ADCT reported in its Q3 results that net loss was $51 million, or a net loss of $0.65 per basic and diluted share, for the quarter ended September 30, 2022. This compares to a net loss of $72 million, or a net loss of $0.93 per basic and diluted share, for the same quarter in 2021.
Immunogen announced that FDA has granted accelerated approval for its Elahere (mirvetuximab soravtansine-gynx) for the treatment of adult patients with folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens.
Mersana reported net loss for the third quarter of 2022 was $60 million, or $0.61 per share, compared to a net loss of $46 million, or $0.63 per share, for the same period in 2021.
Seagen announced that FDA has approved Adcetris (brentuximab vedotin) for the treatment of pediatric patients 2 years and older with previously untreated high risk classical Hodgkin lymphoma, in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide.
Alkermes reported net loss of $64 million for the quarter, or $0.39 per share. This compares to net loss of $29 million, or $0.18 loss per share, for the same period in the prior year. Separately, the company ennounced its intention to separate its oncology pipeline from the CNS business.
ImmunityBio has published results from the QUILT 3.032 trial studying N-803 plus BCG in adults with NMIBC CIS with or without Ta/T1 papillary disease. These positive data form the basis of ImmunityBio’s BLA for BCG-unresponsive NMIBC CIS, which the FDA accepted for review in July 2022. The published results demonstrate that in patients with BCG-unresponsive NMIBC CIS and papillary disease, BCG plus N-803 (referred to as NAI) CRs were achieved with a persistence of effect with 90% probability of avoiding cystectomies in responders, a life-changing procedure of removing the bladder, and 100% bladder cancer-specific survival at 24 months.
Nektar announced the first presentation of preclinical data for NKTR-288 at SITC meeting. NKTR-288 is a novel PEG-conjugate of IFN-γ, designed to modify binding of IFN-γ to its substrates and optimize the duration of IFN-γ signaling. The presentation showed the sustained pharmacological properties of NKTR-288 relative to native cytokine, including durable exposure and induction of the well characterized interferon gamma response.
Xencor announced topline clinical data from its Phase 1a single-dose, healthy volunteer study of XmAb564, in development for patients with autoimmune diseases. XmAb564 is a wholly owned, monovalent IL2 Fc fusion protein, engineered with dramatically lowered potency and heightened binding affinity for the IL-2 alpha receptor (CD25), resulting in selective activation of regulatory T cells (Tregs). XmAb564 was well-tolerated across all dose levels.
Allogene presented preclinical data on a novel approach to immune “cloaking” designed to protect AlloCAR T cells from rapid host rejection. The technology is designed to prevent AlloCAR T cells from being recognized by host T cells without triggering substantial NK cell rejection and while preserving CAR T cell function. The findings were presented at SITC.
Autolus announced its operational and financial results for the third quarter. Net loss attributable to ordinary shareholders was $43 million for the three months ended September 30, 2022, compared to $34 million for the same period in 2021.
Bellicum reported a loss from operations of $7 million and $20 million for the three and nine months ended September 30, 2022, respectively, compared to a loss from operations of $3 and $20 million for the three and nine months ended September 30, 2021, respectively.
Mustang reported net loss was $19 million, or $0.18 per share, for the third quarter of 2022, compared to a net loss of $17 million, or $0.19 per share, for the third quarter of 2021.
Immutep and Merck KGaA announced they will jointly fund the INSIGHT-005 urothelial cancer study. It will be conducted as part of the investigator-initiated INSIGHT platform for studies investigating efti in different combination treatments and routes of administration.
Clovis announced the presentation of data from the TRITON3 Phase 3 trial in men with mCRPC with BRCA or ATM mutations. The positive results further demonstrate the important role that Rubraca may play as a treatment option for men with mCRPC associated with homologous recombination deficiency.