Abselion Introduces Protein G Total Antibody Quantification Kit




Abselion Introduces Protein G Total Antibody Quantification Kit

New kit enables rapid, accurate titre measurement across broad range of IgG subclasses and species on Amperia platform

CAMBRIDGE, England–(BUSINESS WIRE)–#Abselion–Abselion, a pioneering life sciences technology company focused on simplifying biomolecule quantification, today announced the launch of its Protein G Total Antibody Quantification Kit. The new kit is designed for use with the company’s Amperia™ benchtop platform and complements the existing Protein A-based format, enabling researchers to quantify a broader range of antibody isotypes and species using the same protocol-guided, user-friendly workflow and highly sensitive electrochemical readout. Abselion’s extended antibody quantification offering reflects continued investment in expanding the capabilities of its flexible Amperia platform to help streamline decision-making and optimise bioprocess workflows for scientists working across diverse antibody discovery and development settings.

Abselion’s Amperia benchtop platform is a simple-to-use solution for rapid and accurate automated quantification of a range of biomolecules, without optics or fluidics. The Protein G Total Antibody Quantification Kit is supplied in a ready-to-use format, including Protein G-coated sensor strips, assay plates, detection reagents, and assay buffers. The kit is suitable for use with purified or partially purified antibody samples in research and process development settings. Combined with Amperia’s intuitive software and step-by-step guidance, it allows researchers to generate reliable antibody titre data without the need for complex setup or specialised training.

The assay uses sensor strips pre-coated with Protein G, enabling direct capture of antibodies from a sample. After incubation, a labelled detection molecule binds to any remaining unoccupied Fc-binding sites on the sensor. The assay takes place directly on the sensor tip, where the bound analyte triggers an electrical signal, which is read instantaneously by Amperia. As antibody concentration increases, fewer sites are available for detection, resulting in a lower signal. This inverse occupancy format produces a signal that is inversely proportional to antibody concentration.

Current quantitative methods, such as bio-layer interferometry and surface plasmon resonance, are often limited to centralised analytical laboratories due to their cost and complexity of operation. This can lead to analytical delays and requirements for sample storage. Abselion’s Amperia system offers a robust, cost-effective, automated alternative for efficient, accurate antibody titre measurement. By introducing a Protein G-based option, users working with humanised antibodies, rodent IgGs, or engineered variants can now run reliable titre measurements without the need for revalidating or redesigning their assay setup.

Dr Ruizhi Wang, CEO and Founder, Abselion, said: “Antibody-based research and development often involves a wide variety of formats, subclasses, and species. Having the flexibility to choose the most appropriate assay without adjusting workflows can simplify decision-making and improve efficiency.

This launch reflects Abselion’s commitment to evolving its platform in response to real-world research needs. Expanding our antibody quantification offering with Protein G allows us to better support scientists working with a broader range of antibody formats, and reflects our ongoing focus on making practical, application-driven tools more accessible.”

For further information about Abselion’s Protein G Total Antibody Quantification Kit, please visit: https://www.abselion.com/assay-kits or download the application note “Supporting Antibody Quantification in Biologic Development”.

Meet the Abselion team at Festival of Biologics from 30 Sep–02 Oct in Basel, Switzerland (Booth 240) and ELRIG Drug Discovery 2025 from 21–22 Oct in Liverpool, UK (Booth H06) to learn more.

Please contact Codon Communications for high-resolution images.

Contacts

Codon Communications
Dr Michelle Ricketts

Tel: +44 7789 053885

Email: michelle.ricketts@codoncommunications.com

Positive Phase III Results Show Genentech’s Giredestrant Significantly Improved Progression-Free Survival in ER-positive Advanced Breast Cancer




Positive Phase III Results Show Genentech’s Giredestrant Significantly Improved Progression-Free Survival in ER-positive Advanced Breast Cancer

– evERA met its co-primary endpoints; giredestrant plus everolimus demonstrated significant benefit in ITT and ESR1-mutated populations in the post-CDK inhibitor setting, compared with standard of care plus everolimus –

– The all-oral combination was well tolerated and adverse events were consistent with the known safety profiles of the individual study treatments; no new safety signals were observed –

– evERA is the first positive head-to-head Phase III trial investigating an all-oral selective estrogen receptor degrader-containing regimen versus a standard of care combination –

– Data will be presented at an upcoming medical meeting and shared with health authorities –

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today positive results from the Phase III evERA study evaluating investigational giredestrant in combination with everolimus in people with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer previously treated with a cyclin-dependent kinase (CDK) 4/6 inhibitor and endocrine therapy. The study met both co-primary endpoints, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS) in both the intention-to-treat and ESR1-mutated populations, compared with standard-of-care endocrine therapy plus everolimus. Overall survival (OS) data were immature, but a clear positive trend was observed. Follow-up continues to the next OS analysis. The giredestrant combination was well tolerated. Adverse events were consistent with the known safety profiles of the individual study treatments, and no new safety signals were observed. This is the first positive head-to-head Phase III trial investigating an all-oral selective estrogen receptor degrader-containing regimen versus a standard of care combination.

“These results show that the giredestrant combination provides a meaningful benefit for ER-positive breast cancer patients whose disease has progressed following treatment with a CDK inhibitor,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “We look forward to discussing these results with regulatory authorities with the goal of making this giredestrant-based regimen available to many people with advanced ER-positive breast cancer.”

ER-positive breast cancer accounts for approximately 70% of breast cancer cases. Despite treatment advances, ER-positive breast cancer remains particularly challenging to treat due to its biological complexity. Resistance to endocrine therapies, particularly in the post-CDK inhibitor setting, increases the risk of disease progression and is associated with poor outcomes. Combination therapies, such as giredestrant plus everolimus, could address this by targeting two different signaling pathways, with the potential for improved patient outcomes. Additionally, as an all-oral combination, this regimen could help minimize the impact of treatment on people’s lives without the need for injections.

Our extensive giredestrant clinical development program spans multiple treatment settings and lines of therapy, reflecting our commitment to deliver innovative medicines to as many people with ER-positive breast cancer as possible.

