CEO Marc Gleeson (Azura)

Azu­ra Oph­thalmics gets a $20M boost for its R&D work on eye dis­eases

Three years af­ter clos­ing a $16 mil­lion Se­ries B, the same group of in­vestors are back to give Azu­ra Oph­thalmics a $20 mil­lion boost.

That brings the Tel Aviv-Yafo, Is­rael-based biotech’s to­tal fundraise to $38 mil­lion, and should pave the way for a reg­is­tra­tion study of its lead can­di­date in Mei­bo­mi­an gland dys­func­tion (MGD) and re­lat­ed eye dis­eases, CEO Marc Glee­son told End­points News.

The top­i­cal can­di­date, dubbed AZR-MD-001, is de­signed to ad­dress ab­nor­mal hy­per­k­er­a­tiniza­tion, or the build-up and shed­ding of pro­teins at the open­ing of or with­in the Mei­bo­mi­an gland. When Mei­bo­mi­an glands be­come dys­func­tion­al, rapid evap­o­ra­tion of the tear film can oc­cur, lead­ing to dry eye dis­ease.

“If suc­cess­ful, we think we will have a fair­ly dra­mat­ic im­pact on the key rea­son why peo­ple end up with dry eye dis­ease,” Glee­son said. The can­di­date would be ap­plied to the low­er eye­lid be­fore bed­time.

The ap­proach has been used for decades in der­ma­tol­ogy. While study­ing MGD, Azu­ra’s founders “re­al­ized that there was this link be­tween the func­tion­al­i­ty of Mei­bo­mi­an glands and se­ba­ceous glands” in the skin, Glee­son ex­plained. The can­di­date is now at the thresh­old of a reg­is­tra­tion study in MGD, and is al­so be­ing test­ed in oth­er in­di­ca­tions such as con­tact lens in­tol­er­ance.

“The cur­rent op­tions we have to treat pa­tients with Mei­bo­mi­an gland dys­func­tion fo­cus pri­mar­i­ly on re­liev­ing ob­struc­tion and have not fo­cused on the role of ker­atin with­in meibum. There are mil­lions of pa­tients with oc­u­lar sur­face dis­ease and MGD world­wide; we need bet­ter treat­ments to help our symp­to­matic pa­tients,” Preeya Gup­ta, clin­i­cal med­ical di­rec­tor of Duke Eye Cen­ter at Page Road and as­so­ciate pro­fes­sor of oph­thal­mol­o­gy at Duke Uni­ver­si­ty Eye Cen­ter, said in a state­ment.

Azu­ra ex­pects the first reg­is­tra­tion study in MGD to take place in Aus­tralia and New Zealand, yield­ing re­sults in 2021 or ear­ly 2022. That study will be fol­lowed by a sec­ond reg­is­tra­tion tri­al, Glee­son said. He ex­pects a full read-out on Phase II da­ta in Q1 of next year.

The 4-year-old biotech has sev­er­al oth­er can­di­dates in the pipeline, in­clud­ing ones for ble­phar­i­tis and aque­ous de­fi­cient dry eye.

Azu­ra’s re­cent fi­nanc­ing was led by Or­biMed, TPG Biotech, Bran­don Cap­i­tal’s Med­ical Re­search Com­mer­cial­iza­tion Fund, and Gan­ot Cap­i­tal.

“We’re very pos­i­tive, and we look for­ward to get­ting on with the reg­is­tra­tion stud­ies and mov­ing the pro­gram for­ward,” Glee­son said.

Im­ple­ment­ing re­silience in the clin­i­cal tri­al sup­ply chain

Since January 2020, the clinical trials ecosystem has quickly evolved to manage roadblocks impeding clinical trial integrity, and patient care and safety amid a global pandemic. Closed borders, reduced air traffic and delayed or canceled flights disrupted global distribution, revealing how flexible logistics and supply chains can secure the timely delivery of clinical drug products and therapies to sites and patients.

