Man­u­fac­tur­ing roundup: Cana­da to in­vest $58M+ in­to 'crit­i­cal' med­i­cines man­u­fac­tur­ing; FDA to ac­cept apps for CMC pi­lot

Cana­da’s gov­ern­ment will in­vest $58.6 mil­lion over five years to sup­port the Cana­di­an Crit­i­cal Drug ini­tia­tive and 350 jobs.

The ini­tia­tive plans to boost the R&D and man­u­fac­tur­ing sec­tor in the province of Al­ber­ta and is spear­head­ed by the not-for-prof­it Ap­plied Phar­ma­ceu­ti­cal In­no­va­tion (API), which helps life sci­ence com­pa­nies in the com­mer­cial­iza­tion phase.

The fund­ing will help push for­ward a new 40,000 square foot man­u­fac­tur­ing site in Ed­mon­ton to pro­duce “crit­i­cal” med­i­cines, but the spe­cif­ic prod­ucts were not im­me­di­ate­ly an­nounced. The fa­cil­i­ty, once com­plet­ed, will be able to pro­duce 70 mil­lion dos­es an­nu­al­ly. The funds will al­so go to­ward up­grad­ing API’s ex­ist­ing R&D fa­cil­i­ty in Ed­mon­ton as well as oth­er R&D pro­grams and clin­i­cal tri­al sup­port.

“This project will trans­form our abil­i­ty to pro­duce crit­i­cal med­i­cines through strength­ened re­search and man­u­fac­tur­ing sys­tems that will re­sult in eco­nom­ic and health ben­e­fits to Cana­di­ans while pro­tect­ing them for years to come,” said the Cana­di­an Min­is­ter of in­no­va­tion, sci­ence and in­dus­try François-Philippe Cham­pagne, in a re­lease.

FDA is tak­ing ap­pli­ca­tions for new CMC pi­lot pro­gram

The FDA will be open­ing ap­pli­ca­tions on April 1 for its chem­istry, man­u­fac­tur­ing and con­trols (CMC) de­vel­op­ment and readi­ness pi­lot pro­gram.

The pro­gram, which was an­nounced last year, will ex­pe­dite CMC de­vel­op­ments un­der an IND ap­pli­ca­tion when nec­es­sary. The FDA is ap­ply­ing the pro­gram to cer­tain CBER- and CDER-reg­u­lat­ed prod­ucts that have ac­cel­er­at­ed de­vel­op­ment time­lines.

The pi­lot looks to ex­plore the use of both sci­ence and risk-based reg­u­la­to­ry ap­proach­es. Those that are ac­cept­ed in­to the pi­lot will be able to dis­cuss CMC de­vel­op­ment strate­gies and goals with an FDA re­view staff as well as have oth­er fol­low-up dis­cus­sions.

Clin­i­gen to di­vest CD­MO Lam­da Lab­o­ra­to­ries

Clinin­gen will be di­vest­ing Eu­rope-based con­tract man­u­fac­tur­er Lam­da Lab­o­ra­to­ries, which will be picked up by the CM­DO Adra­gos Phar­ma.

Lam­da will con­tin­ue to pro­vide ser­vices un­der a phar­ma­ceu­ti­cal de­vel­op­ment ser­vices agree­ment. The fi­nan­cial de­tails of the agree­ment were not dis­closed. The di­vest­ment al­so comes af­ter Clin­i­gen had agreed to sell Pro­leukin (aldesleukin) a treat­ment for adults with metasta­t­ic re­nal cell car­ci­no­ma and metasta­t­ic melanoma to Io­vance Bio­ther­a­peu­tics. No oth­er de­tails on the deal with Adra­gos were dis­closed.

“The agree­ment to di­vest Lam­da Lab­o­ra­to­ries is part of a con­sid­ered re­view of our strate­gic di­rec­tion and rep­re­sents the next nat­ur­al step in this jour­ney. We are pleased to have found in Adra­gos Phar­ma a trust­ed part­ner to build on the suc­cess sto­ry of Lam­da and take it to the next lev­el,” said David Bryant, in­ter­im CEO of Clin­i­gen.

