Vincerx Pharma reports Q2 EPS (52c), consensus (60c)

“I am excited to report that the Investigational New Drug application for our first antibody-drug conjugate, VIP943, was filed and is under review by the U.S. Food and Drug Administration,” said Ahmed Hamdy, M.D., CEO. “We believe that our next-generation ADC technology represents a significant step forward in the treatment of cancer by potentially overcoming the safety and efficacy challenges associated with many ADCs. Our unique combination of internalizing antibodies, selective and stable linkers, novel payloads, and exclusive CellTrapper technology allows for greater intracellular accumulation of the payload, potentially leading to higher efficacy while limiting unwanted side effects. We currently expect to dose our first patient with VIP943 in the fourth quarter. We also continue enrolling patients in our Phase 1 dose escalation study for VIP236, our first-in-class small molecule drug-conjugate. VIP236 is designed to deliver an optimized camptothecin payload to tumors expressing alphavbeta3, which is found in advanced and metastatic tumors. Encouragingly, VIP236 preclinical data shows enhanced efficacy-independent of HER2 status- in patient-derived xenograft and cell line-derived gastric cancer models compared with the ADC ENHERTU. Given the first-in-class nature of this program, we are evaluating several dosing approaches and expect to provide preliminary results by late 2023 or early 2024. On the business development front, we are thrilled to welcome Mr. Steve Bloom as our new Chief Business Officer. With Steve on board, we believe we are positioned to accelerate our ongoing business development activities and capitalize on the burgeoning industry enthusiasm for bioconjugates. As we enter the latter half of the year, we are strategically focusing our resources on VIP943 and VIP236, along with exploring potential research and other collaborations that can bolster the advancement of these two lead programs, as well as leverage the strength of our next-generation modular bioconjugation platform.”