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.

Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

No­var­tis' sec­ond at­tempt to repli­cate a stun­ning can­cer re­sult falls flat

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

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Robert Califf (Pablo Martinez Monsivais, AP Images, File)

As buzz on Califf FDA nom heats up, in­dus­try and agency in­sid­ers of­fer a strong nod for the ‘per­fect’ choice

For once in this long, dramatic road to finding a new FDA commissioner, there’s been some continuity. Both CNN and Politico reported this weekend that Rob Califf met with President Biden to discuss the permanent commish role, following earlier news broken by the Washington Post that all signs point to Califf.

Although there may be a few Democrats who continue to grandstand about the dangers of COI (Califf has worked for Verily, sits on the board of Centessa Pharmaceuticals, and has other ties to industry research), with the pandemic ongoing and the need for some kind of continuity at FDA mounting, Califf is likely to meet the same fate as when he first won Senate confirmation in 2016, by a vote of 89-4 — Bernie Sanders and 6 others didn’t vote.

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AstraZeneca CEO Pascal Soriot (Raphael Lafargue/Abaca/Sipa USA)

A com­bo of As­traZeneca's Imfinzi and chemo wins where oth­ers have failed in piv­otal bil­iary tract test

Looking to run with the big dogs in the PD-(L)1 class, AstraZeneca’s Imfinzi has a tall hill to climb to compete in an increasingly bustling market. An aggressive combo strategy for the drug has paid off so far, and now AstraZeneca is adding another notch to its belt.

A combo of Imfinzi (durvalumab) and chemotherapy significantly extended the lives of first-line patients with advanced biliary tract cancer over chemo alone, according to topline results from the Phase III TOPAZ-1 study revealed Monday.

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Sean Ianchulev, Eyenovia CEO and CMO

Re­cent court de­ci­sion push­es FDA to re­ject and re­clas­si­fy drug-de­vice com­bo, crush­ing shares

Back in April, the FDA lost a crucial court case in which its broad discretion of regulating medical products that might satisfy the legal definitions of either “drug” and/or “medical device” was sharply curtailed.

In addition to the appeals court ruling that Genus Medical Technologies’ contrast agent barium sulfate (aka Vanilla SilQ) should not be considered a drug, as the FDA had initially ruled, but as a medical device, the agency also was forced to spell out which drugs would transition to devices as a result of the ruling.

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Peter Greenleaf, Aurinia CEO

Af­ter pass­ing on Ac­celeron, Bris­tol My­ers eyes bolt-on ac­qui­si­tion of au­toim­mune spe­cial­ist — re­port

Bristol Myers Squibb is looking to beef up its autoimmune portfolio by scooping up Aurinia Pharmaceuticals, Bloomberg reported.

The recent overtures to Aurinia, relayed by anonymous insiders, came just as Bristol Myers turned down buyout talks with partners at Acceleron — which Merck ultimately struck a deal to acquire for $11.5 billion. Bristol Myers has reportedly decided to cash out on its minority stake, likely bagging $1.3 billion in the process, while keeping the royalty deals on two of Acceleron’s blood disorder drugs.

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So — that pig-to-hu­man trans­plant; Po­ten­tial di­a­betes cure reach­es pa­tient; Ac­cused MIT sci­en­tist lash­es back; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

We’re incredibly excited to welcome Beth Bulik, seasoned pharma marketing reporter, to the team. You can find much of her work in our new Marketing channel — and in her weekly newsletter, Endpoints PharmaRx, which will launch in early November. Add it to your subscriptions here.

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NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

No, sci­en­tists are not any clos­er to pig-to-hu­man trans­plants than they were last week

Steve Holtzman was awoken by a 1 a.m. call from a doctor at Duke University asking if he could put some pigs on a plane and fly them from Ohio to North Carolina that day. A motorcyclist had gotten into a horrific crash, the doctor explained. He believed the pigs’ livers, sutured onto the patient’s skin like an external filter, might be able to tide the young man over until a donor liver became available.

UP­DAT­ED: Agenus calls out FDA for play­ing fa­vorites with Mer­ck, pulls cer­vi­cal can­cer BLA at agen­cy's re­quest

While criticizing the FDA for what may be some favoritism towards Merck, Agenus on Friday officially pulled its accelerated BLA for its anti-PD-1 inhibitor balstilimab as a potential second-line treatment for cervical cancer because of the recent full approval for Merck’s Keytruda in the same indication.

The company said the BLA, which was due for an FDA decision by Dec. 16, was withdrawn “when the window for accelerated approval of balstilimab closed,” thanks to the conversion of Keytruda’s accelerated approval to a full approval four months prior to its PDUFA date.

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