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.

Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

No­var­tis' sec­ond at­tempt to repli­cate a stun­ning can­cer re­sult falls flat

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

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How Chi­na turned the ta­bles on bio­phar­ma's glob­al deal­mak­ing

Fenlai Tan still gets chills thinking about the darkest day of his life.

Three out of eight lung cancer patients who received a tyrosine kinase inhibitor developed by his company, Betta Pharma, died in the span of a month. Tan, the chief medical officer, was summoned to Peking Union Medical College Hospital, where the head of the clinical trial department told him that the trial investigators would be conducting an autopsy to see if the patients had died of the disease — they were all very sick by the time they enrolled — or of interstitial lung disease, a deadly side effect tied to the TKI class that’s been reported in Japan.

Ugur Sahin, AP Images

As pres­sure to share tech­nol­o­gy mounts, BioN­Tech se­lects Rwan­da for lat­est vac­cine site

BioNTech’s first mRNA-based vaccine site in Africa will call Rwanda home, and construction is set to start in mid-2022, the company announced Tuesday at a public health forum.

The German company signed a memorandum of understanding, after a meeting between Rwanda’s Minister of Health, Daniel Ngamije, Senegal’s Minister of Foreign Affairs Aïssata Tall Sall, and senior BioNTech officials. Construction plans have been finalized, and assets have been ordered. The agreement will help bring end-to-end manufacturing to Africa, and as many as several hundred million doses of vaccines per year, though initial production will be more modest.

James Peyer, Cambrian CEO

Brent Saun­ders joins $100M Se­ries C for a com­pa­ny out to be the Bridge­Bio of ag­ing

About a year ago, James Peyer, a CEO and co-founder of the little known longevity biotech Cambrian Biopharma, was trying to find some R&D talent last year when he met with more than a bit of experience in that department: David Nicholson, the former R&D chief of the erstwhile pharma giant Allergan.

It turned out Nicholson already had an interest in Peyer’s field. In their Allergan days, he and COO Brent Saunders held weekly meetups where they tried to figure out how to take the company’s dominance in aesthetics — which, until recently, was often what people meant by anti-aging science — and expertise with more traditional drug development, and use it to make drugs that extend people’s lifespan.

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No­var­tis dumps AveX­is pro­gram for Rett syn­drome af­ter fail­ing re­peat round of pre­clin­i­cal test­ing

Say goodbye to AVXS-201.

The Rett syndrome gene therapy drug made by AveXis — the biotech that was bought, kept separate, then renamed and finally absorbed by Novartis into its R&D division — has been dropped by the biopharma.

In Novartis’ third quarter financial report, the pharma had found that preclinical data did not support development of the gene therapy into IND-enabling trials and beyond. The announcement comes a year after Novartis told the Rett Society how excited it was by the drug — and its potential benefits and uses.

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Katie Fanning, Mozart Therapeutics CEO

Mozart Ther­a­peu­tics makes its of­fi­cial de­but, jump­ing in­to the hot Treg R&D field with some big-name in­vestors back­ing it

Treg cells have been getting more and more attention recently among autoimmune specialists. There’s been Jeff Bluestone’s Sonoma, the $157 million launch of GentiBio this summer and Egle Therapeutics — which launched just last week — to name a few.

Now, there’s a new Treg player jumping in that wants to distinguish itself in the market: Mozart Therapeutics. Today, the biotech is emerging from stealth in its official debut with a $55 million Series A — with a bunch of A-list Big Pharma names on board a syndicate led by ARCH.

Vas Narasimhan, Novartis CEO (Simon Dawson/Bloomberg via Getty Images)

With San­doz con­tin­u­ing to drag on No­var­tis, Vas Narasimhan says he may fi­nal­ly be ready for a sale or spin­off

After years of rehab work aimed at getting Sandoz in fighting trim to compete in a market overshadowed by declining prices, CEO Vas Narasimhan took a big step toward possibly selling or spinning off the giant generic drug player.

The pharma giant flagged plans to launch a strategic review of the business in its Q3 update, noting that “options range from retaining the business to separation.”

Analysts have been poking and prodding Novartis execs for years now as Narasimhan attempted to remodel a business that has been a drag on its performance during most of his reign in the CEO suite. The former R&D chief has made it well known that he’s devoted to the innovative meds side of the business, where they see the greatest potential for growth.

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FDA is much worse than its reg­u­la­to­ry peers at proac­tive­ly dis­clos­ing da­ta, re­searchers find

The European Medicines Agency and Health Canada continue to outpace the FDA when it comes to proactively releasing data on drugs and biologics the agency has reviewed, leading to further questions of why the American agency can’t be more transparent.

In a study published recently in the Journal of Law, Medicine, & Ethics, Yale and other academic lawyers and researchers found that between 2016 and April 2021, the EMA proactively released data for 123 unique medical products, while Health Canada proactively released data for 73 unique medical products between 2019 and April 2021. What’s more, the EMA and Health Canada didn’t proactively release the same data on the same drugs. In stark contrast, the FDA in 2018 only proactively disclosed data supporting one drug that was approved that year.

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