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.

Qual­i­ty Con­trol in Cell and Gene Ther­a­py – What’s Re­al­ly at Stake?

In early 2021, Bluebird Bio was forced to suspend clinical trials of its gene therapy for sickle cell disease after two patients in the trial developed cancer. As company scientists rushed to assess whether there was any causal link between the therapy and the cancer cases, Bluebird’s stock value plummeted – as did those of multiple other biopharma companies developing similar therapies.

While investigations concluded that the gene therapy was unlikely to have caused cancer, investors and the public may be more skittish regarding the safety of gene and cell therapies after this episode. This recent example highlights how delicate the fields of cell and gene therapy remain today, even as they show great promise.

Chris Gibson (Photo By Vaughn Ridley/Sportsfile for Web Summit via Getty Images)

Re­cur­sion founders gin for­tunes as IPO back­ers show­er $436M on one of the biggest boasts in AI -- based on some very small deals

In the AI drug development world, boasting often comes with the territory. Yet few can rival Recursion when it comes to claiming the lead role in what company execs like to call the industrialization of drug development, with promises of continued exponential growth in the number of drugs it has in the pipeline.

On Friday, the Salt Lake City-based biotech translated its unicorn-sized boasts into a killer IPO, pricing more than 24 million shares at the high end of its range and bringing in $436 million — with a large chunk of that promised by some deep-pocket backers.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

FDA lays the ham­mer on Emer­gen­t's Bal­ti­more plant af­ter J&J de­ba­cle, halt­ing all pro­duc­tion in un­usu­al move

Emergent BioSolutions has had a tough month: First, the CDMO ruined 15 million doses of J&J’s Covid-19 vaccine in March and then suffered the ignominy of the FDA seizing the reins. Now, as the agency receives a full accounting of the site’s problems, Emergent has slammed the brakes on all production at the FDA’s behest.

Emergent will cease manufacturing at its Baltimore plant until the FDA’s inspection and remediation of any findings is complete, the company said in a statement. Emergent will also quarantine existing materials that have already been manufactured. That stoppage started on Friday, four days after the initiation of the FDA’s inspection.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 107,200+ biopharma pros reading Endpoints daily — and it's free.

UP­DAT­ED: New Kaiser analy­sis shows how lim­it­ing price ne­go­ti­a­tions to tar­get­ed drugs may bet­ter fo­cus up­com­ing leg­is­la­tion

As Congress considers whether to adopt sweeping new legislation to lower prescription drug prices across the board, the Kaiser Family Foundation is out with a new report on Monday showing how a more targeted approach on a subset of drugs might be a more efficient way to save government funds.

“This analysis shows that Medicare Part D and Part B spending is highly concentrated among a relatively small share of covered drugs, mainly those without generic or biosimilar competitors,” wrote Juliette Cubanski, deputy director of the program on Medicare policy at KFF, and Tricia Neuman, SVP of KFF. “Focusing drug price negotiation or reference pricing on a subset of drugs that account for a disproportionate share of spending would be an efficient use of administrative resources, though it would also leave some potential savings on the table.”

Tillman Gerngross (Adagio)

Till­man Gern­gross' Covid-19 an­ti­body moon­shot scores $336M with the help of new ace CFO. Is an IPO next?

Less than a year into its existence, serial biotech entrepreneur Tillman Gerngross’ antibody play Adagio has raced ahead into a pivotal trial for its lead drug for Covid-19 on the back of some very promising preclinical data. Now, crossover investors led by Peter Kolchinsky at RA are rolling up the Brinks truck — and that could spell an IPO in the offing for Adagio.

Adagio has bagged $336 million as part of a Series C round led by RA Capital to advance lead single-shot antibody ADG20 through a pivotal Phase I/II/III trial for the treatment of mild to moderate Covid-19 patients at high risk of infection, the biotech said Monday.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 107,200+ biopharma pros reading Endpoints daily — and it's free.

When is a drug re­al­ly a de­vice? Court knocks down FDA ap­peal in try­ing to sort that grey area

It’s always a surprise when a court has to step in to tell the FDA that it erred in performing one of its main duties: classifying whether a medical product is drug or a device.

But that’s what the US Court of Appeals for the District of Columbia did on Friday, making clear to the world’s top drug regulator that Genus Medical Technologies’ contrast agent barium sulfate (also known as Vanilla SilQ) should not be considered a drug, as the FDA had said, but a medical device.

Q1: A flood of in­vestor cash drove biotech's num­bers to new record highs, and the tor­rent of cash is mov­ing up­stream fast

If you thought biotech was booming last year, wait until you get a load of the numbers from Q1 2021.

On virtually every level, with one exception, the money engine was working around the clock in the first 3 months of this year. Venture capital has reached such a fever peak that the average B round now weighs in at an average mega-weight value of $100 million. The money flow is also finding its way to the mouth of the R&D river, where discovery work now merits the big bucks instead of cautionary seed funds.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Jami Rubin (EQRx)

Ja­mi Ru­bin, once fa­bled for grilling bio­phar­ma ex­ecs, de­camps to head fi­nance at drug pric­ing dis­rupter

As Goldman Sachs’ top pharmaceutical analyst, Jami Rubin was known for asking the tough questions. Now, as she takes the lead on EQRx’s mission to rewrite the rules of drug pricing, we’ll see how good her answers are.

Rubin made the jump to biotech on April 5, becoming EQRx’s new CFO, the company said Monday. She’s coming from PJT Partners, where she’s been a partner providing strategic guidance for biotech and pharmaceutical companies for the last couple years. With EQRx’s recent $500 million Series B round in the books, it wouldn’t be a surprise if she was already lining up a public debut.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 107,200+ biopharma pros reading Endpoints daily — and it's free.

Seagen gets Au­gust PDU­FA for Pad­cev ex­pan­sions; Adap­tate pulls in new cash for gam­ma delta T cell an­ti­bod­ies

Seagen is riding the wave of two new priority reviews straight to the FDA.

The Bothell, WA-based biotech and their partners at Astellas announced Monday that two supplemental BLAs for Padcev had been accepted by US regulators. FDA has set Aug. 17 as the PDUFA date for the reviews.

“With our recent regulatory submissions, we intend to provide the highest level of clinical evidence supporting Padcev use — overall survival data from a randomized Phase III trial — and expand availability in multiple countries where there is unmet medical need,” said Astellas oncology chief Andrew Krivoshik.