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 U.S. Food and Drug Admin­istra­tion (FDA) has lifted the clin­i­cal hold on the Phase 1 MELANI-01 trial eval­u­ating the UCARTCS1 prod­uct can­di­date for the treat­ment of patients with re­lapsed or re­frac­tory mul­ti­ple myeloma (MM).

Cellectis worked closely with the FDA over the past months, to address the agency’s re­quests, which in­clude ad­just­ments to the MELANI-01 clin­i­cal protocol de­signed to en­hance patient safety. …

Adds pro­pri­e­tary next gen­er­a­tion nat­u­ral killer (K-NK) cell plat­form and pipe­line of cell-based can­cer im­mune-therapeutics and infectious dis­ease ther­a­pies

Paris, France and Amsterdam, Netherlands (Press Release) – Sanofi and Kiadis, a clin­i­cal-stage bio­pharma­ceu­tical com­pany devel­op­ing inno­va­tive ‘off the shelf’ nat­u­ral killer (NK) cell based med­i­cines for the treat­ment of life-threatening dis­eases, entered into a definitive agree­ment under which Sanofi will make a pub­lic offer (sub­ject to satisfaction of cer­tain customary con­di­tions) to acquire the entire share capital of Kiadis for EUR 5.45 per share, rep­re­senting an aggregate adjusted equity value of €308m¹.

“We be­lieve the Kiadis ‘off the shelf’ K-NK cell tech­nology plat­form will have broad appli­ca­tion against liquid and solid tumors, …

• Designation will ac­cel­er­ate oNKord®'s mar­ket access for MM
• Together with Clinical Trial Approval for a pivotal phase I-IIa trial in AML, this is another im­por­tant step for­ward in making Glyco­stem's allo­geneic Natural Killer cell-based treat­ment accessible for can­cer patients

Oss, The Netherlands (Press Release) – Glyco­stem Thera­peutics, a lead­ing clin­i­cal-stage com­pany focused on the de­vel­op­ment of thera­peutic off-the-shelf Natural Killer (NK) cells, an­nounces it has re­ceived the FDA's Orphan Drug Desig­na­tion (ODD) for treat­ment of mul­ti­ple myeloma (MM) patients with its inves­ti­ga­tional prod­uct oNKord®. The desig­na­tion will pro­vide Glyco­stem with cer­tain incentives, like eligibility for 7 years of mar­ket exclusivity and clear FDA guidance on spe­cif­ic as­pects of de­vel­op­ment for rare dis­eases. These pave an ac­cel­er­ated path to­wards mar­ket access and treat­ment of patients …

New York, NY and Paris, France (Press Release) – Cytovia Thera­peutics ("Cytovia"), an emerging bio­pharma­ceu­tical com­pany, an­nounces to­day that it has entered a re­search and licensing agree­ment with Inserm to de­vel­op NK engager bi-specific anti­bodies and iPSC CAR NK cell ther­apy targeting CD38, a key marker of mul­ti­ple myeloma. The licensing agree­ment has been negotiated and signed by Inserm Transfert, the private sub­sid­i­ary of Inserm, on behalf of Inserm (the French National In­sti­tute of Health and Medical Re­search) and its academic part­ners. Cytovia is licensing Inserm's CD38 anti­body and Chimeric Antigen Receptor (CAR) …

Increasing BCMA Surface Expression and Reduced Soluble BCMA Levels with Gamma Secretase Inhibitor Niro­gace­stat May Enhance Clinical Benefit in Com­bi­na­tion with PBCAR269A, an Allogeneic BCMA-Targeted CAR T Cell Product

Durham, NC and Stamford, CT (Press Release) – Pre­ci­sion BioSciences, Inc. (Nasdaq: DTIL), a clin­i­cal stage bio­technol­ogy devel­op­ing allo­geneic CAR T and in vivo gene correction ther­a­pies with its ARCUS® genome edit­ing plat­form, and Spring­Works Thera­peutics, Inc. (Nasdaq: SWTX), a clin­i­cal-stage bio­pharma­ceu­tical com­pany focused on devel­op­ing life-changing med­i­cines for patients with severe rare dis­eases and can­cer, to­day an­nounced they have entered into a clin­i­cal trial col­lab­o­ration agree­ment. Per the agree­ment, PBCAR269A, Pre­ci­sion BioSciences’ wholly-owned inves­ti­ga­tional allo­geneic chi­meric an­ti­gen re­cep­tor (CAR) T cell ther­apy can­di­date targeting B-cell maturation an­ti­gen (BCMA), will be eval­u­ated in com­bi­na­tion …

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 the U.S. Food and Drug Admin­istra­tion (FDA) has granted Fast Track Desig­na­tion to PBCAR269A for the treat­ment of re­lapsed / re­frac­tory mul­ti­ple myeloma. This is the com­pany’s sec­ond allo­geneic chi­meric an­ti­gen re­cep­tor (CAR T) cell ther­apy to re­ceive Fast Tack Desig­na­tion for which the FDA pre­vi­ously granted Orphan Drug Desig­na­tion.

“Fast Track Desig­na­tion will help us expedite our allo­geneic CAR T cell ther­apy pro­gram …

• Human trials begin to­day in California using Celularity's CYNK-001 inves­ti­ga­tional immuno­therapy as part of a national clin­i­cal trial that will en­roll approx­i­mately 86 adults who tested COVID-19 pos­i­tive
• CYNK-001 is the only cryo­pre­served allo­geneic, off-the-shelf NK cell ther­apy devel­oped from pla­cen­tal hema­to­poietic stem cells.

Warren, NJ (Press Release) – Celularity an­nounced to­day that the first patient was dosed in a Phase I/II study of human pla­cen­tal hema­to­poietic stem cell derived NK cells (CYNK-001) for the treat­ment of adults with COVID-19 as part of a national clin­i­cal trial. The patient was treated at UC Irvine in California, the first CA site to open for patient en­roll­ment with sup­port from a COVID-19 Project grant awarded to Celularity by the California In­sti­tute for Regenerative Medicine (CIRM). Par­tic­i­pat­ing trial sites in­clude …