Day: August 27, 2021

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ImmunoBrain Checkpoint Awarded $5 Million US NIA Grant for Phase 1b Alzheimer’s Disease Proof-of-Mechanism Study of Anti-PD-L1 IBC-Ab002

ImmunoBrain Checkpoint Awarded $5 Million US NIA Grant for Phase 1b Alzheimer’s Disease Proof-of-Mechanism Study of Anti-PD-L1 IBC-Ab002

NEW YORK, Friday August 27, 2021 – ImmunoBrain Checkpoint Inc. (“IBC”) an innovative biopharmaceutical company developing potential disease-modifying immune therapies that harness the power of the immune system to help protect and repair the brain to combat neurodegenerative diseases, announced today that the National Institute on Aging (NIA) of the US National Institutes of Health (NIH) has awarded the Company a grant totaling $5 million over three years to support a first-in-human clinical study of IBC-Ab002, for the treatment of Alzheimer’s disease.

IBC-Ab002 is a proprietary anti-PD-L1 antibody developed and engineered with differentiating characteristics tailored to treat Alzheimer’s disease, based on a unique mechanism of action that has the potential to arrest, slow-down or even stop Alzheimer’s disease progression. Its development is based on studies carried out at the Weizmann Institute of Science, Israel, demonstrating that the immune system is needed for the maintenance of healthy brain function and repair, but may be impaired in patients with Alzheimer’s disease. IBC-Ab002 aims to empower the immune system to help defeat the disease and, thereby, to change the disease course and slow-down its progression.

In pre-clinical studies, treatment with an anti-PD-L1 antibody has been shown to reduce both amyloid-beta and tau, two key toxic proteins, alteration in the inflammatory milieu of the brain, preservation of synapses and neurons, and improvement in cognition as measured by learning/memory tests.

The phase 1b safety and proof-of-mechanism study of IBC-Ab002 in patients with mild Alzheimer’s disease is expected to start in the first half of 2022 in the UK, the Netherlands and in Israel. In addition to the NIA funding, the study will be funded in part by a grant received from the Alzheimer’s Association under the 2020 Part the Cloud + Bill Gates Partnership Grant Program.

Dr. Eti Yoles, IBC’s Chief Operating Officer, said: “We are grateful to the NIA for this vote of confidence in our novel approach. IBC is committed to finding a therapy that will bring relief to the millions of patients struggling with Alzheimer’s disease and their families.”

Dr. Jesse Cedarbaum, IBC’s Chief Medical Officer, said: “Aging is the major risk factor for the development of Alzheimer’s disease. With aging comes the seemingly paradoxical phenomena of ‘inflammaging’ and ‘immune exhaustion and senescence’. IBC-Ab002 is an antibody that has been designed with the goal of rebalancing the immune system to provide neuroprotection against Alzheimer’s disease and perhaps other neurodegenerative disorders. After a rigorous review process by scientists, clinicians, and key opinion leaders, we thank the NIA for its recognition that augmenting the body’s natural defenses could be an important avenue for treating Alzheimer’s disease.”

Professor Michal Schwartz, IBC’s Chief Scientific Officer, said: “Seeing the robustness of the effect in so many animal models, and on both symptoms and disease pathology, reinforces my optimism that we have the potential to activate a general mechanism needed for brain repair that will overcome many of the unique complexities of Alzheimer’s disease. I am very grateful to the NIA for its belief in and support of our novel therapy.”

Dr. Philip Scheltens, Director of the Alzheimer Center at the VU University Medical Center in Amsterdam and Principal Investigator for the planned clinical study, said: “I am pleased that the NIA recognizes the innovative approach of IBC, supporting its progress to the clinic. I am confident that these funds will help the IBC team to progress its therapeutic target through the clinical study here at Amsterdam UMC.”

There are no approved therapies for Alzheimer’s disease that have been shown to have a major impact on the clinical course of the disease. If successful, IBC’s therapy will be a first-of-its kind approach with the potential to change the course of Alzheimer’s disease and arrest its progression. The success of IBC’s approach would lead to better understanding of how the immune system helps protect the brain, would contribute to the understanding of the biology of Alzheimer’s disease, and could ignite a new era in developing therapies to combat this family of devastating diseases.

