Milestone Triggers $10 Million Payment to Molecular Templates

Austin, TX (Press Release) – Molecular Templates, Inc. (Nasdaq: MTEM, “Molecular Templates” or “MTEM”), a clin­i­cal-stage bio­pharma­ceu­tical com­pany focused on the discovery and devel­op­ment of the com­pany’s pro­pri­e­tary engi­neered toxin bodies (ETBs), which are dif­fer­en­ti­ated, targeted, biologic thera­peutics for cancer and other serious dis­eases, today announced the initiation of dosing in a Phase I study investigating TAK-169 in patients with re­lapsed / re­frac­tory multiple myeloma. Co-developed with Takeda Pharma­ceu­tical Com­pany Limited (“Takeda”), TAK-169 is a poten­tial first-in-class CD38-targeting ETB. As a result of achieving this mile­stone, MTEM will re­ceive a $10 million pay­ment …

Newton, MA and Petah Tikva, Israel (Press Release) – Karyo­pharm Thera­peutics Inc. (Nasdaq:KPTI), an on­col­ogy-focused pharma­ceu­tical com­pany, and Promedico, a member of the Neopharm Group, today announced their entry into an ex­clu­sive distribution agree­ment for the com­mer­cial­iza­tion of XPOVIO® (seli­nexor), Karyo­pharm’s lead SINE com­pound, in Israel and the Palestinian Authority.

Under the terms of the agree­ment, Karyo­pharm will re­ceive cer­tain prespecified pay­ments and is eli­gible to re­ceive addi­tional pay­ments if prespecified regu­la­tory and commercial mile­stones are achieved by Promedico, a fully-owned Neopharm LTD com­pany. Karyo­pharm is also eli­gible to re­ceive double-digit royalties on …

Application is based on pos­i­tive data from the Phase 3 CANDOR study, which were pre­sented at the 2019 American Society of Hematology Annual Meeting

Raritan, NJ (Press Release) – The Janssen Pharma­ceu­tical Com­panies of Johnson & Johnson announced today the sub­mission of a supple­mental Biologics License Application (sBLA) to the U.S. Food and Drug Admin­istra­tion (FDA) seeking approval of DARZALEX® (dara­tu­mu­mab) in com­bi­na­tion with Kyprolis® (car­filz­o­mib) and dexa­meth­a­sone (DKd) for re­lapsed / re­frac­tory multiple myeloma. The sBLA is sup­ported by results from the Phase 3 CANDOR study, which com­pared treat­ment with DKd to car­filz­o­mib and dexa­meth­a­sone (Kd) in patients with multiple myeloma who re­lapsed after one to three prior lines of ther­apy.

"While we con­tinue to …

KP1237, a CD38-Targeting Anti­body Recruiting Molecule (ARM™), to Be Tested in Com­bi­na­tion with NK Cells to Treat Post-Transplant Multiple Myeloma Patients

New Haven, CT (Press Release) – Kleo Pharma­ceu­ticals, Inc., an immuno-oncology com­pany devel­op­ing next-generation, fully syn­thet­ic bispecific com­pounds designed to emulate or en­hance the activity of biologics, announced today that it has re­ceived Inves­ti­ga­tional New Drug (IND) authori­za­tion to proceed from the U.S. Food and Drug Admin­istra­tion (FDA) to ini­ti­ate a safety and tolerability clin­i­cal study combining KP1237, a CD38-targeting anti­body recruiting molecule (ARM™), with patients' own Natural Killer (NK) cells to treat multiple myeloma (MM) in post-transplant patients.

The single-arm study will be conducted in 25-30 patients with exploratory end­points that assess the …

Baltimore, MD and Philadelphia, PA (Press Release) – WindMIL Thera­peutics, a clin­i­cal-stage com­pany devel­op­ing mar­row-infiltrating lym­pho­cytes (MILs™) for cancer immuno­therapy, today announced a col­lab­o­rative pre-clinical re­search part­ner­ship with University of Pennsylvania (Penn) to explore novel chi­meric an­ti­gen re­cep­tor (CAR)-engineered MILs (CAR-MILs™) in hema­to­logical and solid tumor model settings. The col­lab­o­ration will leverage WindMIL’s and Penn’s re­spec­tive­ ex­per­tise to conduct pre-clinical comparisons of the char­ac­ter­istics and functionality of CAR-T and CAR-MIL prod­ucts.

“Today marks an im­por­tant mile­stone in ad­vanc­ing gene-modified MILs to­ward the clinic while further build­ing on WindMIL’s foundational work to de­vel­op MILs …

Lund, Sweden (Press Release) – Active Biotech (NASDAQ STOCKHOLM: ACTI) announces that the Board of Directors, has approved a new direction for the com­pany. This de­ci­sion follows a detailed oppor­tu­ni­ty analysis of the com­pany’s wholly owned clin­i­cal lead assets, laquinimod and tasquinimod. Based on assess­ment of the many scientific pub­li­ca­tions and extensive pre-clinical and clin­i­cal data accumulated, an analysis of the commercial attractiveness of dif­fer­en­t clin­i­cal in­di­ca­tion oppor­tu­ni­ties to Active Biotech, as well as an ex­ternal advisory chal­lenge, new focused target in­di­ca­tions and corporate priorities have been defined.

Tasquinimod will be ad­vanced in …

• Be­lan­ta­mab mafo­dotin ac­cepted for ac­cel­er­ated assess­ment by the EMA's Com­mit­tee for Human Medicinal Products (CHMP)
• Submission based on data from the pivotal DREAMM-2 study of immuno­con­ju­gate targeting B-cell maturation an­ti­gen (BCMA) recently pub­lished in The Lancet Oncology

London, United Kingom (Press Release) – GlaxoSmithKline plc to­day an­nounced that the Euro­pean Medicines Agency (EMA) val­i­dated the mar­ket­ing authori­sa­tion appli­ca­tion (MAA) for be­lan­ta­mab mafo­dotin for the treat­ment of patients with re­lapsed or re­frac­tory mul­ti­ple myeloma whose prior ther­apy in­cluded an immuno­modu­la­tory agent, a pro­te­a­some in­hib­i­tor and an anti-CD38 anti­body. Be­lan­ta­mab mafo­dotin was ac­cepted for ac­cel­er­ated assess­ment by the EMA's Com­mit­tee for Human Medicinal Products (CHMP).

Accelerated assess­ment is granted if the CHMP de­ter­mines the treat­ment is of major interest from a pub­lic health per­spec­tive …