These data will also be presented in a poster session at the
'We are excited to be the first to demonstrate the potential of allogeneic CD19 CAR T to induce durable complete remissions at a rate similar to approved autologous CD19 CAR T therapies. Our Phase 2 regimen also had a safety profile, including immune recovery, in line with approved options,' said
The updated analysis of ALPHA/ALPHA2 examined data from 12 CAR T-naive patients with r/r LBCL who received a single dose of ALLO-501/501A manufactured using the Alloy process following a lymphodepletion regimen (FCA90) comprised of fludarabine (30 mg/m2/day x 3 days) and cyclophosphamide (300 mg/m2/day x 3 days) plus ALLO-647 (30 mg/day x 3 days). The median time from enrollment to the start of therapy was three days and all 12 patients were followed through a minimum of six months.
About ALLO-501 and ALLO-501A
ALLO-501 and ALLO-501A are anti-CD19 AlloCAR T investigational products for the treatment of large B cell lymphoma. ALLO-501A, a next-generation anti-CD19 AlloCAR T, eliminates the rituximab recognition domains in ALLO-501, which could allow for use in a broader patient population, including NHL patients with recent rituximab exposure. This product candidate is currently being studied in an ongoing potentially pivotal Phase 2 trial. In
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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 potential of allogeneic CD19 CAR T to generate durable complete responses similar to approved autologous therapies; ALPHA2 being a potentially pivotal trial; expected completion of enrollment in ALPHA2 in the first half of 2024; the potential safety profile of Allogene's Phase 2 lymphodepletion and cell dose regimen; the potential of Allogene's AlloCAR T product candidates to break down access barriers to CAR 2 and establish a new paradigm in cell therapy and the potential benefits of the Alloy process and AlloCAR T products. Various factors may cause material differences between Allogene's expectations and actual results, including risks and uncertainties related to: Allogene's product candidates are based on novel technologies, which makes it difficult to predict the time and cost of product candidate development and obtaining regulatory approval; Phase 1 data from Allogene's clinical trials is limited and may change as more patient data become available or may not be validated in any future or advanced clinical trial; Allogene's ability to maintain intellectual property rights necessary for the continued development of its product candidates, including pursuant to its license agreements; Allogene's product candidates may cause undesirable side effects or have other properties that could halt their clinical development, prevent their regulatory approval or limit their commercial potential; the extent to which COVID-19 adversely impacts Allogene's business, including its clinical trials; the extent to which the FDA disagrees with Allogene's clinical or regulatory plans, which could cause future delays to Allogene's clinical trials or require additional clinical trials; Allogene may encounter difficulties enrolling patients in its clinical trials; Allogene may not be able to demonstrate the safety and efficacy of its product candidates in its clinical trials, which could prevent or delay regulatory approval and commercialization; challenges with manufacturing or optimizing manufacturing of Allogene's product candidates and Allogene's ability to obtain additional financing to develop its products and implement its operating plans. These and other risks are discussed in greater detail in Allogene's filings with the
Caution should be exercised regarding statements comparing autologous CAR T data. There are differences in the clinical trial design, patient populations, published data, follow-up times and the product candidates themselves, and the results from the clinical trials of autologous products may have no interpretative value on Allogene's existing or future results.
AlloCAR T and Alloy are trademarks of
Allogene's AlloCAR T programs utilize the Cellectis TALEN technologies. ALLO-501 and ALLO-501A are anti-CD19 product candidates being jointly developed under a collaboration agreement between
Contact:
Tel: (714) 552-0326
Email: Christine.Cassiano@allogene.com
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