ADCT announced its MAA for Zynlonta, a CD19-targeted ADC for the treatment of relapsed or refractory DLBCL, has been validated by EMA. Validation of the application enables the evaluation process by the EMA’s CHMP to begin.
ImmunoGen came out with a quarterly loss of $0.18 per share versus the estimate of a loss of $0.19. This compares to loss of $0.13 per share a year ago.
Mersana highlighted new preclinical data for XMT-2056, and immunosynthen STING agonist ADC candidate targeting HER2. The candidate was well tolerated and showed in vivo efficacy as single agent in a SKOV3 HER2 high model. The data were presented at AACR-NCI-EORTC conference.
Seagen and Astellas announced the patient enrollment was completed in Cohort K of the phase 1b/2 EV-103 trial. The cohort is evaluating Padcev in combination with Keytruda as first-line treatment in patients with unresectable locally advanced or metastatic urothelial cancer who are unable to receive cisplatin-based chemotherapy in the first-line setting.
Alkermes announced initiation of ARTISTRY-7, a global Phase 3 trial evaluating the anti-tumor activity and safety of intravenously administered nemvaleukin alfa in combination with Keytruda, compared to chemotherapy, in patients with platinum-resistant ovarian cancer.
ImmunityBio announced that papillary disease (Cohort B), the second indication of its QUILT 3.032 Phase 2/3 study of intravesical BCG plus Anktiva in patients with BCG-unresponsive high-grade NMIBC, also met its primary endpoints with disease-free survival of 57% of patients at 12 months. The company has previously reported that the primary endpoint of Cohort A, patients with CIS disease, has been met with a complete response of 72% (58/81).
Nektar will announce its financial results for the third quarter 2021 on Thursday, November 4, 2021, after the close of US financial markets.
Xencor announced that it is collaborating with Janssen for development and commercialization of plamotamab and XmAb CD28 bispecific antibody combinations to treat patients with B-cell malignancies. Xencor will receive $100 million as upfront payment and $25 million as equity. The company will further be eligible to receive potential milestone payments up to $1.188 billion and royalties on net product sales.
Allogene reported that following a report of a chromosomal abnormality in ALLO-501A CAR T cells in a patient treated in the ALPHA2 study, FDA has placed a hold on the Company’s AlloCAR T clinical trials. Allogene expects to provide additional updates in the coming weeks following consultation with the FDA.
Autolus announced that it will release its third quarter 2021 financial results and operational highlights before open of US markets on Wednesday, November 3, 2021.
The short interest of Bellicum decreased in September by 26% to 777,729 on October 15, compared to 1,049,113 on September 13.
Mustang participated in a fireside chat at Chardan’s Virtual 5th Annual Genetic Medicines Conference, taking place on October 5, 2021.
The market expects Arcus to deliver a year-over-year decline in earnings on lower revenues when it reports results for the quarter ended September 2021. The earnings report might help the stock move higher if the key numbers are better than expectations.
Immutep announced it has received positive feedback from EMA regarding its clinical development program for lead product candidate, eftilagimod alpha, including the planned Phase 3 trial in MBC. In its scientific advice EMA has supported the company’s view to continue the development of efti in MBC in Phase 3 clinical trial, based on clinical data presented in December 2020 at SABCS.
Clovis will announce its third quarter 2021 financial results on Wednesday, November 3, 2021, before the open of the US financial markets. The company separately announced lutetium-177 clinical supply agreement with ITM Isotope Technologies.