China’s 3SBio gains a North American through its $290 million purchase of Canada’s Therapure Biopharma
Marck’s cladribine tablet Mavenclad achieves sustained control of relapsing multiple sclerosis.
A patient enrolled in a CAR-T trial dies.
I’m Nestor Arellano. And these are the stories we’ll discuss today on the Biotechnology Focus Podcast.
But first, let’s talk about the future of Canada’s life science workplace and workforce
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What are the things that employees in Canada’s life science industry value about their workplace?
What is it about their organization that keep life science professionals and workers engage and productive each day?
How can you, as an employer attract and retain great talent?
These are just some of the crucial questions many operators and owners of Canadian life science companies face as they work to grow their business.
The key to finding the answers to these questions is data. And the best way to get that data is through the ongoing
Biotechnology Focus, Stratford Managers Corporation, and BioTalent Canada nationwide 2017 Life Science Workplace Survey.
The poll is one of the most comprehensive attempts to take the pulse Canada’s life science workplace environment.
The findings of the survey will provide life science organizations across the country a critical guide on what areas to focus on in order to enhance their operations and relationships with their workers.
Don’t miss this chance. There’s still time to take part in the poll. All you have to do is head over to
Surveymonkey.com/r/biotechEOS and spend a few minutes taking the poll.
Remember that’s surveymonkey.com/r/biotechEOS.
Do the survey now and have your say counted.
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Early this month, Chinese biotech firm 3SBio Inc., shelled out $290 million
For Mississauga, ont’s biologics manufacturer Therapure Biophrama.
3SBio is focused on oncology, nephrology and auto-immune diseases. It has been slowly extending its reach out of its Shenyang headquarters in north China.
By purchasing Therapure, 3SBio has effectively put its North American expansion plans into high gear.
“3SBio’s global expansion strategy is now on fast track,” according to Dr. Jing Lou, chairman of 3SBio
He called the purchase “a key milestone of the global expansion strategy” of his business.
The acquisition integrates 3SBio’s mammalian cell culture capabilities and Therapure’s downstream purification and plasma source technologies.
This also combines the production capacity of the Chinese company’s recently acquired stakes in Sunshine Guojian Pharmaceutical and Sirton Pharmaceuticals SpA with Therapure’s operations.
More than 340 biologics professionals in North America focusing on operations and management, market development, R&D, and manufacturing are expected to join 3SBio.
3SBio will also get certain rights to Therapure’s plasma production and technology, according to the Canadian company.
Therapure’s CDMO business will continue to operate under the Therapure brand and be led by Therapure’s CEO Nick Green and the current senior management team at its manufacturing facilities located in Mississauga.
+++++ Merck’s Mavenclad branded cladribine tablets for the treatment of
highly active relapsing multiple sclerosis has
demonstrated the medication a achieve sustained control of the disease over four years with a maximum of only 20 days of oral treatment.
The trial, included 806 patients out of 1,184 patients who completed an earlier study.
The latest study assessed several clinical efficacy endpoints including annualized relapse rate (ARR) and confirmed three-month Expanded Disability Status Scale (EDSS) progression.
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CAR-T therapy has been getting a lot of attention recently.
Earlier this month, the FDA gave the green light to Novartis’ CAR-T therapy which uses a patient’s own immune cells to destroy aggressive blood cancer cells.
With this method, the patient’s T-cells are collected and sent to a manufacturing centre
where they are genetically modified to include a new gene that contains a specific protein (a chimeric antigen receptor or CAR) that directs the T-cells
to target and kill leukemia cells that have a specific antigen (CD19) on the surface.
French biopharmaceutical firm Cellectis was not a fortunate with its own research.
The company’s work on an off-the-shelf CAR-T therapy
was placed on hold by the United States Food and Drug Administration
following the death of one of the patients enrolled in the company’s clinical trial for the therapy.
The hold was placed on both UCART123 ongoing Phase 1 studies, respectively in acute myeloid leukemia (AML)
and in blastic plas macy toid dend ritic cell neoplasm (BPDCN).
A 78-year-old BPDCN male patient received a dose of CD123-targeting CAR-T UCART 123 on August 16. Nine days later, the patient died.
Another patient treated in the study experienced a similar but less severe reaction.
The 58-year-old woman with AML was given the same dose of UCART 123 as the BPDCN patient.
Now Cellectis has to determine what precautions to take
before moving forward with enrolling more BPDCN and AML patients for the two phase 1 trials it plans.
The (Data Safety Monitoring Board) has recommended lowering the dose of UCART123 in both studies to 4g over 3 days.
The French biopharmaceutical firm is now working closely with the investigators and the FDA
in order to resume the trials with an amended protocol including a lowered dosing of UCART123.
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That’s all the time we have for today.
Thank you very much for listening in and I hope you enjoyed our podcast.
This is your host Nestor Arellano
Inviting you to join us again next week for more biotech news and views on the Biotechnology Focus Podcast.