Data from the evERA study will be submitted to health authorities with the view of bringing this potential treatment option to patients as soon as possible.

About the evERA Breast Cancer study

evERA Breast Cancer [NCT05306340] is a Phase III, randomized, open-label, multicenter study evaluating the efficacy and safety of giredestrant in combination with everolimus versus standard-of-care endocrine therapy in combination with everolimus in people with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer who have had previous treatment with a cyclin-dependent kinase (CDK) 4/6 inhibitor and endocrine therapy, either in the adjuvant or locally advanced/metastatic setting.

The co-primary endpoints are investigator-assessed progression-free survival in the intention-to-treat and ESR1-mutated populations, defined as the time from randomization to the time when the disease progresses or a patient dies from any cause. The trial has been enriched for ESR1-mutated patients above the natural prevalence to assess the efficacy in this population. In the post-CDK inhibitor setting, up to 40% of people with ER-positive disease have ESR1 mutations. Key secondary endpoints include overall survival, objective response rate, duration of response, clinical benefit rate and safety.

About estrogen receptor (ER)-positive breast cancer

Globally, the burden of breast cancer continues to grow, with 2.3 million women diagnosed and 670,000 dying from the disease every year. Breast cancer remains the number one cause of cancer-related deaths amongst women, and the second most common cancer type.

ER-positive breast cancer accounts for approximately 70% of breast cancer cases. A defining feature of ER-positive breast cancer is that its tumor cells have receptors that attach to estrogen, which can contribute to tumor growth.

Despite treatment advances, ER-positive breast cancer remains particularly challenging to treat due to its biological complexity. Patients often face the risk of disease progression, treatment side effects and resistance to endocrine therapy. There is an urgent need for more effective treatments that can delay clinical progression and reduce the burden of treatment on people’s lives.

About giredestrant

Giredestrant is an investigational oral, next-generation selective estrogen receptor degrader (SERD) and full antagonist.

Giredestrant is designed to block estrogen from binding to the estrogen receptor (ER), triggering its breakdown (known as degradation) and stopping or slowing down the growth of cancer cells.

Giredestrant has an extensive clinical development program and is being investigated in five company-sponsored Phase III clinical trials that span multiple treatment settings and lines of therapy to benefit as many people as possible:

• Giredestrant versus standard-of-care endocrine therapy (SoC ET) as adjuvant treatment in ER-positive, human epidermal growth factor receptor 2 (HER2)-negative early-stage breast cancer (lidERA Breast Cancer; NCT04961996)
• Giredestrant plus everolimus versus SoC ET plus everolimus in ER-positive, HER2-negative, locally advanced or metastatic breast cancer (evERA Breast Cancer; NCT05306340)
• Giredestrant plus palbociclib versus letrozole plus palbociclib in ER-positive, HER2-negative, endocrine-sensitive, recurrent locally advanced or metastatic breast cancer (persevERA Breast Cancer; NCT04546009)
• Giredestrant plus investigator’s choice of a cyclin-dependent kinase (CDK) 4/6 inhibitor versus fulvestrant plus a CDK 4/6 inhibitor in ER-positive, HER2-negative advanced breast cancer resistant to adjuvant endocrine therapy (pionERA Breast Cancer; NCT06065748)
• Giredestrant plus dual HER2 blockade versus dual HER2 blockade in ER-positive, HER2-positive locally advanced or metastatic breast cancer (heredERA Breast Cancer; NCT05296798)

About Genentech in Breast Cancer

Genentech has been advancing breast cancer research for more than 30 years with the goal of helping as many people with the disease as possible. Our medicines, along with companion diagnostic tests, have contributed to bringing breakthrough outcomes in human epidermal growth factor 2-positive and triple-negative breast cancers. As our understanding of breast cancer biology rapidly improves, we are working to identify new biomarkers and approaches to treatment for other subtypes of the disease, including estrogen receptor-positive breast cancer, which is a form of hormone receptor-positive breast cancer, the most prevalent type of all breast cancers.

About Genentech

Founded nearly 50 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.

Contacts

Media Contact: Jared Preston, (650) 467-6800

Advocacy Contact: Katie Creme Henry, (202) 258-8228

Investor Contacts: Loren Kalm, (650) 225-3217

Bruno Eschli, +41 616875284

Scoring Big With Fans: Balchem Spotlights the Power of Vitamin K2 at FC Bayern Women’s Season Opener




Scoring Big With Fans: Balchem Spotlights the Power of Vitamin K2 at FC Bayern Women’s Season Opener

MONTVALE, N. J.–(BUSINESS WIRE)–Balchem, a leading global manufacturer of specialty ingredients for human nutrition and health – and official partner of FC Bayern (FCB) Women’s football team – has launched its first ever direct-to-consumer initiative, showcasing the power of vitamin K2 to FCB fans. The company promoted its K2VITAL™ brand with an exhibition stand at the Allianz Arena in Munich, during the opening game of the Bundesliga (German football league) on 6 September. This initiative is part of Balchem’s latest marketing strategy, which aims to raise consumer awareness of the health benefits vitamin K2 has to offer, bridging the gap between B2B and B2C markets.

Co-Branded K2 Health Vitamins Hit the Pitch

The opening event of the season provided a unique platform for Balchem to promote K2VITAL™, a patented, typically 99.7% all-trans K2 MK-7 supplement ingredient, to 57,762 football fans in attendance – a new German record. The company spotlighted co-branded products of its customer, Natsana, within the Natural Elements® brand portfolio. As part of the pre-match celebrations, visitors to the booth were encouraged to learn more about the health benefits of K2 from Balchem’s experts with a digital quiz and a cornhole game for the chance to win FCB Women co-branded merchandise. Also highlighted at the booth was a dedicated K2VITAL™ promotion page, offering fans a discount code and the chance to explore the co-branded Natural Elements® product range – including liquid drops, capsules and solutions that combine K2 with vitamin D for bone health support.

