Markus Warmuth (Monte Rosa)

Monte Rosa pulls in $95M to test its 'mol­e­c­u­lar glues,' and the first tar­get is GSPT1

Pro­tein degra­da­tion has been a fundrais­ing hotbed in re­cent years, with in­vestors drool­ing over the po­ten­tial to drug the “un­drug­gable.” Al­ready an in­vestor dar­ling, Monte Rosa Ther­a­peu­tics and its “mol­e­c­u­lar glues” are go­ing back to the well with the clin­ic on the hori­zon — and the biotech’s fi­nal­ly re­veal­ing its first tar­get.

Monte Rosa hauled in a $95 mil­lion Se­ries C to pave the way for its lead pro­tein de­grad­er pro­gram to make a run to the clin­ic and flesh out its pipeline, the biotech said Fri­day. The round was led by Avoro Cap­i­tal Ad­vi­sors.

Un­like oth­er small mol­e­cule de­graders such as PRO­TAC that func­tion much like in­hibitors, Monte Rosa’s de­graders help bind E3 lig­as­es — an en­zyme laden with ubiq­ui­tin, a key reg­u­la­to­ry pro­tein in the degra­da­tion process — with tar­get­ed dis­ease-caus­ing pro­teins. The re­sult­ing “glue” avoids the need for avail­able bind­ing sites, which are im­pos­si­ble to hit on the so-called “un­drug­gable” pro­teins.

Monte Rosa’s lead pro­gram, which the biotech hopes to take in­to IND en­abling stud­ies by the mid­dle of the year, will tar­get GSPT1, a reg­u­la­to­ry pro­tein im­pli­cat­ed in the syn­thet­ic lethal­i­ty of sol­id tu­mor cells, CEO Markus War­muth told End­points News. It’s the first time the com­pa­ny is show­ing its hand in terms of an ini­tial tar­get af­ter stay­ing mum through two pri­or fund­ing rounds.

The biotech plans to use the pro­ceeds to scale its drug dis­cov­ery plat­form for nov­el tar­gets as well as build its trans-At­lantic team in Boston and Basel, Switzer­land, War­muth said. Since the biotech last closed its $96 mil­lion Se­ries B in Sep­tem­ber, Monte Rosa has worked out the kinks in its dis­cov­ery plat­form and is ready to keep build­ing.

“The big break­throughs over the last six months have re­al­ly been on plat­form,” he said. “We now have good val­i­da­tion that our com­pu­ta­tion­al ap­proach … has worked out, and we’re look­ing to re­al­ly scale the plat­form ag­gres­sive­ly now.”

Pro­tein degra­da­tion has turned in­to a hotbed of in­vest­ment in re­cent years, but “mol­e­c­u­lar glues” them­selves aren’t brand new. Lep­rosy ther­a­py thalido­mide, first ap­proved way back in 1998, func­tions the same way but found its mech­a­nism of ac­tion large­ly by ac­ci­dent. Mean­while, oth­er pro­tein de­graders such as PRO­TAC look to ac­com­plish the same thing by act­ing as a func­tion­al link­er be­tween the pro­tein re­cep­tor and ubiq­ui­tin en­zyme.

That struc­ture makes PRO­TAC larg­er than mol­e­c­u­lar glues, which can lim­it its drug-like prop­er­ties and low­er its op­ti­miza­tion for spe­cif­ic tar­gets, War­muth said.

With its dis­cov­ery plat­form grow­ing, War­muth re­mained mum on where his team was look­ing for its next tar­gets, but did point specif­i­cal­ly to tran­scrip­tion fac­tor pro­teins that bind to DNA to turn cer­tain genes “on” or “off.” Those pro­teins are an ob­vi­ous tar­get due to the vast ma­jor­i­ty of them be­ing und­drug­gable.

“In our pool of tar­gets we have dis­cov­ered, there’s a clear en­rich­ment for tran­scrip­tion fac­tors,” War­muth said. “We’re not lim­it­ed to tran­scrip­tion fac­tors, but that’s a fam­i­ly that is par­tic­u­lar­ly at­trac­tive.”

Monte Rosa will have a hard time dif­fer­en­ti­at­ing it­self in a mol­e­c­u­lar glue field packed with com­peti­tors. In De­cem­ber, Neo­morph, a Dana-Far­ber-backed play at the field, snared a $105 mil­lion Se­ries A. Ear­li­er in the month, Ab­b­Vie placed a $55 mil­lion up­front bet on Fron­tier Med­i­cines to de­vel­op drug can­di­dates tar­get­ing E3 lig­as­es. Fron­tier will al­so be scout­ing small mol­e­cule binders to tar­get, Ab­b­Vie said.

Oth­er drug­mak­ers, in­clud­ing Sanofi, Roche, Bay­er, Gilead and Ver­tex, have all inked their own pro­tein degra­da­tion pacts in the re­cent past.

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

UP­DAT­ED: Gink­go Bioworks re­sizes the de­f­i­n­i­tion of go­ing big in biotech, rais­ing $2.5B in a record SPAC deal that weighs in with a whop­ping $15B-plus val­u­a­tion

Ginkgo Bioworks execs always thought big. But today should redefine just how big an upstart biotech player can dream.

