Riad Sherif, Oculis CEO

Can a top­i­cal treat­ment beat block­buster eye in­jecta­bles? A Swiss biotech has the cash now to find out

The eye dis­ease ther­a­py mar­ket is a lu­cra­tive one but a pain for pa­tients who must re­ly on in­va­sive in­jec­tions a few times per year. A Swiss biotech is hop­ing to rewrite the game with a pair of lead top­i­cal drugs, and it’s got a fresh round of cash in its war chest to get there.

Oculis has bagged a $57 mil­lion Se­ries C it will use to ad­vance lead drug OCS-01 in­to late-stage tri­als in its bid to un­seat in-the-eye in­jecta­bles for eye dis­ease as well as push ahead an­oth­er can­di­date, OCS-02, the com­pa­ny said Tues­day.

The in­ter­na­tion­al syn­di­cate on Oculis’ round was co-led by new in­vestors BVCF Man­age­ment and Hyfin­i­ty In­vest­ments, giv­ing Oculis some juice as it be­gins a slate of late-stage stud­ies in the US and abroad. First up is OCS-01, which Oculis will move in­to Phase III tri­als for di­a­bet­ic mac­u­lar ede­ma as well as com­plete reg­is­tra­tional stud­ies for the treat­ment of in­flam­ma­tion and pain fol­low­ing oc­u­lar surgery.

The first of the Phase III stud­ies is ex­pect­ed to kick off this quar­ter, CEO Ri­ad Sherif told End­points News, with en­roll­ment pri­mar­i­ly fo­cused in the US. Oculis is fo­cus­ing much of its po­ten­tial com­mer­cial strat­e­gy around the US and Chi­na, where Sherif said an ef­fec­tive top­i­cal prod­uct could of­fer a far more con­ve­nient op­tion than the cur­rent in­jecta­bles.

“We know that in the US, the av­er­age in­jec­tions per year (for these pa­tients) are around three, while in clin­i­cal tri­als they are giv­en be­tween 10 and 12 times per year,” Sherif said. “We do not have any top­i­cal prod­ucts — like noth­ing — there­fore, it’s pret­ty trans­for­ma­tive for pa­tients.”

OCS-01 is de­vel­oped us­ing Oculis’ SNP tech­nol­o­gy — that’s sol­u­bi­liz­ing nanopar­ti­cles — which it says can make drugs in­to a top­i­cal so­lu­tion. Mean­while, OCS-02 is a TNF in­hibitor Oculis hopes to ad­vance in­to Phase IIb tri­als tar­get­ing dry eye dis­ease and chron­ic an­te­ri­or uveitis as an al­ter­na­tive to steroids. The mol­e­cule has shown promise in two pri­or proof-of-con­cept stud­ies, Oculis said, and turned out an in­ter­est­ing geno­type bio­mark­er on re­view that Sherif said could open the doors for use as the first per­son­al­ized op­tions for dry eye dis­ease pa­tients.

If all goes to plan, Oculis will be­gin read­ing out da­ta from those four fo­cal point stud­ies in the June/Ju­ly time frame next year, Sherif said, with the OCS-02 stud­ies ex­pect­ed to read out in Q4 2022 and then mid-2023.

The com­pa­ny cur­rent­ly sports 20 em­ploy­ees as well as a strong net­work of con­tract re­searchers. The plan is to bring full-time staff up to about 30 or 35, with a fo­cus on adding R&D func­tions in the short term, Sherif said.

In ad­di­tion to BVCF and Hyfin­i­ty, the round was joined by new in­vestors VI Part­ners and Wille AG, and ex­ist­ing in­vestors Bay City Cap­i­tal, Brun­nur Ven­tures, Early­Bird, funds man­aged by Tekla Cap­i­tal Man­age­ment, Piv­otal bioVen­ture Part­ners, Nan Fung Life Sci­ences, No­var­tis Ven­ture Fund, Sil­furberg, and oth­ers.

Ed­i­tor’s Note: This sto­ry has been up­dat­ed to cor­rect an er­ror. On­ly Oculis OCS-01 is de­vel­op­ing us­ing SNP tech­nol­o­gy.

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

UP­DAT­ED: Gink­go Bioworks re­sizes the de­f­i­n­i­tion of go­ing big in biotech, rais­ing $2.5B in a record SPAC deal that weighs in with a whop­ping $15B-plus val­u­a­tion

Ginkgo Bioworks execs always thought big. But today should redefine just how big an upstart biotech player can dream.

In the largest SPAC deal to clear the hurdles to Nasdaq, the biotech that envisioned everything from remaking synthetic meat to a whole new approach to developing drugs has joined forces with one of the biggest disruptors in biotech to slam the Richter scale on dealmaking.

Soon after becoming the darling of the VC crew and clearing the bar on a $4 billion valuation, Ginkgo — a synthetic biotech player out to reprogram cells with industrial efficiency — has now struck a deal to go public in the latest leviathan SPAC that sets its pre-money valuation at $15 billion. In one swift vault, Ginkgo will combine with Harry Sloan’s Soaring Eagle Acquisition Corp. and leap into the public markets.

