FDA clears IND for Ph 1/2a trial (TCX-101) of BSB-1001 for patients with R/R AML, ALL and MDS, in conjunction with alloHSCT
“We are eager to begin treating patients in our TCX-101 trial,” said Keir Loiacono, Esq., Chief Executive Officer of BlueSphere. “Our team is focused on accelerated identification, development and translation of novel products to the clinic. While alloHSCT provides a chance of a cure for patients, a large fraction of patients will still relapse or do not have it as an option because of active leukemia. Deploying a TCR-based approach to blood restricted antigens – like miHAs combined with alloHSCT – could provide new options for these patients. We believe that BlueSphere’s unique approach to product and trial design will, among other things, enable us to treat patients who previously were unable to receive alloHSCT because of the presence of active leukemia.”
Share:
More News
PharmaMar has submitted a Marketing Authorization Application to the European Medicines Agency for Zepzelca® (lurbinectedin) in combination with atezolizumab (Tecentriq®) for the maintenance treatment of adult patients with extensive-stage small cell lung cancer, whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide. The MAA submission
“At SR One, our mission is to invest in companies that we believe have the ability to innovate and advance transformational new therapies in areas of high unmet medical need,” said Simeon George, M.D., Chief Executive Officer and Managing Partner at SR One. “Fore Bio is focused on resetting the
The study demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of TACE-progression-free survival (TACE PFS*), and the other primary endpoint of overall survival (OS) is immature at the prespecified first interim analysis. Meanwhile, a clinically meaningful PFS by RECIST v1.1** was also observed. Detailed findings from
“The positive CHMP recommendation for the Itovebi-based regimen represents a significant step towards providing people in the EU with PIK3CA-mutated, ER-positive advanced breast cancer with a targeted therapy in the first-line setting,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “This recommendation is
