Pamela Conley, Nuvig Therapeutics co-founder and CEO

With 30-year in­dus­try chops, Pamela Con­ley launch­es a pro­tein ther­a­peu­tics biotech for au­toim­mune dis­eases

Af­ter about 17 years at Por­to­la Phar­ma­ceu­ti­cals, Pamela Con­ley was ready for her next ven­ture once help­ing tran­si­tion some of the drug­mak­er’s pro­grams in­to Alex­ion in mid-to-late 2020.

Since then, she’s been set­ting up shop at au­toim­mune-fo­cused Nu­vig Ther­a­peu­tics, which broke cov­er Wednes­day with $47 mil­lion from No­vo Hold­ings, Pla­tanus, Bris­tol My­ers Squibb, Dig­i­tal­is Ven­tures and Mis­sion Bio­Cap­i­tal.

A 30-year biotech and phar­ma vet­er­an, Con­ley is now at the helm of her first biotech start­up based on sci­ence li­censed out of the Rock­e­feller Uni­ver­si­ty lab of Jeff Ravetch, Con­ley told End­points News. The Rock­e­feller pro­fes­sor was a sci­en­tif­ic ad­vi­sor while Con­ley was at Por­to­la, where she con­clud­ed as an SVP.

Ravetch has long been a con­trib­u­tor to the drug de­vel­op­ment field, with his lab study­ing an­ti­body-Fc re­cep­tor in­ter­ac­tions in hopes of treat­ing in­flam­ma­to­ry and in­fec­tious dis­eases. He’s co-found­ed Vir­dante Phar­ma­ceu­ti­cals, ac­quired by Mo­men­ta in 2011, and is on the sci­en­tif­ic ad­vi­so­ry board of stem cell trans­plant biotech Jasper Ther­a­peu­tics and a sci­en­tif­ic ad­vi­sor to in­fec­tious dis­eases-fo­cused Vir Biotech­nol­o­gy.

Nu­vig closed the Se­ries A in No­vem­ber 2021 and set up its Red­wood City, CA of­fice in Feb­ru­ary, but is re­veal­ing it­self to­day at what ap­pears to be an ever-es­ca­lat­ing bear mar­ket for the biotech world. Con­ley co-found­ed the start­up with for­mer Por­to­la col­league Greg Cof­fey, now VP of im­munol­o­gy and trans­la­tion­al re­search.

The team is work­ing to bring its first mol­e­cule in­to the clin­ic at an undis­closed time. The pro­ceeds will bankroll pre­clin­i­cal and Phase I work through proof of con­cept, Con­ley said, as the biotech aims to use its pro­tein ther­a­pies to “tone down the im­mune re­sponse af­ter an in­flam­ma­to­ry event.”

“We’re de­vel­op­ing a se­ries of pro­tein ther­a­peu­tics that are ge­net­i­cal­ly en­gi­neered to en­gage a class of im­mune reg­u­la­to­ry re­cep­tors. These re­cep­tors nat­u­ral­ly func­tion to re-es­tab­lish home­osta­sis fol­low­ing in­flam­ma­tion,” Con­ley said.

The com­pa­ny’s drug is in­de­pen­dent of im­mune-sup­pres­sion tac­tics like steroids or “oth­er com­mon ther­a­pies in this space,” the CEO said.

“[T]his mech­a­nism re­al­ly has the po­ten­tial to be life-chang­ing for a lot of pa­tients who don’t have to wor­ry about their ther­a­pies mak­ing them im­muno­com­pro­mised, sus­cep­ti­ble to oth­er dis­eases or even at risk for can­cer, like some of the cur­rent ther­a­pies do,” Con­ley said.

The com­pa­ny’s board in­cludes Pla­tanus man­ag­ing di­rec­tor Han­nah Chang, No­vo Ven­tures part­ner Ken Har­ri­son and Es­pe­ri­on Ther­a­peu­tics CEO Shel­don Koenig.

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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Alan Wise (L) and Peter Trill (Duke Street Bio)

They sold their last biotech to Mer­ck. Now they're back with a PARP out­fit named af­ter a Lon­don street

In 2016, Peter Trill and Alan Wise sold IOmet Pharma (an I/O outfit as the name suggests) to Merck for $400 million.

Now, some six years later, the duo has returned with another cancer biotech, Duke Street Bio, that emerged from stealth Tuesday. Duke Street Bio, named for the street where it’s located in London, is making its public debut as a next-gen PARP player, hoping to break into a field that already has a number of Big Pharma competitors.

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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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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.