Adrian Rawcliffe, Adaptimmune CEO

Adap­ti­m­mune says it's (near­ly) ready to head to the FDA with TCR can­cer ther­a­py

Six months af­ter an ini­tial re­veal at AS­CO, Adap­ti­m­mune is back in the lime­light with new da­ta Thurs­day. And the com­pa­ny be­lieves it now has enough to go to reg­u­la­tors for what would be the first-ever TCR ther­a­py.

The biotech’s afa­mi-cel pro­gram put out up­dat­ed fig­ures Thurs­day morn­ing with re­searchers not­ing as of Sept. 1, 16 of 47 pa­tients saw their tu­mors shrink while on the ex­per­i­men­tal treat­ment. It’s good enough for a 34% over­all re­sponse rate and, while low­er than the May up­date of 39%, makes Adap­ti­m­mune con­fi­dent enough to say the study will reach its pri­ma­ry end­point.

Though the fi­nal da­ta cut is ex­pect­ed by the end of the year, “it is math­e­mat­i­cal­ly im­pos­si­ble not to meet the pri­ma­ry end­point,” CEO Adri­an Raw­cliffe told End­points News. Fol­low­ing dis­cus­sions with the FDA, the biotech had set an 18% re­sponse rate as an ac­cept­able thresh­old to meet the pri­ma­ry.

“If you as­sume all fu­ture pa­tients will not re­spond,” he added, “the ones that have yet to be as­sessed, the tri­al will still meet the pri­ma­ry end­point.”

De­spite Raw­cliffe’s rosy pic­ture, in­vestors didn’t ap­pear too con­vinced as Adap­ti­m­mune shares $ADAP closed down about 9% in Thurs­day trad­ing.

As the tri­al ap­proach­es its end, Raw­cliffe not­ed that the way in which re­spons­es are clas­si­fied may have changed for some pa­tients as in­de­pen­dent in­ves­ti­ga­tors chimed in, lead­ing to the low­er nu­mer­i­cal fig­ure. Raw­cliffe said it’s the main rea­son two pa­tients who were pre­vi­ous­ly said to have achieved com­plete re­spons­es are no longer la­beled as such.

Nev­er­the­less, the biotech is pre­pared to sub­mit its BLA next year once the fi­nal da­ta are ready. Raw­cliffe de­scribed Adap­ti­m­mune is “very com­fort­able” with the whole da­ta pack­age as it stands and high­light­ed the study’s dura­bil­i­ty mea­sures. Even though 75% of re­spon­ders are still re­ceiv­ing treat­ment, the tri­al has not reached me­di­an du­ra­tion of re­sponse.

Pa­tients’ re­sponse times stretch from about four weeks to more than 65 weeks.

Adap­ti­m­mune had en­rolled pa­tients with two types of sar­co­mas: ad­vanced syn­ovial sar­co­ma or myx­oid/round cell li­posar­co­ma. By each can­cer, the ORR was 36% in syn­ovial sar­co­ma pa­tients and 25% for those with MR­CLS. Pa­tients with these can­cers gen­er­al­ly don’t have many treat­ment op­tions af­ter chemo, Raw­cliffe said, and the five-year mor­tal­i­ty rate is around 70-80%.

Now look­ing to­ward its reg­u­la­to­ry fu­ture, Adap­ti­m­mune may like­ly face sim­i­lar ques­tions as oth­er com­pa­nies that have brought forth cell ther­a­pies. TCR is sim­i­lar to CAR-Ts, in that a pa­tient’s cells are re­moved, re-en­gi­neered and re­placed to tar­get can­cer cells, but TCR goes af­ter a dif­fer­ent pro­tein.

TCRs have his­tor­i­cal­ly been met with a lot of skep­ti­cism, both from re­searchers and in­vestors, but this is the sec­ond time this week a biotech is tout­ing new da­ta. Im­mat­ics re­vealed an ear­ly-stage study that saw eight of 16 pa­tients reg­is­ter an ob­jec­tive re­sponse against a range of sol­id tu­mor types on Tues­day.

Raw­cliffe him­self ad­mit­ted the com­pa­ny has al­ready been asked about its CMC process­es. It’s been at the top of the to-do list in the six months since AS­CO, how­ev­er, and the CEO is con­fi­dent every­thing will be in or­der when the FDA comes knock­ing.

“There’s been five cell ther­a­pies ap­proved to date, and they all came with chal­lenges of their own,” Raw­cliffe said. “Very few of those chal­lenges were re­lat­ed to the clin­i­cal da­ta, so any­body who tells you this is easy, or that there is ze­ro risk as­so­ci­at­ed with it, is liv­ing in cloud cuck­oo land.”

Image courtesy of The Janssen Pharmaceutical Companies of Johnson & Johnson.

Pro­tect­ing the glob­al phar­ma­ceu­ti­cal in­no­va­tion ecosys­tem – what’s at stake?

We are living in a new era of healthcare that is rapidly advancing progress impacting patient outcomes and experiences. We’ve seen a remarkable pace of transformational innovation, applied research, and advanced clinical development over the last decade.

