• 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 and mul­ti­ple myeloma. Under the part­ner­ship, Allogene and Notch will create allo­geneic cell ther­apy can­di­dates from T cells or natural killer (NK) cells using Notch’s Engineered Thymic Niche (ETN) plat­form.

Notch was estab­lish­ed in 2018 by Juan Carlos Zúñiga-Pflücker, Ph.D. and Peter Zandstra, Ph.D., recog­nized pioneers in iPSC and T cell dif­fer­en­tiation tech­nology. Notch is devel­op­ing a next-gener­a­tion ap­proach to dif­fer­en­tiating mature immune cells from iPSCs. The Notch ETN tech­nology plat­form offers poten­tial flexibility and scalability for the pro­duc­tion of stem cell-derived immune cell ther­a­pies. iPSCs may provide renewable starting ma­teri­al for AlloCAR T ther­a­pies that could allow for im­proved efficiency of gene edit­ing, greater scalability of supply, prod­uct homogeneity and more streamlined manu­fac­tur­ing.

“This col­lab­o­ration exemplifies Allogene’s long-term com­mitment to ad­vanc­ing the field of cancer treat­ment as we con­tinue to ex­pand and progress our inno­va­tive pipe­line of off-the-shelf AlloCAR can­di­dates,” said David Chang, M.D., Ph.D., Pres­i­dent, CEO and Co-Founder of Allogene Thera­peutics. “The scientific founders of Notch Thera­peutics are among the most respected experts in the field of stem cell biology and its appli­ca­tions to generating T cells and other functional immune cells. We are confident that their tech­nology and ex­per­tise, com­bined with Allogene’s leadership in AlloCAR ther­a­pies, has the poten­tial to unlock future gen­er­a­tions of cell ther­apy treat­ments for patients.”

“Renewable-source, off-the-shelf cell ther­a­pies that may pro­duce cells with greater consistency and at industrial scale have long been the dream for people work­ing in this field,” said Ulrik Nielsen, Ph.D., Executive Chairman of Notch. “We are delighted to spring into the re­search col­lab­o­ration for iPSC-based AlloCAR ther­a­pies with Allogene, a leader in the allo­geneic CAR T field, with the goal of ex­panding op­tions for patients.”

Under the terms of the agree­ment, Notch will be responsible for pre­clin­i­cal re­search of next-gener­a­tion iPSC AlloCAR T™ cells. Allogene will clin­i­cally de­vel­op the prod­uct can­di­dates and holds ex­clu­sive world­wide rights to com­mer­cial­ize re­sult­ing prod­ucts. Allogene will provide to Notch an up­front pay­ment of $10 million. Notch will be eli­gible to re­ceive up to $7.25 million upon achieving cer­tain agreed re­search mile­stones, up to $4.0 million per ex­clu­sive target upon achieving cer­tain pre-clinical devel­op­ment mile­stones, and up to $283 million per ex­clu­sive target and cell type upon achieving cer­tain clin­i­cal, regu­la­tory and com­mer­cial mile­stones as well as tiered royalties on net sales in the mid to high single digits. In addi­tion to this col­lab­o­ration and license agree­ment, Allogene has acquired a 25 per­cent equity position in Notch and will assume a seat on Notch’s Board of Directors.

“Master cell banks of ge­net­ic­ally modified, induced pluripotent stem cells could provide an in­ex­haust­ible source of cell ther­a­pies that may im­prove out­comes and ex­pand applicability to new areas,” said Notch Co-Founder Juan Carlos Zúñiga-Pflücker, Ph.D., a senior scientist at Sunnybrook Research Institute and a Pro­fessor and Chair of the Department of Immunology at the University of Toronto.

“This work with Allogene may also pave the way for addi­tional off-the-shelf cell thera­peutics that are custom-designed to treat other immunity-related dis­eases such as infectious dis­eases, auto­immune dis­eases and aging,” said Notch Co-Founder and Chief Scientific Officer Peter Zandstra, Ph.D., a Pro­fessor at the University of British Columbia and University of Toronto.

About Notch Thera­peutics (www.notchtx.com)

Notch is an immune cell ther­apy com­pany creating universally compatible, allo­geneic (off-the-shelf) T cell ther­a­pies for the treat­ment of dis­eases of high unmet med­i­cal need. Notch’s tech­nology plat­form uses ge­net­ic­ally tailored stem cells as a renewable source for creating allo­geneic T cell ther­a­pies that ex­pand treat­ment op­tions and de­liver safer, con­sis­tently manu­fac­tured and more cost-effective cell immuno­therapies to patients. At the core of Notch’s tech­nology is the syn­thet­ic Engineered Thymic Niche (ETN) plat­form, which drives the ex­pan­sion and dif­fer­en­tiation of stem cells in scalable, fully defined, feeder-free and serum-free cul­tures into T cells that can be ge­net­ic­ally tailored for any T cell-based immuno­therapeutic appli­ca­tion. This tech­nology was invented in the laboratories of Juan-Carlos Zúñiga-Pflücker, Ph.D. at Sunnybrook Research Institute and Peter Zandstra, Ph.D., FRSC at the University of Toronto. Notch was founded by these two in­sti­tu­tions, in conjunction with MaRS Innovation (now Toronto Innovation Acceleration Partners) and the Center for Commercialization of Regenerative Medicine (CCRM) in Toronto.

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 progress the re­search col­lab­o­ration, Notch’s ability to de­vel­op a next-gener­a­tion ap­proach to dif­fer­en­tiating mature immune cells from iPSCs, the ability to de­vel­op and manu­fac­ture new ther­a­pies from Notch tech­nology, and the poten­tial benefits of Notch tech­nology 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 June 30, 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.

Source: Allogene Thera­peutics and Notch Thera­peutics.