Orgenesis Announces Addition of University of California, Davis, to its Point of Care Network; UC Davis Health to Utilize Orgenesis Point of Care…

First collaboration project focused on developing and commercializing lentiviral manufacturing system

GERMANTOWN, Md., Jan. 10, 2020 (GLOBE NEWSWIRE) -- Orgenesis Inc. (ORGS), a leading cell and gene therapy enabling company providing centralized CDMO manufacturing and development services, as well as localized point-of-care development and processing centers through its subsidiary Orgenesis Maryland, Inc., today announced the addition of the University of California, Davis (UC Davis) to its Point of Care (POCare) Network. Under the collaboration agreement, UC Davis Health will utilize Orgenesis POCare platform to develop, commercialize and supply cell and gene products and therapies. Orgenesis POCare Network enables hospitals to design and manage localized clean rooms, implementing Orgenesis proprietary automated, closed systems and know-how to process select cell therapies at each point-of-care site for the treatment of patients.

The first collaboration under the agreement involves scaling up and integrating UC Davis lentiviral vector process as part of the Orgenesis POCare platform for localized, development and processing of cell and gene therapies for treating patients. The UC Davis GMP facility has developed a small-intermediate scale, high quality vector process that has been successfully utilized to manufacture lentiviral vectors in several clinical trials, including manufacturing of CAR T cell therapies. Orgenesis POCare platform, which combines processing and therapeutic technologies, is designed to allow for the efficient production of high quality, affordable cell and gene based products. Upon successful completion of the collaboration, Orgenesis and UC Davis plan to pursue further commercialization of the technology and expand the processing and supply of their products under development at the UC Davis site. Lentivirus is a family of viruses that insert their DNA into the host cells' genome. Lentiviral vectors are increasingly utilized in cell and gene therapy as a method for inserting, modifying, or deleting specific genes within cells.

Vered Caplan, CEO of Orgenesis, stated, We are delighted to add UC Davis to our POCare Network, which will allow us to collaborate with the university to develop and supply therapeutics within the point-of-care setting in general and specifically in our need for virus supply. Additionally, we look forward to leveraging our POCare platform to assist UC Davis in expanding their ability to address the worldwide shortages of lentiviral vectors. Their new system is designed to address the global need for a more efficient, large scale vector manufacturing processes in an efficient manner. We believe this partnership further validates the significant value proposition of our POCare platform.

Adjunct Professor Gerhard Bauer, Director of the GMP Facility at UC Davis, commented, We, at the UC Davis Health, in the Stem Cell Program and in the GMP Facility, are committed to bringing these novel cell and gene therapy based treatments to patients in need and making them affordable.

Professor Jan A. Nolta, Director of the Stem Cell Program and the Gene Therapy Center at UC Davis Health, added, We look forward to leveraging Orgenesis expertise to accelerate the development and commercialization of our lentiviral vector manufacturing system, which addresses a significant unmet need in the market for an efficient and scalable manufacturing process.

About Orgenesis

Orgenesis is a biopharmaceutical company specializing in the development, manufacturing and processing of technologies and services in the cell and gene therapy industry. The Company operates through two platforms: (i) a point-of-care (POCare) cell therapy platform (PT) and (ii) a Contract Development and Manufacturing Organization (CDMO) platform conducted through its subsidiary, Masthercell Global. Through its PT business, the Companys aim is to further the development of Advanced Therapy Medicinal Products (ATMPs) through collaborations and in-licensing with other pre-clinical and clinical-stage biopharmaceutical companies and research and healthcare institutes to bring such ATMPs to patients. The Company out-licenses these ATMPs through regional partners to whom it also provides regulatory, pre-clinical and training services to support their activity in order to reach patients in a point-of-care hospital setting. Through the Companys CDMO platform, it is focused on providing contract manufacturing and development services for biopharmaceutical companies. Additional information is available at: http://www.orgenesis.com.

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About UC Davis Stem Cell Program and Gene Therapy Center

UC Davis Stem Cell Program brings together physicians, research scientists, biomedical engineers and a range of other experts and collaborative partners at its Institute for Regenerative Cures, which is located on the universitys Sacramento campus. The $62 million facility, which was supported by the California Institute for Regenerative Medicine (CIRM), is the hub for collaborative, team-oriented science that is advancing breakthrough discoveries designed to bring stem cell therapies and cures to patients everywhere.

