Peri-operative checkpoint inhibition improved survival in lung-cancer patients
Adding the PD-1 inhibitor nivolumab (Opdivo, BMS) before and after surgery improved event-free survival in non-small cell lung cancer (NSCLC) patients enrolled into the Phase 3 CheckMate77T trial. No specific survival rate has been published.
The randomized, double-blind, placebo-controlled trial combines nivolumab with chemotherapy in >400 subjects with resectable stage IIA to IIIB NSCLC. Nivolumab was approved as a neoadjuvant treatment of NSCLC in 2022.
Booster dose of Lyme disease vaccine was safe and immunogenic in children and adults
Seroconversion of 95% was reported from the Phase 2 VLA15–221 trial testing a booster dose of the Lyme disease vaccine candidate VLA15 (Valneva). Antibodies against the OmpA protein of all six targeted Borrelia serotypes were elicited in all age groups tested (5–65 years of age).
The placebo-controlled trial tested two vaccination regimens of the alum-adjuvanted VLA15 (0-2-6 and 0–6 months) and a booster dose 18 months later.
There is no approved vaccine for Lyme disease, which affects almost half a million people annually in the US alone.
Immunotherapy combination induced responses in > 50% of metastatic lung cancer patients
The IDO vaccine IO102-IO103 (IO Biotech) combined with the PD-1 inhibitor pembrolizumab (Keytruda, Merck) as a first-line treatment, induced partial responses in 8 of 15 subjects with metastatic NSCLC and high PDL1 levels, who were involved in the Phase 2 IOB-022/KN-D38 trial.
The vaccine targets indoleamine 2,3-dioxygenase, which is overexpressed in several cancer types, and due to its inhibitory effect on T and NK cells, is considered an immune checkpoint.
Viral immunotherapy improved antitumor immunity in advanced lung cancer
Oncolytic virotherapy CAN-2409 (Candel Therapeutics) in combination with pembrolizumab and the anti-HSV drug valacyclovir increased T-cell expansion and tumor infiltration in non-resectable, stage III/IV NSCLC patients who had not responded to immune checkpoint therapy. Ten of 40 subjects survived ≥18 months. Median survival in this patient population is 10–13 months.
CAN-2409 consists of non-replicative adenovirus design to deliver the herpes simplex virus thymidine kinase into tumors, where valacyclovir (administered orally) converts it into a toxic compound. The regimen has received the US Food and Drug Administration’s Fast-Track designation.
Oral norovirus vaccine was moderately efficacious in a challenge trial
The monovalent, oral tablet norovirus vaccine (Vaxart) reduced the rate of infection and viral shedding by 30% and 85%, respectively, in a Phase 2 challenge trial. A total of 165 healthy adults received the vaccine or placebo and were challenged with the norovirus GI.1 strain four weeks later. The vaccine was safe with no serious adverse events reported.
There is no approved vaccine for norovirus, which infects 15% of all children under 5 in the US and leads to 900 deaths.
Bispecific antibody approved in EU for treatment of lymphoma
The European Commission has approved the bispecific MAb epcoritamab (Tepkinly, Genmab) as a third-line treatment of adults with relapsed or refractory diffuse large B-cell lymphoma. The decision is based on Phase 1/2 trial data showing epcoritamab induced 60% and 40% overall and complete response rates, respectively, and a median duration of response >15 months.
Epcoritamab, which was approved in the US earlier in 2023, is designed to engage cytotoxic T cells with the malignant B cells by simultaneously targeting the T-cell receptor CD3 and the B-cell marker CD20.
Sublingual Covid-19 vaccine was immunogenic in a preclinical trial
A sublingual COVID-19 vaccine candidate induced both mucosal and systemic antibody responses in non-human primates.Citation1 The poly(I:C)-adjuvanted vaccine targeting the receptor-binding domain of the SARS-CoV-2 spike protein was administered in three doses 4 and 15 weeks apart. Two dosage levels were tested: the higher and lower doses were immunogenic in two and one out of three animals, respectively.
HIV vaccine enters clinical trials
A randomized, double-blind, placebo-controlled Phase 1 trial has started testing safety and immunogenicity of the HIV vaccine candidate VIR-1388 (Vir Biotechnology). It aims to enroll 95 healthy subjects aged 18–55 years.
VIR-1388 consists of human cytomegalovirus carrying HIV antigens designed to elicit T-cell responses. The vaccine is administered subcutaneously.