Zenas BioPharma Submits Investigational New Drug Application in China for ZB001 for the Treatment of Thyroid Eye Disease

WALTHAM, Mass. and SHANGHAI, China, May 15, 2022 (GLOBE NEWSWIRE) — Zenas BioPharma, a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immune-based therapies for patients in need around the world, today announced the submission of an investigational new drug (IND) application to the China National Medical Products Administration (NMPA) for the initiation of a Phase 1/2 clinical study of ZB001 for the treatment of Thyroid Eye Disease (TED). This study is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ZB001.

“The ZB001 IND submission to the NMPA marks a significant milestone for Zenas,” said Hua Mu, MD, PhD, Chief Executive Officer at Zenas. “There are currently no approved therapies for TED patients in China. Treatment options are limited and often involve high doses of steroids associated with serious side effects or surgical intervention. ZB001 has the potential to change the treatment paradigm for TED patients in China.”

ZB001 is a differentiated humanized monoclonal antibody targeting insulin-like growth factor 1 receptor (IGF-1R) for the treatment of TED. TED is a debilitating autoimmune disease that causes inflammation and fibrosis within the orbit of the eye, which can cause double vision, pain, and potential blindness. Patients with severe disease often require multiple remedial surgeries to the orbit, eye muscles and eyelids.

Zenas BioPharma licensed the exclusive rights to develop, manufacture and commercialize ZB001 (Viridian VRDN-001) and other compounds targeting IGF-1R in non-oncology indications in the greater area of China from Viridian Therapeutics, Inc. (Viridian) in October 2020. In October 2021, Viridian submitted an IND for VRDN-001 to the U.S. Food and Drug Administration and in December 2021 initiated a Phase 1/2 clinical trial to evaluate proof of concept in TED patients in North America.

About Zenas BioPharma

Zenas BioPharma is a global biopharmaceutical company based in the USA and China committed to becoming a leader in the development and commercialization of immune-based therapies for patients in the US, China and around the world. Zenas is rapidly advancing a deep pipeline of innovative therapeutics that 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
Zenas BioPharma
IR@zenasbio.com

Ukraine counter-attacks Russian forces in the east

Published by
Reuters

By Jonathan Landay and Tom Balmforth RUSKA LOZOVA, Ukraine (Reuters) – Russia attacked positions in eastern Ukraine as it tries to encircle Ukrainian forces in the Donbas and fend off a counteroffensive around the city of Izium. NATO Secretary-General Jens Stoltenberg said Russia’s offensive in Donbas had stalled and Ukraine could win the war, an outcome few military analysts predicted at the outset of the conflict. “Russia’s war in Ukraine is not going as Moscow had planned,” Stoltenberg told reporters on Sunday. In a strategic blow for Russia, which has long opposed NATO expansion, Finland o… Continue reading “Ukraine counter-attacks Russian forces in the east”

Somali parliament elects Hassan Sheikh Mohamud as president

Somali lawmakers from both houses of parliament who gathered in a hangar inside heavily fortified Mogadishu International Airport elected Hassan Sheikh Mohamud as president Sunday, defeating incumbent President Mohamed Abdullahi Mohamed, also known as Farmajo.

Mohamud, who was Mohamed’s immediate predecessor as president, won 214 out of 327 votes.

The incumbent president received 110 votes, while three votes disqualified, according to Somali parliament speaker Sheikh Adan Mohamed Nuur Madobe, who announced the election results.

The election has been very tense and saw three rounds and 36 candidates contesting.

Mohamed conceded, saying: “I thank all of the members of parliament who voted for me and those who did not vote for me.”

Mohamud was sworn in minutes after the results were announced and thanked his predecessor for transferring power to him peacefully.

Source: Anadolu Agency

Sweden to send delegation to Turkiye to discuss NATO membership

Sweden will send a delegation of diplomats to Turkiye to discuss the Scandinavian country’s decision to apply for NATO membership, the government announced Sunday.

