Cullen Buie (L) and Paulo Garcia (Credit: The Engine)

On a jour­ney to dras­ti­cal­ly speed up cell ther­a­py man­u­fac­tur­ing, Ky­topen lands $30M Se­ries A

Spun out of an MIT lab, sit­ting in an of­fice space above a Cam­bridge tapas restau­rant from world-renowned chef Ken Oringer is a biotech fo­cused on dras­ti­cal­ly re­duc­ing the amount of time it takes to make cell ther­a­pies. And Tues­day, the com­pa­ny co-found­ed by Paulo Gar­cia and Cullen Buie said it raised $30 mil­lion in Se­ries A fund­ing.

The fund­ing will go to­ward com­mer­cial­iz­ing its sys­tem for ac­cel­er­at­ing en­gi­neered cell ther­a­py pro­duc­tion, known as Flow­fect Tx. The round al­so will al­low the com­pa­ny to move to­ward treat­ing its first hu­man with the tech­nol­o­gy, which it says can en­gi­neer sim­ple non-vi­ral man­u­fac­tur­ing of cell ther­a­pies in just a few days as op­posed to weeks.

The fundrais­ing round was led by North­pond Ven­tures, which said that Ky­topen stood out be­cause of its plat­form-dri­ven ap­proach that broad­ly ad­dress­es the needs of ther­a­peu­tics. Cur­rent in­vestors The En­gine, Hori­zon Ven­tures, and Mass Ven­tures all con­tributed to the round, as well as Alde­vron co-founders Michael Cham­bers and John Bal­lan­tyne and Alexan­dria Ven­ture In­vest­ments.

Adam Wi­eschhaus

“While there’s so many op­por­tu­ni­ties for cell ther­a­pies to ad­dress the lim­i­ta­tions of more tra­di­tion­al ther­a­peu­tics, man­u­fac­tur­ing these cells is ex­treme­ly dif­fi­cult, and what we found to be a key bot­tle­neck,” Adam Wi­eschhaus, di­rec­tor at North­pond, said in an in­ter­view with End­points News.

Gar­cia said the man­u­fac­tur­ing process is ex­treme­ly fast, and has the po­ten­tial to un­lock more per­son­al­ized treat­ments. It us­es electro­mechan­i­cal en­er­gy to gen­tly in­tro­duce ge­net­ic ma­te­r­i­al like RNA and DNA to cells that are typ­i­cal­ly hard to trans­fect.

“When you have a gen­tle process, that means how­ev­er many ma­te­ri­als you in­tro­duce, that ma­te­r­i­al, in terms of cell num­bers, you’re get­ting sig­nif­i­cant­ly more out­put,” Gar­cia said. “Mean­ing you can get to 100s of mil­lions of cells in a short­er amount of time.”

Ky­topen wants to un­lock that bot­tle­neck and open up ways for cost-ef­fec­tive cell ther­a­pies. Its key, Gar­cia and Buie said, is in the abil­i­ty to scale up from dis­cov­ery to clin­i­cal man­u­fac­tur­ing very quick­ly.

There are three key mile­stones that Ky­topen’s team hopes this fund­ing will help them achieve: to demon­strate the pow­er of its tech­nol­o­gy in a clin­i­cal set­ting, to launch the Flow­fect cGMP man­u­fac­tur­ing sys­tem, and to ac­cel­er­ate the high-through­out dis­cov­ery plat­form.

“Our view of the world — and oth­ers agree — is that there’s been a lot of talk of chal­lenges with man­u­fac­tur­ing in this field, in ex vi­vo cell ther­a­pies, and our view is that those man­u­fac­tur­ing chal­lenges ac­tu­al­ly start in dis­cov­ery,” Buie told End­points. “So you start when you’re in­vent­ing your ther­a­py, and this is one of the rea­sons we’re re­al­ly ex­cit­ed about our tech­nol­o­gy, be­cause we ac­tu­al­ly have so­lu­tions at the ther­a­py cre­ation phase and at the scale up phase, thus the part­ners that will work with us, their man­u­fac­tur­ing chal­lenges are ef­fec­tive­ly solved by the way they do the dis­cov­ery.”

The way Ky­topen man­u­fac­tures at small scale is al­so the same way it’s done at a larg­er scale. Buie com­pared it to cook­ing pas­ta: just be­cause the group is mak­ing more pas­ta, doesn’t mean that a larg­er pot is re­quired. Be­cause the flow rate is so high, you can run the man­u­fac­tur­ing process for frac­tions of sec­onds for small scale work, and sec­onds-to-min­utes for larg­er scale man­u­fac­tur­ing.

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.

FDA warns Proc­ter & Gam­ble over NyQuil la­bel's in­gre­di­ent list­ings

The FDA on Tuesday released a warning letter sent earlier this month to the Mason, OH-based site of Procter & Gamble Manufactura, raising questions about the list of ingredients on the label and in the electronic filing.

