No­var­tis backs eye drop mak­er in $20M round, meds to fill gap left by Eylea/Lu­cen­tis

Eye-ob­sessed No­var­tis, in a syn­di­cate with oth­er in­vestors, has backed a $20 mil­lion round for Swiss biotech Oculis. The hope is to see the com­pa­ny’s ex­per­i­men­tal eye drops even­tu­al­ly snag a chunk of the mar­ket that drugs like Eylea and Lu­cen­tis have failed to cap­ture.

The 15-year-old com­pa­ny is work­ing on a top­i­cal ver­sion of the well-known steroid dex­am­etha­sone with the goal of de­liv­er­ing the drug via eye drops. The prod­uct can­di­date, which the com­pa­ny is call­ing OC-118, is be­ing de­vel­oped us­ing Oculis’ nov­el plat­form called “sol­u­bi­liz­ing nanopar­ti­cle” tech­nol­o­gy, or SNP. This tech­nol­o­gy, the com­pa­ny hopes, can boost the drug’s abil­i­ty to reach the front and the back of the eye — some­thing that pre­vi­ous drugs haven’t achieved un­less de­liv­ered via nee­dle to the eye.

De­liv­er­ing dex­am­etha­sone top­i­cal­ly could be sig­nif­i­cant for pa­tients with di­a­bet­ic mac­u­lar ede­ma (DME), the pa­tient group Oculis is first tar­get­ing. Along with a slew of oth­er symp­toms di­a­bet­ics en­dure, mac­u­lar ede­ma is one of those com­pli­ca­tions that can arise over the course of a di­a­bet­ic’s life. The con­di­tion in­volves swelling of the reti­na due to leak­ing flu­ids from blood ves­sels, and it af­fects about 7% of cur­rent di­a­bet­ics and 25% of di­a­bet­ics who have had the dis­ease for 20 years or longer. DME is al­so the lead­ing cause of blind­ness in young adults in de­vel­oped coun­tries.

Right now, there are four ap­proved drugs that can treat DME: Eylea, Lu­cen­tis, Ozur­dex, and Ilu­vien. To reach the back of the eye where the drug is need­ed, the meds have had to be for­mu­lat­ed as in­jecta­bles.

“The down­side is hav­ing a nee­dle in the eye,” Oculis’ CEO Ri­ad Sherif tells me. He al­so adds that these in­jectable drugs re­quire fre­quent trips to spe­cial­ists.

If OC-118 works, it would be the first eye drop prod­uct that pa­tients could take home and use to treat them­selves. And Sherif es­ti­mates that it could cap­ture 25-30% of the DME mar­ket.

“This is the holy grail if it works,” Sherif said. “It would mean a com­plete­ly new era of treat­ment, and it would be trans­for­ma­tive for eye care.”

OC-118 is cur­rent­ly in a Phase IIb tri­al to test for im­prove­ment in vi­su­al acu­ity and re­duc­tion of cen­tral mac­u­lar thick­ness in DME pa­tients. Oculis is al­so ad­vanc­ing OC-118 in oth­er oph­thalmic in­di­ca­tions.

The new cash from this round came from No­var­tis Ven­ture Fund, Bay City Cap­i­tal, and Piv­otal bioVen­ture Part­ners, along with ex­ist­ing in­vestors.

Sherif, who is still new in the CEO seat, came along with the fi­nanc­ing. He comes from No­var­tis Ven­ture Fund, where he was an en­tre­pre­neur-in-res­i­dence. But he tells me a No­var­tis-ap­point­ed CEO was not nec­es­sar­i­ly part of the deal.

“It was not an oblig­a­tion at all, it was more my­self be­ing re­al­ly ex­cit­ed about this tech­nol­o­gy, the med­ical need, and ex­cit­ed about what the team has been able to do,” said Sherif, who for­mer­ly served as an area pres­i­dent at glob­al eye care com­pa­ny Al­con. “It mo­ti­vat­ed me to move on to some­thing new.”

Fund­ing Oculis makes sense for No­var­tis’ ven­ture arm, as the drug­mak­er has made a point to build its eye drug pipeline and ex­per­tise in the field. The com­pa­ny has a strong in­ter­est in oph­thal­mol­o­gy, and its block­buster Eylea ri­val RTH258 has been tout­ed as a $1-bil­lion-plus drug for wet age-re­lat­ed mac­u­lar de­gen­er­a­tion.

Oculis is re­lo­cat­ing its head­quar­ters from Ice­land to Switzer­land, al­though R&D will re­main in Ice­land.

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.

The slate of products we’re offering here at Endpoints is continuing to grow, and it’s not just limited to editorial. If you haven’t, do visit your reader profile to see if there are any other weekly newsletters you’re interested in — as each comes with its own exclusive content. And don’t miss the publisher’s note from Arsalan Arif on Endpoints Studio, our latest avenue for advertising on Endpoints.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,600+ biopharma pros reading Endpoints daily — and it's free.

Usama Malik

Ex-Im­munomedics CFO charged with in­sid­er trad­ing, faces up to 20 years in prison af­ter al­leged­ly tip­ping off girl­friend and rel­a­tives of a PhI­II suc­cess

The former CFO of Immunomedics, who helped steer the company to its $21 billion buyout by Gilead last year, has been charged with insider trading, the Department of Justice announced Thursday.

Usama Malik tipped off his then-girlfriend and four others that a Phase III study for Trodelvy would be stopped early four days before Immunomedics publicly announced the result in April 2020, DoJ alleged in its complaint. The individuals then purchased Immunomedics shares, selling them after the news broke and Immunomedics’ stock price doubled.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,600+ biopharma pros reading Endpoints daily — and it's free.

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.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,600+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,600+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,600+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,600+ biopharma pros reading Endpoints daily — and it's free.