Canaan leaps in­to UK biotech by co-lead­ing $14M Se­ries A for im­muno-on­col­o­gy up­start Grey Wolf

Check­point in­hibitors have done won­ders for im­muno-on­col­o­gy, but the po­tent class of drugs doesn’t work across all can­cers. To rem­e­dy this, UK-based biotech up­start Grey Wolf Ther­a­peu­tics is work­ing on a fresh ap­proach that does not di­rect­ly tar­get the im­mune sys­tem, but in­stead al­ters tu­mor cells by il­lu­mi­nat­ing and prim­ing them for im­mune sys­tem an­ni­hi­la­tion — a strat­e­gy that could work in con­junc­tion with ex­ist­ing im­munother­a­pies.

An­dera Part­ners and Canaan have shown their faith in the con­cept by lead­ing an ap­prox­i­mate­ly $14 mil­lion se­ries A round for the com­pa­ny.

Pe­ter Joyce

Found­ed by for­mer Ver­tex ex­ec­u­tive Pe­ter Joyce and ex-chief of Spinifex Phar­ma­ceu­ti­cals Tom Mc­Carthy, Grey Wolf is de­vel­op­ing small mol­e­cule mod­u­la­tors of en­do­plas­mic retic­u­lum aminopep­ti­das­es (ER­APs) pro­teins, an ap­proach de­signed to shore up the quan­ti­ty and range of neoanti­gens pre­sent­ed on tu­mor cells.

“The en­zyme tar­gets we’re go­ing af­ter are ER­AP1 and ER­AP2 — they work in the anti­gen pre­sen­ta­tion path­way and es­sen­tial­ly by mod­u­lat­ing their ac­tiv­i­ty, we can mod­u­late what is pre­sent­ed on the sur­face of a can­cer cell, so we ac­tu­al­ly change the neoanti­gens and mod­u­late their vis­i­bil­i­ty,” Joyce told End­points News, adding that pre­clin­i­cal da­ta sug­gests that a monother­a­py ap­proach is fea­si­ble, as is a com­bi­na­tion with ex­ist­ing PD-1s.

Grey Wolf is work­ing with the Uni­ver­si­ty of Ox­ford, Uni­ver­si­ty of Southamp­ton, and has a strate­gic part­ner­ship with Syg­na­ture Dis­cov­ery, a Not­ting­ham-based provider of drug dis­cov­ery and pre­clin­i­cal ser­vices. Syg­na­ture and Mc­Carthy to­geth­er put in £420,000 in seed fund­ing for Grey Wolf, Joyce said.

Back in 2015, Mc­Carthy was in charge of Spinifex when it was sold to Swiss drug­mak­er No­var­tis $NVS in a $700 mil­lion deal af­ter the pub­li­ca­tion of pos­i­tive Phase II da­ta on its non-opi­oid painkiller. Not­ed VC Canaan was an in­vestor in Spinifex.

Canaan has made its first-ever in­vest­ment in UK biotech with its Grey Wolf in­vest­ment, thanks in part to Mc­Carthy’s re­la­tion­ship with the firm, and due to the sci­en­tif­ic po­ten­tial of the ER­AP ap­proach, Joyce said. “(The) fact that we’re do­ing some­thing very nov­el re­al­ly piqued their in­ter­est.”

Ac­cord­ing to Joyce, out­side of aca­d­e­m­ic in­sti­tu­tions, there aren’t any oth­er com­mer­cial en­ti­ties look­ing at mod­u­lat­ing ER­AP pro­teins for im­muno-on­col­o­gy to his knowl­edge and Grey Wolf is “aim­ing to be first-in-class.”

The com­pa­ny, which has a core team of 6, is cur­rent­ly in the drug dis­cov­ery phase, and this round of fund­ing will be used to take the com­pa­ny to pre-IND en­abling stud­ies in the next 2-3 years. “We ei­ther ex­it at that point — which we would be open to — or get a part­ner. Or we might do a Se­ries B and take it to Phase I/II. I think be­yond…the com­plex­i­ty of im­muno-on­col­o­gy clin­i­cal de­vel­op­ment re­al­ly then does need one of the big­ger part­ners,” Joyce said.

“I’m a fly fish­er­man by back­ground and Grey Wolf is a type of mayfly and it’s a bit of lucky fly for me…so I’m hop­ing it will be a sort of a good luck omen.”

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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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.”