Proactiveinvestors USA & Canada Orgenesis https://www.proactiveinvestors.com Proactiveinvestors USA & Canada Orgenesis RSS feed en Tue, 26 Mar 2019 07:23:30 -0400 http://blogs.law.harvard.edu/tech/rss Genera CMS action@proactiveinvestors.com (Proactiveinvestors) action@proactiveinvestors.com (Proactiveinvestors) <![CDATA[News - Orgenesis subsidiary MaSTherCell Global to build new facility in Belgium for cell and gene therapy manufacturing ]]> https://www.proactiveinvestors.com/companies/news/217146/orgenesis-subsidiary-masthercell-global-to-build-new-facility-in-belgium-for-cell-and-gene-therapy-manufacturing-217146.html Orgenesis Inc (NASDAQ:ORGS) said Monday that it plans to build an advanced production site in Belgium to help its subsidiary MaSTherCell Global manufacture commercially approved cell and gene therapy products.

The company signed a lease agreement for a 61,354 square foot space in a building located within Gosselies Biopark, in Belgium.

The new commercial facility, expected to be up-and-running by early-2021 will triple MaSTherCell Global’s capacity. The facility will include industry 4.0 precepts such as “software integration, intelligent equipment and integrated processes” which will provide cost-effective manufacturing solutions for cell and gene therapy customers.

DEEP DIVE: Orgenesis leads the charge at an exciting time for cell therapy

Once the new commercial facility is operational, the current facility, also located within the Gosselies Biopark biotech cluster, will shift its focus to industrial manufacturing process development and early to mid-stage, clinically-focused cell and gene therapy products.

“We are excited to launch this new facility, which will significantly enhance our capacity to meet growing demand,” said Orgenesis CEO Vered Caplan in a statement. “This new facility will provide our customers unparalleled manufacturing capabilities and a strong competitive advantage. We believe this facility, in addition to our current global capabilities, will also help patients by providing greater access to life saving therapies.”

Expansion mode

MaSTherCell Global is a leading cell and gene therapy global contract development and manufacturing organization, or CDMO.

“As a leading CDMO, MaSTherCell is working hard to address the lack of commercial manufacturing capacity, especially in Europe,” said Dr Denis Bedoret, president at MaSTherCell Global. “With this facility, we aim to be the first CDMO in Europe to have a dedicated area for large-scale commercial manufacturing.”

The new production facility will create local employment.

“It will create several hundred jobs and allow us to tap into local Belgian expertise to train our teams within the heart of Europe, in support of our international recruitment goals,” said Eric Mathieu, chief operating officer of MaSTherCell’s Belgium operations.

Contact Uttara Choudhury at uttara@proactiveinvestors.com

Follow her on Twitter: @UttaraProactive 

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Mon, 25 Mar 2019 10:35:00 -0400 https://www.proactiveinvestors.com/companies/news/217146/orgenesis-subsidiary-masthercell-global-to-build-new-facility-in-belgium-for-cell-and-gene-therapy-manufacturing-217146.html
<![CDATA[News - Orgenesis leads the charge at an exciting time for cell therapy ]]> https://www.proactiveinvestors.com/companies/news/216323/orgenesis-leads-the-charge-at-an-exciting-time-for-cell-therapy-216323.html  • The Germantown, Maryland-based biopharmaceutical company has expertise in developing advanced cell therapies and manufacturing.

 • Its MaSTherCell Global subsidiary is a global contract development and manufacturing organization, or CDMO.

 • Masthercell Global generated $22.6 million in sales and an operating profit of $4 million on a standalone basis in 2018.

 • Oslo-based Zelluna Immunotherapy has selected MaSTherCell as its manufacturing partner for its T-cell receptor immunotherapies targeting cancer antigens

• Orgenesis is a pioneer in transdifferentiation, which involves direct reprogramming of an adult tissue or cell into another type of specialized cell

Company overview

Orgenesis Inc (NASDAQ:ORGS) is a vertically integrated biopharmaceutical company with expertise in developing advanced cell therapies and manufacturing.