Cel­lipont re­ceives in­vest­ment for Texas fa­cil­i­ty

The cell ther­a­py CD­MO Cel­lipont has net­ted a debt in­vest­ment from the health­care in­vest­ment com­pa­ny Or­biMed to fi­nance its man­u­fac­tur­ing fa­cil­i­ty in The Wood­lands, TX.

While the fund­ing was not dis­closed, the 76,000-square-foot fa­cil­i­ty will be able to man­u­fac­ture CAR-T, IP­SC and MSC cell ther­a­pies, among oth­ers. The project broke ground last No­vem­ber and will be con­struct­ed in sev­er­al phas­es.

Cel­lipont CEO Deb­o­rah Wild said in a re­lease that the fa­cil­i­ty will open some­time in 2023.

“Once com­plet­ed, Cel­lipont will be unique­ly po­si­tioned to of­fer tech­ni­cal­ly su­pe­ri­or, high­ly-re­spon­sive out­sourced con­tract de­vel­op­ment and GMP man­u­fac­tur­ing ser­vices to in­no­v­a­tive cell ther­a­py com­pa­nies. Or­biMed un­der­stands our vi­sion, has a unique port­fo­lio of life sci­ence com­pa­nies, and was the ide­al part­ner for Cel­lipont in this jour­ney,” Wild said.

Al­ca­mi names new CFO

The North Car­oli­na-based CD­MO Al­ca­mi has pro­mot­ed Ken Mor­gan to the role of CFO, tak­ing over for Er­ic Evans, who will be re­tir­ing this year af­ter 40 years.

Mor­gan him­self has over 25 years of ex­pe­ri­ence in the in­dus­try and joined Al­ca­mi in 1997 when it was known as AAIPhar­ma and has served in var­i­ous fi­nan­cial roles with­in the CD­MO.

Image courtesy of The Janssen Pharmaceutical Companies of Johnson & Johnson.

Pro­tect­ing the glob­al phar­ma­ceu­ti­cal in­no­va­tion ecosys­tem – what’s at stake?

We are living in a new era of healthcare that is rapidly advancing progress impacting patient outcomes and experiences. We’ve seen a remarkable pace of transformational innovation, applied research, and advanced clinical development over the last decade.

Despite this tremendous progress, there is much more work to be done, and patients are counting on us – now more than ever – to continue that momentum. At the heart of our industry is a focus on developing and delivering medicines for some of the world’s most challenging diseases, including those that have few or no effective treatments today.

Roger Perl­mut­ter lines up deals, fresh fund­ing at Eikon; Sec­ond RSV vac­cine ap­proved; Sev­er­al biotechs flash­ing red; and more

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.

As you come back to our website this weekend for ASCO news, don’t forget to check out our updated event lineup at BIO, which will cover everything from the current state of VC investing in biotech to top pharma R&D chiefs discussing how to make pipeline decisions.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,400+ biopharma pros reading Endpoints daily — and it's free.

Peter van de Sande, Synaffix CEO

Lon­za shells out $107M cash to snap up Synaf­fix and its ADC plat­form

After lining up a string of partnerships over the years, Dutch antibody-drug conjugate specialist Synaffix has found a new home: Lonza, the contract development and manufacturing giant.

Lonza is paying about $107 million (€100 million) in cash to acquire Synaffix, with up to $64 million (€60 million) in “additional performance-based consideration” on the table. Synaffix’s ADC tech platform will now become part of Lonza’s offering for biopharma clients, lending its bioconjugate technologies to not just ADCs but also targeted gene therapy, immune cell engagers and other applications.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,400+ biopharma pros reading Endpoints daily — and it's free.

Full TIG­IT da­ta from Gilead, Ar­cus show low­er PFS rates than De­cem­ber read­out: #AS­CO23

CHICAGO — Gilead and Arcus unveiled a fuller snapshot of a Phase II study testing their experimental cancer immunotherapy combo that showed lower progression-free survival rates than its previous update, results that are likely to spark further debate over the closely-watched clinical trial.

