Generate co-founder Molly Gibson and CEO Mike Nally

Flag­ship's ma­chine learn­ing start­up Gen­er­ate bags $370M in lat­est round with plans for a big hir­ing spree

As the fu­ture of ma­chine learn­ing and AI promis­es to make ma­jor break­throughs in drug de­vel­op­ment, a suite of star­tups is look­ing to scale their own com­pet­ing ro­bot brain trusts. An am­bi­tious start­up out of Flag­ship Pi­o­neer­ing’s in­cu­ba­tor un­cloaked last year with its own spin in that arms race — and now it’s primed and ready for a ma­jor ex­pan­sion in the com­ing years.

Gen­er­ate Bio­med­i­cines has closed a gi­ant $370 mil­lion Se­ries B from found­ing in­vestor Flag­ship as well as Alas­ka Per­ma­nent Fund, Al­ti­tude Life Sci­ence Ven­tures, ARCH Ven­ture Part­ners, and funds and ac­counts ad­vised by T. Rowe Price As­so­ci­ates, the com­pa­ny said.

Gen­er­ate, which de­buted in late 2020, is Flag­ship’s shot at us­ing ma­chine learn­ing ad­vances to change the game in the de­vel­op­ment of pro­tein ther­a­peu­tics, with the com­pa­ny promis­ing much faster de­vel­op­ment times and dis­cov­ery suc­cess rates. It’s a mod­el be­ing tried else­where from com­pa­nies like Ex­sci­en­tia and In­sil­i­co, but Gen­er­ate sets it­self apart with its fo­cus on pro­tein se­quenc­ing and the goal to pro­duce de no­vo bi­o­log­ics.

Since launch, Gen­er­ate has been hard at work crunch­ing da­ta through its sys­tem in an at­tempt to give it the broad­est pos­si­ble plat­form for dis­cov­ery. Now, the com­pa­ny is ready to great­ly ex­pand its “wet lab” and bi­ol­o­gy ca­pa­bil­i­ties, CEO Mike Nal­ly told End­points News, and that will spell a huge hir­ing spree for the com­pa­ny as well as new cor­po­rate digs in the Somerville, MA area and an­oth­er site in An­dover.

Cur­rent­ly op­er­at­ing with a work­force of around 80, Gen­er­ate is plan­ning to make the quan­tum leap to 500 em­ploy­ees over the course of the next two years while al­so mov­ing in­to two new fa­cil­i­ties in the com­ing weeks and months. The An­dover site will be used to ex­pand the biotech’s range in struc­tur­al bi­ol­o­gy, in­clud­ing a big in­vest­ment in cryo­genic elec­tron mi­croscopy (cryo-EM), a cut­ting-edge tech­nique used to de­ter­mine the struc­ture of pro­teins.

The im­me­di­ate goal is to move past the work of the past two years, pri­mar­i­ly prov­ing Gen­er­ate’s plat­form could pro­duce high­er bind­ing affin­i­ty pro­teins from pre­cur­sor ref­er­ence bi­o­log­ics, in­to the realm of de­vel­op­ing pro­tein drugs from scratch us­ing pro­pri­etary da­ta learn­ing, Gen­er­ate’s chief strat­e­gy and in­no­va­tion of­fi­cer and co-founder Mol­ly Gib­son told End­points.

“Since in­cep­tion, we’ve set out to an­swer this ques­tion whether we can pro­gram pro­teins at the DNA lev­el, and what we’ve done over the past year is take those first in­sights … re­al­ly show that at scale and push pro­grams for­ward,” Gib­son said. “We’ve shown that we’ve been able to make sig­nif­i­cant ad­vances over where we start­ed cre­at­ing these ma­chine learn­ing al­go­rithms us­ing pub­lic da­ta.”

Now, the team said it will be ready to start churn­ing out pre­clin­i­cal can­di­dates by the end of the year with some of those pro­grams ex­pect­ed to hit hu­man tri­als as ear­ly as 2023.

