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.”

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data is messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data is exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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David Lockhart, ReCode Therapeutics CEO

Pfiz­er throws its weight be­hind LNP play­er eye­ing mR­NA treat­ments for CF, PCD

David Lockhart did not see the meteoric rise of messenger RNA and lipid nanoparticles coming.

Thanks to the worldwide fight against Covid-19, mRNA — the genetic code that can be engineered to turn the body into a mini protein factory — and LNPs, those tiny bubbles of fat carrying those instructions, have found their way into hundreds of millions of people. Within the biotech world, pioneers like Alnylam and Intellia have demonstrated just how versatile LNPs can be as a delivery vehicle for anything from siRNA to CRISPR/Cas9.

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David Livingston (Credit: Michael Sazel for CeMM)

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

Leen Kawas (L) has resigned as CEO of Athira and will be replaced by COO Mark Litton

Ex­clu­sive: Athi­ra CEO Leen Kawas re­signs af­ter in­ves­ti­ga­tion finds she ma­nip­u­lat­ed da­ta

Leen Kawas, CEO and founder of the Alzheimer’s upstart Athira Pharma, has resigned after an internal investigation found she altered images in her doctoral thesis and four other papers that were foundational to establishing the company.

Mark Litton, the company’s COO since June 2019 and a longtime biotech executive, has been named full-time CEO. Kawas, meanwhile, will no longer have ties to the company except for owning a few hundred thousand shares.

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Sen. Richard Durbin (D-IL, foreground) and Sen. Richard Blumenthal (D-CT) (Patrick Semansky/AP Images)

Sen­a­tors back FDA's plan to re­quire manda­to­ry pre­scriber ed­u­ca­tion for opi­oids

Three Senate Democrats are backing an FDA plan to require mandatory prescriber education for opioids as overdose deaths have risen sharply over the past decade, with almost 97,000 American opioid-related overdose deaths in the past year alone.

While acknowledging a decline in overall opioid analgesic dispensing in recent years, the FDA said it’s reconsidering the need for mandatory prescriber training through a REMS given the current situation with overdoses, and is seeking input on the aspects of the opioid crisis that mandatory training could potentially mitigate.

Suresh Katta, Saama CEO (via YouTube)

As AI con­tin­ues to en­tice Big Phar­ma, a Car­lyle-led drug­mak­er syn­di­cate shells out $430M for cloud com­put­ing play­er

The AI revolution permeating Big Pharma took a big financial step forward Wednesday, with VCs and major drugmakers coming together to acquire a cloud-focused company.

Led by the Carlyle Group, the investors will put up $430 million for a majority stake in Saama, a company that collects patient data to help speed along the drug development process. The investment arms of Pfizer, Merck, Amgen and McKesson all participated in the financing, in addition to other prominent life sciences VCs like Northpond.

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Raju Mohan, Ventyx Biosciences CEO

Ven­tyx sprints to Wall Street less than a year af­ter emerg­ing from stealth

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

It took seven months from exiting “quiet mode” for Ventyx Biosciences to land its very own stock ticker, raising $165 million in venture funds along the way.

Now, after pricing a massive $151.5 million IPO, the Encinitas, CA-based biotech is gunning for Phase II.

Ventyx priced close to 9.5 million shares at $16 apiece on Wednesday, the midpoint of its $15 to $17 range. CEO Raju Mohan filed the S-1 papers at the end of September, just over a week after unveiling a $114 million Series B round. He penciled in the standard figure of $100 million at first, likely knowing that in the last year, it’s been common for biotechs to raise much more than those initial estimates.

Bris­tol My­ers pledges to sell its Ac­celeron shares as ac­tivist in­vestors cir­cle Mer­ck­'s $11.5B buy­out — re­port

Just as Avoro Capital’s campaign to derail Merck’s proposed $11.5 billion buyout of Acceleron gains steam, Bristol Myers Squibb is leaning in with some hefty counterweight.

The pharma giant is planning to tender its Acceleron shares, Bloomberg reported, which add up to a sizable 11.5% stake. Based on the offer price, the sale would net Bristol Myers around $1.3 billion.

To complete its deal, Merck needs a majority of shareholders to agree to sell their shares.