Frédéric Desdouits, TreeFrog Therapeutics CEO

UP­DAT­ED: French biotech rais­es $75M for new cell ther­a­py man­u­fac­tur­ing tech, Parkin­son's treat­ment

A French cell ther­a­py start­up is get­ting two new of­fices in op­po­site parts of the world, and a new CEO to boot as it an­nounces a new round of fund­ing Mon­day.

Biotech TreeFrog Ther­a­peu­tics, which is fo­cused on stem cell ther­a­py, closed a $75 mil­lion Se­ries B, the com­pa­ny an­nounced. The round brings the com­pa­ny’s to­tal fund­ing to $83 mil­lion, and al­lows them to open up of­fices in Boston and Kobe, Japan, as it ad­vances its bio­mimet­ic C-Stem tech­nol­o­gy for clin­i­cal man­u­fac­tur­ing. The US of­fice will start with a staff of around 10 to 15 peo­ple, but if all goes well, that will change quick­ly.

Kévin Alessan­dri

As a part of the ex­pan­sion, board mem­ber Frédéric Des­douits has been hired as the com­pa­ny’s CEO, and ex­ec­u­tive vice pres­i­dent Kévin Alessan­dri will move to Boston to over­see the new of­fice. As far as the new of­fices are con­cerned, the move to Boston was at least par­tial­ly in­spired by the in­vest­ment from Bris­tol My­ers Squibb. As the ca­pa­bil­i­ties of the tech­nol­o­gy are dis­cov­ered, the team wants to be close to its part­ners, as it col­lab­o­rates with oth­er play­ers.

“They came in be­cause we are a very young com­pa­ny…and we are learn­ing about the po­ten­tial of the tech­nol­o­gy al­most every month,” Des­douits said in a phone call with End­points News Mon­day. “We know we have a dis­rup­tive tech­nol­o­gy…we know we bring some­thing new, and we know it’s go­ing to take time.”

Des­douits has been with Tree Frog as a part-time ad­vi­sor for near­ly two years. He’s served as a di­rec­tor for Gen­fit, a French ther­a­peu­tics com­pa­ny fo­cused on liv­er dis­ease, for more than 7 years be­fore that, and was the man­ag­ing di­rec­tor of French CD­MO Se­qens un­til Ju­ly 2020.

“In just two years and, with on­ly $7M in Se­ries A fund­ing, the TreeFrog Ther­a­peu­tics team tran­si­tioned C-StemTM from the bench to an in­dus­tri­al tech­nol­o­gy ap­plic­a­ble to any cell ther­a­py. We demon­strat­ed that C-StemTM out­per­forms all ex­ist­ing tech­nolo­gies for pluripo­tent stem cell ex­pan­sion in terms of scale and qual­i­ty,” he said in a state­ment. “We al­so con­firmed best-in-class pre­clin­i­cal da­ta for our cell ther­a­py pro­gram for Parkin­son’s dis­ease.”

The com­pa­ny was found­ed in 2018 in Bor­deaux, France. Its fi­nanc­ing was led by Bpifrance Large Ven­ture, a func­tion of the French Pub­lic In­vest­ment Bank that in­vests in life sci­ences and green tech­nol­o­gy, and Leonard Green & Part­ners, a Los An­ge­les-based pri­vate eq­ui­ty firm fo­cused on health­care. Eu­ro­pean ven­ture cap­i­tal group XAnge al­so led the round.

C-Stem al­lows for the mass pro­duc­tion of stem cells in in­dus­tri­al biore­ac­tors, which TreeFrog says can im­prove the qual­i­ty of cells and re­duce the cost over ex­ist­ing tech­nolo­gies. In June 2020, the team’s 50 em­ploy­ees moved in­to a 13,000 square-foot man­u­fac­tur­ing fa­cil­i­ty in France. This April, it pro­duced its first batch of stem cells in a 10-liter biore­ac­tor.

“In short, fund­ing, man­age­ment and gov­er­nance are now se­cured, as we em­bark on a very ex­cit­ing jour­ney, with the de­ploy­ment of tech­no­log­i­cal hubs in Kobe, Japan, and Boston, MA, and the prospect of treat­ing our first pa­tients in 2024,” Alessan­dri said in a press re­lease.

As a part of the fi­nanc­ing round, Lau­rent Higueret of Bpifrance Large Ven­ture and Pe­ter Zip­pelius of Leonard Green & Part­ners will join the board of di­rec­tors. Girish Pendse of Bris­tol My­ers Squibb will join as an ob­serv­er.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Albert Bourla, Pfizer CEO (Efren Landaos/Sipa USA/Sipa via AP Images)

Pfiz­er makes an­oth­er bil­lion-dol­lar in­vest­ment in Eu­rope and ex­pands again in Michi­gan

Pfizer is continuing its run of manufacturing site expansions with two new large investments in the US and Europe.

