
==== Front
Hum Vaccin Immunother
Hum Vaccin Immunother
Human Vaccines & Immunotherapeutics
2164-5515
2164-554X
Taylor & Francis

39288357
10.1080/21645515.2024.2402171
2402171
Version of Record
Editorial
News, Policy, & Profiles
Human vaccines and immunotherapeutics: News August 2024
NEWS, POLICY, & PROFILES
HUMAN VACCINES & IMMUNOTHERAPEUTICS
Ellis Ronald
Weiss Adam
Editor-in-Chief, Jerusalem, Israel
Acquisitions Editor, Taylor & Francis Group
rellis.hvi@gmail.com.
adam.c.weiss@taylorandfrancis.com.
17 9 2024
2024
17 9 2024
20 1 2402171Integra14 9 2024
Integra14 9 2024
© 2024 The Author(s). Published with license by Taylor & Francis Group, LLC.
2024
The Author(s)
https://creativecommons.org/licenses/by-nc-nd/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License (http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited, and is not altered, transformed, or built upon in any way. The terms on which this article has been published allow the posting of the Accepted Manuscript in a repository by the author(s) or with their consent.

The author(s) reported that there is no funding associated with the work featured in this article.
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pmcImmunotherapy combination improves outcomes in follicular lymphoma

Adding the CD19 inhibitor tafasitamab (Monjuvi, Incyte) to the combination of lenalidomide and anti-CD20 rituximab extended progression-free survival in >650 adults with relapsed or refractory follicular lymphoma. No actual survival numbers have been disclosed in a report from the placebo-controlled Phase 3 inMIND trial.

The immunotherapeutics and their combination have been approved for various lymphoma and leukemia indications.

RSV vaccine induces strong immunity in immunocompromised subjects

The RSV vaccine RSVpreF (Abrysvo, Pfizer) was safe and induced neutralizing antibodies in 200 immunocompromised adults. The placebo-controlled Phase 3 MONeT trial tested two doses of RSVpreF, one month apart, in patients with lung cancer, autoimmune diseases on therapy, those on hemodialysis, and solid organ transplant recipients.

RSVpreF targets the prefusion conformation of the F protein from both major RSV strains, A and B. The vaccine has been approved in the US for prevention of RSV-linked lower respiratory tract disease in older adults and infants via maternal immunization.

Oncolytic immunotherapy was safe and efficacious in a phase 2 trial with basal cell carcinoma

50% complete response rate and overall tumor size reduction of 86% were reported from a dose-escalation Phase 2 trial testing the peptide immunotherapy VP-315 (Verrica Pharmaceuticals) in 90 adults with basal cell carcinoma. No dose-limiting toxicities were observed.

VP-315, administered intratumorally, is designed to stimulate the immune system by inducing cell death via a lactoferrin-derived signaling peptide, leading to the lysis of cancer cells in situ.

mRNA influenza vaccine safe and immunogenic

A trivalent mRNA influenza vaccine candidate (Pfizer & BioNTech) induced non-inferior immune responses to both influenza A and B, compared to a licensed quadrivalent vaccine. The Phase 2 trial enrolled 450 adults <65 years old.

A combination mRNA vaccine for prevention of both influenza and COVID-19 demonstrated non-inferior immunogenicity to influenza A and SARS-CoV-2 but failed to match seroconversion rates for influenza B.

Both vaccine candidates were safe with no severe adverse events.

>90% response rate for CAR-T treatment in pediatric leukemia

The CAR-T cell therapeutic ORG-101 (Orgenesis) achieved 93% and 82% response rates in children and adults, respectively, with CD19-positive acute lymphoblastic leukemia. According to the study from China, which included >200 patients, cytokine-release syndrome affected 2% adults and 6% children, a low rate compared to approved CAR-T regimens.

First T-cell therapy of solid cancer approved in US

The US Food and Drug Administration (FDA) has granted accelerated approval to afamitresgene autoleucel (Tecelra, Adaptimmune) as second-line treatment of metastatic synovial sarcoma. A clinical trial showed a 40% response rate with a 6-month median duration of response in 44 subjects with rare soft-tissue cancer and limited treatment options.

Afamitresgene autoleucel consists of autologous T cells engineered to target the tumor-associated antigen MAGE-A4.

Updated covid-19 vaccine approved

The FDA has approved the BNT162b2 vaccine (Pfizer & BioNTech) adapted for the Omicron KP.2 strain, which is expected to dominate the 2024–5 season. The vaccine is recommended for all people aged ≥12 years and for younger individuals under emergency-use authorization.

Dostarlimab can be used in wider endometrial cancer indication

The FDA has extended the label of the PD-1 inhibitor dostarlimab (Jemperli, GSK) in endometrial cancer to include mismatch repair proficient and microsatellite-stable tumors. The decision is based on Phase 3 RUBY trial data showing that dostarlimab, when added to chemotherapy, extended overall survival by 16 months.

Priority review for a chikungunya vaccine candidate

The FDA has granted its Priority Review designation to the chikungunya vaccine candidate CHIKV VLP (Bavarian Nordic). The vaccine, which is designed for use in individuals 12 years of age and older, demonstrated safety and immunogenicity in two Phase 3 trials.

Ronald Ellis received his PhD at Cornell University. He worked 35 years in line and senior management of pharma, mid biotech, small biotech companies and biotechnology incubator in the research and development of nw vaccines and drugs, including leadership roles for five products that became commercially licensed worldwide. He worked subsequently as an independent consultant. He is the founding (2005) and incumbent Editor-in-Chief of Human Vaccines & Immunotherapeutics.

Adam Weiss received training in Microbiology at Uppsala University (MSc) and molecular cell biology at the University of Vienna (PhD). His portfolio at Taylor & Francis includes seven titles publishing in the area of molecular biology and biomedicine. He resides in Prague, Czech Republic.
