Elad Kedar, Orasis CEO (Orasis)

Ora­sis Phar­ma­ceu­ti­cals snags $30M to see its pres­by­opia treat­ment through to PhI­II

Ora­sis Phar­ma­ceu­ti­cals is one of sev­er­al biotechs de­vel­op­ing mi­otic-based eye drops as a po­ten­tial al­ter­na­tive to read­ing glass­es — one drop, and no more squint­ing at text mes­sages. With the help of a $30 mil­lion Se­ries C, the Is­rael-based com­pa­ny has its sights set on Phase III.

“Read­ing glass­es are in­con­ve­nient, they are not aes­thet­i­cal­ly pleas­ing for many peo­ple, and then fi­nal­ly, they are al­so one of the very first signs of ag­ing,” said CEO Elad Kedar, who joined Ora­sis in 2015 short­ly af­ter the com­pa­ny was found­ed.

The pres­by­opia treat­ment works through pupil mod­u­la­tion — con­strict­ing the pupil to cre­ate a “pin­hole ef­fect” and in­crease depth of field, im­prov­ing near vi­sion. The chal­lenge is find­ing the “sweet spot,” Kedar said. Con­strict the pupil too far, and pa­tients could ex­pe­ri­ence near­sight­ed­ness.

Ora­sis will use Se­ries C fund­ing to push its lead can­di­date, CSF-1, in­to Phase III. Two iden­ti­cal tri­als will be con­duct­ed in the US with about 300 par­tic­i­pants each, Kedar said, adding that it’s a ‘mat­ter of weeks” be­fore test­ing be­gins. The com­pa­ny will eval­u­ate the drug for ef­fi­ca­cy, safe­ty and com­fort.

Ora­sis met its pri­ma­ry end­point in a Phase IIb study of CSF-1 with about 160 par­tic­i­pants. The drug showed three-line im­prove­ment in par­tic­i­pants’ abil­i­ty to read an ET­DRS chart, a stan­dard eye chart used by oph­thal­mol­o­gists, Kedar said.

But the biotech isn’t alone in the race for a mi­otic-based eye drop. Ab­b­Vie is cur­rent­ly in Phase III with its can­di­date, pres­bysol, which it in­her­it­ed in the Al­ler­gan buy­out. PRX-100, in de­vel­op­ment by Pres­by­opia Ther­a­pies, is ex­pect­ed to en­ter Phase III this year, ac­cord­ing to Mod­ern Op­tom­e­try. And in a proof-of-con­cept study, 78% of pa­tients giv­en OS­RX Phar­ma­ceu­ti­cals’ Eye Fo­cus main­tained 20/40 vi­sion for 8 hours.

“There is a lot of ex­pec­ta­tion for eye drops for pres­by­opia to be­come very strong el­e­ments with­in the tools that eye care pro­fes­sion­als can fi­nal­ly pro­vide their pa­tients,” Kedar said.

In ad­di­tion to con­duct­ing its Phase III study, Ora­sis will use the Se­ries C to help pre­pare for a com­mer­cial launch.

“I mean, we’re not try­ing to elim­i­nate read­ing glass­es from the world. There are some peo­ple that would like to use the drop every day when they go to work, and some peo­ple may want to use it when they go Fri­day night to the restau­rant and they don’t want to use the read­ing glass­es … ” Kedar said. “So, this is re­al­ly … what we are go­ing to be able to of­fer so many peo­ple in the US and glob­al­ly.”

The fi­nanc­ing round was led by Bluestem Cap­i­tal and Vi­sion­ary Ven­tures, and joined by re­turn­ing in­vestors in­clud­ing Se­quoia Cap­i­tal, SBI (Japan) In­no­va­tion Fund, Mav­er­ick Ven­tures Is­rael and LifeSci Ven­ture Part­ners.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

#ES­MO20: Push­ing in­to front­line, Mer­ck and Bris­tol My­ers duke it out with new slate of GI can­cer da­ta

Having worked in parallel for years to move their respective PD-1 inhibitors up to the first-line treatment of gastrointestinal cancers, Merck and Bristol Myers Squibb finally have the data at ESMO for a showdown.

Comparing KEYNOTE-590 and CheckMate-649, of course, comes with the usual caveats. But a side-by-side look at the overall survival numbers also offer some perspective on a new frontier for the reigning checkpoint rivals, both of whom are claiming to have achieved a first.