“When we initiated the partnership with FC Bayern Women, our goal was to educate consumers about vitamin K2 and reinforce the high-quality standards embodied in our K2VITAL™. The team proved to be the perfect partner – acting as outstanding ambassadors of health with over a billion fans worldwide,” comments Dominik Mattern, VP Science, Business Development and Marketing, Balchem Human Nutrition and Health. “Now, we’re taking the next step by hosting our first-ever direct-to-consumer event and harnessing the value of our branded ingredients to drive differentiation. We are so glad to be able to integrate in this first experience a collaboration with our partner Natsana, creating a mutual opportunity for growth.”

“Women’s sports are gaining popularity, especially football, with a rapidly growing global fanbase. Balchem’s partnership with FC Bayern Munich gave us the perfect opportunity to showcase the co-branded products range to a large, engaged audience,” concludes Mattern. “Featuring a trusted branded ingredient like K2VITAL™ not only strengthens confidence, but also provides a direct path for consumers to purchase our customers’ products – demonstrating how supplier-brand partnerships can deliver tangible business results.”

For more information about Balchem and its brand K2VITAL™, visit: https://balchem.com/hnh/mn/

Notes to Editors:

About Balchem Corporation

Balchem Corporation develops, manufactures, and markets specialty ingredients that improve and enhance the health and well-being of life on the planet, providing state-of-the-art solutions and the finest quality products for a range of industries worldwide. The company reports three business segments: Human Nutrition & Health; Animal Nutrition & Health; and Specialty Products. The Human Nutrition & Health segment delivers customized food and beverage ingredient systems, as well as key nutrients into a variety of applications across the food, supplement and pharmaceutical industries. The Animal Nutrition & Health segment manufactures and supplies products to numerous animal health markets. Through Specialty Products, Balchem provides specialty-packaged chemicals for use in healthcare and other industries, and also provides chelated minerals to the micronutrient agricultural market.

About K2VITAL™

K2VITAL™ is patented, typically 99.7% all-trans K2 MK-7. Identical to the K2 molecule found in nature, all-trans MK-7 is the biologically active form of vitamin K2, a fat-soluble vital vitamin that supports calcium metabolism. Vitamin K2 activates vitamin K-dependent proteins, which help direct calcium away from the arteries and deposit it into the bone, supporting bone and heart. K2VITAL™ offers uncompromising quality and stability, providing the maximum benefits of vitamin K2.

More information at:

https://balchem.com/human-nutrition-health/

Follow on LinkedIn:

https://www.linkedin.com/company/balchemhumannutritionandhealth/

Follow on Facebook:

https://www.facebook.com/BalchemHNH

Contacts

For further details, contact:

Matilde Martinuzzi
Senior PR Account Executive

BDB Global

matilde.martinuzzi@bdb.co.uk

Bettina Bendig
Director Marketing Consumer Strategy & B2B2C Growth

Balchem Human Nutrition and Health

Bettina.bendig@balchem.com

Vertex Announces CASGEVY® Reimbursement Agreement for the Treatment of Transfusion-Dependent Beta Thalassemia and Sickle Cell Disease in Italy




Vertex Announces CASGEVY® Reimbursement Agreement for the Treatment of Transfusion-Dependent Beta Thalassemia and Sickle Cell Disease in Italy

– CASGEVY is the first, and only, gene editing therapy approved for the treatment of transfusion-dependent beta thalassemia (TDT) and sickle cell disease (SCD) in Europe –

– Italy has the largest population of people living with TDT in Europe –

LONDON–(BUSINESS WIRE)–Vertex Pharmaceuticals (Nasdaq: VRTX) announced today a reimbursement agreement with the Italian Medicines Agency (AIFA) for eligible transfusion-dependent beta thalassemia (TDT) and severe sickle cell disease (SCD) patients to access the CRISPR/Cas9 gene-edited therapy, CASGEVY^® (exagamglogene autotemcel).

“Today is a turning point for eligible people in Italy living with transfusion-dependent beta thalassemia and sickle cell disease, two life-shortening diseases with limited treatment options,” said Ludovic Fenaux, Senior Vice President, Vertex International. “Italy has the largest TDT population in Europe, which underscores the importance of this agreement. We appreciate the collaboration with AIFA to recognize the value a one-time transformative treatment provides to patients, families and the health care system.”

In Italy, there are approximately 5,000 people 12 years and older living with TDT and around 2,300 with SCD. Italy joins a number of countries that have signed reimbursement agreements for CASGEVY including Austria, Bahrain, Denmark, England, the Kingdom of Saudi Arabia and the United Arab Emirates.

About Transfusion-Dependent Beta Thalassemia (TDT)

TDT is a serious, life-threatening genetic disease. TDT patients report health-related quality of life scores below the general population and significant health care resource utilization. TDT requires frequent blood transfusions and iron chelation therapy throughout a person’s life. Due to anemia, patients living with TDT may experience fatigue and shortness of breath, and infants may develop failure to thrive, jaundice and feeding problems. Complications of TDT can also include an enlarged spleen, liver and/or heart, misshapen bones and delayed puberty. TDT requires lifelong treatment and significant use of health care resources, and ultimately results in reduced life expectancy, decreased quality of life and reduced lifetime earnings and productivity. In Europe, the mean age of death for patients living with TDT is 50-55 years.

About Sickle Cell Disease (SCD)

SCD is a debilitating, progressive, life-shortening genetic disease. SCD patients report health-related quality of life scores well below the general population and significant health care resource utilization. SCD affects the red blood cells, which are essential for carrying oxygen to all organs and tissues of the body. SCD causes severe pain, organ damage and shortened life span due to misshapen or “sickled” red blood cells. The clinical hallmark of SCD is vaso-occlusive crises (VOCs), which are caused by blockages of blood vessels by sickled red blood cells and result in severe and debilitating pain that can happen anywhere in the body at any time. SCD requires lifelong treatment and significant use of health care resources, and ultimately results in reduced life expectancy, decreased quality of life and reduced lifetime earnings and productivity. In Europe, the mean age of death for patients living with SCD is around 40 years.

