Day: August 1, 2023

Study found obexelimab produced rapid, strong, and sustained clinical improvement, including complete clinical remission, in most patients with active IgG4-RD

Results support the continued development of obexelimab for the treatment of IgG4-RD and potentially other B cell-mediated autoimmune conditions

WALTHAM, Mass., Aug. 01, 2023 (GLOBE NEWSWIRE) — Zenas BioPharma, a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immune-based therapies, announces The Lancet Rheumatology has published findings from a Phase 2 study evaluating obexelimab for the treatment of patients with IgG4-Related Disease (IgG4-RD). Based on the results of this study, a Phase 3 study in patients with IgG4-RD is ongoing to further investigate the efficacy and safety of obexelimab administered as a subcutaneous injection.

IgG4-RD is a chronic, immune-mediated fibro-inflammatory disease that can affect multiple organs including the major salivary glands, orbits, lacrimal glands, pancreas, biliary tree, lungs, kidneys, and retroperitoneum. Approximately 20,000 patients are diagnosed with IgG4-RD in the United States alone. Despite its increasing recognition, there remains a need for further research and effective therapeutic options for individuals living with this debilitating disease.

Across the world, the use of glucocorticoids is widely considered to be the standard of care for treating IgG4-RD. There are no approved treatment options for this condition. While commonly used, glucocorticoids and available B cell depleting therapies rarely lead to long-term, treatment-free remissions, and are associated with a high risk of toxicity in these patients. Such therapies also impair vaccine responses, including those for SARS-CoV-2 and influenza.

In a prospective, open-label, single arm, single-center pilot study to assess the efficacy and safety of obexelimab in the treatment of patients with IgG4-RD (clinicaltrials.gov registration NCT02725476), obexelimab demonstrated strong improvement in the IgG4-RD Responder Index, a measure of disease activity, by inhibiting B cell function, without depleting B cells.

The published manuscript, titled “Obexelimab for the Treatment of Patients with IgG4-Related Disease: An Open-Label, Single-Arm, Pilot Study to Evaluate Efficacy, Safety, and Mechanism of Action,” is available online and will appear in the August issue of The Lancet Rheumatology 2023;5(8) [E428-E429].

The following are the key findings in the paper:

• Obexelimab produced rapid, strong, and sustained clinical improvement, including complete remission (IgG4-RD Responder Index score of 0), in most patients with active IgG4-RD.
• During obexelimab treatment, reductions in circulating B cells, including plasmablasts, were observed without evidence of cell death.
• Additionally, reduction of circulating B cells and rapid return to near normal levels after treatment discontinuation suggests that obexelimab may lead to B cell sequestration in lymphoid organs or the bone marrow.
• Obexelimab was well tolerated. The majority of treatment-related adverse events were grades 1 or 2, with the most common adverse events being gastrointestinal infusion-related events, most of which were mild.

“Our findings are a significant step forward in understanding the underlying mechanisms of IgG4-Related Disease; paving the way for more targeted treatment strategies,” said John Stone, MD, MPH, Professor of Medicine at Harvard Medical School, and the Edward A. Fox Chair in Medicine at Mass General Hospital. “Our team is honored to have our research recognized by The Lancet Rheumatology, and we are immensely grateful to the patients who participated in this groundbreaking study.”

About Obexelimab

Obexelimab is an investigational Phase 3-stage, bifunctional, non-cytolytic, humanized monoclonal antibody that mimics the action of antigen-antibody complexes by binding CD19 and FcγRIIb to inhibit B-lineage cell activity. In several early-stage clinical studies in various autoimmune diseases, 198 subjects were treated with obexelimab. In these clinical studies, obexelimab demonstrated effective inhibition of B cell function without depleting the cells, resulting in encouraging treatment effect in patients with various autoimmune diseases. Zenas acquired exclusive worldwide rights to obexelimab from Xencor, Inc.

More information on the Phase 3 (INDIGO) study for the treatment of IgG4 Related Disease is available at clinicaltrials.gov: NCT05662241.

