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.”

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Volker Wagner (L) and Jeff Legos

As Bay­er, No­var­tis stack up their ra­dio­phar­ma­ceu­ti­cal da­ta at #ES­MO21, a key de­bate takes shape

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

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Rafaèle Tordjman (Jeito Capital)

Con­ti­nu­ity and di­ver­si­ty: Rafaèle Tord­j­man's women-led VC firm tops out first fund at $630M

For a first-time fund, Jeito Capital talks a lot about continuity.

Rafaèle Tordjman had spotlighted that concept ever since she started building the firm in 2018, promising to go the extra mile(s) with biotech entrepreneurs while pushing them to reach patients faster.

Coincidentally, the lack of continuity was one of the sore spots listed in a report about the European healthcare sector published that same year by the European Investment Bank — whose fund is one of the LPs, alongside the American pension fund Teacher Retirement System of Texas and Singapore’s Temasek, to help Jeito close its first fund at $630 million (€534 million). As previously reported, Sanofi had chimed in €50 million, marking its first investment in a French life sciences fund.

Mi­rati tri­umphs again in KRAS-mu­tat­ed lung can­cer with a close­ly watched FDA fil­ing now in the cards

After a busy weekend at #ESMO21, which included a big readout for its KRAS drug adagrasib in colon cancer, Mirati Therapeutics is ready to keep the pressure on competitor Amgen with lung cancer data that will undergird an upcoming filing.

In topline results from a Phase II cohort of its KRYSTAL-1 study, adagrasib posted a response rate of 43% in second-line-or-later patients with metastatic non-small cell lung cancer containing a KRAS-G12C mutation, Mirati said Monday.

Ex­elix­is pulls a sur­prise win in thy­roid can­cer just days ahead of fi­nal Cabome­tyx read­out

Exelixis added a thyroid cancer indication to its super-seller Cabometyx’s label on Friday — months before the FDA was expected to make a decision, and days before the company was set to unveil the final data at #ESMO21.

At a median follow-up of 10.1 months, differentiated thyroid cancer patients treated with Cabometyx (cabozantinib) lived a median of 11 months without their disease worsening, compared to just 1.9 months for patients given a placebo, Exelixis said on Monday.

Dave Lennon, former president of Novartis Gene Therapies

Zol­gens­ma patent spat brews be­tween No­var­tis and Re­genxbio as top No­var­tis gene ther­a­py ex­ec de­parts

Regenxbio, a small licensor of gene therapy viral vectors spun out from the University of Pennsylvania, is now finding itself in the middle of some major league patent fights.

In addition to a patent suit with Sarepta Therapeutics from last September, Novartis, is now trying to push its smaller partner out of the way. The Swiss biopharma licensed Regenxbio’s AAV9 vector for its $2.1 million spinal muscular atrophy therapy Zolgensma.

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As­traZeneca, Dai­ichi Sanky­o's ADC En­her­tu blows away Roche's Kad­cy­la in sec­ond-line ad­vanced breast can­cer

AstraZeneca and Japanese drugmaker Daiichi Sankyo think they’ve struck gold with their next-gen ADC drug Enhertu, which has shown some striking data in late-stage breast cancer trials and early solid tumor tests. Getting into earlier patients is now the goal, starting with Enhertu’s complete walkover of a Roche drug in second-line breast cancer revealed Saturday.

Enhertu cut the risk of disease progression or death by a whopping 72% (p=<0.0001) compared with Roche’s ADC Kadcyla in second-line unresectable and/or metastatic HER2-positive breast cancer patients who had previously undergone treatment with a Herceptin-chemo combo, according to interim data from the Phase III DESTINY-Breast03 head-to-head study presented at this weekend’s #ESMO21.

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