On­colyt­ic con­tender Turn­stone bags a $41M B round to push a suc­ces­sor for Im­ly­g­ic

Turn­stone CEO Sam­my Farah

Ever since Am­gen made it to the mar­ket with a pi­o­neer­ing on­colyt­ic virus can­cer ther­a­py called Im­ly­g­ic (T-Vec), which it bagged in a bil­lion-dol­lar deal to ac­quire BioVex, you could see a wave of biotech com­peti­tors form­ing — look­ing to do the same ther­a­peu­tic job bet­ter.

To­day, Cana­da’s Turn­stone Bi­o­log­ics takes an­oth­er big step in that march, bag­ging a $41.4 mil­lion Se­ries B that will go a long way to demon­strat­ing whether it has a re­al con­tender for that mar­ket, while fu­el­ing ad­di­tion­al work in build­ing the pipeline.

“The raise comes pret­ty quick­ly af­ter our ini­tial Se­ries A,” says CEO Sam­my Farah. “What re­al­ly drove our de­sire to bring in more fund­ing, we want­ed to ex­pand and ac­cel­er­ate clin­i­cal de­vel­op­ment pro­grams, do much more in the clin­ic and do much more in the very near term.”

That means wrap­ping an on­go­ing Phase I/II study for the lead pro­gram for an en­gi­neered virus, with a sec­ond tri­al ready to launch lat­er this year that will in­clude one of the ap­proved check­point in­hibitors (they’re not say­ing which one, for now). Two more pro­grams will launch next year, bring­ing Turn­stone up to four ac­tive clin­i­cal ef­forts.

Turn­stone has been work­ing with a trio of found­ing sci­en­tists in its cor­ner, led by John Bell.

“I think we are quite unique,” Bell tells me. Their ther­a­py en­codes a tu­mor anti­gen de­signed to spur an im­mune re­sponse while al­so stim­u­lat­ing pe­riph­er­al im­mu­ni­ty, of­fer­ing an on­colyt­ic to pen­e­trate and de­stroy can­cer cells and a can­cer vac­cine at the same time. And like oth­er ri­val biotechs in the field, in­clud­ing PsiOxus, the biotech be­lieves that sys­temic de­liv­ery of their drug will make a big dif­fer­ence for pa­tients.

“The oth­ers,” he says about the com­pe­ti­tion, “can’t gen­er­ate a po­tent vac­cine ef­fect.” The check­point in­hibitor, which takes the brakes off the im­mune sys­tem as the vac­cine ap­plies the gas, makes for a nat­ur­al com­bi­na­tion ap­proach, as the lead­ers in that field work hard to pur­sue hun­dreds of new com­bi­na­tion ap­proach­es.

Bell al­so has been work­ing on new strate­gies de­signed to match next-gen drugs specif­i­cal­ly for cer­tain tu­mors. That may call for new and im­proved on­colyt­ic ap­proach­es while al­so ex­am­in­ing which of the check­points are more suit­able for cer­tain tu­mors.

“In ad­di­tion to the clin­i­cal pro­gram we talked about be­fore,” adds Farah, “we’re al­so look­ing at some ex­cit­ing ar­eas, like neoanti­gen per­son­al­ized vac­cines. Our tech­nol­o­gy is very suit­ed to per­son­al­ized can­cer field.”

Or­biMed led this round, with an ex­pand­ed syn­di­cate that in­cludes new in­vestor F-Prime Cap­i­tal Part­ners and ex­ist­ing in­vestors FAC­IT and Ver­sant Ven­tures, which led Turn­stone’s Se­ries A.

It’s fi­nal­ly over: Bio­gen, Ei­sai scrap big Alzheimer’s PhI­I­Is af­ter a pre­dictable BACE cat­a­stro­phe rais­es safe­ty fears

Months after analysts and investors called on Biogen and Eisai to scrap their BACE drug for Alzheimer’s and move on in the wake of a string of late-stage failures and rising safety fears, the partners have called it quits. And they said they were dropping the drug — elenbecestat — after the independent monitoring board raised concerns about…safety.

We don’t know exactly what researchers found in this latest catastrophe, but the companies noted in their release that investigators had determined that the drug was flunking the risk/benefit analysis.

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Lisa M. DeAngelis, MSKCC

MSK picks brain can­cer ex­pert Lisa DeAn­ge­lis as its next CMO — fol­low­ing José Basel­ga’s con­tro­ver­sial ex­it

It’s official. Memorial Sloan Kettering has picked a brain cancer expert as its new physician-in-chief and CMO, replacing José Baselga, who left under a cloud after being singled out by The New York Times and ProPublica for failing to properly air his lucrative industry ties.