The New York-based pharma giant’s site in Kalamazoo, MI, has seen a lot of attention over the past year. As a major piece of the manufacturing network for Covid-19 vaccines and antivirals, Pfizer is gearing up to place more money into the site. Pfizer announced it will place $750 million into the facility, mainly to establish “modular aseptic processing” (MAP) production and create around 300 jobs at the site.

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Rick Modi, Affinia Therapeutics CEO

Ver­tex-part­nered gene ther­a­py biotech Affinia scraps IPO plans

Affinia Therapeutics has ditched its plans to go public in a relatively closed-door market that has not favored Nasdaq debuts for the drug development industry most of this year. A pandemic surge in 2020 and 2021 opened the doors for many preclinical startups, which caught Affinia’s attention and gave the gene therapy biotech confidence in the beginning days of 2022 to send in its S-1.

But on Friday, Affinia threw in the S-1 towel and concluded now is not the time to step onto Wall Street. The biotech has put out few public announcements since the spring of this year. Endpoints News picked the startup as one of its 11 biotechs to watch last year.

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Vas Narasimhan, Novartis CEO (Thibault Camus/AP Images, Pool)

No­var­tis bol­sters Plu­vic­to's case in prostate can­cer with PhI­II re­sults

The prognosis is poor for metastatic castration-resistant prostate cancer (mCRPC) patients. Novartis wants to change that by making its recently approved Pluvicto available to patients earlier in their course of treatment.

The Swiss pharma giant unveiled Phase III results Monday suggesting that Pluvicto was able to halt disease progression in certain prostate cancer patients when administered after androgen-receptor pathway inhibitor (ARPI) therapy, but without prior taxane-based chemotherapy. The drug is currently approved for patients after they’ve received both ARPI and chemo.

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Ken Greenberg, SonoThera CEO

Gene ther­a­py goes acoustic as ARCH-backed biotech launch­es with ul­tra­sound gene de­liv­ery plat­form

After co-founding two biotechs off virus-based therapies, one for pain and one for cancer, Ken Greenberg decided to go in a different direction for his newest biotech, SonoThera.

Based out of San Francisco, SonoThera announced Monday morning that it raised $60.75 million to develop new gene therapies — but delivered by ultrasound, which Greenberg says can address the major challenges facing more conventional viral gene therapies.

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Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Yuling Li, Innoforce CEO

In­no­force opens new man­u­fac­tur­ing site in Chi­na

Innoforce is off to the races at its new site in the city of Hangzhou, China.

The Chinese CDMO announced last week that it has started manufacturing at the new facility, which was built to offer process development and manufacturing operations for RNA, plasmid DNA, viral vectors and other cell therapeutics. It will also serve as Innoforce’s corporate HQ.

The company said it’s investing more than $200 million in the 550,000-square-foot manufacturing base for advanced therapies. The GMP manufacturing facility features space for producing plasmids with three 30-liter bioreactors. For viral vector manufacturing, Innoforce also has 200- and 500-liter bioreactors at its disposal, along with eight suites to make cell therapies. The site also includes several labs and warehouse spaces.

FDA grants or­phan drug des­ig­na­tion to Al­ger­non's ifen­prodil, while ex­clu­siv­i­ty re­mains un­clear

As the FDA remains silent on orphan drug exclusivity in the wake of a controversial court case, the agency continues to hand out new designations. The latest: Algernon Pharmaceuticals’ experimental lung disease drug ifenprodil.

The Vancouver-based company announced on Monday that ifenprodil received orphan designation in idiopathic pulmonary fibrosis (IPF), a chronic lung condition that results in scarring of the lungs.  Most IPF patients suffer with a dry cough, and breathing can become difficult.

Nkarta CEO Paul Hastings at Endpoints' #BIO22 panel (J.T. MacMillan Photography for Endpoints News)

Nkar­ta un­der­scores safe­ty of CAR-NK, boasts ear­ly re­spons­es

The first generation of personalized CAR-T therapies made big waves in the treatment of lymphoma for their stunning efficacy. Nkarta is hoping its off-the-shelf natural killer cell approach will stand out on safety — while keeping some of those impressive numbers on responses.

In a new update from its Phase I dose escalation study, the South San Francisco-based biotech reported that seven out of 10 patients treated with the highest doses of its NK cell therapy, NKX019, achieved a complete response, translating to a complete response rate of 70%.