Phase 1/2 Study to Evaluate KPT-8602 in Patients With Relapsed/Refractory Multiple Myeloma

Newton, MA (Press Release) – Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clin­i­cal-stage phar­ma­ceu­ti­cal com­pany, announced today the initiation of a Phase 1/2 study of oral KPT-8602, a novel, second gen­er­a­tion, small-molecule selective inhibitor of nuclear export (SINE^TM) protein XPO1, in patients with re­lapsed/​refractory multiple myeloma (MM). This first-in-human study is designed to eval­u­ate the safety, tolerability and activity of approx­i­mately eight dose levels of KPT-8602 in up to 116 patients in multiple centers in the United States and Canada. Karyopharm con­tinues to expand its leadership in SINE-based ther­a­pies and is committed to being …

• Recent Previous Reports Showed Positive Findings for WT1 Cancer Vaccine in Mesothelioma and Acute Myeloid Leukemia (AML) Patients
• SELLAS to Present at the Annual JP Morgan Healthcare Conference on January 12th at 3:30pm PST

Zug, Switzerland, and New York (Press Release) – SELLAS Life Sciences Group (SELLAS), a devel­op­ment-stage bio­pharma­ceu­tical com­pany focused on inno­va­tive prod­ucts to treat cancers and central nervous system (CNS) diseases, today reported positive results from the Company's Phase 1/2 clin­i­cal study of its WT1 cancer vaccine in patients with multiple …

• The Lancet published data from the Phase II study of dara­tu­mu­mab as a mono­therapy to treat heavily pre­treated and refractory multiple myeloma
• Updated data was presented at the American Society of Hematology Annual Meeting in December

Copenhagen (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today The Lancet has published data from the Phase II study (Sirius MMY2002) of dara­tu­mu­mab in patients with re­lapsed and refractory multiple myeloma. Patients that received 16 mg/kg of dara­tu­mu­mab had a median of five prior lines of ther­apy and 95.3% were refractory to both pro­te­a­some inhibitors (PIs) and immuno­modu­la­tory drugs, which are current standard of care treat­ments for multiple myeloma. The data showed a 29.2% over­all re­sponse rate (31 of 106), in­­clud­ing three …

Safety and Activity Data Reviewed From First Cohort of Patients; CLR 131 Performance Triggers Advancement Into Second Cohort at Higher Dose

Madison, WI (Press Release) – Cellectar Biosciences, Inc. (NASDAQ:CLRB), an on­col­ogy-focused bio­tech­nology com­pany, to­day an­nounces data from the first cohort of patients en­rolled in its orphan drug-desig­nated Phase 1 study of CLR 131 in patients with re­lapsed or re­frac­tory mul­ti­ple myeloma. Based on safety and ef­fi­cacy data from the first cohort, the trial’s Data Monitoring Com­mit­tee approved en­roll­ment of the sec­ond cohort of patients with a 50 per­cent escalation in dose level of CLR 131.

The pri­mary objective of the multi-center, open label, Phase 1 dose escalation study is to char­ac­ter­ize …

• No dose limiting toxicity re­lated to the inves­ti­ga­tional treat­ment re­ported at 30 days post treat­ment of the first patient of the sec­ond dose-level
• The trial is a dose escalation study eval­u­ating safety and feasibility of a CAR T-cell ther­apy in patients with acute myeloid leukemia or mul­ti­ple myeloma.

Mont-Saint-Guibert, Belgium (Press Release) Celyad (Paris:​CYAD) (Brussels:​CYAD) (Euronext Brussels and Paris, and NASDAQ: CYAD), a leader in the discovery and devel­op­ment of engi­neered cell ther­a­pies, with clin­i­cal pro­grams in cardiovascular dis­ease and immuno-oncology, to­day an­nounced the com­ple­tion of the 30-day safety follow-up of the first patient en­rolled in the sec­ond cohort in the Phase I clin­i­cal trial eval­u­ating the safety and feasibility of its NKG2D CAR T-cell ther­apy, in cancer patients suffer­ing from acute myeloid leukemia (AML) or mul­ti­ple myeloma (MM).

Dr. …

• Natco to Acquire License to Sell Generic Lena­lido­mide in the U.S. Without Volume Limitation commencing in late Jan­u­ary­, 2026
• License Will Also Provide Natco With a Volume-Limited Entry Beginning in March, 2022 with Anticipated Mid-Single-Digit Percentage Of Capsules Sold In the First 12 Months, Anticipated to Increase Gradually Each Year

Summit, NJ (Press Release) – Celgene Corpo­ra­tion (NASDAQ: CELG) today announced the settle­ment of lit­i­ga­tion with Natco Pharma Ltd. of India, Natco’s U.S. partner, Arrow Inter­na­tional Limited, and Arrow’s parent com­pany, Watson Laboratories, Inc. (a wholly-owned sub­sid­i­ary of Allergan plc) relating 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 Natco from mar­ket­ing generic lena­lido­mide before the expiration of the patents-in-suit, …

Boudry, Switzerland, and Tokyo (Press Release) – Celgene Inter­na­tional Sàrl, a wholly-owned sub­sid­i­ary of Celgene Corpo­ra­tion (NASDAQ:CELG), today announced that REVLIMID^® (lena­lido­mide), a cancer medi­cine that is admin­istered orally, has been granted full market­ing authori­za­tion by Japan’s Ministry of Health, Labour and Welfare (MHLW) for use in com­bi­na­tion with dexa­meth­a­sone as a treat­ment for patients newly diag­nosed with multiple myeloma. This market­ing authori­za­tion expands upon the approval of REVLIMID in 2010 for the treat­ment of patients with re­lapsed or refractory multiple myeloma.

“The approval of REVLIMID as an option for use in …