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Growing pipeline of submitted bids and another period of solid results and operating cash flow for Mabion in Q1 2024

Very good results and successful implementation of Mabion Strategy in 2023

Nigel Stapleton to support Mabion’s sales growth in role of Business Development Director for Europe

Marty Henehan will strengthen Mabion’s sales operations as Vice President of Business Development for North America

Mabion presents ESG Strategy for 2024-2027

Following a very good period of Q1–Q3, Mabion raises expectations for the full year results in 2023

Changes in the composition of the Management Board of Mabion S.A.

Third consecutive quarter of very strong results,high profitability and consistent transformation towards CDMO

Mabion with agreement to buy new bioreactors, diversifies technology and opens to new customers

Mabion with a quarter of record results. Implementation of activities announced in the Strategy

Mabion announces Strategy for 2023-2027 and summarizes very good Q4 and full year 2022

Mabion expands collaboration with Novavax for vaccine antigen for COVID-19 variant Omicron

Mabion with tenth order under Novavax partnership

Mabion has received ODD status from the FDA for the drug MabionCD20 in the indication of autoimmune hemolytic anemia

Mabion has signed a loan agreement with the EBRD for $15 million (about PLN 66 million)

Mabion has secured approval from the FDA to designate MabionCD20 as an orphan drug for the indication of membranous nephropathy

Nobel prize in medicine awarded to micro-RNA discoverers

This year’s Nobel prize in physiology or medicine has been awarded to Victor Ambros and Gary Ruvkun who discovered microRNAs (miRNAs) and elucidated their role in regulating gene expression. MicroRNAs are a class of small RNA molecules that reduce the expression of specific genes by binding to and disrupting their corresponding mRNAs. This regulation of gene expression pattern by miRNAs plays a key role in driving cell differentiation and determining cell fate. The discoveries of this year’s Nobel laureates are likely to pave the way for novel cancer therapies.

Zolbetuximab demonstrates significant benefit in gastric cancer and receives approval in the EU

A genetically engineered factor VIII concentrate with an extended half-life, almost completely prevented spontaneous bleeding among children suffering from hemophilia A. Unlike older FVIII preparations that require infusions every 2 or 3 days, the new drug can be administered once per week.

Are mucosal vaccines the future of COVID-19 prevention?

A genetically engineered factor VIII concentrate with an extended half-life, almost completely prevented spontaneous bleeding among children suffering from hemophilia A. Unlike older FVIII preparations that require infusions every 2 or 3 days, the new drug can be administered once per week.

Lecanemab, a breakthrough Alzheimer’s drug, rejected by EMA

A genetically engineered factor VIII concentrate with an extended half-life, almost completely prevented spontaneous bleeding among children suffering from hemophilia A. Unlike older FVIII preparations that require infusions every 2 or 3 days, the new drug can be administered once per week.

Huge spike in the use of GLP-1 analogs amid severe shortages

A genetically engineered factor VIII concentrate with an extended half-life, almost completely prevented spontaneous bleeding among children suffering from hemophilia A. Unlike older FVIII preparations that require infusions every 2 or 3 days, the new drug can be administered once per week.

Recombinant coagulation factor with extended half-life prevents bleeding in children with severe hemophilia A

A genetically engineered factor VIII concentrate with an extended half-life, almost completely prevented spontaneous bleeding among children suffering from hemophilia A. Unlike older FVIII preparations that require infusions every 2 or 3 days, the new drug can be administered once per week.

Antibody-drug conjugates continue their victory march

The victory march of antibody-drug conjugates continues unabated. In two recent trials, benlatamab mafodotin was found to delay the progression of pre-treated or relapsed multiple myeloma outperforming the standard therapy.

COVID-19 vaccines for 2024/25 season will target JN.1 variant

WHO and EMA published a recommendation to update the composition of COVID-19 vaccines for 2024/25 season to JN.1 variant. In recent months JN.1 has become the most widely circulating variant worldwide. It differs from the XBB variant included in the current season vaccines, causing substantial fall in their effectiveness.

First-in-class IL-15 superagonist wins FDA approval

The first-ever superagonist of interleukin-15 (IL-15), with a highly unique structure, has just received FDA approval in the treatment of bladder cancer.

Next step to revise pharmaceutical legislation made by EU parliament

European Parliament adopted a comprehensive pharmaceutical reform package to address drug pricing, accessibility, and safety concerns across the EU. Reform measures include enhancing price transparency, strengthening pharmacovigilance efforts, and streamlining regulatory processes to ensure patient access to safe and affordable medications.

A biologic drug for diabetes effective in early Parkinson’s disease

Lixisenatide, a popular biologic for type 2 diabetes, was found to delay the progression of Parkinson’s disease in a Phase II clinical trial. However, larger studies are needed to confirm this finding and secure regulatory approval.

First denosumab biosimilar approved by FDA

Sandoz has just won the race for the first FDA-approved biosimilar to denosumab. Approval spans all indications of the reference product.

EMA considers dropping efficacy studies for certain biosimilars

EMA released a new concept paper which proposes waiving the clinical efficacy studies if biosimilar candidate demonstrates high similarity to the reference product at analytical level.

Effectiveness of 2023-24 season COVID vaccines: First estimates are in

First studies estimating the effectiveness of updated COVID-19 vaccines have been published. Effectiveness against hospitalization was calculated at 70.7%-76.1% and against symptomatic SARS-CoV-2 infection at 54%.

Monoclonal antibody targeting CD3 receptor preserves insulin secretion in early type 1 diabetes

Teplizumab, an anti-CD3 monoclonal antibody, was found to preserve the function of pancreatic β cells in newly diagnosed type 1 diabetes mellitus. Earlier, the drug has received FDA approval in the prevention of type 1 diabetes in high-risk individuals.

EMA and FDA investigating cancer signal for CAR-T therapies

EMA and FDA have started a safety review of CAR-T therapies following the notification of 23 cases of T-cell malignancies. The investigation involves all registered CAR-T products, which are used for treating relapsed and treatment-resistant hematologic malignancies.