Sammy Farah, Turnstone Biologics CEO

The piv­ot: Turn­stone Bi­o­log­ics opens a new chap­ter with a switch to clin­i­cal de­vel­op­ment and a new ven­ture round to pay for it

In biotech, most star­tups get about 5 years to get their pre­clin­i­cal act in or­der and jump in­to hu­man stud­ies be­fore the back­ers get restive and start look­ing for the ex­its. At the 2015-found­ed Turn­stone Bi­o­log­ics, they hit that line. But in­stead of los­ing its in­vestors’ in­ter­est, it’s been pick­ing up speed and back­ers.

Now, with a lead on­colyt­ic virus in an ear­ly-stage study and a sec­ond ther­a­py from the TIL side poised for an IND, the team un­der CEO Sam­my Farah has changed the sto­ry to clin­i­cal de­vel­op­ment. And they scored an $80 mil­lion Se­ries D from a broad syn­di­cate to get this new chap­ter un­der way in style.

“Turn­stone evolved, I think, in a more tra­di­tion­al way than the com­pa­nies be­ing de­vel­oped to­day are,” says Farah. “We raised, be­fore this Se­ries D, 3 ven­ture cap­i­tal rounds. And they’ve all been pret­ty mod­est.”

The to­tal was $90 mil­lion for the first 3 years, and they added busi­ness deals — an al­liance with Take­da, which took an eq­ui­ty stake, stands out — for non-di­lu­tive cash.

Now he sees Turn­stone as more of a mo­men­tum sto­ry com­ing out of the rel­a­tive­ly slow ini­tial buildup.

Jer­el Davis

“I think in many ways this was the tra­di­tion­al mod­el,” agrees Ver­sant’s Jer­el Davis, who jumped in­to the game here with the A round in 2015. “Their A, B and C are what you typ­i­cal­ly see in the A to­day. But I think the re­al­i­ty is that the com­pa­ny piv­ot­ed.”

And the busi­ness deals al­lowed the biotech to wait to ad­vance the more promis­ing pro­grams for­ward.

That piv­ot was away from on­colyt­ic virus­es sim­ply as a can­cer vac­cine — a “bru­tal­ly tough” propo­si­tion, in Farah’s words, which af­flict­ed oth­ers in the field — to a new on­colyt­ic virus tech with more of a cut­ting-edge ap­proach that could al­so de­liv­er oth­er ther­a­peu­tics.

The pay­load in­cludes CT­LA-4, FLT3 lig­and and IL-12, on top of the vi­ral ap­proach of in­fect­ing can­cer cells, blow­ing them up and re­cruit­ing im­mune cells to the tu­mor.

Turn­stone looped in the TIL work at the be­gin­ning of the year with the ac­qui­si­tion of Myst Ther­a­peu­tics, which added San Diego to its list of work sites. It didn’t say how much it paid for the com­pa­ny, but it wasn’t like­ly a big sum — at least not up­front. And now Farah and the team see sig­nif­i­cant up­side not just as a sep­a­rate, in­di­vid­ual ap­proach, but al­so com­bined with their on­colyt­ic virus ther­a­py.

Farah al­so be­lieves that they have a bet­ter ap­proach to tu­mor in­fil­trat­ing lym­pho­cytes, mov­ing away from “bulk TILs” to ex­pand­ing larg­er sets of lym­pho­cytes bet­ter suit­ed to the task of at­tack­ing a tu­mor. That’s what they have to prove as clin­i­cal work launch­es be­fore the end of this year.

There have been some changes in the C-suite. CMO Mike Burgess left for Spring­Works — though he re­mains on the board — and the com­pa­ny re­cruit­ed Stew­art Ab­bot from Adicet as CSO.

PFM Health Sci­ences and Point72 led this last round. Ad­di­tion­al new in­vestors Even­tide As­set Man­age­ment, Sur­vey­or Cap­i­tal (a Citadel com­pa­ny), Ridge­back Cap­i­tal In­vest­ments, Take­da Ven­tures Inc., CaaS Cap­i­tal, JM Fam­i­ly En­ter­pris­es, Inc., North­leaf Cap­i­tal Part­ners, 404 Bio and an undis­closed in­vestor were joined by ex­ist­ing in­vestors Ver­sant Ven­tures, Or­biMed, F-Prime Cap­i­tal, Sec­toral As­set Man­age­ment, Six­ty De­gree Cap­i­tal, Brace Phar­ma Cap­i­tal and Teralys Cap­i­tal.

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.

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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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.

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.

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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