On the manufacturing side, the company’s subsidiary MaSTherCell Global is a global contract development and manufacturing organization, or CDMO. MaSTherCell helps companies shorten lead time and lower costs in getting cell therapies and products to the market.

On the technology side, the company’s subsidiary Orgenesis Ltd, is a pioneer in transdifferentiation, which simply means cell reprograming. It has utilized its proprietary technology to successfully reprogram human liver cells into glucose-responsive, fully functional, insulin-producing cells.

Spurring the arrival of new therapies 

MaSTherCell Global has facilities in Europe, Israel through Atvio-Biotech and through subsidiaries in Asia and the US.

It helps customers — pharma, cell, gene therapy companies, as well as research institutions and hospitals — with tech selection, assay development, cell therapy manufacturing and business modeling. This helps speed up the arrival of therapies to market. 

“Orgenesis brings the two worlds together — the engineering world and the biological world,” Vered Caplan, the CEO of the company, told Proactive Investors. “We really focus on industrializing drugs,” added Caplan, an industry veteran with bio-medical engineering and business development degrees from Tel-Aviv University, in Israel. 

Orgenesis has a strategic partnership with Great Point Partners LLC, a healthcare investment firm in Greenwich, Connecticut which will give it $25 million to develop global services.

MaSTherCell has received the first milestone payment of $6.6 million from Great Point Partners and is expanding into the US by building a new 30,000 square feet manufacturing facility in Houston.

Expansion mode

MaSTherCell unveiled a new production wing at its Belgium site which gives it five additional clean rooms. The new wing includes two development labs, a quality control lab and warehouse capabilities.

“It was important for us to expand our current Belgium plant because the cell therapy industry, and specifically our partners, need to have access to reliable facilities for their commercial projects,” said Caplan. “Our objective is to help them access the market faster with tailormade capabilities.”

Oslo-based Zelluna Immunotherapy has selected MaSTherCell as its manufacturing partner for its T-cell receptor immunotherapies targeting cancer antigens.

Novel technology platform

Orgenesis is also a pioneer in transdifferentiation, which involves direct reprogramming of an adult tissue or cell into another type of specialized cell with its distinct function. Transdifferentiation potentially provides the use of a patient's own adult tissues to restore any damaged organs or tissue. This ability to convert one cell type to another holds great promise in the stem cell field.  

Orgenesis founder and chief scientific officer Professor Sarah Ferber is the inventor of the company’s groundbreaking transdifferentiation platform technology. 

Ferber, who completed a post-doctoral fellowship from Harvard Medical School, made a discovery suggesting adults carry their own stem cells, obviating the need for embryonic stem cells for generating an organ in need.  

The first indication Orgenesis is pursuing is for the treatment of severe diabetes following a pancreatectomy, a surgical procedure performed to treat severe pancreatitis. Through its Israeli subsidiary, Orgenesis Ltd, the company is also targeting insulin-dependent diabetes.

Converting a diabetic’s own tissue into insulin-producing cells has the potential to provide a cure for insulin dependence and overcoming donor shortages, costs and risks involved with transplant rejection. 

“This is a cell taken from your own body, utilized and manipulated, so it can go back and do an even better job,” said Caplan.

Big market opportunity

Orgenesis is eying an expanding cell therapy market pegged at $32 billion.

At heart, cell therapy is the treatment of disease through cells which have been selected, multiplied and manipulated outside the body. The most common type of cell therapy is the replacement of mature, functioning cells through blood and platelet transfusions.

While academic and industrial research has led scientific development in the sector, industrialization and manufacturing expertise remains insufficient. 

The beauty of Orgenesis is that has built a platform of know-how and expertise for a multitude of cell therapies including autoimmune, oncologic, neurologic and orthopedic diseases, among other indications.  

Orgenesis is building a fundamental base platform of expertise for a multitude of cell types crucial for the regenerative medicine industry.

