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.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Dipal Doshi, Entrada Therapeutics CEO

Ver­tex just found the next big ‘trans­for­ma­tive’ thing for the pipeline — at a biotech just down the street

Back in the summer of 2019, when I was covering Vertex’s executive chairman Jeff Leiden’s plans for the pipeline, I picked up on a distinct focus on myotonic dystrophy Type I, or DM1 — one of what Leiden called “two diseases (with DMD) we’re interested in and we continue to look for those assets.”

Today, Leiden’s successor at the helm of Vertex, CEO Reshma Kewalramani, is plunking down $250 million in cash to go the extra mile on DM1. The lion’s share of that is for the upfront, with a small reserve for equity in a deal that lines Vertex up with a neighbor in Seaport that has been rather quietly going at both of Vertex’s early disease targets with preclinical assets.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Ab­b­Vie slapped with age dis­crim­i­na­tion law­suit, fol­low­ing oth­er phar­mas

Add AbbVie to the list of pharma companies currently facing age discrimination allegations.

Pennsylvania resident Thomas Hesch filed suit against AbbVie on Wednesday, accusing the company of passing him over for promotions in favor of younger candidates.

Despite 30 years of pharma experience, “Hesch has consistently seen younger, less qualified employees promoted over him,” the complaint states.

David Light, Valisure CEO

Val­isure in the hot seat: New Form 483 over a 2021 in­spec­tion as CEO fires back

The notorious drug testing company Valisure, which has made a name for itself by forcing FDA’s hand with some of its safety-related uncoverings, received a letter this week after the FDA uncovered violations at its Connecticut-based testing lab in 2021.

The letter, which was sent on Dec. 5, stated that the FDA is “concerned” that Valisure was not aware of  drug supply chain security requirements.

Bags of shred­ded docs: In­di­an drug­mak­er Lupin hand­ed a Form 483 by FDA in­spec­tors

The generics manufacturer Lupin has been given another Form 483 from the FDA this year.

US regulators inspected Lupin’s pharmaceutical manufacturing site in the town of Mandideep, India from Nov. 14 through Nov. 23, with the 14-page report marking 16 observations.

The inspection report stated that the site did not have the appropriate controls over its computer systems to ensure that changes in “master production” or records are only done by authorized personnel, along with written procedures not being established to conduct annual reviews of records associated with drug batches.

Mark Cuban (Jed Jacobsohn/AP Images)

Mov­ing to the em­ploy­er side of health­care, Mark Cuban's Cost Plus Drugs part­ners with a PBM

From “Shark Tank” to direct-to-consumer generic drugs, Mark Cuban has made another inroad in the ongoing battle over prescription drug prices. His cost-plus-15% generic drug company, frequently undercutting many competitors, now has its sights set on the employer healthcare market.

Cost Plus Drugs, which originally pledged to cut out PBMs, has now partnered with the PBM EmsanaRx, majority owned by the Purchaser Business Group on Health, to launch a supplemental drug discount program designed specifically for self-funded employers, the company announced Thursday.

WIB22: Am­ber Salz­man had few op­tions when her son was di­ag­nosed with a rare ge­net­ic dis­ease. So she cre­at­ed a bet­ter one

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

Amber Salzman’s life changed on a cold, damp day in Paris over tiny plastic cups of lukewarm tea.

She was meeting with Patrick Aubourg, a French neurologist studying adrenoleukodystrophy, or ALD, a rare genetic condition that causes rapid neurological decline in young boys. It’s a sinister disease that often leads to disability or death within just a few years. Salzman’s nephew was diagnosed at just 6 or 7 years old, and died at the age of 12.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 154,300+ biopharma pros reading Endpoints daily — and it's free.

Ahead of ad­comm, FDA rais­es un­cer­tain­ties on ben­e­fit-risk pro­file of Cy­to­ki­net­ic­s' po­ten­tial heart drug

The FDA’s Cardiovascular and Renal Drugs Advisory Committee will meet next Tuesday to discuss whether Cytokinetics’ potential heart drug can safely reduce the risk of cardiovascular death and heart failure in patients with symptomatic chronic heart failure with reduced ejection fraction.

The drug, known as omecamtiv mecarbil and in development for more than 15 years, has seen mixed results, with a first Phase III readout from November 2020 hitting the primary endpoint of reducing the odds of hospitalization or other urgent care for heart failure by 8%. But it also missed a key secondary endpoint analysts had pegged as key to breaking into the market.

Nashville-based CD­MO nets a $65M Se­ries B to ex­pand fa­cil­i­ty and ca­pa­bil­i­ties

Another $65 million is music to the ears of the team at August Bioservices, a contract manufacturer in Nashville.

The company announced the Series B round last week, which will fund equipment in a new building expected to open in 2023, according to CEO Jenn Adams. It was led by Oak HC/FT, the same firm that led August’s Series A round in July 2020.

August Bioservices, a producer of materials such as prefilled syringes, IV bags and vials, was formed back in 2020 after the acquisition of PMI BioPharma Solutions, also based in Nashville. Adams said the goal was to build a business that could “address the scarcity of supply relative to sterile injectable manufacturing based in the US” and provide a broad range of manufacturing services.