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.

Pi­o­neer­ing Click Chem­istry in Hu­mans

Reimagining cancer treatments

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, which is nearly one in six deaths. Recently, we have seen incredible advances in novel cancer therapies such as immune checkpoint inhibitors, cell therapies, and antibody-drug conjugates that have revamped cancer care and improved survival rates for patients.

Despite this significant progress in therapeutic targeting, why are we still seeing such a high mortality rate? The reason is that promising therapies are often limited by their therapeutic index, which is a measure of the effective dose of a drug, relative to its safety. If we could broaden the therapeutic indices of currently available medicines, it would revolutionize cancer treatments. We are still on the quest to find the ultimate cancer medicine – highly effective in several cancer types, safe, and precisely targeted to the tumor site.

Joshua Cohen (L) and Justin Klee, Amylyx co-CEOs

BREAK­ING: Af­ter long and wind­ing road, FDA ap­proves Amy­lyx's ALS drug in vic­to­ry for pa­tients and ad­vo­ca­cy groups

For just the third time in its 116-year history, the FDA has approved a new treatment for Lou Gehrig’s disease, or ALS.

US regulators gave the thumbs-up to the drug, known as Relyvrio, in a massive win for patients and their families. The approval, given to Boston-area biotech Amylyx Pharmaceuticals, comes after two years of long and contentious debates over the drug’s effectiveness between advocacy groups and FDA scientists, following the readout of a mid-stage clinical trial in September 2020.

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Ivan Cheung, Eisai US chairman and CEO

Bio­gen, Ei­sai re­fresh amy­loid hy­poth­e­sis with PhI­II show­ing Alzheimer's med slows cog­ni­tive de­cline

In the first look at Phase III data for lecanemab, Eisai and Biogen’s follow-up Alzheimer’s drug to the embattled Aduhelm launch, results show the drug passed with flying colors on a test looking at memory, problem solving and other dementia metrics.

One of the most-watched Alzheimer’s therapies in the clinic, lecanemab met the study’s primary goal on the CDR-SB — Clinical Dementia Rating-Sum of Boxes — giving the biotech the confidence to ask for full approval in the US, EU and Japan by next March 31. The experimental drug reduced clinical decline on the scale by 27% compared to placebo at 18 months, the companies said Tuesday night Eastern time and Wednesday morning in Japan.

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Nooman Haque, head of life sciences and healthcare at Silicon Valley Bank, and John Carroll

I’m head­ed to Lon­don soon for #EU­BIO22. Care to join me?

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.

Some­one old, some­one new: Mod­er­na pro­motes CTO, raids No­var­tis for re­place­ment amid pipeline push

Moderna CEO Stéphane Bancel made clear on the last quarterly call that “now is not the time to slow down.” On Thursday, he made a bit more room in the cockpit.

The company unveiled a new executive role on Thursday, promoting former chief technical operations and quality officer Juan Andres to president of strategic partnerships and enterprise expansion, and poaching a former Novartis exec to take his place.

Gilead names 'k­ing­pin­s' in coun­ter­feit HIV med law­suit

Gilead is mounting its counterfeit drug lawsuit, naming two “kingpins” and a complex network of conspirators who allegedly sold imitation bottles of its HIV meds, some of which ended up in US pharmacies.

The pharma giant on Wednesday provided an update on what it called a “large-scale, sophisticated counterfeiting conspiracy,” accusing two new defendants of “leading and orchestrating” a scheme to sell hundreds of millions of dollars in illegitimate drugs posing as meds such as Biktarvy and Descovy.

Vlad Coric, Biohaven CEO (Photo Credit: Andrew Venditti)

As Amy­lyx de­ci­sion waits in the wings, Bio­haven’s ALS drug sinks (again) in plat­form tri­al

The FDA’s decision on Amylyx’s ALS drug is set to come out sometime Thursday. In a space with few drugs, any approval would be a major landmark.

But elsewhere in the ALS field, things are a bit more tepid.

Thursday morning, Biohaven announced that its drug verdiperstat failed its arm of an ALS platform trial led by Massachusetts General Hospital. According to a press release, the drug did not meet its primary endpoint — improvement on an ALS functional status test — or any key secondary endpoints at 24 weeks. The trial had enrolled 167 patients, giving them either verdiperstat or placebo twice a day.

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Tar­sus looks to raise aware­ness of eye­lid mite dis­ease in cam­paign aimed at eye­care spe­cial­ists

Eyelid mite disease may be “gross” but it’s also fairly common, affecting about 25 million people in the US.

Called demodex blepharitis, it’s a well-known condition among eyecare professionals, but they often don’t always realize how common it is. Tarsus Pharmaceuticals wants to change that with a new awareness campaign called “Look at the Lids.”

The campaign and website debut Thursday — just three weeks after Tarsus filed for FDA approval for a drug that treats the disease.

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Marcelo Bigal, Ventus Therapeutics CEO

No­vo Nordisk joins No­var­tis, Roche in NL­RP3 are­na, bet­ting $70M cash on NASH, car­diometa­bol­ic us­es

As a drug target, the NLRP3 inflammasome has drawn serious interest from Big Pharma, inspiring a series of M&A deals from Novartis and Roche on top of venture investments by others. Now Novo Nordisk is jumping on the bandwagon — and the Danish pharma giant is taking the target where it knows best.

Novo Nordisk is getting its NLRP3 inhibitors from Ventus Therapeutics, a Versant-backed startup that set out to make some of the best NLRP3 drugs out there by incorporating new insights into the structure of the target complex.

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