild cards; Tough sell for Bio­gen? Googling pro­teins; Ken Fra­zier's new gig; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

If you enjoy the People section in this report, you may also want to check out Peer Review, my colleagues Alex Hoffman and Kathy Wong’s comprehensive compilation of comings and goings in biopharma.

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