About ImmunoBrain Checkpoint

ImmunoBrain Checkpoint (IBC) is a biopharmaceutical company focused on developing novel disease-modifying immune therapies to combat neurodegenerative diseases, and in particular, Alzheimer’s disease. IBC’s IP platform emerged from the laboratory of Professor Michal Schwartz and licensed from Yeda, the commercialization arm of the Weizmann Institute of Science in Israel. IBC’s technology is based on more than 20 years of studies by Schwartz’s team, who pioneered the idea that the brain engages in a life-long dialogue with the immune system for its maintenance and repair, and that this communication is compromised in aging and Alzheimer’s disease. Schwartz’s team’s results in preclinical studies indicate that loosening the restraints from the immune system using antibodies that target inhibitory immune checkpoints (commonly expressed by exhausted immune cells), can rewire brain/immune communication, and thereby protect the brain from functional loss.

Previously, IBC received a $500,000 grant from the ALS Association to pursue a novel immunotherapeutic approach to treat ALS and identify optimal immune-checkpoint pathways to target, a $1,000,000 grant from the Alzheimer’s Association under the 2020 Part the Cloud + Bill Gates Partnership Grant Program, and additional support from the Israel Innovation Authority. www.immunobrain.com

About IBC-Ab002

IBC’s therapeutic approach seeks to harness the body’s own immune mechanism of repair to optimize the communication between the body and the brain. IBC-Ab002 is a proprietary antibody developed by IBC’s team led by Drs. Eti Yoles and Carol David, specifically optimized for IBC’s therapeutic mechanism of action. It is designed to transiently inhibit the activity of certain immune system molecules that act as “checkpoints” to restrain the activity of the immune system, and thereby enable a neuroprotective immunological cascade to combat the effects of neurodegenerative proteinopathy. In preclinical studies, anti-PD-L1 treatment was found to be effective in five different animal models of Alzheimer’s disease, including both amyloid and tau transgenic mice. In these studies, anti-PD-L1 antibody treatment reduced both cognitive deficits and toxic pathological proteins that accumulate in the brain.

IBC-Ab002 has also been engineered to have an improved safety profile relative to other antibodies with respect to inducing immune-mediated adverse effects. IBC plans to start its phase 1b clinical trial in the first half of 2022 in patients with early Alzheimer’s disease.

Disclaimer: Research reported in this press release will be supported by the National Institute On Aging of the National Institutes of Health under Award Number R01AG071810. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health

For more information, please contact info@immunobrain.com

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Junshi Biosciences Announces Acceptance by NMPA of Investigational New Drug Application for the Subcutaneous Injection of Anti-BLyS Monoclonal Antibody

SHANGHAI, China, Aug. 27, 2021 (GLOBE NEWSWIRE) — Junshi Biosciences (HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced today that the National Medical Products Administration (NMPA) of China has accepted an investigational new drug application for UBP1213sc, its subcutaneous injection of recombinant humanized anti-BLyS monoclonal antibody.

About UBP1213sc
UBP1213sc is a subcutaneous injection of a recombinant humanized anti-B lymphocyte stimulator (“BLyS”) monoclonal antibody, which is used to treat Systemic Lupus Erythematosus (“SLE”).

In November 2016, the intravenous dosage form (IV) of UBP1213 was approved by the NMPA for clinical trial. Junshi Biosciences was the first domestic company to obtain the approval for investigational new drug (IND) application for an anti-BLyS target monoclonal antibody drug. The subcutaneous injection has certain advantages over IV administration, including the flexibility to allow patients to administrate the drug themselves after training, which improves patient compliance.

About Systemic Lupus Erythematosus (“SLE”).
SLE is a highly heterogeneous systemic autoimmune disease with limited treatment options. According to the data in the Journal of Rheumatology and the Journal of Arthritis Research & Treatment, the current prevalence of SLE is 0-241/100,000 globally and 30-70/100,000 in mainland China. SLE is characterized by overactive B cells and massive autoantibody production. An anti-BLyS monoclonal antibody can inhibit the proliferation and survival of B cells by combining itself with soluble BLyS, so as to achieve long-term alleviation of SLE and reduce the risk of recurrence.