The UC Davis Gene Therapy Center brings together a uniquely comprehensive and established interdisciplinary network of experts and resources to lead the field of gene therapy through research, manufacturing, training and policy. The Gene Therapy Center offers expertise and state-of-the-art facilities and equipment including one of the largest university-based Good Manufacturing Practice (GMP) facilities and a Viral Vector Core.

About UC Davis

UC Davis is one of the top public universities in the United States. Since opening in 1908, it has been known for standout academics, sustainability and Aggie Pride as well as valuing the Northern California lifestyle. These themes are woven into its 100-plus-year history and its reputation for solving problems related to food, health, the environment and society. The universitys health system is based in Sacramento and provides the region's only academic health center. UC Davis Health is focused on discovering and sharing knowledge and providing the highest quality of care. It is a hub of innovation that encompasses UC Davis Medical Center, UC Davis School of Medicine, The Betty Irene Moore School of Nursing at UC Davis and UC Davis Medical Group.

Notice Regarding Forward-Looking Statements

This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended. These forward-looking statements involve substantial uncertainties and risks and are based upon our current expectations, estimates and projections and reflect our beliefs and assumptions based upon information available to us at the date of this release. We caution readers that forward-looking statements are predictions based on our current expectations about future events. These forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions that are difficult to predict. Our actual results, performance or achievements could differ materially from those expressed or implied by the forward-looking statements as a result of a number of factors, including, but not limited to, the success of our reorganized CDMO operations, the success of our partnership with Great Point Partners, our ability to achieve and maintain overall profitability, the sufficiency of working capital to realize our business plans, the development of our POCare strategy, our trans-differentiation technology as therapeutic treatment for diabetes which could, if successful, be a cure for Type 1 Diabetes, the technology behind our in-licensed ATMPs not functioning as expected, our ability to retain key employees, our competitors developing better or cheaper alternatives to our products and the risks and uncertainties discussed under the heading "RISK FACTORS" in Item 1A of our Annual Report on Form 10-K for the fiscal year ended November 30, 2018, and in our other filings with the Securities and Exchange Commission. We undertake no obligation to revise or update any forward-looking statement for any reason.

Contact for Orgenesis:Crescendo Communications, LLCTel: 212-671-1021Orgs@crescendo-ir.com

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Orgenesis Announces Addition of University of California, Davis, to its Point of Care Network; UC Davis Health to Utilize Orgenesis Point of Care...

How Kyoto Is Rebuilding Itself As A Nanotech And Regenerative Medicine Powerhouse – Forbes

As humans continue to pump more and more carbon dioxide into the atmosphere, concerns about global warming and climate change continue to grow. But what if that CO2 could be turned into a source of energy? One startup in Kyoto has developed cutting-edge nano-materials that could trap atmospheric CO2 and harness it as a power source. Its one way that Japans ancient capital is harnessing its large scientific and biomedical potential to address environmental and social problems.

Panning for invisible gold

Porous coordination polymers can be a form of carbon-capture technology, says discoverer Susumu Kitagawa, second from left, with (left to right) Atomis CTO Masakazu Higuchi, CEO Daisuke Asari, R&D officer Kenji Sumida, and COO Dai Kataoka.

Atomis is a new materials company that was spun off from Kyoto University. Founded in 2015 following government-supported research, its business is based on studies led by Susumu Kitagawa, a professor in the universitys Institute for Advanced Study. Its core technology is the production of materials comprising extremely small void spaces that can trap gases, including CO2. A breakthrough discovery in 1997 by Kitagawa, who has been considered a contender for the Nobel Prize in Chemistry, these porous coordination polymers (PCPs, aka metal-organic frameworks) have enormous potential as tools to precisely control gases.

