ADCT and SOBI announced the EC has granted conditional marketing authorization for the use of Zynlonta (loncastuximab tesirine) for the treatment of relapsed or refractory DLBCL. The approval follows a positive opinion issued in September by the CHMP of EMA.
Immunogen announced a clinical collaboration with Gilead to evaluate the safety and anti-leukemia activity of pivekimab sunirine in combination with magrolimab, a potential, first-in-class, investigational CD47 inhibitor, in patients with relapsed or refractory CD123-positive AML.
Mersana announced a research collaboration and commercial license agreement with a subsidiary of Merck KGaA to discover novel Immunosynthen ADCs directed against up to two targets. Mersana will receive an upfront payment of $30 million and is also eligible to receive up to $800 million in potential milestones.
Seagen announced that FDA has accepted for Priority Review sBLAs for Padcev (enfortumab vedotin-ejfv) with Keytruda for use of these two agents in combination for the treatment of patients with locally advanced or metastatic urothelial cancer who are not eligible to receive cisplatin-containing chemotherapy. The respective applications are intended to expand both labels for PADCEV and KEYTRUDA. The agency set a PDUFA goal date for each application of April 21, 2023.
Alkermes announced that its CEO Richard Pops will provide a corporate overview and update at the 41st Annual J.P. Morgan Healthcare Conference on January 11, 2023.
ImmunityBio raised $157 million, mostly from “Nant” entities affiliated with founder and Executive Chairman Patrick Soon-Shiong, via an equity financing from a single, undisclosed investor, a debt financing and conversion of about $57 million of debt held by NantWorks into ImmunityBio equity.
Nektar presented two presentations of NKTR-255 at ASH. NKTR-255 was well tolerated in heavily pre-treated patients with hematologic malignancies (NHL and MuMy). Early evidence of clinical activity was observed in this heavily pre-treated and highly refractory patient population with the doublet (NKTR-255 + daratumumab).
Xencor announced additional clinical data from expansion cohorts in its Phase 1 study of plamotamab, a CD20 x CD3 bispecific antibody, in patients with relapsed or refractory NHL. The recommended intravenous dose was well tolerated, and the responses observed in the study are encouraging.
Short interest of Allogene decreased by 3% to 30,531,363 reported on December 15, compared to 31,457,546 on November 15.
Autolus announced that its obe-cel met the primary endpoint of the pivotal Phase 2 FELIX trial to treat acute lymphoblastic leukemia. Autolus will now receive $70 million in milestone payments from Blackstone Life Sciences as part of a deal struck last year. With these positive news, Autolus raised $150 million in public offering, but priced the offering with 33% discount, which sent its stock down.
Bellicum announced a poster presentation by UNC Lineberger team at the ASH meeting. The presentation provided data on four patients who received rimiducid to activate the CaspaCIDe safety switch in an investigator sponsored trial.
Mustang announced recent CAR T cell therapy portfolio updates and provided anticipated milestones for 2023. MB-106 clinical trial under Mustang’s IND continues to enroll patients. Additional IND filing and published research expected in 2023 across portfolio.
Immutep announced that a GMP compliant manufacturing process has been established for IMP761, its proprietary preclinical candidate for autoimmune diseases. The 200L scale attained by Northway Biotech, an end-to-end biopharmaceutical CDMO, will ensure supply of IMP761 for IND-enabling studies and ensuing clinical trials.
A month after laying off 115 employees, Clovis sold the rights to radiopharmaceutical pipeline candidate FAP-2286 to Novartis for $50 million upfront, and then filed for Chapter 11 bankruptcy protection. The company had reported falling sales for its sole approved product, PARP inhibitor Rubraca rucaparib, which it withdrew from the market in June to treat BRCA-mutated ovarian cancer. Clovis is eligible for up to $333.8 million in development and regulatory milestones and $297 million in sales milestones in connection with the FAP-2286 sale.