Press Releases

[ May 15, 2019 8:30 am ]
  • Results dem­onstrated 50% partial re­sponse rate, 50% minimal re­sponse rate, and 100% dis­ease con­trol rate
  • Independent Data Monitoring Com­mit­tee de­ter­mines dose to be safe and well tol­er­ated and rec­om­mends study con­tinue to Cohort 7

CLR 131 Achieves 50% Overall Response Rate In Cohort 6 Of Ongoing Phase 1 Study In Relapsed Or Refractory Multiple Myeloma 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 initial results from Cohort 6 in the Com­pany’s on­go­ing Phase 1 clin­i­cal study with CLR 131 in Re­lapsed or Re­frac­tory Multiple Myeloma (R/R MM). The 37.5 mCi/m2 frac­tion­ated dose was de­ter­mined to be safe and tol­er­able by the in­de­pen­dent Data Monitoring Com­mit­tee (DMC). Following the deter­mi­na­tion, the Com­pany has ini­ti­ated …

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[ May 13, 2019 8:00 am ]
Poseida Therapeutics Receives US FDA Orphan Drug Designation For P-BCMA-101 For The Treatment Of Multiple Myeloma

San Diego, CA (Press Release) – Poseida Therapeutics Inc., a clin­i­cal-stage bio­pharma­ceu­tical com­pany leveraging pro­pri­e­tary non-viral gene engi­neer­ing tech­nolo­gies to create life-saving thera­peutics, today announced the United States Food and Drug Admin­istra­tion (FDA) has granted orphan drug desig­na­tion to P-BCMA-101 for the treat­ment of re­lapsed and/or refractory multiple myeloma. P-BCMA-101 is an au­tol­o­gous CAR-T ther­apy devel­oped using Poseida’s piggyBac® plat­form tech­nology. P-BCMA-101 is com­prised of a high per­cent­age of long-lived, self-renewing stem cell memory T cells targeting cancer cells expressing B-cell maturation an­ti­gen (BCMA).

“FDA orphan desig­na­tion is an im­por­tant regu­la­tory mile­stone in …

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[ May 13, 2019 8:00 am ]

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

Cellectar Receives FDA Fast Track Designation For CLR 131 In Relapsed Or Refractory Multiple Myeloma 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 …

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[ May 8, 2019 7:30 am ]
Mustang Bio Announces City Of Hope Opens First-Of-Its-Kind Multiple Myeloma CAR T Cell Therapy Trial Targeting CS1 Protein

New York, NY (Press Release) – Mustang Bio, Inc. (“Mustang”) (NASDAQ: MBIO), a clin­i­cal-stage bio­pharma­ceu­tical com­pany focused on translating today’s medical breakthroughs in cell and gene ther­a­pies into poten­tial cures for hema­to­logic cancers, solid tumors and rare genetic diseases, today announced that City of Hope, a world-renowned independent cancer research and treat­ment center, has begun enrolling patients with re­lapsed or treat­ment-resistant multiple myeloma in an inno­va­tive CS1 chi­meric an­ti­gen re­cep­tor (CAR) T cell ther­apy (MB-104) trial.

The Phase 1 clin­i­cal trial is the first au­tol­o­gous CAR T trial to target the CS1 protein, …

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[ Apr 30, 2019 11:36 am ]
I-Mab Biopharma And MorphoSys Announce First Patient Dosed In Phase 3 Clinical Study Of TJ202/MOR202 In Multiple Myeloma

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 / …

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[ Apr 29, 2019 8:00 am ]
Teneobio Announces US FDA Approval Of The Investigational New Drug Application For TNB-383B And The Initiation Of Phase I Clinical Studies In Multiple Myeloma Patients

Newark, CA (Press Release) – Teneobio, Inc. and its affiliate TeneoOne, Inc. announced today that their inves­ti­ga­tional new drug appli­ca­tion (IND) for TNB-383B, a bispecific T-cell engaging anti­body for the treat­ment of multiple myeloma, was cleared for the initiation of Phase I clin­i­cal studies by the US Food and Drug Admin­istra­tion (FDA) on April 24th, 2019. The ongoing devel­op­ment of TNB-383B is being pursued in col­lab­o­ration with AbbVie, Inc.

TNB-383B is a fully human bispecific anti­body with two binding moieties for B-Cell Maturation Antigen (BCMA) on one arm and a unique anti-CD3 on …

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[ Apr 24, 2019 1:46 am ]
Oncopeptides Provides New Guidance On The Patient Recruitment In The OCEAN Study And A Clinical Program Update In A Webcast At 10:00 (CET)

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: …

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