New York, NY (Press Release) – Starton Thera­peutics Inc. (“Starton” or the “Com­pany”), a bio­technol­ogy com­pany focused on trans­forming standard of care thera­peutics, to­day an­nounced that it has filed PCT (“Patent Cooperation Treaty”) and US Non-Provisional pat­ent appli­ca­tions entitled “Continuous Delivery of Lena­lido­mide and Other Immuno­modu­la­tory Agents” on April 21, 2020 (PCT Appli­ca­tion No. PCT/US20/29159 and U.S. Appli­ca­tion No. 16/854,810).

The PCT appli­ca­tion, filed with the PCT re­ceiv­ing office at the U.S. Patent & Trademark Office, allows Starton to file pat­ent appli­ca­tions to seek pro­tec­tion for the methods disclosed therein in most major …

Shanghai, China and Rockville, MD (Press Release) – I-Mab (NASDAQ: IMAB), a clin­i­cal stage bio­pharma­ceu­tical com­pany com­mit­ted to the discovery, de­vel­op­ment and com­mer­cial­iza­tion of novel or highly dif­fer­en­ti­ated biologics to treat dis­eases with sig­nif­i­cant unmet med­i­cal needs, and MorphoSys AG (FSE: MOR; Prime Standard Segment, MDAX & TecDAX; NASDAQ: MOR), to­day jointly an­nounced that the first patient has been dosed in a phase 3 clin­i­cal study in main­land China to eval­u­ate MorphoSys’ inves­ti­ga­tional human CD38 anti­body TJ202 / MOR202 in com­bi­na­tion with lena­lido­mide plus dexa­meth­a­sone in patients with re­lapsed or re­frac­tory multiple myeloma (r/r …

Initiation of the clin­i­cal trial triggers $50 million mile­stone pay­ment from AbbVie

South San Francisco, CA (Press Release) – Harpoon Thera­peutics, Inc. (NASDAQ: HARP), a clin­i­cal-stage immuno­therapy com­pany devel­op­ing a novel class of T cell engagers, to­day announced that the first patient has been dosed with HPN217 in a Phase 1/2 clin­i­cal trial focused on re­lapsed, re­frac­tory multiple myeloma (RRMM). HPN217 is being devel­oped under a global license and option agree­ment with AbbVie Inc. (NYSE:ABBV) and dosing of the first patient in a clin­i­cal trial has triggered a $50 million mile­stone pay­ment to Harpoon. HPN217 targets B-cell maturation an­ti­gen (BCMA), a well-validated an­ti­gen ex­pressed …

Shanghai, China (Press Release) – CARsgen Thera­peutics Co., Ltd., a clin­i­cal-stage bio­pharma­ceu­tical com­pany, to­day an­nounced the Euro­pean Medicines Agency (EMA) Com­mit­tee for Orphan Medicinal Products (COMP) adopted a pos­i­tive opinion on CARsgen's appli­ca­tion for orphan desig­na­tion of its inves­ti­ga­tional CT053 CAR T-cell ther­apy, fully human anti-BCMA (B cell maturation an­ti­gen) au­tol­o­gous chi­meric an­ti­gen re­cep­tor (CAR) T cells for the treat­ment of mul­ti­ple myeloma. CT053 was pre­vi­ously granted orphan drug desig­na­tion by the US Food and Drug Admin­istra­tion in August 2019.

"The COMP's adoption of a pos­i­tive opinion for CT053 orphan drug desig­na­tion is …

San Diego, CA (Press Release) – Halozyme Thera­peutics, Inc. (NASDAQ: HALO) to­day an­nounced the sub­mission of a New Drug Appli­ca­tion (NDA) to the Ministry of Health, Labour and Welfare (MHLW) by Janssen Pharma­ceu­tical K.K. (Janssen) seek­ing ap­­prov­al of a new sub­cu­tane­ous (SC) for­mu­la­tion of dara­tu­mu­mab, an in­tra­venous (IV) treat­ment approved for patients with mul­ti­ple myeloma.

"We are pleased to see this New Drug Appli­ca­tion sub­mission in Japan, which builds on Janssen's prior regu­la­tory sub­missions in the U.S. and EU that are cur­rent under re­view," said Dr. Helen Torley, pres­i­dent and chief exec­u­tive of­fi­cer. …

Newton, MA (Press Release) – Karyo­pharm Thera­peutics Inc. (Nasdaq:KPTI) to­day an­nounced dosing of the first patient in a ran­dom­ized Phase 2 clin­i­cal study eval­u­ating low dose oral selinexor in hos­pi­talized patients with severe COVID-19. This global study is ex­pected to en­roll approx­i­mately 230 patients at clin­i­cal sites in the U.S., Europe, and Israel. Selinexor is an oral selective in­hib­i­tor of nuclear export (SINE) com­pound which blocks the cellular pro­tein XPO1 which is in­volve­d in both the rep­li­ca­tion of SARS-CoV-2, the virus that causes COVID-19, and in the in­flam­ma­tory re­sponse to the virus.

The …

• Company to Initiate a Global Randomized Clinical Trial to Treat Patients with COVID-19
• XPO1 Inhibitors have Previously Demonstrated Pre­clin­i­cal Activity Against Numerous Respiratory Viruses (Including SARS-CoV) and Asso­ci­ated Inflammation
• BOSTON sNDA Submission on Target for Q2 2020
• Management to Host Conference Call Today at 8:30 AM ET

Newton, MA (Press Release) – Karyo­pharm Thera­peutics Inc. (Nasdaq:KPTI) to­day announced plans to ini­ti­ate a global ran­dom­ized clin­i­cal trial for low dose oral selinexor in hos­pi­talized patients with severe COVID-19. Selinexor, mar­keted as XPOVIO®, is cur­rent approved at higher doses by the Food and Drug Admin­istra­tion (FDA) as a treat­ment for patients with re­lapsed or re­frac­tory multiple myeloma. Selinexor is an oral, selective in­hib­i­tor of nuclear export (SINE) com­pound which blocks the cellular pro­tein XPO1. In addi­tion to …