Ex-Cel­gene deal­mak­er George Golumbes­ki joins up to guide Car­rick on its can­cer drug quest — and maybe an IPO as well

George Golumbes­ki

Dublin-based Car­rick Ther­a­peu­tics has picked up a clin­i­cal stage can­cer drug, as well as a well-con­nect­ed new chair­man of the board.

Ex-Cel­gene deal­mak­er George Golumbes­ki has added to his con­sid­er­able range of ac­tiv­i­ties by tak­ing the chair at Car­rick, which hit the scene two years ago with a $95 mil­lion start­up round and plans to scoop up a pipeline through a se­ries of part­ner­ing deals.

Speak­ing of which.

The biotech al­so bagged rights to CT900 from BTG, a com­bi­na­tion of tar­get­ing fo­late re­cep­tor α and in­hibit­ing thymidy­late syn­thase. The drug had been in a small, very ear­ly-stage study for ovar­i­an can­cer, with 7 of 10 mol­e­c­u­lar­ly marked pa­tients demon­strat­ing a re­sponse to the drug.

Terms weren’t dis­closed, but the drug is go­ing in­to the pipeline along­side CT7001, an oral CDK7 in­hibitor they got from Can­cer Re­search UK.

Golumbes­ki — now pres­i­dent of Grail — is po­si­tioned to use some of his con­sid­er­able skills and con­nec­tions to help guide Car­rick along. The biotech gained its back­ing from Arch and Wood­ford In­vest­ments, the co-lead­ers of the big A round, with more cash com­ing in from Google’s GV, Cam­bridge En­ter­prise Seed Funds, Cam­bridge In­no­va­tion Cap­i­tal, Evotec AG and Light­stone Ven­tures.

Elaine Sul­li­van

Their mon­ey has been com­mit­ted to build­ing up a new can­cer com­pa­ny by tap­ping Eu­ro­pean sources, where the sci­ence is great and the hunt­ing may be some­what less in­tense than in the US.

The goal at Car­rick re­mains the same as it was at the be­gin­ning, says CEO Elaine Sul­li­van: “Build a sus­tain­able, lead­ing on­col­o­gy biotech based in Eu­rope.”

In Car­rick’s case that meant build­ing a core team of 12, with about 40 FTEs from out­side shops ded­i­cat­ed to their drugs. CT900 has the po­ten­tial to fol­low a rapid route to mar­ket, she tells me, through a piv­otal pro­gram. They have more drugs on the pre­clin­i­cal side as well to beef up the pipeline as the biotech pon­ders a pos­si­ble IPO.

Sul­li­van met Golumbes­ki through her work at Evotec, where she’s on the board. Golumbes­ki — a deal­mak­er with ex­ten­sive glob­al con­nec­tions — helped shape re­search pacts be­tween Cel­gene and Evotec, giv­ing them a chance to get to know one an­oth­er.

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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It is 'kind of a proven tech­nol­o­gy': Hep B vac­cine mak­er joins glob­al hunt for coro­n­avirus vac­cine

Using lab-grown proteins that are engineered to mimic the architecture of viruses to induce an immune response, VBI Vaccines is joining the hunt for a coronavirus vaccine — harnessing technology that has initially been proved safe in early trials as a prophylactic for cytomegalovirus (CMV) infection.

Unlike the raft of the companies in the Covid-19 vaccine race — including Moderna, CureVac and J&J — VBI is taking a pan-coronavirus approach, by developing a vaccine that will encompass Covid-19, severe acute respiratory syndrome (SARS), and Middle East respiratory syndrome (MERS).

Covid-19 roundup: J&J, BAR­DA set ear­ly 2021 fin­ish line for $1B vac­cine race; FDA al­lows emer­gency drug use, ahead of piv­otal da­ta

J&J has zeroed in on a Covid-19 vaccine candidate that it hopes to begin testing in humans by September this year — with the extraordinary goal of getting it ready for emergency use in early 2021. And together with BARDA, it’s committing $1 billion to make it happen.

That kind of accelerated timeline would fall on the fast side of NIAID director Anthony Fauci’s well-publicized prediction that it would be another 12 to 18 months before a vaccine can be available for public use. A Phase I trial of Moderna’s mRNA vaccine began two weeks ago, and both the biotech and fellow mRNA player CureVac have discussed similar, if not even faster, timelines for emergency use among healthcare workers.

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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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Can a pair of top AveX­is alum­ni steer a new gene ther­a­py up­start to R&D glo­ry? 3 VCs bet $60M on it

VCs love few things more than a proven executive team when it comes to launching a new company. And now a group of A-listers has turned to a pair of top execs out of AveXis to steer the latest gene therapy player into the clinic.

The biotech is Waltham, MA-based Affinia and the two execs are Sean Nolan and Rick Modi — the former CEO and CBO respectively of AveXis, the gene therapy pioneer that fetched $8.7 billion in a sale to Novartis. Nolan has now taken the chairman’s role at Affinia while Modi moves up to the CEO post at the company.

Un­de­terred by a pan­dem­ic, Gilde Health­care rais­es their largest fund yet

When Pieter van der Meer started raising the capital for Gilde Healthcare’s fifth fund in the waning months of 2019, he had his eyes on a different chain of events that could change the healthcare system and perhaps even play to his firm’s advantage: The US presidential election.

Since raising their third fund in 2011, the 34-year-old Dutch firm had focused on value-based care. They chose late-stage biotechs that came up with new devices and delivery systems for de-risked established compounds, and when they chose preclinical biotechs, they spoke with potential pharma partners, payers and regulators to ask where and at what prices the drug made sense. As the Democratic primary became a contest over how to lower healthcare costs, it looked like a strategy that could pay off.

Just in time to as­sure a de­ci­sion be­fore CVR dead­line, Bris­tol My­ers Squibb files NDA for Cel­gene/blue­bird CAR-T

A new CAR-T therapy may be coming. And maybe $9 per share for Celgene investors, too.

Bristol Myers Squibb announced they submitted an NDA for the multiple myeloma “ide-cel” CAR-T therapy Celgene developed in partnership with bluebird. The therapy is one of the three that has to be approved to unlock the BMS-Celgene contingent value agreement that would give shareholders of the absorbed NJ company $9 per share. The first, ozanimod, was approved last week. The second, a CAR-T treatment for non-Hodgkin’s lymphoma called liso-cel, was submitted to the FDA in December.