ADCT reported Q4 and annual financial results. Net loss was $34 million, or a net loss of $0.45 per share, for the quarter, and $230 million, or a net loss of $3 per share, for the full year 2021. This compares to a net loss of $56 million for the same quarter in 2020 and a net loss of $246 million for the full year 2020.
ImmunoGen submitted BLA under the accelerated approval pathway to the US FDA for mirvetuximab soravtansine monotherapy in patients with folate receptor alpha (FRα)-high platinum-resistant ovarian cancer who have been previously treated with 1 to 3 prior systemic treatments. The submission is based on results from the pivotal Phase 3 SORAYA trial.
Mersana presented an analysis based on the June 10th, 2021 data cut from the expansion cohort of the company’s Phase 1 trial of upifitamab rilsodotin at SGO Meeting on Women’s Cancer. The data highlighted the compound’s robust clinical activity and differentiated safety profile which further support design of ongoing UPLIFT registrational trial in platinum-resistant ovarian cancer.
Seagen and Sanofi today announced an exclusive collaboration agreement to design, develop, and commercialize ADCs for up to three cancer targets. The collaboration will utilize Sanofi’s proprietary monoclonal antibody technology and Seagen’s proprietary ADC technology.
The short interest of Alkermes decreased in March by 23 % to 9,030,611 on March 15, compared to 11,675,403 on February 15.
The short interest of ImmunityBio increased in March by 14 % to 16,670,227 on March 15, compared to 14,565,139 on February 15.
Nektar announced an update following the first analysis of the Phase 3 PIVOT IO-001 study evaluating the doublet therapy of bempeg in combination with Opdivo compared to Opdivo monotherapy as a first-line treatment for previously untreated unresectable or metastatic melanoma. The study did not meet the primary endpoints of PFS and ORR as assessed by Blinded Independent Central Review.
Xencor presented preclinical data on two novel XmAb cytokine programs at the AACR meeting. The company reported data of its LAG3-targeted IL15/IL15Rα-Fc fusion proteins for preferential TIL expansion, and that its engineered IL18 heterodimeric Fc-fusions featuring improved stability, reduced potency, and insensitivity to IL18BP.
Allogene announced that the FDA has granted Fast Track designation to its first AlloCAR T solid tumor clinical candidate, ALLO-316. The designation is granted to the candidate as a potential treatment for patients with advanced or metastatic clear cell RCC. Allogene is currently evaluating ALLO-316 in a phase 1 study for treating advanced or metastatic clear cell RCC.
Autolus announced that EMA has granted obe-cel, Autolus’ leading CAR T clinical candidate, Orphan Medical Product Designation for treatment of ALL patients. Recruitment is ongoing in the Phase 2 portion of the pivotal study of obe-cel and we look forward to announcing first Phase 2 data this year.
Bellicum reported net income of $3 million and a net loss of $10 million for 4Q and full year 2021, respectively, compared to net income of $19 million and a net loss $8 million for 4Q and full year 2020, respectively.
Mustang reported net loss of $66.4 million, or $0.76 per share, for the full year 2021, compared to a net loss attributable to common stockholders of $60 million, or $1.14 per share, for 2020.
Arcus announced initial PK/PD data for AB521, Arcus’s HIF-2a inhibitor, in healthy volunteers confirms its potential to have an improved clinical profile compared to that of the only approved HIF-2a inhibitor.
Immutep announced new interim data in 2nd line metastatic NSCLC from its Phase 2 TACTI-002 trial evaluating eftilagimod alpha with pembrolizumab in a total of 36 patients with PD-L1 unselected 2nd line PD-X refractory metastatic NSCLC. The new data reflects the first interim results combining Stages 1 (23 patients) and 2 (13 patients) in 2nd line NSCLC.
Clovis announced positive topline data from the monotherapy arm of Phase 3 ATHENA-MONO trial of Rubraca as first-line maintenance treatment in ovarian cancer. Rubraca achieved the primary endpoint of significantly improved PFS compared with placebo (20.2 months vs. 9.2 months). The median PFS for the HRD-positive patient population treated with rucaparib was 28.7 months vs. 11.3 months among those who received a placebo.