Elisa Kieback (T-knife)

Ver­sant funds TCR ther­a­py biotech T-knife's $78M+ Se­ries A to boost hu­man­ized T cell mice plat­form

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.”

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

UP­DAT­ED: Boehringer nabs FDA's first in­ter­change­abil­i­ty des­ig­na­tion for its Hu­mi­ra com­peti­tor — but will it mat­ter?

The FDA late Friday awarded Boehringer Ingelheim the first interchangeability designation for its Humira biosimilar Cyltezo, meaning that when it launches in July 2023, pharmacists will be able to automatically substitute the Boehringer’s version for AbbVie’s mega-blockbuster without a doctor’s input.

The designation will likely give Boehringer, which first won approval for Cyltezo in 2017, the leg up on a crowded field of Humira competitors.

Bio­gen hit by ALS set­back with PhI­II fail­ure for tofersen — but fol­lows a fa­mil­iar strat­e­gy high­light­ing the pos­i­tive

Patients and analysts waiting to hear Sunday how Biogen’s SOD1-ALS drug tofersen fared in Phase III didn’t have to wait long for the top-line result they were all waiting for. The drug failed the primary endpoint on significantly improving the functional and neurologic decline of patients over 28 weeks as well as the extension period for continued observation.

In fact, there was very little difference in response.

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Scott Struthers, Crinetics CEO

Cri­net­ics spins out ra­dio­phar­ma ef­forts in­to a new com­pa­ny, high­light­ing the grow­ing field­'s al­lure

Largely known for its nonpeptide small molecule research, Crinetics has been keeping its radiopharma work comparatively under wraps. But that changed Monday afternoon as the California biotech spun out a new company focused solely on the burgeoning field.

Crinetics launched Radionetics after the closing bell Monday, the company announced, seeding the new entity with $30 million raised from 5AM Ventures and Frazier Healthcare Partners. Radionetics will start with its own radiopharma-centric platform and a pipeline of 10 programs aimed at solid tumors.

Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

Two drug­mak­ers hit with PDU­FA date de­lays from FDA amid back­log of in­spec­tions

As the FDA is weighed down with more and more pandemic responsibilities, the agency is beginning to miss PDUFA dates with more frequency too. Two different companies on Monday said they received notices that the FDA has not completed their drug reviews on time.

The review of an NDA for Avadel Pharmaceuticals’ candidate treatment for narcolepsy is not coming this month, the company said, and the review of UCB’s BLA for bimekizumab, used to treat moderate to severe plaque psoriasis, will miss its target date as well.

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Reshma Kewalramani, Vertex CEO (YouTube)

Ver­tex gets much-need­ed win with ‘ex­tra­or­di­nary’ first pa­tient re­sults on po­ten­tial di­a­betes cure

Vertex said Monday that the first patient dosed with its cell therapy for type 1 diabetes saw their need for insulin injections vanish almost entirely, a key early step in the decades-long effort to develop a curative treatment for the chronic disease.

The patient, who had suffered five potentially life-threatening hypoglycemic — or low blood sugar — episodes in the year before the therapy, was injected with synthetic insulin-producing cells. After 90 days, the patient’s new cells produced insulin steadily and ramped up their insulin production after a meal like normal cells do, as measured by a standard biomarker for insulin production.

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Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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