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.

Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

Members of the G7 from left to right: Prime Minister of Italy Mario Draghi, European Commission President Ursula von der Leyen, President Joe Biden, German Chancellor Olaf Scholz, British Prime Minister Boris Johnson, Canadian Prime Minister Justin Trudeau, Prime Minister of Japan Fumio Kishida, French President Emmanuel Macron and European Council President Charles Michel (AP Photo/Susan Walsh)

Biden and G7 na­tions of­fer funds for vac­cine and med­ical prod­uct man­u­fac­tur­ing project in Sene­gal

Amidst recently broader vaccine manufacturing initiatives from the EU and European companies, the G7 summit in the mountains of Bavaria has brought about some positive news for closing vaccine and medical product manufacturing gaps around the globe.

According to a statement from the White House, the G7 leaders have formally launched the partnership for global infrastructure, PGII. The effort will aim to mobilize hundreds of billions of dollars to deliver infrastructure projects in several sectors including the medical and pharmaceutical manufacturing space.

State bat­tles over mifepri­s­tone ac­cess could tie the FDA to any post-Roe cross­roads

As more than a dozen states are now readying so-called “trigger” laws to kick into effect immediate abortion bans following the overturning of Roe v. Wade on Friday, these laws, in the works for more than a decade in some states, will likely kick off even more legal battles as states seek to restrict the use of prescription drug-based abortions.

Since Friday’s SCOTUS opinion to overturn Americans’ constitutional right to an abortion after almost 50 years, reproductive rights lawyers at Planned Parenthood and other organizations have already challenged these trigger laws in Utah and Louisiana. According to the Guttmacher Institute, other states with trigger laws that could take effect include Arkansas, Idaho, Kentucky, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, and Wyoming.

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Deborah Dunsire, Lundbeck CEO

Af­ter a 5-year re­peat PhI­II so­journ, Lund­beck and Ot­su­ka say they're fi­nal­ly ready to pur­sue OK to use Rex­ul­ti against Alzheimer's ag­i­ta­tion

Five years after Lundbeck and their longtime collaborators at Otsuka turned up a mixed set of Phase III data for Rexulti as a treatment for Alzheimer’s dementia-related agitation, they’ve come through with a new pivotal trial success they believe will finally put them on the road to an approval at the FDA. And if they’re right, some analysts believe they’re a short step away from adding more than $500 million in annual sales for the drug, already approved in depression and schizophrenia.

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A Mer­ck part­ner is sucked in­to the fi­nan­cial quag­mire as key lender calls in a note

Another biotech standing on shaky financial legs has fallen victim to the bears.

Merck partner 4D Pharma has reported that a key lender, Oxford Finance, shoved the UK company into administration after calling in a $14 million loan they couldn’t immediately make good on. Trading in their stock was halted with a market cap that had fallen to a mere £30 million.

“Despite the very difficult prevailing market conditions,” 4D reported on Friday, the biotech had been making progress on finding some new financing and turned to Oxford with an alternative late on Thursday and then again Friday morning.

Fed­er­al judge de­nies Bris­tol My­er­s' at­tempt to avoid Cel­gene share­hold­er law­suit

Some Celgene shareholders aren’t happy with how Bristol Myers Squibb’s takeover went down.

On Friday, a New York federal judge ruled that they have a case against the pharma giant, denying a request to dismiss allegations that it purposely slow-rolled Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights (CVR).

When Bristol Myers put down $74 billion to scoop up Celgene back in 2019, liso-cel — the CAR-T lymphoma treatment now marketed as Breyanzi — was supposedly one of the centerpieces of the deal. After going back and forth on negotiations for about six months, BMS put $6.4 billion into a CVR agreement that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date.

Chris Anzalone, Arrowhead CEO

Take­da, Ar­row­head spot­light da­ta from small tri­al show­ing RNAi works in a rare liv­er con­di­tion

Almost two years after Takeda wagered $300 million cash to partner with Arrowhead on an RNAi therapy for a rare disease, the companies are spelling out Phase II data that they believe put them one step closer to their big dreams.

In a small, open label study involving only 16 patients who had liver disease associated with alpha-1 antitrypsin deficiency (AATD), Arrowhead’s candidate — fazirsiran, previously ARO-AAT — spurred substantial reductions in accumulated mutant AAT protein in the liver, a hallmark of the condition. Investigators also tracked improvements in symptoms, with seven out of 12 who received the high, 200 mg dose seeing regression of liver fibrosis.

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No stranger to gene ther­a­py woes, Astel­las runs in­to an­oth­er safe­ty-re­lat­ed clin­i­cal hold

Astellas Pharma, which has been at the forefront of uncovering the risks associated with gene therapies delivered by adeno-associated viruses, must take another safety alarm head-on.

The FDA has slapped a clinical hold on Astellas’ Phase I/II trial of a gene therapy candidate for late-onset Pompe disease, after investigators flagged a serious case of peripheral sensory neuropathy.

It marks the latest in a streak of setbacks Astellas has encountered since making a splashy entry into the gene therapy space with its $3 billion buyout of Audentes. But the lead program, AT132 for the treatment of X-linked myotubular myopathy (XLMTM), had to be halted more than once after a total of four patients died in the trial — and the scientific community still doesn’t have all the answers of what caused the deaths.

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