Markus Warmuth, Monte Rosa CEO

Monte Rosa takes this week's IPO lead as a nine-fig­ure raise push­es in­dus­try to­tal past $9B

Ed­i­tor’s note: In­ter­est­ed in fol­low­ing bio­phar­ma’s fast-paced IPO mar­ket? You can book­mark our IPO Track­er here.

Ma­jor League Base­ball isn’t the on­ly in­dus­try that’s un­der­go­ing a reck­on­ing over “sticky stuff,” as Monte Rosa Ther­a­peu­tics takes its mol­e­c­u­lar glues pub­lic Thurs­day ready to shake up Nas­daq.

The Boston-based biotech priced its IPO late Wednes­day night and plans to start trad­ing Thurs­day at a launch price of $19 per share. Monte Rosa se­cured $222.3 mil­lion with the of­fer­ing as biotech con­tin­ues its record IPO pace: now with 54 com­pa­nies go­ing pub­lic in 2021, the in­dus­try is on track to see more than 100 de­buts in a cal­en­dar year for the first time ever, ac­cord­ing to the End­points News tal­ly.

And this year’s com­bined IPO raise? It’s over $9 bil­lion.

If they main­tain their pace, both to­tals would eclipse the marks set dur­ing last year’s pan­dem­ic-fu­eled craze, when biotech saw $16.5 bil­lion fun­neled to­ward 91 new­ly pub­lic com­pa­nies, per fig­ures from Nas­daq.

Monte Rosa has blazed a path to the pub­lic mar­ket ever since it closed a $96 mil­lion Se­ries B back in Sep­tem­ber 2020. CEO Markus War­muth suc­cess­ful­ly drummed up in­vestor ex­cite­ment over the biotech’s “mol­e­c­u­lar glue” tech­nol­o­gy that seeks to re­pro­gram how ubiq­ui­tin lig­as­es work, a func­tion crit­i­cal to the process of pro­tein degra­da­tion.

While oth­er com­pa­nies in this space had sought to de­vel­op in­hibitors, War­muth said at the time, that ap­proach re­quired tar­gets to have an ac­tive site. Monte Rosa’s ap­proach al­lows the biotech to go af­ter those with­out such sites, par­tic­u­lar­ly when the his­tor­i­cal­ly tricky tran­scrip­tion mech­a­nism is in­volved.

War­muth fol­lowed up that raise with an­oth­er $95 mil­lion round in March, short­ly af­ter which Monte Rosa filed to go pub­lic. Hav­ing raised enough cap­i­tal to get its lead pro­gram in­to the clin­ic, the biotech is ear­mark­ing some of the IPO funds for a planned Phase I/II tri­al.

The pro­gram, tar­get­ing GSPT1 for some ge­net­i­cal­ly-de­fined can­cers, had been ex­pect­ed to reach the IND phase by the end of 2020, War­muth told End­points last Sep­tem­ber. Now, though, launch­ing IND-en­abling stud­ies isn’t ex­pect­ed un­til the sec­ond half of this year.

Per Monte Rosa’s up­dat­ed S-1, the com­pa­ny plans to spend on­ly $47 mil­lion to $57 mil­lion on this study, sav­ing the ma­jor­i­ty of the funds for its oth­er can­di­dates. The biotech will save about $120 mil­lion to $130 mil­lion for this ef­fort, bankrolling a quar­tet of pre­clin­i­cal pro­grams that seek to tar­get CDK2, NEK7, VAV1 and BCL11A in a range of can­cers, in­flam­ma­to­ry dis­eases and au­toim­mune dis­eases.

At least three of these will hit the IND-en­abling phase with the cash, the S-1 says, though it’s un­clear which is the fur­thest ahead. Monte Rosa will set aside the re­main­ing $65 mil­lion to $75 mil­lion to con­tin­ue de­vel­op­ing its plat­form.

The biggest win­ner of the IPO is Ver­sant, which owns the largest stake in the com­pa­ny at 20.5% post-of­fer­ing. New En­ter­prise As­so­ci­ates takes home sec­ond with a 15.6% share af­ter the IPO fin­ish­es, while Cor­morant As­set Man­age­ment clocks in third at 6.1%. War­muth him­self will al­so take home some cash, giv­en that he owns more than 400,000 shares. Post-IPO, that will equate to a 1% stake in his com­pa­ny.

Monte Rosa plans to trade un­der the tick­er $GLUE. And next up on IPO watch, an­oth­er quar­tet of com­pa­nies are ex­pect­ed to price their IPOs in time for Fri­day trad­ing, in­clud­ing Graphite Bio, GH Re­search, El­e­va­tion On­col­o­gy and Al­pha Tekno­va.

Adap­tive De­sign Meth­ods Of­fer Rapid, Seam­less Tran­si­tion Be­tween Study Phas­es in Rare Can­cer Tri­als

Rare cancers account for 22 percent of cancer diagnoses worldwide, yet there is no universally accepted definition for a “rare” cancer. Moreover, with the evolution of genomics and associated changes in categorizing tumors, some common cancers are now characterized into groups of rare cancers, each with a unique implication for patient management and therapy.

