December 6, 2017, WUXI, China, Dec. 6, 2017 — WuXi Biologics (2269.HK), a leading global open-access biologics technology platform company, offering end-to-end solutions for biologics discovery, development and manufacturing, announced that its cGMP biologics manufacturing facility in Wuxi city with 30,000 L bioreactor capacity entered into full operations. This marks a significant milestone for WuXi Biologics as well as the biologics industry in China.
ISCT Webinar on Cell and Gene Therapy (CGT) Products in Japan
Have you heard of the recent regulatory changes surrounding cell and gene therapy (CGT) products in Japan?
These changes have greatly increased the interest in taking CGT clinical programs to Japan from development through commercialization. ISCT (International Society for Cellular Therapy) and FIRM (Forum for Innovative Regenerative Medicine) have created a partnership to facilitate the entry and development of future CGT products in Japan.
Robert Preti, PhD (General Manager of Hitachi Chemical’s Regenerative Medicine Business Sector) and Kazuchika Furuishi, PhD (Deputy General Manager) are joining a leading Japanese management consultant (Colin Novick) to discuss the challenges to consider and examples of solutions for successfully taking your clinical cell or gene therapy program to Japan.
On Wednesday, December 6, the webinar will explore the attractive regulatory changes in Japan, as well as:
- Increased offshore filing activity
- Challenges to consider
- Successful CGT programs brought to Japan
Register now for the Hitachi Chemical Advanced Therapeutics Solutions, LLC sponsored webinar and learn from experts:
http://www.celltherapysociety.org/?page=wbnr_BMI
FDA Lifts Clinical Hold on Cellectis Phase 1 Clinical Trials with UCART123 in AML and BPDCN
Cellectis agreed with the FDA to the following main revisions to be implemented in Phase 1 UCART123 protocols to lift the hold:
- Decrease of the cohort dose level to 6.25×104 UCART123 cells/kg;
- Decrease of the cyclophosphamide dose of the lympho-depleting regimen to 750 mg/m²/day over three days with a maximum daily dose of 1.33 grams of cyclophosphamide;
- Inclusion of specific criteria at Day 0, the day of UCART123 infusion, such as no new uncontrolled infection after receipt of lymphodepletion, afebrile, off all but replacement dose of corticosteroids, no organ dysfunction since eligibility screening;
- Provision to ensure that the next three patients to be treated in each protocol will be under the age of 65;
- Provision to ensure that the enrollment will be staggered across the UCART123 protocols AML123 and ABC123: at least 28 days should elapse between the enrollments of two patients across the two studies.
Mustang Bio Establishes CAR T Cell Therapy Manufacturing Facility in Massachusetts
Facility located in the UMass Medicine Science Park will support clinical development and commercialization of CAR T pipeline
Preparations underway for clinical production in 2018
NEW YORK, Oct. 30, 2017 — Mustang Bio, Inc. (“Mustang”) (NASDAQ:MBIO), a Fortress Biotech, Inc. (NASDAQ:FBIO) company focused on the development of novel immunotherapies based on proprietary chimeric antigen receptor engineered T cell (CAR T) technology, announced today that it has entered into a lease agreement with the UMass Medicine Science Park in Worcester, Massachusetts, for a manufacturing facility to support the clinical development and commercialization of the Company’s CAR T product candidates.
The facility is expected to be operational for the production of personalized CAR T therapies in 2018. Mustang anticipates initially building cell-processing capabilities to support its lead CAR T product candidates MB-101 in glioblastoma, and MB-102 in acute myeloid leukemia and blastic plasmacytoid dendritic cell neoplasm. [Read more…]
Inside Scoop on Biostage, a World Leader in Bioengineered Organs
Biostage is a clinical-stage company specializing in bioengineered organ implants to treat cancer and other conditions involving the esophagus, bronchus and trachea. In August 2017, Biostage transplanted its esophageal implant product into its first patient worldwide, a 75-year old man with cancer. On the heels of this historic accomplishment, I am pleased to share this interview with Jim McGorry, President and CEO at Biostage, Inc. In this interview, we discuss the company’s vision, its research partnerships, clinical trial strategy, and five-year goals.
Please note that this interview was conducted prior to Biostage’s breach and failure to fund by First Pecos.
Read on to learn more about how Biostage is introducing bioengineered organ implants to the regenerative medicine landscape. [Read more…]