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.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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Alaa Halawa, executive director at Mubadala’s US venture group

The ven­ture crew at Mubadala are up­ping their biotech cre­ation game, tak­ing care­ful aim at a new fron­tier in drug de­vel­op­ment

It started with a cup of coffee and a slow burning desire to go early and long in the biotech creation business.

Wrapping up a 15-year discovery stint at Genentech back in the summer of 2021, Rami Hannoush was treated to a caffeine-fueled review of the latest work UCSF’s Jim Wells had been doing on protein degradation — one of the hottest fields in drug development.

“Jim and I have known each other for the past 15 years through Genentech collaborations. We met over coffee, and he was telling me about this concept of the company that he was thinking of,” says Hannoush. “And I got immediately intrigued by it because I knew that this could open up a big space in terms of adding a new modality in drug discovery that is desperately needed in pharma.”

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Sanofi, Re­gen­eron boast PhI­II win with Dupix­ent in COPD, clear­ing first bar for ex­pan­sion

Dupixent, the blockbuster anti-inflammatory drug from Sanofi and Regeneron, has cleared a high-stakes Phase III study in chronic obstructive pulmonary disease, the companies announced Thursday morning.

If they hold up in a second, identical trial, the data pave the way for Dupixent to become the first biologic to treat patients whose COPD remains uncontrolled despite being on maximal standard-of-care inhaled therapy — the patient population studied in the pivotal program. The companies had spotlighted this as a key readout as they look to expand the Dupixent franchise and explore its full potential.

Genen­tech to stop com­mer­cial man­u­fac­tur­ing at Cal­i­for­nia head­quar­ters

Genentech is halting commercial manufacturing at its California headquarters — and laying off several hundred employees.

The move is the result of a decision Genentech made in 2007 to relocate manufacturing operations from its South San Francisco headquarters location to other facilities or move the work to CDMOs, said Andi Goddard, Genentech’s SVP of quality and compliance for pharmaceutical technical operations, in an interview with Endpoints News. Genentech has made changes in capabilities and invested more in technology, so it doesn’t need as many large-scale manufacturing facilities as it did in the past, she said.

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Chat­G­PT with phar­ma da­ta de­buts for med­ical meet­ings, be­gin­ning with AACR

What do you get when you combine ChatGPT generative AI technology with specific pharma and clinical datasets? A time-saving tool that can answer questions about medical conference abstracts and clinical findings in seconds in one new application from ZoomRx called FermaGPT.

ZoomRx is debuting a public version of its generative AI product specifically for medical conferences beginning this week for the upcoming American Association for Cancer Research (AACR) annual meeting that runs April 14-19.

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Quince Ther­a­peu­tics faces takeover bid from share­hold­er Echo Lake Cap­i­tal

A bid to take over the biotech Quince Therapeutics has been put forward by one of its shareholders.

On Tuesday, Echo Lake Capital sent a letter to Quince’s board of directors putting forth a proposal to acquire all the biotech’s stock for $1.60 per share, which would value a takeover at around $58 million.

In the letter, Echo Lake said that it believes Quince’s stock is severely undervalued and that no drugs are being actively marketed or developed that require cash expenditures. It’s trading below the value of its assets, Echo Lake said.

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Flare Therapeutics biochemists Yong Li (L) and Valerie Vivat

A $123M Flare will get Third Rock on­col­o­gy biotech in­to the clin­ic this year

Flare Therapeutics will start its first human trial this year with an investigational urothelial cancer drug after pulling together a $123 million Series B from Big Pharmas, VCs and its incubator, Third Rock Ventures.

Launched in 2021 on the idea that a biotech could finally succeed at drugging the much-sought-after but stubborn transcription factor, Flare Therapeutics said Wednesday it is now primed for the clinic after closing its large financing haul earlier this year. The raise is a relatively stark figure in a tough startup financing environment but further buoys the upbeat signals coming out of other Third Rock biotechs in recent weeks, including the $200 million CARGO Therapeutics and $100 million Rapport Therapeutics rounds.

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In­cyte wins ac­cel­er­at­ed ap­proval for PD-1 in rare skin can­cer

Incyte touted an accelerated approval for its PD-1 retifanlimab in a rare skin cancer on Wednesday, roughly a year and a half after the drug suffered a rejection in squamous cell carcinoma of the anal canal (SCAC).

Retifanlimab, marketed as Zynyz, was approved for metastatic or recurrent locally advanced Merkel cell carcinoma (MCC), a fast-growing skin cancer typically characterized by a single, painless nodule. It’s roughly 40 times rarer than melanoma, according to the nonprofit Skin Cancer Foundation — but incidence is growing, particularly among older adults, Incyte said in its announcement.