Ronald Lorijn, NeuExcell CEO

NeuEx­cell heads east, land­ing sub­ur­ban Philly head­quar­ters

Penn­syl­va­nia’s al­ready well-es­tab­lished biotech scene got word of a boost last week with sev­er­al an­nounce­ments, in­clud­ing the build­ing of a mas­sive life sci­ences man­u­fac­tur­ing cen­ter in Pitts­burgh thanks to some fund­ing from an area non­prof­it and a lo­cal uni­ver­si­ty. But those jawns in Philadel­phia aren’t let­ting go of its stran­gle­hold on the state eas­i­ly.

NeuEx­cell Ther­a­peu­tics, a pre­clin­i­cal gene ther­a­py biotech that fo­cus­es on neu­rode­gen­er­a­tive dis­eases, an­nounced that it signed a deal with The Dis­cov­ery Labs in King of Prus­sia, about 25 miles north­west of down­town Philly.

The lease will al­low NeuEx­cell to es­tab­lish a long-term cor­po­rate head­quar­ters and en­able the com­pa­ny to tap in­to the mas­sive cell and gene ther­a­py tal­ent pool in the greater Philadel­phia re­gion. The com­pa­ny will take over 20,000 square feet of lab space on the 1 mil­lion square-foot cam­pus.

In King of Prus­sia, NeuEx­cell will ex­pand its R&D op­er­a­tions to sup­port IND ap­pli­ca­tions for clin­i­cal tri­als and up its ade­no an­tivirus man­u­fac­tur­ing op­er­a­tions, as well as its qual­i­ty con­trol test­ing and an­a­lyt­i­cal and as­say de­vel­op­ment.

“We are very ex­cit­ed to es­tab­lish a pres­ence in the midst of Philadel­phia’s cell and gene ther­a­py epi­cen­ter,” Ronald Lori­jn, NeuEx­cell’s CEO, said in a press re­lease. “This will al­low us to at­tract key tal­ent who will dri­ve progress for­ward for our in­no­v­a­tive gene ther­a­py tech­nol­o­gy.”

The com­pa­ny will join the Penn Med­i­cine gene ther­a­py pro­gram, Glax­o­SmithK­line, WuXi Bi­o­log­ics and the Cen­ter for Break­through Med­i­cines, among oth­ers, on the cam­pus. Right now, the com­pa­ny op­er­ates out of State Col­lege, PA, home of Penn State Uni­ver­si­ty.

In Sep­tem­ber, NeuEx­cell struck a deal with Fu­ji­film Diosynth Biotech­nolo­gies to pro­duce drug sub­stance at a site in Col­lege Sta­tion, TX. The sub­stance is for the first in-hu­man tri­als of NXL-001, to help pa­tients suf­fer­ing from is­chemic cor­ti­cal strokes.

On the oth­er side of the state, a 178-acre prop­er­ty got a $100 mil­lion boost from the Richard King Mel­lon Foun­da­tion and the Uni­ver­si­ty of Pitts­burgh. That site is be­ing trans­formed in­to Pitt Bio­Forge, a home for cell and gene ther­a­py man­u­fac­tur­ing, and $75 mil­lion of that fund­ing will go to­ward ro­bot­ics and ad­vanced man­u­fac­tur­ing. The goal is to cre­ate a tech hub that ri­vals that of Boston or San Fran­cis­co and brings lo­cal jobs to a mar­ket that used to be pri­mar­i­ly dri­ven by steel.

In a re­cent mar­ket re­port pub­lished by Col­liers Life Sci­ences, The Dis­cov­ery Labs was dubbed one of the eight sig­nif­i­cant life sci­ences neigh­bor­hoods in the Philadel­phia re­gion. Glax­o­SmithK­line has a 780,000-square-foot site that fea­tures R&D and man­u­fac­tur­ing op­er­a­tions, which re­ceived a $120 mil­lion ren­o­va­tion in 2019, ac­cord­ing to the re­port. The site is lo­cat­ed in the Up­per Meri­on neigh­bor­hood, which al­so fea­tures Re­nais­sance Park, an­oth­er life sci­ences lo­ca­tion di­rect­ly across the street from Dis­cov­ery Labs.

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.