Oys­ter Point in­vestors bet $93M on a PhI­II study aimed at dis­rupt­ing a ma­jor con­sumer mar­ket and top­pling Al­ler­gan


Every­one who ever felt the tears well up in their eyes as they bit in­to a red hot chili pep­per should be able to quick­ly gain a ba­sic un­der­stand­ing of what Oys­ter Point Phar­ma is try­ing to do. The team there be­lieves they’re on to a new and bet­ter way to treat dry eye dis­ease. And they now have a whop­ping $93 mil­lion round from some so­phis­ti­cat­ed in­vestors will­ing to back a Phase III to give it a fi­nal push — hope­ful­ly to­ward reg­u­la­tors.

The con­cept is sim­ple: use an in­tranasal ther­a­py to stim­u­late the trigem­i­nal parasym­pa­thet­ic path­way to kick up nat­ur­al tear pro­duc­tion. And they have a re­for­mu­la­tion of Chan­tix — OC-01 — which com­ple­ments an in-house NCE — OC-02 — to pick from for the piv­otal. There’s some mixed but most­ly pos­i­tive mid-stage da­ta on dis­play — some of which reg­u­la­tors ev­i­dent­ly be­lieve are good enough to stand in as a well-con­trolled tri­al need­ed to back up their Phase III.

Sound easy? Any­thing but.

Ste­fan Vi­torovic

While a whole host of biotech star­tups are go­ing af­ter rare dis­eases or can­cer nich­es to keep stud­ies small and com­mer­cial prospects man­age­able, Oys­ter Point staffers — all 8 of them — are go­ing af­ter a com­mon ail­ment suf­fered by tens of mil­lions. In biotech land, it’s ab­solute­ly es­sen­tial that you make a con­vinc­ing case that you can man­age com­mer­cial­iza­tion work on your own; you may even claim that that is your strat­e­gy. 

Part­ners and po­ten­tial buy­ers are put on alert that they don’t have to take any of­fer on the ta­ble. And you have to be able to con­trol your own des­tiny.

Gulp.

Sure, the big com­mer­cial out­fit at Brent Saun­ders’ Al­ler­gan now dom­i­nates the space with Resta­sis — which faces cheap gener­ic com­pe­ti­tion, says Oys­ter Point. But on­ly a frac­tion of pa­tients are be­ing treat­ed prop­er­ly, and Resta­sis and the oth­er prod­ucts are de­liv­ered via eye drops. This new path­way is bet­ter.

That’s Oys­ter Point’s sto­ry, and they’re stick­ing to it as they set out to prove their case.

“Com­pa­nies like us have to plan to take it all the way to the goal line,” Oys­ter Point CEO Jef­frey Nau tells me. Maybe some­body would buy the com­pa­ny, he adds in re­sponse to my ob­vi­ous query, but ei­ther route “is vi­able.”

An IPO could work as well to fund a launch.

Set­ting aside the fea­si­bil­i­ty of a tiny biotech field­ing a con­sumer prod­uct for dry eye dis­ease, Nau’s clear­ly pumped by the $93 mil­lion B round, which does give him a clear shot at tak­ing one of his drugs through a large Phase III study with about 600 or so pa­tients and on to an NDA. The CEO ex­pects to kick that study off at the mid-point of this year, with a read­out in ear­ly 2020.

Nau says his syn­di­cate is back­ing what he be­lieves is the largest sin­gle round ever as­sem­bled for an oph­thal­mol­o­gy up­start. The mon­ey is com­ing from two new lead in­vestors, In­vus Op­por­tu­ni­ties and Fly­ing L Part­ners al­lied with Fal­con Vi­sion. NEA and Ver­sant, which launched the com­pa­ny, are back, joined by Vi­da Ven­tures, where co-founder Ste­fan Vi­torovic has cham­pi­oned their strat­e­gy.

Their mon­ey will al­low the com­pa­ny to quadru­ple its staff in the near-term. And they can even think in terms of the com­mer­cial plan. Which they can han­dle. On their own. If needs be.

Let the Phase III be­gin.


Im­age: Jef­frey Nau. OYS­TER POINT

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Dipal Doshi, Entrada Therapeutics CEO

Ver­tex just found the next big ‘trans­for­ma­tive’ thing for the pipeline — at a biotech just down the street

Back in the summer of 2019, when I was covering Vertex’s executive chairman Jeff Leiden’s plans for the pipeline, I picked up on a distinct focus on myotonic dystrophy Type I, or DM1 — one of what Leiden called “two diseases (with DMD) we’re interested in and we continue to look for those assets.”

