Carol Robinson, Professor Dame Carol Robinson Research Group

Drug dis­cov­ery in HD: Ox­ford spin­of­f's mass spec­trom­e­try ap­proach scores fresh fund­ing

The tech­nol­o­gy used to de­tect ex­plo­sives at air­ports — mass spec­trom­e­try — is be­ing pi­lot­ed as an en­gine for drug dis­cov­ery.

Mass spec­trom­e­try is a tool de­signed to mea­sure with pro­found ac­cu­ra­cy the mass of a sin­gle mol­e­cule. Typ­i­cal­ly, mass spec­trom­e­ters can be used to iden­ti­fy un­known com­pounds, to quan­ti­fy known com­pounds, and to de­ter­mine the struc­ture and chem­i­cal prop­er­ties of mol­e­cules.

Us­ing this in­for­ma­tion to de­vel­op drugs, ver­sus us­ing tra­di­tion­al cell-based as­says is an ap­proach pi­o­neered by Car­ol Robin­son, the first fe­male pro­fes­sor of chem­istry at the Uni­ver­si­ty of Ox­ford. Along­side her for­mer stu­dents, Robin­son found­ed OMass Ther­a­peu­tics to move it for­ward in the field of mem­brane tar­gets, in­clud­ing GPCRs.

On Mon­day, the Ox­ford spin­off un­veiled £27.5 mil­lion in ad­di­tion­al Se­ries A fi­nanc­ing from Syn­cona, Ox­ford Sci­ences In­no­va­tion (OSI), and the Uni­ver­si­ty of Ox­ford, bring­ing its to­tal haul to £41.5 mil­lion.

“It’s drug dis­cov­ery in high de­f­i­n­i­tion…it’s all about re­veal­ing the pic­ture with high­er res­o­lu­tion. And it’s about high con­tent da­ta. The rea­son mass spec­trom­e­try is in­ter­est­ing in drug dis­cov­ery is that the con­tent that you get from the da­ta is much high­er res­o­lu­tion than through a cell-based as­say,” OMass chief Ros Dee­gan told End­points News.

“So in a cell-based as­say, you’re ef­fec­tive­ly an­swer­ing on­ly the ques­tion that you asked, where­as, in na­tive mass spec­trom­e­try, it’s a bio­phys­i­cal ap­proach.”

The ma­jor­i­ty of ex­ist­ing ther­a­peu­tics tar­get mem­brane pro­tein — ac­ces­si­ble on the sur­face of cells — to mod­i­fy cel­lu­lar sig­nal­ing. In con­trast to tra­di­tion­al cell-based as­says, the mass spec­trom­e­try ap­proach of­fers ‘high de­f­i­n­i­tion’ in­sight in­to un­der­stand­ing mem­brane pro­tein bi­ol­o­gy, Dee­gan not­ed.

The plat­form pro­vides ac­cess to dif­fer­ent chem­i­cal start­ing points be­cause bio­phys­i­cal ap­proach­es tend to point to­ward dif­fer­ent chem­istry — as they are not bi­ased to spe­cif­ic types of chem­istry through the use of cell-based as­says, she said. “Cell-based as­says tend to put you in lipophilic, quite of­ten large lipophilic com­pounds.”

If the ap­proach is shown to work, it could serve to short­en drug dis­cov­ery time­frames.

“Ul­ti­mate­ly the com­pa­ny aims to use high de­f­i­n­i­tion tech­nolo­gies to ef­fi­cient­ly ac­cess can­di­dates with a greater PoS (prob­a­bil­i­ty of suc­cess) in high-val­ue ar­eas, there­fore sig­nif­i­cant­ly short­en­ing the drug dis­cov­ery time­line for small mol­e­cules,” said Lach­lan MacK­in­non, prin­ci­pal at OSI in an email to End­points.

OMass in­tends to not just iden­ti­fy mol­e­cules of in­ter­est but to take them through to the mar­ket them­selves. It has three pro­grams at the mo­ment — al­though they are far from be­ing ready for the clin­ic.

The cap­i­tal in­jec­tion will give OMass — which is fo­cus­ing on im­munol­o­gy and ge­net­i­cal­ly de­fined dis­eases out­side of im­munol­o­gy — just over two years of run­way and will be used to shep­herd its lead pro­gram in­to pre­clin­i­cal de­vel­op­ment.

Bob Nelsen at the Milken Institute Global Conference on April 29, 2019 in Beverly Hills, California. (Photo by Michael Kovac/Getty Images)

ARCH chief Bob Nelsen has $1.5B to prove 2 sim­ple points: ‘We’re in the most in­no­v­a­tive time ever’ and in­vestors are stay­ing

ARCH co-founder and managing director Bob Nelsen has a well known yen for the home run swing, betting big on potentially transformative meds and tech and the biotech teams he helps bring together. He thrives and bleeds on the cutting edge. And now Nelsen and the ARCH group have debuted 2 big funds to prove that this is the time for the best of biotech to shine — deadly pandemic be damned.

Two new funds, ARCH Venture Fund X and ARCH Venture Fund X Overage, gathered a combined $1.46 billion. And that’s a record. ARCH Venture Fund IX and ARCH Venture Fund IX Overage closed in 2016 with a combined $1.1 billion. ARCH Venture Fund VIII and ARCH Venture Fund VIII Overage closed in 2014 with a combined $560 million.

