CEO Markus Warmuth (Monte Rosa)

Monte Rosa rakes in $96M Se­ries B as it pre­pares 'mol­e­c­u­lar glue' plat­form for IND-en­abling stud­ies

About four months af­ter com­plet­ing an ex­ten­sion to its Se­ries A, Monte Rosa Ther­a­peu­tics is putting its next foot for­ward with an­oth­er heap of cash.

The Boston-based biotech is back with $96 mil­lion in Se­ries B fi­nanc­ing with a goal to get its lead pro­gram ready for IND-en­abling stud­ies by the end of the year. Though Monte Rosa is keep­ing its spe­cif­ic tar­get a se­cret for now, the com­pa­ny has been re­search­ing how to uti­lize its pro­tein degra­da­tion tech­nol­o­gy in breast can­cer and non-small cell lung can­cer, among oth­er ar­eas.

“It’s a pro­tein that we’ve found to be es­sen­tial in me­di­at­ing the ac­tiv­i­ty of a tran­scrip­tion fac­tor, one that the field has tried to find med­i­cines for for quite a while,” CEO Markus War­muth told End­points News. “Be­cause of the breadth of can­cers that are de­pen­dent on that, it could be very broad.”

Wednes­day’s round was led by Ais­ling, with Ver­sant and New En­ter­prise As­so­ci­ates par­tic­i­pat­ing once again. New in­vestors in­clud­ed HBM, Cor­morant, GV, Amzak Health, Cas­din Cap­i­tal, Six­ty De­gree Cap­i­tal and Cam­bridge As­set Man­age­ment.

Monte Rosa’s plat­form re­volves around de­vel­op­ing “mol­e­c­u­lar glues” that can re­pro­gram ubiq­ui­tin lig­as­es cen­tral to pro­tein degra­da­tion. By tak­ing con­trol of this process, the biotech hopes to redi­rect the body’s nat­ur­al degra­da­tion ef­forts and elim­i­nate the pro­teins al­to­geth­er rather than mere­ly in­hib­it their func­tions.

His­tor­i­cal­ly, War­muth said, many drugs have at­tempt­ed to fol­low the in­hi­bi­tion method, but that re­quires tar­gets to have an ac­tive site. Monte Rosa’s mol­e­c­u­lar glues al­low the biotech to go af­ter tar­gets that don’t have such sites, es­pe­cial­ly when it comes to the no­to­ri­ous­ly dif­fi­cult area of tran­scrip­tion.

“Part of the ex­cite­ment around our plat­form is we can fi­nal­ly go very sys­tem­at­i­cal­ly af­ter tran­scrip­tion, with few ex­cep­tions,” War­muth said. “Try­ing to go af­ter the in­ter­ac­tion be­tween a tran­scrip­tion fac­tor and DNA has been in­her­ent­ly dif­fi­cult, and so this mol­e­c­u­lar glue-based plat­form that we have re­al­ly of­fers up that op­por­tu­ni­ty.”

War­muth com­pared Monte Rosa’s ap­proach with that of PRO­TACs, which he de­scribed as a scaf­fold, with one part bind­ing to the ubiq­ui­tin lig­ase and the oth­er to the tar­get of in­ter­est, con­nect­ed to a hy­dropho­bic link­er that unites those two paths. Though that makes the mol­e­cules rel­a­tive­ly big, this helps it in­duce changes with­in the lig­as­es that ul­ti­mate­ly dri­ve the dis­ease-fight­ing func­tion.

The best known ex­am­ple of a glue-based de­grad­er is lenalido­mide, the mul­ti­ple myelo­ma chemother­a­py drug made by Cel­gene, War­muth said. In this ap­proach, two tran­scrip­tion fac­tors are glued to­geth­er to the lig­ase and trans­formed in­to the “per­fect shape” to be de­stroyed in help­ing treat the can­cer.

Pro­tein degra­da­tion it­self isn’t all that new, but mon­ey has poured in­to the area re­cent­ly and es­pe­cial­ly this year. Back in March, the biotechs Kymera and Nurix com­bined to raise $220 mil­lion on back-to-back days, and both went pub­lic over the sum­mer. Cur­rent­ly, on­ly Arv­inas’ pro­tein de­graders, an an­dro­gen re­cep­tor-tar­get­ing drug for prostate can­cer and an es­tro­gen re­cep­tor-tar­get­ing drug for breast can­cer, have reached the clin­ic, get­ting in­to hu­man test­ing in 2019.

But what War­muth hopes sep­a­rates Monte Rosa from the pack is the spe­cif­ic fo­cus on their glue-based tech­nol­o­gy. De­spite keep­ing in­for­ma­tion about their lead pro­gram — as well as the rest of their pipeline — close to the chest, War­muth ex­pressed con­fi­dence in the plat­form and the team his com­pa­ny has as­sem­bled.

“The rea­son why we’re fo­cus­ing on it is re­al­ly this promise of now go­ing af­ter pre-clin­i­cal­ly val­i­dat­ed tar­gets, things we’ve al­ways want­ed to go af­ter but have es­caped be­cause there’s no drug­gable site,” War­muth said. “That’s re­al­ly what dis­tin­guish­es us from the field sci­en­tif­i­cal­ly.”

