• ALLO-715 Utilizes Gene-Editing of TRAC and CD52 Loci to Enable Allogeneic CAR T Therapy
• ALLO-715 will be Evaluated in Com­bi­na­tion with ALLO-647, Allogene’s Proprietary anti-CD52 Anti­body as Part of the Lymphodepletion Regimen
• Allogene Plans to Initiate the UNIVERSAL Study for ALLO-715 in Re­lapsed / Re­frac­tory Multiple Myeloma in the Second Half of 2019

South San Francisco, CA (Press Release) – 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 Allogene’s Inves­ti­ga­tional New Drug (IND) appli­ca­tion for ALLO-715 in patients with re­lapsed / re­frac­tory mul­ti­ple myeloma. The Phase 1 portion of the UNIVERSAL study, which will in­clude ALLO-647 as part of the lym­pho­de­ple­tion regi­men, is ex­pec­ted to be ini­ti­ated in the sec­ond half of 2019.

“We are very pleased to have re­ceived clear­ance for our sec­ond IND this year and look for­ward to initiating the UNIVERSAL trial in 2019,” said David Chang, M.D., Ph.D., Pres­i­dent, Chief Executive Officer and Co-Founder of Allogene. “We be­lieve an “off-the-shelf” CAR T cell ther­apy could be game-changing for patients, and we plan to leverage learnings from our ALLO-501 ALPHA trial in non-Hodgkin lym­phoma ini­ti­ated in Q2 2019 to ac­cel­er­ate the devel­op­ment of ALLO-715.”

Multiple myeloma is the sec­ond most common hema­to­logical malig­nan­cy in the United States, with 32,110 new cases and 12,960 deaths esti­mated in 2019.¹

About ALLO-715

ALLO-715, an AlloCAR T ther­apy targeting B-cell maturation an­ti­gen (BCMA), is a poten­tial novel treat­ment for mul­ti­ple myeloma and other BCMA-positive malig­nan­cies. Multiple myeloma is char­ac­ter­ized by ab­nor­mal­i­ties in plasma cells that reproduce un­con­trol­lably in the bone mar­row of people with the dis­ease,² mul­ti­ple myeloma is incurable for most patients, and most patients relapse despite the treat­ments avail­able.³ Pre­clin­i­cal study results for ALLO-715 were pub­lished in the journal Molec­ular Therapy validating the poten­tial for an AlloCAR T to treat mul­ti­ple myeloma and demonstrating the ability for ALLO-715 to sustain potent anti-tumor re­sponses in pre-clinical models. Allogene ex­pec­ts com­ple­tion of site initiation ac­­tiv­i­ties, pro­duc­tion of addi­tional ALLO-715 clin­i­cal supply, and initiation of the UNIVERSAL study in the sec­ond half of 2019.

ALLO-715 uti­lizes the TALEN® gene-editing tech­nology pioneered and owned by Cellectis. Allogene has an ex­clu­sive license to the Cellectis tech­nology for allo­geneic prod­ucts directed at the BCMA target. Allogene holds the global devel­op­ment and com­mer­cial rights for this inves­ti­ga­tional can­di­date.

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 world-class 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 ability to com­plete site initiation ac­­tiv­i­ties, pro­duce addi­tional ALLO-715 clin­i­cal supply and ini­ti­ate the UNIVERSAL study in the sec­ond half of 2019, the ability to de­vel­op addi­tional AlloCAR T ther­a­pies for cancer and the poten­tial benefits of ALLO-715 and AlloCAR T ther­apy. Various factors may cause dif­fer­ences be­tween Allogene’s ex­pec­ta­tions and actual results as discussed in greater detail in Allogene’s filings with the Se­cu­ri­ties and Ex­change Com­mis­sion (SEC), in­clud­ing without lim­i­ta­tion in its Form 10-Q for the quarter ended March 31, 2019. 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.

References

1. U.S. SEER database
2. Multiple myeloma - Genetics Home Reference - NIH. Retrieved from https://ghr.nlm.nih.gov/condition/multiple-myeloma#
3. Sonneveld P, Broijl A. Treatment of re­lapsed and refractory multiple myeloma. Haematologica. 2016;101(4):396-406

Source: Allogene Thera­peutics.