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- CRISPR-based CAR-T cell therapy candidates targeting CD19+, BCMA and CD70 demonstrate high editing rates, and potent anti-tumor activity in preclinical models -
- Expanding applicability of CRISPR-based CAR-T therapy to solid tumors -
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“We are making rapid progress on our portfolio of CRISPR-based allogeneic CAR-T programs. Today at the SITC Annual Meeting, scientists from CRISPR presented encouraging data from our CD19 Allogeneic CAR-T development program including in vitro and in vivo data demonstrating potent anti-tumor activity. Based on these data, we have initiated manufacturing and other pre-clinical activities and expect to file an IND for this program in late 2018,” said
“We believe that the precision and efficiency of multiplexed editing with CRISPR/Cas9 will allow us to access the full potential of immune cell therapy in solid tumors and off-the-shelf products,” commented
CRISPR believes that its CAR-T cells therapies may have distinct advantages over the current generation of autologous cell therapies including better access due to its “off-the-shelf” nature, and greater efficacy and safety due to the homogeneity and consistency of the product.
These data were presented during the
About CRISPR-based allogeneic CAR-T programs
The lead program in CRISPR’s immuno-oncology portfolio, CTX101, is an allogeneic CD19 CAR-T product that has several potential advantages over other approaches in the clinic due to the unique capabilities of the CRISPR/Cas9 system to achieve efficient and specific multiplexed editing. First, the CD19 chimeric antigen receptor, or CAR, is inserted into a specifically chosen locus rather than the random insertion common in current-generation products. Second, the T cell receptor (TCR) is eliminated to enable off-the-shelf use of a single batch of product in many different patients. Finally, the class 1 major histocompatibility complex (MHC I) is eliminated to improve durability of the CAR-T cells in the off-the-shelf setting. CTX101 is based on healthy donor cells that are edited ex vivo using CRISPR/Cas9, a process that the company has optimized and successfully transitioned to a GMP-capable CMO. CRISPR anticipates filing and IND with the US FDA in late 2018 with clinical trials beginning for CTX101 in early 2019.
To supplement its internal programs, the company is continuing to develop collaborations in immuno-oncology, and recently announced a two-year research collaboration and license option agreement with
About
CRISPR Forward-Looking Statement
Certain statements set forth in this press release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the timing of filing of clinical trial applications and INDs and timing of commencement of clinical trials, the intellectual property coverage and positions of the Company, its licensors and third parties, the sufficiency of the Company’s cash resources and the therapeutic value, development, and commercial potential of CRISPR/Cas-9 gene editing technologies and therapies. You are cautioned that forward-looking statements are inherently uncertain. Although the Company believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, the forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual performance and results may differ materially from those projected or suggested in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others: uncertainties regarding the intellectual property protection for our technology and intellectual property belonging to third parties; uncertainties inherent in the initiation and completion of preclinical studies for the Company’s product candidates; availability and timing of results from preclinical studies; whether results from a preclinical trial will be predictive of future results of the future trials; expectations for regulatory approvals to conduct trials or to market products; and those risks and uncertainties described under the heading “Risk Factors” in the Company’s most recent annual report on Form 10-K, and in any other subsequent filings made by the Company with the U.S. Securities and Exchange Commission (
Media Contacts:
WCG on behalf of CRISPR
1 347-658-8290
jpaganelli@wcgworld.com
Investor Contacts:
chris.erdman@crisprtx.com
617.307.7227
Westwicke Partners for CRISPR
339-970-2843
chris.brinzey@westwicke.com