Daily Archives: April 10, 2017
Cellular Biomedicine Group (CBMG) and GE Healthcare Life Sciences China Announce Strategic Partnership to Establish Joint Technology Laboratory to Develop Control Processes for the Manufacture of CAR-T and Stem Cell Therapies
SHANGHAI, China and CUPERTINO, Calif., April 10, 2017 (GLOBE NEWSWIRE) — Cellular Biomedicine Group Inc. (NASDAQ:CBMG) (CBMG or the Company), a leading clinical-stage biopharmaceutical firm engaged in the development of immunotherapies for cancer and stem cell therapies for degenerative diseases and GE Healthcare Life Sciences China, today announced that they have established a strategic research collaboration to co-develop certain high-quality industrial control processes in Chimeric Antigen Receptor T-cell (CAR-T) and stem cell manufacturing. In connection with the collaboration, a joint laboratory within CBMG’s new Shanghai Zhangjiang GMP-facility will be established and dedicated to the joint research and development of a functionally integrated and automated immunotherapy cell preparation system.
A photo accompanying this announcement is available at http://www.globenewswire.com/
CBMG and GE Healthcare Life Sciences China plan to develop state-of-the-art automated CAR-T and stem cell manufacturing capabilities that build upon the accreditation of CBMG’s GMP facilities in Shanghai, Wuxi and Beijing. The co-development activity will aim to standardize the delivery of cell manufacturing to potentially improve throughput, alleviate cost burdens and to minimize variability in cell production, which may increase the availability of engineered cells upon commercialization.
This partnership combines CBMG’s scientific expertise in the manufacturing of CAR-T and stem cell production in China and GE Healthcare’s renowned expertise in the design and development of innovative manufacturing technologies for the biopharmaceutical industry.
Recently, CBMG announced that its new Zhangjiang facility, together with an expanded Wuxi, and Beijing GMP-facilities, will have a combined 70,000 square feet for development and production. This will enable CBMG to conduct simultaneous clinical trials for multiple CAR-T and stem cell product candidates. At full production volumes, these facilities could support the treatment of up to 10,000 cancer patients and 10,000 knee osteoarthritis patients per year.
“GE Healthcare‘s selection of our facility to serve as their showcase site in China, credits our GMP stature and capabilities. Our team of scientists has spent years refining our manufacturing process to become one of the very few cell therapy companies with fully in-house integrated chemistry, manufacturing, and controls (CMC) processes for clinical grade CAR-T cells, plasmid and viral vectors bank production. We understand that one of the impending barriers to adoption of immuno-oncology and stem cell therapies is the logistics in manufacturing and we look to take an expanded role both domestically and potentially globally. We are pleased to be in a strategic partnership with GE Healthcare and look forward to showcasing our facilities and the mutual benefit this joint laboratory will bring,” commented Tony Liu, Chief Executive Officer, CBMG.
“Cell therapy as an industry continues to refine and evolve in China with vast potential to change the ways various diseases are treated. GE continues investing in technologies and services aimed at the thriving cell therapy industry with a firm commitment of making these promising therapies accessible through successful industrialization. We are pleased to partner with CBMG, a leader in CAR-T and stem cell development in China and to take advantage of their excellent CMC cell production capabilities. Collaboration with ambitious partners like CBMG who share our vision is necessary for advancing innovation and delivering comprehensive manufacturing solutions for cell and regenerative medicines,” said Li Qing, General Manager, GE Healthcare Life Sciences, Greater China.
