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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Passoré/Great oratorical debates: The Toussaint Louverture Municipal High School wins

The regional final of the 5th edition of the Great Oratory Debates of the North (GDO / North), was held on Saturday July 29, 2023 in the multipurpose room of the Yako youth and culture center. The Lycée municipal Toussaint Louverture wins first place.

"Providing a framework for expression, training and development to the youth of the Northern region", such were among others the objectives pursued by the Yam-Weekré Youth Association (AJYW) initiator of the great oratory debates of the North (GDO /North).

Started on February 15, it was on Saturday July 29, 2023 that the GDOs of the North had their epilogue under the theme: "Engaged and resilient youth in the face of the security crisis in Burkina Faso, pledge of a country of peace".

The 5th edition of the competition for detecting the oratorical talents of young people from the North, saw the participation of 14 post-primary and secondary establishments, from the provincial capitals of Yatenga, Zondoma and Passoré.

The final opposed the Yam-Waya Polyvalent High School of Ouahigouya to the Toussaint Louverture Municipal High School (LMTL) of Yako.

According to the chairman of the organizing committee of the event, Ali Nanema, the event is placed under the sign of resilience and resistance.

Several activities were on the program, namely a blood drive, a public conference on the issue of civic participation of young people in the region under the theme: "Citizen participation of young people", a shopping street and a major concert in support of the Forces. Defense and Security (FDS) and Volunteers for the Defense of the Fatherland (VDP).

Represented by four debaters, each of the two finalist teams spoke on a theme that coincides with current judicial issues in the country: “Is Burkinabè justice independent? ".

At the end of the 4 minutes, in addition to a bonus of 30 seconds granted to each debater, it was finally the team of the Municipal Lycée Toussaint Louverture in Yako, who succeeded in convincing the members of the jury and the public, made up of personalities and administrative authorities.

For this title of champion of the 5th edition of the GDO du Nord, the LMTL of Yako (82.6 points/100) in addition to the trophy obtained gadgets, the sum of 100,000 CFA francs, 5 bags and 5 novels.

The Yam-Waya Polyvalent High School in Ouahigouya (77.8 points/100) received the sum of 75,000 FCFA, 5 bags, 5 novels plus gadgets.

For his 3rd place, the provincial of Zondoma left with the sum of 50,000 CFA francs.

Ranked 4th, 5th and 6th respectively, the Lycée Sainte-Marie girl of Ouahigouya, the municipal Lycée of Gourcy and the versatile provincial Lycée of Yako, each received the sum of 25,000 CFA francs in addition to gadgets.

The best supervisors and speakers in publishing also saw their efforts rewarded.

The president of the organizing committee of the GDOs of the North, Ali Nanema, meant that beyond what any human work is never satisfied, the 5th edition of the Great Oratory Debates of the North is more than a successful bet with regard to the achievement of the assigned objectives.

He addressed his sincere thanks to all those who contributed to the success of the edition.

“We have taken a big step in the training of young people. And this is the best way for us to prepare young people for the management of power tomorrow. “, he rejoiced.

Source: Burkina Information Agency

Nahouri/Georges Namoano de Pô Military Academy: Activities launched for the official release of active cadets

The Commander of the Georges Namoano de Pô Military Academy, Battalion Commander Williams Baguéra, proceeded on Saturday July 22, 2023 in Pô, to the launch of a series of activities, as part of the official release of the 22nd class of active cadets.

It is by a popular cross that the High Commissioner of the province of Nahouri, Auguste Kinda and the Commander of the Military Academy Georges Namoano, the battalion commander Williams Baguéra, launched the activities falling within the framework of the official exit of the 22nd promotion of active cadets of the said Academy.

While waiting for the official date of the graduation ceremony of the 22nd promotion which will be chaired by the Head of State, several activities have been organized to honor these young officers.

It is a popular cross, two days of community service on the national road N ° 5, a Maracana tournament, a blood donation, a day of health, an inter-corps military competition and games of society.

For the Commander of the Military Academy Georges Namoano Williams Baguéra, these activities aim to break down the barriers between populations and the defense and security forces of the Pô garrison.

“They also aim to sensitize the populations so that they accompany, bless the FDS and collaborate effectively with the latter by reporting any suspicious case”, he indicated.

It should be noted that this series of activities was punctuated by a handing over of garbage cans from the 22nd promotion of cadets to the commune of Pô.

They were received by the first vice-president of the special delegation, Francis Yaguibou.

He took the opportunity to express his gratitude and that of the entire population of the commune of Pô to these young officers and to the entire Command.