Bullish investment case

The company is seeing steady growth on an expansion of services, particularly CAR T-cell therapies. This is a type of treatment that involves a patient's T-cells being changed in the lab, so they attack cancer cells. 

Orgenesis reported a 139% expansion in profit to $7.8 million for fiscal year 2018, compared to $3.3 million for the previous financial year.

"We are pleased to report strong growth, increased gross profit and solid gross margin improvement in fiscal 2018,” said Caplan. “Our CDMO segment, Masthercell Global generated $22.6 million in sales, and an operating profit of $4 million on a standalone basis. We continue to grow Masthercell's backlog and customer base.”

Contact Uttara Choudhury at uttara@proactiveinvestors.com

Follow her on Twitter: @UttaraProactive

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Tue, 12 Mar 2019 15:30:00 -0400 https://www.proactiveinvestors.com/companies/news/216323/orgenesis-leads-the-charge-at-an-exciting-time-for-cell-therapy-216323.html
<![CDATA[News - Orgenesis stock climbs after it posts 139% expansion in gross profit for fiscal 2018 on revenue surge ]]> https://www.proactiveinvestors.com/companies/news/214660/orgenesis-stock-climbs-after-it-posts-139-expansion-in-gross-profit-for-fiscal-2018-on-revenue-surge-214660.html Orgenesis Inc (NASDAQ:ORGS), stock climbed Thursday after the developer of advanced cell therapies, posted a 139% expansion in gross profit to $7.8 million for fiscal year 2018, compared to $3.3 million for the previous financial year.

Revenues for the Germantown, Maryland-based company also increased 85% to $18.7 million in the 2018 financial year compared to $10.1 million for fiscal 2017. Meanwhile, gross margin increased to 42% from 32.5%.

READ: Orgenesis kicks off US expansion of MaSTherCell Global subsidiary with Houston facility

The company also finished with cash and cash equivalents of $16.1 million as of November 30, 2018. It improved its working capital surplus substantially compared to a loss of $9.6 million in the same period a year ago.

Shares in Orgenesis climbed 2.02% to $4.97.

The company’s subsidiary, MaSTherCell Global is a global contract development and manufacturing organization, or CDMO. Orgenesis highlighted that the fast-growing CDMO segment achieved $4 million in operating profits.

"We are pleased to report strong growth, increased gross profit and solid gross margin improvement in fiscal 2018,” said Orgenesis CEO Vered Caplan in a statement. “Our CDMO segment, Masthercell Global generated $22.6 million in sales, and an operating profit of $4 million on a standalone basis. While we continue to grow Masthercell's backlog and customer base, one of our key challenges in fiscal 2018 was ramping up to meet the growing global demand.”

Caplan said that to address “capacity constraints” the company recently opened a new 6,458 square feet production wing at its Belgium site to provide Masthercell with five “additional late-stage and commercial-ready clean rooms.”

“In total, we have more than doubled our manufacturing capacity in 2018, which positions us for continued strong growth in 2019. In addition, we recently announced expansion plans into the US,” said Caplan.

READ: Orgenesis unveils new offices, labs at Accessia Pharma in Belgium to boost its point-of-care cellular therapy platform

MaSTherCell Global Inc is building a new 30,000 square feet manufacturing facility in Houston. With the US expansion, the company, which develops advanced cell therapies, will now have manufacturing facilities in three continents spanning North America, Europe and Asia

MaSTherCell is also backed by Great Point Partners LLC, a healthcare investment firm based in Greenwich, Connecticut.

Meanwhile, Orgenesis said that it is opening new offices and labs at Accessia Pharma in Liège, Belgium, for its Belgian subsidiary, Orgenesis SPRL, to support its point-of-care cellular therapy platform.

Caplan said the new laboratories in Belgium would “strengthen the roll-out” of the US company’s point-of-care strategy across Europe.

"In addition, we have partnered with local companies to expand our point-of-care activity to Japan and India. Importantly, we have already entered agreements that will begin generating revenue within this segment," said Caplan.

