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.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Phar­ma com­pa­ny con­tin­ues its FDA law­suit spree, this time af­ter agency de­nies fast-track des­ig­na­tion

Vanda Pharmaceuticals is making a name for itself, at least in terms of suing the FDA.

The DC-headquartered firm on Monday filed its latest suit against the agency, with the company raising concerns over the FDA’s failure to grant a fast track designation for Vanda’s potential chronic digestive disorder drug tradipitant, which is a neurokinin 1 receptor antagonist.

Specifically, Vanda said FDA’s “essential point” in its one-page denial letter on the designation pointed to “the lack of necessary safety data,” which was “inconsistent with the criteria for … Fast Track designation.”

Mod­er­na seeks to dis­miss Al­ny­lam suit over Covid-19 vac­cine com­po­nent, claim­ing wrong venue

RNAi therapeutics juggernaut Alnylam Pharmaceuticals made a splash in March when it sued and sought money from both Pfizer and Moderna regarding their use of Alnylam’s biodegradable lipids, which Alnylam claims have been integral to the way both companies’ mRNA-based Covid-19 vaccines work.

But now, Moderna lawyers are firing back, telling the same Delaware district court that Alnylam’s claims can only proceed against the US government in the Court of Federal Claims because of the way the company’s contract is set up with the US government. The US has spent almost $10 billion on Moderna’s Covid-19 vaccine so far.

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Cracks in the fa­cade: Is phar­ma's pan­dem­ic ‘feel good fac­tor’ wan­ing?

The discordant effects of the Covid-19 pandemic on pharma reputation continues. While the overall industry still retains a respectable halo from its Covid-19 quick response and leadership, a new patient group study reveals a different story emerging in the details.

On one hand, US patient advocacy groups rated the industry higher-than-ever overall. More than two-thirds (67%) of groups gave the industry a thumbs up for 2021, a whopping 10 percentage point increase over the year before, according to the PatientView annual study, now in its 9th year.

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Michael Corbo, Pfizer CDO of inflammation & immunology

UP­DAT­ED: Plan­ning ahead for crowd­ed ul­cer­a­tive col­i­tis mar­ket, Pfiz­er spells out PhI­II da­ta on $6.7B Are­na drug

Pfizer has laid out the detailed results behind its boast that etrasimod — the S1P receptor modulator at the center of its $6.7 billion buyout of Arena Pharma — is the winner of the class, potentially leapfrogging an earlier entrant from Bristol Myers Squibb.

Pivotal data from the ELEVATE program in ulcerative colitis — which consists of two Phase III trials, one lasting 52 weeks and the other just 12 weeks — illustrate an “encouraging balance of efficacy and safety,” according to Michael Corbo, chief development officer of inflammation & immunology at Pfizer. The company is presenting the results as a late breaker at Digestive Disease Week.

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Robert Califf (Michael Brochstein/Sipa USA via AP Images)

House Re­pub­li­cans at­tack Chi­na-on­ly da­ta in FDA sub­mis­sions, seek new in­ves­ti­ga­tion in­to re­search in­spec­tions

Three Republican representatives are calling on the FDA to take a closer look at the applications including only clinical data from China.

The letter to FDA commissioner Rob Califf late last week comes as the agency recently rejected Eli Lilly’s anti-PD-1 antibody, which attempted to bring China-only data but ran into a bruising adcomm that may crush the hopes of any other companies looking to bring cheaper follow-ons based only on Chinese data.

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Amid mon­key­pox fears, biotechs spring to ac­tion; Mod­er­na’s CFO trou­ble; Cuts, cuts every­where; Craft­ing the right pro­teins; 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.

It’s always a bittersweet moment saying goodbye, but as Josh Sullivan goes off to new adventures we are grateful for the way he’s built up the Endpoints Manufacturing section — which the rest of the team will now carry forward. If you’re not already, this may be a good time to sign up for your weekly dose of drug manufacturing news. Thank you for reading and wish you a restful weekend.

Co­pay coupons gone wrong, again: Pfiz­er pays al­most $300K to set­tle com­plaints in four states

Pfizer has agreed to pay $290,000 to settle allegations of questionable copay coupon practices in Arizona, Colorado, Kansas, and Vermont from 2014 to 2018.

While the company has not admitted any wrongdoing as part of the settlement, Pfizer has agreed to issue restitution checks to about 5,000 consumers.

A Pfizer spokesperson said the company has “enhanced its co-pay coupons to alleviate the concerns raised by states and agreed to a $30,000 payment to each.”

Delaware court rules against Gilead and Astel­las in years-long patent case

A judge in Delaware has ruled against Astellas Pharma and Gilead in a long-running patent case over Pfizer-onwed Hospira’s generic version of Lexiscan.

The case kicked off in 2018, after Hospira submitted an Abbreviated New Drug Application (ANDA) for approval to market a generic version of Gilead’s Lexiscan. The drug is used in myocardial perfusion imaging (MPI), a type of nuclear stress test.