• Phase 1 clin­i­cal trial of off-the-shelf (allogeneic) anti-BCMA CAR T ther­apy can­di­date for patients with re­lapsed / re­frac­tory mul­ti­ple myeloma ex­pec­ted to begin dosing patients in 2020
• PBCAR269A has re­ceived Orphan Drug Desig­na­tion from the FDA for the treat­ment of mul­ti­ple myeloma
• First pro­gram for which clin­i­cal trial ma­teri­al will be gen­er­ated fully in-house at Precision’s Manu­factur­ing Center for Advanced Thera­­peutics (MCAT) in Durham, N.C.

Durham, NC (Press Release) – Precision BioSciences, Inc. (Nasdaq: DTIL), a genome edit­ing com­pany ded­i­cated to im­prov­ing life through the appli­ca­tion of its pioneering, pro­pri­e­tary ARCUS® plat­form, to­day an­nounced that the U.S. Food and Drug Admin­istra­tion (FDA) has ac­cepted its Inves­ti­ga­tional New Drug (IND) appli­ca­tion for PBCAR269A, the Com­pany’s third allo­geneic chi­meric an­ti­gen re­cep­tor (CAR) T cell ther­apy can­di­date. The FDA has also granted Orphan Drug Desig­na­tion to PBCAR269A for the treat­ment of mul­ti­ple myeloma. Wholly-owned by Precision, PBCAR269A is an allo­geneic CAR …

Increasing BCMA Surface Expression with Gamma Secretase Inhibitor Niro­gace­stat May Enable Deep and Durable Responses to ALLO-715, an Inves­ti­ga­tional Anti-BCMA Allogeneic CAR T Therapy

South San Francisco, CA and Stamford, CA (Press Release) – Allogene Thera­peutics, Inc. (Nasdaq: ALLO), a clin­i­cal-stage bio­technol­ogy com­pany pioneering the de­vel­op­ment of allo­geneic chi­meric an­ti­gen re­cep­tor T cell (AlloCAR T™) ther­a­pies for cancer and Spring­Works Thera­peutics, Inc. (Nasdaq: SWTX), a clin­i­cal-stage bio­pharma­ceu­tical com­pany focused on devel­op­ing life-changing med­i­cines for patients with severe rare dis­eases and cancer, to­day an­nounced that they have entered into a clin­i­cal trial col­lab­o­ration agree­ment. This agree­ment will eval­u­ate ALLO-715, Allogene’s inves­ti­ga­tional anti-B-cell maturation an­ti­gen (BCMA) AlloCAR T ther­apy in com­bi­na­tion with Spring­Works’ inves­ti­ga­tional gamma secretase in­hib­i­tor (GSI), niro­gace­stat, …

• The com­pa­nies will con­tinue to col­lab­o­rate to discover and de­vel­op the next gen­er­a­tion of engi­neered alpha-beta T cells
• Editas Medicine to re­ceive a $70 million pay­ment and may be eli­gible for future mile­stone and royalty pay­ments

Cambridge, MA (Press Release) – Editas Medicine, Inc. (Nasdaq: EDIT), a lead­ing genome edit­ing com­pany, to­day an­nounced an amended col­lab­o­ration with Celgene Corpo­ra­tion (Nasdaq: CELG) under which the parties may re­search, de­vel­op, and com­mer­cial­ize au­tol­o­gous and allo­geneic alpha-beta T cell med­i­cines for the treat­ment of cancer and auto­immune dis­eases. Under the terms of the amended agree­ment, Editas Medicine will re­ceive a pay­ment of $70 million.

“Celgene is the leader in ad­vanc­ing inno­va­tive cell med­i­cines to treat blood cancers, and we are ex­cited to …

• Collaboration Includes Exclusive Rights and Targets for Initial Appli­ca­tions in Non-Hodgkin Lymphoma, Leukemia and Multiple Myeloma
• Notch to Receive Upfront Payment, Research Funding and an Equity Investment Plus De­vel­op­ment and Commercial Milestones and Royalties on Net Sales

South San Francisco, CA and Toronto, ON (Press Release) – Allogene Thera­peutics, Inc. (Nasdaq: ALLO), a clin­i­cal-stage bio­technology com­pany pioneering the devel­op­ment of allo­geneic CAR T (AlloCAR T™) ther­a­pies for cancer, and Notch Thera­peutics Inc., an immune cell ther­apy com­pany creating universally compatible, allo­geneic T cell ther­a­pies for the treat­ment of dis­eases of high unmet need, to­day an­nounced an ex­clu­sive world­wide col­lab­o­ration and license agree­ment to re­search and de­vel­op induced pluripotent stem cell (iPSC) AlloCAR™ ther­apy prod­ucts for initial appli­ca­tion in non-Hodgkin lym­phoma, leukemia …

Toronto, ON (Press Release) – Notch Thera­peutics, a com­pany in the emerging field of gene-modified T cell ther­apy, has been created to com­mer­cial­ize a revolutionary tech­nology that creates allo­geneic (donor) gene-edited T cells from stem cells on an industrial scale, efficiently making T cell ther­a­pies that are clin­i­cally robust and of a con­sis­tently high quality. Notch is actively pursuing industry part­ner­ships.

The founders of Notch - Sunnybrook Health Sciences Centre, University of Toronto (UoT), Toronto Innovation Acceleration Partners (TIAP) and CCRM, with Lumira Ventures as an addi­tional in­vestor - created Notch to provide …

Cellectis’ UCARTCS1 MELANI-01 Trial Commenced at MD Anderson Cancer Center

New York, NY (Press Release) – Cellectis (Paris:ALCLS) (NASDAQ:CLLS) (Euronext Growth: ALCLS; Nasdaq: CLLS), a bio­pharma­ceu­tical com­pany focused on devel­op­ing immuno­therapies based on gene-edited off-the-shelf CAR T-cells (UCART), to­day an­nounced the Com­pany has dosed the first patient in its UCARTCS1 clin­i­cal trial, MELANI-01, the first allo­geneic off-the-shelf CAR-T prod­uct can­di­date the U.S. Food and Drug Admin­istra­tion (FDA) has cleared to enter into clin­i­cal devel­op­ment for re­lapsed / re­frac­tory mul­ti­ple myeloma (R/R MM). The UCARTCS1 clin­i­cal trial is a Phase 1 dose-escalation study to eval­u­ate the safety, ex­pan­sion, persistence and clin­i­cal ac­­tiv­ity of UCARTCS1 cells …

• Agreement covers manu­fac­tur­ing of clin­i­cal supply for Cellectis’ UCART pipe­line
• Manufacturing to take place at Lonza’s GMP site in Geleen, Netherlands

Basel, Switzerland and New York, NY (Press Release) – Cellectis (Paris:ALCLS) (NASDAQ:CLLS) (Euronext Growth: ALCLS – Nasdaq: CLLS), a clin­i­cal-stage bio­pharma­ceu­tical com­pany focused on devel­op­ing immuno­therapies based on allo­geneic gene-edited CAR T-cells (UCART), and Lonza (SWX: LONN), an­nounced to­day that the com­pa­nies have entered into a manu­fac­tur­ing service agree­ment covering clin­i­cal manu­fac­tur­ing of Cellectis’ allo­geneic UCART prod­uct can­di­dates targeting hema­to­logical malig­nan­cies. Lonza is in charge of implementing Cellectis’ manu­fac­tur­ing processes as per current Good Manufacturing Practices (cGMP) in a way that meets the highest quality …