Synergistic Potential of Kleo’s Anti­body Recruiting Molecule (ARM™) and Celularity’s Placental-Derived NK Cells to Be Evaluated in the Context of COVID-19 and Multiple Myeloma

New Haven, CT (Press Release) – Kleo Pharma­ceu­ticals, Inc., a lead­ing com­pany in the field of devel­op­ing next-gener­a­tion, fully syn­thet­ic bispecific com­pounds de­signed to emulate or en­hance the ac­­tiv­ity of bio­log­ics, and Celularity, Inc., a lead­ing de­vel­oper of allo­geneic, or “off-the-shelf”, natural killer (NK) cell ther­a­pies, to­day an­nounced a pre­clin­i­cal re­search col­lab­o­ration to rapidly ad­vance syn­­er­gis­tic com­bi­na­tions of each com­pany’s tech­nology plat­form as poten­tial treat­ments for COVID-19 and mul­ti­ple myeloma.

The col­lab­o­ration comes at an opportune time for both com­pa­nies. Earlier this year, Kleo re­ceived IND authori­za­tion from the U.S. Food and Drug Admin­istra­tion (FDA) …

• Phase 1 Clinical Study to Evaluate Multiple Doses of FT538 as Monotherapy for Acute Myeloid Leukemia and in Com­bi­na­tion with Anti-CD38 Monoclonal Anti­body Therapy for Multiple Myeloma
• Off-the-shelf NK Cell Product Candidate Derived from Clonal Master iPSC Line Engineered with Three Functional Components to Enhance Innate Immunity

San Diego, CA (Press Release) – Fate Thera­peutics, Inc. (NASDAQ: FATE), a clin­i­cal-stage bio­pharma­ceu­tical com­pany ded­i­cated to the de­vel­op­ment of pro­grammed cellular immuno­therapies for cancer and immune disorders, an­nounced to­day that the U.S. Food and Drug Admin­istra­tion (FDA) has cleared the Com­pany’s Inves­ti­ga­tional New Drug (IND) appli­ca­tion for FT538, the first CRISPR-edited, iPSC-derived cell ther­apy. FT538 is an off-the-shelf natural killer (NK) cell cancer immuno­therapy that is derived from a clonal master induced pluripotent stem cell (iPSC) line engi­neered with three functional components …

CYNK-001, the com­pany's allo­geneic, off-the-shelf, cryo­pre­served Natural Killer cell ther­apy to be used in Phase I/II study

Warren, NJ (Press Release) – Celularity Inc. ("Celularity" or the "Com­pany"), a clin­i­cal-stage com­pany devel­op­ing allo­geneic cel­lu­lar ther­a­pies from human pla­cen­tas, to­day an­nounced the U.S. Food and Drug Admin­istra­tion (FDA) has cleared the Com­pany's Inves­ti­ga­tional New Drug (IND) appli­ca­tion for the use of its pro­pri­e­tary CYNK-001 in adults with COVID-19. With this, Celularity will com­mence a Phase I/II clin­i­cal study in­clud­ing up to 86 patients with COVID-19. The Com­pany be­lieves CYNK-001 is the first immuno­therapy IND cleared by the FDA to treat COVID-19 infected adults.

"This IND rep­re­sents a sig­nif­i­cant step to­ward a po­ten­tial …

• Ongoing Phase 1/2a Study of CD19 CAR-NK with Pivotal Study Expected to Enroll Patients in 2021
• Potential to be the First CAR Cell Therapy Approved for Outpatient Admin­istra­tion

Houston, TX and Osaka, Japan (Press Release) – The University of Texas MD Anderson Cancer Center and Takeda Pharma­ceu­tical Com­pany Limited (TSE:4502/NYSE:TAK) (“Takeda”) to­day an­nounced an ex­clu­sive license agree­ment and re­search agree­ment to de­vel­op cord blood-derived chi­meric an­ti­gen re­cep­tor-directed natural killer (CAR NK)-cell ther­a­pies, ‘armored’ with IL-15, for the treat­ment of B-cell malig­nan­cies and other cancers.

Under the agree­ment, Takeda will re­ceive access to MD Anderson’s CAR NK plat­form and the ex­clu­sive rights to de­vel­op and com­mer­cial­ize up to four pro­grams, in­clud­ing a CD19-targeted …

• 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 …

Initially Launching a Novel, High-Affinity BCMA CAR Targeting NK Cell De­vel­op­ment Candidate for Multiple Myeloma, with an Option for up to Five Additional CAR Targeting Sequences

San Diego, CA (Press Release) – NantKwest, Inc. (Nasdaq:NK), a leading clin­i­cal-stage Natural Killer (NK) cell based thera­peutics com­pany, and ProMab Biotech­nol­ogies to­day an­nounced the estab­lish­ment of a world­wide license to a B-Cell Maturation Antigen (BCMA) targeted anti­body sequence for mul­ti­ple myeloma along with an op­tion for up to five undisclosed targeting sequences for ex­clu­sive use in the devel­op­ment of chi­meric an­ti­gen re­cep­tor (CAR) based NK cell ther­a­pies.

“We are pleased to an­nounce this col­lab­o­ration with ProMab Biotech­nol­ogies, marking another mile­stone for NantKwest in the devel­op­ment of targeted, next gen­er­a­tion, NK cell thera­peutics …

• FT516 off-the-shelf NK cell cancer immuno­therapy cleared for clin­i­cal in­ves­ti­ga­tion by FDA
• Product can­di­date derived from clonal master iPSC line engi­neered with novel CD16 Fc re­cep­tor
• Clinical trial to eval­u­ate multi-dose cycles of FT516 for treat­ment of hema­to­logic malig­nancies, in­clud­ing in combi­nation with targeted anti­body ther­apy

San Diego, CA (Press Release) – Fate Thera­peutics, Inc. (NASDAQ: FATE), a clin­i­cal-stage bio­pharma­ceu­tical com­pany ded­i­cated to the devel­op­ment of pro­grammed cellular immuno­therapies for cancer and immune disorders, an­nounced to­day that the U.S. Food and Drug Admin­istra­tion (FDA) has allowed its Inves­ti­ga­tional New Drug (IND) appli­ca­tion for FT516, the Com­pany’s off-the-shelf natural killer (NK) cell prod­uct can­di­date derived from a clonal master induced pluripotent stem cell (iPSC) line engi­neered to express a novel CD16 Fc re­cep­tor. FT516 is the first-ever cell …