ADCT announced that a permanent J-code, J9359, has been issued for Zynlonta by US Centers for Medicare & Medicaid Services effective as of April 1, 2022.
ImmunoGen announced that it will host a conference call on May 6, 2022 to discuss its first quarter 2022 operating results. Management will also provide a brief update on the business.
Mersana presented three posters highlighting data for XMT-1660, XMT-2056, and the Immunosynthen ADC platform at AACR Meeting. XMT-1660 demonstrates robust activity in preclinical models of breast cancer. XMT-2056 demonstrates robust activity as monotherapy, in combination with standard of care therapies and in both HER2-high and HER2-low expressing preclinical models.
Seagen announced that European Commission approved Padcev (enfortumab vedotin) for lovally advanced or metastatic urothelial cancer.
Separately, Seagen reported net loss for Q1 2022 was $137 million, or $0.74 per share, compared to net loss in Q1 2021 of $121 million, or 0.67 per share.
Alkermes announced that it commenced binding arbitration proceedings in respect of two license agreements with Janssen. Under these agreements, Janssen received access and rights to Alkermes' small particle pharmaceutical compound technology, known as NanoCrystal technology, which enabled a number of successful products, such as Invega Sustenna, Invega Trinza, Invega Hafyera and Cabenuva.
Separately, Alkermes reported net loss was $36 million for the quarter, or $0.22 per share, compared $22 million, or $0.14 per share, for the same period in the prior year.
ImmunityBio announced the first participants have been enrolled in a study that is part of an 800-site master protocol trial for NSCLC. The Lung-MAP trial includes a study of Anktiva (N-803) plus Keytruda vs investigator choice of SOC chemotherapy in patients with NSCLC whose cancer has progressed after prior checkpoint-inhibitor-containing regimens.
Nektar and BMS announced they have jointly decided to end the global clinical development of bempeg in combination with Opdivo. Nektar also announced plans to cut 70% of its staff.
Xencor presented new data from its preclinical-stage IL-18 and LAG3-targeted IL-15 cytokine programs at AACR Meeting. Xencor engineered LAG3-targeted IL15/IL15Rα-Fc cytokine/antibody fusion proteins (LAG-3 x IL-15) for selective activation of LAG3-positive immune cells, which may potentially avoid systemic toxicities arising from off-target activation and expansion of peripheral immune cells.
Allogene announced that FDA has granted Orphan Drug designation to ALLO-605, the next-generation AlloCAR T product candidate targeting BCMA for the treatment of multiple myeloma. ALLO-605 is in Phase 1 in IGNITE trial and part of Allogene’s multi-pronged strategy targeting BCMA.
Autolus announced that FDA granted Regenerative Medicine Advanced Therapy designation to its obe-cel, a CD19-directed autologous CAR T therapy that is in FELIX Phase 2 study of relapsed or refractory B-acute lymphocytic leukemia.
The short interest of Bellicum decreased in April by 14 % to 214,089 on April 14, compared to 249,400 on March 15.
Mustang announced updated interim data from the ongoing Phase 1/2 clinical trial of MB-106, a CD20-targeted, autologous CAR T cell therapy for patients with relapsed or refractory B-cell NHL and CLL. Very favorable safety profile suitable for outpatient treatment, high complete response rate and strong durability was observed, including patients with Waldenstrom macroglobulinemia and those who received prior CD19-directed CAR T therapy.
Arcus announced it will report financial results and key pipeline updates for the first quarter on May 9, 2022.
Immutep announced new interim data from first line NSCLC patients (Part A) of the Phase 2 TACTI-002 trial has been selected for an oral presentation at ASCO.
Clovis presented two abstracts featuring non-clinical data from studies evaluating FAP-2286 and Rubraca and a Trial-in-Progress poster detailing the Phase 1 portion of the LuMIERE study at AACR. FAP-2286 demonstrated potent affinity for human fibroblast activation protein by biochemical and cell-based assays.