Adaptive designs, which allow for prospectively planned modifications to study design based on accumulating data from subjects in the trial, can be used to optimize rare oncology trials (see Figure 1). Adaptive design studies may include multiple cohorts and multiple tumor types. In addition, numerous adaptation methods may be used in a single trial and may facilitate a more rapid, seamless transition between study phases.

Matt Gline (L) and Pete Salzmann

UP­DAT­ED: Roivant bumps stake in Im­muno­vant with a $200M deal. But with M&A off the ta­ble, shares crater

Roivant has worked out a deal to pick up a chunk of stock in its majority-owned sub Immunovant $IMVT, but the stock buy falls far short of its much-discussed thoughts about buying out all of the 43% of shares it doesn’t already own.

Roivant, which recently inked a SPAC move to the market at a $7 billion-plus valuation, has forged a deal to boost its ownership in Immunovant by 6.3 points, ending with 63.8% of the biotech’s stock following a $200 million injection. That cash will bolster Immunovant’s cash reserves, giving it a $600 million war chest to fund a slate of late-stage studies for its big drug: the anti-FcRn antibody IMVT-1401.

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Sanofi preps a multi­bil­lion-dol­lar buy­out of an mR­NA pi­o­neer af­ter falling be­hind in the race for a Covid-19 jab — re­port

It looks like Sanofi CEO Paul Hudson is dead serious about his intention to vault directly into contention for the future of mRNA vaccines.

A year after paying Translate Bio a whopping $425 million in an upfront and equity payment to help guide the pharma giant to the promised land of mRNA vaccines for Covid-19, Sanofi is reportedly ready to close the deal with a buyout.

Translate’s stock $TBIO soared 78% after the market closed Monday. A spokesperson for Sanofi declined to comment on the report, telling Endpoints News that the company doesn’t comment on market rumors.

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Anthony Sun, Zentalis and Zentera CEO (Zentalis)

With clin­i­cal tri­als lined up for Zen­tal­is drugs, Chi­na's Zen­tera sets its sights on more deal­mak­ing and an IPO

As Zentalis geared up for an AACR presentation of early data on its WEE1 inhibitor earlier this year, its Chinese joint venture Zentera wasn’t idle, either.

Zentera, which has headquarters in Shanghai, had already nabbed clearance to start clinical trials in China for three of the parent company’s drugs. In May — just a month after Zentalis touted three “exceptional responses” out of 55 patients for their shared lead drug, ZN-c3 — it got a fourth CTA approval.

Thomas Soloway, T-knife CEO

What hap­pens when you give a mouse a hu­man self-anti­gen? In­vestors bet $110M to find out

T-knife Therapeutics launched last August on a mission to isolate T cell receptors not from human donors, but from mice. Now, with a new CEO and a candidate bound for the clinic, the Versant-backed company is reloading with a fresh $110 million.

“What we are trying to do for the field of TCR therapy and solid tumor therapy is very analogous to what the murine platforms have done in antibody development,” CEO Thomas Soloway told Endpoints News. 

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UP­DAT­ED: Watch out Glax­o­SmithK­line: As­traZeneca's once-failed lu­pus drug is now ap­proved

Capping a roller coaster journey, AstraZeneca has steered its lupus drug anifrolumab across the finish line.

Saphnelo, as the antibody will be marketed, is the only treatment that’s been approved for systemic lupus erythematosus since GlaxoSmithKline’s Benlysta clinched an OK in 2011. The British drugmaker notes it’s also the first to target the type I interferon receptor.

Mirroring the population that the drug was tested on in late-stage trials, regulators sanctioned it for patients with moderate to severe cases who are already receiving standard therapy — setting up a launch planned for the end of August, according to Ruud Dobber, who’s in charge of AstraZeneca’s biopharmaceuticals business unit.

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Not all mR­NA vac­cines are cre­at­ed equal. Does it mat­ter?; Neu­ro is back; Pri­vate M&A af­fair; 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.

As part of our broader and deeper drive, Endpoints has been pairing webinars with our special reports to cover more angles on a given topic. In conjunction with Max Gelman’s neuroscience feature, Kyle Blankenship moderated an insightful panel to discuss where the field is headed. You can register to watch it on demand here.

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Bris­tol My­ers pulls lym­phoma in­di­ca­tion for Is­to­dax af­ter con­fir­ma­to­ry tri­al falls flat

Amid an industrywide review of cancer drugs with accelerated approval, Bristol Myers Squibb had to make the tough call last month to yank an approval for leading I/O drug Opdivo after flopping a confirmatory study. Now, a second Bristol Myers drug is on the chopping block.

Bristol Myers has pulled aging HDAC inhibitor Istodax’s indication in peripheral T cell lymphoma after a Phase III confirmatory study for the drug flopped on its progression-free survival endpoint, the drugmaker said Monday.

Rick Pazdur (via AACR)

FDA's on­col­o­gy head Rick Paz­dur de­fends the ac­cel­er­at­ed ap­proval path­way, claim­ing it is 'un­der at­tack'

The FDA is sounding the alarm over its accelerated approval pathway as backlash continues over the recent nod in favor of Biogen’s Alzheimer’s drug Aduhelm, and an ODAC meeting on six such approvals that could potentially be pulled from the market — two of which already have.

“Do you think accelerated approval is under attack? I do,” Rick Pazdur, head of FDA’s Oncology Center of Excellence, said at a Friends of Cancer Research webinar on Thursday.

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