ADC T. announced six data presentationsfrom the ongoing trials of Zynlonta and ADCT-602 at ASH. This included presentations from investigators on subset data from pivotal Phase 2 study and data on the use of Zynlonta post-CAR-T.
ImmunoGen announced that updated initial safety and efficacy findings from Phase 1b/2 study of IMGN632 in combination with Vidaza (azacitidine) and Venclexta (venetoclax) in patients with relapsed or refractory AML were presented in oral session at ASH.
Mersana participated in a fireside chat at the 4th Annual Evercore ISI HealthCONx Conference.
Seagen and Astellas announced that the EMA’s CHMP has adopted a positive opinion, recommending approval of the ADC Padcev (enfortumabvedotin) as monotherapy for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received platinum-containing chemotherapy and a PD-1/L1 inhibitor.
Alkermes participated in a fireside chat at the 4th Annual Evercore ISI HealthCONx Conference.
ImmunityBio has successfully raised an aggregate $470 million of equity and debt financing in 2021, with $300 million in new debt financing from NantCapital. With this new financing from ImmunityBio’s Patrick Soon-Shiong, the company is well positioned to pursue its late-stage clinical portfolio, expand large-scale GMP manufacturing capacity, and advance recruitment of a commercial organization in the urology market.
Nektar announced two data presentations from the dose-escalation portion of its ongoing Phase 1 study of NKTR-255 in patients with relapsed or refractory hematologic malignancies at ASH. The data underscore the potential of NKTR-255 and provide clinical evidence of its unique ability to trigger the induction of natural killer and CD8+ T cells and highlight its potential role in rescuing and enhancing CAR-T cell persistence.
Xencor presented at ASH data from Phase 1 dose-escalation study of plamotamab, a CD20 x CD3 bispecific antibody, in patients with B-cell NHL. Plamotamab is generally well tolerated and demonstrates encouraging clinical activity in heavily pretreated patients at our recommended intravenous Phase 2 dose of 50 mg flat dosing every two weeks following step-up dosing.
Allogene reported updated data from two Phase 1 clinical trials (ALPHA and ALPHA2) of its lead anti-CD19 AlloCAR T therapy programs (ALLO-501 and ALLO-501A) at ASH. Data from the trials continue to validate the promise of AlloCAR T platform to be a safe and durable alternative to approved autologous CAR T therapies.
Autolus presented further progress on obe-cel in an oral presentation at ASH. The company also presented an update of obe-cel in relapsed or refractory aggressive and indolent B-Cell NHL and CLL patients from the ALLCAR19 extension study, as well as preclinical and initial engraftment data with AUTO1/22 in Pediatric ALL in two poster presentations.
Bellicum announced positive interim data from its ongoing Phase 1/2 GoCAR-T trials, including a confirmed partial response in the first cohort of mCRPC patients treated in the clinical trial for BPX-601. Bellicum has also entered into an agreement for a $35 million private placement of equity securities with two biotechnology specialist investment funds. Proceeds will be used to support development of BPX-601 and BPX-603.
Mustang announced updated 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. Investigators observed 95% ORR, 65% CRR and favorable safety profile in patients treated with modified cell manufacturing process.
Arcus and Gilead announced the closing of Gilead’s option exercises to three programs in Arcus’s clinical-stage portfolio and a new research collaboration between the two companies.
Immutep announced it has signed a Manufacturing Service Agreement (MSA) with Northway Biotech, an end-to-end biopharmaceutical contract development and manufacturing organization, to manufacture IMP761 ahead of clinical testing.
Clovis presented at the 3rd Targeted Radio-pharmaceuticals Summit, reviewing the company’s preclinical data and described Phase 1/2 study currently enrolling for its targeted radiotherapy candidate FAP-2286, the first PTRT and imaging agent targeting FAP to enter clinical development.