Architectural rendering of the OmniaBio facility at Hamilton’s McMaster Innovation Park (CNW Group/Invest Ontario)

On­tario antes up $580M for C&G ther­a­py plant in Hamil­ton

In 2017, a plan that could use $252 mil­lion to trans­form the home of On­tario’s ju­nior hock­ey team, the Hamil­ton Bull­dogs, was out­lined, but lat­er rec­om­mend­ed against by city staff.

Fast for­ward to this week, when it seems that no mat­ter how im­por­tant the Bull­dogs are to the com­mu­ni­ty, the gov­ern­ment is mak­ing a bet that cell and gene ther­a­py man­u­fac­tur­ing could be even more im­por­tant. On­tario’s gov­ern­ment un­veiled plans for a $580 mil­lion new cell and gene ther­a­py man­u­fac­tur­ing cen­ter set to be built just a 10-minute dri­ve from the sta­di­um. And the gov­ern­ment is foot­ing $40 mil­lion worth of the bill.

The site will be built at the Mc­Mas­ter In­no­va­tion Park, and cre­ate at least 250 new jobs by 2024. Om­ni­aBio will work on cures for can­cer, car­dio­vas­cu­lar dis­ease, Parkin­son’s dis­ease and di­a­betes. There will be two build­ings, and the site is tak­ing the place of an old au­to­mo­tive man­u­fac­tur­ing cen­ter. The site will start to be op­er­a­tional by 2024, and it will al­low

“This is a fac­to­ry – it’s not a re­search lab, it’s not clin­i­cal stage ac­tiv­i­ty – so when you think about how to in­dus­tri­al­ize, how you go to that next scale, Hamil­ton is the per­fect lo­ca­tion,” Om­ni­aBio chair­man Michael May said to CHCH News at the event’s ground­break­ing. “Cell and gene ther­a­py is the med­i­cine of the fu­ture. We want to make sure we an­chor this in­no­va­tion with the right strat­e­gy to­ward man­u­fac­tur­ing.”

In­vest On­tario will give a $40 mil­lion loan, in ad­di­tion to an over­all in­vest­ment of $580 mil­lion for the project, and pro­vide “non-fi­nan­cial sup­port” as well, and in­clude help with tal­ent scout­ing and lo­cal skill de­vel­op­ment part­ner­ships.

“This is the kind of val­ue-added, strate­gic in­vest­ment that our gov­ern­ment is proud to cham­pi­on – cre­at­ing skilled jobs, ad­vanc­ing our health­care and dri­ving in­no­va­tion,” Min­is­ter of Eco­nom­ic De­vel­op­ment Vic Fedeli said.

Om­ni­aBio spun out of the Toron­to-based Cen­tre for Com­mer­cial­iza­tion of Re­gen­er­a­tive Med­i­cine and builds up­on its ex­ist­ing client base. The com­pa­ny’s ul­ti­mate goal is to in­crease its bio­man­u­fac­tur­ing ca­pac­i­ty six-fold. Om­nia us­es AI to ex­plore pa­tient-spe­cif­ic da­ta, iden­ti­fy­ing the best dis­ease sub­groups to tar­get and de­sign­ing pa­tient-spe­cif­ic treat­ment op­tions.

“Om­ni­aBio Inc. will be a game-chang­er for On­tario and Cana­da. It will pro­vide miss­ing in­fra­struc­ture to al­low On­tario and Cana­di­an cell and gene com­pa­nies to re­main here, while al­so at­tract­ing for­eign com­pa­nies,” May said in a state­ment. “Cell and gene ther­a­py is Cana­da’s op­por­tu­ni­ty to be glob­al lead­ers in life sci­ences. In­vest­ing in man­u­fac­tur­ing is a key dri­ver, and we’re grate­ful to In­vest On­tario for its lead­er­ship and fore­sight.”

CCRM inked a deal to­ward the end of 2021 with Cam­bridge-based im­muno-on­col­o­gy com­pa­ny Exacis Bio­ther­a­peu­tics to man­u­fac­ture mR­NA-en­gi­neered nat­ur­al killer cell prod­ucts.

Al­so near­by in On­tario is iP­SC spe­cial­ist Cen­tu­ry Ther­a­peu­tics. The com­pa­ny’s Hamil­ton space fo­cus­es on tar­get­ing glioblas­toma brain can­cer. On­tario makes up more than 50% of the Cana­di­an life sci­ence sec­tor.

Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

Members of the G7 from left to right: Prime Minister of Italy Mario Draghi, European Commission President Ursula von der Leyen, President Joe Biden, German Chancellor Olaf Scholz, British Prime Minister Boris Johnson, Canadian Prime Minister Justin Trudeau, Prime Minister of Japan Fumio Kishida, French President Emmanuel Macron and European Council President Charles Michel (AP Photo/Susan Walsh)

Biden and G7 na­tions of­fer funds for vac­cine and med­ical prod­uct man­u­fac­tur­ing project in Sene­gal

Amidst recently broader vaccine manufacturing initiatives from the EU and European companies, the G7 summit in the mountains of Bavaria has brought about some positive news for closing vaccine and medical product manufacturing gaps around the globe.

According to a statement from the White House, the G7 leaders have formally launched the partnership for global infrastructure, PGII. The effort will aim to mobilize hundreds of billions of dollars to deliver infrastructure projects in several sectors including the medical and pharmaceutical manufacturing space.

Fed­er­al judge de­nies Bris­tol My­er­s' at­tempt to avoid Cel­gene share­hold­er law­suit

Some Celgene shareholders aren’t happy with how Bristol Myers Squibb’s takeover went down.

On Friday, a New York federal judge ruled that they have a case against the pharma giant, denying a request to dismiss allegations that it purposely slow-rolled Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights (CVR).

When Bristol Myers put down $74 billion to scoop up Celgene back in 2019, liso-cel — the CAR-T lymphoma treatment now marketed as Breyanzi — was supposedly one of the centerpieces of the deal. After going back and forth on negotiations for about six months, BMS put $6.4 billion into a CVR agreement that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date.

AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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Am­gen takes next step with its Chi­na am­bi­tions, out-li­cens­ing drugs to Fo­s­un Phar­ma

In a bid to increase its market share in China, Amgen has agreed to a partnership with a Shanghai biotech — a collaboration and out-licensing agreement for two of its drugs.

Amgen and Fosun Pharma announced a deal Monday in a bid to increase Amgen’s presence in the country. The stated goal so far is to commercialize Amgen’s blockbuster psoriasis drug Otezla alongside Parsabiv, a drug for secondary hyperparathyroidism in adults with chronic kidney disease and on a specific type of dialysis.

As court case looms, Bris­tol My­ers touts la­bel ex­pan­sion for Breyanzi

As Bristol Myers Squibb braces for a court battle over a costly delay — at least for Celgene shareholders — for its CAR-T lymphoma treatment Breyanzi, the pharma giant is touting a label expansion in the second-line setting.

Breyanzi, also known as liso-cel, snagged a win on Friday in adults with large B-cell lymphoma (LBCL) who: don’t respond to chemotherapy, or relapse within 12 months; don’t respond or relapse after 12 months; or are not eligible for hematopoietic stem cell transplant after chemo due to their age or comorbidities.

State bat­tles over mifepri­s­tone ac­cess could tie the FDA to any post-Roe cross­roads

As more than a dozen states are now readying so-called “trigger” laws to kick into effect immediate abortion bans following the overturning of Roe v. Wade on Friday, these laws, in the works for more than a decade in some states, will likely kick off even more legal battles as states seek to restrict the use of prescription drug-based abortions.

Since Friday’s SCOTUS opinion to overturn Americans’ constitutional right to an abortion after almost 50 years, reproductive rights lawyers at Planned Parenthood and other organizations have already challenged these trigger laws in Utah and Louisiana. According to the Guttmacher Institute, other states with trigger laws that could take effect include Arkansas, Idaho, Kentucky, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, and Wyoming.

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Deborah Dunsire, Lundbeck CEO

Af­ter a 5-year re­peat PhI­II so­journ, Lund­beck and Ot­su­ka say they're fi­nal­ly ready to pur­sue OK to use Rex­ul­ti against Alzheimer's ag­i­ta­tion

Five years after Lundbeck and their longtime collaborators at Otsuka turned up a mixed set of Phase III data for Rexulti as a treatment for Alzheimer’s dementia-related agitation, they’ve come through with a new pivotal trial success they believe will finally put them on the road to an approval at the FDA. And if they’re right, some analysts believe they’re a short step away from adding more than $500 million in annual sales for the drug, already approved in depression and schizophrenia.

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