His way: Greg Ver­dine is build­ing a new kind of drug, with back­ing from a dif­fer­ent kind of in­vestor

Af­ter help­ing spear­head the launch of a long string of biotechs over the years from his pres­ti­gious perch at Har­vard, Greg Ver­dine is now de­vot­ing the bulk of his time to lead­ing the ef­fort on grow­ing two biotechs from scratch. And he’s just chalked up a $66 mil­lion round to move one of them — Fog­Phar­ma — in­to the clin­ic next year with a new tech­nol­o­gy he’s con­vinced can break its way in­to ther­a­peu­tic ter­ri­to­ries that have re­mained off lim­its to de­vel­op­ers up to now.

Fog­Phar­ma has been en­gi­neer­ing a new kind of ther­a­peu­tic class, one that com­bines the cell-pen­e­trat­ing ca­pac­i­ty of small mol­e­cules with the tar­get-en­gag­ing tenac­i­ty of bi­o­log­ics in­to what he calls CPMPs — cell pen­e­trat­ing minipro­teins. 

The big idea here — if you strip it all down to the chas­sis — is that Ver­dine and his crew have de­vel­oped a struc­tur­al “brace” that promis­es to make their polypep­tides ef­fec­tive against tough tar­gets like β-catenin. The brace — Ver­dine’s “se­cret sauce” — locks the struc­ture in place and amps up its abil­i­ty to pen­e­trate a cell, ze­ro in on the spe­cif­ic tar­get and main­tain a high lev­el of the drug in blood for a sus­tained pe­ri­od. And he says that each suc­ces­sive it­er­a­tion of their drugs in pre­clin­i­cal test­ing has proven bet­ter at the big job they’re de­signed for: drug­ging the un­drug­gable.

Leon Chen

This new mon­ey in the B round gives Fog­Phar­ma the op­por­tu­ni­ty to take its β-catenin pro­gram — which in­volves Wnt path­way ac­ti­va­tion — in­to a Phase I/II pro­gram in the sec­ond half of next year while lin­ing up an IND on a Cbl-b in­hibitor pro­gram, with a third undis­closed ef­fort com­ing up the line. The dis­cov­ery plat­form in­cludes “three ad­di­tion­al, dis­tinct and dif­fer­en­ti­at­ed forms of cell-pen­e­trat­ing minipro­teins.” 

“The en­tire fi­nanc­ing is three-and-a-half years worth of mon­ey,” Ver­dine tells me. Add that to the $11 mil­lion in Se­ries A cash raised at three sep­a­rate points be­gin­ning in ear­ly 2016, and Ver­dine has round­ed up a to­tal of $77 mil­lion for Fog­Phar­ma.

But it could have been more if he had need­ed it.

Ge Li

Much of the seed mon­ey for Fog­Phar­ma came from Deer­field and WuXi’s cor­po­rate fund, over­seen by Ge Li, a man with ac­cess to a vast amount of cap­i­tal around the world. That kind of fi­nanc­ing al­lowed Ver­dine to cre­ate Fog­Phar­ma with­out be­ing forced to adopt the short-term tac­tics of tra­di­tion­al VCs in the busi­ness.

“We built the com­pa­ny on a dif­fer­ent mod­el,” says Ver­dine. “I want­ed to do this one from soup to nuts. For that rea­son in the Se­ries A we didn’t turn to ven­ture in­vestors who would come in and have a sig­nif­i­cant role in build­ing the com­pa­ny.”

With­out even a hint of boast­ing, Ver­dine be­lieves that with his re­la­tion­ships among elite biotech in­vestors, at this point in his ca­reer of de­vel­op­ing new drugs, he could raise a bil­lion dol­lars if need­ed. There’s an ap­petite for tru­ly pi­o­neer­ing drug de­vel­op­ment work, says Ver­dine, that looks to vault ahead on crit­i­cal, break­through ther­a­pies.

