• Licensing agree­ment in­cludes equity investment and poten­tial devel­op­ment, clin­i­cal, regu­la­tory and commercial mile­stones and tiered royalties
• Ayala retains world­wide rights to all other indi­ca­tions for AL102

Rehovot, Israel, and Wilmington, DE (Press Release) – Ayala Pharma­ceu­ticals, Inc., a clin­i­cal-stage com­pany devel­op­ing medicines for cancers that are genetically identified, announced today that it entered into an option to license agree­ment with Novartis for its inves­ti­ga­tional agent AL102 in multiple myeloma. Under the terms of the deal, Ayala will receive a $10 million equity investment from Novartis …

Beerse, Belgium (Press Release) – The Janssen Pharma­ceu­tical Com­panies of Johnson & Johnson today announced that the European Com­mis­sion has granted mar­ket­ing authori­sa­tion to provide health­care professionals with the option to split the first in­fusion of Darzalex® (dara­tu­mu­mab) over two consecutive days.

“We are committed to the devel­op­ment of new treat­ments, com­bi­na­tions, and for­mu­la­tions that will sup­port people living with multiple myeloma across the full disease spectrum,” said Dr Catherine Taylor, Europe, Middle East and Africa (EMEA) Haematology Therapeutic Area Lead, Janssen. “This is an im­por­tant de­ci­sion for health­care professionals and patients, as …

• Split dosing regi­men approved by European Com­mis­sion
• Provides health­care professionals with option to split first DARZALEX in­fusion over two consecutive days
• Approval sup­ported by data from EQUULEUS (MMY1001) clin­i­cal trial

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that the European Com­mis­sion (EC) has granted mar­ket­ing authori­za­tion for a split dosing regi­men for DARZALEX® (dara­tu­mu­mab). The approval will be in­cluded in an update of the Summary of Product Characteristics in order to provide health care professionals the option to split the first in­fusion of DARZALEX over two consecutive days. The EC approval follows a pos­i­tive opinion issued for DARZALEX by the European Committee for Medicinal Products for …

DARZALEX® com­bi­na­tion ther­apy sig­nif­i­cantly reduced the risk of dis­ease pro­gres­sion or death com­pared to a preferred regi­men alone.^1,2

Toronto, ON (Press Release) – The Janssen Pharma­ceu­tical Com­panies of Johnson & Johnson announced today that Health Canada has approved DARZA­LEX® (dara­tu­mu­mab), in com­bi­na­tion with bor­tez­o­mib, mel­phalan and pred­ni­sone (VMP), for the treat­ment of patients newly diag­nosed with multiple myeloma who are in­eli­gible for au­tol­o­gous stem cell trans­plan­ta­tion.³ DARZA­LEX® is the first mono­clonal anti­body to be approved for newly diag­nosed patients in Canada.

Multiple myeloma is an incurable blood cancer that occurs when malignant plasma cells grow un­con­trol­lably in the bone marrow.^4,5 The dis­ease can be very complex to treat as most patients …

• Supplemental new drug appli­ca­tion submitted in Japan for dara­tu­mu­mab in com­bi­na­tion with bor­tez­o­mib, mel­phalan and pred­ni­sone for the treat­ment of patients with newly diag­nosed multiple myeloma in­eli­gible for au­tol­o­gous stem cell trans­plant
• Submission based on data from Phase III ALCYONE study
• Genmab to receive USD 2 million mile­stone pay­ment from Janssen

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that Janssen Pharma­ceu­tical K.K. has submitted a supple­mental new drug appli­ca­tion (sNDA) to the Ministry of Health, Labor and Welfare (MHLW) in Japan, for the use of dara­tu­mu­mab (DAR­ZALEX®) in com­bi­na­tion with bor­tez­o­mib, mel­phalan and pred­ni­sone for the treat­ment of patients with newly diag­nosed multiple myeloma who are in­eli­gible for au­tol­o­gous stem cell trans­plant (ASCT). The appli­ca­tion will receive a priority review. The sub­mission of the appli­ca­tion triggers …

Calgary, AB and San Diego, CA (Press Release) – Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), cur­rently devel­op­ing pelareorep, an in­tra­venously delivered immuno-oncolytic virus, today announced that the first patient was treated in a phase 1 dose escalation study combining pelareorep and car­filz­o­mib with Bristol-Myers Squibb’s checkpoint inhibitor Opdivo® (nivolumab) to treat re­lapsed multiple myeloma patients. This study is based on findings from the NCI 9603 multiple myeloma study that com­bined pelareorep with car­filz­o­mib that resulted in objective responses, elimination of multiple myeloma cells and most importantly, an inflamed pheno­type with PD-L1 …

Patent covers composition of mat­ter and use in solid and liquid tumor cancer indi­ca­tions

Florham Park, NJ (Press Release) – Cellectar Biosciences, Inc. (Nasdaq: CLRB), a clin­i­cal-stage bio­pharma­ceu­tical com­pany focused on the discovery, devel­op­ment and com­mer­cial­iza­tion of targeted treat­ments for cancer, an­nounces that the Japan Patent Office has granted the pat­ent titled “Phos­pho­lipid Analogs as Diapeutic Agents and Methods of Use Thereof” with appli­ca­tion num­ber 2016135920. The pat­ent provides composition of mat­ter and use pro­tec­tion for the com­pany’s pro­pri­e­tary phos­pho­lipid ether (PLE) analogs and spe­cif­i­cally CLR 131 in breast, brain, leukemias and a variety of other cancers.

“Certain cancers such as pedi­atric lym­phomas and leukemias have a …