Mr. Yaguibou explained that this is the second time in a row that donations have been offered to the commune of Pô as part of the outing of cadets from the activities of the academy.

In 2022, the town had benefited from the 21st promotion of a borehole and road signs.

The Maracana tournament was won by the informal sector team ahead of the civil servants by the score of 2 goals to 1.

The High Commissioner of the province of Nahouri, Auguste Kinda welcomed the strong mobilization of the populations of the commune of Pô around the defense and security forces.

For him, this testifies to the good collaboration between the population and the FDS.

Source: Burkina Information Agency

Ganzourgou/Montée des couleurs: The High Commissioner invites public services to adopt the flag

The High Commissioner of the Ganzourgou province, Aminata Sorgho/Gouba presided over the traditional ascent of the colors, on August 1, 2023 at the Zorgho territorial gendarmerie brigade. She invited the heads of public services to equip themselves with the national flag to allow the rise of the colors in a rotating way in the administrations.

This Tuesday, August 1, 2023, like all the other first Tuesdays of the month, the directors and heads of provincial departments of Ganzourgou took part in the traditional rise of colors.

Since last May, the provincial authorities have decided to observe the rise of the colors in a rotating way in the administrations.

Thus, after the provincial directorate in charge of the environment and then that in charge of primary education, it is the turn of the Zorgho gendarmerie brigade to host this ceremony.

The High Commissioner thanked all those who took part in this "sober but meaningful" ceremony.

For her, this is a great opportunity to strengthen the cohesion and collaboration between the agents of the administration.

Aminata Sorgho/Gouba invited everyone to cultivate these values around him, because the country needs more than ever a sacred union of its daughters and sons to defeat terrorism which is putting a strain on living together.

Finally, the High Commissioner invited the heads of the services to rehabilitate or build masts and to equip themselves with the flag to allow the continuation of the initiative of the raising of the colors in a rotating way in the services

Source: Burkina Information Agency

The Dominican Republic “reiterates its absolute recognition of the Moroccanness of the Sahara” (Moroccan Ministry of Foreign Affairs)

The Dominican Minister of Foreign Relations, Mr. Roberto Alvarez seized by letter, his Moroccan counterpart, in order to bring to the Very High Knowledge of His Majesty King Mohammed VI – May God attends, on behalf of the President of the Dominican Republic, His Excellency Mr. Luis Abinader, the following position of his country concerning the question of the Moroccan Sahara, learned the AIB from sources close to the file.

The Dominican Republic “reiterates its absolute recognition of the Moroccanness of the Sahara”;

The Ministry of External Relations of the Dominican Republic "considers favorably", "the opening of a Dominican consulate in the city of Dakhla".

The Dominican Republic “reaffirms that the autonomy initiative presented by the Kingdom of Morocco in 2007 constitutes the realistic, credible and serious solution to reach a negotiated agreement between the parties”;

The Dominican Minister also informed his Moroccan counterpart that "President Luis ABINADER has expressed the wish to make a State visit to the Kingdom of Morocco, in order to further strengthen political, commercial and cooperation ties" between the Kingdom of Morocco and the Dominican Republic.

Source: Burkina Information Agency

Former Ivory Coast president Henri Konan Bédié died today

The President of the Democratic Party of Côte d'Ivoire (PDCI), Henri Konan Bédié, died on Tuesday August 1, 2023, in Abidjan, at the age of 89, following a discomfort in his hometown of Daoukro, we learn from concordant sources.

Konan Bédié was President of the National Assembly for 13 years (1980-1993) before becoming the country's supreme magistracy on December 7, 1993, on the death of Félix Houphouët-Boigny, thanks to the article by the constitution which made him the constitutional dolphin.

He was ousted from power on December 24, 1999 following a coup led by General Guéi.

Presidential candidate of 2020, on behalf of his party, he had called for a boycott of the ballot before proclaiming himself a few days later, president of a National Transitional Council (CNT).

Source: Burkina Information Agency

Burkina: Creation of two commando infantry regiments in Tougan and Nouna (decrees)

The Head of State, Captain Ibrahim Traoré, signed on July 21, 2023, a decree creating the 52nd Commando Infantry Regiment (RIC) based in Tougan.

In another decree on the same date, Ibrahim Traoré set up the 53rd RIC stationed in Nouna.

These two cities are part of the localities of Burkina Faso, regularly confronted with terrorist abuses.

Source: Burkina Information Agency

Pô: An NGO donates more than 9 million FCFCA of food and non-food items to Burkinabè expelled from Ghana

The NGO ''Guardian Angels of Nature'' (AGN) handed over, on Monday, in Pô (Centre-South), to the authorities of the province of Nahouri, food and non-food items worth 9 million 465 thousand CFA francs for the benefit of Burkinabe expelled from Ghana.