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UP­DAT­ED: Have a new drug that promis­es to fight Covid-19? The FDA promis­es fast ac­tion but some de­vel­op­ers aren't hap­py

After providing an emergency approval to use malaria drugs against coronavirus with little actual evidence of their efficacy or safety in that setting, the FDA has already proven that it has set aside the gold standard when it comes to the pandemic. And now regulators have spelled out a new approach to speeding development that promises immediate responses in no uncertain terms — promising a program offering the ultimate high-speed pathway to Covid-19 drug approvals.

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Noubar Afeyan, Flagship

Step­ping out along­side ARCH's record raise, Flag­ship adds a $1.1B mon­ster fund of its own

ARCH’s unveiling this morning of 2 new funds bulging with $1.5 billion in cash for biotech startups was just the first round of today’s venture news.

Right on its heels we have another monster fund debuting at Flagship Pioneering, another big venture group known for making huge bets on cutting-edge tech — the kind it brews up in its labs.

And this one weighs in at $1.1 billion, which will operate in tandem with the $1.1 billion in funds Flagship rolled out last year.

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Once fu­ri­ous over No­var­tis’ da­ta ma­nip­u­la­tion scan­dal, the FDA now says it’s noth­ing they need to take ac­tion on

Back in the BP era — Before Pandemic — the FDA ripped Novartis for its decision to keep the agency in the dark about manipulated data used in its application for Zolgensma while its marketing application for the gene therapy was under review.

Civil and criminal sanctions were being discussed, the agency noted in a rare broadside at one of the world’s largest pharma companies. Notable lawmakers cheered the angry regulators on, urging the FDA to make an example of Novartis, which fielded Zolgensma at $2.1 million — the current record for a one-off therapy.

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Covid-19 roundup: GSK, Am­gen tai­lor R&D work to fit the coro­n­avirus age; Doud­na's ge­nomics crew launch­es di­ag­nos­tic lab

You can add Amgen and GSK to the list of deep-pocket drug R&D players who are tailoring their pipeline work to fit a new age of coronavirus.

Following in the footsteps of a lineup of big players like Eli Lilly — which has suspended patient recruitment for drug studies — Amgen and GSK have opted to take a more tailored approach. Amgen is intent on circling the wagons around key studies that are already fully enrolled, and GSK has the red light on new studies while the pandemic plays out.

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In a stun­ning set­back, Amarin los­es big patent fight over Vas­cepa IP. And its high-fly­ing stock crash­es to earth

Amarin’s shares $AMRN were blitzed Monday evening, losing billions in value as reports spread that the company had lost its high-profile effort to keep its Vascepa patents protected from generic drugmakers.

Amarin had been fighting to keep key patents under lock and key — and away from generic rivals — for another 10 years, but District Court Judge Miranda Du in Las Vegas ruled against the biotech. She ruled that:
(A)ll the Asserted Claims are invalid as obvious under 35 U.S.C.§ 103. Thus, the Court finds in favor of Defendants on Plaintiff’s remaining infringementclaim, and in their favor on their counterclaims asserting the invalidity of the AssertedClaims under 35 U.S.C. § 103.

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Mene Pangalos via YouTube

As­traZeneca says its block­buster Farx­i­ga proved to be a game-chang­er in CKD — wrap­ping PhI­II ear­ly

If the FDA can still hold up its end of the bargain, AstraZeneca is already on a short path to scooping up a cutting-edge win with a likely approval for their SGLT2 drug Farxiga in cutting the risk of heart failure. Now the pharma giant says it can point to solid evidence that the drug — initially restricted to diabetes — also works for chronic kidney disease, potentially adding a blockbuster indication for the franchise.

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Daniel O'Day (AP Images)

Gilead CEO Dan O'­Day of­fers a de­tailed ex­pla­na­tion on remde­sivir ac­cess — re­as­sur­ing an­a­lysts that Covid-19 da­ta are com­ing fast

After coming under heavy fire from consumer groups ready to pummel them for grabbing the FDA’s orphan status for remdesivir — reserved to encourage the development of rare disease therapies — Gilead CEO Daniel O’Day had some explaining to do about the company’s approach to providing access to this drug to patients suffering from Covid-19. And he set aside time over the weekend to patiently explain how they are making their potential pandemic drug available in a new program — one he feels can better be used to address a growing pack of infected patients desperately seeking remdesivir under compassionate use provisions.

In addition to trying to reassure patients that they will once again have an avenue to pursue access, O’Day also reassured some analysts who had been fretting that China’s quick comeback from the coronavirus outbreak could derail its ultra-fast schedule for testing the drug in patients. The data are still expected in a few weeks, he says in the letter, putting the readout in April.

O’Day emphasizes that Gilead intends to pursue a pricing approach that will make this drug widely available — if it proves effective and safe. But no one is quite sure just what the longterm value would be, given the work being done on a variety of vaccines that may be rolled out as early as this fall — at least to the most heavily threatened groups.

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Mer­ck scores new ad­vance on tu­mor-ag­nos­tic front as Keytru­da beat chemo-based reg­i­mens in a type of col­orec­tal can­cer

Back in 2017, before the term “tumor agnostic” really took hold among cancer drug developers, Merck became the first to secure such an approval for Keytruda as a second-line treatment for patients characterized by a biomarker — rather than where the cancer started in the body. Now it’s looking to break fresh ground with a new slate of data suggesting the drug’s utility in the frontline setting for colorectal cancer.