Sam­sung Bi­o­log­ics takes on man­u­fac­tur­ing du­ties for Green­Light's Covid-19 vac­cine

Sam­sung Bi­o­log­ics has en­tered an agree­ment with biotech Green­Light Bio­Sciences to man­u­fac­ture its mR­NA Covid-19 vac­cine at com­mer­cial scale, the two com­pa­nies an­nounced.

Sam­sung Bi­o­log­ics, one of the fastest grow­ing man­u­fac­tur­ers in the world right now, will use its vac­cine man­u­fac­tur­ing ex­per­tise to help pa­tients in low­er-in­come coun­tries, CEO John Rim said in a press re­lease. This will help ex­pand their ca­pa­bil­i­ties from drug sub­stance to asep­tic fill-fin­ish and all the way to com­mer­cial re­lease from one site.

“At this time of ur­gent glob­al de­mand, we will strive for seam­less ser­vice across our bio­man­u­fac­tur­ing net­work to fight the COVID pan­dem­ic and in turn, help make progress to­wards Ko­rea’s vac­cine hub goal,” he said in a press re­lease.

Sam­sung’s Song­do fa­cil­i­ty will be ready for cGMP op­er­a­tions in ear­ly 2022, the com­pa­ny said. It added drug sub­stance ca­pa­bil­i­ties to the site ear­li­er this year, in an at­tempt to be proac­tive in ac­com­mo­dat­ing clients’ needs.

In Au­gust, Green­light re­verse-merged its way on­to the Nas­daq, land­ing a $1.5 bil­lion val­u­a­tion af­ter merg­ing with the SPAC En­vi­ron­men­tal Im­pact Ac­qui­si­tion Corp., which is backed by Canac­cord Ge­nu­ity Group and Hud­son Bay Cap­i­tal Man­age­ment. That merg­er land­ed the com­pa­ny $207 mil­lion and $105 mil­lion in PIPE fi­nanc­ing.

The com­pa­ny was found­ed in 2008 to use its mR­NA tech­nol­o­gy to pro­tect both hu­mans and agri­cul­ture, in­clud­ing hon­ey­bees and crops. It was vir­tu­al­ly un­known be­fore the merg­er. Now, the com­pa­ny is look­ing to set up a blue­print for vac­ci­nat­ing the world from Covid-19, and hopes to do so through im­proved mR­NA man­u­fac­tur­ing ca­pa­bil­i­ties. It’s been work­ing on sea­son­al flu and sick­le cell dis­ease vac­cines as well, but it got its start while try­ing to shake up the pes­ti­cides mar­ket for in­dus­tri­al agri­cul­ture.

“There is an ur­gent need to de­vel­op vac­cines for the whole world,” Green­Light CEO An­drey Zarur said in a press re­lease. “Our vac­cine tri­al will open the way to make vac­cines that are avail­able to every­body, not just cit­i­zens of de­vel­oped coun­tries.”

There are cur­rent­ly three plants at the Sam­sung Song­do cam­pus. A fourth is on the way, and the CD­MO just got ap­proved to build a fifth in No­vem­ber.

Sam­sung will fin­ish the $259 mil­lion site on 32,808-square-feet of land in the city, which comes on the heels of its newest cell line, which launched in Au­gust 2020. It’s al­so in talks to ac­quire more land to de­vel­op a sec­ond bio com­plex. This, and all of Sam­sung’s oth­er ex­pan­sions, come on the heels of a 64% in­crease in sales from last year to $375 mil­lion, large­ly thanks to an in­creased de­mand for CD­MO ser­vices.

A pre­vi­ous ver­sion of this sto­ry stat­ed that Green­Light was based in South Ko­rea. It is based out of Boston, MA.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Alaa Halawaa, executive director at Mubadala’s US venture group

The ven­ture crew at Mubadala are up­ping their biotech cre­ation game, tak­ing care­ful aim at a new fron­tier in drug de­vel­op­ment

It started with a cup of coffee and a slow burning desire to go early and long in the biotech creation business.

Wrapping up a 15-year discovery stint at Genentech back in the summer of 2021, Rami Hannoush was treated to a caffeine-fueled review of the latest work UCSF’s Jim Wells had been doing on protein degradation — one of the hottest fields in drug development.

“Jim and I have known each other for the past 15 years through Genentech collaborations. We met over coffee, and he was telling me about this concept of the company that he was thinking of,” says Hannoush. “And I got immediately intrigued by it because I knew that this could open up a big space in terms of adding a new modality in drug discovery that is desperately needed in pharma.”