Orgenesis said its goal is to utilize its know-how and intellectual property to advance new autologous cell therapies to a clinical stage and enable point-of-care cell therapy development and services.

Two of the most common types of stem cell transplants are autologous and allogeneic transplants. Both kinds of stem cell transplantations are a common treatment option for cancers such as leukemia, lymphoma, and multiple myeloma.

An autologous transplant uses a person's own stem cells, while an allogeneic transplant uses stem cells from a donor whose human leukocyte antigens (HLA) are acceptable matches to the patient’s.

-- (Updates with CEO comments about point-of-care strategy and partnerships) -- 

Contact Uttara Choudhury at uttara@proactiveinvestors.com

Follow her on Twitter: @UttaraProactive 

 

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Thu, 14 Feb 2019 10:14:00 -0500 https://www.proactiveinvestors.com/companies/news/214660/orgenesis-stock-climbs-after-it-posts-139-expansion-in-gross-profit-for-fiscal-2018-on-revenue-surge-214660.html
<![CDATA[News - Orgenesis unveils new offices, labs at Accessia Pharma in Belgium to boost its point-of-care cellular therapy platform ]]> https://www.proactiveinvestors.com/companies/news/214020/orgenesis-unveils-new-offices-labs-at-accessia-pharma-in-belgium-to-boost-its-point-of-care-cellular-therapy-platform-214020.html Orgenesis Inc (NASDAQ:ORGS), a developer of advanced cell therapies, said Tuesday that it is opening new offices and labs at Accessia Pharma in Liège, Belgium, for its Belgian subsidiary, Orgenesis SPRL, to support its point-of-care cellular therapy platform.

Germantown, Maryland-based Orgenesis said it was supported by its partners Theracell (Greece), Hemogenyx (UK), Serpin (USA), to expand cellular therapy development in the Walloon region of Belgium.

Orgenesis said its goal is to utilize its know-how and intellectual property to advance new autologous cell therapies to a clinical stage and enable point-of-care cell therapy development and services.

Two of the most common types of stem cell transplants are autologous and allogeneic transplants. Both kinds of stem cell transplantations are a common treatment option for cancers such as leukemia, lymphoma, and multiple myeloma.

READ: Orgenesis kicks off US expansion of MaSTherCell Global subsidiary with Houston facility

An autologous transplant uses a person's own stem cells, while an allogeneic transplant uses stem cells from a donor whose human leukocyte antigens (HLA) are acceptable matches to the patient’s.

"We are excited to further expand in the Walloon Region of Belgium, a leading center for talent and R&D within Europe,” said Orgenesis CEO Vered Caplan, in a statement. “The opening of our new offices and laboratories at Accessia Pharma will strengthen the roll-out of our point-of-care strategy across Europe. We are honored to work closely with a number of leading international partners and believe they will greatly benefit from our expanded European activity within the supportive Walloon Region.”

Rapidly building global network

The company is focused on rapidly building its global network and views the new center as a “significant starting location” in Europe.

Orgenesis said it was “strategically positioned” in Europe through two of its own subsidiaries in the Walloon Region. One of them is MaSTherCell Belgium, a member of Orgenesis’ gene therapy global contract development and manufacturing organization (CDMO), MaSTherCell Global. The other is Orgenesis SPRL, which is active in the autologous cell therapy and service segment with a strong focus on advancing the company's novel autologous trans-differentiation cell therapy technologies for the treatment of diabetes and other potential indications.

"We believe that through our point-of-care strategy, we can significantly reduce development costs through joint ventures with local partners who bring strong regional networks,” said Efrat Assa Kunik, general manager of Orgenesis SPRL Belgium.

Kunik said partnerships with local hospitals would allow them to engage in continuous in-licensing of autologous therapies from academia and research institutes. The utilization of hospital networks would also boost the clinical development of new therapies.

Orogenesis stock was trading flat at $4.94 in morning trade.

