ADCT reported net loss of $17 million, or a net loss of $0.22 per share, for Q1 2022. This compares to a net loss of $52 million, or a net loss of $0.67 per share, for the same quarter in 2021.
Immunogen said that FDA accepted and filed the BLA for mirvetuximab soravtansine monotherapy in patients with FRα-high platinum-resistant ovarian cancer who have been previously treated with 1 to 3 prior systemic treatments. The application has been granted Priority Review designation.
Mersana announced that FDA has granted orphan drug designation to XMT-2056, the company’s lead Immunosynthen STING-agonist ADC, for the treatment of gastric cancer.
Seagen announced positive topline results from the pivotal phase 2 MOUNTAINEER trial investigating Tukysa in combination with trastuzumab in patients with previously treated HER2-positive metastatic CRC. Data from this trial will form the basis of a planned sNDA to FDA under the FDA’s Accelerated Approval Program. Results showed a 38.1% confirmed ORR. The median DOR was 12.4 months.
Alkermes announced the acceptance of four abstracts related to nemvaleukin, the company's IL-2 variant immunotherapy at ASCO. The final dataset from the phase 1/2 ARTISTRY-1 trial, evaluating nemvaleukin as monotherapy and in combination with pembrolizumab, will be shared in an oral presentation. In addition, trial-in-progress posters from ongoing ARTISTRY-3 trial and the potential registration-enabling studies ARTISTRY-6 and ARTISTRY-7 will be presented.
ImmunityBio has submitted BLA to FDA for N-803, IL-15 superagonist, plus Bacillus Calmette-Guérin (BCG) for the treatment of BCG-unresponsive non-muscle invasive bladder carcinoma in situ with or without Ta or T1 disease. The BLA is supported by the results of ImmunityBio’s studies in bladder cancer including the pivotal QUILT 3032 study.
Nektar came out with a quarterly loss of $0.49 per share versus estimate of a loss of $0.72. This compares to loss of $0.68 per share a year ago. The company said the workforce reduction is on track.
Xencor reported initial dose-escalation data from the Phase 1 study evaluating XmAb®104, a PD-1 x ICOS bispecific antibody, in patients with advanced solid tumors (DUET-3). These results will be presented at ASCO. XmAb104 has been well tolerated and is exhibiting a distinct safety profile compared to other clinical ICOS programs, which, along with early anti-tumor activity in patients, supports its evaluation in expansion cohorts.
Allogene presented preclinical findings evaluating the characteristics and function of donor-derived allogeneic CAR T cells. Data showed that cells from a diverse set of younger donors had improved characteristics and better in vitro anti-tumor activity compared to cells from older donors. The study also showed that cells from patients with certain cancers generally performed suboptimally based on functional assays and often could not be used to generate viable CAR T therapies.
Autolus reported net loss of $37 million, or $0.41 per share, for 1Q 2022, compared to $33 million, or 0.53 per share, for the same period in 2021.
Bellicum reported a net loss of $8 million for the first quarter 2022, compared to a net loss of $11 million for first quarter 2021.
Mustang announced that results from the follicular lymphoma cohort of the ongoing Phase 1/2 trial of MB-106, a CD20-targeted, autologous CAR T cell therapy, in patients with relapsed or refractory B-cell NHL and CLL were selected for an oral presentation at the EHA.
Arcus reported net loss was $68 million for the three months ended March 31, 2022, compared to a net loss of $72.6 million for the same period in the prior year.
Immutep announced new interim data from Part A of the Phase 2 TACTI-002 trial in 1st line NSCLC has been published in an abstract at ASCO 2022. The oral presentation will present data from all 114 patients with a more recent data cut off and will be the subject of a further announcement from the company.
Clovis reported a net loss for Q1 2022 of $60 million, or ($0.44) per share, compared to a net loss for Q1 2021 of $66 million, or ($0.64) per share.