• PBCAR269A Targets BCMA for the Treatment of Re­lapsed / Re­frac­tory Multiple Myeloma and is the Com­pany’s Third Inves­ti­ga­tional Allogeneic CAR T Candidate Advanced to the Clinic
• PBCAR269A is the First Off-the-Shelf Candidate Produced at In-House Manufacturing Center

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 that the first patient has been dosed in a Phase 1/2a clin­i­cal trial of PBCAR269A, its third allo­geneic chi­meric an­ti­gen re­cep­tor (CAR) T cell ther­apy can­di­date. Wholly-owned by Pre­ci­sion, PBCAR269A targets the B-cell maturation an­ti­gen (BCMA) and is being eval­u­ated for the treat­ment of re­lapsed / re­frac­tory mul­ti­ple myeloma.

“PBCAR269A is our third off-the-shelf CAR T can­di­date to …

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 …

Lund, Sweden (Press Release) – Active Biotech (Nasdaq Stockholm: ACTI) to­day provides a status up­date in the proj­ects fol­low­ing the new direction com­mu­ni­cated in early Feb­ru­ary. This abbre­vi­ated up­date is provided as a midterm replacement of the Capital Markets Day pre­vi­ously an­nounced for May 19, which we now instead are planning to host during Q4 this year subject to the status of Covid-19. Despite the Covid-19 pandemic, most ac­­tiv­i­ties in our proj­ects have proceeded ac­cord­ing to plan and, so far, no proj­ect timelines have been sig­nif­i­cantly affected.

The Phase 1b/2 study with naptumomab …

• 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 …

Stockholm, Sweden (Press Release) – Oncopeptides AB (Nasdaq Stock­holm: ONCO) an­nounces that patients in the OCEAN study stay on treat­ment longer than pre­vi­ously esti­mated. As a con­se­quence, top-line re­­sults are esti­mated for H1 2021 instead of pre­vi­ously com­mu­ni­cated Q4 2020. Patient recruitment in OCEAN will re­main open to ensure that the 339 dis­ease pro­gres­sion events needed to com­plete the study can be reached within a reason­able time­frame.

OCEAN is a ran­dom­ized, comparative study be­tween mel­flu­fen and poma­lido­mide in patients with re­lapsed re­frac­tory mul­ti­ple myeloma (RRMM). The patients en­rolled in the study have pre­vi­ously …