London, United Kingdom (Press Release) – GlaxoSmithKline plc (LSE/NYSE: GSK) to­day an­nounced the US Food and Drug Admin­istra­tion (FDA) will convene a meeting of the Oncologic Drugs Advisory Com­mit­tee (ODAC) to re­view data sup­port­ing the com­pany’s Biologics License Appli­ca­tion (BLA) for be­lan­ta­mab mafo­dotin for the poten­tial treat­ment of 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. The ODAC will meet virtually on 14 July 2020.

Dr Axel Hoos, Senior Vice Pres­i­dent and Head of Oncology …

Despite stress and setbacks, and a lot more ex­pense than we had ex­pected, I am in my new home in Julian, California, a small mountain com­munity famous for its apples and daffodils. My wonderful mate Kaitlin has gone back to Tucson to prepare our house for sale, but our old dog, Gus, is keeping me com­pany as I sit and read in front of the wood-burning stove.

Our manu­fac­tured home, turned into an amazing refuge by Kaitlin, is on a hillside, and uphill gets to me pretty quick, but I walk …

• 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 …

• 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 …

Applications based on pos­i­tive results from pivotal KarMMa study in re­lapsed and re­frac­tory mul­ti­ple myeloma and QUAZAR®-AML-001 study in acute myeloid leukemia

Princeton, NJ (Press Release) – Bristol Myers Squibb (NYSE: BMY) to­day an­nounced that the Euro­pean Medicines Agency (EMA) has val­i­dated its Marketing Authori­za­tion Appli­ca­tions (MAA) for both idecabtagene vicleucel (ide-cel, bb2121) and CC-486. Validation of each appli­ca­tion con­firms the re­spec­tive sub­missions are com­plete and begins the EMA’s centralized review process.

The MAA for ide-cel, the com­pany’s inves­ti­ga­tional B-cell maturation an­ti­gen (BCMA)-directed chi­meric an­ti­gen re­cep­tor (CAR) T cell immuno­therapy co-developed with bluebird bio, Inc., is for the treat­ment of adult patients with mul­ti­ple myeloma who have re­ceived at least three prior ther­a­pies, in­clud­ing an immuno­modu­la­tory …

Stockholm, Sweden (Press Release) – Oncopeptides AB (Nasdaq Stock­holm: ONCO) an­nounces a suc­cess­ful com­ple­tion of en­roll­ment in the pivotal phase 3 study OCEAN for the treat­ment of re­lapsed re­frac­tory mul­ti­ple myeloma. The study in­cludes 450 patients from more than 100 hos­pi­tals around the world. Top line re­­sults are ex­pected to be pre­sented later this year.

OCEAN is a ran­dom­ized, comparative study be­tween mel­flu­fen and poma­lido­mide in patients with re­lapsed re­frac­tory mul­ti­ple myeloma (RRMM). The patients have been treated with immuno­modu­la­tory in­hib­i­tors (IMiD) and pro­te­a­some in­hib­i­tors (PI), they have devel­oped re­sis­tance to their last …