Autolus delays multiple CAR-T clinical programs

FierceBiotech | August 09, 2019

A manufacturing delay is stymying progress of a clutch of Autolus CAR-T programs. Autolus revealed the setbacks alongside news that it is dumping the first-generation version of AUTO2 in the face of tough competition in the BCMA space. The manufacturing issue, which is affecting three Autolus programs, relates to a five-month delay in the timeline for qualifying the U.Ks Cell Therapy Catapult. Autolus clinical trial manufacturing site at Catapult was licensed in March and has supplied materials to studies since then. But the ramp-up of output has been slowed by delays at the broader Catapult complex. “The Cell Therapy Catapult site is a brand-new facility. And the challenge that we're seeing with the facility is a delay on the construction and qualification of the main facility. That actually basically resulted in a situation where the delay in the buildup and the construction of facility had a knock-on effect on our own ability to get our own suite that we're operating fully licensed and operational,” Autolus CEO Christian Itin said on a second-quarter results conference call with investors. Those delays pushed back overall qualification of the Catapult by five months. Itin said Autolus was able to claw back some of the lost time but still faces delays to multiple clinical trials programs. Autolus now plans to start the phase 2 portion of a trial of CD19xCD22 dual-CAR-T therapy AUTO3 in the second quarter of 2020. The phase 2 was due to get underway before the end of 2019. AUTO4 and AUTO5 have suffered similar delays. Autolus pushed back initial phase 1 data on AUTO4, a TRBC1-targeting CAR-T, from the first quarter of 2020 into the second half of the year. AUTO5 is now due to enter the clinic in the second half of 2020.

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iXCells Biotechnologies Secures Strategic Growth Investment from Great Point Partners

iXCells Biotechnologies | September 30, 2022

iXCells Biotechnologies a high growth provider of cell-based products and discovery services to the academic, biotech and pharmaceutical communities worldwide, with special focus on primary and induced pluripotent stem cell derived cellular models, today announced receiving a growth investment from Connecticut-based Great Point Partners a private investment firm focusing on the healthcare industry. “iXCells is delighted to join GPP’s portfolio of companies operating within the rapidly growing biotech manufacturing and DD&D services space. We’re grateful for GPP’s support of our vision to translate human cell technology into innovative solutions that advance cell biology research and drug discovery. Our partnership with GPP is a critical step forward for our Company’s growth journey.” Dr. Lynn Zhang, CEO and co-founder iXCells President and co-founder, Dr. Nianwei Lin added, “Our customers will clearly benefit from the deployment of additional capital towards key growth initiatives that will increase iXCells’ operational capacity, expand our product/service offering and bioanalytical capabilities. In particular, we’ll be strengthening our ability to service unmet market needs in areas of personalized medicine including rare diseases. We’re very much looking forward to collaborating with GPP’s management team and broad network to advance iXCells’ mission for the benefit of all stakeholders.” Noah Rhodes, Managing Director at GPP, commented, “Lynn and Nianwei have done an exceptional job building a rapidly growing company serving academic, biotech and pharma clients with best-in-class drug discovery solutions and disease-relevant cellular models. We were extremely impressed by the scientific expertise the management team has built within the organization, and we look forward to helping them expand their product and service offering into adjacent high-growth end markets.” About iXCells Biotechnologies Founded in 2014 and based in San Diego, CA, iXCells Biotechnologies is an innovative cell biology and cell technology company that provides preclinical drug discovery solutions with the focus on disease relevant cellular models enabling technologies and services to the academic, biotech and pharma communities to accelerate the pace of drug discovery. iXCells offers customers access to high quality primary and iPSC derived cells, custom iPSC services, functional bioassay development and drug screening. About Great Point Partners Great Point Partners, founded in 2003 and based in Greenwich, CT, is a leading health care investment firm with 30 professionals, investing in the United States, Canada, and Western Europe. GPP is currently making new minority and majority private equity investments from GPP IV. Great Point manages $1.5B of capital in its private funds and public life sciences equity strategy (BioMedical Value Fund). Great Point Partners has provided growth equity, growth recapitalization, and management buyout financing to more than 200 growing health care companies. The private equity funds invest across all sectors of the health care industry with a particular emphasis on biopharmaceutical services and supplies, alternate site care, medical device and information technology enabled businesses. The firm pursues a proactive and proprietary approach to sourcing investments and tuck-in acquisitions for its portfolio companies.

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Kriya Acquires Redpin Therapeutics, Adding Neurology Pipeline to Gene Therapy Portfolio

Kriya Therapeutics | November 17, 2022

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Rocket Pharmaceuticals to Acquire Renovacor, Extending Leadership in AAV-based Cardiac Gene Therapy

Rocket Pharmaceuticals, Inc. | September 21, 2022

Rocket Pharmaceuticals, Inc. a leading late-stage, clinical biotechnology company advancing an integrated and sustainable pipeline of genetic therapies for rare childhood disorders with high unmet need, and Renovacor, Inc. a biotechnology company focused on delivering innovative precision therapies to improve the lives of patients and families battling genetically-driven cardiovascular and mechanistically-related diseases, today announced a definitive agreement under which Rocket will acquire Renovacor in an all-stock transaction for an implied value of approximately $2.60 per share, based on the volume weighted average trading price of Rocket shares of $15.51 for the 30 trading days through and including Monday, September 19, 2022. 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