Ningbo, China (Press Release) – Ningbo NewBay Medical Technology Co., Ltd., a sub­sid­i­ary of Ningbo Tai Kang Medical Technology Co., Ltd. announced today that it has entered into a licensing agree­ment with Genentech, a member of the Roche Group, under which it has been granted the ex­clu­sive global rights to further de­vel­op and com­mer­cial­ize GDC-0570, a small molecule Pan-PIM in­hib­i­tor that is active against multiple myeloma and prostate cancer in pre­clin­i­cal models. PIM kinases regulate cell metabolism, growth and sur­vival.

“We are very pleased to enter this global ex­clu­sive license agree­ment with Genentech. …

• Biologics License Appli­ca­tion based on re­­sults from the pivotal DREAMM-2 study of immuno­con­jugate targeting B-cell maturation an­ti­gen (BCMA) in heavily pre-treated patient pop­u­la­tion who was re­frac­tory to an immuno­modu­la­tory drug and a pro­te­a­some in­hib­i­tor, and re­frac­tory or intolerant to an anti-CD38 anti­body
• Belantamab mafo­dotin has poten­tial to be the first anti-BCMA treat­ment avail­able to patients

London, United Kingdom (Press Release) – GlaxoSmithKline plc (LSE/NYSE: GSK) an­nounced the US Food and Drug Admin­istra­tion (FDA) granted a priority re­view for the com­pany's Biologics License Appli­ca­tion (BLA) seek­ing ap­prov­al of be­lan­ta­mab mafo­dotin (GSK2857916) 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.

The BLA is based on data from the pivotal DREAMM-2 (DRiving Excellence in Approaches to Multiple Myeloma) study, recently pub­lished in The Lancet Oncology, …

• DARZALEX® (dara­tu­mu­mab) approved in Europe in com­bi­na­tion with bor­tez­o­mib, thalido­mide and dexa­meth­a­sone for the treat­ment of adult patients with newly diag­nosed multiple myeloma who are eli­gible for au­tol­o­gous stem cell trans­plant
• Approval follows pos­i­tive opinion by European Com­mit­tee for Medicinal Products for Human Use (CHMP) in De­cem­ber
• Approval based on data from Phase III CASSIOPEIA study

Copenhagen, Denmark; Jan­u­ary­ 20, 2020 – Genmab A/S (Nasdaq: GMAB) announced today that the European Com­mis­sion (EC) has granted mar­ket­ing authori­za­tion for DARZALEX® (dara­tu­mu­mab) in com­bi­na­tion with bor­tez­o­mib, thalido­mide and dexa­meth­a­sone for the treat­ment of adult patients with newly diag­nosed multiple myeloma who are eli­gible for au­tol­o­gous stem cell trans­plant (ASCT). The EC approval follows a pos­i­tive opinion issued for DARZALEX by the CHMP of the European Medicines Agency (EMA) in De­cem­ber 2019. In August 2012, Genmab granted Janssen Biotech, …

• Phase 1 clin­i­cal trial of off-the-shelf (allogeneic) anti-BCMA CAR T ther­apy can­di­date for patients with re­lapsed / re­frac­tory mul­ti­ple myeloma ex­pec­ted to begin dosing patients in 2020
• PBCAR269A has re­ceived Orphan Drug Desig­na­tion from the FDA for the treat­ment of mul­ti­ple myeloma
• First pro­gram for which clin­i­cal trial ma­teri­al will be gen­er­ated fully in-house at Precision’s Manu­factur­ing Center for Advanced Thera­­peutics (MCAT) in Durham, N.C.

Durham, NC (Press Release) – Precision BioSciences, Inc. (Nasdaq: DTIL), a genome edit­ing com­pany ded­i­cated to im­prov­ing life through the appli­ca­tion of its pioneering, pro­pri­e­tary ARCUS® plat­form, to­day an­nounced that the U.S. Food and Drug Admin­istra­tion (FDA) has ac­cepted its Inves­ti­ga­tional New Drug (IND) appli­ca­tion for PBCAR269A, the Com­pany’s third allo­geneic chi­meric an­ti­gen re­cep­tor (CAR) T cell ther­apy can­di­date. The FDA has also granted Orphan Drug Desig­na­tion to PBCAR269A for the treat­ment of mul­ti­ple myeloma. Wholly-owned by Precision, PBCAR269A is an allo­geneic CAR …

Increasing BCMA Surface Expression with Gamma Secretase Inhibitor Niro­gace­stat May Enable Deep and Durable Responses to ALLO-715, an Inves­ti­ga­tional Anti-BCMA Allogeneic CAR T Therapy

South San Francisco, CA and Stamford, CA (Press Release) – Allogene Thera­peutics, Inc. (Nasdaq: ALLO), a clin­i­cal-stage bio­technol­ogy com­pany pioneering the de­vel­op­ment of allo­geneic chi­meric an­ti­gen re­cep­tor T cell (AlloCAR T™) ther­a­pies for cancer and 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 they have entered into a clin­i­cal trial col­lab­o­ration agree­ment. This agree­ment will eval­u­ate ALLO-715, Allogene’s inves­ti­ga­tional anti-B-cell maturation an­ti­gen (BCMA) AlloCAR T ther­apy in com­bi­na­tion with Spring­Works’ inves­ti­ga­tional gamma secretase in­hib­i­tor (GSI), niro­gace­stat, …

Shanghai, China (Press Release) – I-Mab Bio­pharma­ ("I-Mab"), a global bio­pharma­ceu­tical com­pany based in China and the United States and focused on the discovery and devel­op­ment of novel or highly dif­fer­en­ti­ated biologics in immuno-oncology and auto­immune dis­eases today announced the dosing of the first patient in mainland China in its reg­is­tra­tional study eval­u­ating its human CD38 anti­body (TJ202/MOR202) in patients with re­lapsed or re­frac­tory multiple myeloma (MM).

I-Mab ini­ti­ated two reg­is­tra­tional trials with TJ202 / MOR202 in re­lapsed or re­frac­tory MM in Taiwan in early 2019 and ex­panded these trials into mainland China in …

New York, NY (Press Release) – Starton Thera­peutics Inc. (“Starton” or the “Company”), a bio­technol­ogy com­pany focused on trans­forming standard of care thera­peutics, to­day an­nounced the com­ple­tion of a proof of concept study of multiple myeloma with lena­lido­mide using a model which emulates trans­dermal de­livery. The results of the study dem­onstrate that a con­tin­uous sub­cu­tane­ous (SC) de­livery of lena­lido­mide is superior in terms of efficacy and equivalent in tolerability when com­pared to a standard once daily pulsatile dosing of Revlimid® (Celgene Corpo­ra­tion) in mice. The pos­i­tive out­come provides a clear path for de­vel­op­ment …