Digital rendering of the 75,000-square-foot BioAccelerator facility (PEI BioAlliance)

A bio­man­u­fac­tur­ing site is com­ing to Cana­da’s Prince Ed­ward Is­land

Prince Ed­ward Is­land may be known more to read­ers of the Anne of Green Gables se­ries of books, but a new ef­fort by the lo­cal and na­tion­al au­thor­i­ties looks to turn the pic­turesque is­land in­to a hub for bio­man­u­fac­tur­ing and biotech ac­tiv­i­ty.

The gov­ern­ments of Cana­da and Prince Ed­ward Is­land are plac­ing a CAN 50 mil­lion ($37.4 mil­lion) in­vest­ment in­to what is be­ing dubbed the BioAc­cel­er­a­tor, with the project be­ing spear­head­ed by Prince Ed­ward Is­land BioAl­liance, a lo­cal busi­ness or­ga­ni­za­tion. Ac­cord­ing to an email from a PEI BioAl­liance spokesper­son, both the Cana­di­an gov­ern­ment and the lo­cal gov­ern­ment con­tributed CAN 25 mil­lion ($18.7 mil­lion) to the project.

This will be a new 75,000-square-foot bio­man­u­fac­tur­ing fa­cil­i­ty, al­low­ing Cana­di­an biotechs to car­ry out R&D op­er­a­tions as well as build out any man­u­fac­tur­ing op­er­a­tions. The site will al­so pro­vide ac­cess to man­u­fac­tur­ing train­ing. Ac­cord­ing to the email from PEI BioAl­liance, the site will have ex­per­tise from the Na­tion­al Re­search Coun­cil and the Cana­di­an Al­liance for Skills and Train­ing in Life Sci­ences.

The site, lo­cat­ed in Char­lot­te­town, plans to have ten­ants that will in­clude small and medi­um-sized biotechs at dif­fer­ent stages of de­vel­op­ment from across Cana­da and even from in­ter­na­tion­al lo­ca­tions. How­ev­er, de­tails on the ex­act ten­ants or the num­ber of work­ers at the site have not been dis­closed. The site is ex­pect­ed to be open by 2025.

“The BioAc­cel­er­a­tor will pro­vide es­sen­tial bio­man­u­fac­tur­ing fa­cil­i­ties and ser­vices for busi­ness­es across the re­gion and be­yond, that are crit­i­cal to busi­ness growth and bio­man­u­fac­tur­ing self-suf­fi­cien­cy for Cana­da,” said Prince Ed­ward Is­land BioAl­liance CEO Ro­ry Fran­cis in a re­lease.

While the US has been fo­cused on build­ing out its man­u­fac­tur­ing, Cana­da has al­so been com­mit­ting to its fair share of projects.

Last year, both Re­silience and Mod­er­na com­mit­ted to projects in the coun­try, while a $580 mil­lion new cell and gene ther­a­py man­u­fac­tur­ing cen­ter for Om­ni­aBio in Hamil­ton, On­tario start­ed to make progress.

Ed­i­tors Note: A pre­vi­ous ver­sion of this sto­ry had mis­spelled Om­ni­aBio

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Feng Zhang (Susan Walsh/AP Images)

In search of new way to de­liv­er gene ed­i­tors, CRISPR pi­o­neer turns to mol­e­c­u­lar sy­ringes

Bug bacteria are ruthless.

Some soil bacteria have evolved tiny, but deadly injection systems that attach to insect cells, perforate them and release toxins inside — killing a bug in just a few days’ time. Scientists, on the other hand, want to leverage that system to deliver medicines.

In a paper published Wednesday in Nature, MIT CRISPR researcher Feng Zhang and his lab describe how they engineered these syringes made by bacteria to deliver potential therapies like toxins that kill cancer cells and gene editors. With the help of an AI program, they developed syringes that can load proteins of their choice and selectively target human cells.

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Luke Miels, GSK chief commercial officer

GSK picks up Scynex­is' FDA-ap­proved an­ti­fun­gal drug for $90M up­front

GSK is dishing out $90 million cash to add an antifungal drug to its commercial portfolio, in a deal spotlighting the pharma giant’s growing focus on infectious diseases.

The upfront will lock in an exclusive license to Scynexis’ Brexafemme, which was approved in 2021 to treat a yeast infection known as vulvovaginal candidiasis, except in China and certain other countries where Scynexis already out-licensed the drug.

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Dif­fu­sion to hand Nas­daq spot to EIP Phar­ma for PhI­Ib de­men­tia study of ex-Ver­tex drug

One of the more than a dozen bidders for Diffusion Pharmaceuticals’ spot on Nasdaq has prevailed.

Boston biotech EIP Pharma will merge with Diffusion in an all-stock deal, with plans to start a Phase IIb clinical trial in the coming months in a common form of dementia with no approved treatments. The combined company will be renamed CervoMed.

The nine-year-old privately-held EIP is working on a former Vertex drug that it will test in a 160-person Phase IIb in patients with dementia with Lewy bodies, or DLB. The National Institute on Aging is expected to fund that trial with a $21 million grant. With the reverse merger, slated for closing in the middle of this year, EIP will be funded through that readout in the second half of 2024. EIP’s equity and debt holders will own about 77.25% of the combined company.

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CSL CEO Paul McKenzie (L) and CMO Bill Mezzanotte

Q&A: New­ly-mint­ed CSL chief ex­ec­u­tive Paul McKen­zie and chief med­ical of­fi­cer Bill Mez­zan­otte

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

Boehringer re­ports ro­bust sales led by type 2 di­a­betes and pul­monary drugs, promis­es more to come high­light­ing obe­si­ty

Boehringer Ingelheim reported human pharma sales of €18.5 billion on Wednesday, led by type 2 diabetes and heart failure drug Jardiance and pulmonary fibrosis med Ofev. Jardiance sales reached €5.8 billion, growing 39% year over year, while Ofev took in €3.2 billion, notching its own 20.6% annual jump.

However, Boehringer is also looking ahead with its pipeline, estimating “In the next seven years the company expects about 20 regulatory approvals in human pharma.”

Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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FDA ap­proves Nar­can opi­oid over­dose re­ver­sal spray for over-the-counter sale

The FDA today approved Emergent BioSolutions’ Narcan brand naloxone nasal spray for over-the-counter sales. The nod was expected and comes on the heels of a unanimous 19-0 advisory committee vote in favor of approval last month.

The move to OTC means the opioid overdose reversal agent will now be available on grocery, convenience and gas stations shelves, as well as potentially for purchase online.

J&J bows out of RSV vac­cine race, end­ing PhI­II study and ced­ing to Pfiz­er, GSK

Johnson & Johnson announced Wednesday morning it is ending development of its adult RSV vaccine that was in the middle of a 27,200-patient trial, giving up a big slice of what’s expected to be the next multibillion-dollar pharma market.

The decision came down to the shifting RSV “competitive landscape,” a company spokesperson tells Endpoints News, adding the “breadth of options” was much different than when J&J first started its pivotal study. The spokesperson declined to comment on the Phase III data, saying only the shot is undergoing an “ongoing assessment.”

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