Zenas BioPharma Announces Publication of Phase 2 Study of Obexelimab, an Investigational Treatment for IgG4-Related Disease (IgG4-RD), in The Lancet Rheumatology

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

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Conagen and Sumitomo Chemical jointly develop a new era of renewable carbon materials

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

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

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World breastfeeding week 2023, WHO recommends babies be breastfed until age 2

Cameroon joins the international community this week to observe the 31st World Breastfeeding Week which runs from August 1st to August 7th under the theme “Enabling breastfeeding: making a difference for working parents”.

The World Health Organization says Breastfeeding is fundamental to good nutrition, food security, the reduction of inequalities and is one of the most efficient ways of ensuring child health and survival.

Medics say babies who are fed nothing but breast milk from birth to 6 months of age get the best start in life.

“Breastfeeding is the best way recommended to feed a child. It has advantages to both the mother and child. It contains all nutrients in their quantities enough for the child,” says Dr. Belanquale Claude, Head of the Bangang Medical Center in the Bamboutos division, West region of Cameroon.

“To mothers, breastfeeding helps reshape the body after birth and helps prevent you from cancer,” he adds.

In Cameroon, commemorative activities to mark this year’s celebrations were launched by the Minister of Public Health, Dr Malachie Manaouda on July 26 2023 in Yaounde. During the launch ceremony, women were sensitized on the importance of breastfeeding newborns for at least 6 months.

World breastfeeding week is a global campaign that aims to raise awareness about breastfeeding and its benefits. Research proves that there is a surge in the infant mortality rate due to a drop in the number of mothers willing to breastfeed thus making the campaign even more essential.

Source: Cameroon News Agency

‘Ghana needs an elimination action plan for viral hepatitis’

Frontliners in the fight against viral hepatitis in Ghana Monday called on the Government to consider an action plan for the elimination of the disease. Ghana presently has a National Policy on Viral Hepatitis dated 2014 but has no elimination plan. Dr Kenneth Tachi, a Gastronomy Specialist, said the nation annually recorded more than 50,000 cases of the disease that infects a third of the global population. There was, therefore, the need for a clear-cut elimination plan with targets aligned to the World Health Organisation Global Strategy to halt the over 7000 lives claimed yearly. Dr Tachi was the Guest Speaker at a stakeholders’ meeting to mark the World Hepatitis Day in Ho, organised by the Ghana Association for the Study of the Liver and Digestive Diseases (GASLIDD), and the Ho Teaching Hospital. He said the action plan should help enhance critical indicators and interventions such as testing as the disease deserved attention equal to HIV, malaria and other resident life reapers. Dr Tachi, who co-founded a virtual clinic that offers hepatitis care support, said the present disease awareness rate among the infected was at 60 per cent as Hepatitis was often downplayed, adding that even professionals in the medical field seemed to ignore its impact. ‘If the current trajectory continues, more people will die from hepatitis than the major killer diseases combined,’ he said. Stigma surrounding the disease added psychological burdens to the financial costs of managing it, and so the gaps, including in information, prevention, testing, and treatment, must be addressed. He said there was also a lack of policy on vaccination, which should ensure introduction of a birth dose, an important component. Dr Tachi told the Ghana News Agency that Ghana had less that 50 specialists in gastronomical diseases, while several smaller health facilities did not have the expertise. A total of about 42,300 cases of Hepatitis B Virus (HBV), and about 9,200 of Hepatitis C (HCV) are recorded annually in Ghana, and with deaths of about 4000 and 3000, respectively. Approximately 90 per cent of the infected are undiagnosed. The WHO Global Elimination Strategy says hepatitis infections should be reduced by 90 per cent by 2030 and deaths by 65 per cent. It also aims to ensure that at least 90 per cent of people with Hepatitis B and C are diagnosed, and at least 80 per cent of those eligible receive the appropriate treatment. This year’s World Hepatitis Day is on the theme: ‘One Life One Liver,’ and the stakeholder meeting climaxed a week-long activity by GASLIDD to mark the occasion. Management of the Ho Teaching Hospital, students of the University of Health and Allied Sciences (UHAS), some senior high schools in Ho among other organisations attended the programme. Professor Lydia Aziato, the Vice Chancellor of UHAS, who was the Guest of Honour, said the elimination of the disease was achievable with the availability of vaccines and treatments, as well as ‘greater awareness and understanding’ of the disease, the risks, and access to cheaper diagnostics and treatment. ‘With Covid-19 no longer a global health emergency, now is the time to prioritise a hepatitis-free world and meet the Global 2030 targets,’ she said. Prof. Yaw Asante Awuku, the President of GASLIDD, said a series of health screening, networking and education activities were undertaken during the week to mark the Day. More than 900 were screened, and 600 were vaccinated in the Ho Ahoe Community, the Anfoega SHS, and the Ho Teaching Hospital’s Taxi Rank, with similar activities ongoing across the country. Prof Awuku bemoaned what he described as ‘inadequate action’ by the Government and stakeholders, including the Ghana Health Service, saying healthcare for the prevention of the virus was inadequate and should receive total coverage from the National Health Insurance Scheme. ‘If it is fully placed on the NHIS, we would be able to fully eliminate viral hepatitis within a decade,’ he said.

