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.

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; 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.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,300+ biopharma pros reading Endpoints daily — and it's free.

Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,300+ biopharma pros reading Endpoints daily — and it's free.

Yong Dai, Frontera Therapeutics CEO

Scoop: Lit­tle-known Or­biMed-backed biotech clos­es $160M round to start gene ther­a­py tri­al

Frontera Therapeutics, a China and US biotech, has closed a $160 million Series B and received regulatory clearance to test its first gene therapy stateside, Endpoints News has learned.

Led by the largest shareholder, OrbiMed, the biotech has secured $195 million total since its September 2019 founding, according to an email reviewed by Endpoints. The lead AAV gene therapy program is for an undisclosed rare eye disease, according to the source.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,300+ biopharma pros reading Endpoints daily — and it's free.

Spanish Prime Minister Pédro Sanchez and European Commission President Ursula von der Leyen (AP Photo/Geert Vanden Wijngaert)

EU to launch vac­cine de­vel­op­ment and man­u­fac­tur­ing part­ner­ship with Latin Amer­i­can and Caribbean coun­tries

While European companies, including BioNTech, are focused on increasing vaccine access to African countries by setting up vaccine manufacturing facilities, the European Union is looking westward to Latin America and the Caribbean.

Speaking at a press conference with Spanish Prime Minister Pédro Sanchez, EU Commission president Ursula von der Leyen said that the EU is launching a new initiative for vaccines and medicines manufacturing in Latin America, to get drugs to Latin America and the Caribbean faster.

DEM BioPharma CEO David Donabedian (L) and executive chair Jan Skvarka

Long­wood sets an­oth­er 'don't eat me' biotech in­to gear with help of for­mer Tril­li­um CEO Jan Skvar­ka

Jonathan Weissman and team are out with a cancer-fighting biotech riding the appetite for those so-called “don’t eat me” and “eat me” signals.

The scientific co-founder — alongside fellow Whitehead Institute colleague Kipp Weiskopf and Stanford biologist Michael Bassik — has launched DEM BioPharma with incubator Longwood Fund and a crop of other investors.

In all, the nascent, 10-employee biotech has $70 million to bankroll hematology- and solid tumor-based programs, including a lead asset that could enter human trials in two to three years, CEO David Donabedian told Endpoints News.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,300+ biopharma pros reading Endpoints daily — and it's free.

Man­u­fac­tur­ing roundup: GSK opens a new fa­cil­i­ty at Barnard Cas­tle lo­ca­tion; Tenaya Ther­a­peu­tics com­pletes build­out of Bay Area ge­net­ic med­i­cine man­u­fac­tur­ing site

GSK is continuing to build out its Barnard Castle site in the UK.

According to the company, it has opened a new aseptic smart manufacturing facility at the site, which is located in County Durham in the northeast of England.

The new facility, known as Q Block, is a fully automated and digital facility that leverages digital technology to make manufacturing operations as efficient as possible.

The 11,500-square-meter facility started construction in 2018 and according to the UK news site Business Live, the costs for the new building were £90 million, or around $110 million.

FDA warns Mex­i­can glyc­erin man­u­fac­tur­er for re­fus­ing an in­spec­tion

A drug manufacturing facility in Mexico is drawing the ire of the FDA after it ignored the US regulator’s inspection requests and phone calls.

According to the warning letter issued on June 13, Glicerinas Industriales refused a pre-announced inspection during a phone call with FDA prior to the inspection at the company’s facility in Zapopan, Mexico, a city next to Guadalajara, which was planned for May 16 to May 20.