About Cellular Biomedicine Group
Cellular Biomedicine Group, Inc. (NASDAQ:CBMG) develops proprietary cell therapies for the treatment of cancer and degenerative diseases. We conduct immuno-oncology and stem cell clinical trials in China using products from our integrated GMP laboratory. Our GMP facilities in China, consisting of twelve independent cell production lines, are designed and managed according to both China and U.S. GMP standards. CBMG recently commenced two Phase I human clinical trials in China using CAR-T to treat relapsed/refractory CD19+ B-cell Acute Lymphoblastic Leukemia (ALL) and Refractory Diffuse Large B-cell Lymphoma (DLBCL) as well as an ongoing Phase I trial in China for AlloJoinTM (CBMG’s “Off-the-Shelf” Allogeneic Human Adipose-derived Mesenchymal Stem Cell) for the treatment of Knee Osteoarthritis (KOA). CBMG was also recently awarded $2.29 million from the California Institute for Regenerative Medicine (CIRM) to support pre-clinical studies of AlloJoinTM for Knee Osteoarthritis in the United States. To learn more about CBMG, please visit www.cellbiomedgroup.com.
About GE Healthcare
GE Healthcare provides transformational medical technologies and services to meet the demand for increased access, enhanced quality and more affordable healthcare around the world. GE (NYSE:GE) works on things that matter – great people and technologies taking on tough challenges. From medical imaging, software & IT, patient monitoring and diagnostics to drug discovery, biopharmaceutical manufacturing technologies and performance improvement solutions, GE Healthcare helps medical professionals deliver great healthcare to their patients. For more information about GE Healthcare, visit our website at www.gehealthcare.com.
This press release contains forward-looking statements—including descriptions of plans, strategies, trends, specific activities, investments and other non-historical facts—as defined by the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking information is inherently uncertain, and actual results could differ materially from those anticipated due to a number of factors, which include risks inherent in doing business, trends affecting the global economy (including the devaluation of the RMB by China in August 2015), and other risks detailed in CBMG’s reports filed with the Securities and Exchange Commission, quarterly reports on form 10-Q, current reports on form 8-K and annual reports on form 10-K. Forward-looking statements may be identified by terms such as “may,” “will,” “expects,” “plans,” “intends,” “estimates,” “potential,” “continue” or similar terms or their negations. Although CBMG believes the expectations reflected in the forward-looking statements are reasonable, they cannot guarantee that future results, levels of activity, performance or achievements will be obtained. CBMG does not have any obligation to update these forward-looking statements other than as required by law.
The photo is also available at Newscom, www.newscom.com, and via AP PhotoExpress.
Contacts: Sarah Kelly Director of Corporate Communications, CBMG +1 408-973-7884 [email protected]
com Vivian Chen Managing Director Investor Relations, Citigate Dewe Rogerson +1 347 481-3711 [email protected]
Egypt: Authorities must address sectarian violence, not abuse emergency powers to further curtail rights
Egypt: Authorities must address sectarian violence, not abuse emergency powers to further curtail rights
Emergency measures included in a declaration of a state of emergency by President Abdelfattah al-Sissi in the aftermath of three deplorable church bombings in Egypt will do little to resolve the root causes of sectarian attacks against Copts in Egypt and are likely to lead to a further deterioration in human rights, Amnesty International said today.
The Islamic State armed group (IS) claimed responsibility for the synchronized bombings in Tanta and another two in Alexandria which targeted Palm Sunday church services and left at least 44 dead.
The deadly church attacks demonstrate an appalling disregard for human life and must be utterly condemned. Nothing can justify a horrifying attack on ordinary citizens attending a place of worship, said Najia Bounaim, North Africa Campaigns Director at Amnesty International.
It is the duty of the Egyptian authorities to protect the lives and safety of its population, but the solution is not to continue and intensify curtailing what little freedoms remain in Egypt. Addressing sectarian violence requires genuine political will to end impunity and provide protection.
Egypt has a decades-long history of relying on emergency measures which grant security forces sweeping powers to commit human rights violations unchecked, leading to arbitrary detention, torture and other serious violations.
State of emergency in Egypt
A state of emergency was last imposed in Egypt in August 2013 for a period of three months after the violent dispersal of the Rabaa and Al-Nahda sit-ins.
