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.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

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Lisa Deschamps, AviadoBio CEO

Ex-No­var­tis busi­ness head hops over to a gene ther­a­py start­up — and she's reeled in $80M for a dash to the clin­ic

Neurologist and King’s College London professor Christopher Shaw has been researching neurodegenerative diseases like ALS and collaborating with drugmakers for the last 25 years in the hopes of pushing new therapies forward. But unfortunately, none of those efforts have come anywhere close to fruition.

“So, you know, after 20 years in the game, I said, ‘Let’s try and do it ourselves,’” he told Endpoints News. 

Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Radek Spisek, Sotio CEO (Cellestia)

A qui­et Czech biotech bags $315M to dri­ve its blos­som­ing can­cer pipeline through the clin­ic

In the rather insular world of biotech, most innovation inevitably comes from a cluster of R&D hubs — Cambridge, San Francisco, etc. But sometimes success stories sprout from rocky soil, which is most certainly the case with Prague-based Sotio Biotech and its suddenly jam-packed pipeline of cancer drugs.

After years in quiet development, Sotio now has $315 million in new funds to play with from parent company PPF Group, an investment group founded in the Czech Republic, as the biotech looks to advance its growing pipeline through early- and mid-stage trials.

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In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

Ab­b­Vie tacks on a new warn­ing to Rin­voq la­bel as safe­ty frets crimp JAK class

The safety problems that continue to plague the JAK class as new data highlight some severe side effects are casting a large shadow over AbbVie’s Rinvoq.

As a result of a recent readout highlighting major adverse cardiac events (MACE), malignancy, mortality and thrombosis with Xeljanz a couple of months ago, AbbVie put out a notice late Friday afternoon that it is adding the new class risks to its label for their rival drug.

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Biospec­i­men M&A: Dis­cov­ery ac­quires Al­bert Li's he­pa­to­cyte project; PhI­II tri­al on Bay­er's Nube­qa reached pri­ma­ry end­point

Discovery Life Sciences has acquired what claims to be the Maryland-based host of the world’s largest hepatocyte inventory, known as IVAL, to help researchers select more effective and safer drug candidates in the future.

The combined companies will now serve a wider range of drug research and development scientists, according to Albert Li, who founded IVAL in 2004 and is set to join the Discovery leadership team as the CSO of pharmacology and toxicology.

Pfiz­er, Am­gen and Janssen seek fur­ther clar­i­ty on FDA's new ben­e­fit-risk guid­ance

Three top biopharma companies are seeking more details from the FDA on how the agency conducts its benefit-risk assessments for new drugs and biologics.

While Pfizer, Amgen and Janssen praised the agency for further spelling out its thinking on the subject in a new draft guidance, including a discussion of patient experience data as part of the assessment, the companies said the FDA could’ve included more specifics in the 20-page draft document.

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