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.

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When the FDA approved Pfizer’s JAK inhibitor Xeljanz for rheumatoid arthritis in 2012, they slapped on a black box warning for a laundry list of adverse events and required the New York drugmaker to run a long-term safety study.

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Covid-19 roundup: EU and As­traZeneca trade blows over slow­downs; Un­usu­al unions pop up to test an­ti­bod­ies, vac­cines

After coming under fire for manufacturing delays last week, AstraZeneca’s feud with the European Union has spilled into the open.

The bloc accused the pharma giant on Wednesday of pulling out of a meeting to discuss cuts to its vaccine supplies, the AP reported. AstraZeneca denied the reports, saying it still planned on attending the discussion.

Early Wednesday, an EU Commission spokeswoman said that “the representative of AstraZeneca had announced this morning, had informed us this morning that their participation is not confirmed, is not happening.” But an AstraZeneca spokesperson later called the reports “not accurate.”

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Vir's CMO says he's sur­prised that a low dose of their he­pati­tis B drug ap­pears promis­ing in ear­ly slice of da­ta — shares soar

Initial topline data from a Phase I study of a new therapeutic for chronic hepatitis B virus was so promising that it surprised even the CMO of the company that produces it.

Vir Biotechnology on Tuesday announced that its VIR-3434 molecule reduced the level of virus surface antigens present in a blinded patient cohort after eight days of the trial with just a single 6 mg dose. Six of the eight patients in the cohort were given the molecule, and the other two a placebo—all six who received the molecule saw a mean antigen reduction of 1.3 log10 IU/mL, Vir said.

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Florian Brand (L) and Srinivas Rao (ATAI)

Psy­che­del­ic biotech ATAI hopes to ex­pand port­fo­lio through re­search part­ner­ship with Mass Gen­er­al

Psychedelics have made a comeback for mental health research, with companies like startup biotech ATAI Life Sciences raising millions and earning the backing of prominent investors like Peter Thiel, but there’s a hole at the heart of the resurgence: Researchers still don’t fully understand how they work.

A new partnership between ATAI and world-renowned Mass General Hospital hopes to change that.

Pascal Soriot, AP

As­traZeneca CEO Pas­cal So­ri­ot sev­ers an un­usu­al board con­nec­tion, steer­ing clear of con­flicts while re­tain­ing im­por­tant al­liances

CSL Behring chief Paul Perreault scored an unusual coup last summer when he added AstraZeneca CEO Pascal Soriot to the board, via Zoom. It’s rare, to say the least, to see a Big Pharma CEO take any board post in an industry where interests can simultaneously connect and collide on multiple levels of operations.

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Adeno-associated virus-1 illustration; the use of AAVs resurrected the gene therapy field, but companies are now testing the limits of a 20-year-old technology (File photo, Shutterstock)

Af­ter 3 deaths rock the field, gene ther­a­py re­searchers con­tem­plate AAV's fu­ture

Nicole Paulk was scrolling through her phone in bed early one morning in June when an email from a colleague jolted her awake. It was an article: Two patients in an Audentes gene therapy trial had died, grinding the study to a halt.

Paulk, who runs a gene therapy lab at the University of California, San Francisco, had planned to spend the day listening to talks at the American Association for Cancer Research annual meeting, which was taking place that week. Instead, she skipped the conference, canceled every work call on her calendar and began phoning colleagues across academia and industry, trying to figure out what happened and why. All the while, a single name hung in the back of her head.

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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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Anthony Fauci, NIAID director (AP Images)

As new Covid-19 task force gets un­der­way, threat looms of vac­cine, mon­o­clon­al an­ti­body-re­sis­tant vari­ants

Hours before President Biden’s Covid-19 team gave their first virtual press conference, the famed AIDS researcher David Ho delivered concerning news in a new pre-print: SARS-CoV-2 B.1.351, the variant that emerged in South Africa, is “markedly more resistant” to antibodies from convalescent plasma and vaccinated individuals.

The news for several monoclonal antibodies, including Eli Lilly’s bamlanivimab, was even worse: Their ability to neutralize was “completely or markedly abolished,” Ho wrote. Lilly’s antibody cocktail, which was just shown to dramatically reduce the risk of hospitalizations or death, also became far less potent.