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Chris Garabedian (Xontogeny)

Per­cep­tive Ad­vi­sors, Xon­toge­ny bring the band back and then some with a $515M sec­ond fund sniff­ing out lead com­pounds

When Perceptive Advisors and startup accelerator Xontogeny initially teamed up on an early-stage VC round in 2019, the partners hoped to prove their investments could be a force multiplier for early-stage companies. Now, with that proof of concept behind them, the pair have closed a second VC round worth more than double the money.

Dubbed PXV Fund II and headed by Xontogeny CEO and former Sarepta head Chris Garabedian, the $515 million fund will target 10 to 12 early-stage preclinical companies with Series A rounds in the $20 million to $40 million range with opportunities for Series B follow-ups. The oversubscribed fund is bringing the band back with initial investors from PXVI as well as new investors that include “top-tier” asset managers, endowments, foundations, family offices, and individual investors.

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Stephen Squinto, Gennao Bio CEO (Gennao)

Alex­ion co-founder Stephen Squin­to is back in the game as CEO, this time for a small gene ther­a­py play­er

With his name already behind a rare disease success story in Alexion, Stephen Squinto was looking for a great story to drive him to jump back into the biotech game. He found that in a fledging non-viral gene therapy company, and now he’s got a few backers on board as well.

On Tuesday, Gennao Bio launched with a $40 million Series A co-led by OrbiMed and Logos Capital with participation by Surveyor Capital. The biotech, which is looking to use its cell-penetrating antibody platform to deliver nucleic acid “payloads” during into the nucleus, had to rush for its initial series — and had a name change along the way.

FDA un­veils six ICH guide­lines ahead of meet­ing with Health Cana­da

A sign that the FDA’s non-Covid-related processes are beginning to normalize: The release of six guidelines from the International Council of Harmonisation.

Years in development, the ICH documents offer an international perspective on drug development, with these latest guidelines covering everything from recommendations to support the classification of drug substances, featured in the M9 guidance, to standards for nonclinical safety studies for pediatric medicines in the S11 guideline.

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Sanofi, Glax­o­SmithK­line, Boehringer ac­cused of play­ing games, de­stroy­ing emails re­lat­ed to law­suit over con­t­a­m­i­nat­ed Zan­tac

A recent court filing raises new questions about how major pharma companies like Sanofi, GlaxoSmithKline, and Boehringer Ingelheim have dealt with a lawsuit related to recalls of certain over-the-counter heartburn drugs due to the presence of a potentially cancer-causing substance found in them.

More than 70,000 people who took Sanofi’s Zantac and other heartburn drugs containing ranitidine, which have been recalled over the past two years, have sued the manufacturers, including generic drugmakers, and other retailers and distributors as part of a consolidated suit before US District Court Judge Robin Rosenberg in Florida.

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Dan Vahdat, Huma CEO (Yang Guanyu/Xinhua/Alamy Live News)

With back­ing from Bay­er, a Lon­don firm will pitch its 'hos­pi­tals at home' con­cept for de­cen­tral­ized tri­als

Money is flying for companies promising to revolutionize the way clinical trials are conducted. Leaps by Bayer is the latest to get behind one of these players, leading a $200 million venture round for Huma Therapeutics and its digital “hospital at home” tech.

London-based Huma unveiled a $130 million Series C on Wednesday, which it will use to expand its digital platform in the US, Asia and the Middle East. As part of the round, the company can exercise another $70 million commitment later on.

David Halbert, Caris Life Sciences CEO (Caris via Twitter)

The grow­ing liq­uid biop­sy field sees a uni­corn en­trant as Caris pulls in $830M megaround

Caris Life Sciences has pulled in another massive raise, and this time they’re reportedly one step closer to launching their IPO.

The AI-focused Caris pulled in an $830 million growth equity round, the company announced Tuesday afternoon, earning a valuation of about $7.83 billion. Tuesday’s raise also brings their total financing amount to $1.3 billion since 2018 and $1.14 billion since last October. According to the Wall Street Journal, which first reported on the raise, Caris expects to complete their IPO sometime within the next 12 months.

A clos­er look at the FDA’s more than 700 pan­dem­ic-re­lat­ed record re­quests to re­place on­site in­spec­tions

As the pandemic constrained the FDA’s ability to travel for onsite manufacturing inspections, the agency increasingly turned to requesting records to fill the gap, even for hundreds of US-based facilities.

FDA explains in its guidance on manufacturing inspections during the pandemic that the agency can request records (not to be confused with the FDA’s remote interactive evaluations) directly from facilities “in advance of or in lieu of” certain onsite inspections. Companies are legally required to fulfill those requests because a denial may be considered limiting an inspection, which could lead to the FDA deeming a drug made at that site to be adulterated.

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