TCR deal spree in­ten­si­fies as Roche com­mits up to $2B in Adap­tive Biotech to de­vel­op per­son­al­ized can­cer drugs

The ap­petite for TCR ther­a­pies and their po­ten­tial to tar­get sol­id tu­mors — a lim­i­ta­tion of ex­ist­ing cel­lu­lar ther­a­pies — has bur­geoned, fu­el­ing a string of deals.  On Fri­day, Roche’s Genen­tech agreed to fork out a meaty $300 mil­lion up­front for ac­cess to Adap­tive Biotech­nolo­gies’ tech plat­form, which is de­signed to iden­ti­fy T-cell re­cep­tors (TCRs) for ther­a­peu­tic use. The deal, which of­fers Adap­tive up to $2 bil­lion over time in mile­stone pay­ments, will be used to de­vel­op per­son­al­ized can­cer ther­a­pies.

One of the key com­po­nents of the im­mune sys­tem are T cells, which oblit­er­ate can­cer cells by us­ing T cell re­cep­tor (TCR) recog­ni­tion of cell sur­face mark­ers known as anti­gens. When a T cell rec­og­nizes a tu­mor anti­gen via the TCR, it snuffs the ma­lig­nant cell on which it re­sides. TCR tech typ­i­cal­ly in­volves reengi­neer­ing T-cell re­cep­tors so that they can bet­ter rec­og­nize can­cer pro­teins, spark­ing an as­sault on tu­mors. Un­like CAR-T cells that can rec­og­nize ab­nor­mal pro­teins ex­pressed on the sur­face, TCRs can rec­og­nize tu­mor-spe­cif­ic pro­teins on the in­side of cells. That makes CAR-T ther­a­pies more amenable to blood can­cers, while TCR ther­a­pies-in-de­vel­op­ment have po­ten­tial across mul­ti­ple tu­mors.

Genen­tech is hop­ing Adap­tive’s plat­form — TruT­CR — will iden­ti­fy TCRs that can ef­fec­tive­ly rec­og­nize and tar­get spe­cif­ic neoanti­gens, which are pro­teins gen­er­at­ed by tu­mor-spe­cif­ic mu­ta­tions not found in nor­mal tis­sues. Es­sen­tial­ly, Adap­tive aims to use its tech­nol­o­gy to iso­late op­ti­mal TCRs that will most ef­fec­tive­ly tar­get each pa­tient’s neoanti­gens for treat­ment, while Genen­tech will en­gi­neer and man­u­fac­ture the tai­lored cel­lu­lar med­i­cine for the pa­tient.

Har­lan Robins

“Cel­lu­lar ther­a­py ap­proach­es in can­cer have been lim­it­ed by the in­abil­i­ty to ef­fec­tive­ly screen and trans­late the im­mune re­sponse to pa­tient-spe­cif­ic neoanti­gens. Ac­cu­rate recog­ni­tion of such neoanti­gens is a ma­jor dri­ver in the ac­tiv­i­ty of nov­el im­munother­a­pies,” said Adap­tive co-founder Har­lan Robins in a state­ment.

Un­der the deal — ex­pect­ed to close in the first quar­ter of 2019 — Genen­tech is in charge of the clin­i­cal and reg­u­la­to­ry process as well as com­mer­cial­iza­tion, while Adap­tive is re­spon­si­ble for pa­tient-spe­cif­ic screen­ing.

There were a spate of TCR deals and an­nounce­ments in 2018: TCR2 Ther­a­peu­tics is plan­ning a $100 mil­lion-plus IPO, Gilead-owned CAR-T play­er Kite Phar­ma has paid $10 mil­lion to ac­cess Hi­FiBiO’s TCR tech plat­form, blue­bird bio tied up with neoanti­gen biotech Grit­stone to look for new tar­gets to beef up its TCR pipeline, and joined forces with Re­gen­eron to de­vel­op TCR tar­gets in a five-year al­liance.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Stéphane Bancel, Moderna CEO

'This is not go­ing to be good': Mod­er­na CEO Ban­cel warns of a 'ma­te­r­i­al drop' in vac­cine ef­fi­ca­cy as Omi­cron spreads

Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.

Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?

