Stockholm, Sweden (Press Release) – XNK Thera­peutics AB ("XNK") to­day an­nounced it has re­ceived Orphan Drug Desig­na­tion (ODD) from the U.S. Food and Drug Admin­istra­tion (FDA) for its lead­ing inves­ti­ga­tional drug can­di­date in the treat­ment of mul­ti­ple myeloma (MM).

Receiving ODD status from the FDA for the treat­ment of mul­ti­ple myeloma is a crit­i­cal next step for the de­vel­op­ment of XNK's lead­ing inves­ti­ga­tional drug can­di­date. XNK has already re­ceived ODD status in the EU.

"Obtaining an ODD by the FDA is a sig­nif­i­cant mile­stone for XNK and our goal of taking the present …

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) …

• 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 …

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 …

• 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 …