• Phase 3 APOLLO ran­dom­ized study eval­u­ating sub­cu­tane­ous dara­tu­mu­mab in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone versus poma­lido­mide and dexa­meth­a­sone alone in re­lapsed or re­frac­tory mul­ti­ple myeloma met the pri­mary end­point of im­prov­ing pro­gres­sion-free sur­vival
• Janssen in­tends to discuss the data with health author­i­ties for po­ten­tial regu­la­tory sub­missions

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq: GMAB) an­nounced to­day that the Euro­pean Myeloma Network (EMN) in col­lab­o­ration with Janssen Re­search & De­vel­op­ment, LLC (Janssen) re­ported pos­i­tive re­­sults from the Phase 3 APOLLO (MMY3013) study of the sub­cu­tane­ous (SC) for­mu­la­tion of dara­tu­mu­mab in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone (Pd) versus Pd alone as treat­ment for patients with re­lapsed or re­frac­tory mul­ti­ple myeloma who have pre­vi­ously been treated with lena­lido­mide (an immuno­modu­la­tory drug) and a pro­te­a­some in­hib­i­tor (PI). The study met the pri­mary …

• 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 …

Rockville, MD and Beijing, China (Press Release) – CASI Pharma­ceu­ticals, Inc. (Nasdaq: CASI), a U.S. bio­pharma­ceu­tical com­pany focused on devel­op­ing and com­mer­cializing inno­va­tive thera­peutics and pharma­ceu­tical prod­ucts, to­day an­nounced that it sub­mitted a Clinical Trial Appli­ca­tion (CTA) (IND) with the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA) for CID-103, its novel anti-CD38 mono­clonal anti­body for the treat­ment of mul­ti­ple myeloma and other hema­to­logical malig­nan­cies.

Wei-Wu He, Ph.D., CASI's Chairman and Chief Executive Officer, commented, "Submitting this CTA is an im­por­tant step in the clin­i­cal de­vel­op­ment of this promising ther­apy in our …

• New sub­cu­tane­ous, fixed-dose for­mu­la­tion of dara­tu­mu­mab reduces treat­ment time from hours to min­utes, with com­parable ef­fi­cacy and fewer in­fusion-related reac­tions^1,2
• Daratumumab is now the only approved sub­cu­tane­ous CD38-directed anti­body for the treat­ment of these mul­ti­ple myeloma in­di­ca­tions in Europe

Beerse, Belgium (Press Release) – The Janssen Pharma­ceu­tical Com­panies of John­son & John­son an­nounced to­day that the Euro­pean Com­mis­sion (EC) has granted mar­ket­ing authori­sa­tion for DAR­ZA­LEX®▼ (dara­tu­mu­mab) sub­cu­tane­ous (SC) for­mu­la­tion for the treat­ment of adult patients with mul­ti­ple myeloma (MM). Dara­tu­mu­mab SC is admin­istered as a fixed dose, which sig­nif­i­cantly reduces treat­ment time, from hours to approx­i­mately three to five min­utes, when com­pared to dara­tu­mu­mab in­tra­venous (IV) for­mu­la­tion.¹ In addi­tion, only the first dose of dara­tu­mu­mab SC needs to be admin­istered in an en­viron­ment where resuscitation …

• Subcutaneous fixed-dosed for­mu­la­tion of DAR­ZA­LEX® (dara­tu­mu­mab) approved in Europe for the treat­ment of adult patients with mul­ti­ple myeloma
• Approval follows pos­i­tive opinion by Euro­pean Com­mit­tee for Medicinal Products for Human Use (CHMP) in April 2020 and applies to all cur­rent dara­tu­mu­mab in­di­ca­tions in front­line and re­lapsed / re­frac­tory settings
• Approval based on data from Phase III COLUMBA and Phase II PLEIADES stud­ies
• In the stud­ies, the fixed-dose sub­cu­tane­ous for­mu­la­tion reduced treat­ment time from hours to min­utes and dem­onstrated similar ef­fi­cacy and safety with sig­nif­i­cantly fewer in­fusion-related reac­tions com­pared with the in­tra­venous for­mu­la­tion

Copenhagen, Denmark; June 4, 2020 – Genmab A/S (Nasdaq: GMAB) an­nounced to­day that the Euro­pean Com­mis­sion (EC) has granted mar­ket­ing authori­za­tion for the sub­cu­tane­ous (SC) for­mu­la­tion of DAR­ZA­LEX® (dara­tu­mu­mab), for the treat­ment of adult patients with mul­ti­ple myeloma in all cur­rently approved dara­tu­mu­mab in­tra­venous (IV) for­mu­la­tion in­di­ca­tions in front­line and re­lapsed / re­frac­tory settings. The ap­prov­al follows a Positive Opinion by the CHMP of the Euro­pean Medicines Agency (EMA) in April 2020. The SC for­mu­la­tion is …

• EC ap­prov­al based on data from first ran­dom­ized Phase 3 trial (ICARIA-MM) to report results eval­u­ating an anti-CD38 mono­clonal anti­body com­bined with poma­lido­mide and dexa­meth­a­sone (pom-dex)
• Sarclisa in com­bi­na­tion with pom-dex sig­nif­i­cantly reduced the risk of pro­gres­sion or death by 40% versus pom-dex alone
• Multiple myeloma is the sec­ond most common blood cancer, with approx­i­mately 40,000 new cases per year in Europe

Paris, France (Press Release) – The Euro­pean Com­mis­sion (EC) has approved Sarclisa® (isatuximab) 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.

Sarclisa is a mono­clonal anti­body (mAb) that binds to a spe­cif­ic epitope on the CD38 re­cep­tor of MM cells.

“The EC ap­prov­al of …