About Junshi Biosciences
Founded in December 2012, Junshi Biosciences is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R & D pipeline comprising 28 innovative drug candidates and 2 biosimilars, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Junshi Biosciences was the first Chinese pharmaceutical company that obtained marketing approval for anti-PD-1 monoclonal antibody in China. Its first-in-human anti-BTLA antibody for solid tumors was the first in the world to be approved for clinical trials by the FDA and NMPA and its anti-PCSK9 monoclonal antibody was the first in China to be approved for clinical trials by the NMPA. In early 2020, Junshi Biosciences joined forces with the Institute of Microbiology Chinese Academy of Science and Eli Lilly to co-develop JS016 (etesevimab), China’s first neutralizing fully human monoclonal antibody against SARS-CoV-2. JS016 administered with bamlanivimab has received Emergency Use Authorization (EUA) from the US FDA in February 2021 for the treatment of recently diagnosed, mild to moderate COVID-19 in patients who are at a high risk of progressing to severe COVID-19 and/or hospitalization. The JS016 program is a part of our continuous innovation for disease control and prevention of the global pandemic. Junshi Biosciences has over 2,000 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing and Guangzhou). For more information, please visit: http://junshipharma.com.

Contact Information

IR Team:
Junshi Biosciences
info@junshipharma.com
+86 021-2250 0300

Solebury Trout
Bob Ai
bai@soleburytrout.com
+1 646-389-6658

PR Team:
Junshi Biosciences
Zhi Li
zhi_li@junshipharma.com
+86 021-6105 8800

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COVID Pandemic Dampens Africa’s Economic Growth

Three years ago, nearly every country in Africa agreed to be part of a continental free trade area intended to lower tariffs and boost economies. But the agreement has yet to be fully implemented because of restrictions stemming from the COVID-19 pandemic.

The World Bank says the Africa Continental Free Trade Area Agreement set up the largest free trade bloc in the world, and has the potential to pull 30 million people out of poverty.

The agreement reduces tariffs between African countries and, the World Bank says, could boost Africa’s combined GDP by $450 billion by 2035.

But those prospects may not materialize because many countries in Africa have yet to fully open their economies due to health restrictions to combat the spread of the coronavirus.

Kennedy Adede, founder of Shining Hope for Communities (SHOFCO), which works in poor neighborhoods in Nairobi, says the lack of employment opportunities has to be addressed.

“People are going through a lot of hardship, people are more scared of dying from hunger than dying from this virus and that has become a challenge. How do we solve that? That’s why this is not just about the vaccine alone,” Adede said. “It needs a multi-angle [approach] to fight this economically to ensure that we drive more jobs. If you think in Africa right now, the population of young people is scary and if they don’t trust what we are saying, then we are gone.”

Speaking at a recent webinar, John Nkengasong, director of the Africa Centers for Disease Control and Prevention, said that if Africa was better prepared to combat the pandemic, the free trade area would be flourishing.

“It’s really for us in public health to continue to make sure that we place the public health agenda at the center of political dialogues, at the center of the economic dialogue. Look at the damage the pandemic has caused to our continental aspiration for the continental free trade area. I will argue that without this pandemic, that whole aspiration, the developmental agenda would have been at a very different level today in the continent,” Nkengasong said.

Nearly 18 months into the pandemic, just 2.5% of Africa’s 1.3 billion people are vaccinated. The African CDC wants to vaccinate 60% of the population by the end of 2022.

The agency says Africa had received 123.5 million vaccine doses by mid-August. The continent secured the vaccine through bilateral agreements and COVAX, a global initiative that seeks to provide vaccine to developing countries.

African countries will also share some 400 million Johnson & Johnson vaccine doses, which are being manufactured in South Africa.

But Nkengasong says Africa is still not receiving enough vaccine.

“When COVID just started, it was very difficult for anyone in Africa to know somebody who has died of COVID but now is a common thing we know, and that is pushing that you see lines of people out there. So the first doses of vaccines that we supplied in the continent, some of those ended up in wastage because we were dealing with misinformation. The challenge we have now is that people are saying here we are with open arms, ready to get the jab, but the jabs are not there,” Nkengasong said.

Africa’s economy is still expected to grow 3.4% this year, but that’s of little consequence to the tens of millions who are struggling to find a steady income as the virus takes away jobs and lives.

Source: Voice of America

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De Beers, National Geographic Form Partnership to Protect Botswana’s Okavango Delta

Mining giant De Beers and the National Geographic Society have announced a partnership to protect the waters and endangered animals of Botswana’s iconic Okavango Delta. The vast UNESCO World Heritage wetland is threatened by climate change and agricultural activities.

The five-year project, “Okavango Eternal,” will see De Beers and National Geographic work with local communities to deliver ecological solutions aimed at preserving the 16,000 square kilometers of the delta.

Bruce Cleaver, De Beers Group CEO, says in a statement the company is committed to preserving the delta for future generations.

He says the project will help protect the delta’s source waters and ensure the protection of wildlife corridors to ensure the free movement of animals.