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Philip Dormitzer, new GSK global head of vaccines R&D

Glax­o­SmithK­line poach­es Pfiz­er's vi­ral vac­cines lead in rush to cap­i­tal­ize on fu­ture of mR­NA

GlaxoSmithKline has appointed Philip Dormitzer, formerly chief scientific officer of Pfizer’s viral vaccines unit, as its newest global head of vaccines R&D, looking to leverage one of the leading minds behind Pfizer and BioNTech’s RNA collaboration that led to Covid-19 jab Comirnaty, the British drug giant said Tuesday.

Dormitzer had been with Pfizer for a little more than six years, joining up after a seven-year stint with Novartis, where he reached the role of US head of research and head of global virology for the company’s vaccines and diagnostics unit.

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In­tro­duc­ing End­points Stu­dio, a new way to ad­ver­tise with End­points-craft­ed brand­ing cam­paigns

Since our start in 2016, Endpoints has grown fast while executing our mission to cover biopharma’s most critical developments for industry pros worldwide. As readership has grown, our advertising business has too. Endpoints advertising partners support the mission and engage their desired audiences through announcements on our email and web platforms, brand recognition in our event coverage and sponsorships of Endpoints daily and weekly reports.

What's fair? New ICER re­port shows pay­ers gen­er­al­ly en­sur­ing fair ac­cess to drugs

The nonprofit Institute for Clinical and Economic Review on Wednesday released a new report highlighting the ways in which payers are generally ensuring fair access to prescription drugs, even when based on a set of criteria set by the nonprofit.

While noting the lack of transparency hindered the report’s results, ICER said that the “great majority” of payer policies in the formularies evaluated are structured in a way to support many key elements of how ICER defines “fair access.”

With on­ly burns to show in gene ther­a­py, Astel­las inks deal with AAV spe­cial­ist Dyno in push for a bet­ter cap­sid

On the hunt for a better AAV capsid for gene therapy, Eric Kelsic’s Dyno Therapeutics has set itself apart with its focus on machine learning to help speed discovery. Now, Japanese drugmaker Astellas — fresh off a slate of gene therapy burns — is taking a bet on Dyno as it looks to the future.

Astellas and Dyno will work together as part of an R&D pact to develop next-gen AAV vectors for gene therapy using Dyno’s CapsidMap platform directed at skeletal and cardiac muscle, the companies said Wednesday. Under the terms of the deal, Dyno will design AAV capsids for gene therapy, while Astellas will be responsible for conducting preclinical, clinical and commercialization activities for gene therapy product candidates using the capsids.

As first Omi­cron case in US crops up, re­searchers won­der: which an­ti­bod­ies, vac­cines will hold up?

As Covid-19 drug and vaccine developers race to figure out which of their products might be hampered by the new variant, the CDC on Wednesday afternoon announced the first confirmed case of the Omicron variant (B.1.1.529) in the US, found in San Francisco.

The unidentified individual was a traveler who returned from South Africa on Nov. 22, 2021, was fully vaccinated, and had mild symptoms that the CDC described as improving. All close contacts have been contacted and have tested negative, the centers said.

GSK 'Target the Future' Ad Campaign

Glax­o­SmithK­line's friend­ly ‘shark tank’ crowd­sources ideas for mul­ti­ple myelo­ma, kicks off big­ger push

GlaxoSmithKline is inviting everyone to its friendly shark tank. Its “Think Tank” challenge launching today aims to gather the best pitches for ideas in multiple myeloma with a final pitch-off “Shark Tank” TV show-style finish next year.

The innovation contest kicks off GSK’s bigger “Target the Future” unbranded campaign to advance innovation and awareness in multiple myeloma.

“We have a good sense of where the unmet need lies and what tools may be welcomed by this community, and we’ll continue to do that as part of this program, but the ‘Think Tank’ kickoff is to bring new ideas to the table — things that come from a more grassroots perspective than a large pharma perspective,” Christine Roth, senior VP and global head of oncology at GSK, said.

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Ap­peals court puts the fi­nal nail in the cof­fin for Tec­fidera patent, adding to Bio­gen's bur­geon­ing set­backs

In another setback for Biogen, the big biotech lost its appeal to revive a patent for the once-blockbuster drug Tecfidera, marking a likely conclusion to the case.

The US Court of Appeals for the Federal Circuit issued the ruling Tuesday morning, saying Biogen failed to satisfy the “written description” requirement for patent law. As a result, Mylan-turned-Viatris will be able to sell its multiple sclerosis generic without fear of infringement and Biogen will have to find a new revenue driver elsewhere.

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