Big Phar­ma's Twit­ter ex­o­dus; Mer­ck wa­gers $1.35B on buy­out; $3.5M gene ther­a­py; and more

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Paul Perreault, CSL Behring CEO

CSL lands FDA ap­proval for he­mo­phil­ia B gene ther­a­py, sets $3.5M list price

The FDA has approved the world’s first gene therapy for hemophilia B, ushering into the market a treatment that’s historic in both what it promises to do and how much it will cost.

CSL will be marketing the drug, Hemgenix, at a list price of $3.5 million — which sets a new record for the most expensive single-use gene therapy in the US.

In a statement provided to Endpoints News, the Australian company noted that the current costs of treating people with moderate to severe hemophilia B can be significant over a lifetime. By some estimates, healthcare systems could spend more than $20 million per person.

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Image: Shutterstock

MIT re­searchers re­veal DNA "Paste" tech be­hind lat­est gene edit­ing start­up

MIT scientists have developed a tool that they say can insert large gene sequences where they want in the genome.

In a paper published Thursday in Nature Biotechnology, MIT fellows Omar Abudayyeh, Jonathan Gootenberg and colleagues detail a technology they call PASTE, which they say can potentially be used to insert long strands of DNA and treat genetic diseases caused by many different mutations, such as cystic fibrosis and Leber congenital amaurosis, a rare eye disorder that causes blindness.

Elon Musk (GDA via AP Images)

Biggest drug com­pa­nies halt­ed Twit­ter ad buys af­ter Lil­ly in­sulin spoof

Almost all of the drug industry’s biggest advertisers cut their spending on Twitter to zero or near-zero over the last two weeks amid worries about impersonation of their brands by pranksters and the future of the social media company.

Among 18 of the biggest pharmaceutical advertisers in the US market, 12 cut their Twitter ad spending to nothing for the week beginning Nov. 14, according to Pathmatics, which tracks data on prescription drug ad spending as well as general corporate advertising. The list of drugmakers cutting spending to zero includes Merck, AstraZeneca, Eli Lilly, Novartis, Pfizer and others.

J&J's Spra­va­to pulls a PhI­II win against Sero­quel XR in treat­ment-re­sis­tant de­pres­sion

A day before Thanksgiving, J&J’s Janssen has a new cut of Phase III Spravato data to be grateful for.

The pharma giant announced on Wednesday that its nasal spray, also known as esketamine, beat extended-release quetiapine, previously sold by AstraZeneca as Seroquel XR, in treatment-resistant depression (TRD). Of 676 adults, a significantly higher number of patients on Spravato were able to achieve remission and avoid relapse after 32 weeks, according to J&J.

Rob Davis, Merck CEO

Up­dat­ed: No Seagen here: 'Do more' means a small $1.35B pur­chase of Ima­go for Mer­ck

Merck is making an acquisition, the Big Pharma announced before Monday’s opening bell. No, Seagen is not entering the fold, as had been speculated for quarters.

Folding under Merck’s wings will be Pfizer-backed Imago BioSciences. For nearly a year, Merck CEO Rob Davis has been saying the pharma giant needs to “do more” on the business development front after its 2021 $11.5 billion acquisition of Acceleron.

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Andrew Phillips, Nexo Therapeutics CEO

Scoop: Ver­sant, NEA launch new biotech helmed by ex-CEO of pro­tein de­grad­er C4 Ther­a­peu­tics

Long-time biotech venture firms Versant and New Enterprise Associates are backing a new startup run by former C4 Therapeutics chief executive Andrew Phillips.

The fledgling biotech has raised at least $30 million so far, according to paperwork filed with the SEC this week. The round could balloon to $60 million.

Phillips, who left protein degradation startup C4 in 2020 to be a managing director at Cormorant Asset Management, is running the show of the new venture as president, the SEC filing outlines. He also served as interim CEO of Cormorant-backed and Hansoh Pharmaceutical-partnered Blossom Bioscience last year.

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Isao Teshirogi, Shionogi president and CEO (Kyodo via AP Images)

Sh­ionogi's Covid an­tivi­ral lands first ap­proval in Japan's new emer­gency ap­proval path­way

Japanese regulators on Tuesday signed off on Shionogi’s homegrown antiviral for Covid-19, known as Xocova (ensitrelvir), making it the first approval under Japan’s emergency regulatory approval system.

The emergency approval, following a back-and-forth with regulators since last February, is based on a safety profile with more than 2,000 patients who have accessed the pill, and clinical symptomatic efficacy for five typical Omicron-related symptoms (primary endpoint) and antiviral efficacy (key secondary endpoint) in patients with mild to moderate SARS-CoV-2 infection, regardless of risk factors or vaccination status, and during the Omicron-dominant phase of the pandemic.

Dermavant Sciences' first consumer TV ad for its Vtama psoriasis med shows people ready for a new topical treatment.

Roivant’s Der­ma­vant de­buts first-ever TV com­mer­cial for pso­ri­a­sis cream Vta­ma

Dermavant Sciences has been marketing its first product, psoriasis med Vtama, to dermatologists for months, but on Tuesday it rolled out its first consumer campaign. The debut DTC effort including a streaming TV commercial encourages patients to a “Topical Uprising” in a nod to Vtama being a topical cream.

In the new commercial, a swell of people discards scarves and jacket coverings, gathering in the street to converge on a pharmacy to demand a steroid-free prescription. A moment of levity follows when a pharmacist says, “You know you can just talk to your doctor, right?” The gathered crowds collectively says, “Oh.”

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