Despite this tremendous progress, there is much more work to be done, and patients are counting on us – now more than ever – to continue that momentum. At the heart of our industry is a focus on developing and delivering medicines for some of the world’s most challenging diseases, including those that have few or no effective treatments today.

Eu­ro­pean Par­lia­ment calls mem­ber states to ac­tion on an­timi­cro­bial re­sis­tance

Members of the European Parliament have called on EU countries to develop national action plans against antimicrobial resistance (AMR), calling it a top-three priority health threat.

Parliament on Thursday announced recommendations for the fight against AMR, including national action plans that must be updated at least every two years, an EU-level database tracking AMR and antimicrobial use and increased partnership between the pharma industry, patient groups and academia.

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Andrey Zarur, GreenLight Biosciences CEO

Green­Light Bio­sciences se­cures merg­er as it looks to go pri­vate

GreenLight Bioscience, the developer and manufacturer of RNA vaccines and therapeutics, is set to be acquired.

The company announced earlier this week that it would be acquired by a group of buyers led by Fall Line Capital in a cash deal valuing GreenLight at around $45.5 million. According to a release, Fall Line and the group agreed to acquire all of the shares of the company for $0.30 per share. The deal is expected to close sometime in the third quarter of this year.

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Roche plans to di­vest from lega­cy Genen­tech man­u­fac­tur­ing fa­cil­i­ty in Cal­i­for­nia

Roche is planning to make some changes to its subsidiary’s manufacturing network in California.

The Swiss pharma announced Wednesday that it plans to divest from Genentech’s manufacturing facility in Vacaville, CA, around 58 miles northeast of San Francisco. According to a statement from Roche, the move is part of a “broader strategy” to bring its manufacturing capabilities in line with its future pipeline. Roche is starting the process of finding a buyer for the site but has not named any candidates yet.

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FDA lifts hold on Mol­e­c­u­lar Tem­plates’ mul­ti­ple myelo­ma tri­al af­ter less than two months

The FDA has lifted a partial clinical hold on Molecular Templates’ early-stage trial for a multiple myeloma drug, the biotech company announced Thursday morning.

Regulators had put the trial on partial hold in early April, pausing patient enrollment, following two adverse heart-related events in patients who received the highest dose of Molecular Templates’ treatment MT-0169 last year. One patient had asymptomatic grade 2 myocarditis, or heart muscle inflammation, while the other had a grade 3 cardiomyopathy. Both recovered within two months.

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Roger Perlmutter, Eikon Therapeutics CEO

Roger Perl­mut­ter builds Eikon's pipeline with deal-mak­ing flur­ry, rais­ing $106M more

Eikon Therapeutics announced three business development deals on Thursday, effectively dropping in a pipeline of cancer drugs alongside more than $100 million in fresh funding.

The Hayward, CA-based company has become one of biotech’s richest startups since its 2019 founding, having raised nearly $775 million. It’s developing a massive, automated research approach built around Nobel Prize-winning microscope science to peer inside cells and watch proteins in action. After its Series B last year, PitchBook reported a $3.02 billion valuation. And while CEO Roger Perlmutter declined to comment on that figure, he said its first tranche of nearly $106 million in Series C funding is a “meaningful step-up to our Series B valuation.”

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Peter van de Sande, Synaffix CEO

Lon­za shells out $107M cash to snap up Synaf­fix and its ADC plat­form

After lining up a string of partnerships over the years, Dutch antibody-drug conjugate specialist Synaffix has found a new home: Lonza, the contract development and manufacturing giant.

Lonza is paying about $107 million (€100 million) in cash to acquire Synaffix, with up to $64 million (€60 million) in “additional performance-based consideration” on the table. Synaffix’s ADC tech platform will now become part of Lonza’s offering for biopharma clients, lending its bioconjugate technologies to not just ADCs but also targeted gene therapy, immune cell engagers and other applications.

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Who's con­fi­dent­ly in­vest­ing in biotech star­tups dur­ing these tense days? We've got some an­swers

We’ve got a changeup to our event schedule in Boston next week, where we’ll be doing a mix of live/streaming events at our base at The Seaport Hotel as part of a two-day lineup of webinars, virtual firesides and a cocktail hour Q&A with a veteran of the biotech financing scene.

The 9:30-10:30 am ET live slot on Tuesday, June 6, will now feature a panel conversation on the current state of affairs for VC investing in biotech, focusing on what startups are getting cash — and how. Alaa Halawa, head of US ventures at Mubadala, is confirmed, along with Brian Goodman at MPM and Geoff von Maltzahn, a general partner at Moderna-buoyed Flagship. I have a couple of other invites out and will let you know how that plays out.

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As­traZeneca gives up on late-stage IL-23 drug due to tri­al de­lays, com­pet­i­tive land­scape

AstraZeneca is shelving an IL-23 antibody that’s been through a winding journey around pharma — including stops at Amgen and Allergan — and putting an end to Phase II and III trials testing the drug for inflammatory bowel disease.

“The decision to discontinue brazikumab’s IBD development follows a recent review of brazikumab’s development timeline and the context of a competitive landscape that has continued to evolve,” a press release reads.

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