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.”

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

The End­points 11: They've got mad mon­ey and huge am­bi­tions. It's time to go big or go home

These days, selecting a group of private biotechs for the Endpoints 11 spotlight begins with a sprint to get ahead of IPOs and the M&A teams at Big Pharma. I’ve had a couple of faceplants earlier this year, watching some of the biotechs on my short list choose a quick leap onto Nasdaq or into the arms of a buyer.

Vividion, you would have been a great pick for the Endpoints 11. I’m sorry I missed you.

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Dave Lennon, former president of Novartis Gene Therapies

So what hap­pened with No­var­tis Gene Ther­a­pies? Here's your an­swer

Over the last couple of days it’s become clear that the gene therapy division at Novartis has quietly undergone a major reorganization. We learned on Monday that Dave Lennon, who had pursued a high-profile role as president of the unit with 1,500 people, had left the pharma giant to take over as CEO of a startup.

Like a lot of the majors, Novartis is an open highway for head hunters, or anyone looking to staff a startup. So that was news but not completely unexpected.

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Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

Emma Walmsley, GlaxoSmithKline CEO (Credit: Fang Zhe/Xinhua/Alamy Live News)

The fire un­der Glax­o­SmithK­line's Em­ma Walm­s­ley grows as an­oth­er well-known ac­tivist in­vestor grabs its pitch­fork — re­port

Bluebell Capital Partners, a proxy brawler fresh off a campaign to oust global food giant Danone’s CEO and most of its board of directors, has bought a stake in UK drugmaker GlaxoSmithKline with its eyes trained directly on Emma Walmsley, the Financial Times reported Wednesday.

The London-based hedge fund joins another notorious activist firm in Paul Singer’s Elliott Management, which earlier this year called for a shakeup in leadership at GSK to handle what the company described as a wealth of riches across the drug giant’s portfolio hindered by limited vision from top staff.

FDA au­tho­rizes Pfiz­er's vac­cine boost­er for se­niors, those at high risk for se­vere Covid-19

The Biden administration’s goal of kicking off its booster shot drive for the entire US population this week is not quite going as planned.

First, Pfizer applied for approval of a supplemental application for the booster shots, but since last Friday’s adcomm reviewing them, the plan has devolved into an EUA, which the FDA issued late Thursday evening.

The population that is now eligible for the booster, six months after receiving the first pair of Pfizer-BioNTech vaccines, also narrowed from what Pfizer applied for (everyone who’s eligible for the initial Pfizer shots) to just those who are 65 or older, or at high-risk of a Covid infection, including health care workers and others with occupational hazards.

Stéphane Bancel, AP Images

Fi­nal analy­sis of US-fund­ed Mod­er­na Covid vac­cine tri­al shows 98% ef­fi­ca­cy against se­vere dis­ease

A final look at the results of the placebo-controlled Moderna trial in the New England Journal of Medicine, published Thursday afternoon, shows how the vaccine continues to prevent Covid-19 and severe cases after more than five months following the second shot.

Of the more than 30,000 enrolled in the trial that ultimately led to the vaccine’s EUA, only two people in the vaccine group got a severe form of the disease, compared to 106 in the placebo group — leading to an efficacy of 98%.

FDA+ roundup: Bs­U­FA III ready for show­time, court tells FDA to re-work com­pound­ing plan, new guid­ance up­dates and more

The FDA has now spelled out what exactly will be included in the third iteration of Biosimilar User Fee Act (BsUFA) from 2023 through 2027, which similarly to the prescription drug deal, sets fees that industry has to pay for submitting applications, in exchange for firm timelines that the agency must meet.

This latest deal includes several sweeteners for the biosimilar industry, which has yet to make great strides in the US market, with shorter review timelines for safety labeling updates and updates to add or remove an indication that does not contain efficacy data.

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Joshua Liang, Clover Biopharmaceuticals CEO

With world still in sore need of dos­es, Clover says its Covid-19 vac­cine is 67% ef­fec­tive in Phase III

With concerns about the Delta variant rising and much of the world still in desperate need of vaccine doses, a Chinese biotech announced Wednesday that a new shot has shown positive results in a large trial against Covid-19, including new variants.

Clover Biopharmaceuticals announced Wednesday that its vaccine candidate showed 79% efficacy against the Delta variant in a Phase II/III trial dubbed Spectra, and 67% effective against Covid-19 overall.