Nordic Life Science 1
CLINICAL TRIALS PH A SE I / PH A SE I I PH A SE I
B / I I IMMUNICUM ADVANCES ITS COMBINATION TRIAL THE COMPANY HAS PRESENTED NEW DATA FROM ITS COMPLETED PHASE IA STUDY WITH MIV-818. HE COMPLETION OF the ABY-039 Phase 1 trial has been announced, as well as the termination of the same program due to tolerability observations that would limit the target product profile of subcutaneous high dose once monthly maintentance injections. Based on these observations Alexion has terminated the codevelopment agreement with Affibody. Affibody has also announced positive data from its 52-week trial investigating the novel bispecific IL-17A inhibitor ABY-035 in patients with moderate-to-severe psoriasis (“AFFIRM-35”). Based on these encouraging clinical results in patients with moderate-to-severe psoriasis, the clinical development program of ABY-035 has been expanded to include further indications for development and commercialization. “In this patient-centric study, we saw direct therapeutic benefit to psoriasis patients by utilizing an experimental medicines adaptive design based on the absolute disease scores of each patient,” says Fredrik Frejd, CSO of Affibody. “Furthermore, the excellent safety and tolerability observed is highly promising, and this is important for the Affibody platform, with repeated high dose administration exceeding two years in a substantial proportion of the patients. The low molecular weight of the molecule enables a very effective way of delivering the drug subcutaneously in a convenient outpatient setting.” The sixth patient has completed the safety period in the ongoing Phase Ib/II ILIAD combination trial with ilixadencel, the company’s cell-based, off-the-shelf immune primer for the treatment of solid tumors. THE DOSE ESCALATION Committee (DEC) confirmed there were no dose limiting toxicities, therefore the study can move into the non-staggered inclusion phase. The Phase Ib portion of Fredrik Frejd, CSO, Affibody PHA SE I / I I B VACCIBODY FINALIZES PATIENT ENROLLMENT IN ITS VB N-01 TRIAL THE COMPANY HAS REACHED THE TARGET OF 50 PATIENTS AND HAS FINALIZED RECRUITMENT TO ALL STUDY ARMS OF ITS ONGOING TRIAL OF THE PERSONALIZED VB10.NEO NEOANTIGEN CANCER VACCINE. VB N-01 IS A basket trial for patients with locally advanced or metastatic melanoma, non-small cell lung carcinoma, clear renal cell carcinoma as well as urothelial cancer or squamous cell carcinoma of the head and neck. In the trial the safety, feasibility and efficacy of treatment with the vaccine is evaluated, including one study arm evaluating the combination of VB10.NEO and bempegaldesleukin (NKTR-214) in patients with head and neck cancer. The trial has been recruiting patients from seven clinical sites in Germany. “We are truly grateful to the patients for participating in the trial, to our investigators at the clinical trial sites, our supply chain partners and the dedicated Vaccibody team who has done a great job by finalizing the enrollment and ensuring successful manufacture of the patient specific VB10.NEO products despite the challenging COVID-19 situation. Further, we are pleased that the recruitment of patients distributes well across all of the six treatment arms,” says Siri Torhaug, CMO, Vaccibody. the ILIAD trial is evaluating the safety and tolerability of ilixadencel in combination with the checkpoint inhibitor (CPI) Keytruda in 21 patients. In the staggered part of the Phase Ib portion, the initial 3 patients received a dose level of 3 million cells of ilixadencel, with a subsequent 3 patients receiving a dose level of 10 million cells of ilixadencel. The non-staggered phase will now allow the remaining 15 patients to proceed more rapidly, as there will no longer be a safety waiting period between patient enrollments. However, due to the COVID-19 pandemic, the company’s ability to further accelerate enrollment with additional clinical centers may be impacted. The next safety update is therefore expected by the end of 2020, with full enrollment of the Phase Ib part of the trial in the first half of 2021, and completion of the Phase Ib with longer duration of follow-up of patients for signs of efficacy towards the second half of 2021. 22 NORDICLIFESCIENCE.ORG