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.

The Fac­tors Dri­ving a Rapid Evo­lu­tion of Gene & Cell Ther­a­py and CAR-T Clin­i­cal Re­search in APAC

APAC is the fastest growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies globally, with China leading in the region. 

APAC is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022. The number of CAR-T trials initiated by Western companies has rapidly increased in recent years (current CAGR of about 60%), with multiple targets being explored including CD19, CD20, CD22, BCMA, CD30, CD123, CD33, CD38, and CD138.

The End­points 11; blue­bird's $3M gene ther­a­py; Bio­gen tout new neu­ro da­ta; Harsh re­views for can­cer drugs; 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.

Reading about John Carroll’s pick of biotech’s most promising startups has become a treasured tradition. If you ever get curious about previous classes of the Endpoints 11, you can find all of them (plus a number of our other regular specials) here.

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EMA warns of short­ages of two Boehringer heart drugs due to a spike in de­mand

The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

The End­points 11: The top pri­vate biotechs in pur­suit of new drugs. Push­ing the en­ve­lope with pow­er­ful new tech­nolo­gies

Right around the beginning of the year, we got a close-up look at what happens after a boom ripples through biotech. The crash of life sciences stocks in Q1 was heard around the world.

In the months since, we’ve seen the natural Darwinian down cycle take effect. Reverse mergers made a comeback, with more burned out shells to go public at a time IPOs and road shows are out of favor. And no doubt some of the more recent arrivals on the investing side of the business are finding greener pastures.

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Fu­ji­film con­tin­ues CD­MO ex­pan­sion, break­ing ground on $435M UK site

Fujifilm’s CDMO arm, Fujifilm Diosynth, has been on a roll this month as the company has recently broken ground on a major project in Europe and it appears to be keeping up the momentum.

Fujifilm Diosynth announced that it has kicked off an expansion project for its microbial manufacturing facility at its campus in the town of Billingham, UK, in the northeast of England.

The 20,000 square-foot, £400 million ($435 million) expansion will add clean rooms, purification suites and a packing area along with more space for the manufacturing itself.

An­oth­er Cipla site lands a Form 483 over clean­ing is­sues and QC con­trols

A Cipla drug manufacturing site in India has once again landed in the crosshairs of FDA inspectors.

The facility in question is Cipla’s drug manufacturing facility in the village of Verna, in the state of Goa in India’s southwest. In a sign that foreign inspections might ramp up again, the FDA’s visit from Aug. 16 to Aug. 22 uncovered six observations.

The 11-page report noted that environmental monitoring at the site did not properly ensure that microbial contaminants were not making any impact in the aseptic filling areas. It also found that procedures meant to stop microbial contamination were not adequately conducted in aseptic areas of the facility.

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Rahul Singhvi, Resilience CEO

Q&A: Re­silience boss Rahul Singhvi talks $2B US bio­man­u­fac­tur­ing ini­tia­tive and post Se­ries D deals

When the Biden administration announced last week, through an executive order, that it is investing $2 billion into domestic efforts to increase biotechnology and biomanufacturing efforts, a lot of ears perked up in the wider manufacturing world. Funding is going towards manufacturing infrastructure, training, R&D and security measures, among others, something that domestic manufacturers are bullish about.

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As­traZeneca, Mer­ck cull one Lyn­parza in­di­ca­tion in heav­i­ly pre­treat­ed ovar­i­an can­cer pa­tients

Just one day after blockbuster Lynparza got access to another indication in China, its Big Pharma owners have decided to withdraw it in certain patients after reviewing Phase III data.

The two companies that work together on Lynparza decided to recall one of the indications several weeks ago in a specific type of ovarian cancer, Lynparza’s first indication when it was first FDA-approved in 2014. Initial data showed that rates of overall survival in patients with at least three rounds of chemo before getting on the PARP inhibitor were lower than in patients with less previous chemo treatment.

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Ab­b­Vie ex­pands man­u­fac­tur­ing pres­ence in Ire­land with a €60M in­vest­ment

Ireland has become awash in manufacturing expansion projects, and AbbVie is the latest to get in on the action.

The government of Ireland announced that AbbVie is injecting €60 million ($58.9 million) into its manufacturing site in the town of Carrigtwohill, Ireland, a suburb of Cork City. According to AbbVie, the 14,000-square-foot facility has been operating since 2001 as a tablet and capsule production site for oncology and virology products. This latest expansion will have the site also support its aesthetics business.