Allogene Therapeutics Receives IND Clearance from the U.S. Food and Drug Administration for ALLO-605, the First TurboCAR™ Candidate, for the Treatment of Patients with Relapsed/Refractory Multiple Myeloma
Allogene Therapeutics announced FDA clearance for an IND application to study ALLO-605 targeting relapsed/refractory multiple myeloma. This marks the initiation of the Phase I IGNITE trial, expected to start in mid-2021, which will assess escalating doses of ALLO-605. This therapy incorporates the proprietary TurboCAR technology designed to enhance T cell function and potency. ALLO-605 is part of a broader strategy targeting BCMA in treating multiple myeloma, complementing ongoing trials with other candidates including ALLO-715 and ALLO-647.
- FDA clearance for ALLO-605 IND allows for clinical trials targeting multiple myeloma.
- ALLO-605 utilizes TurboCAR technology aimed at improving T cell function and reducing dosing requirements.
- The IGNITE trial marks a significant step in Allogene’s multi-pronged strategy against BCMA.
- None.
- TurboCAR Technology Allows a Programmable Cytokine Signaling to Potentially Control T Cell Exhaustion and Improve Function and Potency of AlloCAR T™ Cells
- Phase 1 IGNITE Trial Expected to Begin in Mid-2021
- ALLO-605 is One of Allogene’s Three Strategies to Target BCMA for the Treatment of Patients with Multiple Myeloma
SOUTH SAN FRANCISCO, Calif., April 19, 2021 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) therapies for cancer today announced that the U.S. Food & Drug Administration (FDA) has cleared an Investigational New Drug (IND) application to study ALLO-605 for the treatment of patients with relapsed or refractory multiple myeloma. ALLO-605 is part of the company’s multi-faceted strategy to develop an allogeneic CAR T therapy targeting BCMA for the treatment of multiple myeloma. The Phase I IGNITE trial will evaluate escalating doses of ALLO-605 beginning in mid-2021.
ALLO-605 is the Company’s first TurboCAR™ clinical candidate. TurboCAR is a proprietary, next generation platform technology based on a programmable cytokine signaling, designed to control T cell exhaustion, and improve T cell function and potency to reduce dosing requirement of AlloCAR T™ cells. These properties may enable CAR T therapy to succeed in more difficult to treat hematologic malignancies and solid tumors.
“Clearance of the ALLO-605 IND marks the beginning of the third stage of our three-pronged strategy targeting BCMA for relapsed/refractory multiple myeloma,” said Rafael Amado, M.D., Executive Vice President of Research & Development and Chief Medical Officer of Allogene. “We look forward to initiating the IGNITE trial and are excited to advance a new technology platform that has the potential to transform the field of engineered T cell therapy.”
As part of the Company’s anti-BCMA strategy, Allogene continues to enroll relapsed/refractory multiple myeloma patients in the Phase 1 UNIVERSAL study with the goal of optimizing dosing of ALLO-715 and ALLO-647. Allogene in collaboration with SpringWorks Therapeutics is also evaluating ALLO-715 in combination with the investigational gamma secretase inhibitor, nirogacestat, for the treatment of multiple myeloma.
About ALLO-605
ALLO-605 is a next-generation AlloCAR T investigational therapy that targets the B-cell maturation antigen (BCMA) for the treatment of patients with relapsed/refractory multiple myeloma and other BCMA-positive malignancies. ALLO-605 incorporates Allogene’s proprietary TurboCAR technology, which allows for cytokine activation signaling to be engineered selectively into CAR T cells. Preclinical results with ALLO-605 were presented at the American Society of Hematology (ASH) annual meeting in December 2020.
About Allogene Therapeutics
Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) therapies for cancer. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell therapy candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow @AllogeneTx on Twitter and LinkedIn.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The press release may, in some cases, use terms such as "predicts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the timing and ability to initiate the IGNITE trial; the ability of ALLO-605 and TurboCARs to control T cell exhaustion, improve T cell function, improve potency, and reduce dosing requirements of AlloCAR T™ cells; the ability to manufacture AlloCAR T™ therapies; and the potential benefits of AlloCAR T therapies. Various factors may cause differences between Allogene’s expectations and actual results as discussed in greater detail in Allogene’s filings with the SEC, including without limitation in its Form 10-K for the year ended December 31, 2020. Any forward-looking statements that are made in this press release speak only as of the date of this press release. Allogene assumes no obligation to update the forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
AlloCAR T™ and TurboCAR™ are trademarks of Allogene Therapeutics, Inc.
ALLO-605 utilizes TALEN® gene-editing technology pioneered and owned by Cellectis. Allogene has an exclusive license to the Cellectis technology for allogeneic products directed at BCMA and holds all global development and commercial rights for this investigational candidate.
Allogene Media/Investor Contact:
Christine Cassiano
Chief Communications Officer
(714) 552-0326
Christine.Cassiano@allogene.com
FAQ
What is ALLO-605 and its significance for multiple myeloma?
When is the IGNITE trial for ALLO-605 expected to begin?
What are the benefits of TurboCAR technology in ALLO-605?
How is ALLO-605 part of Allogene's strategy against BCMA?
