|Atara Biotherapeutics Announces Pricing of $150M Public Offering|
July 18, 2019 – (Atara Biotherapeutics) – The offering is expected to close on or about July 23, 2019, subject to customary closing conditions.
|MilliporeSigma and Broad Institute Announce CRISPR License Framework to Encourage Innovation|
July 18, 2019 – (MilliporeSigma) – MilliporeSigma and the Broad Institute of MIT and Harvard announced an agreement to offer non-exclusive licenses to CRISPR intellectual property under their respective control for use in commercial research and product development.
|Precision BioSciences Opens First In-House cGMP Manufacturing Facility Dedicated to Genome-Edited Allogeneic CAR T Cell Therapy in the United States|
July 18, 2019 – (Precision BioSciences) – Currently, the new facility is undergoing CQV (commissioning, qualification, and validation) in preparation for cGMP manufacturing to begin in the fourth quarter of 2019.
|Astellas and Frequency Therapeutics Enter into License Agreement for FX-322, a Regenerative Treatment Candidate for Hearing Loss|
July 17, 2019 – (Frequency Therapeutics) – Frequency will receive an upfront payment of $80M and may also receive up to an additional $545M based on development and commercial milestones, as well as royalties on any future product sales in the licensed territory.
|AVROBIO Announces Pricing of Underwritten Public Offering of $120.25M of Common Stock|
July 16, 2019 – (AVROBIO) – The company intends to use the net proceeds from the offering, in addition to its existing cash resources, to fund the support of the company’s current programs in Fabry disease, Gaucher disease, cystinosis and Pompe disease.
|Catalent Biologics Announces Agreement To Provide Additional Production Of Approved Gene Therapy Treatment For Spinal Muscular Atrophy|
July 16, 2019 – (Catalent) – Catalent Biologics announced a long-term strategic agreement for the development and manufacturing of Zolgensma (onasemnogene abeparvovec-xioi), an AveXis gene therapy treatment for spinal muscular atrophy.
|First iPSC-Derived CAR T-Cell Therapy Created by Kyoto University CiRA and Takeda Collaboration Enters Process Development Toward Clinical Testing|
July 16, 2019 – (Takeda) – Under the terms of the T-CiRA agreement, Takeda has the global rights to develop and commercialize the iCART product and CiRA will receive development and approval milestones.
|Kite Announces Plans to Bolster Industry-Leading Cell Therapy Manufacturing Capabilities With New Viral Vector Facility|
July 16, 2019 – (Gilead) – Kite, a Gilead Company, announced plans for a new 67,000-square-foot facility in Oceanside, California, dedicated to the development and manufacturing of viral vectors, a critical starting material in the production of cell therapies.
|MIT’s Research Enterprise in Singapore Launches New Research Group, Boosting Nation’s Cell Therapies R&D|
July 15, 2019 – (MIT) – The National Research Foundation will support this multi-million, multi-year project that will bring together 35 MIT and Singapore investigators. They will be recruited from researchers working in SMART and Singapore institutes including A*STAR, KK Women’s and Children’s Hospital, the National University Hospital and local universities.
|Gilead Appoints Christi L. Shaw as Chief Executive Officer of Kite|
July 11, 2019 – (Gilead) – Ms. Shaw currently serves as Senior Vice President of Eli Lilly &. Co., and President of Lilly Bio-Medicines. She also serves as a board member of both Avantor, Inc. and the Biotechnology Industry Organization (BIO), and as an advisor to the Healthcare Businesswomen’s Association.
|BioLife Solutions to Acquire SAVSU Technologies|
July 8, 2019 – (BioLife Solutions) – BioLife Solutions announced that it has exercised its option to acquire the remaining 56% of the outstanding shares of privately held SAVSU Technologies that BioLife currently does not own in exchange for 1.1 million shares of BioLife common stock.
|Immatics Presents First Cohort Data on the ACTolog Personalized Multi-Target Cell Therapy Trial Demonstrating Safety and T-cell Persistence in Treated Cancer Patients|
July 19, 2019 – (Immatics) – ACTolog IMA101 is well tolerated. All treated patients had stable disease by RECIST and irRECIST at 6 weeks and are alive to date after a median follow-up of 8 months.
|Adaptimmune Starts the SURPASS Clinical Trial with Its First Next-Generation Spear T-Cells Targeting MAGE-A4 to Enhance Antitumor Responses|
July 18, 2019 – (Adaptimmune) – Preclinical data presented earlier this year at AACR indicate that co-expression of CD8α may broaden the immune response against solid tumors and increase antitumor activity by leveraging CD4+ cells into CD8+ killer or cytotoxic T‑cells while retaining their CD4+ helper function.
|Transgene Receives MHRA Approval for a Clinical Trial of TG6002, a Next-Generation Oncolytic Virus for Patients with Colorectal Cancer with Liver Metastases|
July 18, 2019 – (Transgene) – The Phase 1/2a study is expected to start in Q4 2019 and could enroll up to 75 patients.
|Atara Biotherapeutics Announces Plan to Initiate Tab-Cel FDA Biologics License Application Submission Next Year|
July 16, 2019 – (Atara Biotherapeutics) – Based on Atara’s recent discussions with the FDA, the company plans to initiate a tab-cel biologics license application (BLA) submission for patients with EBV+ PTLD in the second half of 2020.
|LogicBio Therapeutics Receives Rare Pediatric Disease Designation for LB-001 for the Treatment of Methylmalonic Acidemia|
July 16, 2019 – (LogicBio) – In addition to rare pediatric disease designation, LogicBio previously received orphan drug designation from the FDA for LB-001. LogicBio anticipates filing an IND for LB-001 in the fourth quarter of 2019.
|Capricor Therapeutics Announces Positive Results from its Interim Analysis in the HOPE-2 Trial to Treat Patients with Duchenne Muscular Dystrophy|
July 15, 2019 – (Capricor Therapeutics) – Interim analysis showed statistically significant improvements in the performance of the upper limb, grip strength and inspiratory flow reserve in patients treated with CAP-1002.
|Caladrius Biosciences Receives Advanced Therapy Medicinal Product Classification for CLBS12, its CD34+ Cell Therapy for Critical Limb Ischemia|
July 15, 2019 – (Caladrius) – CLBS12 has previously been awarded a SAKIGAKE designation in Japan, a status which makes the product eligible for early conditional approval based on the on-going clinical trial in that country.