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.”

Belgian biotech Confo Therapeutics has landed $183 million, plus potential royalties, in a drug-discovery deal with Daiichi Sankyo.

Early Thursday, Confo Therapeutics put out word of the deal that will be focused on small molecule antagonists to go after an undisclosed target that the company says is associated with CNS diseases.

Confo CEO Cedric Ververken told Endpoints News that Daiichi originally reached out to learn about the biotech’s technology. He added that Confo, founded in 2015, will use its platform to drug a GPCR target that Daiichi has struggled with internally.

In a first, Merck has secured a full approval for Keytruda in a tumor agnostic setting — as a treatment for any unresectable or metastatic solid tumors that are classified as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR).

The FDA granted Keytruda accelerated approval in this indication in 2017, and GSK’s Jemperli followed suit in 2021. But now it’s converted to a full approval for Keytruda. Before prescribing, doctors would have to make sure patients carry this biomarker, using an FDA-approved test.

When Vigil Neuroscience filed its IPO papers in late 2021, the biotech revealed that the FDA had just cleared its Phase I trial — but with a partial clinical hold that limited dosing to under a certain level.

More than a year later, the FDA has lifted the hold.

Vigil is now free to dose VGL101, an antibody targeting TREM2, at levels higher than 20 mg/kg in its ongoing and future clinical trials in patients with adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP), an inherited condition that affects the brain and spinal cord.

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

Boehringer Ingelheim reported human pharma sales of €18.5 billion on Wednesday, led by type 2 diabetes and heart failure drug Jardiance and pulmonary fibrosis med Ofev. Jardiance sales reached €5.8 billion, growing 39% year over year, while Ofev took in €3.2 billion, notching its own 20.6% annual jump.

However, Boehringer is also looking ahead with its pipeline, estimating “In the next seven years the company expects about 20 regulatory approvals in human pharma.”