4 minute read
BuSINESS CORNER
Montréal based ExCellThera Inc., advanced clinical stage biotechnology company, delivers molecules and bioengineering solutions to expand stem and immune cells for use in novel one-time curative therapies for patients with hematologic malignancies, autoimmune and other diseases. Their lead therapy, ECT-001, combines the proprietary molecule UM171 with an optimized culture system.
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In its collaboration with the New York Blood Center (NYBC), ExCellThera will have access to NYBC’s clean room manufacturing facilities to produce ECT-001 to be used in clinical trials mostly in the U.S. “The New York Blood Center holds one of the world’s largest blood banks and has over 50 years of leadership in research and development, medical services and laboratory services. We are extremely pleased to enter into this multi-year agreement which will allow us to work closer together and leverage their leadership and expertise in this specialized field,” said David Millette, Chief Operating and Financial Officer at ExCellThera.
ExCellThera expects substantial scale-up in the production of ECT-001 to meet the needs of new clinical trials during these final phases of clinical development. The FDA has granted ECT-001 orphan drug designation for the prevention of graft-versus-host disease and regenerative medicine advanced therapy designation in the treatment of hematologic malignancies.
CCRM
is your partner in cell and gene therapy manufacturing
Adjacent to world-class research hospitals, and near Toronto Pearson International Airport, the Centre for Cell and Vector Production provides GMP manufacturing of cells and viral vectors for Phase I/II trials. The facility has robust and phase-appropriate quality systems that are designed for USFDA, EMA and Health Canada compliance.
Lab services include cell reprogramming and gene editing, technology translation, protocol and process development. CCRM has expertise in purification, packaging, bioreactor optimization, media development, downstream product concentration and scale up/out manufacturing.
CCRM’s deep expertise in process development and GMP manufacturing provides a comprehensive approach to supporting regenerative medicine discoveries from concept to market. Collaboration, project management, transparency and frequent interaction with technical leadership are the core of its philosophy.
The Centre for Cell and Vector Production (CCVP)
A transparent and flexible approach to manufacturing
• 10 suites: 2 Viral Vector, 8 Cell Therapy • ISO Class 7/Grade
B clean rooms for
Phase I/II trials • CAR-T, PSC,
LVV and AAV
Process DevelopmentCCRM Offices
QC Lab
CCVP20,000 ft 2
CONTACT US
cdmo@ccrm.ca +1 416-978-3751 www.ccrm.ca
F-star expedites its transition to a wholly-owned portfolio strategy
Eliot Forser
F-star, a leading clinical-stage biopharmaceutical company delivering tetravalent bispecific antibodies for a paradigmshift in cancer therapy, has pivoted to a wholly-owned portfolio strategy, creating greater value for shareholders over its former pure partnering model. The company is pursuing a protocol with its lead clinical asset, FS118, the same as was planned with Merck.
To promote tumor elimination, the FS118 is a bispecific antibody that leverages a unique mechanism of action that simultaneously inhibits PD-L1 and LAG-3-mediated inhibitory pathways, potentially reversing the immune system’s down regulation in lymph nodes and at tumor sites.
CEO of F-star, Eliot Forser said, “This new agreement reflects our pivot to building a wholly-owned pipeline, that allows for rapid progress into the clinic and secures greater long-term value from our products. With full rights to FS118, we have an opportunity to accelerate the development of this first-in-class medicine for a group of targeted cancer patients. We are also pleased to continue our long-term collaboration with Merck KGaA, Darmstadt, Germany by advancing assets from F-star’s Modular Antibody TechnologyTM into their pipeline.”
Merck and F-star remain partners under other parts of the original collaboration, but with F-star retaining exclusive rights to develop and commercialize FS118 under the new agreement, F-star believes it can proceed faster, creating greater value for shareholders and patients. Under the terms of the new agreement, Merck has exercised its option for one discovery stage program and retains the right to option a secondary discovery program.
MJBizConNEXT explores future of cannabis industry
This Jun. 12-14, the editors of MJBizDaily host MJBizConNEXT at the Ernest N. Morial Convention Center in New Orleans. MJBizConNEXT is an opportunity for cannabis business executives, lead cultivators and innovators to connect in a personal setting to further important industry discussions through peer-to-peer sessions for CEO’s, attorneys, cultivators and extraction scientists.
“At MJBizConNEXT the pioneers and visionaries of the cannabis industry come together to look at the evolving future of cannabis and the drivers that are pushing it ahead,” said CEO and Co-Founder of MJBizDaily, Cassandra Farrington. “They are here to leverage technology, to meet and learn from their fellow peer executives, and to prepare for what’s to come as legalization lingers in the background and we pave the way to building a safe, regulated industry.”
The event includes 250-hand picked exhibitors with interactive experiences showcasing the impact of innovation on plant production, energy efficiency, industry size and community impacts. General session topics include: • Cannabis Evolution: Products, Cultivation,
Extraction • Level Up: Next Steps for Your Business • On the Horizon: Emerging Markets and
Trends • Money Matters: Investing in Cannabis • On the Radar: Innovations in Cannabis
Technology • Future-Proof Your Business The Hemp Industry Daily Conference, a one-stop source for key market information will be launching alongside MJBizConNEXT. This three-day conference is a deep dive into business opportunities, growing consumer demand for hemp and CBD and updates on regulations and legal developments.