President Donald Trump (via AP Images)

Signs of an 'Oc­to­ber Vac­cine Sur­prise' alarm ca­reer sci­en­tists

President Donald Trump, who seems intent on announcing a COVID-19 vaccine before Election Day, could legally authorize a vaccine over the objections of experts, officials at the FDA and even vaccine manufacturers, who have pledged not to release any vaccine unless it’s proved safe and effective.

In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Trump — who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA — will take matters into his own hands, running roughshod over the usual regulatory process.

#ES­MO20: Bris­tol My­ers marks Op­di­vo's sec­ond ad­ju­vant win — eye­ing a stan­dard of care gap

Moving into earlier and earlier treatment lines, Bristol Myers Squibb is reporting that adjuvant treatment with Opdivo has doubled the time that esophageal or gastroesophageal junction cancer patients stay free of disease.

With the CheckMate-577 data at ESMO, CMO Samit Hirawat said, the company believes it can change the treatment paradigm.

While a quarter to 30% of patients typically achieve a complete response following chemoradiation therapy and surgery, the rest do not, said Ronan Kelly of Baylor University Medical Center. The recurrence rate is also high within the first year, Hirawat added.

Jonathan Rigby, Immune Regulation group CEO

Im­mune Reg­u­la­tion, tak­ing two clin­i­cal pro­grams to 're­set' the im­mune sys­tem, nets $53M+ Se­ries B

A little under two years after a company rebranding, Immune Regulation is taking an even bigger step toward advancing its goals.

Formerly known as Peptinnovate, the British biotech announced a $53.4 million Series B early Monday morning, helping to further advance two clinical programs in rheumatoid arthritis and asthma. Though those are the two initial indications the company is focusing on, CEO Jonathan Rigby told Endpoints News he hopes the candidates can be applied to a broad swath of autoimmune disorders.

Eli Lilly CSO Dan Skovronsky (file photo)

UP­DAT­ED: #ES­MO20: Eli Lil­ly shows off the da­ta for its Verzenio suc­cess. Was it worth $18 bil­lion?

The press release alone, devoid of any number except for the size of the trial, added nearly $20 billion to Eli Lilly’s market cap back in June. Now investors and oncologists will get to see if the data live up to the hype.

On Sunday at ESMO, Eli Lilly announced the full results for its Phase III MonarchE trial of Verzenio, showing that across over 5,000 women who had had HR+, HER2- breast cancer, the drug reduced the odds of recurrence by 25%. That meant 7.8% of the patients on the drug arm saw their cancers return within 2 years, compared with 11.3% on the placebo arm.

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Greg Friberg (File photo)

#ES­MO20: Am­gen team nails down sol­id ear­ly ev­i­dence of AMG 510’s po­ten­tial for NSCLC, un­lock­ing the door to a wave of KRAS pro­grams

The first time I sat down with Amgen’s Greg Friberg to talk about the pharma giant’s KRAS G12C program for sotorasib (AMG 510) at ASCO a little more than a year ago, there was high excitement about the first glimpse of efficacy from their Phase I study, with 5 of 10 evaluable non-small cell lung cancer patients demonstrating a response to the drug.

After decades of failure targeting KRAS, sotorasib offered the first positive look at a new approach that promised to open a door to a whole new approach by targeting a particular mutation to a big target that had remained “undruggable” for decades.

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#ES­MO20: Out to beat Tagris­so, J&J touts 100% ORR for EGFR bis­pe­cif­ic/TKI com­bo — fu­el­ing a quick leap to PhI­II

J&J’s one-two punch on EGFR-mutant non-small cell lung cancer has turned up some promising — although decidedly early — results, fueling the idea that there’s yet room to one up on third-generation tyrosine kinase inhibitors.

Twenty out of 20 advanced NSCLC patients had a response after taking a combination of an in-house TKI dubbed lazertinib and amivantamab, a bispecific antibody targeting both EGFR and cMET engineered on partner Genmab’s platform, J&J reported at ESMO. All were treatment-naïve, and none has seen their cancer progress at a median follow-up of seven months.

Is­raeli biotech rais­es $57M to go where cur­rent BRAF in­hibitors can't, with back­ing from No­var­tis, SR One

For the blockbuster potential of Novartis’ Tafinlar and Pfizer’s Braftovi, all the BRAF inhibitors on the market so far only target V600 mutations — which accounts for roughly 50% of patients.

Israeli biotech Novellus now has $57 million to develop a drug that they say can help the other 50% who have everything else.

The Series C will fund a Phase II trial for PLX-8394, a “paradox breaker” that could block RAF without activating MAPK signaling. In a Phase I trial, a patient with a BRAF fusion saw their tumor go away after taking the drug, allowing Novellus to hit the ground running.