Prior to this, under former President Hosni Mubarak, Egypt was under a state of emergency for 31 years which ended in 2012, facilitating systematic violations and giving Egypt's security forces the power to detain thousands of people for years in administrative detention without respecting procedural guarantees intended to ensure fair administration of justice. In 2013, the Constitutional Court struck down the provision allowing for administrative detention under the Emergency Law (law 162 of 1958).
Since the state of emergency was lifted, the Egyptian authorities have relied on the regular criminal justice system for long-term pre-trial detention and special terrorism chambers for mass trials that have led to the sentencing of hundreds to death or life imprisonment after unfair trials.
Most worryingly however, the Emergency Law allows the authorities to try individuals before the flagrantly unfair Emergency State Security Courts which do not allow for the right to an appeal.
States of emergency can never be allowed to excuse violations of non-derogable rights. Torture, unlawful killings, enforced disappearances, and arbitrary detention cannot be made lawful by declaring an emergency, said Najia Bounaim.
Egypt's President Abdel Fattah al�Sisi has also signed and approved Counter-terrorism Law (law no. 94 of 2015) granting the authorities sweeping powers that would usually only be invoked during a state of emergency, effectively arbitrarily restricting the rights to freedom of expression, peaceful assembly and association.
For decades previously, Egyptian authorities used the state of emergency as a pretext to crack down on dissent, violating the rights to freedoms of expression, peaceful assembly and association, referring individuals to military and emergency courts, and detaining them without judicial order.
The Emergency Law's vaguely worded provisions grant the president the authority to restrict freedom of movement and liberty. It also gives the authorities broad powers to carry out surveillance violating the right to privacy, and prior censorship of the media. Albawaba newspaper, an Egyptian daily newspaper, stated that an hour after the state of emergency was declared the authorities confiscated its Monday edition due to its coverage of the church attacks.
According to the Egyptian constitution the President has the power to declare a state of emergency after consulting the cabinet. The decision must then be approved by parliament within seven days.
Given the history of gross violations associated with prolonged states of emergency in Egypt, Amnesty International urges Egypt's parliament, which is due to discuss the state of emergency tomorrow, to carefully scrutinize the government's justification for the state of emergency. The parliament must ensure that the stated public emergency reaches the very high threshold required under international human rights law and that all proposed emergency measures are strictly required to confront that stated public emergency. This should include evidence demonstrating that only the proposed emergency measures � rather than correctly applying existing laws - can effectively address that threat. This should include careful consideration of the strict necessity and proportionality of such measures,
Although Egypt's constitution restricts the length of a state of emergency to a three month period renewable once, the Egyptian authorities have been circumventing these constitutional restrictions by renewing the state of emergency in North Sinai since 2014 every three months, contributing to serious violations including enforced disappearances, arbitrary detention and unlawful killings.
Background on sectarian attacks
Attacks against the Egyptian Coptic Christian religious minority have escalated since the ouster of former President Mohamed Morsi in July 2013. Coptic churches and homes have been set on fire, members of the Coptic minority have been physically attacked, and their property has been looted. Over the past three years there have been 400 sectarian incidents according to the Tahrir Institute's tally. The Egyptian Initiative for Personal Rights has documented at least 64 sectarian incidents between 2011 and 2016 where the authorities resorted to reconciliation instead of applying the law.
The government's persistent failure to protect Coptic Christians from sectarian violence is alarming. In December 2016 a bombing of a Cairo church killed at least 25. After the killings of seven individuals in North Sinai between 30 January and 23 February 2017, a Sinai affiliate of IS announced more violent attacks against Copts were planned. In Tanta, a week earlier a police officer was killed and 15 were injured as a result of bombing one of the training centers run by the Ministry of interior
The Egyptian authorities have consistently failed to prosecute those responsible for sectarian attacks against Christians, resorting instead to state-sponsored reconciliation agreements which sometimes involve financial agreements or even the forced eviction of Christian families from their homes. As a result, there has been no punishment of the instigators of sectarian violence against Christians.
Source: Amnesty International USA