About CASGEVY^® (exagamglogene autotemcel)

CASGEVY^® is a non-viral, ex vivo CRISPR/Cas9 gene-edited cell therapy for eligible patients with SCD or TDT, in which a patient’s own hematopoietic stem and progenitor cells are edited at the erythroid specific enhancer region of the BCL11A gene through a precise double-strand break. This edit results in the production of high levels of fetal hemoglobin (HbF; hemoglobin F) in red blood cells. HbF is the form of the oxygen-carrying hemoglobin that is naturally present during fetal development, which then switches to the adult form of hemoglobin after birth. CASGEVY has been shown to reduce or eliminate VOCs for patients with SCD and transfusion requirements for patients with TDT.

CASGEVY is approved for eligible SCD and TDT patients 12 years and older by multiple regulatory bodies around the world. In the European Union, CASGEVY is approved for patients 12 years of age and older with either severe SCD with recurrent VOCs or TDT, for whom hematopoietic stem cell (HSC) transplantation is appropriate and a human leukocyte antigen matched related HSC donor is not available.

For complete product information, please see the Summary of Product Characteristics (SmPC) at www.ema.europa.eu.

About Vertex

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases and conditions. The company has approved therapies for cystic fibrosis, sickle cell disease, transfusion-dependent beta thalassemia and acute pain, and it continues to advance clinical and research programs in these areas. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including neuropathic pain, APOL1-mediated kidney disease, IgA nephropathy, primary membranous nephropathy, autosomal dominant polycystic kidney disease, type 1 diabetes and myotonic dystrophy type 1.

Vertex was founded in 1989 and has its global headquarters in Boston, with international headquarters in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry’s top places to work, including 15 consecutive years on Science magazine’s Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex’s history of innovation, visit www.vrtx.com/en-global.

Vertex Special Note Regarding Forward-Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, the statements by Ludovic Fenaux, in this press release, and statements regarding Vertex’s expectations for and the anticipated benefits of CASGEVY, expectations for access to CASGEVY for eligible TDT and SCD patients in Italy, and expectations for the population of people living with TDT and SCD in Europe. While we believe the forward-looking statements contained in this press release are accurate, these forward-looking statements represent the company’s beliefs only as of the date of this press release and there are a number of risks and uncertainties that could cause actual events or results to differ materially from those expressed or implied by such forward-looking statements. Those risks and uncertainties include, among other things, that data from the company’s development programs may not support registration or further development of its compounds due to safety, efficacy, and other reasons, anticipated patient populations may be different than expected, and other risks listed under the heading “Risk Factors” in Vertex’s most recent annual report and subsequent quarterly reports filed with the Securities and Exchange Commission at www.sec.gov and available through the company’s website at www.vrtx.com. You should not place undue reliance on these statements. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available.

(VRTX-GEN)

Contacts

Vertex Pharmaceuticals Incorporated
Investors:
InvestorInfo@vrtx.com

Media:
mediainfo@vrtx.com
or

International: +44 20 3204 5275

or

U.S.: 617-341-6992

Vizient Recognizes Suppliers and Distributors for Service Excellence




Vizient Recognizes Suppliers and Distributors for Service Excellence

IRVING, Texas–(BUSINESS WIRE)–Vizient®, the nation’s largest provider-driven healthcare performance improvement company, honored top suppliers and distributors for outstanding service to its provider clients. The awards were announced at the Vizient Connections Summit Sept. 15 in Las Vegas.

“We are proud to recognize suppliers whose work strengthens healthcare supply chains and supports providers in delivering the highest quality of care,” said Simrit Sandhu, spend management president at Vizient. “Their commitment to innovation and collaboration sets the standard for supplier excellence in our industry.”

The Vizient Pharmaceutical Supplier Partner of the Year is recognized for superior service, support, reliability, ethics, and integrity in collaboration with Vizient and Vizient provider clients. This supplier provides comprehensive contract access, proactively engages the broader Vizient enterprise and demonstrates a commitment to advancing innovation and supplier-client partnerships to meet unmet needs in the market.

The National Account Leadership Award recognizes exemplary representatives of their respective organizations who work diligently and strategically to collaborate with Vizient. This includes demonstrating the ability to connect their organization’s senior leaders and subject matter experts with Vizient peers.

The Supplier of the Year Awards recognize outstanding suppliers by category that support Vizient’s mission to strengthen providers’ delivery of better, more affordable care. Through innovative strategies and deep partnerships with Vizient and Vizient clients, these honorees set the standard for excellence and lasting impact.

The Excellence Awards honor suppliers who demonstrate superior service, support, reliability, ethics and integrity in collaboration with Vizient and Vizient clients within the respective award category. These suppliers provide comprehensive contract access across product and service lines and proactively engage the broader Vizient enterprise. They are committed to value creation and improving total cost of care within their category.

The Program Excellence Awards honor superior service, support, reliability, ethics and integrity in collaboration with Vizient and Vizient clients within the respective program. These suppliers provide differentiated value through these unique program channels.

About Vizient, Inc.

Vizient, Inc., the nation’s largest provider-driven healthcare performance improvement company, provides solutions and services to more than two-thirds of the nation’s acute care providers and more than one-third of ambulatory providers. Vizient offers proprietary data and analytics to deliver unique clinical and operational insights and a contract portfolio representing $156 billion in annual purchasing volume enabling the delivery of cost-effective care. With its acquisition of Kaufman Hall in 2024, Vizient expanded its advisory services to help providers achieve financial, clinical and operational excellence. Headquartered in Irving, Texas, Vizient has offices throughout the United States. Learn more at www.vizientinc.com.

Contacts

Media Contact

Nancy Matocha

(972) 830-9756

nancy.matocha@vizientinc.com

Yellowstone Biosciences Appoints James (“Jim”) MacDonald as Chief Executive Officer




Yellowstone Biosciences Appoints James (“Jim”) MacDonald as Chief Executive Officer

OXFORD, England–(BUSINESS WIRE)–Yellowstone Biosciences Limited (“Yellowstone” or the “Company”), a pioneer of soluble bispecific T-cell receptor (TCR)-based therapies for human leukocyte antigen Class II (“HLA Class II”) targets in oncology, today announced the appointment of Jim MacDonald as its Chief Executive Officer and member of its Board of Directors.

