The year 2023 has been a busy one in cancer vaccine development, marked by advancements after years of stagnation.
The mRNA technology employed by Covid-19 vaccines like those made by Pfizer /BioNTech and Moderna (NASDAQ:MRNA) has demonstrated unprecedented efficacy in triggering an immune response. By leveraging the same principles of instructing cells to produce specific proteins, researchers are exploring the potential of mRNA vaccines to stimulate the immune system against cancer cells.
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By GlobalDataWhile several cancer vaccines remain investigational, as more Phase II and III clinical trials come through, the prospect of approved personalized cancer vaccines is getting closer to becoming a reality for many patients.
Provenge (sipuleucel-T), the first dendritic cell vaccine developed by Dendreon Corporation, gained a landmark approval for the treatment of prostate cancer from the US Food and Drug Administration (FDA) in 2010. However, the personalized nature of Provenge made it expensive to produce the vaccine and uncertainties about reimbursement eventually led to Dendreon filing for bankruptcy in 2014.
The Provenge experience slowed progress with cancer vaccines for a while before newer approaches started being studied—this time in combination with the highly successful checkpoint inhibitors. This past year was marked by several of these vaccines having material updates, while the funding and regulatory support for vaccines also grew.
In this review, we take a look at some of the biggest developments to impact cancer vaccine research.
UK government makes a deal with BioNTech
On 6 January, the UK government entered a historic agreement with BioNTech to accelerate trials for cancer vaccines in England. The secretary of state for Health and Social Care, Steve Barclay, signed an MoU with the company to enable early access to trials for personalized mRNA therapies, including cancer vaccines.
Facilitated through the Cancer Vaccine Launch Pad and developed by NHS England and Genomics England, the trials aim to identify eligible cancer patients swiftly, delivering 10,000 personalized therapies to UK patients by 2030.
The agreement is being put into practice as the University Hospitals Birmingham NHS Foundation Trust (UHB) was chosen as the first UK site to begin the BioNTech mRNA cancer vaccine trial in patients with high-risk stage II and stage III colorectal cancers earlier this year. Additionally, Oxford University Hospitals NHS Foundation Trust (OUH) began a clinical trial last week of an mRNA vaccine manufactured by BioNTech to treat patients with head and neck cancer.
FDA grants Moderna and MSD’s vaccine breakthrough status
In February, the FDA granted breakthrough designation to Moderna and Merck’ & Co (MSD)mRNA-4157 vaccine, designed for the adjuvant treatment of patients with resected high-risk melanoma. Since then, the vaccine has entered into a global Phase III clinical trial in conjunction with MSD’s checkpoint inhibitor Keytruda (pembrolizumab), which will enroll 1,089 patients and is expected to conclude in 2029.
The decision to advance to the Phase III study follows positive Phase IIb outcomes in April, which revealed a 44% lower risk of cancer recurrence or death in patients treated with mRNA-4157 plus Keytruda compared to those receiving Keytruda alone. A separate Phase III trial evaluating the combination in advanced non-small cell lung cancer (NSCLC) also dosed its first patient at the beginning of December.
The companies first entered into a strategic partnership in 2016 to develop novel mRNA-based personalized cancer vaccines. They subsequently expanded the collaboration to include the development of antigen mRNA cancer vaccines in 2018.
As per a GlobalData analyst, MSD and Moderna’s personalised lipid nanoparticle mRNA cancer vaccine, mRNA-4157, is a leader in this field.
Transgene announces positive Phase I viral vector-based cancer vaccine results
French biotech Transgene Biotek presented data where patients treated with its vaccine TG4050 developed a specific immune response, and remained disease-free, at the American Society of Clinical Oncology (ASCO) meeting in Chicago, in June. There are plans to start a Phase II trial in H2 2024.
The vaccine is being developed in partnership with NEC Corporation and is based on Transgene’s myvac platform, which uses the modified vaccinia virus ankara (MVA) viral vector-based personalized immunotherapy. A viral vector-based vaccine uses a modified virus to deliver genetic material into the body, aiming to stimulate an immune response against cancer cells.
Nykode Therapeutics advances plasmid-DNA-based cervical cancer vaccine
In April, Norwegian biotech Nykode Therapeutics reported positive results from the Phase IIa trial of its cervical cancer vaccine, VB10.16. The vaccine, administered alongside Roche’s PD-L1 inhibitor Tecentriq (atezolizumab), was given to 52 patients who were monitored over a year, who reported a median overall survival of 16.9 months.
Unlike mRNA vaccines, VB10.16 is a plasmid DNA-based vaccine encoding a three-part “vaccibody”, which includes a unit with up to 20 neoantigens, a targeting unit that attracts antigen-presenting cells (APCs), and another unit that activates either T cells or B cells based on the type of APC attracted. Nykode is planning to initiate a larger trial of the vaccine in 2024.
OSE reports positive Phase III results for NSCLC with Tedopi
In September, OSE Immunotherapeutics reported positive findings from a Phase III trial of its cancer vaccine Tedopi (OSE-2101), designed for advanced NSCLC.
Tedopi is a DNA-based vaccine and a blend of antigenic peptides intended to activate tumor-killing T cells, which in this case are common in NSCLC patients with the HLA-A2 phenotype. While the vaccine is still being tested in the clinic, it is approved for compassionate use in France, Italy, and Spain.
Notably, trial participants, who had prior treatment with checkpoint inhibitors and chemotherapy without success, demonstrated improved survival and quality of life when treated with Tedopi compared to chemotherapy alone.
Tedopi is also being investigated in Phase II clinical trials for pancreatic ductal adenocarcinoma (PDAC) and recurrent ovarian cancer, and could generate $158m in sales in 2029, according to GlobalData’s patient-based forecast.
Moderna and Immatics partner in a cancer vaccine deal worth $1.8bn
Also in September, Moderna entered into a deal with German drugmaker Immatics to develop mRNA-enabled in vivo expressed T cell engaging receptor (TCER) molecules for cancer vaccines, bispecifics, and cell therapies.
Both companies will bring existing programs to the collaboration, with Immatics’s IMA203 PRAME TCR-T, intended for combination with Moderna’s investigational PRAME mRNA cancer vaccine for the treatment of advanced solid tumors and chronic lymphocytic leukemia (CLL). It consists of peptides specifically tailored to the individual’s human leukocyte antigen (HLA) ligandome, a unique set of peptides presented by the patient’s HLA molecules, enhancing the efficacy of the vaccine based on the patient’s immune profile.
Immatics is one of the leading patent filers in personalized cancer vaccines, according to GlobalData.
BioNTech treats first subject in Phase II autogene cevumeran trial
In October, BioNTech announced that it had treated the first subject in a Phase II trial evaluating its cancer vaccine autogene cevumeran along with Tecentriq and chemotherapy versus chemotherapy alone.
The trial builds on promising results from the Phase I study where the vaccine, in combination with Tecentriq and chemotherapy, led to half of the pancreatic cancer patients being cancer-free 18 months later. The successful outcomes prompted the global randomized follow-up trial, which will enroll 260 subjects.
Other notable news events include: Oslo-based biotech Ultimovacs received an orphan drug designation (ODD) from the FDA for its lead therapeutic cancer vaccine UV1, which is being studied with Bristol Myers Squibb’s checkpoint inhibitors Opdivo (nivolumab) and Yervoy (ipilimumab). In 2023, Swiss biotech Nouscom also raised €67.5m ($72m) in a Series C funding round to advance its cancer vaccine clinical pipeline, including an off-the-shelf vaccine, NOUS-209, which is being studied in a Phase II trial (NCT04041310) with Keytruda.
