Ab­b­Vie jumps on the on­colyt­ics band­wag­on, em­brac­ing Turn­stone in new col­lab­o­ra­tion

Turn­stone CEO Sam­my Farah

Ab­b­Vie has paid for a front row seat on the can­cer drug strat­e­gy be­ing in­ves­ti­gat­ed in the clin­ic at Turn­stone Bi­o­log­ics. The phar­ma out­fit snagged an op­tion to buy Turn­stone’s lead ther­a­py com­bin­ing an on­colyt­ic virus ap­proach and can­cer vac­cine. And if they dive in, Ab­b­Vie ex­pects to line up a shot at a se­ries of tu­mor types with an op­tion on two more pro­grams that Turn­stone will work on.

“This is the largest part­ner­ship ever formed in this field,” says Turn­stone CEO Sam­my Farah, who’s clear­ly pumped to be align­ing his biotech with a promi­nent play­er in can­cer R&D. “It’s a very sig­nif­i­cant, very mean­ing­ful part­ner­ship on many lev­els.”

Us­ing an en­gi­neered Mara­ba virus, re­searchers have pushed Ad-MG1-MAGEA3 in­to two Phase I/II stud­ies. The es­sen­tial ap­proach here fol­lows a clas­sic on­colyt­ics ap­proach — in­fect­ing a can­cer cell with the virus, which then ex­plodes. While there are a host of next-gen pro­grams to fol­low up on Am­gen’s Im­ly­g­ic, Turn­stone al­so in­cludes some­thing of a twist.

Sev­er­al of these sec­ond-wave on­colyt­ics are sys­tem­i­cal­ly ad­min­is­tered, which may help si­mul­ta­ne­ous­ly at­tack the ori­gin tu­mor as well as metasta­t­ic sites. While many of these next-gen pro­grams re­ly on the anti­gens re­leased in the tu­mor ex­plo­sion to re­cruit a CD4- and CD8-pos­i­tive T cell at­tack for a mop­ping up op­er­a­tion — com­bined with a longterm mem­o­ry for the can­cer that should en­hance dura­bil­i­ty — Turn­stone’s ther­a­py en­codes a spe­cif­ic shared tu­mor anti­gen to make it in­to a can­cer vac­cine.

That added el­e­ment, Farah notes, makes for a key dif­fer­en­ti­a­tion from the rest of the drugs now in the clin­ic.

The third leg of this calls for a check­point in­hibitor, an­oth­er com­mon fea­ture in the on­colyt­ics are­na, so physi­cians could add a dis­arm­ing pro­ce­dure with a tar­get­ed at­tack and im­mune sys­tem as­sault.

Im­ly­g­ic, bet­ter known in some cir­cles at T-Vec, has helped es­tab­lish the proof that on­colyt­ics can make a sig­nif­i­cant dif­fer­ence for pa­tients. And while can­cer vac­cines have been in­ef­fec­tive so far in the clin­ic, they’re role is to en­hance the ther­a­peu­tic ef­fect of the vi­ral at­tack. Check­points, mean­while, are be­ing added to just about every­thing.

Tom Hud­son, Ab­b­Vie

Turn­stone’s lead ther­a­py us­es the MAGE-A3 anti­gen for the vac­cine el­e­ment — the same tar­get that GSK tried and failed with in 2014.

A lit­tle more than a year ago Or­biMed led Turn­stone’s $41.4 mil­lion B round, with an ex­pand­ed syn­di­cate that in­clud­ed new in­vestor F-Prime Cap­i­tal Part­ners and ex­ist­ing in­vestors FAC­IT and Ver­sant Ven­tures, which led Turn­stone’s Se­ries A.

Af­ter the Phase I dose es­ca­la­tion phase is com­plete, Farah says he ex­pects that it will take a cou­ple of more years to com­plete the Phase II part of that tri­al. And along the way, he ex­pects the 25 mem­ber staff at Turn­stone to dou­ble over the next 12 to 18 months.

Ab­b­Vie added an en­dorse­ment with its col­lab­o­ra­tion.

“This unique ap­proach to can­cer treat­ment com­ple­ments our ex­pand­ing port­fo­lio of nov­el ther­a­pies in de­vel­op­ment,” said Tom Hud­son, vice pres­i­dent, on­col­o­gy dis­cov­ery and ear­ly de­vel­op­ment, Ab­b­Vie. “The com­bi­na­tion of our world-class ex­per­tise in on­col­o­gy drug de­vel­op­ment part­nered with Turn­stone’s in­no­v­a­tive ther­a­peu­tic plat­form has the po­ten­tial to gen­er­ate first-in-class im­munother­a­pies that can at­tack tu­mors di­rect­ly and im­prove pa­tients’ re­sponse to treat­ment.”

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

$DNA is once again on NYSE; FDA clears Soliris chal­lenger for the mar­ket; Flag­ship’s think­ing big again with eR­NA; and more

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I still remember the uncertainty in the air last year when nobody was sure whether ASCO would cancel their in-person meeting. But it’s now back again for the second virtual conference, and Endpoints News is here for it. Check out our 2-day event reviewing the landscape of cancer R&D and send news our way.