He has the re­sume to back it up. And he’s built a plat­form com­pa­ny which has the ca­pac­i­ty to find and eval­u­ate new tar­gets and prospec­tive new ther­a­pies in a mat­ter of months.

Jeff Leerink

It’s no ac­ci­dent that Ver­dine’s lead pro­gram forms a junc­tion with check­point ther­a­pies; the β-catenin/Wnt path­way dis­rupts im­mune re­spons­es and an ef­fec­tive push here holds the promise of over­com­ing ini­tial re­sis­tance to im­munother­a­py as well as the de­vel­op­ment of drug re­sis­tance to an ef­fec­tive treat­ment. And it’s the first such ther­a­py to make it to the thresh­old of a clin­i­cal tri­al.

But Ver­dine is a proud pa­pa to mul­ti­ple pro­grams, and he is just as ex­cit­ed, if not more so, by the Cbl-b im­muno-on­col­o­gy drug that’s com­ing up be­hind the lead.

“What we’ve seen is that these mol­e­cules can be tol­er­a­ble at rel­a­tive­ly high dos­es, with a sig­nif­i­cant im­pact on tu­mor growth,” he says.

Kr­ish­na Yesh­want

Ver­dine has been a cel­e­brat­ed sci­en­tist in the field of drug dis­cov­ery for more years than many of his stu­dents have lived. Along the way, he’s earned some close ties to a new breed of biotech in­vestors who have now come in to back Fog­Phar­ma and well as his sec­ond ven­ture, LifeM­ine.

The sci­en­tist and se­r­i­al en­tre­pre­neur owes much of his suc­cess in rais­ing cash to close ties with Asian groups that have be­come ac­tive play­ers in biotech.

Rick Klaus­ner

Ver­dine’s ex­pe­ri­ence in Chi­na has led him to Boyu Cap­i­tal — an in­flu­en­tial pri­vate eq­ui­ty group led by co-founder and part­ner Sean Tong — and Blue Pool. The Chi­nese ven­ture group 6 Di­men­sions Cap­i­tal came in with oth­er new in­vestors, in­clud­ing Google’s GV, Hori­zons Ven­tures, Nan Fung Group and Leerink Part­ners. Deer­field Man­age­ment came back with Boyu Cap­i­tal, WuXi AppTec Cor­po­rate Ven­tures and “a promi­nent in­ter­na­tion­al group of non-in­sti­tu­tion­al in­vestors” to com­plete the syn­di­cate.

That kind of back­ing al­lowed Ver­dine to build his board with in­di­vid­u­als who are all in on his R&D strat­e­gy, with Leon Chen from 6 Di­men­sions, Leerink’s Jeff Leerink, GV gen­er­al part­ner Kr­ish­na Yesh­want and Rick Klaus­ner, a founder at Juno Ther­a­peu­tics, join­ing the group.

The new mon­ey will al­low Fog­Phar­ma to grow from 26 staffers to­day to north of 40 by the end of the year. And it’s still ear­ly days.

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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Tony Coles, Cerevel Therapeutics CEO

Adding $445M, Tony Coles and his big Pfiz­er neu­ro spin­out hitch a ride to Wall Street on Per­cep­tive’s SPAC

Two years ago, after Pfizer abruptly shut down its entire neuroscience division, Bain Capital bet $350 million that those assets were still worth something and packaged them into a new biotech: Cerevel Therapeutics. A year later, they got seasoned executive Tony Coles, who had recently jumped back into the C-suite of another neuroscience startup, to run the company.

Now Coles is steering Cerevel public, in what he says is the largest ever transaction of its kind. Cerevel has agreed to merge with Perceptive Advisors’ specialty acquisition company ARYA II. Between the roughly $125 million Perceptive raised through ARYA and an additional investment of $320 million Bain Capital, Perceptive and — yes, really — Pfizer, among others, Cerevel will now move forward with an added $445 million in its coffers.

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