Pascal Neuville, Domain Therapeutics CEO

Up­dat­ed: A GPCR start­up out of France and Cana­da scores its Se­ries A af­ter 14 years of wheel­ing and deal­ing

Hav­ing al­ready nailed down mul­ti­ple li­cens­ing and col­lab­o­ra­tion deals with Big Phar­ma gi­ants like Bris­tol My­ers Squibb and Pfiz­er, a France- and Que­bec-based GPCR biotech now has its first VC fi­nanc­ing round un­der its belt.

The I/O fo­cused biotech Do­main Ther­a­peu­tics closed a Se­ries A worth $42 mil­lion, the com­pa­ny an­nounced Tues­day — which will last two years, ac­cord­ing to CEO Pas­cal Neuville. Do­main had pre­vi­ous­ly built nu­mer­ous part­ner­ships with dif­fer­ent phar­ma com­pa­nies since its found­ing in 2008, such as Mer­ck KGaA, Take­da and Boehringer In­gel­heim.

“We are pleased to wel­come our new share­hold­ers and I thank them all for their com­mit­ment at this de­ci­sive stage of our com­pa­ny’s growth,” Neuville said in a state­ment. “Af­ter hav­ing de­liv­ered a first GPCR drug can­di­date for im­muno-on­col­o­gy to­geth­er with Mer­ck KGaA, Do­main is now com­mit­ted to ad­vance its own treat­ments re­viv­ing the im­mune sys­tem to de­feat can­cer.”

As for what’s next, Do­main said in a state­ment that it will move pipeline de­vel­op­ment for­ward for a va­ri­ety of drug can­di­dates, in­clud­ing clin­i­cal de­vel­op­ment for an EP4R an­tag­o­nist, push two GPCR pro­grams in­to the IND stage (which does in­clude an an­ti-CCR8 an­ti­body), and ad­vance the biotech’s dis­cov­ery ef­forts for GPCR-tar­get­ing drugs.

Neuville elab­o­rat­ed that Do­main be­gan a shift in 2018, af­ter Dan­ish biotech Prex­ton Ther­a­peu­tics got bought out by Lund­beck for more than $100 mil­lion up­front in a $1.1 bil­lion deal. Prex­ton’s sole can­di­date at the time, foliglu­rax, orig­i­nat­ed from a se­ries of com­pounds that were ini­tial­ly dis­cov­ered by Do­main, and had been out-li­censed to Prex­ton in 2013. As an IP hold­er, Do­main could on­ly re­ceive a cer­tain out — and Neuville said that Do­main on­ly cap­tured 11% of the deal.

And with that new de­vel­op­ment, Neuville said that the biotech has de­cid­ed to keep as­sets with­in the com­pa­ny and cre­ate “more val­ue” for the com­pa­ny. As to what that looks like? Keep­ing a lim­it­ed num­ber of part­ner­ships, and rather em­pha­siz­ing in-house as­sets and push­ing those can­di­dates to­wards the clin­ic.

Neuville told End­points News that with the Se­ries A, the 100-per­son biotech is no longer fo­cused on mul­ti­ple in­di­ca­tions as they used to — no more CNS or rare dis­ease. In his words, the Se­ries A round marks Do­main 2.0, fo­cus­ing specif­i­cal­ly on GPCR-tar­get­ing drugs for im­muno-on­col­o­gy.

GPCRs have been the low-hang­ing fruit and the tar­get of many ap­proved drugs, but a more re­cent suite of biotechs has aimed to build on that foun­da­tion with new tech­no­log­i­cal ap­proach­es. Re­cent­ly, So­sei Hep­tares had signed two dis­cov­ery deals, one be­ing an an­ti­body dis­cov­ery deal with Twist Bio­science last year, and the oth­er com­ing in a deal in Jan­u­ary with Al­pha­bet’s Ver­i­ly af­ter Ab­b­Vie pulled out of a deal with the Japan­ese biotech.

Bel­gian biotech Con­fo al­so signed a deal with Re­gen­eron last year to lever­age its plat­form, which us­es se­lec­tive VHH an­ti­bod­ies to sta­bi­lize GPCRs, to­wards dis­cov­er­ing an­ti­body drug can­di­dates for GPCR tar­gets.

Quite a few in­vestors de­cid­ed to tag along Tues­day: co-lead in­vestors Panacea Ven­ture, 3B Fu­ture Health Fund and CTI Life Sci­ences, along with ad­Mare BioIn­no­va­tions, Schroders Cap­i­tal, Omnes, Turenne Cap­i­tal, Theodor­us, and Vi­va BioIn­no­va­tor. Ex­ist­ing in­vestor Sev­en­ture Part­ners, which had pre­vi­ous­ly in­vest­ed $3.9 mil­lion in­to the com­pa­ny back in 2019, al­so tagged along. The last mon­ey Do­main raised was a $6.7 mil­lion debt fi­nanc­ing from a con­sor­tium of French banks in Jan­u­ary 2020.

Ed­i­tor’s note: This sto­ry has been up­dat­ed af­ter a video in­ter­view with Pas­cal Neuville, CEO of Do­main Ther­a­peu­tics.

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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(Credit: Shutterstock)

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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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.

Taye Diggs (courtesy Idorsia)

Idor­sia inks an­oth­er celebri­ty en­dors­er deal with ac­tor and dad Taye Dig­gs as Qu­viviq in­som­nia am­bas­sador

Idorsia’s latest Quviviq insomnia campaign details the relatable dad story of a well-known celebrity — actor and Broadway star Taye Diggs.

Diggs stopped sleeping well after the birth of his son, now more than 10 years ago. Switching mom-and-dad nightly shifts to take care of a baby interrupted his sleep patterns and led to insomnia.

“When you’re lucky enough to be living out your dream and doing what you want, but because of something as simple as a lack of sleep, you’re unable to do that, it felt absolutely — it was treacherous,” he says in an interview-style video on the Quviviq website.

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