The next Nim­bus? Head of bil­lion-dol­lar drug pro­gram launch­es HotSpot with $45M A round

Re­mem­ber that bil­lion-dol­lar drug idea that got lit­tle Nim­bus on Gilead’s radar back in 2016? Well, the folks be­hind that drug are build­ing a whole plat­form on a sim­i­lar con­cept. And they’re not just tack­ling NASH, but a whole line­up of pre­vi­ous­ly un­drug­gable tar­gets.

The ven­ture, called HotSpot Ther­a­peu­tics, came out Tues­day with news that it’s be­ing backed by Nim­bus’ lead in­vestor — At­las Ven­ture — in a $45 mil­lion Se­ries A round co-led by Sofinno­va.

HotSpot was launched last year by Geral­dine Har­ri­man, the for­mer Nim­bus ex­ec­u­tive who led the com­pa­ny’s NASH pro­gram — the very one that earned the Boston biotech a $1.2 bil­lion part­ner­ship with Gilead. That drug, at the time called NDI-01097, used a way (rel­a­tive­ly new to phar­ma) to ma­nip­u­late pro­teins out­side the ac­tive site, go­ing in­stead af­ter some­thing called “reg­u­la­to­ry hotspots.” These, I’m told, are al­losteric sites that the body us­es to reg­u­late pro­tein func­tion. Har­ri­man says tar­get­ing these hotspots could be a boon for drug de­vel­op­ment, which is why she’s co-found­ed an en­tire­ly new ven­ture on the con­cept.

“The ac­tive sites of pro­teins tend to look a lot like each oth­er, so get­ting mol­e­cules that can be se­lec­tive is a hur­dle,” she said. “It takes a lot of ef­fort and some­times the prob­lem isn’t solved. Reg­u­la­to­ry hotspots, on oth­er hand, are how na­ture con­trols the pro­teins — turn­ing things on and off. And reg­u­la­to­ry hotspots are unique to the pro­tein.”

Bruce Booth

Short­ly af­ter the Gilead deal, Har­ri­man, to­geth­er with an­oth­er ex-Nim­bus ex­ec Jonathan Mon­tagu, formed HotSpot to har­ness what they know about reg­u­la­to­ry hotspots to build a whole slew of drug pro­grams. Mon­tagu is serv­ing as HotSpot’s CEO, while Har­ri­man is CSO.

With its plat­form, the com­pa­ny says it’s iden­ti­fied reg­u­la­to­ry hotspots in over 100 pro­teins span­ning sev­er­al path­ways and dis­eases. Mon­tagu says they’re hom­ing in on im­munol­o­gy, im­muno-on­col­o­gy, and NASH.

Mon­tagu says HotSpot has five pro­grams in the pipeline, al­though they’re mum on de­tails. We do know they’re tar­get­ing PKC-theta, which plays a role in au­toim­mune dis­eases, and S6 ki­nase, a meta­bol­ic en­zyme in­volved in reg­u­lat­ing he­pat­ic in­sulin sen­si­tiv­i­ty and mi­to­chon­dr­i­al func­tion.

Ce­ment­ing its ties to Nim­bus, HotSpot al­so sports the same chair­man: At­las Ven­ture part­ner Bruce Booth.

“HotSpot’s el­e­gant and sys­tem­at­ic ap­proach to al­lostery, fo­cused unique­ly on reg­u­la­to­ry hotspots, sets it apart from every­thing else we have seen in the field,” Booth said in a state­ment. “From the out­set, we knew that reg­u­la­to­ry hotspots were crit­i­cal to pro­tein func­tion and now we see vivid­ly that the known foot­print of the nat­ur­al pro­tein lig­and ac­cel­er­ates our chem­istry ef­forts. HotSpot is chang­ing the way al­losteric drug dis­cov­ery is con­duct­ed in a pro­found way and At­las is very ex­cit­ed about the launch of this com­pa­ny.”

Im­age: Jonathan Man­tagu and Geral­dine Har­ri­man. HOTSPOT

In a sec­ond big set­back for Covid-19 an­ti­body treat­ment hopes, Re­gen­eron halts en­roll­ment for more se­vere pa­tients

Regeneron has just delivered more bad news for the hope that neutralizing antibodies could be used to treat patients with more severe forms of Covid-19.

The New York biotech said today that an independent monitoring committee recommended halting enrollment of patients who need high-flow oxygen or mechanical ventilation in one of the trials on their antibody cocktail, after finding “a potential safety signal” and “an unfavorable risk/benefit profile.” The news comes a week after the NIH scrapped a trial of Eli Lilly’s Covid-19 antibody after finding it was having little effect on an initial cohort of hospitalized patients.

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George Golumbeski (L) and Faheem Hasnain

George Golumbes­ki and Fa­heem Has­nain team up with Ver­tex Ven­tures HC in man­ag­ing $320M of biotech cash

Two longtime biotech veterans are joining a multibillion dollar VC firm in order to help steer its latest fund.

George Golumbeski and Faheem Hasnain have signed on to Vertex Ventures HC as executive advisors, the company announced Thursday, and will assist with their depth of experience in managing $320 million of capital. Both have had previous working relationships with managing partners Carolyn Ng and Lori Hu, which evolved “organically” to get to this point, Ng said.

