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.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Two wild weeks for Grail end in $8B Il­lu­mi­na buy­out

Grail’s whirlwind two weeks have ended in the wealthy arms of its former founder and benefactors.

Illumina has shelled out $8 billion to reacquire the closely-watched liquid biopsy startup they spun out just 5 years ago and sold off much of its shares just 3 years ago. The deal comes nearly two weeks after the well-heeled startup filed for a potentially massive IPO — one that was disrupted just a week later when Bloomberg reported that Illumina was in talks to buy their former spinout for up to $8 billion.

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#ES­MO20: 'As good as any PD-1 out there': Re­gen­eron flash­es PD-(L)1 lung can­cer da­ta to ri­val Mer­ck

Regeneron entered the PD-(L)1 game late, so they devised a two-pronged strategy to catch up with Big Pharma rivals: They would push it into cancers where PD-1s had yet been tested, and they would prove that it’s as powerful in the big indications as any other on the market.

They cleared a hurdle on the first goal Friday, showing a 31% response in patients with the rare skin cancer basal cell carcinoma. And with the data they’re rolling out Monday, Regeneron cancer chief Israel Lowy is ready to declare success on the second.

Roche vaults to the front of the NL­RP3 clin­i­cal race, pay­ing $448M up­front to bag In­fla­zome

Roche is going all in on NLRP3.

The pharma giant is putting down $448 million (€380 million) upfront to snatch Novartis-backed Inflazome, which makes it a clinical player in the space overnight.

Dublin and Cambridge, UK-based Inflazome is the second NLRP3-focused biotech Roche has acquired in less than two years, and although no numbers were disclosed in the Jecure buyout, this is almost certainly a much larger deal.

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As­traZeneca pub­lish­es Covid-19 vac­cine PhI­II pro­to­cols in lock­step with Mod­er­na and Pfiz­er. How are they dif­fer­ent?

Following in the steps of Moderna and Pfizer, the other two American drugmakers currently in Phase III trials for their Covid-19 vaccines, AstraZeneca posted its own study protocols over the weekend. The move is the latest in a series of rare peeks behind the curtain, as such blueprints are typically shared once such trials are completed.

“Given the unprecedented global impact of the Coronavirus pandemic and the need for public information, AstraZeneca has published the detailed protocol and design of our AZD1222 clinical trial. As with most clinical development, protocols are not typically shared publicly due to the importance of maintaining confidentiality and integrity of trials. AstraZeneca continues to work with industry peers to ensure a consistent approach to sharing timely clinical trial information,” the company said in a statement.

Donald Trump and White House chief of staff Mark Meadows, before boarding Marine One (Getty Images)

Pric­ing deal col­laps­es over Big Phar­ma's re­fusal to is­sue $100 'cash card­s' be­fore the elec­tion — re­port

Late in August, as negotiations on a pricing deal with President Trump reached a boiling point, PhRMA president Stephen Ubl sent an email update to the 34 biopharma chiefs that sit on his board. He wrote that if the industry did not agree to pay for a $100 “cash card” sent to seniors before November, White House chief of staff Mark Meadows was going to tell the news media Big Pharma was refusing to “share the savings” with the elderly — and that all of the blame for failed drug pricing negotiations would lie squarely on the industry.

#ES­MO20: As­traZeneca aims to spur PRO­found shift in prostate can­cer treat­ment with Lyn­parza OS da­ta

AstraZeneca has unveiled the final, mature overall survival data that cemented Lynparza’s first approval in prostate cancer approval — touting its lead against rivals with the only PARP inhibitor to have demonstrated such benefit.

But getting the Merck-partnered drug to the right patients remains a challenge, something the companies are hoping to change with the new data cut.

The OS numbers on the subgroup with BRCA1/2 or ATM-mutated metastatic castration-resistant prostate cancer are similar to the first look on offer when the FDA expanded the label in May: Lynparza reduced the risk of death by 31% versus Xtandi and Zytiga. Patients on Lynparza lived a median of 19.1 months, compared to 14.7 months for the anti-androgen therapies (p = 0.0175).

Eli Lilly CSO Dan Skovronsky (file photo)

UP­DAT­ED: #ES­MO20: Eli Lil­ly shows off the da­ta for its Verzenio suc­cess. Was it worth $18 bil­lion?

The press release alone, devoid of any number except for the size of the trial, added nearly $20 billion to Eli Lilly’s market cap back in June. Now investors and oncologists will get to see if the data live up to the hype.

On Sunday at ESMO, Eli Lilly announced the full results for its Phase III MonarchE trial of Verzenio, showing that across over 5,000 women who had had HR+, HER2- breast cancer, the drug reduced the odds of recurrence by 25%. That meant 7.8% of the patients on the drug arm saw their cancers return within 2 years, compared with 11.3% on the placebo arm.

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Sebastian Nijman (file photo)

Roche looks to ge­net­ic mod­i­fiers for new drug tar­gets, team­ing up with Dutch biotech in $375M deal

Roche is gambling on a new way of discovering drug targets and, ultimately, promising to infuse more than $375 million into a small biotech if all goes well.

A spinout of the Netherlands Cancer Institute and Oxford University, Scenic Biotech set out to pioneer a field that’s gaining some traction among top VCs in the US: to harness the natural protecting powers of genetic modifiers — specific genes that suppress a disease phenotype.