Swedish Foreign Minister Ann Linde confirmed that the delegation will visit Turkiye and said it will be sent to Ankara very soon to evaluate the ruling Social Democratic Party’s decision in favor of joining NATO.

Evaluating Russia’s reaction to Sweden’s application for NATO membership, Linde said Russia “violated our confluence area” and made disinformation campaigns that Swedish people are Nazis.

Cyberattacks will be increased, she said, adding there will be a movement on the border.

On Saturday, the Social Democratic Party administration decided to apply for NATO membership. With this decision and with the support of right-wing parties in parliament, Sweden’s application for NATO membership is considered definitive.

Turkish Foreign Minister Mevlut Cavusoglu, who met with Linde at an informal meeting of NATO Foreign Ministers in the German capital Berlin over the weekend, said Sweden and Finland openly support the PKK/YPG terrorist organization.

Earlier, Prime Minister Magdalena Andersson said this would be the best decision for Sweden’s security.

After the decision is discussed in parliament on Monday, Sweden and Finland are expected to formally apply together for membership by Wednesday at the latest.

Source: Anadolu Agency

Sri Lanka police arrest hundreds of suspects over May 9 violent protest

Sri Lankan police have arrested hundreds of suspects in connection with last week’s violent protest, as the government tackles a worsening economic crisis.

According to News 1st, a local media outlet, the police have arrested 159 people after receiving 756 complaints of violence.

Police spokesperson Nihal Thalduwa said their teams are working to arrest more suspects who were part of the clashes last week, which saw at least nine people, including a ruling party parliamentarian and a police officer, killed and many others injured.

People took to the streets late March, protesting hours-long daily power cuts and shortages of food, fuel, and other vital goods after a foreign exchange shortage led to the island nation’s worst-ever economic crisis.

Military units were called to the capital Colombo and the government declared a nationwide curfew. It also ordered troops to open fire on anyone looting public property or causing harm to life.

Mahinda Rajapaksa was forced to resign as premier, and protesters across the Buddhist-majority nation continue to demand the resignation of President Gotabaya Rajapaksa, Mahinda’s younger brother.

Ranil Wickremesinghe took charge as prime minister for a sixth time, but even his appointment has failed to quell public anger at the government for bringing Sri Lanka to the brink of economic collapse.

“There is a lot to be done and undone,” Wickremesinghe said in a tweet on Sunday, adding that the government has “managed to get things moving in the last 48 hours.” Authorities are also in the talks with the International Monetary Fund to overcome the current crisis.

Source: Anadolu Agency

Admission to NATO won’t strengthen Finland, Sweden’s security, Russia says

On the contrary, the general level of tension in Europe will increase, Sergey Ryabkov told reporters in Moscow.

“They should have no illusions that we will just put up with this … in Brussels, in Washington, and in other NATO capitals … the overall level of military tension will increase, and there will be less predictability in this area,” Ryabkov said.

Asked about any possible steps Russia may take in response, the diplomat said moves will depend on “a practical outcome” of Finland and Sweden’s admission to the military alliance.

Ryabkov expressed regret that “common sense is being given up to some phantom ideas” about what should be done in the current situation, meaning the Russia-Ukraine war, which began in February.

“This is another grave mistake with far-reaching consequences. But what to do, such is the level of those who make political decisions in the respective countries today,” he said.

The leaders of Finland and Sweden have confirmed their intention to join NATO, abandoning decades of military non-alignment. The membership needs to be approved by all 30 members of the alliance.

Addressing NATO foreign ministers in Berlin on Sunday, NATO chief Jens Stoltenberg said Sweden and Finland are NATO’s closest partners and if they decide to apply for membership, it would be “historic.”

“Their membership in NATO would increase our shared security, demonstrate that NATO’s door is open and that aggression does not pay,” Stoltenberg said, reiterating that all sovereign nations have the right to choose their own path.

Source: Anadolu Agency

Amid fear of violence, African Union team to assess Kenya’s election preparations

The team includes members of the Panel of the Wise, an AU consultative body, along with independent electoral experts and technical staff from the AU Commission, according to a statement.

