Just a day af­ter an­nounc­ing the for­ma­tion of a start­up in Switzer­land that will de­vel­op al­ter­na­tive TCR cell ther­a­pies, Ver­sant is keep­ing its foot on the gas.

The multi­bil­lion dol­lar life sci­ences VC an­nounced Thurs­day morn­ing it is lead­ing the Se­ries A fund­ing of T-knife, a Ger­man biotech that plans to use its pro­pri­etary hu­man­ized T cell re­cep­tor (HuT­CR) mouse plat­form to treat sol­id tu­mors. T-knife raised about $78.4 mil­lion in the round and hopes to not on­ly de­vel­op its own pipeline but al­so li­cense out its mice for use by oth­er com­pa­nies.

“This plat­form that we have, I would say, is so broad­ly ap­plic­a­ble that we know it has val­ue not on­ly to us but very well give val­ue to oth­er com­pa­nies as well,” CEO Elisa Kieback told End­points News. “So our busi­ness strat­e­gy is, of course, pri­mar­i­ly to de­vel­op our own pipeline of prod­ucts, but at the same time [ap­ply] this plat­form with phar­mas and biotechs to gen­er­ate re­cep­tors for their plat­forms.”

RA Cap­i­tal Man­age­ment co-led the round, and ex­ist­ing in­vestors An­dera Part­ners and Boehringer In­gel­heim Ven­ture Fund al­so par­tic­i­pat­ed.

Thomas Blanken­stein

Pri­va­tized re­search is a bit of a new area for Kieback, as T-knife’s plat­form was spun out of an aca­d­e­m­ic set­ting at the Max-Del­bruck Cen­ter with the sup­port of Char­ité Uni­ver­si­ty Hos­pi­tal in Berlin where Kieback worked with pro­fes­sor Thomas Blanken­stein. Blanken­stein, who is al­so a sci­en­tif­ic co-founder of T-knife, pi­o­neered the foun­da­tion for T-knife’s mice be­gin­ning in the ear­ly 2000s, and he and Kieback have since con­duct­ed aca­d­e­m­ic tri­als pri­or to found­ing the com­pa­ny.

As the costs to run those ex­per­i­ments grew, the duo rec­og­nized the need to take the re­search pri­vate. One of the perks of be­ing pri­vate, Kieback said, is that un­der­tak­ing the nec­es­sary tri­als pro­ceeds at a much faster pace than in acad­e­mia.

“We ba­si­cal­ly re­al­ized what the plat­form could do, but we al­so saw how ex­pen­sive cell ther­a­py is to man­u­fac­ture these prod­ucts and bring them to the clin­ic,” Kieback said. “That was around the time we de­cid­ed we need­ed to take this pri­vate, it couldn’t be lim­it­ed as an aca­d­e­m­ic re­search tool be­cause it re­al­ly had po­ten­tial to bring these re­cep­tors and ther­a­pies to pa­tients, and for that we need­ed pri­vate mon­ey.”

While Mat­ter­horn, which Ver­sant un­veiled Wednes­day, deals al­so with TCR ther­a­pies, it does so in a dif­fer­ent man­ner than T-knife in that the for­mer at­tempts to un­der­stand a class of T cells that could specif­i­cal­ly tar­get MR1. T-knife’s mice, mean­while, ex­press on­ly hu­man TCRs that are re­strict­ed to hu­man leuko­cyte anti­gen, or HLA.

T-knife’s lead prod­uct tar­gets MAGE-A1, which be­longs to the group of can­cer/testis anti­gens, in pa­tients with mul­ti­ple myelo­ma. Nor­mal­ly ex­pressed as testis in healthy tis­sue, this pro­tein can some­times be er­ro­neous­ly ac­ti­vat­ed in tu­mor cells.

“It’s an ide­al tar­get be­cause it’s not present in healthy tis­sue apart from testis, and testis can­not be at­tacked by T cells,” Kieback said. “And the oth­er re­al­ly great thing about it is there are many oth­er tu­mor in­di­ca­tions which are hav­ing MAGE-A1 ex­pres­sion, so we can ap­ply this ther­a­py in so many dif­fer­ent ways.”

The fund­ing will give T-knife three years of run­way, Kieback said, and al­low the biotech to fin­ish Phase I tri­als for that lead can­di­date. In ad­di­tion, the com­pa­ny can al­so bring up to three fur­ther pipeline pro­grams in­to Phase I with the cash.

Long-term, the goal is an IPO, but Kieback isn’t think­ing that far ahead just yet.

“The cur­rent plan is of course to set up as a trans-At­lantic com­pa­ny, so maybe that’s how we’ll be in the be­gin­ning,” Kieback said. “That’s al­so one of the rea­sons why we re­al­ly be­lieve we need US in­vest­ments at this stage be­cause we need to set up of­fices in the US and re­cruit man­age­ment, so this is our next step.”

The top career staff at the FDA have vowed not to let politics get in the way of 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 health agencies under his purview — including the FDA — of their rulemaking 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.

J&J’s one-two punch on EGFR-mutant non-small cell lung cancer has turned up some promising — although decidedly early — results, fueling the idea that there’s yet room to one up on third-generation tyrosine kinase inhibitors.

Twenty out of 20 advanced NSCLC patients had a response after taking a combination of an in-house TKI dubbed lazertinib and amivantamab, a bispecific antibody targeting both EGFR and cMET engineered on partner Genmab’s platform, J&J reported at ESMO. All were treatment-naïve, and none has seen their cancer progress at a median follow-up of seven months.

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).

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.