Immunicum AB (publ) announced that the first patient has been enrolled in the Phase I ALISON clinical study evaluating DCP-001, the Company’s lead cancer relapse vaccine candidate, in High-Grade Serous Ovarian Cancer (HGSOC) patients following primary standard of care treatment. The ALISON study is carried out by Professor Hans Nijman and his research group in Groningen, the Netherlands, and investigates the ability of DCP-001 to trigger the immune system to control cancer cells that may have remained in the body after surgery and treatment with chemotherapy in order to prevent or reduce tumor reccurence. This is the first study using Immunicum’s cancer relapse vaccine approach to target a solid tumor indication and will evaluate the safety, feasibility and immunogenicity of DCP-001.

“The start of the Phase I ALISON study with the first patient enrolled marks an important milestone in our clinical development strategy, as ovarian cancer is a completely new indication for Immunicum and the study is the first evaluation of DCP-001 in a solid tumor indication,” commented Jeroen Rovers, Chief Medical Officer at Immunicum. “Other immunotherapies such as checkpoint inhibitors have shown relatively low responses in ovarian cancer. This study builds on our promising preclinical data showing significant reduction in tumor growth following DCP-001 administration and will further evaluate the immunogenicity of our cancer relapse vaccine candidate in patients with solid tumors for the first time.”

Hans W Nijman, MD, PhD, Principal Investigator of the ALISON study and Professor at University Medical Center in Groningen, the Netherlands, added: “Tumors tend to develop ways that allow them to evade the body’s immune response against them, hence making the tumors resistant to many therapies. Immunicum’s relapse vaccine candidate contains allogeneic dendritic cells that can boost various key elements of the immune system against multiple tumor antigens, potentially making it a vital component in the fight against tumor recurrence and clinical relapse in ovarian cancer patients.”

The Phase I ALISON study is a single-center, open-label study evaluating safety and efficacy of DCP-001 in High-Grade Serous Ovarian Cancer (HGSOC) patients. HGSOC is a unique type of epithelial cancer that is characterized by the loss of function of the tumor suppressor protein, p53, which can lead to chemotherapy resistance and disease relapse. The vaccination regimen with DCP-001 will be scheduled after standard of care treatment, which includes chemotherapy either before or after debulking surgery, and will start 6 weeks following the last cycle of chemotherapy. Patients will receive 4 bi-weekly vaccinations with 25 million cells per DCP-001 vaccination and 2 additional booster vaccinations with 10 million cells per vaccination. Patient follow-ups will be conducted for 24 months. The primary endpoint of the study is change from baseline of DCP-001 vaccine antigen-specific T cells in peripheral blood after treatment. Key secondary endpoints include safety and tolerability after repeated DCP-001 dosing as well as recurrence free survival (RFS) and overall survival (OS) during the follow-up period.

Source: Immunicum (Press release)

Cergentis, a genomics company that develops and commercializes kits and services based on its proprietary Targeted Locus Amplification (TLA) technology, today announced the completion of a successful analytical validation study in lymphoma to show the benefits of TLA for the detection of clinically relevant translocations in tumor biopsies. The results of this study, performed in collaboration with researchers from Hubrecht Institute and lymphoma experts of 5 Dutch pathology labs (UMCU, Amsterdam UMC, UMCG, LUMC and LabPON), have now been published in Nature Communications.

The FFPE-TLC approach promises to revolutionize lymphoma diagnostics and as the technology fits a standard targeted NGS workflow and allows for detection of all clinically relevant mutations, both small and large, in a single diagnostic test. This is especially relevant for precious needle biopsies with limited material available, opening opportunities to improve diagnoses and patient treatments for many more cancer types.

With the help of the EU Horizon 2020 SME grant, awarded in 2018, and its partners, Cergentis has successfully developed the TLA technology specifically for formalin-fixed paraffin-embedded (FFPE) tumor biopsies: FFPE-TLC. FFPE-TLC technology employs the inherent DNA crosslinking and fragmentation of FFPE tissue which, combined with conventional capture enrichment and next generation sequencing (NGS), allows to detect large structural variation in the DNA of a tumor sample over much wider genomic regions than standard NGS technologies, improving robustness and sensitivity. The PLIER algorithm, developed in parallel, allows for automated detection of these structural rearrangements from FFPE-TLC NGS data, providing a major step forward in this field.

