CEO Adrian Rawcliffe (Adaptimmune)

Adap­ti­m­mune 'ready for prime­time' as it pre­pares to launch T cell ther­a­py for sar­co­ma, CEO Adri­an Raw­cliffe says

Philadel­phia’s Adap­ti­m­mune isn’t new to the biotech scene, but CEO Adri­an Raw­cliffe says the com­pa­ny is fi­nal­ly “ready for prime­time.”

Ahead of a Thurs­day pre­sen­ta­tion at JP Mor­gan on the cell ther­a­py com­pa­ny’s five-year plan, Raw­cliffe told End­points News he’s ex­cit­ed to be in a po­si­tion that “very few biotech CEOs ac­tu­al­ly get to be in.”

“I can say that next year we’ll be launch­ing our first prod­uct. And I think that’s par­tic­u­lar­ly an achieve­ment giv­en it’s a com­plete­ly home­grown prod­uct,” he said. “It’ll be the first en­gi­neered T cell ther­a­py for a sol­id tu­mor in syn­ovial sar­co­ma with ADP-A2M4. And prob­a­bly the sec­ond cel­lu­lar prod­uct, full stop, in the sol­id tu­mor set­ting. And it’s just in­cred­i­bly ex­cit­ing, and it’s al­so it’s a per­fect­ly-sized op­por­tu­ni­ty for us.”

Raw­cliffe said the in­dus­try un­til now has viewed Adap­ti­m­mune as more of a “low-key com­pa­ny,” but with ADP-A2M4 ready for launch, it’s demon­strat­ed an abil­i­ty to adapt with the cur­rent needs of on­co­log­i­cal ther­a­peu­tics re­search.

“It’s re­al­ly cool for Adap­ti­m­mune, but most of all, it’s go­ing to be re­al­ly cool and a great ben­e­fit for the peo­ple with sar­co­ma,” he said. “I think, be­yond that, the ex­cite­ment from the rest of the mar­kets and in­dus­try is what we can do out­side of sar­co­ma. Last year, we showed re­spons­es in six dif­fer­ent sol­id tu­mor types, with three whol­ly-owned clin­i­cal as­sets, two gen­er­a­tions of MAGE-A4 tar­get­ing pro­grams, and one of AFP which is (a pro­tein) in liv­er can­cer.”

The com­pa­ny is al­so mov­ing for­ward in two piv­otal tri­als, the first of which is the Spear­head-1 clin­i­cal tri­al for pa­tients with syn­ovial sar­co­ma where ADP-A2M4 will be put to the test. The sec­ond is a tri­al for esophageal can­cers, which in­volves a much more sig­nif­i­cant pop­u­la­tion, Raw­cliffe said.

“We be­lieve that by be­ing an in­te­grat­ed cell ther­a­py com­pa­ny, we will de­liv­er these prod­ucts and huge val­ue both for pa­tients and ob­vi­ous­ly for our in­vestors,” he said. “We’ve set out over the last five years to en­able that we’ve de­liv­ered.”

Many times, biotech CEOs join cer­tain com­pa­nies based on a cri­te­ria of un­met med­ical needs that promis­ing new tech­nol­o­gy says it can ad­dress. Raw­cliffe said that wasn’t quite what drew him to make the jump from pre­vi­ous ven­tures at Glax­o­SmithK­line, where he spent years spear­head­ing the phar­ma gi­ant’s in­vest­ments.

“Cell ther­a­py com­pa­nies are dif­fer­ent and con­struct­ed dif­fer­ent­ly. They have dif­fer­ent ca­dences, and they have dif­fer­ent ca­pa­bil­i­ties,” he said. “We be­lieve that the to­tal sum­ma­tion of that puts us in a re­al­ly good po­si­tion to be a ful­ly in­te­grat­ed cell ther­a­py com­pa­ny with a range of prod­ucts on the mar­ket and in late-stage de­vel­op­ment over the com­ing years.”

Raw­cliffe en­vi­sions Adap­ti­m­mune’s tech­nol­o­gy, which fo­cus­es on en­gi­neer­ing T cell re­cep­tors to rec­og­nize the can­cer cells they should be try­ing to kill, as ul­ti­mate­ly do­ing for T cell re­cep­tors “what Genen­tech and Am­gen did for an­ti­bod­ies.”

“When you have new modal­i­ties of ther­a­py, you have the op­por­tu­ni­ty for trans­for­ma­tion­al change. You think about the im­pact of mon­o­clon­al an­ti­bod­ies on im­mune dis­eases, and how they went from sci­ence projects in aca­d­e­m­ic labs to some of the most wide­ly-used ther­a­pies — and cer­tain­ly most valu­able ther­a­pies out there — treat­ing mil­lions of pa­tients glob­al­ly,” he said.

What in­ter­est­ed him about the cell ther­a­py are­na is that it fo­cus­es on do­ing some­thing dif­fer­ent as a means to treat an on­go­ing and no­to­ri­ous­ly tricky dis­ease spec­trum.

