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.”

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Steve Harr (L) and Hans Bishop

One of the most am­bi­tious start­up teams in biotech just out­lined plans for a $400M IPO and a val­u­a­tion of about $4B

The executive team at Sana Biotechnology has sketched out more details about the full scope of its ambitions as the new unicorn to watch. They amended their S-1 today to include a price range of $20 to $23 a share — which puts them in reach of pulling in around $400 million on the high end with a market value starting right around $4 billion.

That’s not bad for a preclinical biotech with no drugs yet in human studies, but it squares with its ambitions to remake the cell therapy field with a slate of in-house platforms. The biotech raised $705 million — primarily from ARCH (44 million shares) and Flagship (34.2 million shares) — to get to this stage.

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Pfiz­er's big block­buster Xel­janz flunks its post-mar­ket­ing safe­ty study, re­new­ing harsh ques­tions for JAK class

When the FDA approved Pfizer’s JAK inhibitor Xeljanz for rheumatoid arthritis in 2012, they slapped on a black box warning for a laundry list of adverse events and required the New York drugmaker to run a long-term safety study.

That study has since become a consistent headache for Pfizer and their blockbuster molecule. Last year, Pfizer dropped the entire high dose cohort after an independent monitoring board found more patients died in that group than in the low dose arm or a control arm of patients who received one of two TNF inhibitors, Enbrel or Humira.

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Top gene ther­a­py deals, M&A pacts in 2020 high­light an­oth­er big year in one of the hottest fields in bio­phar­ma

Chris Dokomajilar at DealForma has been crunching the numbers on gene therapy deals over the last 2 years and came away with a few key observations.

Both the upfront cash and deal totals last year backed off a bit from the record high hit in 2019, but the totals are still running well ahead of anything we’ve seen in the years prior to 2019/2020.
2020 R&D partnerships came in at 23 deals, with $1.1 billion in disclosed upfront cash and equity and more than $8.5 billion in total deal value. Looking at 2019-2020 M&A, Dokomajilar found: 9 Acquisitions, with over $11.1 billion in disclosed upfront cash and equity and more than $13.4 billion in total M&A value.

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Ther­mo Fish­er plat­form seeks to ex­pe­dite donor cell cul­ti­va­tion for al­lo­gene­ic cell ther­a­pies

One of the world’s leading CDMOs has launched a new technology it says will expedite a quickly-growing sect of biotech drug development: off-the-shelf, allogeneic cell therapies.

It’s been nearly a decade since the FDA approved the first use of the method that uses healthy donor cells to create a master cell bank, which is then used for specific therapies — a cord blood allogeneic treatment called Hemacord. In the years since, the use of allogeneic cells has taken off in research circles, most notably in the use of T cell therapies to target solid tumor cancers.

Bob Nelsen (Michael Kovac/Getty Images)

ARCH an­nounces largest fund yet, rais­ing $1.85B to back men­tal health, cell and gene edit­ing ap­proach­es

Nearly a year ago, as the pandemic encroached and the stock market cratered, Flagship and ARCH Venture announced three mega-funds worth a combined $2.6 billion. They wanted, ARCH’s Bob Nelsen said, to restore confidence “that there was money out there and a lot of it” to invest in biotech.

Since then, the stock market has returned — almost frighteningly so — and Nelsen has kept raising and spending cash. On Thursday, he announced a new fund, worth $1.85 billion. It’s the largest pot yet for a VC famous for its deep pockets.

Covid-19 roundup: EU and As­traZeneca trade blows over slow­downs; Un­usu­al unions pop up to test an­ti­bod­ies, vac­cines

After coming under fire for manufacturing delays last week, AstraZeneca’s feud with the European Union has spilled into the open.

The bloc accused the pharma giant on Wednesday of pulling out of a meeting to discuss cuts to its vaccine supplies, the AP reported. AstraZeneca denied the reports, saying it still planned on attending the discussion.

Early Wednesday, an EU Commission spokeswoman said that “the representative of AstraZeneca had announced this morning, had informed us this morning that their participation is not confirmed, is not happening.” But an AstraZeneca spokesperson later called the reports “not accurate.”

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Janet Woodcock (AP Images)

Ad­vo­ca­cy groups don't want Janet Wood­cock to head the FDA, blast­ing ‘reg­u­la­to­ry fail­ures’ in opi­oid cri­sis

It turns out the controversies around Janet Woodcock’s regulatory legacy weren’t limited to Sarepta’s eteplirsen.

A coalition of advocacy groups dedicated to the opioid crisis urged Norris Cochran and Xavier Becerra — the acting and designated HHS secretary, respectively — to keep her reign as interim FDA chief a “very short transition.” During her lengthy tenure as CDER, they add, Woodcock presided over “one of the worst regulatory agency failures in U.S. history.”

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Dean Li kicks off Mer­ck­'s post-Roger Perl­mut­ter era by team­ing with Arti­va and its off-the-shelf CAR-NK tech

Even though Dean Li has now officially taken over for Roger Perlmutter as R&D chief, Merck’s appetite for dealmaking continues to be ravenous.

Li struck his first big deal at the helm Thursday morning, hammering out a collaboration with Artiva Biotherapeutics that could earn the biotech nearly $1.9 billion when all is said and done. It’s a quick rise and validation for Artiva, which just last June launched with a $78 million Series A.