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.”

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Mathai Mammen (Rob Tannenbaum, Endpoints News at BIO 2018)

Math­ai Mam­men makes an abrupt ex­it as head of the big R&D group at J&J

In an after-the-bell shocker, J&J announced Monday evening that Mathai Mammen has abruptly exited J&J as head of its top-10 R&D group.

Recruited from Merck five years ago, where the soft-spoken Mammen was being groomed as the successor to Roger Perlmutter, he had been one of the top-paid R&D chiefs in biopharma. His group spent $12 billion last year on drug development, putting it in the top 5 in the industry.

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John Quisel, Disc Medicine CEO

Disc Med­i­cine goes pub­lic in re­verse merg­er with strug­gling Gem­i­ni Ther­a­peu­tics

After licensing a failed Roche schizophrenia drug last year, Disc Medicine is going public via a reverse merger with Gemini Therapeutics.

The combined company, while still named Disc Medicine, will trade under the stock symbol $IRON, in reference to Disc’s lineup of therapies for blood iron disorders. Alongside the merger, Disc has secured $53.5 million in another financing round, building on the $90 million Series B it raised in September.

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Amid mas­sive re­struc­tur­ing, Bio­gen looks to re­duce phys­i­cal pres­ence in Boston

Biogen is putting a sizable chunk of office and research space in Kendall Square and Weston, MA up for sublease, marking another big change as the biotech grapples with the aftershock of a disastrous and controversial rollout for its Alzheimer’s drug.

The company calls it “part of Biogen’s overall implementation of the ‘Future of Work,’ which is allowing us to optimize our footprint and reduce the amount of space we occupy, taking into consideration new elements such as the hybrid work model,” the Boston Globe reported, quoting a spokesperson.

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Robert Califf, FDA commissioner (Tom Williams/CQ Roll Call via AP Images)

Hop­ing to ex­pand mon­key­pox vac­cine sup­ply, US paves the way for new route of ad­min­is­tra­tion

After making it clear that the US’ current monkeypox vaccine supply is insufficient, the FDA on Tuesday authorized a new route of administration that should increase the number of available doses by five-fold.

Regulators cleared Bavarian Nordic’s Jynneos vaccine for intradermal injection in adults older than 18. Unlike subcutaneous injection — the current method by which vaccine is delivered under the skin — an intradermal jab goes directly into the skin. It’s believed that this method requires less vaccine, since the dermis is rich in dendritic cells which specialize in taking up foreign antigens and presenting them to the immune system, according to Daniel Kuritzkes, chief of infectious diseases at Brigham and Women’s Hospital in Boston.

Illustration: Kim Ryu for Endpoints News

Why non-opi­oid pain drugs keep fail­ing — and what's next for the field

In 1938, Rita Levi-Montalcini was forced to move her lab into her bedroom in Turin, as Mussolini’s facist government expelled Jewish people from studying or working in schools in Italy. Levi-Montalcini, then just a few years out of medical school and using sewing needles as scalpels in her makeshift lab, would soon discover nerve growth factor, or NGF, in chicken embryos.

Her discoveries formed the basis of our understanding of the peripheral nervous system and how cells talk to each other, and Levi-Montalcini went on to win the Nobel Prize in 1986. Much later, NGF was hailed as a promising target for new pain therapies, with some analysts quoting an $11 billion market. However, the latest anti-NGF candidate, Pfizer and Eli Lilly’s tanezumab, was rejected by the FDA last year because of a side effect that dissolved bone in some of its patients.

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Samantha Du, Zai Lab CEO

Any­one still look­ing for a CD47? Zai Lab shelves PhI pro­gram af­ter re­view­ing 'com­pet­i­tive land­scape'

Over the past few years, the promise of blocking CD47 — a “don’t eat me” signal co-opted by cancer cells — has sent drugmakers big and small into a frenzy. But one biotech is now bowing out.

Zai Lab is deprioritizing ZL-1201, its CD47 inhibitor, scrapping plans for a Phase II trial. It will now “pursue out-licensing opportunities,” the company said in its Q2 update. The decision was based on a review of the competitive landscape, it added, without going into further details.

Steve Paul, Karuna Therapeutics CEO (Third Rock)

Karuna's schiz­o­phre­nia drug pass­es a close­ly-watched PhI­II test, will head to FDA in mid-2023

An investigational pill that combines a former Eli Lilly CNS compound with an overactive bladder drug was better than placebo at reducing a scale of symptoms experienced by patients with schizophrenia in a Phase III trial.

Karuna Therapeutics’ drug passed the primary goal in EMERGENT-2, the Boston biotech said early Monday morning, alongside quarterly earnings. The study is the first of Karuna’s four Phase III clinical trials to read out in schizophrenia and will provide the backbone to the biotech’s first drug approval application, slated for mid-2023.

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HHS Secretary Xavier Becerra (Patrick Semansky/AP Images)

US weighs new route of ad­min­is­tra­tion for mon­key­pox vac­cine as cas­es climb — re­port

Less than a week after HHS Secretary Xavier Becerra declared monkeypox a national health emergency, reports have emerged that the US plans to extend its vaccine supply by opting for a different route of administration.

Officials are expected to call for intradermal injection of Bavarian Nordic’s Jynneos vaccine — the only shot approved specifically for monkeypox in the US — as opposed to subcutaneous injection, unnamed sources told both the New York Times and Washington Post on Tuesday.