“It was the first time that I thought, ‘OK, if you could get that to work, you’ve got a re­al chance of reengi­neer­ing the im­mune sys­tem to make a mas­sive dif­fer­ence on broad pa­tients with can­cer,'” he said.

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.

Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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Jean-Christophe-Hyvert, Lonza

Lon­za look­ing to build on 'd­if­fer­en­ti­at­ed ad­van­tage' in Covid-19, CD­MO mar­ket­place in 2021

It’s not new for Lonza, the Swiss CDMO nearing its quasquicentennial anniversary, to be in the upper echelon of the biotech manufacturing industry.

But 2020 — as it was for many CDMOs — was a special year even by Lonza’s standards. The company inked a deal to produce 1 billion worldwide doses of Moderna’s Covid-19 vaccine and tapped pharma vet Pierre-Alain Ruffieux to lead its operations, moves which have allowed Lonza to make a myriad of other deals that will continue to ramp up its global production capacity.

Matt Gline (L) and Vivek Ramaswamy

Scoop: Vivek Ra­maswamy is hand­ing the CEO job to a top lieu­tenant at Roivant — but he’s not ex­act­ly leav­ing the biotech scene

Over the past 7 years since founding Roivant, Vivek Ramaswamy has been a constant blur of biotech building motion.

He launched his first biotech with an Alzheimer’s drug he picked up cheap, and watched the experiment implode in one of the highest profile pivotal disasters seen in the last decade. But it didn’t slow the 30-something exec down; if anything, he hit the accelerator. Ramaswamy blazed global paths and went on to raise billions to spur the creation of a large lineup of little Vants promising big things at a fast pace. He sold off a section of the Vant brigade to Sumitomo Dainippon for $3 billion. And more recently the relentless dealmaker has been building a computational discovery arm to add an AI-driven approach to kicking up new programs and companies, supplementing the in-licensing drive while pursuing advances that have created more than 700 jobs at Roivant, with $2 billion in reserves.

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Ron Cooper, Albireo CEO

Al­bireo just ad­vanced down to the 10-yard line at the FDA. And Ron Coop­er’s team is get­ting prepped for the next big play

When Albireo Pharma’s board $ALBO moved to bring in Ron Cooper as the CEO more than 5 years ago, the development-stage company went with an experienced commercial player who had a big-time position on his resume after running Bristol Myers’ commercial ops in Europe.

Now, after successfully navigating a pivotal study, putting them in a foot race with a rival toward an FDA OK, Cooper is getting a boost from regulators on the last drive back to an arena he understands completely.

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Hal Barron, GSK via YouTube

What does $29B buy you in Big Phar­ma? In Glax­o­SmithK­line’s case, a whole lot of un­com­fort­able ques­tions about the pipeline

Talk about your bad timing.

A little over a week ago, GSK R&D chief Hal Barron marked his third anniversary at the research helm by taking a turn at the virtual podium during JP Morgan to make the case that he and his team had built a valuable late-stage pipeline capable of churning out more than 10 blockbusters in the next 5 years.

And then, just days later, one of the cancer drugs he bet big on as a top prospect — bintrafusp, partnered with Merck KGaA — failed its first pivotal test in non-small cell lung cancer.

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Can strug­gling Iterum turn the cor­ner to an an­tibi­ot­ic suc­cess sto­ry? They will know in six months

More than five years after Corey Fishman and Michael Dunne dusted sulopenem off Pfizer’s shelves — the second castoff antibiotic they’ve brought out of the pharma giant — and founded Iterum Therapeutics around that single drug, they have lined up a quick shot at approval with priority review from the FDA.

The decision, six months from now, will mark a make-or-break moment for a struggling biotech that has just enough cash to keep the lights on until the third quarter.

Bahija Jallal, Immunocore

Buried in Im­muno­core's IPO fil­ings? A kick­back scheme from a now for­mer em­ploy­ee

Immunocore spent much of 2019 dealing with the fallout of the Neil Woodford scandal, as the former star investor’s fall crashed the biotech’s valuation out of unicorn range. Now it turns out that the company spent 2020 dealing with another internal scandal.

The longtime UK biotech darling disclosed in their IPO filing last week that they had fallen victim to an alleged kickback scheme involving one of their employees. After a whistleblower came forward, they said in their F-1, they spent the summer and spring investigating, finding fraud on the part of an employee and two outside vendors.

Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

Covid-19 roundup: Mod­er­na dou­bles down on Covid-19 with new boost­er tri­als; Aus­tralia plans do­mes­tic pro­duc­tion of As­traZeneca vac­cine amid dis­tri­b­u­tion lag

As Merck bows out of the global race to develop vaccines for Covid-19, Moderna is doubling down to make sure they can quell new variants that have recently emerged and quickly spread.

The Cambridge, MA-based biotech put out word on Monday that in vivo studies indicate their mRNA vaccine works well enough against two strains first detected in the UK and South Africa. But with a six-fold reduction in neutralizing titers observed against the latter strain, the company is launching a new study of a booster version to make sure it can do the job.

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