As can­cer de­tec­tion com­pa­nies thrive, Ex­act Sci­ences looks to con­sol­i­date by spend­ing $2.8B to ac­quire peer Ge­nom­ic Health

As pre­dict­ed by Bloomberg, can­cer di­ag­nos­tics com­pa­ny Ex­act Sci­ences is buy­ing peer Ge­nom­ic Health in a $2.8 bil­lion cash-and-stock deal. 

Ex­act Sci­ences’ flag­ship col­orec­tal can­cer test Co­lo­guard will com­ple­ment Ge­nom­ic Health’s On­co­type DX, a test de­signed to help doc­tors de­ter­mine the best course of treat­ment for women with breast can­cer. To­geth­er the tests help in­form treat­ment de­ci­sions in col­orec­tal, breast and prostate can­cer, rep­re­sent­ing rough­ly 40% of all sol­id tu­mor in­ci­dence, the com­pa­nies said.

Last year, Ex­act Sci­ences en­list­ed Pfiz­er as a US mar­ket­ing part­ner to ex­pand Co­lo­guard adop­tion. The tie-up has ramped up the use of the test — in the sec­ond quar­ter of 2019, Co­lo­guard rev­enue grew 94% year-over-year.

“We re­main Out­per­form on EXAS with our view that Co­lo­guard is still high­ly un­der-pen­e­trat­ed in a pa­tient pop­u­la­tion man­age­ment pegs at 101M where EXAS could de­liv­er 40%+ pen­e­tra­tion or $6B+ in rev­enue longer-term, from just ~5% pen­e­tra­tion to­day,” Leerink an­a­lysts wrote in a note in May.

Ge­nom­ic Health re­port­ed a 19% year-over-year jump in sec­ond-quar­ter rev­enue and es­ti­mates its On­co­type DX suite of prod­ucts in on­col­o­gy and urol­o­gy have a to­tal avail­able mar­ket of $2 bil­lion.

Com­bined un­der one roof, the com­pa­nies are look­ing to take ad­van­tage of economies of scale, as ri­vals loom large. South San Fran­cis­co biotech Freenome raised $160 mil­lion last week to con­duct a piv­otal tri­al for its blood test for col­orec­tal can­cer. Mean­while, Il­lu­mi­na spin­off Grail has raised $1.5 bil­lion to work on a mul­ti-can­cer de­tec­tion test and Third Rock-backed Thrive has scored $110 to build its liq­uid biop­sy plat­form for ear­ly can­cer de­tec­tion.

Kevin Con­roy Ex­act Sci­ences

“To­geth­er, with our col­lec­tive re­sources and broad­er plat­form, we will be able to pro­vide our ex­ist­ing tests to more peo­ple, while al­so ac­cel­er­at­ing the de­vel­op­ment and launch of fu­ture can­cer di­ag­nos­tic tests,” Ex­act Sci­ences chief Kevin Con­roy said in a state­ment on Mon­day. 

“Though we be­lieve the pipeline ben­e­fits, po­ten­tial for kit­ted prod­ucts, ex­pan­sion in­to in­ter­na­tion­al mar­kets…and ex­pe­ri­ence with FDA are win­ning as­pects of the deal; EXAS is like­ly to get more in­vestor ques­tions on the near-mid term strate­gic ra­tio­nale and $25M in 3rd year syn­er­gies,” Leerink an­a­lysts wrote in a note.

On Sat­ur­day, Bloomberg re­port­ed the deal was in­com­ing, cit­ing peo­ple fa­mil­iar with the mat­ter.

Ex­act Sci­ences shares $EXAS closed up about 1.6% on Fri­day at $117.92, while Ge­nom­ic Health’s stock $GHDX closed up 5.5% at $68.66.

Un­der the deal, which is ex­pect­ed to close at the end of the year, Ge­nom­ic Health stock­hold­ers will re­ceive $27.50 in cash and $44.50 in shares of Ex­act Sci­ences stock. If con­sum­mat­ed, Ex­act Sci­ences share­hold­ers are set to own about 91% of the com­bined com­pa­ny, while Ge­nom­ic Health stock­hold­ers will be left with the rest. Next year, the com­bined en­ti­ty ex­pects to gen­er­ate rev­enue of ap­prox­i­mate­ly $1.6 bil­lion and a gross prof­it of ap­prox­i­mate­ly $1.2 bil­lion. 

So­cial im­age: Ex­act Sci­ences

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

Hal Barron, Endpoints UKBIO20 (Jeff Rumans)

'Al­tos was re­al­ly a once-in-a-life­time op­por­tu­ni­ty': Hal Bar­ron re­flects on his big move

By all accounts, Hal Barron had one of the best jobs in Big Pharma R&D. He made more than $11 million in 2020, once again reaping more than his boss, Emma Walmsley, who always championed him at every opportunity. And he oversaw a global R&D effort that struck a variety of big-dollar deals for oncology, neurodegeneration and more.

