• 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 …

The U.S. Food and Drug Admin­istra­tion (FDA) has given the go-ahead for what is likely to be the first clin­i­cal trial of an allo­geneic chi­meric an­ti­gen re­cep­tor (CAR) T-cell ther­apy for mul­ti­ple myeloma.

The poten­tial new myeloma CAR T-cell ther­apy, known as UCARTCS1, is being devel­oped by the French bio­pharma­ceu­tical com­pany Cellectis. The com­pany an­nounced earlier this week that the FDA approved its Investi­ga­tional New Drug (IND) appli­ca­tion for UCARTCS1 in late Jan­u­ary.

The IND ap­prov­al means Cellectis can move for­ward with its plans for MUNDI-01, a Phase 1 dose escalation trial …

Successful manu­fac­tur­ing and re­lease of GMP vials of UCARTCS1

New York, NY (Press Release) – Cellectis (Euronext Growth: ALCLS – Nasdaq: CLLS), a bio­pharma­ceu­tical com­pany focused on devel­op­ing immuno­therapies based on gene-edited CAR T-cells (UCART), an­nounced to­day that the U.S. Food and Drug Admin­istra­tion (FDA) has approved the Com­pany’s Inves­ti­ga­tional New Drug (IND) appli­ca­tion to ini­ti­ate a Phase 1 clin­i­cal trial for UCARTCS1, in patients with mul­ti­ple myeloma (MM). The IND for UCARTCS1 was filed on De­cem­ber 28, 2018 and approved by the FDA within a month, on Jan­u­ary 25, 2019. Cellectis is the sponsor of the UCARTCS1 clin­i­cal study (MUNDI-01) and …