Jonathan Montagu (L) and Gerry Harriman, HotSpot co-founders

HotSpot gets hot­ter with $100M raise to push to­ward clin­ic

HotSpot Ther­a­peu­tics, the al­lostery-fo­cused biotech that works on what it calls “nat­ur­al hotspots” — hence the name — is get­ting a bit hot­ter in its val­u­a­tion from in­vestors. And to that end they’ve raised $100 mil­lion.

The four-year-old AI com­pu­ta­tion­al biotech start­ed by two for­mer Nim­bus ex­ecs an­nounced this morn­ing that it closed its Se­ries C round right at the line of a 9-fig­ure in­vest­ment, cour­tesy of some big in­vestors.

Piv­otal bioVen­ture Part­ners took the lead on the round — with “sig­nif­i­cant par­tic­i­pa­tion” by LSP and B Cap­i­tal Group. A slew of new in­vestors hopped on the band­wag­on, such as Monashee In­vest­ment Man­age­ment and Rev­e­la­tion Part­ners, along with some old in­vestors like At­las Ven­ture, SR One Cap­i­tal Man­age­ment and Sofinno­va Part­ners.

This new round more than dou­bles what HotSpot has pre­vi­ous­ly raised, bring­ing it to a to­tal of $190 mil­lion. The last time HotSpot raised funds was in May 2020, when the biotech an­nounced a $65 mil­lion Se­ries B.

The biotech fol­lows in Nim­bus’ foot­steps of de­vel­op­ing ther­a­pies for so-called al­losteric tar­gets us­ing a com­pu­ta­tion­al plat­form — look­ing at pro­tein pock­ets be­yond ac­tive sites to find ways to drug pro­teins that were pre­vi­ous­ly deemed un­drug­gable or hard to drug.

And as with many rounds, there’s al­so board ap­point­ments. Ash Khan­na, a ven­ture part­ner with Piv­otal bioVen­ture Part­ners, and Fouad Az­zam of LSP will join HotSpot’s board of di­rec­tors.

For HotSpot’s co-founders, CEO Jonathan Mon­tagu and CSO Ger­ry Har­ri­man, this al­lows HotSpot to piv­ot more in­to clin­i­cal de­vel­op­ment.

And with the Se­ries C, an IPO is usu­al­ly not far be­hind. As Mon­tagu put it, this raise puts HotSpot “in the dri­ver’s seat,” he told End­points News — and while it’s too ear­ly to con­sid­er a move in­to the pub­lic eq­ui­ty mar­ket, he says it al­lows HotSpot the flex­i­bil­i­ty as to when it goes pub­lic.

With the cash run­way un­til 2024, the new round al­lows the biotech to move pro­grams in­to the IND-en­abling phase, Mon­tagu said. Their plan is to file an IND on their lead pro­gram some­time next year — a CBL-B tar­get fo­cus­ing on the E3 lig­ase — af­ter HotSpot nom­i­nates a de­vel­op­ment can­di­date for that tar­get. Even­tu­al­ly, HotSpot’s goal is to start dos­ing pa­tients in a clin­i­cal set­ting by the end of 2022.

The com­pa­ny hopes the IND will be the first of many. Out­side of the com­pa­ny’s 3 pub­licly-known tar­gets, there’s a few more that re­main undis­closed that, in Mon­tagu’s mind, gives HotSpot lever­age in ef­fi­cient R&D.

“We’re go­ing to scale the com­pa­ny so that we can have a steady state of 2-3 lead op­ti­miza­tion pro­grams at any one time, which will trans­late in­to a steady ca­dence of mol­e­cules en­ter­ing the clin­ic,” Mon­tagu said in an in­ter­view.

Out­side of the pipeline, the com­pa­ny is al­so look­ing to in­crease the num­ber of em­ploy­ees — which is cur­rent­ly split be­tween Boston and New Jer­sey. HotSpot is cur­rent­ly ex­pand­ing its team over­seas in Berlin, Ger­many, Mon­tagu con­firmed.

“What we would like to do is to re­al­ly build out a num­ber of ar­eas in our re­search or­ga­ni­za­tion that can not on­ly sup­port a grow­ing pipeline, but al­so make deep in­vest­ments in­to our plat­form. So we will see growth in ar­eas such as bi­ol­o­gy, chem­istry, and then our AI ef­forts in our plat­form,” Har­ri­man told End­points in an in­ter­view.

Har­ri­man al­so said they would hire out­side com­pa­nies for man­u­fac­tur­ing when it reach­es that point.

Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

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Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

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Albert Bourla (Photo by Steven Ferdman/Getty Images)

UP­DAT­ED: Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

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Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.

Alexander Lefterov/Endpoints News

A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

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Not cheap­er by the dozen: Bris­tol My­ers be­comes the 12th phar­ma com­pa­ny to re­strict 340B sales

Bristol Myers Squibb recently joined 11 of its peer pharma companies in limiting how many contract pharmacies can access certain drugs discounted by a federal program known as 340B.

Bristol Myers is just the latest in a series of high-profile pharma companies moving in their own direction as the Biden administration’s Health Resources and Services Administration struggles to rein in the drug discount program for the neediest Americans.

Joaquin Duato, J&J CEO (Photo by Charles Sykes/Invision/AP)

New J&J CEO Joaquin Du­a­to promis­es an ag­gres­sive M&A hunt in quest to grow phar­ma sales

Joaquin Duato stepped away from the sideline and directly into the spotlight on Tuesday, delivering his first quarterly review for J&J as its newly-tapped CEO after an 11-year run in senior posts. And he had some mixed financial news to deliver today while laying claim to a string of blockbuster drugs in the making and outlining an appetite for small and medium-sized M&A deals.

Duato also didn’t exactly shun large buyouts when asked about the future of the company’s medtech business — where they look to be in either the top or number 2 position in every segment they’re in — even though the bar for getting those deals done is so much higher.

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Brian Thomas, Metagenomi CEO

Gen 2: Berke­ley spin­out lands $175M megaround to keep it on the cut­ting edge of the boom­ing gene-edit­ing field

The big bucks keep pumping into the gene-editing field.

This morning Metagenomi, allied with one of the biggest names in the mRNA field with a company DNA that includes the ubiquitous Jennifer Doudna, is showing off a $175 million B round that will pay for a rapid swelling of its staff in pursuit of some of the cutting-edge tech that keeps this field in the spotlight. And they’re aligning themselves with some major industry players with an eye on the clinic while getting behind some startups to help expand the work into new fields.

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Amgen's Twitter campaign #DearAsthma inspired thousands of people to express struggles and frustrations with the disease

Am­gen’s #Dear­Asth­ma spon­sored tweet lands big on game day, spark­ing thou­sands to re­spond

Amgen wanted to know how people with asthma really felt about daily life with the disease. So it bought a promoted tweet on Twitter noting the not-so-simple realities of life with asthma and ended the post with a #DearAsthma hashtag, a megaphone emoji and a re-tweet button.

That was just over one week ago and the responses haven’t stopped. More than 7,000 posts so far on Twitter replied to #DearAsthma to detail struggles of daily life, expressing humor, frustration and sometimes anger. More than a few f-bombs have been typed or gif-ed in reply to communicate just how much many people “hate” the disease.