New York, NY (Press Release) – Cytovia Thera­peutics, an emerging bio­pharma­ceu­tical com­pany and the New York Stem Cell Foundation (NYSCF) Re­search in­sti­tute to­day an­nounced the filing of a provisional pat­ent appli­ca­tion with the U.S. Patent & Trade­mark Office (USPTO) for the dif­fer­en­tiation of Natural Killer (NK) cells from induced pluripotent stem cells (iPSCs). The NYSCF Re­search In­sti­tute is a pio­neer and acknowledged leader in stem cell tech­nology, having devel­oped the NYSCF Global Stem Cell Array®, the premier automated robotic plat­form for reprogramming skin or blood into induced pluripotent stem cells (iPSCs) and dif­fer­en­tiating …

• Phase 1 clin­i­cal trial eval­u­ating the off-the-shelf anti-BCMA CAR T can­di­date CYAD-211 for the treat­ment of re­lapsed / re­frac­tory mul­ti­ple myeloma (r/r MM) ex­pected to begin by year-end 2020
• CYAD-211 rep­re­sents the com­pany’s first allo­geneic CAR T clin­i­cal can­di­date using shRNA tech­nology

Mont-Sain-Guibert, Belgium (Press Release) – Celyad Oncology SA (Euronext & Nasdaq: CYAD), a clin­i­cal-stage bio­technol­ogy com­pany focused on the dis­cov­ery and de­vel­op­ment of chi­meric an­ti­gen re­cep­tor T cell (CAR T) ther­a­pies for cancer, to­day an­nounced that the com­pany’s Inves­ti­ga­tional New Drug (IND) appli­ca­tion for CYAD-211, the com­pany’s first-in-class short hairpin RNA (shRNA)-based allo­geneic CAR T can­di­date and sec­ond non-gene edited off-the-shelf pro­gram, is in effect with the U.S. Food and Drug Admin­istra­tion (FDA). The com­pany’s lead allo­geneic can­di­date from its next-gener­a­tion CYAD-200 series, CYAD-211 targets B-cell …

• Combination of Kiadis’ CD38 knock out K-NK cells with Sanofi’s anti-CD38 anti­body Sarclisa® enables optimal tumor cell kill­ing, and offers a po­ten­tial first-in-class treat­ment for patients with mul­ti­ple myeloma
• Kiadis re­ceives €17.5 mil­lion up front pay­ment; po­ten­tial for up to €857.5 mil­lion in pre­clin­i­cal, clin­i­cal, regu­la­tory and com­mer­cial mile­stone pay­ments, and up to double-digit royalties
• Kiadis to hold conference call with in­vestors and analysts at 16:00 CET to­day

Amsterdam, The Netherlands (Press Release) – Kiadis Pharma N.V. (“Kiadis” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clin­i­cal-stage bio­pharma­ceu­tical com­pany devel­op­ing inno­va­tive nat­u­ral killer cell ther­a­pies for patients with life-threatening dis­eases, to­day an­nounces the ex­clu­sive li­cense of Kiadis’ pre­vi­ously undisclosed K-NK004 pro­gram to Sanofi. The agree­ment covers Kiadis’ pro­pri­e­tary CD38 knock out (CD38KO) K-NK thera­peutic for com­bi­na­tion with anti-CD38 mono­clonal anti­bodies, in­clud­ing Sarclisa®, Sanofi’s recently ap­prov­ed ther­apy for patients with mul­ti­ple myeloma. Addi­tionally, Sanofi has ob­tained ex­clu­sive …

New York, NY (Press Release) – Cellectis (Euronext Growth: ALCLS - Nasdaq: CLLS), a bio­pharma­ceu­tical com­pany focused on devel­op­ing immuno­therapies based on gene-edited allo­geneic CAR T-cells (UCART), to­day an­nounced that the MELANI-01 trial has been placed on clin­i­cal hold by the U.S. Food and Drug Admin­istra­tion (FDA).

This clin­i­cal hold which im­pacts one of the three Cellectis prod­uct can­di­dates cur­rently in clin­i­cal stud­ies, was ini­ti­ated fol­low­ing the sub­mission of a safety report re­gard­ing one patient en­rolled in the MELANI-01 study at dose level two (DL2), with re­lapsed and re­frac­tory mul­ti­ple myeloma. This patient, …

• PBCAR269A Targets BCMA for the Treatment of Re­lapsed / Re­frac­tory Multiple Myeloma and is the Com­pany’s Third Inves­ti­ga­tional Allogeneic CAR T Candidate Advanced to the Clinic
• PBCAR269A is the First Off-the-Shelf Candidate Produced at In-House Manufacturing Center

Durham, NC (Press Release) – Pre­ci­sion BioSciences, Inc. (Nasdaq: DTIL), a clin­i­cal stage bio­technol­ogy com­pany ded­i­cated to im­prov­ing life with its novel and pro­pri­e­tary ARCUS® genome edit­ing plat­form, to­day an­nounced that the first patient has been dosed in a Phase 1/2a clin­i­cal trial of PBCAR269A, its third allo­geneic chi­meric an­ti­gen re­cep­tor (CAR) T cell ther­apy can­di­date. Wholly-owned by Pre­ci­sion, PBCAR269A targets the B-cell maturation an­ti­gen (BCMA) and is being eval­u­ated for the treat­ment of re­lapsed / re­frac­tory mul­ti­ple myeloma.

“PBCAR269A is our third off-the-shelf CAR T can­di­date to …

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) …

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 …