Sure, the critics never let up about what they saw as a rather uninspiring late-stage pipeline, where the rubber hits the road in the Big Pharma world’s hunt for the next big near-term blockbuster, but the in-house reviews were stellar. And Barron was firmly focused on bringing up the success rate in clinical trials, holding out for the big rewards of moving the dial from an average 10% success rate to 20%.

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Executive Director of the EMA Emer Cooke (AP Photo/Geert Vanden Wijngaert)

Eu­ro­pean Par­lia­ment signs off on strength­en­ing drug reg­u­la­tor's abil­i­ty to tack­le short­ages

The European Parliament on Thursday endorsed a plan to increase the powers of the European Medicines Agency, which will be better equipped to monitor and mitigate shortages of drugs and medical devices.

By a vote of 655 to 31, parliament signed off on a provisional agreement reached with the European Council from last October, in which the EMA will create two shortage steering groups (one for drugs, the other for devices), a new European Shortages Monitoring Platform to facilitate data collection and increase transparency, and on funding for the work of the steering groups, task force, working parties and expert panels that are to be established.

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Kenneth Galbraith, incoming Zymeworks CEO

Zymeworks re­places half its C-suite, aims to lay off 25% of to­tal work­force as new CEO takes over

New Zymeworks CEO Kenneth Galbraith is aiming to hit the ground running when his tenure officially begins next month, but he’ll be doing so with a much different looking team.

In a lengthy press release outlining the biotech’s 2022 goals, Galbraith said Zymeworks will be laying off at least 25% of its staff over the course of the year. Half of its C-suite will also be replaced immediately as Galbraith looks to remake the company in his image after Ali Tehrani, Zymeworks’ founder and CEO since 2003, stepped down two weeks ago.

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Graphic: Kathy Wong for Endpoints News

What kind of biotech start­up wins a $3B syn­di­cate, woos a gallery of mar­quee sci­en­tists and re­cruits GSK's Hal Bar­ron as CEO in a stun­ner? Let Rick Klaus­ner ex­plain

It started with a question about a lifetime’s dream on a walk with tech investor Yuri Milner.

At the beginning of the great pandemic, former NCI chief and inveterate biotech entrepreneur Rick Klausner and the Facebook billionaire would traipse Los Altos Hills in Silicon Valley Saturday mornings and talk about ideas.

Milner’s question on one of those mornings on foot: “What do you want to do?”

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Crit­ics push back on Alzheimer’s As­so­ci­a­tion ad blitz to get Medicare to change its Aduhelm rul­ing: 'Dead wrong'

The latest Alzheimer’s Association advertising campaign encourages people to fight.

Not against the disease or for more research or treatments, but against the Centers for Medicare and Medicaid Services. More specifically, CMS’ recent reimbursement decision to only pay for Biogen and Eisai’s controversial Alzheimer’s drug Aduhelm for patients in clinical trials.

With CMS’ preliminary decision now in a 30-day comment period, patient advocates’ goal is to convince CMS to reverse its decision with a marketing blitz and public pressure.

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Dan O'Day, Gilead CEO (Jim Watson/AFP via Getty Images)

Fail­ing to con­firm clin­i­cal ben­e­fit, Gilead pulls 2 ac­cel­er­at­ed ap­proval in­di­ca­tions for can­cer drug

Gilead recently decided to pull two indications for its cancer drug Zydelig — in relapsed follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic leukemia (SLL) — after failing to complete the confirmatory trials required as part of the accelerated approvals from 2014.

“As the treatment landscape for FL and SLL has evolved, enrollment into the confirmatory study has been an ongoing challenge,” Gilead said in a statement, noting it formally notified the FDA of its decision to voluntarily withdraw these indications.

Richard Pazdur (via AACR)

Time lim­its on ac­cel­er­at­ed ap­provals? FDA's on­col­o­gy chief Rick Paz­dur eyes po­ten­tial re­forms via in­ter­na­tion­al ap­proach­es

The spotlight on the accelerated approval pathway continues to shine bright, with the FDA’s top oncology official writing in an opinion that the pathway may be strengthened with bits and pieces of what other regulators in Europe and elsewhere have done with their expedited approval pathways, such as adding expiration dates for these faster approvals to ensure they confirm clinical benefit in a timely manner.

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Covid-19 roundup: HHS may strug­gle to ab­sorb Op­er­a­tion Warp Speed; Eu­rope has no plans for a fourth vac­cine dose

Operation Warp Speed, perhaps the greatest achievement of the former Trump administration, promptly delivered Covid-19 vaccine supplies nationwide when they became available, thanks to collaborations between HHS and the Department of Defense, while helping to fund and aid the manufacture of billions of doses.

But since the Biden administration took over a year ago, acting FDA commissioner Janet Woodcock transitioned out of her role as the therapeutics lead in Warp Speed, which has been converted into a new operation without the fancy name (now known as the “HHS-DOD COVID-19 Countermeasures Acceleration Group”), and as of the start of 2022, the Department of Defense is no longer helping HHS on the program.