“We learned of this unfortunate situation through the press (…) and as an NGO working in the province in the daily support of communities to strengthen their level of resilience, we immediately initiated meetings with the various authorities … to be able to to do something and contribute to relieving these compatriots", indicated, about the genesis of the project, the coordinator of projects and programs at the NGO ''Les Anges Gardiens de la Nature'' (AGN), Adama Millogo.

Mr. Millogo spoke after the symbolic delivery of donations to beneficiaries in the presence of provincial administrative authorities and officials of the decentralized service in charge of Humanitarian Action.

The representatives of the beneficiaries and the local authorities express their gratitude to AGN during the symbolic handing over of the donations.

The coordinator of projects and programs at AGN who spoke of compatriots going through an unfortunate situation, alluded to the Burkinabè expelled, in July 2023, from Ghana.

Numbering 513 people, mostly women and children, according to data from the Provincial Directorate in charge of Nahouri Humanitarian Action, they were received and placed in temporary accommodation sites in Dakola, a village in the commune of Pô, bordering Ghana.

The food and non-food goods with a total value of 9 million 465 thousand CFA francs that they receive from the NGO AGN are composed of millet, beans, sugar, pasta, children's clothing, sanitary napkins , underwear for adult women, loincloths, soap, vases for children and kettles, said the secretary general of the Nahouri High Commission, Sanfienalé Sirima who received it.

The Peulh leader of Dakola, Idrissa Sondé, thanks the donors for the gesture

The distribution of these goods to beneficiaries "now in the process of returning to their families or to host families" will be done through the technical service in charge of Humanitarian Action and the Provincial Emergency Relief Committee. and Rehabilitation (COPROSUR) of Nahouri, explained Mr. Sirima.

By diversifying the goods granted, the objective is to support the beneficiaries but also "to strengthen the capacities of the host families who were not prepared for such a situation", noted Adama Millogo.

For the Peulh leader of Dakola, Idrissa Sondé, the gesture towards the Burkinabè expelled from Ghana is "healthy" and "saving".

“We are touched by this mark of solidarity which continues to manifest itself since the arrival of our parents from Ghana. Whether from members of government, regional and provincial authorities and today AGN, we can only say thank you for all the support given,” he said.

“These different goods will be very useful for us because we were unable to take anything when we were expelled,” said beneficiary Raïnatou Diaw.

The Secretary General of the Nahouri High Commission, who congratulates AGN for "its enormous gesture", recalled that the NGO is not in its first action "of support vis-à-vis local communities".

“I would like, on behalf of the High Commissioner of the province of Nahouri, to express our gratitude to the NGO which has made a great gesture towards these compatriots who are currently in need”, said Sanfienalé Sirima.

AGN's donation to those expelled from Ghana is part of a package of activities it carries out within the framework of the promotion of peace, social cohesion and inter-community rapprochement through social safety nets and awareness-raising, a recalled Adama Millogo.

These actions, he adds, are part of the “Resilient Communities” project implemented with the financial support of the European Union (EU).

The said project is carried out in the Pô-Nazinon-Sissili (PONASI) ecological complex composed of three administrative regions which are the Center-South, the Center-West and the Center-East.

Source: Burkina Information Agency

In Bobo-Dioulasso, truckers are begging to pay taxes on aggregates

The special delegation of the municipality of Bobo-Dioulasso went on Monday to raise awareness among truckers who are dragging their feet to pay taxes on aggregates, set between 2,000 and 6,000 FCFA, said learned the AIB.

The president of the special delegation of Bobo-Dioulasso (West, 365km), Adama Bidiga, held a meeting on Monday July 31, 2023 with several actors, about the difficulty of collecting taxes on the levies of aggregates, indicates the daily state Sidwaya, in its Tuesday publication.

He recalled that according to the 2021 deliberation, dump trucks must pay between 2,000 and 6,000 FCFA per load, depending on the volume of the truck and the type of aggregates.

Mr. Bidiga assured that these taxes are used to finance infrastructure and development projects as well as the promotion of environmental initiatives.

According to the president of the Bobo-Dioulasso tipper owners' umbrella, Seydou Kassamba, the truckers in addition to the payment of the aggregates, also pay between 2,000 and 6,000 FCFA to the landowners.

Mr. Kassamba added that some of his colleagues are willing to pay the taxes to the municipality but find them high.

However, Seydou Kassamba has promised to sensitize them so that they pay these taxes.

Source: Burkina Information Agency