Mr. MacDonald brings more than 25 years of leadership and experience to Yellowstone. He most recently served as Venture Partner at Altitude Life Science Ventures. Previously, he was Co-Founder and Executive Vice President & General Counsel at Sana Biotechnology, where he played a key role in securing the foundational intellectual property for the company, building and scaling the business, and undertaking its private financings and Nasdaq IPO. Earlier, he served as Senior Vice President and Chief Intellectual Property Officer at Juno Therapeutics, contributing to the scaling of the company, its private financings and Nasdaq IPO, and the acquisition by Celgene.

“Jim is a proven biotech leader with extensive experience in building innovative life sciences companies,” said Neil Johnston, Chair of Yellowstone. “His experience with advancing novel oncology platforms and executing strategic financings will be instrumental as Yellowstone advances its HLA Class II programmes toward the clinic.”

“Jim’s leadership comes at a critical moment for Yellowstone,” said Prof. Paresh Vyas, Co-Founder and Chief Scientific Officer of Yellowstone. “His experience in scaling high-growth biotech companies will be invaluable as we translate our HLA Class II science into a robust pipeline and advance toward the clinic.”

“I am excited to join Yellowstone at this pivotal stage,” said Jim MacDonald, Chief Executive Officer of Yellowstone. “Yellowstone’s pioneering science in HLA Class II therapeutics has the potential to transform outcomes for patients with AML and solid tumours, and I look forward to working with the team to realise that promise.”

About Yellowstone Biosciences

Yellowstone Biosciences, spun out of the University of Oxford with support from Oxford University Innovation (OUI) and Syncona Limited, is advancing soluble bispecific T-cell receptor (TCR)-based therapies targeting human leukocyte antigen Class II (“HLA Class II”) antigens. Yellowstone is founded on the pioneering research of Professor Paresh Vyas, a world-renowned scientific academic, key opinion leader and practising clinician with a specialist focus on acute myeloid leukaemia (“AML”). The Company is leveraging a proprietary biobank developed in Professor Vyas’ laboratory and novel antigen discoveries to develop a new class of highly selective cancer therapeutics, initially focused on AML and solid tumours. For more information, please visit www.yellowstonebio.com.

Contacts

Yellowstone Biosciences Contacts:

Paresh Vyas, Co-Founder and Chief Scientific Officer

Julian Hirst, Co-Founder and Chief Financial Officer

Email: enquiries@yellowstonebio.com

VarmX Partners With CSL in a Strategic Collaboration and Option Agreement to Develop Novel Investigational Coagulation Treatment




VarmX Partners With CSL in a Strategic Collaboration and Option Agreement to Develop Novel Investigational Coagulation Treatment

• Full funding of VMX-C001 Phase 3 trial, late-stage product development, manufacturing and pre-launch activities
• VarmX shareholders to receive initial $117m upfront and further potential milestone payments up to $2.1bn
• Transformational step for VarmX, well positioned to bring VMX-C001 to patients
• Exclusive option agreement for CSL to acquire all issued and outstanding shares of the company, dependent on Phase 3 data

LEIDEN, Netherlands–(BUSINESS WIRE)–VarmX, a biotech company developing innovative approaches for the bypass of direct oral anticoagulants targeting activated factor Xa (FXa DOACs) and inherited coagulation disorders, has entered into a strategic collaboration with global biotechnology leader, CSL (ASX:CSL), to support the development of its lead asset, VMX-C001. VMX-C001 is a novel treatment to help restore blood coagulation in patients requiring urgent surgery or experiencing severe bleeding while on FXa DOACs. CSL has also entered into an exclusive option agreement with VarmX shareholders to acquire all issued and outstanding shares of the company.

Under the terms of the strategic collaboration agreement, CSL will fully fund VarmX’s global Phase 3 EquilibriX-S trial evaluating VMX-C001 in patients taking FXa DOACs who require urgent surgery. CSL will also fully fund and support VarmX in late-stage product development, manufacturing and pre-launch commercial and medical affairs activities.

CSL will make an upfront payment to VarmX shareholders of USD 117 million upon closing of the transaction for an exclusive option to acquire the company. CSL will have the right to exercise the option upon Phase 3 data. Subject to the achievement of certain milestones, following the exercise of the option and customary regulatory clearances, VarmX shareholders will receive a further USD 388 million in acquisition and additional payments up to the commercial launch of VMX-C001 and up to USD 1.7 billion in sales-based success milestones thereafter.

John Glasspool, Chief Executive Officer of VarmX, said:

“The collaboration with CSL represents a transformative step for VarmX. By securing full funding for the registrational trial, product development, CMC and pre-launch activities, we are well positioned to bring VMX-C001 to patients. We are proud to partner with CSL, whose expertise and global reach will be invaluable as we move forward.”

Dr. Paul McKenzie, Chief Executive Officer of CSL, commented:

“We are excited to partner with VarmX to develop a novel treatment and address a significant unmet need aligning strongly with our strategic ambition to deliver enduring patient impact. It also aligns with our portfolio of medicines designed to minimize bleeding, preserve a patient’s own blood supply, improve surgical and medical outcomes and support global public health approaches to patient blood management.”

Bill Mezzanotte, CSL Executive Vice President and Head of Research & Development, added:

“CSL was particularly interested in VMX-C001’s unique mechanism of action, how it specifically targets Factor Xa inhibitors, compared to the more general action of other treatments, and the preclinical and early clinical data which led to U.S Food and Drug Administration (FDA) approval to proceed straight to a single Phase 3 study.”

VMX-C001 is an investigational, recombinant modified Factor X protein administered as a rapid single-dose, effectively bypassing the FXa anticoagulation activity and swiftly restoring coagulation in patients on Factor Xa inhibitors in urgent surgery and severe bleeding situations. It could offer the potential to be used with all FXa DOACs and be administered with other common anticoagulants like heparin, and potentially, with no additional thrombotic risk.

