Stamford, CT (Press Release) – Spring­Works Thera­peutics, Inc., 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 GlaxoSmithKline to eval­u­ate Spring­Works Thera­peutics’ inves­ti­ga­tional gamma secretase in­hib­i­tor (GSI), niro­gace­stat, in com­bi­na­tion with GlaxoSmithKline’s inves­ti­ga­tional anti-B-cell maturation an­ti­gen (BCMA) anti­body-drug con­ju­gate (ADC), be­lan­ta­mab mafo­dotin (formerly GSK2857916), in patients with re­lapsed or re­frac­tory mul­ti­ple myeloma.

Gamma secretase is an enzyme that cleaves mul­ti­ple transmembrane pro­teins, in­clud­ing BCMA. As evi­denced in pub­li­ca­tions and pre­clin­i­cal ex­per­i­ments, …

Shanghai, China (Press Release) – CARsgen Therapeutics, a clin­i­cal-stage com­pany committed to devel­op­ing Chimeric Antigen Receptor T cell ther­a­pies for cancer, today announced that one of its leading drug can­di­dates, CT053 fully human BCMA (B-Cell Maturation Antigen)-CAR-T cell for the treat­ment of patients suffering from re­lapsed / refractory multiple myeloma (rrMM), has received Inves­ti­ga­tional New Drug (IND) clearance from the United States Food and Drug Admin­istra­tion (FDA). CT053 has also received IND clearance from the National Medical Products Admin­istra­tion in China four months ago and is the subject of an ongoing phase I clin­i­cal …

Stockholm, Sweden (Press Release) – Oncopeptides AB (Nasdaq Stock­holm: ONCO) an­nounced to­day that, after dis­cus­sions with the FDA, the com­pany has ini­ti­ated the preparation for submitting a New Drug Appli­ca­tion (NDA) for ac­cel­er­ated ap­­prov­al of mel­flu­fen for the treat­ment of patients with triple-class re­frac­tory mul­ti­ple myeloma. The com­pany targets to submit the appli­ca­tion in the first quarter of 2020.

During the spring, Oncopeptides has been engaged in dialogue with the FDA to explore whether mel­flu­fen could be eli­gible for ac­cel­er­ated ap­­prov­al based on the promising data gen­er­ated in the on­go­ing phase 2 HORIZON …

Designation could ac­cel­er­ate CLR 131 devel­op­ment and underscores the need for new treat­ments

Florham Park, NJ (Press Release) – Cellectar Biosciences, Inc. (NASDAQ: CLRB), a clin­i­cal-stage bio­pharma­ceu­tical com­pany focused on the discovery, devel­op­ment and com­mer­cial­iza­tion of drugs for the treat­ment of cancer, to­day an­nounced that the U.S. Food and Drug Admin­istra­tion (FDA) has granted Fast Track Desig­na­tion for CLR 131 in fourth line or later re­lapsed / re­frac­tory mul­ti­ple myeloma. CLR 131 is the com­pany’s small-molecule radiotherapeutic phos­pho­lipid drug con­ju­gate (PDC™) de­signed to de­liver cytotoxic radi­a­tion directly and sel­ectively to cancer cells and cancer stem cells. It is cur­rently being eval­u­ated in Cellectar’s on­go­ing CLOVER-1 …

Shanghai, China and Munich, Germany (Press Release) – I-Mab Bio­pharma (I-Mab), a China-based clin­i­cal stage bio­pharma­ceu­tical com­pany ex­clu­sively focused on the devel­op­ment of inno­va­tive biologics in immuno-oncology and auto­immune dis­eases, and MorphoSys AG (FSE: MOR; Prime Standard Segment, MDAX & TecDAX;NASDAQ: MOR), an­nounced to­day that the first patient has been dosed in a phase 3 ran­dom­ized and multi-center clin­i­cal study in Taiwan to eval­u­ate MorphoSys's inves­ti­ga­tional human CD38 anti­body TJ202 / MOR202 in com­bi­na­tion with lena­lido­mide in patients with re­lapsed or re­frac­tory multiple myeloma. I-Mab has the ex­clu­sive rights for devel­op­ment and com­mer­cial­iza­tion of TJ202 / …

Stockholm, Sweden (Press Release) – Oncopeptides AB (Nasdaq Stock­holm: ONCO) an­nounces to­day that the com­pany will provide an up­date on patient recruitment in the on­go­ing phase 3 study OCEAN, as well as a general up­date from all the com­pany's clin­i­cal stud­ies in a webcast at 10.00am (CET) to­day.

Conference call for in­­vestors, analysts and the media, Wednesday, 24 April 2019, at 10 am (CET).

CEO Jakob Lindberg will provide an overview of on­go­ing clin­i­cal stud­ies and ac­­tiv­i­ties in con­nec­tion with these.

Phone num­bers for par­tic­i­pants from:

Sweden: +46850558357
Europe: +443333009030
USA: …

PRIME (PRIority MEdicines) desig­na­tion based on clin­i­cal study re­­sults eval­u­ating safety and ef­fi­cacy of novel CAR-T ther­apy in the treat­ment of patients with ad­vanced re­lapsed or re­frac­tory mul­ti­ple myeloma

Beerse, Belgium (Press Release) - The Janssen Pharma­ceu­tical Com­panies of John­son & John­son to­day an­nounced that the Euro­pean Medicines Agency (EMA) has granted a PRIME (PRIority MEdicines) desig­na­tion for the com­pany’s inves­ti­ga­tional B-cell maturation an­ti­gen (BCMA) chi­meric an­ti­gen re­cep­tor T-cell (CAR-T) ther­apy, JNJ-68284528 (JNJ-4528). PRIME offers en­hanced inter­action and early dialogue to optimise devel­op­ment plans and speed up evaluation of cutting-edge, scientific ad­vances that target a high unmet med­i­cal need.¹

“The PRIME desig­na­tion of this novel BCMA CAR-T ther­apy highlights the value of regu­la­tory inno­va­tion in the Euro­pean Union,” said Sjaak Bot, …