In fi­nal days at Mer­ck, Roger Perl­mut­ter bets big on a lit­tle-known Covid-19 treat­ment

Roger Perlmutter is spending his last days at Merck, well, spending.

Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

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Pascal Soriot (AP Images)

UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Peter Thiel (Riccardo Savi/Sipa via AP Images)

Tech bil­lion­aire Pe­ter Thiel backs a lead­ing psy­che­del­ic drug de­vel­op­er

Right on the heels of investing in antibody drug developer AbCellera, Facebook billionaire Peter Thiel has jumped into a syndicate putting up $125 million for a company with a portfolio of psychedelic drugs in the clinic for mental health.

The C round — which includes a $32 million conversion of notes to equity — will fuel the development programs at ATAI Life Sciences, a Berlin-based biotech that has assembled a portfolio of companies with psychedelic and non-psychedilc approaches to depression, anxiety and addiction.

Ramy Farid, Schrödinger CEO (Schrödinger)

Bris­tol My­ers fronts new Schrödinger al­liance with $55M up­front, ex­pand­ing pre­ci­sion on­col­o­gy pro­file

Bristol Myers Squibb has a new R&D partner, one to which they’re paying a pretty penny to use their discovery platform.

The pharma company is doling out $55 million upfront to Schrödinger $SDGR to work on up to five small molecules, with the potential for $2.7 billion in milestone payments. Schrödinger’s initial targets include HIF-2 alpha and SOS1/KRAS for a type of kidney cancer and KRAS-driven cancers, respectively.

Carl Hansen, AbCellera CEO (University of British Columbia)

From a pair of Air Jor­dans to a $200M-plus IPO, Carl Hansen is craft­ing an overnight R&D for­tune fu­eled by Covid-19

Back in the summer of 2019, Carl Hansen left his post as a professor at the University of British Columbia to go full time as the CEO at a low-profile antibody shop he had founded called AbCellera.

As biotech CEOs go, even after a fundraise Hansen wasn’t paid a whole heck of a lot. He ended up earning right at $250,000 for the year. His compensation package included a loan — which he later paid back — and a pair of Air Jordan tennis shoes. His newly-hired CFO, Andrew Booth, got a sweeter pay packet than that — which included his own pair of Air Jordans.

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Frank Zhang (AP Images)

Plot thick­ens around Leg­end Biotech, Gen­Script with founder Frank Zhang's ar­rest

Two months after Legend Biotech made the startling disclosure that founder and then-CEO Frank Zhang was placed under “residential surveillance,” its parent company revealed that he’s been formally arrested.

Zhang — who, since founding GenScript 18 years ago, has taken the CRO public and groomed Legend Biotech in-house until the J&J-partnered CAR-T player was mature enough for its own Nasdaq listing — is severing his final ties with both. He is resigning as board chair/non-executive director of GenScript and director of Legend.

Vipin Suri, Catamaran Bio CSO

Cata­ma­ran Bio sails in­to the CAR-NK wa­ters with a $42M launch round

Catamaran Bio’s founding members decided to jump into the CAR-NK game last December over drinks at a trendy bar in Boston.

They were sitting around a table, discussing an MD Anderson study which provided some of the first clinical proof that natural killer (NK) cells can be reengineered to attack tumors, much like CAR-T therapies. It was a “long and lively” discussion, COO Mark Boshar recalls. And by the time it was over, they had a starting point to launch a company.

Leonard Schleifer, Regeneron CEO (Andrew Harnik/AP)

Trail­ing Eli Lil­ly by 12 days, Re­gen­eron gets the FDA OK for their Covid-19 an­ti­body cock­tail

A month and a half after becoming the experimental treatment of choice for a newly diagnosed president, Regeneron’s antibody cocktail has received emergency use authorization from the FDA. It will be used to treat non-hospitalized Covid-19 patients who are at high-risk of progressing.

Although the Rgeneron drug is not the first antibody treatment authorized by the FDA, the news comes as a significant milestone for a company and a treatment scientists have watched closely since the outbreak began.