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

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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Hill­house re­casts spot­light on Chi­na's biotech scene with $160M round for Shang­hai-based an­ti­body mak­er

Almost two years after first buying into Genor Biopharma’s pipeline of cancer and autoimmune therapies, Hillhouse Capital has led a $160 million cash injection to push the late-stage assets over the finish line while continuing to fund both internal R&D and dealmaking.

The Series B has landed right around the time Genor would have listed on the Hong Kong stock exchange, according to plans reported by Bloomberg late last year. Insiders had said that the company was looking to raise about $200 million.

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Ken Frazier, AP Images

Why Mer­ck wait­ed, and what they now bring to the Covid-19 fight

Nicholas Kartsonis had been running clinical infectious disease research at Merck for almost 2 years when, in mid-January, he got a new assignment: searching the pharma giant’s vast libraries for something that could treat the novel coronavirus.

The outbreak was barely two weeks old when Kartsonis and a few dozen others got to work, first in small teams and then in a larger task force that sucked in more and more parts of the sprawling company as Covid-19 infected more and more of the globe. By late February, the group began formally searching for vaccine and antiviral candidates to license. Still, while other companies jumped out to announce their programs and, eventually and sometimes controversially, early glimpses at human data, Merck remained silent. They made only a brief announcement about a data collection partnership in April and mentioned vaguely a vaccine and antiviral search in their April 28 earnings call.

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Gilead re­leas­es an­oth­er round of murky remde­sivir re­sults

A month after the NIH declared the first trial on remdesivir in Covid-19 a success, Gilead is out with new results on their antiviral. But although the study met one of its primary endpoints, the data are likely to only add to a growing debate over how effective the drug actually is.

In a Phase III trial, patients given a 5-day dose of remdesivir were 65% more likely to show “clinical improvement” compared to an arm given standard-of-care. The trial, though, gave little indication for whether the drug had an impact on key endpoints such as survival or time-to-recovery. And in a surprising twist, a 10-day dosing arm of remdesivir didn’t lead to a statistically significant improvement over standard of care.

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Mark Genovese (Stanford via Twitter)

Gilead woos fil­go­tinib clin­i­cal in­ves­ti­ga­tor from Stan­ford to lead the charge on NASH, in­flam­ma­to­ry dis­eases

With an FDA OK for the use of filgotinib in rheumatoid arthritis expected to drop any day now, Gilead has recruited a new leader from academia to lead its foray into inflammatory diseases.

Mark Genovese — a longtime Stanford professor and most recently the clinical chief in the division of immunology and rheumatology — was the principal investigator in FINCH 2, one of three studies that supported Gilead’s NDA filing. In his new role as SVP, inflammation, he will oversee the clinical development of the entire portfolio.

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Stephen Isaacs, Aduro president and CEO (Aduro)

Once a high fly­er, a stag­ger­ing Aduro is auc­tion­ing off most of the pipeline as CEO Stephen Isaacs hands off the shell to new own­ers

After a drumbeat of failure, setbacks and reorganizations over the last few years, Aduro CEO Stephen Isaacs is handing over his largely gutted-out shell of a public company to another biotech company and putting up some questionable assets in a going-out-of-business sale.

Isaacs —who forged a string of high-profile Big Pharma deals along the way — has wrapped a 13-year run at the biotech with one program for kidney disease going to the new owners at Chinook Therapeutics. A host of once-heralded assets like their STING agonist program partnered with Novartis (which dumped their work on ADU-S100 after looking over weak clinical results), the Lilly-allied cGAS-STING inhibitor program and the anti-CD27 program out-licensed to Merck will all be posted for auction under a strategic review process.

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Federico Mingozzi (Spark)

Spark touts an­i­mal da­ta for a so­lu­tion to AAV gene ther­a­py's an­ti­body prob­lem

Among all the limitations of using an adeno-associated virus as a vector to deliver a gene — still the most established modality in gene therapy given years of trial and error and finally success — the presence of neutralizing antibodies, whether pre-existing or induced, looms large.

“When I think about the immune responses in AAV, I try to sort of layer them,” Federico Mingozzi, the CSO at Spark Therapeutics, told Endpoints News. “The antibody is the first layer. It’s the first block that you find when you’re trying to do gene transfer.”

Fangliang Zhang (Imaginechina via AP Images)

The big mon­ey: Poised to make drug R&D his­to­ry, a Chi­na biotech un­veils uni­corn rac­ing am­bi­tions in a bid to raise $350M-plus on Nas­daq

Almost exactly three years after Shanghai-based Legend came out of nowhere to steal the show at ASCO with jaw-dropping data on their BCMA-targeted CAR-T for multiple myeloma, the little player with Big Pharma connections is taking a giant step toward making it big on Wall Street. And this time they want to seal the deal on a global rep after staking out a unicorn valuation in what’s turned out to be a bull market for biotech IPOs — in the middle of a pandemic.

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