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'Band­ing to­geth­er': 50 fe­male biotech ex­ec­u­tives lay out plans for board di­ver­si­ty, new com­pa­nies and men­tor­ing founders

Earlier this month, during the Silicon Valley Bank meltdown, Angie You recalled the speed with which female biotech CEOs were helping each other connect with bankers, get their wires through and assuage concerns during a financial implosion.

This past weekend, 50 of about 125 women who are part of that Slack group and a broader coalition self-dubbed the Biotech Sisterhood met in person in Cancun for the second rendition of an annual summit connecting female biotech CEOs. The attendance list doubled that of the inaugural gathering in Arizona 12 months ago.

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No­var­tis touts sev­en years of dura­bil­i­ty da­ta for Zol­gens­ma

The same day that Roche touted positive durability and safety data for its spinal muscular atrophy drug Evrysdi, Novartis also made a splash with its multi-million dollar gene therapy for the disease.

Novartis rolled out interim data from two long-term follow-up studies Monday at the 2023 Muscular Dystrophy Association (MDA) Clinical and Scientific Conference. In the first study, LT-001, all children in the trial that were treated after showing symptoms of SMA “maintained all previously achieved motor milestones” up to 7.5 years after being dosed. The average time since Zolgensma was given was 6.86 years.

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Rohan Palekar, 89bio CEO

89bio’s PhII da­ta add to quick suc­ces­sion of NASH read­outs as field seeks turn­around

89bio said its drug was better than placebo at lessening fibrosis without worsening nonalcoholic steatohepatitis, or NASH, in two of three dose groups.

The San Francisco biotech said it thinks the Phase IIb data pave the way for a potential Phase III, following in the footsteps of another biotech in its drug class, Akero Therapeutics. To fund a late-stage study, CEO Rohan Palekar told Endpoints News 89bio “would need to raise additional capital,” with the company having about $188 million at the end of last year.

Flare Therapeutics biochemists Yong Li (L) and Valerie Vivat

A $123M Flare will get Third Rock on­col­o­gy biotech in­to the clin­ic this year

Flare Therapeutics will start its first human trial this year with an investigational urothelial cancer drug after pulling together a $123 million Series B from Big Pharmas, VCs and its incubator, Third Rock Ventures.

Launched in 2021 on the idea that a biotech could finally succeed at drugging the much-sought-after but stubborn transcription factor, Flare Therapeutics said Wednesday it is now primed for the clinic after closing its large financing haul earlier this year. The raise is a relatively stark figure in a tough startup financing environment but further buoys the upbeat signals coming out of other Third Rock biotechs in recent weeks, including the $200 million CARGO Therapeutics and $100 million Rapport Therapeutics rounds.

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Francesco Marincola, newly-appointed Sonata Therapeutics CSO

Kite's head of re­search leaves for Flag­ship start­up Sonata

Another leader is departing Kite Pharma, and will to spend the “last part” of his career exploring how cancer evades the immune system.

Kite’s senior VP and global head of cell therapy research Francesco Marincola left the Gilead CAR-T unit last week for Sonata Therapeutics. Flagship last May unveiled the startup, which was pieced together from two fledgling biotechs Inzen and Cygnal Therapeutics. As CSO, Marincola will lead Sonata’s push to reprogram cancer cells to make them more immunogenic.

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FDA in­di­cates will­ing­ness to ap­prove Bio­gen ALS drug de­spite failed PhI­II study

Ahead of Wednesday’s advisory committee hearing to discuss Biogen’s ALS drug tofersen, the FDA appeared open to approving the drug, newly released briefing documents show.

Citing the need for flexibility in a devastating disease like ALS, regulators signaled a willingness to consider greenlighting tofersen based on its effect on a certain protein associated with ALS despite a failed pivotal trial. The documents come after regulatory flexibility was part of the same rationale the agency expressed when approving an ALS drug last September from Amylyx Pharmaceuticals, indicating the FDA’s openness to approving new treatments for the disease.

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Roche and Lil­ly team up to de­vel­op blood test to de­tect ear­ly signs of Alzheimer's

Eli Lilly is teaming up with Roche to help develop a blood test to detect early signs of Alzheimer’s disease and determine whether a patient should go for further confirmatory testing.

Roche’s Elecsys Amyloid Plasma Panel (EAPP) measures pTau 181 protein assay and APOE E4 assay in human blood plasma – elevations in pTau 181 are present in the early stages of Alzheimer’s, while the presence of APO E4 is the most common genetic risk factor for the disease.

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