San Diego, CA (Press Release) – Poseida Therapeutics Inc., a clin­i­cal-stage bio­pharma­ceu­tical com­pany leveraging pro­pri­e­tary non-viral gene engi­neer­ing tech­nolo­gies to create life-saving thera­peutics, today announced the United States Food and Drug Admin­istra­tion (FDA) has granted orphan drug desig­na­tion to P-BCMA-101 for the treat­ment of re­lapsed and/or refractory multiple myeloma. P-BCMA-101 is an au­tol­o­gous CAR-T ther­apy devel­oped using Poseida’s piggyBac® plat­form tech­nology. P-BCMA-101 is com­prised of a high per­cent­age of long-lived, self-renewing stem cell memory T cells targeting cancer cells expressing B-cell maturation an­ti­gen (BCMA).

“FDA orphan desig­na­tion is an im­por­tant regu­la­tory mile­stone in …

New York, NY (Press Release) – Mustang Bio, Inc. (“Mustang”) (NASDAQ: MBIO), a clin­i­cal-stage bio­pharma­ceu­tical com­pany focused on translating today’s medical breakthroughs in cell and gene ther­a­pies into poten­tial cures for hema­to­logic cancers, solid tumors and rare genetic diseases, today announced that City of Hope, a world-renowned independent cancer research and treat­ment center, has begun enrolling patients with re­lapsed or treat­ment-resistant multiple myeloma in an inno­va­tive CS1 chi­meric an­ti­gen re­cep­tor (CAR) T cell ther­apy (MB-104) trial.

The Phase 1 clin­i­cal trial is the first au­tol­o­gous CAR T trial to target the CS1 protein, …

The U.S. Food and Drug Admin­istra­tion (FDA) has given the go-ahead for what is likely to be the first clin­i­cal trial of an allo­geneic chi­meric an­ti­gen re­cep­tor (CAR) T-cell ther­apy for mul­ti­ple myeloma.

The poten­tial new myeloma CAR T-cell ther­apy, known as UCARTCS1, is being devel­oped by the French bio­pharma­ceu­tical com­pany Cellectis. The com­pany an­nounced earlier this week that the FDA approved its Investi­ga­tional New Drug (IND) appli­ca­tion for UCARTCS1 in late Jan­u­ary.

The IND ap­prov­al means Cellectis can move for­ward with its plans for MUNDI-01, a Phase 1 dose escalation trial …

PRIME (PRIority MEdicines) desig­na­tion based on clin­i­cal study re­­sults eval­u­ating safety and ef­fi­cacy of novel CAR-T ther­apy in the treat­ment of patients with ad­vanced re­lapsed or re­frac­tory mul­ti­ple myeloma

Beerse, Belgium (Press Release) - The Janssen Pharma­ceu­tical Com­panies of John­son & John­son to­day an­nounced that the Euro­pean Medicines Agency (EMA) has granted a PRIME (PRIority MEdicines) desig­na­tion for the com­pany’s inves­ti­ga­tional B-cell maturation an­ti­gen (BCMA) chi­meric an­ti­gen re­cep­tor T-cell (CAR-T) ther­apy, JNJ-68284528 (JNJ-4528). PRIME offers en­hanced inter­action and early dialogue to optimise devel­op­ment plans and speed up evaluation of cutting-edge, scientific ad­vances that target a high unmet med­i­cal need.¹

“The PRIME desig­na­tion of this novel BCMA CAR-T ther­apy highlights the value of regu­la­tory inno­va­tion in the Euro­pean Union,” said Sjaak Bot, …

Successful manu­fac­tur­ing and re­lease of GMP vials of UCARTCS1

New York, NY (Press Release) – Cellectis (Euronext Growth: ALCLS – Nasdaq: CLLS), a bio­pharma­ceu­tical com­pany focused on devel­op­ing immuno­therapies based on gene-edited CAR T-cells (UCART), an­nounced to­day that the U.S. Food and Drug Admin­istra­tion (FDA) has approved the Com­pany’s Inves­ti­ga­tional New Drug (IND) appli­ca­tion to ini­ti­ate a Phase 1 clin­i­cal trial for UCARTCS1, in patients with mul­ti­ple myeloma (MM). The IND for UCARTCS1 was filed on De­cem­ber 28, 2018 and approved by the FDA within a month, on Jan­u­ary 25, 2019. Cellectis is the sponsor of the UCARTCS1 clin­i­cal study (MUNDI-01) and …

Milan, Italy (Press Release) – MolMed S.p.A. (MLMD.MI), a bio­technology com­pany focused on research, devel­op­ment, pro­duc­tion and clin­i­cal val­i­da­tion of gene and cell ther­a­pies for the treat­ment of cancer and rare diseases, announces to have obtained the authori­za­tion from AIFA to start phase I-II first in man clin­i­cal trials with its own CAR-T CD44v6 for the treat­ment of patients with acute myeloid leukemia (AML) and multiple myeloma (MM). The authori­za­tion from AIFA follows the positive tech­ni­cal opinion expressed by the Italian National Institute of Health – ISS (Istituto Superiore di Sanità) on March …

Shanghai, China (Press Release) – CARsgen Therapeutics, a clin­i­cal-stage com­pany committed to devel­op­ing chi­meric an­ti­gen re­cep­tor T cell ther­a­pies for cancer, today announced that one of its leading drug can­di­dates, CT053 fully human BCMA (B-Cell Maturation Antigen)-CAR-T cell for the treat­ment of patients suffering from re­lapsed / refractory multiple myeloma (rrMM), has received Inves­ti­ga­tional New Drug (IND) clearance from the National Medical Products Admin­istra­tion (NMPA).

"At the American Society of Hematology meeting in December 2018, our col­lab­o­rator, Dr. Songfu Jiang presented en­cour­ag­ing safety and efficacy data in patients with rrMM who received CT053 …