Stockholm, Sweden (Press Release) – Oncopeptides AB (publ) (Nasdaq Stock­holm: ONCO) to­day an­nounces that the Com­pany submits a New Drug Appli­ca­tion (NDA) to the U.S. Food and Drug Admin­istra­tion, FDA, for ac­cel­er­ated ap­prov­al of mel­flu­fen (INN mel­phalan flufenamide) in com­bi­na­tion with dexa­meth­a­sone for the treat­ment of adult patients with mul­ti­ple myeloma whose dis­ease is re­frac­tory to at least one pro­te­a­some in­hib­i­tor, one immuno­modu­la­tory agent and one anti-CD38 mono­clonal anti­body (i.e., triple-class re­frac­tory mul­ti­ple myeloma patients).

Melflufen is the lead can­di­date com­ing out of the Oncopeptides' pro­pri­e­tary PDC-platform. The prod­uct is a first-in-class aminopeptidase-targeting …

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 first patient has been dosed in a Phase 1b clin­i­cal trial eval­u­ating Spring­Works Thera­peutics’ inves­ti­ga­tional gamma secretase in­hib­i­tor, niro­gace­stat, in com­bi­na­tion with GlaxoSmithKline’s (GSK) inves­ti­ga­tional anti-B-cell maturation an­ti­gen (BCMA) anti­body-drug con­ju­gate, be­lan­ta­mab mafo­dotin, in patients with re­lapsed or re­frac­tory mul­ti­ple myeloma. The niro­gace­stat and be­lan­ta­mab mafo­dotin com­bi­na­tion is being eval­u­ated as a sub-study in GSK’s on­go­ing DREAMM-5 plat­form trial.

Gamma secretase in­hib­ition …

London, United Kingdom (Press Release) – GlaxoSmithKline plc (LSE/NYSE: GSK) to­day an­nounced the US Food and Drug Admin­istra­tion (FDA) will convene a meeting of the Oncologic Drugs Advisory Com­mit­tee (ODAC) to re­view data sup­port­ing the com­pany’s Biologics License Appli­ca­tion (BLA) for be­lan­ta­mab mafo­dotin for the poten­tial treat­ment of patients with re­lapsed or re­frac­tory mul­ti­ple myeloma who have re­ceived at least four prior ther­a­pies in­clud­ing an immuno­modu­la­tory agent, a pro­te­a­some in­hib­i­tor and an anti-CD38 anti­body. The ODAC will meet virtually on 14 July 2020.

Dr Axel Hoos, Senior Vice Pres­i­dent and Head of Oncology …

Oxford, United Kingdom (Press Release) – In March 2020, the RECOVERY (Ran­domised Eval­u­a­tion of COVid-19 thERapY) trial was estab­lished as a ran­domised clin­i­cal trial to test a range of poten­tial treat­ments for COVID-19, in­clud­ing low-dose dexa­meth­a­sone (a steroid treat­ment). Over 11,500 patients have been en­rolled from over 175 NHS hos­pi­tals in the UK.

On 8 June, recruitment to the dexa­meth­a­sone arm was halted since, in the view of the trial Steering Com­mit­tee, suf­fi­cient patients had been en­rolled to estab­lish whether or not the drug had …

Seattle, WA (Press Release) – AVM Biotech­nol­ogy has been awarded a National Cancer In­sti­tute Small Business Innovation Re­search (SBIR) Grant from the National In­sti­tutes of Health (NIH) to study the use of their lead mol­e­cule AVM0703 as a pre­con­di­tion­ing agent to allow safe and efficient de­livery of thera­peutic im­mune cells for cancer treat­ment. This novel solu­tion could offer clin­i­cal ad­van­tages to any cell-based immuno­therapy, im­prov­ing access to poten­tially life-saving ther­a­pies by all cancer patients, in­clud­ing those too frail to re­ceive chemo­ther­apy.

Cellular immuno­therapy has the poten­tial to be­come a crucial solu­tion for cancer. …

Covers composition of mat­ter and method of use into 2036 for pro­pri­e­tary PLE analogs in com­bi­na­tion with var­i­ous small mol­e­cule chemo­ther­a­peu­tics

Florham Park, NJ (Press Release) – Cellectar Bio­sciences, Inc. (NASDAQ: CLRB), a clin­i­cal-stage bio­pharma­ceu­tical com­pany focused on the discovery, de­vel­op­ment and com­mer­cial­i­za­tion of drugs for the treat­ment of cancer, to­day an­nounced that the Euro­pean Patent Office has an­nounced the intent to grant pat­ent num­ber EP3229810 (B1) titled “Phospholipid Ether Analogs as Cancer-Targeting Drug Vehicles.” The pat­ent provides composition of mat­ter and use pro­tec­tion for the com­pany’s pro­pri­e­tary PLE, targeted de­livery vehicle analogs in com­bi­na­tion with a broad range of chemo­ther­a­peu­tics such as paclitaxel, gemcitabine, and other classes of small mol­e­cule chemo­ther­a­peu­tic …

• Acquisition of Stemline estab­lishes Menarini’s presence in the U.S. bio­pharma­ceu­tical on­col­ogy mar­ket
• Menarini will sup­port fur­ther de­vel­op­ment of Stemline’s ELZONRIS® and enable global ex­pan­sion by leveraging its com­mer­cial infrastructure in Europe and other ex-U.S. geographies
• Following the trans­action, Menarini will con­tinue to re­search ELZONRIS in addi­tional CD123-expressing in­di­ca­tions

Florence, Italy (Press Release) – Menarini Group, a privately held Italian pharma­ceu­tical and diagnostics com­pany, to­day an­nounced that is has suc­cess­fully com­pleted the ac­qui­si­tion of Stemline Thera­peutics Inc., a com­mer­cial-stage bio­pharma­ceu­tical com­pany focused on the de­vel­op­ment and com­mer­cial­i­za­tion of novel on­col­ogy thera­peutics (Nasdaq: STML), for an aggregate cash con­sid­er­a­tion up to $677 million on a fully diluted basis.

The trans­action, which was an­nounced on 4 May 2020, strengthens Menarini’s on­col­ogy port­folio with the addi­tion of both com­mer­cial and clin­i­cal-stage assets. Menarini acquired Stemline for an up­front …