Stem cell spe­cial­ist Ncar­dia bags new funds to help scale man­u­fac­tur­ing ops

A Bel­gian cell ther­a­py com­pa­ny has se­cured $60 mil­lion in fund­ing to strength­en its man­u­fac­tur­ing op­er­a­tions, and grow the cell and gene ther­a­py ecosys­tem across the world.

Ncar­dia land­ed the fund­ing from Kinic­i­ti, a US in­vest­ment plat­form backed by Welsh, Car­son, An­der­son & Stowe, a New York City pri­vate eq­ui­ty com­pa­ny. The move gives Kinic­i­ti a con­trol­ling stake in Ncar­dia to en­hance any­thing from dis­cov­ery to clin­i­cal pro­grams to com­mer­cial­ized pro­duc­tion, the com­pa­ny said in a press re­lease.

Ncar­dia will use the cap­i­tal from Kinic­i­ti to boost drug dis­cov­ery though build­ing ad­di­tion­al hu­man cel­lu­lar mod­els that have the abil­i­ty to pre­dict whether drugs are safe and ef­fec­tive ear­li­er in the de­vel­op­ment process. It will al­so use new man­u­fac­tur­ing tech­nol­o­gy to cre­ate iP­SC-based al­lo­genic plat­forms for im­muno-on­col­o­gy. This will hope­ful­ly ex­pand ac­cess and dri­ve down the cost of the cell ther­a­pies.

“Com­bin­ing Ncar­dia’s rev­o­lu­tion­ary, dif­fer­en­ti­at­ed sci­ence with our abil­i­ty to build glob­al com­pa­nies and sup­port­ing ecosys­tems will cre­ate sig­nif­i­cant val­ue for ther­a­peu­tic cus­tomers,” Kinic­i­ti CEO Ge­off Glass said in a press re­lease. “We’re ex­cit­ed to make Ncar­dia the cen­ter­piece of an ecosys­tem that we will build to en­sure that cell ther­a­pies claim their right­ful place in ad­vanc­ing hu­man health. Through this part­ner­ship, Ncar­dia’s cus­tomers will ben­e­fit from the com­pa­ny’s ex­pand­ed cGMP ca­pa­bil­i­ties in cell ther­a­py and more ro­bust of­fer­ings in dis­cov­ery ser­vices.”

Ncar­dia us­es in­duced pluripo­tent stem cells (iP­SC), which can be gen­er­at­ed di­rect­ly from a so­mat­ic cell such as blood or skin.

The com­pa­ny en­tered a non-ex­clu­sive li­cens­ing agree­ment with Evotec back in 2017 that gave the Ger­man biotech ac­cess to Ncar­dia’s stem cell de­rived cel­lu­lar dis­ease mod­el­ing IP. That deal came just months af­ter Ncar­dia an­nounced it would en­ter a li­cense agree­ment with Roche for its first-ever part­ner­ship.

In a 2020 in­ter­view with Drug Tar­get Re­view, CEO Ste­fen Braam said that his com­pa­ny strug­gled with the scal­a­bil­i­ty process for years and years. Now, the com­pa­ny gen­er­ates large batch­es of cells and cry­op­re­serves them to en­able the us­age of the same batch for de­vel­op­ment and the screen to min­i­mize vari­abil­i­ty of the iP­SCs.

“Now, we’ve re­al­ly got that un­der con­trol,” he said in the in­ter­view. “The key thing in solv­ing that was chang­ing the cul­tur­ing method­ol­o­gy to sus­pen­sion cul­ture in biore­ac­tors. With biore­ac­tors, we have now reached sizes of ap­prox­i­mate­ly 20 bil­lion car­diomy­ocytes in a sin­gle batch. The bil­lion is the new mil­lion.”

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; and more

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Usama Malik

Ex-Im­munomedics CFO charged with in­sid­er trad­ing, faces up to 20 years in prison af­ter al­leged­ly tip­ping off girl­friend and rel­a­tives of a PhI­II suc­cess

The former CFO of Immunomedics, who helped steer the company to its $21 billion buyout by Gilead last year, has been charged with insider trading, the Department of Justice announced Thursday.

Usama Malik tipped off his then-girlfriend and four others that a Phase III study for Trodelvy would be stopped early four days before Immunomedics publicly announced the result in April 2020, DoJ alleged in its complaint. The individuals then purchased Immunomedics shares, selling them after the news broke and Immunomedics’ stock price doubled.

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Biospec­i­men M&A: Dis­cov­ery ac­quires Al­bert Li's he­pa­to­cyte project; PhI­II tri­al on Bay­er's Nube­qa reached pri­ma­ry end­point

Discovery Life Sciences has acquired what claims to be the Maryland-based host of the world’s largest hepatocyte inventory, known as IVAL, to help researchers select more effective and safer drug candidates in the future.

The combined companies will now serve a wider range of drug research and development scientists, according to Albert Li, who founded IVAL in 2004 and is set to join the Discovery leadership team as the CSO of pharmacology and toxicology.

One work­er at a Lat­vian man­u­fac­tur­er is dead af­ter a fire breaks out at fa­cil­i­ty

A press release referred to it as simply, “the incident.” But a fire at an Olainfarm site in Latvia last week has left one person dead, and injured another, the company announced Monday.

Just before midnight Nov. 26, a fire broke out in the production building of JSC Olainfarm,  as the result of an “accident,” a company spokesperson said in an email to Endpoints News. The two victims were both company employees, and the causes of the accident are still being determined.

Fu­ji­film Diosynth dumps an­oth­er $454M in­to its sup­ply chain, this time at a fa­cil­i­ty in the UK

Fujifilm Diosynth Biotechnologies is in the middle of a monumental point in the company’s 10-year history, and the CDMO is about to grow even more, as it sets out to be the “beating heart” of the UK’s North East Life Sciences ecosystem.

A site in Billingham, Teeside, UK will receive a $453.72 million investment package from the manufacturer to double the existing footprint and create the largest multi-modal biopharmaceutical manufacturing site in the UK, bringing another 350 jobs to the region by late 2023.

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With on­ly burns to show in gene ther­a­py, Astel­las inks deal with AAV spe­cial­ist Dyno in push for a bet­ter cap­sid

On the hunt for a better AAV capsid for gene therapy, Eric Kelsic’s Dyno Therapeutics has set itself apart with its focus on machine learning to help speed discovery. Now, Japanese drugmaker Astellas — fresh off a slate of gene therapy burns — is taking a bet on Dyno as it looks to the future.

Astellas and Dyno will work together as part of an R&D pact to develop next-gen AAV vectors for gene therapy using Dyno’s CapsidMap platform directed at skeletal and cardiac muscle, the companies said Wednesday. Under the terms of the deal, Dyno will design AAV capsids for gene therapy, while Astellas will be responsible for conducting preclinical, clinical and commercialization activities for gene therapy product candidates using the capsids.

In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.