Cir­cled by ri­val phar­ma gi­ants and a biotech pow­er­house, Ko­di­ak asks for a $100M-plus IPO for new eye drug

Ko­di­ak Sci­ences was nev­er one of those biotechs that liked to tout every fi­nanc­ing round or talk up its drug prospects. Helmed by biotech vet and for­mer MPM ven­ture part­ner Vic­tor Perl­roth, it turns out the biotech has been steadi­ly jock­ey­ing a new oph­thal­mol­o­gy drug right to the thresh­old of a soon-to-launch Phase II tri­al. And he’s aim­ing straight at cut­ting the legs out from un­der a block­buster fierce­ly de­fend­ed by one of the tough­est play­ers in drug R&D — once he com­pletes a $100 mil­lion-plus IPO.

And he has a an­oth­er pair of ma­jor league ri­vals look­ing to beat him to the punch.

Ko­di­ak — not to be con­fused with Doug Williams’ Co­di­ak — got start­ed in 2009; a few years af­ter Perl­roth sold off Avidia to Am­gen for $290 mil­lion in cash, plus an­oth­er $90 mil­lion in mile­stones.

Vic­tor Perl­roth

The com­pa­ny has burned through $85.7 mil­lion so far, ac­cord­ing to the S-1, which is close to the $93 mil­lion in rev­enue it’s not­ed rais­ing since launch, in­clud­ing a $33 mil­lion mez­za­nine round that came in last April, with Per­cep­tive Ad­vi­sors and Ar­row­Mark Part­ners lead­ing the round.

So far, those are the on­ly in­vestors that Ko­di­ak has pub­licly ac­knowl­edged. As a re­sult, Perl­roth is the biggest in­vestor high­light­ed in the IPO, with 24% of the shares, while co-founder Stephen Charles has 10%. That’s an un­usu­al­ly high founder fig­ure, if you com­pare it to the av­er­age ven­ture-backed biotech go­ing pub­lic.

Stephen Charles

The in­vest­ment cash has pushed a lead drug through a small, 9-pa­tient Phase I dos­ing and safe­ty study, which Ko­di­ak says came through with fly­ing col­ors. Now, though, the next step will cost con­sid­er­ably more than any­thing they’ve done so far.

The Pa­lo Al­to, CA-based biotech is lay­ing the ground­work for two Phase II stud­ies of its lead drug — KSI-301. The first will be an up­com­ing 400-pa­tient head-to-study pitch­ing its drug di­rect­ly against Eylea for wet age-re­lat­ed mac­u­lar de­gen­er­a­tion, Re­gen­eron’s cash cow. They’re go­ing af­ter a 16-week dos­ing sched­ule for eye in­jec­tions, com­pared to an 8-week dose that Re­gen­eron has in the la­bel, hop­ing to show that its less fre­quent in­jec­tion is non­in­fe­ri­or to the block­buster stan­dard. An­oth­er Phase II will ex­plore its ef­fi­ca­cy in di­a­bet­ic retinopa­thy.

Re­gen­eron re­cent­ly scored an ap­proval for a once-every-12 week dos­ing sched­ule, but Ko­di­ak’s S-1 notes that can on­ly start in the sec­ond year of treat­ment.

The cur­rent an­ti-VEGF drugs, Lu­cen­tis, Avastin and Eylea, have some lim­i­ta­tions that Ko­di­ak hopes to ex­ploit. 

For ex­am­ple, Lu­cen­tis was test­ed and failed to suc­cess­ful­ly ex­tend the treat­ment in­ter­val to 12-week dos­ing, with pa­tients go­ing back to pre-treat­ment base­line or even los­ing vi­sion at the end of the first year of treat­ment, on av­er­age. The Lu­cen­tis U.S. prod­uct la­bel­ing refers to this reg­i­men as an op­tion which is “not as ef­fec­tive” as month­ly dos­ing. Re­cent­ly, the FDA al­lowed an up­date to EYLEA’s la­bel­ing to al­low 12-week dos­ing, but on­ly in the sec­ond year of treat­ment (af­ter one full year of in­ten­sive treat­ment). The la­bel­ing refers to it as “not as ef­fec­tive as the rec­om­mend­ed every 8-week dos­ing.” Even a small de­vi­a­tion from per la­bel dos­ing can be dev­as­tat­ing for vi­sion. Miss­ing as few as one or two in­jec­tions in a year from EYLEA’s rec­om­mend­ed dos­ing, re­sults in al­most one line of vi­sion lost.

Ko­di­ak’s S-1 al­so notes that No­var­tis has a late-stage (the high­ly tout­ed ri­val brolu­cizum­ab), while Al­ler­gan is al­so a po­ten­tial com­peti­tor in the field with abic­i­par. There’s more, with Roche in hot pur­suit of RG7716 af­ter its first Phase II wrap ear­li­er this year.

Ko­di­ak couldn’t have cho­sen a more ag­gres­sive group of ma­jor league play­ers to take on. But they ap­pear ready to make a game try at beat­ing the lot.

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.