Humans have used the principle behind PCPs for thousands of years. They work the same way that a hunk of charcoal traps ambient odor molecules in its large surface area, but PCPs are many times more powerful. To the naked eye, PCPs look like powders, pellets or granules of various colors, shapes and sizes. But if you were to zoom in, you would see that PCPs are sponge-like materials with pores the size of a nanometer, or one billionth of a meter. They can be designed as scaffoldlike 3D structures from metals and organic ligands, and can be used for storage, separation and conversion of molecules.

These materials are unique in that we can design the shapes and chemical properties of the pores to suit specific applications, and some of the materials have flexible structures, which can potentially provide them with even more advanced features, says Daisuke Asari, president and CEO of Atomis. The company is basically the only business in Japan working with these materials in an industrial context. Collaborating with Kitagawa is a big advantage over foreign rivals, adds Kenji Sumida, executive officer for R&D.

One challenge related to these nanomaterials is that its difficult and costly to produce more than a few kilograms per day. Massively scaling production so that PCPs can be used to fight climate change is one reason that Atomis was founded, says Atomis founder and CTO Masakazu Higuchi, one of Kitagawas collaborators. The firm is developing solid-state techniques and making capital investments to increase PCP production capacity. Meanwhile, Atomis has developed products that harness the groundbreaking potential of PCPs, including Cubitan, a compact and lightweight gas cylinder for industrial and consumer use packed with smart features, such as the ability to notify users when the amount of reserve gas becomes low.

When viewed without special equipment, PCPs look like powders, pellets or granules of various colors, shapes and sizes, but they are sponge-like materials with countless pores the size of a nanometer.

Kitagawa has his sights on the bigger picture. He believes PCPs can be used as a form of carbon-capture technology, allowing the synthesis of methanol, an energy source. Thats why he calls CO2 invisible gold.

In ancient China, Taoist mystics were said to live in the mountains and survive simply on mist, which consists of water, oxygen and CO2, says Kitagawa. They were taking something valueless and using it for energy. Similarly, PCPs can control gases that humans cannot use and turn them into something beneficial, for instance absorbing CO2 in the air and turning into methanol and other hydrocarbon materials.

Building a regenerative medicine Silicon Valley

Atomis is one of many science startups in Kyoto that have benefitted from collaborative research between industry and government. Its part of a growing startup industry in Japan, where total funding for new companies reached a record high of 388 billion yen in 2018, up from 64.5 billion yen in 2012, according to Japan Venture Research. One driver for this expansion is science and technology discoveries.

While it may be known for its traditional culture, Kyoto has a strong pedigree in scientific research. It is home to 38 universities and about 150,000 students, which form a large pool of institutional knowledge, experience and talent. Many recent Nobel laureates either graduated from or taught at Kyoto University, including professors Tasuku Honjo and Shinya Yamanaka, who won the Nobel Prize for Physiology or Medicine in 2018 and 2012, respectively. Working on discoveries by Yamanaka, Megakaryon has become a world leader in creating artificial blood platelets made from synthetic stem cells.Theres also a large group of high-tech companies that have carved out niches for themselves internationally.

Kyoto is a unique city in that it has an independent spirit that is similar to the U.S. West Coast, says Eiichi Yamaguchi, a professor at Kyoto University who has founded four companies.

Kyoto companies like Murata Manufacturing, Horiba, Shimadzu, and Kyocera have a global market and theyre competing with China, says Eiichi Yamaguchi, a professor at Kyoto University who has founded four companies. Thats the difference with companies in Tokyo, which are more domestically oriented.

Yamaguchi has authored several books on innovation, and says there is a growing awareness of the importance of collaborative research and entrepreneurship in Kyoto. He cites a recently formed cooperative group of seven university chairpersons and presidents from leading materials and biosciences companies that meets to discuss issues such as fostering new technologies, for instance building high-speed hydrogen fueling systems.

Kyoto is a unique city in that it has an independent spirit that is similar to the U.S. West Coast, says Yamaguchi. Kyoto is only a fraction of the size of Tokyo, but if you take a stand here, people will pay attention.

Another group that is promoting local high-tech business is Innovation Hub Kyoto. Its an open innovation facility based in the Kyoto University Graduate School of Medicine aimed at commercializing research from the university. Steps away from Kyotos historic Kamo River, its geared to researchers, investors, startups, and established companies working in the field of medical innovation including device development and drug discovery. This is where Japanese researchers are trying to build a Silicon Valley of regenerative medicine.