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Daphne Koller, Getty

Bris­tol My­er­s' Richard Har­g­reaves pays $70M to launch a neu­rode­gen­er­a­tion al­liance with a star play­er in the ma­chine learn­ing world

Bristol Myers Squibb is turning to one of the star upstarts in the machine learning world to go back to the drawing board and come up with the disease models needed to find drugs that can work against two of the toughest targets in the neuro world.

Daphne Koller’s well-funded insitro is getting $70 million in cash and near-term milestones to use their machine learning platform to create induced pluripotent stem cell-derived disease models for ALS and frontotemporal dementia.

Patrick Soon-Shiong at the JP Morgan Healthcare Conference, Jan. 13, 2020 (David Paul Morris/Bloomberg via Getty Images)

Af­ter falling be­hind the lead­ers, dissed by some ex­perts, biotech show­man Patrick Soon-Sh­iong fi­nal­ly gets his Covid-19 vac­cine ready for a tri­al. But can it live up to the hype?

In January, when dozens of scientists rushed to start making a vaccine for the then-novel coronavirus, they were joined by an unlikely compatriot: Patrick Soon-Shiong, the billionaire doctor most famous for making big, controversial promises on cancer research.

Soon-Shiong had spent the last 4 years on his “Cancer Moonshot,” but part of his project meant buying a small Seattle biotech that specialized in making common-cold vectors, called adenoviruses, to train the immune system. The billionaire had been using those vectors for oncology, but the company had also developed vaccine candidates for H1N1, Lassa fever and other viruses. When the outbreak began, he pivoted.

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Noubar Afeyan, Flagship founder and CEO (Victor Boyko/Getty Images)

UP­DAT­ED: Flag­ship launch­es Sen­da Bio­sciences with $88M in back­ing, look­ing to pi­o­neer the field of 'In­ter­sys­tems Bi­ol­o­gy'

Flagship Pioneering has a fresh company out this week, one that aims to lay the groundwork for a whole new discipline.

Senda Biosciences launched Wednesday with $88 million in Flagship cash. The goal? Gain insights into the molecular connections between people and coevolved nonhuman species like plants and bacteria, paving the way for “Intersystems Biology.”

Guillaume Pfefer has been tapped to run the show, a 25-year biotech veteran who comes from GSK after leading the development of the company’s shingles vaccine.

As­traZeneca sells off heart fail­ure and hy­per­ten­sion drugs to Chep­lapharm for $400M

Out with the old and in with the new: AstraZeneca is selling off two heart failure and hypertension drugs to Germany-based Cheplapharm, bagging $400 million and making way for development in other areas.

Cheplapharm paid $200 million for the European rights to Atacand (candesartan cilexetil) and Atacand Plus (candesartan cilexetil and hydrochlorothiazide) back in 2018. They’re now doubling that amount for commercial control in more than 70 countries.

News brief­ing: Ax­o­vant faces months of de­lay on lead Parkin­son's gene ther­a­py; Chi­nese CAR-T biotech nabs $100M

One of Axovant’s top gene therapy prospects for its second act is hitting a roadblock that could push its clinical timelines back by almost a year.

In an update, the biotech said it was informed about delays in CMC data and third-part fill-finish issues around mid-October by its manufacturing partner, Oxford Biomedica. Axovant has been developing a suspension-based process for the Parkinson’s drug; with that taking longer than expected, it now believes “it is unlikely that its planned randomized, sham-controlled trial of AXO-Lenti-PD will enroll patients by the end of calendar year 2021.”

Ugur Sahin, BioNTech CEO (Andreas Arnold/picture-alliance/dpa/AP Images)

Covid-19 roundup: Flush with $486M con­tract, As­traZeneca signs Lon­za up to man­u­fac­ture an­ti­bod­ies; BioN­Tech's Ugur Sahin ex­pects vac­cine da­ta 'in a fort­night'

Days after scoring a $486 million BARDA contract to develop and manufacture its long-acting antibody combo for Covid-19, AstraZeneca has tapped Lonza to produce the drug substance at its mid-scale facility in Portsmouth, NH.

The drug, dubbed AZD7442, puts together two antibodies, first discovered by scientists at Vanderbilt University Medical Center, derived from convalescent patients who recovered from a SARS-CoV-2 infection. AstraZeneca licensed them in June and has since further engineered them with half-life extension and reduced Fc receptor binding.

CEO Kenji Yasukawa (Astellas)

In ear­ly blow to Ken­ji Ya­sukawa's R&D re­vamp, Astel­las drops out of the TIG­IT race, cit­ing PhI fail­ure

Just after AstraZeneca jumped into the TIGIT race, Astellas quietly disclosed that it was leaving, dropping out of a hunt for an immunotherapy approach that has shown tantalizing promise but remains largely unproven.

Astellas revealed in their second quarter earnings today that they’ve ended development of the anti-TIGIT antibody they acquired in their up to $400 million buyout of Potenza in 2018. The Japanese pharma had been testing it in combination with Keytruda in a 300-person Phase I study on patients with advanced solid tumors. A smaller study testing the antibody alone was completed, 2 years ahead of schedule, in July.

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