Today, Leiden’s successor at the helm of Vertex, CEO Reshma Kewalramani, is plunking down $250 million in cash to go the extra mile on DM1. The lion’s share of that is for the upfront, with a small reserve for equity in a deal that lines Vertex up with a neighbor in Seaport that has been rather quietly going at both of Vertex’s early disease targets with preclinical assets.

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Christian Itin, Autolus CEO (UKBIO19)

Au­to­lus tips its hand, bags $220M as CAR-T show­down with Gilead looms

The first batch of pivotal data on Autolus Therapeutics’ CAR-T is in, and execs are ready to plot a path to market.

With an overall remission rate of 70% at the interim analysis featuring 50 patients, the results set the stage for a BLA filing by the end of 2023, said CEO Christian Itin.

Perhaps more importantly — given that Autolus’ drug, obe-cel, is going after an indication that Gilead’s Tecartus is already approved for — the biotech highlighted “encouraging safety data” in the trial, with a low percentage of patients experiencing severe immune responses.

WIB22: Am­ber Salz­man had few op­tions when her son was di­ag­nosed with a rare ge­net­ic dis­ease. So she cre­at­ed a bet­ter one

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

Amber Salzman’s life changed on a cold, damp day in Paris over tiny plastic cups of lukewarm tea.

She was meeting with Patrick Aubourg, a French neurologist studying adrenoleukodystrophy, or ALD, a rare genetic condition that causes rapid neurological decline in young boys. It’s a sinister disease that often leads to disability or death within just a few years. Salzman’s nephew was diagnosed at just 6 or 7 years old, and died at the age of 12.

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Ahead of ad­comm, FDA rais­es un­cer­tain­ties on ben­e­fit-risk pro­file of Cy­to­ki­net­ic­s' po­ten­tial heart drug

The FDA’s Cardiovascular and Renal Drugs Advisory Committee will meet next Tuesday to discuss whether Cytokinetics’ potential heart drug can safely reduce the risk of cardiovascular death and heart failure in patients with symptomatic chronic heart failure with reduced ejection fraction.

The drug, known as omecamtiv mecarbil and in development for more than 15 years, has seen mixed results, with a first Phase III readout from November 2020 hitting the primary endpoint of reducing the odds of hospitalization or other urgent care for heart failure by 8%. But it also missed a key secondary endpoint analysts had pegged as key to breaking into the market.

Ab­b­Vie slapped with age dis­crim­i­na­tion law­suit, fol­low­ing oth­er phar­mas

Add AbbVie to the list of pharma companies currently facing age discrimination allegations.

Pennsylvania resident Thomas Hesch filed suit against AbbVie on Wednesday, accusing the company of passing him over for promotions in favor of younger candidates.

Despite 30 years of pharma experience, “Hesch has consistently seen younger, less qualified employees promoted over him,” the complaint states.

Rami Elghandour, Arcellx CEO

Up­dat­ed: Gilead, Ar­cel­lx team up on an­ti-BC­MA CAR-T as biotech touts a 100% re­sponse rate at #ASH22

Gilead and Kite are plunking down big cash to get into the anti-BCMA CAR-T game.

The pair will shell out $225 million in cash upfront and $100 million in equity to Arcellx, Kite announced Friday morning, to develop the biotech’s lead CAR-T program together. Kite will handle commercialization and co-development with Arcellx, and profits in the US will be split 50-50.

Concurrent with the deal, Arcellx revealed its latest cut of data for the program known as CART-ddBCMA, ahead of a full presentation at this weekend’s ASH conference — a 100% response rate among patients getting the therapy. Investors jumped at the dual announcements, sending Arcellx shares $ACLX up more than 25% in Friday’s morning session.

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WIB22: Lead­ing NK cell re­searcher re­flects on roots in Iran, the UK and Texas

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

In a small but widely-cited 11-person study published in NEJM in 2020, seven patients saw signs of their cancer completely go away after getting a new therapy made from natural killer cells. The study was one of the earliest to provide clinical proof that the experimental treatment method had promise.

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Philip Astley-Sparke, Replimune CEO

Replimune looks to rope in $225M on the back of melanoma da­ta

The Massachusetts-based, oncolytic virus biotech Replimune is feeling bullish now that it has lifted the cover on data for its lead product.

Replimune said Thursday it looks to nab about $225 million from a public offering after giving a snapshot of some initial data from its IGNYTE clinical study earlier this week. The trial is investigating RP1 in combination with Opdivo, for patients with melanoma and who did not have a response when being treated with a PD-1.