New York, NY (Press Release) – Phosplatin Thera­peutics LLC, a clin­i­cal stage pharma­ceu­tical com­pany focused on on­col­ogy thera­peutics, to­day an­nounced that the United States Patent and Trade­mark Office (USPTO) has issued US Patent No. 10,668,080, entitled: "Phosphaplatin Compounds as Thera­peutics Agents for Treatment of Bone or Blood Cancers." The granted claims are directed to the use of (pyrophosphato)platinum(II) or (pyrophosphato)platinum(IV) complexes, in­clu­sive of the Com­pany's lead com­pound, PT-112, as thera­peutic agents for the treat­ment of bone and blood can­cers, such as mul­ti­ple myeloma, or solid tumor can­cers that metastasize to bone, such as …

Newton, MA (Press Release) – Karyo­pharm Thera­peutics Inc. (Nasdaq:KPTI), an inno­va­tion-driven pharma­ceu­tical com­pany, to­day an­nounced that the U.S. Food and Drug Admin­istra­tion (FDA) has ac­cepted for filing its supple­mental New Drug Appli­ca­tion (sNDA) seek­ing ap­prov­al for XPOVIO^® (seli­nexor), its first-in-class, oral Sel­ective Inhibitor of Nuclear Export (SINE) com­pound, as a new treat­ment for patients with mul­ti­ple myeloma after at least one prior line of ther­apy. Karyo­pharm ex­pects a de­ci­sion from the FDA re­gard­ing this sNDA before the end of the first quarter of 2021.

“This sNDA ac­ceptance brings us one step closer to …

• Recommendation based on re­view of DREAMM clin­i­cal trial pro­gramme, in­clud­ing the pivotal DREAMM-2 study
• If approved, be­lan­ta­mab mafo­dotin will be a first-in-class anti-BCMA ther­apy for the treat­ment of re­lapsed / re­frac­tory mul­ti­ple myeloma

London, United Kingdom (Press Release) – GlaxoSmithKline to­day an­nounced the US Food and Drug Admin­istra­tion (FDA) Oncologic Drugs Advisory Com­mit­tee (ODAC) voted 12-0 in favour of the dem­onstrated ben­e­fit of mono­therapy treat­ment with be­lan­ta­mab mafo­dotin outweighing the risks for patients with re­lapsed or re­frac­tory mul­ti­ple myeloma who have re­ceived at least four prior ther­a­pies in­clud­ing an immuno­modu­la­tory agent, a pro­te­a­some in­hib­i­tor and an anti-CD38 anti­body. Two com­mit­tee members could not par­tic­i­pate in the final vote.

Dr Axel Hoos, Senior Vice Pres­i­dent and Head of …

• 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 …

• First and only anti-CD38 anti­body in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone (pom-dex) to be approved in Canada^1,2
• SARCLISA™ in com­bi­na­tion with pom-dex sig­nif­i­cantly reduced the risk of dis­ease pro­gres­sion or death by 40% com­pared to pom-dex alone in a pivotal trial²
• Multiple myeloma is the third most common blood cancer in Canada³

Mississauga, ON (Press Release) – Sanofi Canada is pleased to an­nounce that Health Canada has approved SARCLISA™ in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone for the treat­ment of adults with re­lapsed and re­frac­tory mul­ti­ple myeloma (RRMM) who have re­ceived at least two prior ther­a­pies in­clud­ing lena­lido­mide and a pro­te­a­some in­hib­i­tor.²

"Immunotherapies like SARCLISA™ leverage the im­mune sys­tem to fight mul­ti­ple myeloma and we're seeing real progress in their ability to help patients. This was not the case over a decade ago," says Dr. …

• 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, …