His replacement, who now will be in charge of MSK’s cutting-edge research work as well as the cancer care delivered by hundreds of practitioners, is Lisa M. DeAngelis. DeAngelis had been chair of the neurology department and co-founder of MSK’s brain tumor center and was moved in to the acting CMO role in the wake of Baselga’s departure.

Penn team adapts CAR-T tech, reengi­neer­ing mouse cells to treat car­diac fi­bro­sis

After establishing itself as one of the pioneer research centers in the world for CAR-T cancer therapies, creating new attack vehicles to eradicate cancer cells, a team at Penn Medicine has begun the tricky transition of using the basic technology for heart repair work.

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Tal Zaks. Moderna

The mR­NA uni­corn Mod­er­na has more ear­ly-stage hu­man da­ta it wants to show off — reach­ing new peaks in prov­ing the po­ten­tial

The whole messenger RNA field has attracted billions of dollars in public and private investor cash gambled on the prospect of getting in on the ground floor. And this morning Boston-based Moderna, one of the leaders in the field, wants to show off a few more of the cards it has to play to prove to you that they’re really in the game.

The whole hand, of course, has yet to be dealt. And there’s no telling who gets to walk with a share of the pot. But any cards on display at this point — especially after being accused of keeping its deck under lock and key — will attract plenty of attention from some very wary, and wired, observers.

“In terms of the complexity and unmet need,” says Tal Zaks, the chief medical officer, “this is peak for what we’ve accomplished.”

Moderna has two Phase I studies it wants to talk about now.

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It's not per­fect, but it's a good start: FDA pan­elists large­ly en­dorse Aim­mune's peanut al­ler­gy ther­a­py

Two days after a fairly benign review from FDA staff, an independent panel of experts largely endorsed the efficacy and safety of Aimmune’s peanut allergy therapy, laying the groundwork for approval with a risk evaluation and mitigation strategy (REMS).

Traditionally, peanut allergies are managed by avoidance, but the threat of accidental exposure cannot be nullified. Some allergists have devised a way to dose patients off-label with peanut protein derived from supermarket products to wean them off their allergies. But the idea behind Aimmune’s product was to standardize the peanut protein, and track the process of desensitization — so when accidental exposure in the real world invariably occurs, patients are less likely to experience a life-threatening allergic reaction.

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Rit­ter bombs fi­nal PhI­II for sole lac­tose in­tol­er­ance drug — shares plum­met

More than two years ago Ritter Pharmaceuticals managed to find enough silver lining in its Phase IIb/III study — after missing the top-line mark — to propel its lactose intolerance toward a confirmatory trial. But as it turned out, the enthusiasm only set the biotech and its investors up to be sorely disappointed.

This time around there’s little left to salvage. Not only did RP-G28 fail to beat placebo in reducing lactose intolerance symptoms, patients in the treatment group actually averaged a smaller improvement. On a composite score measuring symptoms like abdominal pain, cramping, bloating and gas, patients given the drug had a mean reduction of 3.159 while the placebo cohort saw a 3.420 drop on average (one-sided p-value = 0.0106).

Ear­ly snap­shot of Ad­verum's eye gene ther­a­py sparks con­cern about vi­sion loss

An early-stage update on Adverum Biotechnologies’ intravitreal gene therapy has triggered investor concern, after patients with wet age-related macular degeneration (AMD) saw their vision deteriorate, despite signs that the treatment is improving retinal anatomy.

Adverum, on Wednesday, unveiled 24-week data from the OPTIC trial of its experimental therapy, ADVM-022, in six patients who have been administered with one dose of the therapy. On average, patients in the trial had severe disease with an average of 6.2 anti-VEGF injections in the eight months prior to screening and an average annualized injection frequency of 9.3 injections.

Alex Ar­faei trades his an­a­lyst's post for a new role as biotech VC; Sanofi vet heads to Vi­for

Too often, Alex Arfaei arrived too late. 

An analyst at BMO Capital Markets, he’d meet with biotech or pharmaceutical heads for their IPO or secondary funding and his brain, trained on a biology degree and six years at Merck and Endo, would spring with questions: Why this biomarker? Why this design? Why not this endpoint? Not that he could do anything about it. These execs were coming for clinical money; their decisions had been made and finalized long ago.

Arde­lyx bags its first FDA OK for IBS, set­ting up a show­down with Al­ler­gan, Iron­wood

In the first of what it hopes will be a couple of major regulatory milestones for its new drug, Ardelyx has bagged an FDA approval to market Ibsrela (tenapanor) for irritable bowel syndrome.

The drug’s first application will be for IBS with constipation (IBS-C), inhibiting sodium-hydrogen exchanger NHE3 in the GI tract in such a way as to increase bowel movements and decrease abdominal pain. This comes on the heels of two successful Phase III trials.