David Eveleth, Trefoil

San Diego oph­thalmic biotech up­start rais­es $28M on al­ter­na­tive to corneal trans­plant

Texas VC Bios Part­ners has found a new ear­ly-stage play to love out of San Diego, lead­ing a $28 mil­lion Se­ries A to help Tre­foil Ther­a­peu­tics make the leap to the clin­ic.

Stel­la Robert­son Bios Part­ners

Stel­la Robert­son, who head­ed R&D at No­var­tis’ eye care unit Al­con be­fore co-found­ing Bios Part­ners, is par­tic­u­lar­ly ex­cit­ed about this one. With a tech plat­form that en­gi­neers fi­brob­last growth fac­tor-1 pro­tein (FGF-1), Tre­foil is out to tack­le se­ri­ous corneal en­dothe­lial dis­eases and ep­ithe­lial dis­or­ders by prompt­ing the en­dothe­lial cells to flour­ish and mi­grate. Ul­ti­mate­ly — if the pre­clin­i­cal da­ta hold up — the goal is to en­hance heal­ing and re­verse vi­sion loss.

“Tre­foil’s re­gen­er­a­tive ap­proach of­fers a promis­ing op­por­tu­ni­ty to de­vel­op first-in-class phar­ma­co­log­ic treat­ments for corneal dis­eases,” Robert­son said in a state­ment.

A new op­tion in this space could al­low for ear­li­er treat­ment and cut down on the need for cornea surgery trans­plant, which of­ten leaves pa­tients re­liant on im­muno­sup­pres­sants for life, added Pro­fes­sor Richard Ab­bott of UCSF.

FGF-1 ex­perts Ralph Brad­shaw, Ken Thomas and Michael Blaber pro­vid­ed the sci­en­tif­ic foun­da­tion for the com­pa­ny, with the fi­nal tech­nol­o­gy li­censed from Blaber’s lab at Flori­da State Uni­ver­si­ty. David Eveleth — who led the oph­thal­mol­o­gy group at Pfiz­er for over 10 years — joined the co-founder group and took up the CEO role.

With the new fund, the small team plans to first test an in­tra­cam­er­al in­jec­tion of their lead drug, TTHX1114, ear­ly next year for cornea sur­face dis­ease, al­so known as en­dothe­lial dy­s­tro­phy. The cash in­fu­sion will al­so fund IND-en­abling stud­ies of a top­i­cal for­mu­la­tion in pa­tients with ul­cer­a­tive con­di­tions of the cornea. That sec­ond IND is slat­ed for 2021.

Ac­cess Biotech­nol­o­gy came on board for the round, along­side all ex­ist­ing in­vestors. The full list: Hat­teras Ven­ture Part­ners, Aju IB In­vest­ment, Cor­re­la­tion Ven­tures, ExSight Ven­tures and In­Fo­cus Cap­i­tal Part­ners.

5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

Hal Barron, GSK via YouTube

What does $29B buy you in Big Phar­ma? In Glax­o­SmithK­line’s case, a whole lot of un­com­fort­able ques­tions about the pipeline

Talk about your bad timing.

A little over a week ago, GSK R&D chief Hal Barron marked his third anniversary at the research helm by taking a turn at the virtual podium during JP Morgan to make the case that he and his team had built a valuable late-stage pipeline capable of churning out more than 10 blockbusters in the next 5 years.

And then, just days later, one of the cancer drugs he bet big on as a top prospect — bintrafusp, partnered with Merck KGaA — failed its first pivotal test in non-small cell lung cancer.

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Janet Woodcock (AP Images)

End­points poll: Janet Wood­cock takes the (in­ter­im) helm at the FDA. And a large ma­jor­i­ty of our read­ers want her to stay there

It’s official: Janet Woodcock is now the acting chief of the FDA.

And — according to an Endpoints poll — most industry readers would like her to stay there, although a significant minority is strongly opposed.

To recap: Joe Biden is reportedly choosing between Woodcock and former deputy FDA commissioner Joshua Sharfstein as his nominee for the permanent position. Given their respective track records, the decision is set to determine the agency’s lodestar for years to come.

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What’s next for End­points — and how to sup­port our in­de­pen­dent bio­phar­ma news mis­sion

The firehose of biopharma news is gushing these days.

That’s why broader and deeper is the theme for 2021 at Endpoints. You can expect new coverage outside our core R&D focus, with deeper reporting in some key areas. When John Carroll and I launched Endpoints nearly five years ago, we were wading in waist-high waters. Now we’re a team of 25 full-time staffers (and growing) with plans to cover the flood of biopharma news, Endpoints-style.

Janet Woodcock and Joshua Sharfstein (AP, Images)

Poll: Should Joshua Sharf­stein or Janet Wood­cock lead the FDA from here?

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.

Fast on Glax­o­SmithK­line's heels, Au­rinia wins OK to steer a sec­ond lu­pus nephri­tis drug straight to the mar­ket

GlaxoSmithKline’s Benlysta isn’t alone in the small circle of approved lupus nephritis drugs anymore.

Little Aurinia Pharmaceuticals has gotten the green light from the FDA to start marketing its first and only program, voclosporin, under the brand name Lupkynis — something CEO Peter Greenleaf says it’s been ready to do since December.

Regulators went right down to the wire on the decision, keeping the company and the entire salesforce it’s already assembled on its toes.

Charlie Fuchs, Roche and Genentech global head of product development for oncology and hematology (Yale Cancer Center)

Yale can­cer spe­cial­ist Char­lie Fuchs tapped as new glob­al de­vel­op­ment chief for Roche/Genen­tech

Roche and their big sub Genentech have just recruited a top cancer specialist at Yale to head up global product development in oncology and hematology.

I just got word that the pharma giant, which leads one of the most active cancer research operations in the world, recruited Charlie Fuchs, director of the Yale Cancer Center and physician-in-chief of Smilow Cancer Hospital. He’ll join the global operation March 1 and will be based in South San Francisco, where Genentech is based.

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Neu­vo­gen un­cloaks with broad plan of at­tack for whole-cell can­cer vac­cines, clin­i­cal hopes with­in the year

After about four stealthy years in the development phase, San Diego-based Neuvogen is emerging with a new approach to whole-cell cancer vaccines and nine solid tumor programs bound for the clinic.

Whole-cell tumor vaccines are developed by taking cancer cells from patients and modifying them to make them immunogenic.

“What’s different from what we do, is most people use one cell line. We use six,” CEO Todd Binder said. From there, the company builds out six modifications to eliminate problematic immunosuppressive factors, and add what the executive called three “stimulatory factors” to generate a prime and overcome peripheral tolerance.

Jonathan Weissman (MIT)

Can a new CRISPR tech­nique un­lock the se­crets of how can­cer spreads?

Jonathan Weissman’s team watched the cancer cells spread across the doomed mouse. Engineered with a bioluminescent enzyme, they appeared in scans first as a small navy blue diamond lodged near the heart; a week later, as a triangle splayed across the mouse’s upper body, with streaks of green and two distinct bright red hubs of activity. By day 54, the mouse resembled a lava lamp.

The images would have been familiar to any cancer biologist, but they didn’t actually tell you much about what was going on: why the cancer was metastasizing or which cells were responsible. For that, Weissman’s team had designed a new tool. Inside the original navy blue diamond, they had engineered the microbiological equivalent of an airplane’s black box — a “molecular recorder” that, after the mouse’s death, could allow them to extract the cells and wind back intimate footage of a single cancer’s ascent.

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