By 2030, an estimated 30 million patients in the US, Europe, and Japan will be on Factor Xa (FXa) direct oral anticoagulants (DOACs) for chronic indications such as stroke prevention in atrial fibrillation and treatment of deep vein thrombosis. While these therapies are highly effective, 2-4% of patients each year face severe, life-threatening bleeding or require emergency surgery, amounting to more than 30,000 affected patients every week.

Despite the unmet clinical need, no fully approved therapeutic agent is currently available in the E.U. or the U.S. for treating acute major bleeding in patients on Factor Xa inhibitors.

VMX-C001 was recently granted Fast Track Designation by the FDA, as announced on 3 September 2025, recognizing its potential to address a critical unmet medical need in restoring coagulation for patients on FXa DOACs requiring urgent surgery. Commercial launch is anticipated in 2029.

John Glasspool, Chief Executive Officer of VarmX concluded:

“We are grateful for the continued support of our investors, including Sound Bioventures, EIC, EQT Life Sciences, INKEF, Lundbeckfonden BioCapital, Ysios Capital, BioGeneration Ventures, InnovationQuarter, LEH and UNIIQ, who share our vision of transforming urgent care for patients and have been instrumental in helping the company grow and reach this milestone.”

UBS AG is acting as the exclusive financial advisor to VarmX. NautaDutilh N.V. is acting as legal advisor to VarmX.

Notes to Editors

About VarmX

VarmX is a spin-off from the Leiden University Medical Center (LUMC), founded in 2016 by Professor Pieter Reitsma, a world leading expert in hemostasis and thrombosis. VarmX’s lead compound VMX-C001 is a modified recombinant blood factor X. The compound is being developed for the treatment of severe spontaneous bleeding and for the prevention of bleeding during urgent surgery in patients taking oral factor Xa inhibitors (FXa DOACs) as anticoagulation therapy. The Company is supported by a strong syndicate of investors including Sound Bioventures, EIC, EQT Life Sciences (formerly LSP), Inkef, Lundbeckfonden BioCapital, Ysios Capital, BioGeneration Ventures and InnovationQuarter. For more information, please visit www.varmx.com.

About VMX-C001

VMX-C001 is a modified, human, factor X protein, designed to be insensitive to FXa DOACs, effectively bypassing their anticoagulant activity and swiftly restoring the coagulation cascade.VMX-C001 has been developed with significant clinical advantages, including universal dosing regardless of the specific FXa DOAC used, rapid and easy administration, compatibility with common anticoagulants like heparin, and crucially, no additional thrombotic risk.

About CSL

CSL (ASX:CSL; USOTC:CSLLY) is a global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat haemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our three businesses: CSL Behring, CSL Seqirus and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 32,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest. For more information about CSL, visit www.CSL.com.

Contacts

For further information, please contact:
Vigo Consulting (media enquiries)
Rozi Morris

+44 20 7390 0230

VarmX@vigoconsulting.com

Biocytogen Announces ADC Innovator Tubulis Has Signed Global Exclusive License Agreement for Single Antibody




Biocytogen Announces ADC Innovator Tubulis Has Signed Global Exclusive License Agreement for Single Antibody

BEIJING–(BUSINESS WIRE)–Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, HKEX: 02315), a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies, today announced that ADC therapeutics developer, Tubulis has exercised an exclusive license for the global development and commercialization of a fully human antibody developed by Biocytogen. The antibody will be applied in a novel ADC candidate proprietary to Tubulis. It is part of a previously signed research collaboration and option agreement to discover and advance antibody components for the development and commercialization of ADC products based on Biocytogen’s antibody discovery engine.

The antibody was generated using Biocytogen’s proprietary RenMice^® platform and features high affinity, low immunogenicity, and favorable developability. Tubulis will apply its proprietary linker and payload technologies to develop innovative ADC therapies based on this antibody, aiming to address areas of high unmet clinical need in cancer treatment.

Dr. Yuelei Shen, President and CEO of Biocytogen, said, “We are very pleased that Tubulis has exercised its option, which reflects the international competitiveness and translational potential of our fully human antibody discovery platform. We look forward to seeing this antibody advance through Tubulis’ powerful ADC development engine and into clinical development to benefit patients around the world.”

Jonas Helma-Smets, PhD, CSO and co-founder of Tubulis, stated: “Our goal is to drive innovation in ADC development and deliver uniquely positioned ADC therapeutics that can improve treatment outcomes to patients with solid tumors. The R&D collaboration with Biocytogen has yielded an antibody candidate that we believe fits well with our ADC technology platforms and that may support us in the development of a novel therapeutic candidate.”

Under the terms of the agreement, Biocytogen will receive an upfront payment and is eligible for certain development, regulatory, and commercial milestone payments, and single-digit royalties on net sales.

About Biocytogen

Biocytogen (HKEX: 02315) is a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies. Founded on gene editing technology, Biocytogen leverages genetically engineered proprietary RenMice^® (RenMab^™/ RenLite^®/ RenNano^®/ RenTCR mimic™) platforms for fully human monoclonal/bispecific/multispecific antibody discovery, bispecific antibody-drug conjugate discovery, nanobody discovery and TCR mimic antibody discovery, and has established a sub-brand, RenBiologics™, to explore global partnerships for an off-the-shelf library of >1,000,000 fully human antibody sequences against over 1000 targets for worldwide collaboration. As of June 30, 2025, approximately 280 therapeutic antibody and multiple clinical asset co-development/out-licensing/transfer agreements and over 50 target-nominated RenMice^® licensing projects have been established around the globe, including several partnerships with multinational pharmaceutical companies (MNCs). Biocytogen pioneered the generation of drug target knock-in humanized models for preclinical research, and currently provides a few thousand off-the-shelf animal and cell models under the company’s sub-brand, BioMice™, along with preclinical pharmacology and gene-editing services for clients worldwide. Headquartered in Beijing, Biocytogen has branches in China (Haimen Jiangsu, Shanghai), USA (Boston, San Francisco, San Diego), and Germany (Heidelberg). For more information, please visit https://biocytogen.com.

