T cell ex­perts at Kiadis bag Cy­toSen's NK cell tech, plot­ting a dual can­cer killing ap­proach with tips from Carl June

In an ef­fort to mar­ry T cell and nat­ur­al killer cell tech­nolo­gies for the treat­ment of blood can­cer, Dutch biotech Kiadis has inked an all-stock deal to ac­quire US-based Cy­toSen Ther­a­peu­tics.

Arthur Lahr

Both com­pa­nies have had the same goal: to boost the chances of can­cer pa­tients un­der­go­ing hematopoi­et­ic stem cell trans­plants by su­per­charg­ing their im­mune sys­tem while their bone mar­row re­cov­ers from the pro­ce­dure. Kiadis does this with en­gi­neered T cells; Cy­toSen chose NK cells, de­signed to at­tack any re­main­ing ma­lig­nant cells that could lead to a re­lapse. Both tech­nolo­gies take cells from a fam­i­ly mem­ber of the pa­tient so that the im­mune cells would be par­tial­ly matched.

Aside from a new tech plat­form, Kiadis al­so scored a net­work of promi­nent col­lab­o­ra­tors on Cy­toSen’s found­ing team, in­clud­ing Dean Lee of Na­tion­wide Chil­dren’s Hos­pi­tal, Ste­fan Ciurea of the MD An­der­son Can­cer Cen­ter and Robert Igarashi from the Uni­ver­si­ty of Cen­tral Flori­da. Carl June, the pi­o­neer­ing CAR-T ex­pert, is al­so join­ing its sci­en­tif­ic ad­vi­so­ry board.

UCF first came up with the Cy­toSen method, which de­rives nanopar­ti­cles from anti­gen pre­sent­ing cells to stim­u­late pro­lif­er­a­tion of NK cells. Na­tion­wide fur­ther re­fined it, and the first hu­man stud­ies were con­duct­ed at MD An­der­son.

Carl June

The com­pa­ny, which is list­ed on Eu­ronext Am­s­ter­dam and Brus­sels ($KDS) now ex­pects to take Cy­toSen’s lead pro­gram, CS­DT002-NK, in­to the clin­ic in 2020, tar­get­ing high-risk acute myeloid leukemia pa­tients. Ear­li­er proof-of-con­cept da­ta from 25 pa­tients had demon­strat­ed a re­lapse rate of 8% and pro­gres­sion-free sur­vival of 66%, ac­cord­ing to a press re­lease.

Mean­while, Kiadis’ ATIR101 is un­der re­view in Eu­rope for a mar­ket­ing ap­proval, with a po­ten­tial launch planned for this year.

“The ATIR T-cell and CS­DT002-NK-cell pro­grams each have the po­ten­tial to make trans­plants safer and more ef­fec­tive,” CEO Arthur Lahr said. “In com­bi­na­tion, they have the po­ten­tial to rev­o­lu­tion­ize HSCT, mak­ing it suit­able for an even wider group of pa­tients.”

Per the deal, Cy­toSen in­vestors — who have re­mained un­named — will gain a 7.4% stake in Kiadis, or 1.94 mil­lion shares. They are el­i­gi­ble to re­ceive up to 5.82 mil­lion more shares should de­vel­op­ment and reg­u­la­to­ry mile­stones be reached.

The com­bined en­ti­ty will have $55.4 mil­lion (€ 49 mil­lion) from Kiadis and $6 mil­lion from Cy­toSen to work with.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Lat­est on ul­tra-rare dis­ease ap­proval; Pos­i­tive, if mixed, signs for Bio­gen's ALS drug; Clay Sie­gall finds a new job; 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.

Over the last four years, we’ve honored 80 women whose extraordinary accomplishments have changed the game in biopharma R&D. You can now nominate someone to be highlighted in this year’s special report. Details are here.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,600+ biopharma pros reading Endpoints daily — and it's free.

FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,600+ biopharma pros reading Endpoints daily — and it's free.

FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,600+ biopharma pros reading Endpoints daily — and it's free.

No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,600+ biopharma pros reading Endpoints daily — and it's free.

Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to clinicaltrials.gov, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Stuart Peltz, former PTC Therapeutics CEO

Stu­art Peltz re­signs as PTC Ther­a­peu­tics CEO af­ter 25 years

Stuart Peltz, the longtime CEO of PTC Therapeutics who’s led the rare disease drug developer since its founding 25 years ago, is stepping down.

Succeeding him in the top job is Matthew Klein, who joined PTC in 2019 and was promoted to chief operating officer in 2022. In a call with analysts, he said the CEO transition has been planned for “quite some time” — in fact, as part of it, he gave the company’s presentation at the JP Morgan healthcare conference earlier this year.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,600+ biopharma pros reading Endpoints daily — and it's free.

Bet­ter Ther­a­peu­tics cuts 35% of staff while await­ing dig­i­tal ther­a­peu­tic ap­proval

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.