It will be in Kenya until May 20 to review the “state of preparedness … and the overall context in which the polls will take place,” the AU said.

“Importantly, the mission is deployed jointly with members of the Common Market for Eastern and Southern Africa (COMESA) and the East African Community (EAC),” the statement said.

It will also “engage in consultations and dialogue with key political and electoral stakeholders in Kenya to promote peaceful, credible, and inclusive elections.”

Millions of voters will elect Kenya’s new president and members of the National Assembly and Senate on Aug. 9.

Having served the maximum possible two terms, incumbent Uhuru Kenyatta is out of the presidential race.

A close contest is expected between the two main contenders – William Ruto, Kenya’s deputy president since 2013 and leader of the United Democratic Alliance, and former Prime Minister Raila Odinga, who heads the Orange Democratic Movement.

Kenyatta has opted to support Odinga, his former rival for the top post who is making his fifth presidential run, rather than his own deputy.

Kenya grappled with months of post-election violence in 2017 that claimed dozens of lives.

Kenyatta and Odinga eventually announced a rapprochement in 2018, bringing to an end months of unrest and poll-related violence.

Source: Anadolu Agency

Sweden, Finland turned back most of Turkiye’s requests for terrorist extraditions over last 5 years

Sweden and Finland turned back most of Turkiye’s requests for terrorist extraditions over the last five years, according to Turkish sources, a matter that takes on more importance as the two nations seek to join the NATO military alliance alongside Turkiye.

The Turkish Justice Ministry, in line with court verdicts, requested from Finland the extradition of 12 terrorists – half affiliated with the PKK terror group, and half with the Fetullah Terrorist Organization (FETO), the group behind the defeated coup of 2016, the sources said.

Likewise, during the same period, Sweden was asked to extradite 21 terrorists, 10 FETO members, and 11 PKK members.

However, Sweden and Finland, which have stated their intention to seek NATO membership, have not responded positively to requests from Turkiye – a NATO member for over 70 years – for the extradition of a total of 33 terrorists.

Out of 33 requests over the last five years, 19 were rejected while no response was provided for five others.

Meanwhile, the legal process on the extradition requests by Turkiye for nine other terrorists – two from Finland and seven from Sweden – is still underway.

In its more than 35-year terror campaign against Turkiye, the PKK – listed as a terrorist organization by Turkiye, the US, and EU – has been responsible for the deaths of over 40,000 people, including women, children, and infants.

FETO and its US-based leader Fetullah Gulen orchestrated the defeated coup of July 15, 2016 in Turkiye, in which 251 people were killed and 2,734 injured.

The Turkish government accuses FETO of being behind a long-running campaign to overthrow the state through the infiltration of Turkish institutions, particularly the military, police, and judiciary.

For decades, Sweden and Finland took a neutral foreign policy posture in the region, but the ongoing Russia-Ukraine war that started on Feb. 24 triggered a shift in their approach, with both the public and most politicians favoring joining the NATO alliance.

Source: Anadolu Agency

Putin says Finland, Sweden’s entry to NATO no threat to Russia, but will draw a response

President Vladimir Putin said on Monday that Russia has no issues with Finland and Sweden and therefore their entry into NATO does not create a threat for Moscow, but the move will certainly draw a response.

“Russia has no problems with these states (Finland, Sweden). There is no immediate threat to Russia … But the expansion of military infrastructure to this territory will certainly provoke our response,” he told a meeting of the leaders of the Collective Security Treaty Organization (CSTO) in Moscow.

The response will depend on the steps taken by the alliance vis-à-vis military development in Finland and Sweden, Putin added.

The CSTO summit marked the 30th anniversary of the Collective Security Treaty, and the 20th anniversary of the organization, which was formed 10 years after the signing of the agreement.

The leaders of Finland and Sweden have confirmed their intention to join NATO, abandoning decades of military non-alignment.

Source: Anadolu Agency