Contacts

Biocytogen Contacts
Antibody assets and platforms: BD-Licensing@biocytogen.com
Media: pr@bbctg.com.cn

Biocytogen Announces ADC Innovator Tubulis Has Signed Global Exclusive License Agreement for Single Antibody




Biocytogen Announces ADC Innovator Tubulis Has Signed Global Exclusive License Agreement for Single Antibody

BEIJING–(BUSINESS WIRE)–#ADCTherapeutics–Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, HKEX: 02315), a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies, today announced that ADC therapeutics developer, Tubulis has exercised an exclusive license for the global development and commercialization of a fully human antibody developed by Biocytogen. The antibody will be applied in a novel ADC candidate proprietary to Tubulis. It is part of a previously signed research collaboration and option agreement to discover and advance antibody components for the development and commercialization of ADC products based on Biocytogen’s antibody discovery engine.

The antibody was generated using Biocytogen’s proprietary RenMice^® platform and features high affinity, low immunogenicity, and favorable developability. Tubulis will apply its proprietary linker and payload technologies to develop innovative ADC therapies based on this antibody, aiming to address areas of high unmet clinical need in cancer treatment.

Dr. Yuelei Shen, President and CEO of Biocytogen, said, “We are very pleased that Tubulis has exercised its option, which reflects the international competitiveness and translational potential of our fully human antibody discovery platform. We look forward to seeing this antibody advance through Tubulis’ powerful ADC development engine and into clinical development to benefit patients around the world.”

Jonas Helma-Smets, PhD, CSO and co-founder of Tubulis, stated: “Our goal is to drive innovation in ADC development and deliver uniquely positioned ADC therapeutics that can improve treatment outcomes to patients with solid tumors. The R&D collaboration with Biocytogen has yielded an antibody candidate that we believe fits well with our ADC technology platforms and that may support us in the development of a novel therapeutic candidate.”

Under the terms of the agreement, Biocytogen will receive an upfront payment and is eligible for certain development, regulatory, and commercial milestone payments, and single-digit royalties on net sales.

About Biocytogen

Biocytogen (HKEX: 02315) is a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies. Founded on gene editing technology, Biocytogen leverages genetically engineered proprietary RenMice^® (RenMab^™/ RenLite^®/ RenNano^®/ RenTCR mimic^™) platforms for fully human monoclonal/bispecific/multispecific antibody discovery, bispecific antibody-drug conjugate discovery, nanobody discovery and TCR mimic antibody discovery, and has established a sub-brand, RenBiologics^™, to explore global partnerships for an off-the-shelf library of >1,000,000 fully human antibody sequences against over 1000 targets for worldwide collaboration. As of June 30, 2025, approximately 280 therapeutic antibody and multiple clinical asset co-development/out-licensing/transfer agreements and over 50 target-nominated RenMice^® licensing projects have been established around the globe, including several partnerships with multinational pharmaceutical companies (MNCs). Biocytogen pioneered the generation of drug target knock-in humanized models for preclinical research, and currently provides a few thousand off-the-shelf animal and cell models under the company’s sub-brand, BioMice™, along with preclinical pharmacology and gene-editing services for clients worldwide. Headquartered in Beijing, Biocytogen has branches in China (Haimen Jiangsu, Shanghai), USA (Boston, San Francisco, San Diego), and Germany (Heidelberg). For more information, please visit https://biocytogen.com.

Contacts

Biocytogen Contacts
Antibody assets and platforms: BD-Licensing@biocytogen.com
Media: pr@bbctg.com.cn

Paysign, Inc. Announces Summary Notice of Pendency and Proposed Settlement of Stockholder Derivative Actions




Paysign, Inc. Announces Summary Notice of Pendency and Proposed Settlement of Stockholder Derivative Actions

HENDERSON, Nev.–(BUSINESS WIRE)–Paysign, Inc. (NASDAQ: PAYS), a leading provider of patient affordability programs, donor compensation solutions, engagement and management platforms and integrated payment processing for the life sciences industries, today posted the following summary notice of pendency and proposed settlement of stockholder derivative actions.

To: All Record Holders and Beneficial Owners of Paysign, Inc. (“Paysign” of the “Company”) Common Stock as of November 25, 2024.

Please read this summary notice carefully and in its entirety and as your rights may be affected by proceedings in the litigation.

YOU ARE HEREBY NOTIFIED that the following stockholder derivative actions (the “Derivative Actions”), are being settled on the terms set forth in a Stipulation and Agreement of Settlement dated November 25, 2024 (the “Stipulation”): (i) the above-captioned consolidated action, titled Toczek v. Newcomer et al, Case No. 2:20-cv-01722-JCM-NJK; (ii) Blanchette v. Paysign, Inc. et al., Case No. 2:23-cv-01632-JCM-BNW (D. Nev.); and (iii) Jeewa v. Newcomer, et al., Case No. 2:23-cv-02129-RFB-EJY (D. Nev.).

The Derivative Actions allege that, inter alia, between March 12, 2019 through September 17, 2020, at least, the Individual Defendants breached their fiduciary duties by issuing and/or causing the Company to issue materially false and misleading statements (including by soliciting a materially false and misleading proxy statement allegedly in violation of Section 14(a) of the Securities Exchange Act of 1934) and by failing to disclose material facts to the public regarding, among other things, that: (1) the Company failed to design, implement, and maintain effective IT general controls, specifically pertaining to user access and the Company’s systems change management; (2) the Company failed to maintain effective disclosure controls and internal controls over its financial reporting; and (3) due to the foregoing, the Company would be forced to delay filing its 2019 10-K and holding its 2019 year-end earnings call. The Derivative Actions also allege that the Individual Defendants breached their fiduciary duties by failing to correct and/or causing the Company to fail to correct these false and misleading statements and omissions of material fact to the investing public, while four of the Individual Defendants engaged in lucrative insider sales, netting combined proceeds of over $5.7 million. The Derivative Actions allege that, as a result of the foregoing, the Company experienced reputational and financial harm. Defendants have denied and continue to deny each and all of the claims and allegations of wrongdoing asserted in the Derivative Actions.