Last December, the anti-TIGIT/anti-PD-L1 combo, positioned as a first-line treatment for non-small cell lung cancer, recorded data that drew mixed reactions. The latest analysis, presented Saturday afternoon at ASCO, included only a handful more patients than the previous update, but PFS rates fell — in one cohort by nearly three months.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,400+ biopharma pros reading Endpoints daily — and it's free.

Bris­tol My­er­s' Op­di­vo keeps can­cer at bay in more lym­phoma pa­tients than Seagen's Ad­cetris in PhI­II: #AS­CO23

CHICAGO — In a study pitting Seagen’s Adcetris against Bristol Myers Squibb’s Opdivo in newly diagnosed patients with advanced classic Hodgkin lymphoma, a greater proportion of those who received Opdivo saw no cancer growth at one year compared to those who got Adcetris.

In addition, patients in the Opdivo arm of the Phase III trial reported reduced toxicities, according to lead investigator Alex Herrera, a hematologist-oncologist at City of Hope’s cancer cancer in Duarte, CA. Notably, the trial included more than 200 children across both arms. Generally, more than half of children with advanced Hodgkin lymphoma receive radiation therapy, but in this trial, dubbed SWOG S1826, only a handful of patients in the two arms received radiotherapy, sparing many children from long-term side effects of radiation.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,400+ biopharma pros reading Endpoints daily — and it's free.

Servi­er’s vo­rasi­denib stalls pro­gres­sion of brain can­cer by 61% in piv­otal PhI­II IN­DI­GO study: #AS­CO23

An experimental pill from Servier Pharmaceuticals showed potentially practice-changing results in a narrow group of brain cancer patients, cutting the risk of their cancers progressing by 61%, according to a late-stage clinical trial.

The drug, vorasidenib, is a precision medicine that only works in certain people whose cancer carries mutations in one of two genes called IDH1/2. Doctors hope that the therapy will delay the need for chemotherapy or radiation, which are often used to combat relapses in patients who’ve previously undergone surgery to remove brain tumors.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,400+ biopharma pros reading Endpoints daily — and it's free.

Catal­ent makes ad­di­tion­al lay­offs at In­di­ana fa­cil­i­ty

Contract manufacturer Catalent is making more staff cuts at one of its locations in the US amid dramatic corrective actions it’s been taking over the past few months.

In an email to Endpoints News, a Catalent spokesperson confirmed the company is making “a number of personnel changes” at a manufacturing facility in Bloomington, IN. While a specific number was not given to Endpoints, several local media outlets, including Indiana Public Media and the Bloomington Herald-Times, have put the number of layoffs at 150. No postings have been made to the Indiana Department of Workforce Development’s WARN notice.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,400+ biopharma pros reading Endpoints daily — and it's free.

Roche plans to di­vest from lega­cy Genen­tech man­u­fac­tur­ing fa­cil­i­ty in Cal­i­for­nia

Roche is planning to make some changes to its subsidiary’s manufacturing network in California.

The Swiss pharma announced Wednesday that it plans to divest from Genentech’s manufacturing facility in Vacaville, CA, around 58 miles northeast of San Francisco. According to a statement from Roche, the move is part of a “broader strategy” to bring its manufacturing capabilities in line with its future pipeline. Roche is starting the process of finding a buyer for the site but has not named any candidates yet.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,400+ biopharma pros reading Endpoints daily — and it's free.

As­traZeneca tri­al shows mod­est ben­e­fit in ovar­i­an can­cer, but doc­tors say it's hard to ap­ply find­ings: #AS­CO23

CHICAGO — Adding AstraZeneca’s Imfinzi and Lynparza to the treatment regimen for patients with advanced ovarian cancer and no BRCA mutation extended progression-free survival (PFS) by five months, according to interim data released at the ASCO annual meeting Saturday morning.

However, the design of the Phase III study obscures how much Imfinzi is contributing to the PFS extension, doctors said, making it difficult to apply the findings to clinical practice.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,400+ biopharma pros reading Endpoints daily — and it's free.