Patritumab deruxtecan BLA submission received complete response letter from FDA

CLINICAL AND REGULATORY 

Patritumab deruxtecan BLA submission received complete response letter from FDA 

The CRL results from findings pertaining to an inspection of a third-party manufacturing facility. The CRL did not identify any issues with the efficacy or safety data submitted. Patritumab deruxtecan is a specifically engineered potential first-in-class HER3 directed DXd ADC discovered by Daiichi Sankyo and being jointly developed by Daiichi Sankyo and Merck. The BLA is based on the primary results from the HERTHENA-Lung01 pivotal Phase 2. Patritumab deruxtecan was studied in 225 patients with EGFR-mutated locally advanced or metastatic NSCLC following disease progression with an EGFR TKI and platinum-based chemotherapy, which demonstrated ORR of 29.8%. The median DoR was 6.4 months. 

Enhertu demonstrated median PFS of 13.2 months in HR-positive metastatic breast cancer 

Detailed positive results from DESTINY-Breast06 Phase 3 trial showed that Enhertu demonstrated a statistically significant and clinically meaningful improvement in PFS compared to SOC chemotherapy in patients with HR-positive, HER2-low metastatic breast cancer and the overall trial HER2-low and HER2-ultralow following one or more lines of endocrine therapy. Enhertu is a specifically engineered HER2-directed DXd ADC. In the primary analysis of DESTINY-Breast06, results showed Enhertu reduced the risk of disease progression or death by 38% by BICR versus chemotherapy in patients with HER2-low expression. Median PFS was 13.2 months in the Enhertu arm compared to 8.1 months for chemotherapy. PFS results by BICR in the overall trial population were similar and showed Enhertu achieved a 37% reduction in the risk of disease progression or death compared to chemotherapy, with a median PFS of 13.2 months with Enhertu versus 8.1 months for chemotherapy. A prespecified exploratory analysis showed the clinically meaningful improvement in PFS was consistent between patients with HER2-low and HER2-ultralow expression. In patients with HER2-ultralow expression, Enhertu reduced the risk of disease progression or death by 22% compared to chemotherapy with a median PFS of 13.2 months versus 8.3 months. 

FDA puts partial clinical hold on Biontech’s ADC trial after fatalities 

Less than a month after BioNTech and Chinese partner MediLink Therapeutics disclosed promising Phase 1 data for HER3-targeting ADC BNT326 (YL201), BioNTech reported that FDA has placed a clinical hold on the study. BioNTech said in an SEC filing that it had been informed by MediLink, that the FDA held concerns that BNT326/YL202 may, at higher doses, expose human subjects to “unreasonable and significant risk of illness or injuries”. The first-in-human trial is evaluating BNT326/YL202 as a later-line treatment in heavily pre-treated patients with advanced or metastatic EGFR-mutated NSCLC or HR+/HER2-negative breast cancer. The partial clinical hold follows BioNTech’s presentation of data from the Phase 1 trial at ASCO 2024, which showed that three patient deaths were observed in two dose cohorts. 

Elahere shows promising results in Phase 2 in high FRα expressing platinum-sensitive ovarian cancer 

AbbVie announced positive topline results from the Phase 2 PICCOLO trial evaluating investigational mirvetuximab soravtansine (Elahere) monotherapy in heavily pre-treated patients with folate receptor-alpha (FRα) positive, platinum-sensitive ovarian cancer. The study met its primary endpoint with an ORR of 51.9% (95%CI 40.4 – 63.3%). In addition, the median DOR, a key secondary endpoint, was 8.25 months. The safety profile of mirvetuximab soravtansine was consistent with findings from previous studies, and no new safety concerns were identified. Full data from the PICCOLO study will be presented at a future medical meeting. 

DEALS AND FINANCING 

Adcytherix launches with €30 million in seed funding to develop next generation ADCs 

Adcytherix announced its incorporation and seed funding of €30 million to develop novel ADCs for the treatment of high unmet need diseases such as cancer. The company was founded by Jack Elands and Pontifax Venture Capital with Xavier Preville and Carsten Dehning as co-founders. Adcytherix’ senior management team comprises Jack Elands (CEO), Carsten Dehning (CFO) and Xavier Preville (VP, Head of Research and Preclinical Development). The seed round was led by Pontifax and supported by Pureos Bioventures, RA Capital Management and Dawn Biopharma (a platform controlled by KKR). Management also participated in the seed round.