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.

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.

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.

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.