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 …

Singapore (Press Release) – KYAN Thera­peutics, Inc. ("KYAN"), a frontier bio­tech com­pany with a novel drug-dose com­bi­na­tion op­ti­miz­ing plat­form, Optim.AI, has entered into an ex­clu­sive li­cense agree­ment with Georgetown Uni­ver­sity for novel sel­ective Class II HDAC in­hib­i­tors. KYAN has already com­menced pre­clin­i­cal de­vel­op­ment of the lead can­di­date, which has been designated as KYAN-001, with early pos­i­tive re­­sults.

In vitro and in vivo stud­ies of KYAN-001 have shown high ef­fi­cacy for Multiple Myeloma and Prostate Cancer. The low toxicity and metabolic stability of KYAN-001 in­di­cates a better safety and tol­er­a­bil­ity profile than FDA ap­prov­ed …

• FDA set a target action date of March 27, 2021
• Ide-cel is the first CAR T cell ther­apy ac­cepted for regu­la­tory re­view for mul­ti­ple myeloma

Princeton, NJ and Cambridge, MA (Press Release) – Bristol Myers Squibb (NYSE: BMY) and blue­bird bio, Inc. (Nasdaq: BLUE) to­day an­nounced that the U.S. Food and Drug Admin­istra­tion (FDA) has ac­cepted for Priority Review their Biologics License Appli­ca­tion (BLA) for idecabtagene vicleucel (ide-cel; bb2121), the com­pa­nies’ inves­ti­ga­tional B-cell maturation an­ti­gen (BCMA)-directed chi­meric an­ti­gen re­cep­tor (CAR) T cell immuno­therapy, for the treat­ment of adult patients with mul­ti­ple myeloma who have re­ceived at least three prior ther­a­pies, in­clud­ing an immuno­modu­la­tory agent, a pro­te­a­some in­hib­i­tor and …

Increasing BCMA Surface Expression and Reduced Soluble BCMA Levels with Gamma Secretase Inhibitor Niro­gace­stat May Enhance Clinical Benefit in Com­bi­na­tion with PBCAR269A, an Allogeneic BCMA-Targeted CAR T Cell Product

Durham, NC and Stamford, CT (Press Release) – Pre­ci­sion BioSciences, Inc. (Nasdaq: DTIL), a clin­i­cal stage bio­technol­ogy devel­op­ing allo­geneic CAR T and in vivo gene correction ther­a­pies with its ARCUS® genome edit­ing plat­form, 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 they have entered into a clin­i­cal trial col­lab­o­ration agree­ment. Per the agree­ment, PBCAR269A, Pre­ci­sion BioSciences’ wholly-owned inves­ti­ga­tional allo­geneic chi­meric an­ti­gen re­cep­tor (CAR) T cell ther­apy can­di­date targeting B-cell maturation an­ti­gen (BCMA), will be eval­u­ated in com­bi­na­tion …

• Dr. Reddy’s li­censed to sell vol­ume-limited amounts of ge­ner­ic lena­lido­mide in the U.S. be­gin­ning on a con­fi­den­tial date after the March 2022 date pre­vi­ously granted to Natco
• Dr. Reddy’s also li­censed to sell ge­ner­ic lena­lido­mide in the U.S. without vol­ume lim­i­ta­tion be­gin­ning on Jan­u­ary 31, 2026
• The earliest li­censed entry of any ge­ner­ic lena­lido­mide in the U.S. con­tinues to be March 2022, based on set­tle­ments reached

New York, NY (Press Release) – Bristol Myers Squibb (NYSE:BMY) to­day an­nounced that its wholly owned sub­sid­i­ary, Celgene, and Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc. (collectively, DRL) have set­tled their lit­i­ga­tion re­lated to pat­ents for REVLIMID® (lena­lido­mide).

As part of the set­tle­ment, the parties will file Consent Judgments with the United States District Court for the District of New Jersey that enjoin DRL from mar­ket­ing ge­ner­ic lena­lido­mide be­fore the expiration of the pat­ents-in-suit, except as provided for in the set­tle­ment, …

Third col­lab­o­ration to eval­u­ate niro­gace­stat in com­bi­na­tion with BCMA ther­a­pies 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 col­lab­o­ration and supply agree­ment with Janssen Bio­tech, Inc. (Janssen) to eval­u­ate Spring­Works Thera­peutics’ inves­ti­ga­tional gamma se­cre­tase in­hib­i­tor (GSI), niro­gace­stat, in com­bi­na­tion with Janssen’s bispecific anti­body targeting B-cell maturation an­ti­gen (BCMA) and CD3, teclistamab, in patients with re­lapsed or re­frac­tory mul­ti­ple myeloma.

Gamma se­cre­tase in­hib­ition prevents the cleavage and shedding of BCMA from the surface of myeloma …