Tenants at Innovation Hub Kyoto can use this wet lab for research.

Part of the Kyoto University Medical Science and Business Liaison Organization, the hub was established about 15 years ago and opened a new building in 2017 with the support of the Ministry of Education, Culture, Sports, Science and Technology. The structure has a variety of labs, including ones meeting biosafety level P2 and for animal experiments.

Its tough for startups in Japan to access to animal laboratories like the one we have, says hub leader Yutaka Teranishi, a professor in the Graduate School of Medicine who estimates that some 50% of university researchers want to work with industry, up from 10% a few years ago. Were focused on university startups because its very difficult for them to develop drugs from just an alliance between companies and universities.

About 28 companies are tenants at Innovation Hub Kyoto. They include major brands such as Shimadzu and Nippon Boehringer Ingelheim as well as younger businesses. One is AFI, founded in 2013 and focused on fluid, electric filtering and sorting (FES) technology that can be used for applications ranging from food safety inspections to rapid diagnosis of disease to regenerative medicine.

Tomoko Bylund heads the Japan office of CELLINK, a Swedish bioprinting and bioink company that is a tenant at Innovation Hub Kyoto.

Another tenant is CELLINK, a Swedish bioprinting and bioink company headed in the Japan by Tomoko Bylund. Using its products, researchers can print body parts with human cells for drug and cosmetics testing. In 2019, the first 3D print of a human cornea in the U.S. was accomplished with the companys BIO X Bioprinter.

iHeart Japan is also a tenant. It was established in 2013 as a regenerative medicine business and is aiming to address a major shortage in the Japanese medical system: only about 40 out of 200,000 people on national waiting lists can receive donor hearts every year. The company is developing innovative medical products such as multi-layered cardiac cell sheets derived from synthetic stem cells. The Hub basis its success in fostering companies on its diversity and the business environment in Kyoto.

We have people from different backgrounds here who are exchanging cultures and experimental results, and this diversity is powering innovation here, says Teranishi. There are many traditional industries in Kyoto, and though people say its a conservative city, these companies have survived because theyre open to new technologies and have taken the time to choose which ones can help them. Thats how this city and its businesses have lasted for more than 1,000 years.

Diversity is powering innovation here, says Yutaka Teranishi, center, head of Innovation Hub Kyoto, with Kyoto University professor Hirokazu Yamamoto, left, and Graduate School of Medicine lecturer Taro Yamaguchi, right.

To learn more about Atomis, click here.

To learn more about Innovation Hub Kyoto, click here.

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How Kyoto Is Rebuilding Itself As A Nanotech And Regenerative Medicine Powerhouse - Forbes

Aspen Neuroscience Announces Board of Directors and Scientific Advisory Board – PRNewswire

SAN DIEGO, Jan. 9, 2020 /PRNewswire/ -- Aspen Neuroscience, Inc.,a private biotechnology company developing the first autologous neuron replacement therapy to treat Parkinson disease, has announced the members of its Board of Directors and Scientific Advisory Board. These boards bring together many of the world's most distinguished industry and academic minds to deliver Aspen's personalized cell therapy to persons suffering with Parkinson disease.

"We are proud of the talented groups we have assembled," said Aspen CEO Howard Federoff, MD, PhD. "They bring a wealth of insights and experience in biomedical research and therapeutic development that will be essential for our success. Together, we are motivated to bring best-in-class treatments to Parkinson patients as rapidly as possible. They have waited long enough."

Last month, Aspen announced it has raised $6.5 million in seed fundingand unveiled its plans to use neurons derived from induced pluripotent stem cells (iPSCs) to combat the debilitating motor symptoms of Parkinson disease. These iPSCs will be created from each patient's own cells and then differentiated into dopamine-producing neurons, replacing the critical cells lost in Parkinson disease. Because the therapy is created from each patient's own tissue, no immunosuppression will be necessary.

"The creation of our esteemed Board of Directors and Scientific Advisory Board is an important step for Aspen's future development as it will help guide the company's progress toward regulatory approval," said Kim P. Kamdar, PhD, Aspen Board Chair and Partner at Domain Associates. "The members of each board bring significant expertise, complementary skills and an external perspective, which will be very valuable in informing Aspen's strategy."

