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Mabion’s high cost discipline and intensification of business development activities in 3Q 2024

Changes in the composition of Mabion S.A.’s Board of Directors.

Mabion’s solid results and balance sheet in Q2’24, first CDMO orders signed and readiness to acquire more

Mabion will complete CDMO orders worth about PLN 5.5 million for a new UK client

Mabion expands collaboration with Novavax to include analytical work for new product – combined influenza vaccine and COVID

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

How long might CAR-T cell therapy work?

In a remarkable medical milestone, a woman has remained cancer-free for an unprecedented 19 years following a pioneering CAR-T cell therapy administered during her childhood. This groundbreaking case offers renewed hope for the long-term efficacy of CAR-T cell treatments in combating rare pediatric cancers.

Mabion Wins Best of Industry Insights Award for Biologics Outsourcing Article in Outsourced Pharma Best Of 2024

Mabion SMEs’s article has been awarded Best of Industry Insights in the Biologics Outsourcing category of the Outsourced Pharma Best Of 2024 awards.

FDA approves first medication for obstructive sleep apnea: Eli Lilly’s Zepbound GLP-1 agonist

The FDA has approved Eli Lilly’s Zepbound (tirzepatide) as the first-ever medication for treating moderate to severe obstructive sleep apnea (OSA) in adults with obesity, providing a pharmacological alternative to CPAP machines and surgery.

Biocon’s Yesintek receives EMA and FDA approval as the next ustekinumab biosimilar

Yesintek, a biosimilar to ustekinumab developed by Biocon, has received approval from both the EMA and FDA, joining other ustekinumab biosimilars like Amgen’s Wezlana and Alvotech’s Selarsdi.

Lecanemab approved by EMA in early Alzheimer’s after re-evaluation

The European Medicines Agency (EMA) reversed its initial rejection and approved lecanemab (Leqembi) for early-stage Alzheimer’s, limiting its use to patients with one or no copies of the ApoE4 gene. The restriction of indication is intended to maximize the benefit-risk ratio of the new drug.

Transplantation of stem cells islets cures patient from type 1 diabetes

Chinese scientists have reversed Type 1 diabetes in a patient by transplanting chemically-induced pluripotent stem-cell-derived islets (CiPSC islets), marking a significant medical breakthrough. The procedure reprogrammed the patient’s own fat cells into insulin-producing islets, eliminating the need for insulin therapy and reducing the risk of immune rejection frequently seen with donor-based transplants. Stable glycemic control was maintained at least for one year, with no registered complications.

Nobel prize in medicine awarded to microRNA 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

Zolbetuximab, a monoclonal antibody targeting CLDN18.2, demonstrated significant benefits in advanced gastric and gastroesophageal junction cancer. The trials reported improvement both in progression-free and overall survival, over chemotherapy alone, leading to the recent approval by EMA.

Are mucosal vaccines the future of COVID-19 prevention?

A bivalent mucosal vaccine against COVID-19 significantly increased IgA antibodies in upper and lower respiratory tracts, and induced durable protection against challenge with SARS-CoV-2 XBB.1.16 virus in non-human primates. Mucosal vaccines are expected to reduce viral transmission, and provide broader and more sustained protection against the newly emerging variants than the currently used mRNA vaccines.

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

Lecanemab, an FDA-approved amyloid-targeting antibody for Alzheimer’s disease, has been recently rejected by the EMA on the ground of unfavorable benefit-risk ratio.

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

The use of GLP-1 analogs is growing rapidly, with increasing share of users having no diabetes. The annual rate of prescriptions in the US surged from 0.22% between 2011 and 2014 to 2.11% in between 2019 and 2023. This growth is mostly attributed to the recent approval of two GLP-1 analogs, semaglutide and liraglutide, for weight management in obese and overweight patients. The climbing demand for these drugs driven by expanded indications and increasing off-label use for cosmetic weight loss, led to insurmountable shortages on the market.

Recombinant drug 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 conjugate 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 vaccine 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.