BIOTECHNOLOGY

Neogap has now obtained final approval from the European Patent Office for their pioneering approach to multiplying T-cells outside the body using their EpiTCer® technology and the production of tumor-specific T-cells.

Amplo Biotechnology's development of AMP-201 builds upon it's progression of AMP-101, an AAV-DOK7 gene therapy targeting Dok-7 congenital myasthenic syndrome, which Amplo expects to bring to clinical trial in 2024. Upon demonstrating initial safety and efficacy, the company plans to expand into other neuromuscular conditions, leveraging the vast potential of AMP-101 and AMP-201 to significantly enhance the quality of life for the majority of CMS patients.

“Given the unmet medical need for patients with recurrent/metastatic HPV16+ head and neck cancers, we are thrilled to share the preliminary data on HB-200 in combination with pembrolizumab as they show a robust improvement in objective response rate and prolonged tumor control compared to pembrolizumab alone,” said Joern Aldag, Chief Executive Officer at HOOKIPA. “Efficacy, immunogenicity and safety data observed in our HB-200 program to-date support our decision to progress to a pivotal trial of HB-200 in combination with pembrolizumab as 1st-line treatment for these patients. The data also underscore the scalability of our arenaviral platform across a range of cancers.”

Novan conducted a deliberate and thorough review of its commercial and development portfolio of assets to determine a path to optimally deploy capital and maximize shareholder value.

Pascal Prigent, CEO of GENFIT commented: “We are excited to be announcing this licensing deal which marks an additional milestone in the execution of our development strategy in liver diseases with high unmet medical needs. ACLF is a complex disorder that will likely require the combination of different approaches and with this acquisition, we continue to strengthen our leadership in this indication. We now have a unique portfolio of three differentiated clinical stage programs in ACLF. Considering its liver-centric activity, the potential for multi-organ benefits and the breadth of evidence supporting further development in ACLF, we strongly believe in the potential of SRT-015.”

To date, the ACTISAVE study has enrolled more than 300 patients across 10 countries in the world. Out of them, 100 have been treated with thrombolysis with thrombectomy, reaching the target for the first futility analysis. The Independent Data Meeting Committee (IDMC) will gather in Q4 2023 to confirm safety and ascertain that preliminary results are aligned with the initial trial assumptions notes Acticor Biotech.

f approved for Europe, PYLCLARI® (INN: Piflufolastat (18F) formerly known as [18F]-DCFPyL) will offer prostate cancer patients access to a diagnostic imaging agent more sensitive than conventional imaging notes Curium.

EMERALD Clinical Study is a Phase 3 registrational trial that demonstrated statistically significant PFS with elacestrant versus SOC endocrine monotherapy (fulvestrant, letrozole, anastrozole, exemestane). Based on these results, the U.S. Food & Drug Administration (FDA) approved ORSERDU (elacestrant) on January 27, 2023, for the treatment of postmenopausal women or adult men with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.