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.

J&J gets a fresh OK for es­ke­t­a­mine, but is it re­al­ly the game-chang­er for de­pres­sion Trump keeps tweet­ing about?

Backed by an enthusiastic set of tweets from President Trump and a landmark OK for depression, J&J scooped up a new approval from the FDA for Spravato today. But this latest advance will likely bring fresh scrutiny to a drug that’s spurred some serious questions about the data, as well as the price.

First, the approval.

Regulators stamped their OK on the use of Spravato — developed as esketamine, a nasal spray version of the party drug Special K or ketamine — for patients suffering from major depressive disorder with acute suicidal ideation or behavior.

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FDA hands Mor­phoSys and In­cyte a quick OK on their po­ten­tial block­buster CAR-T al­ter­na­tive

Nearly three years after okaying the CAR-Ts Yescarta and Kymriah, the FDA has approved a new CD19 therapy.

MorphoSys’ Monjuvi, or tafasitamab-cxix, was cleared Friday for use in refractory diffuse large B-cell lymphoma (DBLCL). The approval sets up both MorphoSys and their commercial partner Incyte to compete with Gilead and Novartis in the ultra-competitive indication, where similar trial results and far easier delivery could allow them to cut a fair share of the market.

Rich Heyman (ARCH)

Rich Hey­man joins PMV Phar­ma, a p53 biotech, as it adds $70 mil­lion in Se­ries D

Less than a year after pulling in an impressive $62 million Series C round, PMV Pharma is back at it again.

The Cranbury, NJ-based biotech announced Monday an additional $70 million in Series D financing as it seeks to develop cancer therapies targeting p53 mutations. Additionally, PMV also introduced longtime biotech entrepreneur Rich Heyman as chairman of the board of directors.

“This financing provides PMV Pharma with the resources to expand our pipeline and to potentially advance multiple p53 therapies into the clinic,” said PMV president and CEO David Mack in a statement.

Sanofi un­der for­mal in­ves­ti­ga­tion for De­pakine al­le­ga­tions; Beam li­cens­es CAR-T tech from Ox­ford Bio­med­ica

Sanofi is facing a formal investigation on manslaughter charges, due to accusations that its epilepsy drug Depakine caused birth malfunctions and slow neurological development when taken during pregnancy.

The French pharma was formally charged in February, years after evidence surfaced that the drug, sodium valproate, posed neurodevelopmental risks. Sodium valproate first hit the market in 1967 for the treatment of epilepsy and bipolar disorder, and is currently prescribed in more than 100 countries.

Days af­ter seal­ing Sanofi pact, Kymera beats a path to the Nas­daq with $100M IPO pitch

Back in March, when Kymera Therapeutics closed $102 million in Series C funding led by Biotechnology Value Fund and Redmile Group, CEO Nello Mainolfi noted the protein degradation player was “at the cusp of transitioning” into a fully integrated R&D company. Five months and a major Sanofi pact later, he’s back asking for another little push to get there.

Kymera has penciled in $100 million in its first IPO pitch — although given the public market’s seemingly insatiable appetite for biotechs these days the final figure is anyone’s guess.

CymaBay flash­es pos­i­tive re­sults from the tri­al they have to re­launch

Two weeks after the FDA lifted its clinical hold on their lead drug, CymaBay said it showed positive results in an aborted Phase III trial.

The drug, a small molecule known as seladelpar, had been in development for three different liver conditions before an independent review of a NASH study last year showed that it might actually be damaging patient’s liver cells. The FDA slapped a clinical hold across all three trials, only lifting it last month when an FDA review determined that the drug hadn’t caused liver damage.

Covid-19 roundup: Eli Lil­ly retro­fits RVs for first-of-its-kind an­ti­body tri­al with NIH; Am­gen, Ab­b­Vie, Take­da team on a drug

Eli Lilly and the NIH are about to start a first-of-its-kind trial that researchers and developers have talked about for months as a way of providing temporary immunity to the most at-risk populations.

Lilly announced this morning that it will start a 2,400-person trial with the National Institute for Allergy and Infectious Diseases to test whether its experimental Covid-19 neutralizing antibody can prevent people in nursing homes and assisted living facilities from developing the disease. The idea, known as passive immunity, is that rather than waiting on a vaccine to induce people to develop antibodies, doctors can give them lab-grown antibodies. Ideally, those antibodies will either attack the new SARS-CoV-2 infection, if the patient has recently been exposed, or persist in the blood for several weeks and prevent infection or disease for that period.

So Covid-19 leader BioN­Tech has a can­cer vac­cine in de­vel­op­ment? Yes, and Re­gen­eron just jumped in for the PhII com­bo study

Before the coronavirus global emergency stole the R&D show in biopharma, the leaders in the race to develop new mRNA therapies had a big interest in determining if their tech could be used to create an effective cancer vaccine after all the first-gen tries had failed to impress. So perhaps it’s not surprising that an early cut of the data at frontrunner BioNTech went largely unnoticed.

Unless you were at Regeneron.

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Sev­en plucky di­ag­nos­tics com­pa­nies win a $249M round of con­tracts af­ter sur­viv­ing NI­H's Covid-19 'Shark Tank' com­pe­ti­tion

As US Covid-19 deaths creep past 150,000 and officials stress the importance of contact tracing, the NIH’s Rapid Acceleration of Diagnostics (RADx) program has inked contracts totaling $248.7 million to expand testing capabilities.

The seven contracts, which were chosen “Shark Tank”-style from a pool of 100 proposals, are part of an effort to bump daily testing capacity to 2% of the country’s population by late summer or fall. That would be about 6 million people per day, compared to the current 520,000 to 823,000 tests being administered daily.