Pursuant to the terms of the Settlement, Paysign agrees to implement and maintain certain corporate governance reforms that are outlined in Exhibit A to the Stipulation (the “Reforms”). The Reforms shall be maintained for five (5) years. Paysign acknowledges and agrees that the filing, pendency, and settlement of the Derivative Actions was the cause of the Company’s decision to adopt, implement, and maintain the Reforms. Paysign also acknowledges and agrees that the Reforms confer substantial benefits to Paysign and its shareholders.

After negotiating the principal terms of the Settlement, counsel for the Parties, with the assistance of the Mediator, negotiated the attorneys’ fees and expenses to be paid to Plaintiffs’ Counsel, subject to Court approval (the “Fee and Expense Amount”). In light of the substantial benefits conferred upon the Company and its stockholders, Defendants’ insurers shall pay to Plaintiffs’ Counsel $607,500.00 for their attorneys’ fees and expenses, subject to Court approval. Defendants also agreed not to object to the request for the Court to approve Service Awards of up to two thousand dollars ($2,000.00) for each of the four Plaintiffs, to be paid from the Fee and Expense Amount.

On November 14, 2025 at 1:00 p.m., a hearing (the “Settlement Hearing”) will be held before the Honorable Richard F. Boulware at the United States District Court for the District of Nevada, Las Vegas Division, 333 Las Vegas Boulevard South, Las Vegas, Nevada 89101, for the purpose of determining whether the Settlement should be approved as fair, reasonable, and adequate and whether the Court should approve the agreed-to Fee and Expense Amount and the Service Awards for Plaintiffs. Because this is not a class action, except as otherwise provided for in the Stipulation with respect to the Plaintiffs, no Current Paysign Stockholder has the right to receive any individual compensation as a result of the Settlement.

This Summary Notice provides a condensed overview of certain provisions of the Stipulation and the full Notice of Pendency and Proposed Settlement of Stockholder Derivative Actions (the “Notice”). It is not a complete statement of the events of the Derivative Actions or the terms set forth in the Stipulation. This summary should be read in conjunction with, and is qualified in its entirety by reference to, the text of the Stipulation. For additional information about the claims asserted in the Derivative Actions, and the terms of the proposed Settlement, you may inspect the full Notice and the Stipulation and its exhibits and other papers at the Clerk’s office in the Court at any time during regular business hours. In addition, copies of the Stipulation and its exhibits and the Notice are available on the Investor Relations page of the Company’s website, www.paysign.com.

The Court may, in its discretion, change the date, time, or format of the Settlement Hearing without further notice to you. If you intend to attend the Settlement Hearing, please consult the Court’s calendar or Investor Relations page of the Company’s website, www.paysign.com, for any change in the date, time, or format of the Settlement Hearing.

Inquiries about the Derivative Actions or the Settlement may be made to: Timothy Brown, The Brown Law Firm, P.C., 767 Third Avenue, Suite 2501, New York, NY 10017, Telephone: (516) 922-5427, Email: tbrown@thebrownlawfirm.net.

You may enter an appearance before the Court, at your own expense, individually or through counsel of your choice. If you want to object at the Settlement Hearing, you must be a Current Paysign Stockholder and you must first comply with the procedures for objecting that are set forth in the Notice. Any objection to any aspect of the Settlement must be filed with the Clerk of the Court and sent to Plaintiffs’ Counsel and Defendants’ Counsel no later than October 24, 2025 (21 days before the Settlement Hearing), in accordance with the procedures set forth in the Stipulation and the Notice. Any Current Paysign Stockholder who fails to object in accordance with such procedures will be bound by the Order and Final Judgment of the Court granting final approval to the Settlement and the releases of claims therein, and shall be deemed to have waived the right to object (including the right to appeal) and forever shall be barred, in this proceeding or in any other proceeding, from raising such objection.

PLEASE DO NOT CALL THE COURT OR DEFENDANTS WITH QUESTIONS ABOUT THE SETTLEMENT.

About Paysign

Paysign, Inc. (NASDAQ: PAYS) operates at the intersection of fintech and healthcare, integrating advanced payment processing and program management with tailored technologies for the plasma, pharmaceutical and life sciences industries. Their breakthrough patient affordability solutions ensure patients receive the financial assistance they need to adhere to prescribed therapies by mitigating the effects of copay accumulators and maximizers. Paysign specializes in blood and plasma donor compensation programs, as well as comprehensive engagement and management platforms optimized for life sciences. Paysign’s proprietary processing architecture supports physical, virtual, mobile and bank-based payments with real-time transaction intelligence, enabling efficient, compliant and scalable program delivery. Through advanced reporting, analytics and in-house 24/7 bilingual customer support, Paysign delivers measurable value, exceptional service and a superior experience for donors, patients, healthcare providers, pharmaceutical manufacturers and program sponsors across their growing fintech healthcare ecosystem. The company is committed to improving efficiencies, reducing costs, streamlining communications, increasing program performance and providing actionable insights to those they serve.

Forward-Looking Statements

Certain statements in this news release may contain forward-looking information within the meaning of Rule 175 under the Securities Act of 1933 and Rule 3b-6 under the Securities Exchange Act of 1934, and are subject to the safe harbor created by those rules. All statements, other than statements of fact, included in this release, including, without limitation, statements regarding potential future plans and objectives of the companies, are forward-looking statements that involve risks and uncertainties. There is no assurance that such statements will prove to be accurate, and actual results and future events could differ materially. Paysign undertakes no obligation to publicly update or revise any statements in this release, whether as a result of new information, future events or otherwise.

Contacts

Investor Relations

ir@paysign.com
888.522.4853

paysign.com/investors

Media Relations

Alicia Ches

888.522.4850

pr@paysign.com