As the clin­ic moves clos­er, the Gen­er­ate team is keep­ing a close eye on the po­ten­tial for strate­gic part­ner­ships giv­en the po­ten­tial breadth of its plat­form’s ca­pa­bil­i­ties. Those strate­gic part­ner­ships, more in the line of sub­stan­tial R&D team-ups, are a key part of the com­pa­ny’s BD strat­e­gy mov­ing for­ward, Nal­ly said, which the com­pa­ny will have to lever­age with its own in-house work.

“The re­al­i­ty is … we can pro­duce far more than we can con­sume so we want to make sure we com­ple­ment our ex­per­tise in pro­tein en­gi­neer­ing with oth­ers’ dis­tinct ca­pa­bil­i­ty in ar­eas like dis­ease-area bi­ol­o­gy, man­u­fac­tur­ing and clin­i­cal de­vel­op­ment,” Nal­ly said. “Ul­ti­mate­ly there’s a huge in­vest­ment across biotech and phar­ma in un­der­stand­ing tar­get bi­ol­o­gy so we think if there’s an ap­pro­pri­ate task, this tech­nol­o­gy may be able to ad­dress it in a way that very few oth­er tech­nolo­gies can.”

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.

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.

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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Work taking place in the clean rooms at Vor (Credit: Vor)

Vor Bio opts to keep man­u­fac­tur­ing op­er­a­tions in-house for de­vel­op­ing stem cell, CAR-T ther­a­pies

While it is not uncommon for a biotech to go down the route of having the product manufactured by a contract organization, one small biotech is looking to keep its card close to its chest.

Vor Biopharma has started manufacturing operations at an in-house facility at its HQ in Cambridge, MA after beginning construction last summer.

According to the biotech, the facility aims to develop Vor’s hematopoietic stem cells (eHSCs) and CAR-T therapies for patients with blood cancers. The site will initially manufacture a clinical supply of its candidate VCAR33allo to support its IND, which is slated to be submitted in the first half of next year. It also plans to transfer the production of VOR33 to the facility. Vor is getting to work quickly as engineering runs for VCAR33allo has started this week.

Aim­ing for fourth nod, Sarep­ta files an­oth­er DMD gene ther­a­py to FDA; Ax­some head­ed to­ward mi­graine re­sub­mis­sion

Sarepta Therapeutics has filed the data needed for an FDA accelerated approval, which would be the biotech’s fourth if granted by the agency.

The biotech has yet to complete confirmatory trials for those first three conditional nods. The filing for its fourth Duchenne muscular dystrophy treatment, disclosed Thursday, is not a surprise. Sarepta said in late-July it would do so after releasing positive results for the Roche-partnered gene therapy.

Phillip Gomez, Siga Technologies CEO

Siga nabs $10.7M from the US gov­ern­ment in deal for its mon­key­pox an­tivi­ral

The US government is all set to buy $10.7 million worth of Siga Technologies’ monkeypox oral antiviral, the company announced Thursday.

Of the total doses, $5.1 million worth of oral antivirals called Tpoxx (tecovirimat) will be delivered this year, with the US Department of Defense having the option of buying the rest at a later point.

The new contract follows an earlier one in which the government had purchased $7.4 million worth of Tpoxx from the company.

Renhong Tang, Simcere co-CEO

Almi­rall part­ners up with Sim­cere in po­ten­tial $500M+ deal — with plans to take IL-2 can­di­date glob­al

A Chinese pharma is looking to go international with one of its preclinical candidates, and it’s teaming up with a Spanish company in a new pact potentially worth half a billion dollars to do just that.

Simcere and Almirall announced Thursday that the two companies had reached a deal for Simcere’s IL-2 mutant fusion protein drug candidate, called SIM0278. According to a statement, Almirall gets an exclusive right to develop and commercialize the drug candidate in all indications and markets outside of China, Hong Kong, Taiwan and Macau.

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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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