Source: Ghana News Agency

Volta Regional ECG searches businesses, homes to recover fake meters

The Volta Regional Directorate of Electricity Company of Ghana (ECG) has clamped down on users of fake and illegal electricity meters in some communities in the Denu District of the Company. The exercise, which forms part of the Company’s Operation Zero’ saw the Company clampdown on fake meters installed at Agbogbome, Aveshive, Wudoaba, Kologa, Dzodze, Gakli and Soshime. The Operation Zero exercise, which started on July 11, is expected to last for two months and ensure people, who consume electricity settle all arrears. Ms. Christina Jatoe-Kaleo, General Manager of ECG, Volta Region, in a statement to the media said the Operation Zero exercise was ongoing in all the 11 Districts of ECG in Volta and Oti Regions. She said the exercise was different from the previous ones as it aimed to target both customers in the ECG database and capture customers consuming power but not in its database. ‘Our team visited customers in these communities and noticed they had strange meters which were not in the ECG database. Some of the customers were even distributing electricity to other customers illegally with these fake meters and substandard network that pose danger to life and property,’ she said. The General Manager revealed that these meters were substandard and could cause fire outbreaks to customers. ‘Our meters are properly tested and calibrated to meet the tariff standards of our country but these meters are not calibrated so customers using these meters are likely to consume higher than our standard meters,’ she added. Ms. Jatoe-Kaleo advised customers to avoid purchasing such meters or dealing with third parties, when they needed meters and visit the ECG Office for such services. The ECG General Manager called on the public to assist the Company win the war against these fake meters to enable the company gather enough revenue to sustain the electricity supply chain. ‘These fake meters allow customers to consume power illegally since they are not in our system and were obtained illegally which is not fair to customers who pay their bills. We want everyone consuming power to prioritize the payment of bills since it is a patriotic act to pay for electricity consumed,’ she added. She further appealed to customers consuming power without paying through such foreign meters, faulty meters or direct connections to take advantage of the moratorium granted during the operation zero exercise by visiting any ECG Office to regularize their supply. Ms. Jatoe-Kaleo urged customers to download the ECG PowerApp or use the shortcode *226# to pay all their outstanding bills to enable the company provide stable power supply. Meanwhile, Ghana News Agency investigations has revealed that more than 200 fake meters were seized from customers in that enclave.

Source: Ghana News Agency

Africa must entrench rule of law for peace and stability – President Akufo-Addo

President Nana Addo Dankwa Akufo-Addo has urged the West African Bar Association (WABA) to be vociferous in championing the cause of human rights and the rule of law. The members, he said, were obliged to support their respective governments in upholding those democratic tenets for stability, peace and security. ‘We must make concrete and deliberate efforts to integrate these in our strategic interventions at both national and regional levels,’ he advised. President Nana Akufo-Addo gave the advice in a speech read on his behalf by the Interior Minister, Mr. Ambrose Dery, at the opening session of the annual conference of WABA, in Accra. The two-day programme is being held on the theme: ‘Promoting Democratic Consolidation through the Respect of the Rule of Law and Human Rights: Leveraging the Role of Bar Associations’. Topics being discussed encompass ‘Unconstitutional Changes of Government and Engaging with Transitions – the Role of Bar Associations’, ‘Promoting Access to Regional Justice Mechanisms – Contribution of Bar Associations’, and ‘Rule of Law and Human Rights Challenges in the West African Region’. The rest are ‘Instrumentalisation of the Justice System’, ‘Enhancing Institutional Partnerships – Challenges and Opportunities’, and the ‘WABA Strategic Plan’. WABA is a civil society organisation whose membership is drawn from the leadership of Bar Associations and legal practitioners in the sub-Region. It is the pioneer organisation that promoted the ECOWAS Community Court of Justice and instrumental in the expansion of the court’s jurisdiction to include human rights mandate and right of individual’s access to court. This year’s annual conference is coming in the wake of the incidence of the unconstitutional changes in government, electoral processes fraught with violence and issues with the justice system in the sub-Region. President Nana Akufo-Addo pointed out that given the centrality of the rule of law to peace and security, there was the need for stakeholders to take steps to reinforce the legislative and institutional frameworks towards a sustained protection of human rights. He said it was imperative that the leaders worked hard to establish functional, effective and independent institutions to enhance democratic consolidation, peace and security. ‘Bar Associations are expected to play a key role in this regard, especially in the context of multiple challenges facing the region. ‘As you strengthen partnerships with national stakeholders, I would urge you to also invest in reinforcing regional networks, which are crucial for experience sharing and exchange of best practices,’ the President advocated. That, he noted, could not be glossed over given the fact that the challenges faced by the region were multifaceted and not confined within any country. He, therefore, asked the WABA members to take advantage of the annual conference to adopt more concerted and comprehensive approaches in search of durable solutions to the region’s problems. ‘I am happy to note that during the next two days, you will have the opportunity to discuss some of the key challenges undermining judicial governance in our region and make recommendations in this regard. ‘We look forward to your recommendations with the expectation that they will provide additional options to enhance respect for the rule of law,’ the President noted. Ms. Obiageli Oraka-Oifoghe, the Chief Executive Officer (CEO) of WABA, said the Association was committed to promoting human rights issues and the rule of law in the region. The members would continue to play an active advocacy role in enhancing democratic governance for the benefit of the people, she assured.

Source: Ghana News Agency