Cleaver says it is important to support livelihoods, particularly in the eco-tourism sector hard hit by COVID-19 travel restrictions.

Koketso Mookodi, National Geographic country director for the project, says the protection of the delta is an “urgent” priority.

“It is exciting to see this level of support and partnership at a time when coming together to protect this one-of-a-kind place is so urgently needed. The people of the Okavango basin rely on its life-giving waters, and we must unite our efforts to do everything in our power to ensure that they continue to flow for the future of the people and the wildlife that call this place home,” she said.

The Okavango Delta forms part of a large conservation area known as the Kavango-Zambezi Transfrontier Conservation Area (KAZA), which covers five southern African countries.

Nyambe Nyambe, KAZA executive director, says the project presents an exciting opportunity for local communities and protecting the environment.

“It is a welcome development,” he said. “The threats that the Okavango Delta faces are real [and] range from climate change, potential for agriculture development, large-scale water abstraction and infrastructure development, and related threats. All these threats cannot be addressed by one entity, so partnerships are very welcome.”

The delta is one of Botswana’s prime tourist attractions, drawing an average of 50,000 visitors per year.

Source: Voice of America

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3 Groups of Students Freed in Nigeria in 24 Hours

Authorities in northern Nigeria announced three separate groups of kidnapped students were freed within 24 hours, prompting speculation late Friday that large ransoms had been paid to the gunmen blamed for a spate of recent abductions.

Among those now free are some of the youngest children ever taken hostage in Nigeria, a group of 90 pupils who had spent three months in captivity. Hours after those youngsters were brought to the Niger state capital, police in Zamfara state said that 15 older students also had been freed there.

Then late Friday, word came of a third hostage liberation in Kaduna state. Thirty-two more of the students taken from a Baptist high school in early July also had been freed, according to the Rev. Joseph Hayab, chairman of the Kaduna state chapter of the Christian Association of Nigeria.

The wave of releases comes after more than 1,000 students have been kidnapped since December, according to an AP tally. While earlier school abductions had been blamed on Islamic extremists in the northeast, authorities have only said that bandits are behind the latest kidnappings for ransom.

“The happiness can’t be quantified,” said Yahya Aliyu Babangida, 54, a teacher whose two children aged 7 and 17 were among those who had been kidnapped from the Salihu Tanko Islamic School in Tegina in late May.

Some of the kidnapped preschoolers who spent months in captivity were just 4 years old, and authorities said Friday that one child had died during the ordeal. Several others were undergoing medical treatment after their release late Thursday.

“They are exposed to this harsh weather, no food, mosquitos everywhere,” he said. “Some of them had never been outside the comfort of their homes.”

News of the children’s release was celebrated across Nigeria, where abductions have stepped up pressure on the government to do more to secure educational facilities in remote areas.

But questions remained Friday about how much ransom had been paid to secure the children’s release, and if so whether that could in turn fuel further abductions by the unknown armed groups referred to locally as bandits.

Muhammad Musa Kawule, 42, acknowledged paying intermediaries in hopes of securing his 6-year-old daughter’s freedom.

“I spent a lot of money but today, I’m happy,” he told The Associated Press on Friday. He did not specify how much he had paid nor whether government officials had been involved.

The youngsters were later brought to the Niger state capital, Minna, where they underwent medical checkups and met the governor. Video showed scores of children as young as kindergartners coming out of white minibuses, the little girls wearing long blue hijabs known as chadors.

While Nigeria has seen scores of school abductions for ransom, the Niger state kidnappings left people aghast because the children were so young. The ramifications also could be long lasting as parents reconsider whether to send their children to school.

“This has affected the morale and confidence of the people and has even made parents think twice before they send their children to school,” Niger state Gov. Abubakar Sani Bello said of the children’s abduction. “We will do whatever it takes to bring (the kidnappers) to justice.”

As the attacks have mounted across the north, there are also signs they are becoming more violent.

After one kidnapping at a university in Kaduna state earlier this year, gunmen demanded ransoms equivalent to hundreds of thousands of dollars. They killed five students to compel other students’ parents to raise the money and later released 14.

Also Friday, Zamfara state police spokesperson Mohammed Shehu said that 15 other students had been handed over to officials on Friday, 11 days after they were abducted from the College of Agriculture and Animal Science in Nigeria’s troubled northwest.

It was not immediately clear how they were rescued, but the students are now being looked after by Zamfara state officials and will soon be reunited with their parents, authorities said.

Source: Voice of America