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 …

Suzhou, China (Press Release) – CStone Pharma­ceu­ticals (Suzhou) Co., Ltd. ("CStone", stock code: 2616.HK) announced that the National Medical Products Admin­istra­tion (NMPA) recently approved com­pany's histone deacetylase 6 (HDAC6) selective inhibitor CS3003 for Phase I clin­i­cal trial in China. This is a multi-center, Phase I dose escalation study synchronously conducted in China and Australia in patients with ad­vanced solid tumors and re­lapsed or refractory multiple myeloma.

Dr. Frank Jiang, Chairman and CEO, commented: "CS3003 is the ninth drug can­di­date of CStone with Investigational New Drug approval obtained in China. At present, there …

Henderson, NV and San Diego, CA (Press Release) – Secura Bio, Inc. (www.securabio.com), an integrated, commercial-stage bio­pharma­ceu­tical com­pany dedicated to the world­wide com­mer­cial­iza­tion of sig­nif­i­cant on­col­ogy ther­a­pies, today announced that it has acquired the global rights to Farydak® (panobinostat) from Novartis.

Farydak® (panobinostat) is a prescription oral medication used in com­bi­na­tion with pro­te­a­some inhibitors and corticosteroids to treat patients with re­lapsed or refractory multiple myeloma who had received prior treat­ments. Farydak is a member of the histone deacetylase (HDAC) inhibitor family with a very potent and unique mode of action slowing the growth …

Interim Results from Phase 1b/2 ACE-MM-102 and Phase 1a/1b ACE-MM-200 Studies to be Presented at the 57th Annual Meeting of the American Society of Hematology

Boston (Press Release) Acetylon Pharma­ceu­ticals, Inc., the leader in the devel­op­ment of selective histone deacetylase (HDAC) inhibitors for en­hanced thera­peutic out­comes, today announced that it will present clin­i­cal data demonstrating promising tolerability and over­all response rates from a Phase 1b/2 study of a selective HDAC6 inhibitor, ricolinostat (ACY-1215), in com­bi­na­tion with poma­lido­mide (Pomalyst^®, Celgene) and dexa­meth­a­sone for the treat­ment of re­lapsed-and-refractory multiple myeloma (ACE-MM-102 study). These data …

• Farydak (panobinostat) combination is approved in the EU for patients with multiple myeloma who received >=2 prior regimens including bortezomib and IMiD[1]
• In clinical trials, Farydak combination increased PFS by 7.8 months in patients who received >=2 prior regimens, including bortezomib and an IMiD[1]
• As the first HDAC inhibitor approved in the EU for multiple myeloma, Farydak may help reset key cell function in multiple myeloma through epigenetic activity[2]
• Farydak is approved in the US and Japan

 …

• Farydak (panobinostat) combination improved PFS by 7.8 months for patients who received >=2 prior regimens including bortezomib and an IMiD[1]
• Farydak would be the first HDAC inhibitor with epigenetic activity to treat multiple myeloma[2],[3]
• CHMP positive opinion marks a key milestone toward panobinostat availability in the EU, aligning with recent US FDA approval

Basel, Switzerland (Press Release) – The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion …

Silver Spring, MD (Press Release) – On February 23, 2015, the U.S. Food and Drug Admin­istra­tion (FDA) granted accelerated approval to panobinostat (FARYDAK capsules, Novartis Pharma­ceu­ticals) in com­bi­na­tion with bor­tez­o­mib and dexa­meth­a­sone for the treat­ment of patients with multiple myeloma who have received at least two prior regi­mens, in­­clud­ing bor­tez­o­mib and an immuno­modu­la­tory agent. As a con­di­tion of this accelerated approval, FDA requires the sponsor to conduct a trial to verify and describe the clin­i­cal benefit of panobinostat for patients with multiple myeloma.

Panobinostat is a histone deacetylase inhibitor.

The approval was …