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Science News

Discover the news and inspiring materials from the world of biotechnology.

2025 CDMO Leadership Awards Europe highlights Mabion’s dedication to quality, expertise, and service, as judged directly by the biopharma partners. International CDMO for Biologics

Mabion is a Biologics CDMO Leadership Award Europe Finalist

Mabion has been honored as a 2025 CDMO Leadership Awards Europe winner in the Biologics category, marking a significant recognition of our scientific and operational excellence. This year’s edition of the awards represents the first European celebration of CDMO achievement, hosted at CPHI Frankfurt.

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Jakub Knurek, a marketing specialist at Mabion with a strong foundation in the sciences, has been announced as a finalist for the Future Leader category at the CPHI Pharma Awards 2025, set to take place during CPHI Frankfurt on 28 October.

Jakub Knurek became a finalist of the CPHI Pharma Awards in the Future Leader category

Jakub Knurek, a Marketing Specialist at Mabion S.A., has been named a finalist in the Future Leader category of the CPHI Pharma Awards 2025, to be awarded at CPHI Frankfurt on 28 October. The award recognizes rising talents in pharma, biopharma, academia, or research settings, with at least five years of relevant experience and a maximum age of 35 by the ceremony date.

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NovalGen to Begin World’s First Clinical Trial for a Self-Regulating Immunotherapy with Mabion manufacturing capacity.

Mabion Participates in Groundbreaking Clinical Trial of Self-Regulating Immunotherapy

The world’s first therapeutic drug to be equipped with NovalGen’s pioneering AutoRegulation (AR) technology has been approved for evaluation in the clinic by the UK’s Medicine and Healthcare Products Regulatory Agency (MHRA).

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The FDA breakthrough decision removes clinical efficacy studies from the biosimilar pathway in suitable cases, underscoring a smarter, evidence-based regulatory approach.

FDA Grants First Ever Waiver of Clinical Efficacy Studies for Monoclonal Antibody Biosimilar

For the first time in history, the FDA has granted an exemption from the requirement to conduct Clinical Efficacy Studies of biosimilar drugs containing monoclonal antibodies, signaling a fundamental shift toward evidence-based approval pathways. This exemption underscores the growing confidence in a regulatory approach based on high quality scientific research, recognizing that robust comparative data can sufficiently demonstrate biosimilarity. The removal of the requirement for Clinical Efficacy Studies represents a historic milestone for the biopharmaceutical sector, reducing the duplication of clinical knowledge already established for reference products.

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Biologics CDMO is calling. Read more about the biopharma market outlook from Marty and Nigel.

Biologics CDMO Market – Mabion Approach to Establishing Cooperation

The CDMO industry for biologics continues to grow, offering complex solutions for the biopharmaceutical industry. Mabion’s winning formula? You will find the answer in a conversation between Nigel Stapleton and Marty Henehan.

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Cancer Reversion Therapy is groundbreaking new strategy instead aims to reprogram tumor cells back into normal cells, potentially overcoming drug resistance and side effects associated with cell-killing therapies. Research demonstrates that inhibiting a few key genetic “switches” can induce malignant colon cells to differentiate into benign intestinal cells, effectively reversing their cancerous state.

Reprogramming Cancer Cells: A New Paradigm in Colon Cancer Reversion Therapy

Cancer Reversion Therapy is groundbreaking new strategy instead aims to reprogram tumor cells back into normal cells, potentially overcoming drug resistance and side effects associated with cell-killing therapies. Research demonstrates that inhibiting a few key genetic “switches” can induce malignant colon cells to differentiate into benign intestinal cells, effectively reversing their cancerous state.

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Many lifesaving biopharmaceuticals are suffering from a slump in venture funding. Novel recombinant protein based therapeutics, but also biosimilars are needed to fill the gaps in unmet patient needs. At Mabion we understand how to advance promising biosimilars and novel biotherapeutics to the clinic and from there to patients. Unfortunately, many promising biopharmaceutical innovations spanning novel recombinant protein therapeutics to biosimilars are being held back in the current, limiting funding climate, depriving patients from access to advanced therapies. Yet the urgency to close gaps in unmet patient care has never been greater. That is why we are launching the “Unlocking the Future of Therapeutics” competition a unique opportunity to support and accelerate biologics development and scale up for an oncology-targeted therapeutic. We are offering €500,000 credit in development services to support an exceptional therapeutic project. This can be a novel therapeutic, but might also be a biosimilar drug which expands patients access to lifesaving care. We have partnered with respected academic experts focused on cancer research to select the most promising candidate.

Mabion Launches €500,000 Services Contest to Support Next-Gen Oncology Breakthroughs

At Mabion we understand how to advance promising biosimilars and novel biotherapeutics to the clinic and from there to patients. Unfortunately, many promising biopharmaceutical innovations spanning novel recombinant protein therapeutics to biosimilars are being held back in the current, limiting funding climate, depriving patients from access to advanced therapies. Yet the urgency to close gaps in unmet patient care has never been greater.That is why we are launching the “Unlocking the Future of Therapeutics” competition a unique opportunity to support and accelerate biologics development and scale up for an oncology-targeted therapeutic.We are offering €500,000 credit in development services to support an exceptional therapeutic project. This can be a novel therapeutic, but might also be a biosimilar drug which expands patients access to lifesaving care.We have partnered with respected academic experts focused on cancer research to select the most promising candidate.

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Modulation of the immune system to treat cancer and on novel approaches to further extend the efficacy of current and emerging immunotherapies led us to our current understanding of the melanoma immune microenvironment in humans and the mechanistic work supporting these observations.

Melanoma Immunotherapy Enhance by Immunity Activation

By reintroducing the Interleukin-4 into IFN-I–dominant, inflammation-deficient tumors, scientists successfully reinvigorated T cell–driven tumor rejection. Whether introduced directly or delivered via engineered T cells in ACT, IL-4 helped reshape the immune landscape, boosting effector T cells and improving survival in mouse models.

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Cumulative incidence of P. falciparum blood-stage infection during a 6-month malaria season (irrespective of symptoms being present) after a single IV infusion of 10 mg kg−1 of CIS43LS (n = 110), 40 mg kg−1 of CIS43LS (n = 110) or placebo (n = 110). P. falciparum infections were detected by 18S qRT–PCR analysis of DBS collected during scheduled trial visits and unscheduled illness visits when malaria was suspected. DBS were collected before the administration of CIS43LS or placebo on day 0 and then on days 1, 3, 7, 14, 21 and 28 and every 2 weeks thereafter for a total of 24 weeks (day 168). Only DBS collected between days 21 and 168 were included. Estimates of the cumulative risk of infection are plotted along with the 95% CIs (shaded areas).

Single-Dose Monoclonal Antibody Therapy Offers Durable Protection Against Malaria

Monoclonal antibody CIS43LS reduced the cumulative incidence of infection by 87.4% at 40 mg/kg during the 6-month qRT-PCR monitoring period. This Phase 2 trial evaluated its efficacy in 330 adults in Mali during a 6-month high-transmission season.CIS43LS is a human IgG1 monoclonal antibody targeting the circumsporozoite protein of Plasmodium falciparum, designed to confer long-acting protection with a single intravenous dose.

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