About Zenas BioPharma

Zenas BioPharma is a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immune-based therapies for patients around the world. With clinical development and operations globally, Zenas is advancing a deep and balanced global portfolio of potential first- and best-in-class autoimmune therapeutics in areas of high unmet medical need while meeting the value requirements of the dynamic global healthcare environment. The company’s pipeline continues to grow through our successful business development strategy. Our experienced leadership team and network of business partners drive operational excellence to deliver potentially transformative therapies to improve the lives of those facing autoimmune and rare diseases. For more information about Zenas BioPharma, please visit www.zenasbio.com and follow us on Twitter at @ZenasBioPharma and LinkedIn.

Investor and Media Contact:
Joe Farmer, President & COO
Zenas BioPharma
IR@zenasbio.com

GlobeNewswire Distribution ID 8884766

Bedford, Mass., Aug. 01, 2023 (GLOBE NEWSWIRE) — Conagen, the bioplatform innovator and biomanufacturer, and Sumitomo Chemical, Japan’s leading chemical company, have announced to jointly develop p-hydroxystyrene (HS) and its polymer, poly p-hydroxystyrene (PHS), using a combination of biosynthesis, chemosynthesis, and polymerization. The monomer and the polymer are 100% renewable carbon, marking a new era of sustainable production.

Developing PHS using a combination of biosynthesis, chemosynthesis, and polymerization represents a significant breakthrough in sustainable material production. Efforts to reduce reliance on petroleum and transition towards renewable and sustainable alternatives have gained momentum in recent years. With renewable biomass as the starting material, this joint devolvement between Conagen and Sumitomo Chemical creates an environmentally friendly and cost-effective product. The partnership is in the lead position of active global initiatives to reduce petroleum-based products’ consumption and environmental impact.

This partnership represents a significant milestone in developing sustainable materials, and this approach to PHS production is expected to reduce the carbon footprint associated with traditional chemical synthesis methods. It is a crucial step towards more sustainable manufacturing processes with a positive impact.

The Conagen-Sumitomo partnership leverages Conagen’s expertise in microbial strain design and development with Sumitomo Chemical’s proficiency in chemical production and commercialization. The collaboration aims to create a platform that enables the production of sustainable chemicals to replace petrochemicals in an extended range of many applications.

PHS is used to produce polymers, resins, and other chemicals. The monomer HS can also be used as an input for the synthesis of other substances, such as pharmaceuticals and fragrances. The applications of HS and PHS are limitless and can span uses from electronics to personal care and other consumer products.

“This partnership represents a significant step forward in pursuing green chemicals for sustainable material production,” said J. McNamara, Ph.D., V.P. of chemical applications at Conagen. “Our commitment is a testament to the power of collaboration and the potential of combining our technologies with synthetic and polymer chemistries to create innovative, sustainable solutions that can significantly reduce petroleum-based products in the environment,” McNamara stated. “Together, we’re marking a new era of carbon-neutral material production efforts.”

The monomer HS, with the chemical formula C₈H₈O, is a derivative of styrene in which a hydroxyl group (-OH) is attached to the aromatic ring’s para position (carbon atom 4). The HS and PHS are examples of green chemistry for minimizing waste, reducing hazardous chemicals, and using catalysts that can be easily separated and reused. This joint development project promises to potentially pave the way for developing novel renewable and sustainable materials. “Similar technology can be used to produce other key chemical ingredients by fermentation at industrial scale, such as cinnamic acid, monohydroxy-benzoic acid, and dihydroxy-benzoic acid,” said McNamara.

About Conagen

Conagen is making the impossible possible. It is a product-focused, synthetic biology R&D company with large-scale manufacturing service capabilities. Its proprietary strain development, fermentation, and scale-up technologies enhance our partners’ sales, production, and profitability across a broad spectrum of current and developing markets in food, beverage, nutrition, flavor and fragrance, pharmaceutical, and renewable materials.

About Sumitomo Chemical

Sumitomo Chemical is Japan’s leading chemical company, with a global presence in the chemicals, petrochemicals, and plastics industries. The company is committed to sustainability and has a product portfolio contributing to the United Nations Sustainable Development Goals.Top of Form

Attachments

• Conagen and Sumitomo Chemical, Japan’s leading chemical company develop together p-hydroxystyrene (HS) and its polymer, poly p-hydroxystyrene (PHS), using a combination of biosynthesis, chemosynthesis and polymerization.
• PHS is used to produce polymers, resins, and other chemicals.

Ana Capretz, Head of Public Relations and Communications
Conagen
+1-781-271-1588
ana.capretz@conagen.com

GlobeNewswire Distribution ID 8884420