Contact Uttara Choudhury at uttara@proactiveinvestors.com

Follow her on Twitter: @UttaraProactive 

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Tue, 05 Feb 2019 10:24:00 -0500 https://www.proactiveinvestors.com/companies/news/214020/orgenesis-unveils-new-offices-labs-at-accessia-pharma-in-belgium-to-boost-its-point-of-care-cellular-therapy-platform-214020.html
<![CDATA[Media files - Orgenesis subsidiary MaSTherCell Global expanding into the US ]]> https://www.proactiveinvestors.com/companies/stocktube/12058/orgenesis-subsidiary-masthercell-global-expanding-into-the-us-12058.html Thu, 31 Jan 2019 15:15:00 -0500 https://www.proactiveinvestors.com/companies/stocktube/12058/orgenesis-subsidiary-masthercell-global-expanding-into-the-us-12058.html <![CDATA[News - Orgenesis kicks off US expansion of MaSTherCell Global subsidiary with Houston facility ]]> https://www.proactiveinvestors.com/companies/news/213368/orgenesis-kicks-off-us-expansion-of-masthercell-global-subsidiary-with-houston-facility-213368.html Orgenesis Inc (NASDAQ:ORGS) said Friday its subsidiary MaSTherCell Global Inc is expanding into the US and building a new 30,000 square feet manufacturing facility in Houston. 

The Germantown, Maryland-based company’s subsidiary MaSTherCell Global is a leading cell and gene therapy global contract development and manufacturing organization, or CDMO.

READ: Orgenesis subsidiary Masthercell Global unveils new production wing at Belgian plant

With the US expansion, the company, which develops advanced cell therapies, will now have manufacturing facilities in three continents spanning North America, Europe and Asia

MaSTherCell is also backed by Great Point Partners LLC, a healthcare investment firm based in Greenwich, Connecticut.

In July, MaSTherCell announces a planned investment for MaSTherCell Global of up to $25 million to develop its global services through a strategic partnership between Orgenesis and Great Point Partners. According to the terms of the agreement, MaSTherCell would receive an initial upfront payment of $11.8 million, with the balance subject to achieving certain specified EBITDA and revenue targets.

The company said MaSTherCell has received the first milestone payment of $6.6 million as a result of its strategic partnership with Great Point Partners.

“We are thrilled with the performance of MaSTherCell Global since the Great Point Partners investment, and this latest tranche of funding will help drive additional growth,” said Orgenesis CEO Vered Caplan in a statement. “The additional capacity provided by this expansion should allow us to expand our presence in North America and enhance the services for our customers in order to fully capitalize on the growing global market demand.”

Through its MaSTherCell subsidiary, Orgenesis works with cell therapy organizations and drug makers to provide business modeling as well as help with manufacturing and technology selection in a bid to speed up the arrival of their therapies to the market.

The additional funding through Great Point Partners will be ploughed into launching the new US facility, and expanding the facilities in Europe, Israel, and Korea.

“The new US facility will enable new and existing clients to work with MaSTherCell across the world. MaSTherCell Global’s international reach will allow for more innovation and efficient processes, while ensuring the same quality standards across the company,” said Noah Rhodes, managing director at MaSTherCell.

Orgenesis stock opened flat at $4.69.