Aspen's Board of Directors includes well-known industry veterans and financial minds from leading venture capital firms that are poised todirect the growth of Aspen through clinical trials and regulatory approval.

Aspen Neuroscience Board of Directors

The Scientific Advisory Board consists of leaders in the fields of bioethics, regenerative medicine clinical trials, autologous iPSC-based therapy, and Parkinson disease neuron replacement and neuroimaging.

Aspen Neuroscience Scientific Advisory Board

The newly established boards will join Aspen's impressive leadership team: Howard J. Federoff, MD, PhD, Chief Executive Officer; Jeanne Loring, PhD, Chief Scientific Officer; Edward Wirth, MD, PhD, Chief Medical Officer; Jay Sial, Chief Financial Officer; Andres Bratt-Leal, PhD, Vice President of Research and Development; Thorsten Gorba, PhD, Senior Director of Manufacturing; and Naveen M. Krishnan, MD, MPhil, Senior Director of Corporate Development.

About Aspen NeuroscienceAspen Neuroscience, Inc., is a development stage, private biotechnology company that uses innovative genomic approaches combined with stem cell biology to deliver patient-specific, restorative cell therapies that modify the course of Parkinson disease. Aspen's therapies are based upon the scientific work of world-renowned stem cell scientist, Dr. Jeanne Loring, who has developed a novel method for autologous neuron replacement. For more information and important updates, please visithttp://www.aspenneuroscience.com.

SOURCE Aspen Neuroscience

https://www.aspenneuroscience.com

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Aspen Neuroscience Announces Board of Directors and Scientific Advisory Board - PRNewswire

ASH 2019 | The impact of donor clonal hematopoiesis on aGvHD and patient outcomes – AML Global Portal

The presence of preleukemic mutations in peripheral blood (PB) samples is termed clonal hematopoiesis of indeterminate potential (CHIP). CHIP is defined as the absence of definitive morphologic evidence of hematologic neoplasms, with the presence of a somatic mutation with a variate allele frequency (VAF) of > 2%. The incidence of CHIP increases with age and comes with an increased risk of developing myeloid malignancies and cardiovascular complications. Therefore, using older donors with CHIP may impact the outcomes of patients undergoing transplantation.

During the 61st meeting of the American Society of Hematology (ASH), Betul Oran, MD Anderson Cancer Center, Houston, US, presented the results from a study which evaluated the impact of donor clonal hematopoiesis on the risk of acute graft-versus-host disease (GvHD, aGvHD) and patient outcomes. The trial was conducted in patients with AML or MDS who received a transplant from a matched-related donor (MRD) aged 55 years or older.

Table 1. Impact of CHIP on transplant outcomes

CHIP positive

CHIP negative

HR

95% CI

p value

N

57

245

-

-

-

Relapse incidence (RI) at 5-years

Not reported (NR)

NR

0.9

0.51.5

0.7

Age-adjusted RI at 5-years

NR

NR

0.9

0.61.4

0.7

Progression incidence at 5-years, %

40

44

0.9

0.51.4

0.5

TRM at 6 months, %

12

9

1.6

0.54.9

0.4

Age adjusted RM at 6 months

NR

NR

1.3

0.62.9

0.5

PFS at 5-years, %

38

36

0.97

0.71.4

0.9

Age adjusted PFS at 5-years

NR

NR

0.96

0.71.4

0.8

OS at 5-years, %

43

41

1.05

0.71.5

0.8

Table 2. Impact of donor CHIP on rates of GvHD

CHIP positive

CHIP negative

HR

95% CI

p value

N

57

245

-

-

-

Grade II-IV aGvHD at 6 months

Total, %

51

27

2.1

1.43.3

0.001

Donor > 65 years, %

54

27

2.1

1.054.4

0.04

Donor 65 years %

48

28

2

1.13.5

0.001

Grade III-IV aGvHD at 6 months

Total, %

16

5

3.2

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ASH 2019 | The impact of donor clonal hematopoiesis on aGvHD and patient outcomes - AML Global Portal