The warning says that for P&G’s over-the-counter Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion, there’s a “mismatched” list of active ingredients between the labeling and the electronic listing file. The listing file for the active ingredients did not match the active ingredients in the electronic file.

No­vo Nordisk re­mains un­der UK scruti­ny as MHRA con­ducts its own re­view in 'in­cred­i­bly rare' case

The UK’s Medicines and Healthcare products Regulatory Agency is now reviewing Novo Nordisk’s marketing violation that resulted in its loss of UK trade group membership last week. Novo Nordisk was suspended on Thursday from the Association of the British Pharmaceutical Industry (ABPI) for two years after an investigation by its regulatory arm found the pharma broke its conduct rules.

MHRA said on Tuesday that its review of the Prescription Medicines Code of Practice Authority (PMCPA) investigation is standard practice. An MHRA spokesperson emphasized in an email to Endpoints News that the situation with Novo Nordisk is “incredibly rare” while also noting ABPI took “swift and proportionate action.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,200+ biopharma pros reading Endpoints daily — and it's free.

Growth hor­mone from No­vo Nordisk is in short­age over man­u­fac­tur­ing de­lays

Novo Nordisk’s growth hormone Norditropin is in shortage because of manufacturing delays, according to an FDA site that tracks drug shortages as well as the American Society of Health-System Pharmacists’ shortages list.

The FDA has shortages of the drug listed for its 5, 10, 15 and 30 mg doses, while the pharmacists’ group, also known as ASHP, reported shortages of the same doses, except for the 15 mg version.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,200+ biopharma pros reading Endpoints daily — and it's free.

Andy Plump, Takeda R&D chief (Jeff Rumans for Endpoints News)

What kind of PhI­Ib da­ta is worth $4B cash? Take­da’s Andy Plump has some thoughts on that

A few months back, when Takeda caused jaws to drop with its eye-watering $4 billion cash upfront for a mid-stage TYK2 drug from Nimbus, it had already taken a deep dive on the solid Phase IIb data Nimbus had assembled from its dose-ranging study in psoriasis.

Now, it’s rolling that data out, eager to demonstrate what inspired the global biopharma to go long in a neighboring, but new, disease arena for the pipeline. And the most avid students of the numbers will likely be at Bristol Myers Squibb, who will have a multi-year head start on pioneering the TYK2 space with Sotyktu (deucravacitinib) as Takeda makes its lunge for best-in-class status.

Endpoints Premium

Premium subscription required

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

Francesco Marincola, newly-appointed Sonata Therapeutics CSO

Kite's head of re­search leaves for Flag­ship start­up Sonata

Another leader is departing Kite Pharma, and will to spend the “last part” of his career exploring how cancer evades the immune system.

Kite’s senior VP and global head of cell therapy research Francesco Marincola left the Gilead CAR-T unit last week for Sonata Therapeutics. Flagship last May unveiled the startup, which was pieced together from two fledgling biotechs Inzen and Cygnal Therapeutics. As CSO, Marincola will lead Sonata’s push to reprogram cancer cells to make them more immunogenic.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,200+ biopharma pros reading Endpoints daily — and it's free.

FDA in­di­cates will­ing­ness to ap­prove Bio­gen ALS drug de­spite failed PhI­II study

Ahead of Wednesday’s advisory committee hearing to discuss Biogen’s ALS drug tofersen, the FDA appeared open to approving the drug, newly released briefing documents show.

Citing the need for flexibility in a devastating disease like ALS, regulators signaled a willingness to consider greenlighting tofersen based on its effect on a certain protein associated with ALS despite a failed pivotal trial. The documents come after regulatory flexibility was part of the same rationale the agency expressed when approving an ALS drug last September from Amylyx Pharmaceuticals, indicating the FDA’s openness to approving new treatments for the disease.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,200+ biopharma pros reading Endpoints daily — and it's free.

FTC says patent bat­tle over Parkin­son's drug could have 'sig­nif­i­cant im­pli­ca­tion­s' for pa­tients

The Federal Trade Commission has gotten involved in a patent feud over Supernus’ Parkinson’s drug Apokyn, a case the agency said may have ‘‘significant implications” for patients who rely on the drug.

Sage Chemical won the first generic approval for its Apokyn formulation (also known as apomorphine hydrochloride injection) back in 2022. The non-ergoline dopamine agonist is approved to treat Parkinson’s symptoms during “off episodes,” such as difficulty moving, tremors and intense cramping. However, regulators specified that the approval pertained to the generic drug cartridges only, not the injector pen required for administration.

PhRMA calls for more di­verse in­fra­struc­ture up­grades to US emer­gency tri­als frame­work

The White House’s Office of Science and Technology Policy (OSTP) last year sought to find ways to better coordinate large-scale clinical trials in the US — as the UK lead by example during the pandemic — especially for these emergency clinical trials.

The lobbying group PhRMA Tuesday called for more clinical trial diversity in underserved areas, including by making participation less of a burden, and expanding eligibility criteria when appropriate.