Nordic Life Science 1
PHASE I/IIA NEW CLINICAL DATA FROM BIOINVENT Team
Targovax COMB I N AT ION T RI A L Martin Welschof, CEO, BioInvent Clinical responses were observed in three out of nine patients in part 1 of the ONCOS-102 and Keytruda combination trial in anti-PD1 checkpoint inhibitor (CPI) refractory advanced melanoma. HE PRIMARY AND secondary endpoints of the trial are to assess safety, immune activation and clinical responses of ONCOS-102 and Keytruda combination treatment. The main scientific aim is to test the hypothesis that ONCOS-102 can immune activate anti-PD1resistant patients to respond to re-challenge with an antiPD1 CPI. Part 1 safety data now shows that the sequential ONCOS-102 and Keytruda treatment regimen is well tolerated. The efficacy is also very encouraging, with three of nine patients demonstrating a clinical response (33% ORR). The data also confirms the hypothesis that ONCOS-102 is able to immune activate treatment-resistant tumors to respond to re-challenge with an anti-PD-1 CPI. ONCOS-102 was also seen to induce profound innate and adaptive immune activation. Part 2 of the trial is currently enrolling patients, where safety and efficacy of a more intensive treatment regimen of twelve ONCOS-102 injections will be evaluated. TARGOVAX HAS NOW also initiated an expansion part in their phase I/II trial with ONCOS-102 in combination with durvalumab. All safety reviews during the dose escalation phase have been completed with no Dose Limiting Toxicities (DLT) reported and the five US hospital sites are now open for further recruitment. This trial investigates the safety, biologic and anti-tumor activity of ONCOS-102 in combination with Imfinzi Magnus Jäderberg, CEO, Targovax (durvalumab, anti-PD-L1) in patients with advanced peritoneal malignancies who have failed prior standard chemotherapy and have histologically confirmed platinum-resistant or refractory epithelial ovarian or colorectal cancer. THE COMPANY HAS announced the publication of the first data from two parallel Phase l/lla clinical trials of its lead product candidate BI-1206 as a single agent and/or in combination with rituximab, currently being conducting in the UK and the US/EU, respectively. In the UK trial, 10 patients have received single agent therapy with up to 100 mg BI-1206 once weekly for a period of 4 weeks. In the US/EU study, five patients have received up to 100 mg BI-1206 in combination with rituximab. Receptor occupancy is dose proportionate and anticipated to yield high levels of receptor blockade at clinically relevant doses of BI-1206. While target-mediated drug disposition has not yet been overcome, as the optimal dose has still not been reached, pharmacodynamic analysis at the current doses showed depletion of peripheral B cells, including circulating mantle cell lymphoma cells during the first week of induction therapy. “These are exciting results that further support the development of BI-1206 as a potential first-in-class therapeutic with a unique mechanism of action. Circumventing rituximab internalization by FcγRIIB blocking means it will potentially enhance rituximab’s efficacy,” says BioInvent’s CEO, Martin Welschof. NORDICLIFESCIENCE.ORG 19