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 …

Kite and Teneobio will Collaborate on Next-Generation Dual-Targeting CAR T Therapies in Multiple Myeloma Utilizing UniAb® Antibodies

Santa Monica, CA and Newark, CA (Press Release) – Kite, a Gilead Com­pany (Nasdaq: GILD), and Teneobio, Inc. announced the com­pa­nies have entered into a license and col­lab­o­ration agree­ment through which Kite will re­ceive ex­clu­sive rights to cer­tain anti­bodies directed to B-cell maturation an­ti­gen (BCMA). The fully human variable heavy chain of one such anti­body is cur­rent undergoing clin­i­cal evaluation in a chi­meric an­ti­gen re­cep­tor (CAR) format for the treat­ment of patients with multiple myeloma in a Phase 1 clin­i­cal trial at the National Cancer Institute. Kite and Teneobio will also col­lab­o­rate on …

BLA sub­mission in­cludes results from pivotal Phase 2 KarMMa study eval­u­ating ide-cel in a heavily pre-treated patient pop­u­la­tion with re­lapsed and re­frac­tory mul­ti­ple myeloma

Princeton, NJ and Cambridge, MA (Press Release) – Bristol Myers Squibb (NYSE: BMY) and bluebird bio, Inc. (Nasdaq: BLUE) to­day an­nounced the sub­mission of their Biologics License Appli­ca­tion (BLA) to the U.S. Food and Drug Admin­istra­tion (FDA) for idecabtagene vicleucel (ide-cel; bb2121), the com­pa­nies’ lead inves­ti­ga­tional B-cell maturation an­ti­gen (BCMA)-directed chi­meric an­ti­gen re­cep­tor (CAR) T cell immuno­therapy, for the treat­ment of adult patients with mul­ti­ple myeloma who have re­ceived at least three prior ther­a­pies, in­clud­ing an immuno­modu­la­tory agent, a pro­te­a­some in­hib­i­tor and an anti-CD38 anti­body.

The sub­mission is based on results from …

• Positive CHMP opinion based on data from ICARIA-MM, the first ran­dom­ized Phase 3 trial to eval­u­ate an anti-CD38 in com­bi­na­tion with pom-dex
• Sarclisa in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone (pom-dex) sig­nif­i­cantly reduced the risk of dis­ease pro­gres­sion or death in adults by 40% com­pared to pom-dex alone in the trial
• Sarclisa was approved by the FDA on March 2 in com­bi­na­tion with pom-dex for the treat­ment of cer­tain adults with RRMM
• Multiple myeloma remains an incurable cancer asso­ci­ated with sig­nif­i­cant patient burden and need for addi­tional treat­ments

Paris, France (Press Release) – The European Medicines Agency’s Com­mit­tee for Medicinal Products for Human Use (CHMP) has adopted a pos­i­tive opinion for Sarclisa® (isatuximab). The CHMP rec­om­mends Sarclisa in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone (pom-dex) for the treat­ment of adult patients with re­lapsed and re­frac­tory multiple myeloma (MM) who have re­ceived at least two prior ther­a­pies in­clud­ing lena­lido­mide and a pro­te­a­some in­hib­i­tor and have dem­onstrated dis­ease pro­gres­sion on the last ther­apy.

The European Com­mis­sion …

Stockholm, Sweden (Press Release) – Oncopeptides AB (Nasdaq Stock­holm: ONCO) an­nounces to­day the final top­line re­­sults from the pivotal phase 2 HORIZON study eval­u­ating mel­flu­fen in re­lapsed re­frac­tory mul­ti­ple myeloma (RRMM) patients. These re­­sults will form the basis for the up­com­ing NDA for ac­cel­er­ated ap­­prov­al in the US. The appli­ca­tion is on track for a sub­mission to the FDA at the end of Q2 2020. Oncopeptides will host a webcast to­day to provide an up­date on the final study re­­sults at 14.00 (CET).

The final HORIZON re­­sults rep­re­sent an Over­all Re­sponse Rate (ORR) …

Stamford, CT (Press Release) – Spring­Works Thera­peutics, Inc. (Nasdaq: SWTX) announced today that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 10,590,087 (the ‘087 patent), directed to niro­gace­stat, the Com­pany’s lead prod­uct can­di­date in devel­op­ment for patients with desmoid tumors and as a com­bi­na­tion ther­apy for patients with multiple myeloma. The ‘087 patent, assigned to Pfizer, Inc., expires in 2039. The ‘087 patent is a composition of matter patent that covers the polymorphic form of niro­gace­stat that is cur­rently in clin­i­cal devel­op­ment. Spring­Works has ex­clu­sive rights to the …

Phase 1 trial in re­lapsed and re­frac­tory mul­ti­ple myeloma con­tinues to en­roll patients

Gaithersburg, MD (Press Release) – Arcellx, a clin­i­cal-stage bio­pharma­ceu­tical com­pany devoted to devel­op­ing immune cell ther­a­pies for cancer and other dis­eases, to­day an­nounced that the U.S. Food and Drug Admin­istra­tion (FDA) has granted Orphan Drug Desig­na­tion to CART-ddBCMA, its engi­neered T cell ther­apy uti­liz­ing a novel binding domain, for the treat­ment of patients with mul­ti­ple myeloma. Arcellx con­tinues to en­roll patients in its Phase 1 trial of CART-ddBCMA ther­apy for the treat­ment of re­lapsed and re­frac­tory mul­ti­ple myeloma, the first in a series of clin­i­cal trials planned for the stepwise devel­op­ment of …