TOP Pharma & Biotech News #5?? May Edition

Welcome to the world of pharma news???

In May, you'll read about the world-first approval of the mRNA cancer vaccine. Also about the possible alternative to antibiotics produced by bacteria. Last, what impact will the EU sustainability directive have on supply chains? Please take a look at all the articles with answers below.

Once commercialised, the mRNA therapeutic cancer vaccine will offer a new option to treat advanced Epstein–Barr virus-positive solid tumours and haematologic malignancies.

The US Food and Drug Administration (FDA) has granted the first approval of an Epstein–Barr virus-related mRNA therapeutic cancer vaccine.

Biotech company WestGene has received the investigational new drug (IND) approval for its mRNA vaccine, WGc-043.

This authorisation of the immunotherapy from the FDA “represents a significant advance in cancer treatment”, stated WestGene. The FDA’s decision means that patients with advanced Epstein–Barr virus-related cancers will be given another treatment option.

Over ten malignancies, are “highly correlated” with Epstein–Barr virus, according to WestGene. These include nasopharyngeal carcinoma (NPC), natural killer T-cell lymphoma (NKTL), lung cancer, liver cancer and breast cancer. Autoimmune diseases such as multiple sclerosis also have a strong link to this virus. These conditions are potential indications for WGc-043, the company added.

Promise of the cancer therapeutic vaccine

The biotech shared that the mRNA therapeutic vaccine has “promising efficacy, low toxicity, broad applicability, efficient scalability, and cost effectiveness” in cancer.

For instance, its potential was reported following investigator-initiated trials in nasopharyngeal carcinoma (NPC) and natural killer T-cell lymphoma (NKTL). WGc-043 demonstrated “superior safety and efficacy compared to other publicly available mRNA therapeutic cancer vaccines”, WestGene explained.

Future of mRNA therapeutics?

On its website, the company noted that mRNA vaccines first became prominent in the market during the COVID-19 pandemic. It highlighted that current challenges in mRNA therapeutics include mRNA sequence optimisation, targeting delivery system and large-scale manufacture and long-term storage.?

The WGc-043 therapeutic vaccine is indicated for cancer and utilises mRNA technology. Therefore, the FDA’s approval aligns with findings from a recent market report. Two of the main factors influencing the growth of the injectable drug delivery market were reported to be the further advancement in technology and a greater prevalence of chronic disease. Overall, the report predicted that the market will value $1139.4 billion by 2029.

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Many bacteria produce substances to gain an advantage over competitors in their highly competitive natural environment. Researchers at the University Hospital Bonn (UKB), the University of Bonn and the German Center for Infection Research (DZIF) have discovered a new so-called lantibiotic, namely epilancin A37. It is produced by staphylococci that colonize the skin and acts specifically against their main competitors there, the corynebacteria. This specificity is presumably mediated by a very special mechanism of action, which the researchers were able to decipher in detail. Their results have now been published in the ISME Journal.

Due to increasing antibiotic resistance in pathogens causing infections, the development of new antibacterial substances is important. Hopes are pinned on a new group of substances produced by gram-positive bacteria, the lantibiotics. These are antimicrobial peptides that often have a very narrow spectrum of activity. "Such compounds are highly interesting from a medical point of view, as they could specifically attack individual groups of organisms without affecting the entire bacterial flora, as is the case with broad-spectrum antibiotics, for example," says corresponding author Dr. Fabian Grein, until recently head of the DZIF research group "Bacterial Interference" at the Institute of Pharmaceutical Microbiology at the UKB and member of the Transdisciplinary Research Area (TRA) "Life & Health" at the University of Bonn.

The UKB research team led by Fabian Grein and Tanja Schneider, together with the team led by Ulrich Kubitscheck, Professor of Biophysical Chemistry at the University of Bonn, have now discovered a new lantibiotic, namely epilancin A37. It is produced by staphylococci, which are typical colonizers of the skin and mucous membranes. Little is known about these antimicrobial peptides. "We were able to show that epilancins are widespread in staphylococci, which underlines their ecological importance," says first author Jan-Samuel Puls, a doctoral student from the University of Bonn at the Institute of Pharmaceutical Microbiology at the UKB. This is because staphylococci and corynebacteria are important genera of the human microbiota - i.e. the totality of all microorganisms such as bacteria and viruses - in the nose and skin, which are closely linked to health and disease. The need to produce such a compound indicates a pronounced competition between the species. The researchers were able to show that the newly discovered epilancin A37 acts very specifically against corynebacteria, which are among the main competitors of staphylococci within the skin microbiome.

"This specificity is presumably mediated by a very special mechanism of action that we were able to decipher in detail," says Grein. Epilancin A37 penetrates the corynebacterial cell, initially without destroying it. The antimicrobial peptides accumulate in the cell and then dissolve the cell membrane from the inside, thus killing the corynebacterium. Co-author Dr. Thomas Flie?wasser from the Institute of Pharmaceutical Microbiology at the UKB, postdoctoral researcher at the University of Bonn and acting head of the DZIF research group "Bacterial Interference" adds: "Our study shows how a specific mechanism of action can be used to specifically combat a single bacterial species. It therefore serves us as a 'proof of concept.'"

This project was funded by the German Center for Infection Research and the Transregio SFB TRR 261 "Antibiotic CellMAP" of the German Research Foundation.

Survey results

Compliance with the directive is “achievable”, according to 74 percent of the companies who responded.

Measures already implemented by these firms include:

Developing compliance procedures (77 percent)
Issuing an annual financial report (69 percent)
Collaborating with other companies in the same sector (63 percent)
Monitoring performance indicators (63 percent).

The survey found that 60 percent of participants thought that in the long-term, “the financial impact of the directive will be positive and anticipate a return on investment”.

Furthermore, fifty five percent expect that stricter?regulations?could have a positive influence on the company’s image.

Another key benefit highlighted by the participants was greater environmental responsibility (51 percent).

Notably, 47 percent of respondents from the pharma and healthcare sectors considered that financial performance was “the main task of procurement”.

Despite these potential benefits, responding companies in the healthcare sector believed that practically, two major challenges of implementing the measures were a lack of capacity (25 percent) and unclear directive guidelines (20 percent).

Sustainability of the future pharma supply chain

“UK [healthcare] businesses with international operations need to consider carefully how they need to align their operations with that of the EU,” shared Sabrina Morton, Principal at INVERTO.

By creating transparency, companies can identify opportunities for cost savings and reallocate resources. This contributes to operational efficiency and thus promotes innovation and competitiveness, Morton explained.?

The survey gained insight from more than 680 decision-makers from B2C and B2B companies with more than 500 employees, between November and December 2023, INVERTO shared.

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