Stockholm, Sweden (Press Release) – Oncopeptides AB (publ) (Nasdaq Stock­holm: ONCO) to­day an­nounces that the Com­pany has sub­mitted an Inves­ti­ga­tional New Drug (IND) appli­ca­tion to the U.S. Food and Drug Admin­istra­tion (FDA), for OPD5 – a sec­ond drug can­di­date based on the pro­pri­e­tary Peptide Drug Con­ju­gate plat­form (PDC).

Oncopeptides plans to ini­ti­ate clin­i­cal de­vel­op­ment of OPD5 with an open-label phase 1, dose escalation study on safety and tol­er­a­bil­ity of OPD5 as a myeloablative regi­men fol­lowed by au­tol­o­gous stem cell trans­plan­ta­tion in patients with re­lapsed re­frac­tory mul­ti­ple myeloma. The spe­cif­ic for­mu­la­tion enables admin­istra­tion of high …

Boston, MA (Press Release) – OncoPep, Inc. to­day an­nounced a licensing agree­ment with MANA Thera­peutics for use of its EDIFY™ plat­form for the de­vel­op­ment of an au­tol­o­gous multi-tumor an­ti­gen adoptive T cell ther­apy for the treat­ment of mul­ti­ple myeloma and solid tumors, as an addi­tional T cell focused im­mu­no­ther­apeutic for its prod­uct pipe­line.

“The addi­tion of a multi-antigen adoptive T cell ther­apy to our pipe­line ex­pands the breadth of our immuno-oncology pro­grams in mul­ti­ple myeloma in addi­tion to solid tumors, and pro­vides patients with another po­ten­tial treat­ment op­tion for a dis­ease for which …

• Designation will ac­cel­er­ate oNKord®'s mar­ket access for MM
• Together with Clinical Trial Approval for a pivotal phase I-IIa trial in AML, this is another im­por­tant step for­ward in making Glyco­stem's allo­geneic Natural Killer cell-based treat­ment accessible for can­cer patients

Oss, The Netherlands (Press Release) – Glyco­stem Thera­peutics, a lead­ing clin­i­cal-stage com­pany focused on the de­vel­op­ment of thera­peutic off-the-shelf Natural Killer (NK) cells, an­nounces it has re­ceived the FDA's Orphan Drug Desig­na­tion (ODD) for treat­ment of mul­ti­ple myeloma (MM) patients with its inves­ti­ga­tional prod­uct oNKord®. The desig­na­tion will pro­vide Glyco­stem with cer­tain incentives, like eligibility for 7 years of mar­ket exclusivity and clear FDA guidance on spe­cif­ic as­pects of de­vel­op­ment for rare dis­eases. These pave an ac­cel­er­ated path to­wards mar­ket access and treat­ment of patients …

Stockholm, Sweden (Press Release) – Oncopeptides AB (publ) (Nasdaq Stock­holm: ONCO) to­day an­nounces that the Com­pany has in­formed the Euro­pean Medicines Agency, EMA, about its intention to submit an appli­ca­tion for a con­di­tional mar­ket­ing autho­ri­za­tion of mel­flu­fen (INN mel­phalan flufenamide) in the EU, based on the pivotal phase 2 HORIZON study in re­lapsed re­frac­tory mul­ti­ple myeloma (RRMM).

The de­ci­sion to submit an appli­ca­tion for con­di­tional ap­prov­al has been grounded on an in-depth analysis of the regu­la­tory en­viron­ment and is endorsed by key opinion leaders in the EU. Previously the Com­pany in­tended to await …

New York, NY and Paris, France (Press Release) – Cytovia Thera­peutics ("Cytovia"), an emerging bio­pharma­ceu­tical com­pany, an­nounces to­day that it has entered a re­search and licensing agree­ment with Inserm to de­vel­op NK engager bi-specific anti­bodies and iPSC CAR NK cell ther­apy targeting CD38, a key marker of mul­ti­ple myeloma. The licensing agree­ment has been negotiated and signed by Inserm Transfert, the private sub­sid­i­ary of Inserm, on behalf of Inserm (the French National In­sti­tute of Health and Medical Re­search) and its academic part­ners. Cytovia is licensing Inserm's CD38 anti­body and Chimeric Antigen Receptor (CAR) …

With the start of its sec­ond clin­i­cal trial, NexImmune ex­pands de­vel­op­ment of its unique non-genetically engi­neered T cell immuno­therapies across a range of hema­to­logic malig­nan­cies

Gaithersburg, MD (Press Release) – NexImmune, a clin­i­cal-stage bio­technol­ogy com­pany devel­op­ing a port­folio of unique non-genetically-engi­neered T cell im­muno­therapies, an­nounced to­day that it has dosed the first patient in its Phase 1/2 clin­i­cal trial for NEXI-002. NEXI-002 is a patient-derived cel­lu­lar prod­uct that con­tains pop­u­la­tions of nat­u­rally-occurring CD8+ T cells directed against sev­er­al mul­ti­ple myeloma (MM)-specific an­ti­gen targets. It is the sec­ond clin­i­cal prod­uct NexImmune has gen­er­ated with its AIM nanoparticle tech­nology.

“While the pri­mary objective in this trial with NEXI-002 is to dem­onstrate safety and tol­er­a­bil­ity, we also hope to see ini­tial …

Fifth in­dus­try col­lab­o­ration to eval­u­ate niro­gace­stat as a BCMA po­ten­ti­ator 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 trial col­lab­o­ration agree­ment with Pfizer Inc. (NYSE: PFE) to eval­u­ate Spring­Works Thera­peutics’ inves­ti­ga­tional gamma se­cre­tase in­hib­i­tor (GSI), niro­gace­stat, in com­bi­na­tion with Pfizer’s anti-B-cell maturation an­ti­gen (BCMA) CD3 bispecific anti­body, PF‐06863135, in patients with re­lapsed or re­frac­tory mul­ti­ple myeloma.

Gamma se­cre­tase in­hib­ition prevents the cleavage and shedding of BCMA from the surface of myeloma cells. In pre­clin­i­cal …