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Gene ther­a­py from Bio­gen's $800M buy­out flops in mid-stage study, deal­ing blow to new am­bi­tions

The #2 candidate from Biogen’s $800 million ocular gene therapy buyout has failed in a mid-stage trial, dealing an early blow to the big biotech’s plans to revitalize its pipeline with new technologies.

Biogen announced that the candidate, an experimental treatment for a rare and progressive form of blindness called X-linked retinitis pigmentosa (XLRP), failed to sufficiently improve vision in patients’ treated eye — patients only received an injection in one eye — after a year, on a standard scale, compared to their untreated eye. The company said they saw “positive trends” on several secondary endpoints, including visual acuity, but declined to say whether the trial actually hit any of those endpoints.

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Vas Narasimhan (Photographer: Simon Dawson/Bloomberg via Getty Images)

No­var­tis whiffs on En­tresto study af­ter heart at­tacks — but that does­n't mean it's go­ing down qui­et­ly

If Novartis learned one thing from its interaction with the FDA over its latest heart failure approval for Entresto, it was that missing a primary endpoint may not be the nail in the coffin. Now, Entresto has missed again on a late-stage study in high-risk heart patients, and it’s already sowing the seeds for a path forward regardless.

Novartis’ Entresto couldn’t best standard-of-care ramipril in staving off a composite of deaths and heart failure events in patients with left ventricular systolic dysfunction and/or pulmonary congestion who have had a prior heart attack, according to topline data from the Phase III PARADISE-MI study revealed Saturday at the virtual American College of Cardiology meeting.

BAR­DA slows its $9B en­gine for new Covid-19 ther­a­peu­tics

The Biomedical Advanced Research and Development Authority is cooling its jets in looking for new, potential Covid-19 treatments, at least in the near term.

An HHS spokesperson told Endpoints News via email, “to date, BARDA has obligated more than $9 billion for the development and/or purchase of 13 therapeutics, beginning in February 2020 with support to develop Regeneron’s monoclonal antibody therapeutic. Therapeutics are an important element of the COVID-19 response, and we are focused on the programs currently underway and/or in negotiation using the funds available to us.”

Bris­tol My­ers backs up its case for heart drug mava­camten as FDA weighs app in car­diomy­opa­thy

When Bristol Myers Squibb signed off on its $13 billion acquisition of MyoKardia back in October, it was making a big bet that lead drug mavacamten could prove a game changer in cardiac myopathy. Now, with the drug up for FDA review, Bristol Myers is backing up its case with new quality of life data.

Patients dosed with myosin inhibitor mavacamten posted a clinically significant increase in scores on the Kansas City Cardiomyopathy Questionnaire, a catch-all summary of symptoms and quality of life markers, over placebo at 30 weeks, according to data from the Phase III EXPLORER-HCM study presented Saturday at the virtual American College of Cardiology meeting.

Michael Dell (Richard Drew, AP Images)

'Dude, you're get­ting a Del­l' — as a new deep-pock­et biotech in­vestor

What happens when you marry longtime insiders in the global biotech VC game with the family fund of tech billionaire Michael Dell, a synthetic biology legend out of MIT and Harvard and the former director of the NCI?

Today, the answer is a newly financed, $200 million biotech SPAC now cruising the industry for a top player interested in finding a short cut to Nasdaq.

Orion Biotech Opportunities priced their blank check company today, raising $200 million with Dell’s multibillion-dollar MSD group’s commitment on investing another $20 million in a forward-purchase agreement.

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Marshall Fordyce, Vera CEO

Gene ther­a­py play­er turned kid­ney spe­cial­ist Ve­ra drops a dud in lead­up to Nas­daq, pric­ing well be­low range

Vera Therapeutics took a big risk at the start of the year, pivoting away from its gene editing mission statement to chase a lead kidney drug instead — and they doubled down with an IPO just months later. But investors don’t seem impressed with Vera’s promise, and now the biotech is looking at a far more scaled-back offering.

On Friday, Vera priced its 4.35-million-share IPO at $11 per share, well below its targeted range of $14 to $16 and good for $47.58 million in proceeds. The biotech will start trading Monday under the ticker $VERA.

Darren Ji, Elpiscience CEO (Lilly Asia Ventures)

Kept an ocean away from its sci­en­tif­ic ad­vi­sors, Shang­hai's Elpi­science keeps up the clin­i­cal progress, re­fu­els for its I/O pipeline

When Elpiscience pooled $100 million for its Series B in late 2019, CEO Darren Ji promised to move what he described as one of the broadest immuno-oncology pipelines swiftly through the clinic in both the US and China.

Then a pandemic got in the way — but not by much. The Shanghai-based biotech managed to keep testing its 4-1BB/PD-L1 drug, get an OX40 agonist cleared for clinical trials (nabbing a collaboration with Junshi in the process), while in-licensing a Phase I bispecific from California’s TRIGR Therapeutics.

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