6th Patient dosed in ACHIEVE Study in Patients with AML
“The dosing and restart of ACHIEVE represents an important milestone in our progress towards Phase 2b efficacy data in AML with an interim data announcement in the next six to nine months, as well as proof in our ability to successfully navigate potentially arduous regulatory and clinical trial environments in both ACHIEVE and ACHIEVE2,” said Bryan Kobel, CEO of TC BioPharm. “In addition to dosing our 6th patient and restarting ACHIEVE, we’ve screened and enrolled additional patients into the trial and expect to dose up to 10 more in 2024 and expect to open at least one additional clinical trial site in Q3. These efforts, combined with additional refinement of TCB-008 over the last 6 months, escalating the dose size in the ACHIEVE trial and existing data, have us poised for inflection points in 2024 and confidence in our ability to continue to execute on our clinical trial plans. Based on the substantial clinical safety and efficacy data to date and encouraging tolerability information generated in the five-patient safety cohort of ACHIEVE, we are excited to realize the potential of TCB-008 as a mono-therapy and continue to pursue partners for combination therapies.”
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
