NeuExcell heads east, landing suburban Philly headquarters

Ronald Lorijn, NeuExcell CEO

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.

Australia’s Avance Clinical: no IND required and a 43.5% rebate on clinical spend for CGT biotechs

Avance Clinical is the specialist Australian CRO, with CGT accreditation, for international biotechs that leverages Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend.

Learn more about Avance ClinicReady here.

Contact us about your next study.

Download our Frost & Sullivan APAC CRO Report here. 

The cell and gene therapies (CGT) sector offers unprecedented opportunities for patient disease management across virtually all therapeutic areas. However, finding the right accredited clinical teams to take a therapy through to the clinic and manage the regulatory process can be a major challenge for biotechs with a CGT product.

Bluebird bio may, at long last, get a gene therapy approved in the US.

The Cambridge, MA biotech announced Monday that the FDA had accepted and given priority review for Zynteglo, its gene therapy for the rare blood disorder beta-thalassemia. The announcement sets up an expedited FDA decision by May 20, 2022.

A priority review doesn’t guarantee approval, and more than a few recent biotechs have been spurned after receiving the designation, including Incyte, Sesen, and Provention. But it represents a substantial step forward for a therapy that has seen repeated setbacks and an application that was slapped down with a refuse-to-file letter.

Paul Hudson, Sanofi CEO (Eric Piermont/AFP via Getty Images)

Back in June, Sanofi unveiled a big project to reshape its R&D around the future of mRNA, and followed that up Monday by taking a step toward achieving that goal.

The French drugmaker signed a deal with Chinese tech giant Baidu to access its AI algorithm for mRNA-based therapeutics, Baidu said Monday morning. It’s for an undisclosed sum, but Baidu noted its platforms will be used to ‘contribute to the optimization of mRNA sequences’ in Sanofi’s drug development processes.

Unlock this story instantly and join 123,800+ biopharma pros reading Endpoints daily — and it’s free.

Most people know if they’re ‘Team Pfizer’ or ‘Team Moderna,’ but few know if they got the Comirnaty or Spikevax Covid-19 vaccine. Those are the brand names of Pfizer and Moderna vaccines, respectively, however they have yet to take hold with consumers, media or even medical professionals.

And there are others. Covid vaccine brand names also include AstraZeneca’s Vaxzevria, Novovax’s Nuvaxovid, and Sanofi and GlaxoSmithKline’s Vidprevtyn. J&J’s Janssen-developed Covid vaccine is the lone major holdout and is still yet to be named, if ever. In EMA filings approving its conditional use, the brand name is listed simply as ‘Covid-19 Vaccine Janssen.’

Unlock this story instantly and join 123,800+ biopharma pros reading Endpoints daily — and it’s free.

Joan Perelló, Sanifit CEO

Joan Perelló beat all the odds with his little Spanish biotech startup Sanifit.

Working on the far perimeter of the big US/European drug development scene, he took a drug born out of his PhD work and got enough seed cash to get started. That’s one near miracle. In the second near miracle he gathered a previously unheard of venture raise in Spain — helping build an industry ecosystem from scratch — to pursue a successful search for solid human data for his drug, SNF472. And while gathering a virtual team of developers from Europe and the US, the CEO/co-founder steered it into the late-stage arena.

Unlock this story instantly and join 123,800+ biopharma pros reading Endpoints daily — and it’s free.

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.

We are wrapping up this year’s special report on 20 trailblazing women in biopharma R&D, and can’t be more excited to share their stories on December 7, both through the written profiles and a live event, followed by a panel on gender issues moderated by Nicole DeFeudis and myself. Learn more and sign up here.

Unlock this story instantly and join 123,800+ biopharma pros reading Endpoints daily — and it’s free.

Ameet Mallik, Rafael Holdings CEO

Ameet Mallik left Novartis to claim the CEO spot at Rafael Holdings back in May, taking the reins from founder Howard Jonas. Now — one month after a stock-crushing pivotal failure in pancreatic cancer that sent Rafael’s team back to the drawing board — Mallik is taking off for greener pastures.

Mallik will hand his chief executive responsibilities back to Jonas on Feb. 1 as part of an overhaul that’s set to shake up the highest rungs of the company, Rafael announced Monday.

Unlock this story instantly and join 123,800+ biopharma pros reading Endpoints daily — and it’s free.

Following news last week that Biogen received ‘a negative trend vote’ in Europe for its controversial Alzheimer’s drug aducanumab, the company has officially pulled out of the EU’s priority medicines scheme, known as PRIME.

First granted entry into the PRIME program back in May 2016, the EMA said recently that aducanumab’s PRIME eligibility was withdrawn at the request of Biogen. The EMA also noted that Biogen’s Phase III trials have been discontinued, likely lessening the odds that Biogen would re-submit its application in Europe.

German biotech Affimed caught some attention earlier this year with a pair of complete responses in an early study of its NK cell regimen for lymphoma. The biotech is back with more data from that study, and the results look promising — but will durability hold up?

A combination regimen of donor NK cells and Affimed’s CD30-targeting innate cell engager AFM13 spurred responses in 16 of 18 patients with relapsed or refractory Hodgkin and non-Hodgkin lymphomas, including seven complete responses, as part of the first of two rounds of treatment in a Phase I/II study, the biotech said Monday.
https://endpts.com/neuexcell-heads-east-landing-suburban-philly-headquarters/