The published study shows that FFPE-TLC has clear advantages over FISH (fluorescence in situ hybridization) analysis, the most common used method for translocation detection in lymphoma diagnostics, yielding more information, showing better sensitivity and higher resolution. Prof. Daphne de Jong, hematopathologist at Amsterdam University Medical Centre and one of the collaborators:

“The FFPE-TLC approach can greatly improve lymphoma diagnostics and promises to be the hoped-for alternative for cumbersome FISH analyses.”

FFPE-TLC proves to be a robust assay which also has clear benefits over targeted NGS methods as it provides an automated analysis workflow and enables detection of translocations independent of the exact fusion sequence.

“We are very proud of the results of this technological breakthrough. In collaboration with thought leaders at Hubrecht Institute and renowned clinical institutions, we have demonstrated the value of FFPE-TLC technology for cancer diagnostics.”

Joris Schuurmans, CEO of Cergentis, stated.

“With this recognition in hand we are set out to make the technology available for use in pathology labs to help improve diagnosis of patients suffering from lymphoma and other cancer types.”

Source: Cergentis (Press release)

Nu onze vaccinatiecampagne op stoom is en we dankzij de dalende infectiedruk voorzichtig onze maatregelen versoepelen, begint ook de reflectie en bezinning op “de Nederlandse corona-aanpak”.

In Trouw en de Volkskrant trappen huisarts Berend Jansen en oud CBG-voorzitter Bert Leufkens af met hun inzichten over de Nederlandse coronakeuzes. Voor beide heren staat centraal dat we in een situatie als deze zo snel mogelijk, zo veel mogelijk mensen -mondiaal- van een werkzaam vaccin moeten voorzien. En hoe medisch-wetenschappelijk verantwoord ook, precies aan dat doel zijn we volgens beide heren met onze keuzes voorbij gegaan. Want vooruitlopend op de kennis over de werkzaamheid en bijwerkingen, zijn twee nog altijd veilige en effectieve vaccins afgeserveerd, met grote gevolgen voor het vertrouwen van de samenleving in andere vaccins.

Reflecterend op het vaccinatiebeleid vraagt HollandBIO zich af of wetenschappelijke adviesraden en overheden in pandemische tijden niet veel meer in samenwerking zouden moeten optreden, in plaats van in elke lidstaat individueel te adviseren of beoordelen welk vaccin naar wie gaat. Zouden we niet beter af zijn als we hier op Europees -of misschien zelfs globaal- niveau afspreken over maken, daarbij vanaf dag 1 rekening houdend met de impact en toegankelijkheid van vaccins op minder bevoorrechte delen van de wereld? Prikken wat de pot schaft dus, alleen dan in optima forma.

Lonza announced the expansion of its collaboration with Moderna, a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines. The expanded collaboration will further extend the manufacture of the drug substance for the COVID-19 Vaccine Moderna and provides for the installation of a new manufacturing line for drug substance production at Lonza’s Geleen (NL) site.

The new production line in Geleen (NL) will complement Lonza’s existing drug substance production network for COVID-19 Vaccine Moderna and deliver a crucial manufacturing step to increase overall drug substance output. As such, the new production line will contribute to the supply of up to an additional 300 million doses per year, at a 50ug dose, once operating at full capacity. 

In May 2020, Lonza and Moderna announced a ten-year strategic collaboration agreement to enable the manufacture of Moderna’s COVID-19 vaccine and additional Moderna products in the future. Since then, Lonza has installed three production lines at its Visp (CH) site and one production line in Portsmouth (US). In April 2021, Lonza and Moderna entered a new agreement to add three further production lines at its Visp (CH) site. 

The new production line in Geleen (NL) is expected to be operational by the end of 2021. Lonza will leverage its existing infrastructure in Geleen (NL) to provide fast build-out and ramp-up of operations.

Source: Lonza (Press release)