Applications sup­ported by pos­i­tive re­sults from the Phase 3 APOLLO study, which dem­onstrated longer pro­gres­sion-free sur­vival in patients re­ceiv­ing the sub­cu­tane­ous for­mu­la­tion of dara­tu­mu­mab¹

RARITAN, N.J., Nov. 12, 2020 /PRNewswire/ -- The Janssen Pharma­ceu­tical Com­panies of John­son & John­son an­nounced to­day the sub­mission of regu­la­tory appli­ca­tions to the U.S. Food and Drug Admin­istra­tion (FDA) and Euro­pean Medicines Agency (EMA) seek­ing ap­prov­al of the dara­tu­mu­mab sub­cu­tane­ous (SC) for­mu­la­tion, known as DAR­ZA­LEX FASPRO™ (dara­tu­mu­mab and hyal­uron­i­dase-fihj) in the U.S. and as DAR­ZA­LEX® SC in the Euro­pean Union (EU). The appli­ca­tions seek ap­prov­al of the com­bi­na­tion of DAR­ZA­LEX FASPRO™ / DAR­ZA­LEX® SC in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone (D-Pd) for the treat­ment of patients with re­lapsed or re­frac­tory mul­ti­ple …

Stockholm, Sweden (Press Release) – Oncopeptides AB (publ) (Nasdaq Stock­holm: ONCO) to­day an­nounces that the Com­pany has sub­mitted an Inves­ti­ga­tional New Drug (IND) appli­ca­tion to the U.S. Food and Drug Admin­istra­tion (FDA), for OPD5 – a sec­ond drug can­di­date based on the pro­pri­e­tary Peptide Drug Con­ju­gate plat­form (PDC).

Oncopeptides plans to ini­ti­ate clin­i­cal de­vel­op­ment of OPD5 with an open-label phase 1, dose escalation study on safety and tol­er­a­bil­ity of OPD5 as a myeloablative regi­men fol­lowed by au­tol­o­gous stem cell trans­plan­ta­tion in patients with re­lapsed re­frac­tory mul­ti­ple myeloma. The spe­cif­ic for­mu­la­tion enables admin­istra­tion of high …

Stockholm, Sweden (Press Release) – Oncopeptides AB (publ) (Nasdaq Stock­holm: ONCO) to­day an­nounces that the Com­pany has in­formed the Euro­pean Medicines Agency, EMA, about its intention to submit an appli­ca­tion for a con­di­tional mar­ket­ing autho­ri­za­tion of mel­flu­fen (INN mel­phalan flufenamide) in the EU, based on the pivotal phase 2 HORIZON study in re­lapsed re­frac­tory mul­ti­ple myeloma (RRMM).

The de­ci­sion to submit an appli­ca­tion for con­di­tional ap­prov­al has been grounded on an in-depth analysis of the regu­la­tory en­viron­ment and is endorsed by key opinion leaders in the EU. Previously the Com­pany in­tended to await …

With the start of its sec­ond clin­i­cal trial, NexImmune ex­pands de­vel­op­ment of its unique non-genetically engi­neered T cell immuno­therapies across a range of hema­to­logic malig­nan­cies

Gaithersburg, MD (Press Release) – NexImmune, a clin­i­cal-stage bio­technol­ogy com­pany devel­op­ing a port­folio of unique non-genetically-engi­neered T cell im­muno­therapies, an­nounced to­day that it has dosed the first patient in its Phase 1/2 clin­i­cal trial for NEXI-002. NEXI-002 is a patient-derived cel­lu­lar prod­uct that con­tains pop­u­la­tions of nat­u­rally-occurring CD8+ T cells directed against sev­er­al mul­ti­ple myeloma (MM)-specific an­ti­gen targets. It is the sec­ond clin­i­cal prod­uct NexImmune has gen­er­ated with its AIM nanoparticle tech­nology.

“While the pri­mary objective in this trial with NEXI-002 is to dem­onstrate safety and tol­er­a­bil­ity, we also hope to see ini­tial …

Fifth in­dus­try col­lab­o­ration to eval­u­ate niro­gace­stat as a BCMA po­ten­ti­ator across modalities

Stamford, CT (Press Release) – Spring­Works Thera­peutics, Inc. (Nasdaq: SWTX), a clin­i­cal-stage bio­pharma­ceu­tical com­pany focused on devel­op­ing life-changing med­i­cines for patients with severe rare dis­eases and can­cer, to­day an­nounced that the com­pany has entered into a clin­i­cal trial col­lab­o­ration agree­ment with Pfizer Inc. (NYSE: PFE) to eval­u­ate Spring­Works Thera­peutics’ inves­ti­ga­tional gamma se­cre­tase in­hib­i­tor (GSI), niro­gace­stat, in com­bi­na­tion with Pfizer’s anti-B-cell maturation an­ti­gen (BCMA) CD3 bispecific anti­body, PF‐06863135, in patients with re­lapsed or re­frac­tory mul­ti­ple myeloma.

Gamma se­cre­tase in­hib­ition prevents the cleavage and shedding of BCMA from the surface of myeloma cells. In pre­clin­i­cal …

Stockholm, Sweden (Press Release) – Oncopeptides AB (publ) (Nasdaq Stock­holm: ONCO) an­nounced to­day that the open-label Expanded Access Program, sEAPort, for eli­gible U.S. patients, is formally open. Melflufen (INN mel­phalan flufenamide), is cur­rently being eval­u­ated in sev­er­al clin­i­cal stud­ies as a treat­ment for patients with triple-class re­frac­tory mul­ti­ple myeloma. The sEAPort pro­gram is avail­able to adults, age 18 and older, who have re­ceived at least two prior lines of ther­apy and whose mul­ti­ple myeloma is re­frac­tory to at least one pro­te­a­some in­hib­i­tor, one immuno­modu­la­tory drug and one anti-CD38 mono­clonal anti­body, (i.e., triple-class re­frac­tory …

Wilmington, DE (Press Release) – Prelude Thera­peutics Incorporated (Nasdaq: PRLD), a clin­i­cal-stage pre­ci­sion on­col­ogy com­pany, to­day an­nounced that the first patient has been dosed in its first-in-human Phase 1 open-label, multi­center, dose-escalation study of PRT1419 in patients with re­lapsed / re­frac­tory hema­to­logic malig­nan­cies. PRT1419, the Com­pany’s third clin­i­cal can­di­date, is de­signed to be an orally avail­able, potent and sel­ective MCL1 in­hib­i­tor.

The dose escalation portion of the study will be con­ducted across two groups, in­clud­ing in patients with re­lapsed / re­frac­tory high-risk myelo­dys­plastic syn­drome (MDS) and acute myeloid leukemia (AML) (Group A), as well as …