In the largest SPAC deal to clear the hurdles to Nasdaq, the biotech that envisioned everything from remaking synthetic meat to a whole new approach to developing drugs has joined forces with one of the biggest disruptors in biotech to slam the Richter scale on dealmaking.

Soon after becoming the darling of the VC crew and clearing the bar on a $4 billion valuation, Ginkgo — a synthetic biotech player out to reprogram cells with industrial efficiency — has now struck a deal to go public in the latest leviathan SPAC that sets its pre-money valuation at $15 billion. In one swift vault, Ginkgo will combine with Harry Sloan’s Soaring Eagle Acquisition Corp. and leap into the public markets.

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FDA un­veils six ICH guide­lines ahead of meet­ing with Health Cana­da

A sign that the FDA’s non-Covid-related processes are beginning to normalize: The release of six guidelines from the International Council of Harmonisation.

Years in development, the ICH documents offer an international perspective on drug development, with these latest guidelines covering everything from recommendations to support the classification of drug substances, featured in the M9 guidance, to standards for nonclinical safety studies for pediatric medicines in the S11 guideline.

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Chris Garabedian (Xontogeny)

Per­cep­tive Ad­vi­sors, Xon­toge­ny bring the band back and then some with a $515M sec­ond fund sniff­ing out lead com­pounds

When Perceptive Advisors and startup accelerator Xontogeny initially teamed up on an early-stage VC round in 2019, the partners hoped to prove their investments could be a force multiplier for early-stage companies. Now, with that proof of concept behind them, the pair have closed a second VC round worth more than double the money.

Dubbed PXV Fund II and headed by Xontogeny CEO and former Sarepta head Chris Garabedian, the $515 million fund will target 10 to 12 early-stage preclinical companies with Series A rounds in the $20 million to $40 million range with opportunities for Series B follow-ups. The oversubscribed fund is bringing the band back with initial investors from PXVI as well as new investors that include “top-tier” asset managers, endowments, foundations, family offices, and individual investors.

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Stephen Squinto, Gennao Bio CEO (Gennao)

Alex­ion co-founder Stephen Squin­to is back in the game as CEO, this time for a small gene ther­a­py play­er

With his name already behind a rare disease success story in Alexion, Stephen Squinto was looking for a great story to drive him to jump back into the biotech game. He found that in a fledging non-viral gene therapy company, and now he’s got a few backers on board as well.

On Tuesday, Gennao Bio launched with a $40 million Series A co-led by OrbiMed and Logos Capital with participation by Surveyor Capital. The biotech, which is looking to use its cell-penetrating antibody platform to deliver nucleic acid “payloads” during into the nucleus, had to rush for its initial series — and had a name change along the way.

Sanofi, Glax­o­SmithK­line, Boehringer ac­cused of play­ing games, de­stroy­ing emails re­lat­ed to law­suit over con­t­a­m­i­nat­ed Zan­tac

A recent court filing raises new questions about how major pharma companies like Sanofi, GlaxoSmithKline, and Boehringer Ingelheim have dealt with a lawsuit related to recalls of certain over-the-counter heartburn drugs due to the presence of a potentially cancer-causing substance found in them.

More than 70,000 people who took Sanofi’s Zantac and other heartburn drugs containing ranitidine, which have been recalled over the past two years, have sued the manufacturers, including generic drugmakers, and other retailers and distributors as part of a consolidated suit before US District Court Judge Robin Rosenberg in Florida.

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Dan Vahdat, Huma CEO (Yang Guanyu/Xinhua/Alamy Live News)

With back­ing from Bay­er, a Lon­don firm will pitch its 'hos­pi­tals at home' con­cept for de­cen­tral­ized tri­als

Money is flying for companies promising to revolutionize the way clinical trials are conducted. Leaps by Bayer is the latest to get behind one of these players, leading a $200 million venture round for Huma Therapeutics and its digital “hospital at home” tech.

London-based Huma unveiled a $130 million Series C on Wednesday, which it will use to expand its digital platform in the US, Asia and the Middle East. As part of the round, the company can exercise another $70 million commitment later on.

David Halbert, Caris Life Sciences CEO (Caris via Twitter)

The grow­ing liq­uid biop­sy field sees a uni­corn en­trant as Caris pulls in $830M megaround

Caris Life Sciences has pulled in another massive raise, and this time they’re reportedly one step closer to launching their IPO.

The AI-focused Caris pulled in an $830 million growth equity round, the company announced Tuesday afternoon, earning a valuation of about $7.83 billion. Tuesday’s raise also brings their total financing amount to $1.3 billion since 2018 and $1.14 billion since last October. According to the Wall Street Journal, which first reported on the raise, Caris expects to complete their IPO sometime within the next 12 months.

A clos­er look at the FDA’s more than 700 pan­dem­ic-re­lat­ed record re­quests to re­place on­site in­spec­tions

As the pandemic constrained the FDA’s ability to travel for onsite manufacturing inspections, the agency increasingly turned to requesting records to fill the gap, even for hundreds of US-based facilities.

FDA explains in its guidance on manufacturing inspections during the pandemic that the agency can request records (not to be confused with the FDA’s remote interactive evaluations) directly from facilities “in advance of or in lieu of” certain onsite inspections. Companies are legally required to fulfill those requests because a denial may be considered limiting an inspection, which could lead to the FDA deeming a drug made at that site to be adulterated.

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