Contact Uttara Choudhury at uttara@proactiveinvestors.com

Follow her on Twitter: @UttaraProactive 

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Fri, 25 Jan 2019 10:20:00 -0500 https://www.proactiveinvestors.com/companies/news/213368/orgenesis-kicks-off-us-expansion-of-masthercell-global-subsidiary-with-houston-facility-213368.html
<![CDATA[Media files - HekaBio CEO says Orgenesis taken 'great steps' to solve biotech manufacturing cost problem ]]> https://www.proactiveinvestors.com/companies/stocktube/11814/hekabio-ceo-says-orgenesis-taken--great-steps--to-solve-biotech-manufacturing-cost-problem-11814.html Fri, 11 Jan 2019 13:51:00 -0500 https://www.proactiveinvestors.com/companies/stocktube/11814/hekabio-ceo-says-orgenesis-taken--great-steps--to-solve-biotech-manufacturing-cost-problem-11814.html <![CDATA[Media files - Orgenesis CEO says investors realizing building out infrastructure in biotechs is important ]]> https://www.proactiveinvestors.com/companies/stocktube/11789/orgenesis-ceo-says-investors-realizing-building-out-infrastructure-in-biotechs-is-important-11789.html Thu, 10 Jan 2019 15:48:00 -0500 https://www.proactiveinvestors.com/companies/stocktube/11789/orgenesis-ceo-says-investors-realizing-building-out-infrastructure-in-biotechs-is-important-11789.html <![CDATA[News - Biotech CEOs gather in San Francisco to mull 2019 outlook ]]> https://www.proactiveinvestors.com/companies/news/211991/biotech-ceos-gather-in-san-francisco-to-mull-2019-outlook-211991.html When the annual Biotech Showcase kicks off next Monday in San Francisco, the CEOs of prominent biotech companies will outline thoughts on pressing topics ranging from the state of next-generation immunotherapies to how to make a dent in rare and orphan diseases.

High on the agenda at this popular yearly forum, which runs from January 7 through January 9 at the Hilton San Francisco Union Square, is a panel discussion entitled “Cell and gene therapy: The financing surge” featuring Vered Caplan, the CEO of Orgenesis (NASDAQ:ORGS), a developer of advanced cell therapies.

Caplan has been invited to discuss how disruptive therapeutic products in the area of gene and cell therapy are generating tremendous interest from investors. Her presentation will be held Tuesday, January 8 at 8 am (PST) (Yosemite A room).

Industry chieftains see the Biotech Showcase as a must-go-to meeting as it comes as JP Morgan’s annual healthcare conference starts in San Francisco (Westin St. Francis Hotel).

“The showcase is perhaps the most important investor meeting that we have this year,” pointed out Robert Beckman, director of business development for Orgenesis, in an interview with Proactive. “Everyone will be in San Francisco who either has an interest in investment or raising capital in the biotechnology industry.”

Also on the list of talks is a presentation by Rodney Varner, the CEO of Genprex Inc (NASDAQ:GNPX), the clinical-stage gene therapy company based in Austin, Texas, that focuses on cancer.

At 3:30 pm (PST) on Monday (Franciscan A- ballroom level), Varner will present the case for Genprex’s approach to treating cancer, which includes the company’s flagship immunogene therapy, Oncoprex that aims to fight non-small cell lung cancer. Researchers at MD Anderson Cancer Center in Houston have reported favorable trial results with the therapy which is capable of interrupting cell signaling pathways that cause the replication and proliferation of cancer cells.

READ: How Genprex took an abandoned pipeline drug and turned it into Oncoprex, an innovative treatment for non-small cell lung cancer

“Genprex stands at the forefront of the new age in the fight against cancer, and I am immensely proud to be with a company operating in that position,” noted Varner in a statement sent to Proactive.

Richard Schumacher, the CEO of Pressure BioSciences Inc (OTCQB:PBIO), meanwhile, will provide an overview of the platform technology company’s business and offer an outlook for 2019 on Monday, January 7 at 2 pm (Franciscan A).

The company’s pressure-cycling technology hinges on the use of hydrostatic pressure and its devices are used for drug development and biomarker discovery as well as food science research.

“This is a very important meeting as it gives me a chance to meet in a three-day period with potential investors and customers,” said Schumacher in a telephone interview with Proactive.

READ: Pressure BioSciences' Ultra Shear Technology system may solve the cannabinoid delivery issue

Among the other companies presenting in San Francisco are the UK-based cell therapy specialist ReNeuron Group PLC (LON:RENE), which is gearing up for a busy 2019 thanks to two clinical trials. Patient screening and enrollment have commenced for its most advanced program, a CTX stem cell therapy for strokes, which is entering phase IIb trials. Top-line data from the US study is expected in early 2020.

At the same time, ReNeuron’s scientists have optimized the dosing for the company’s hRPC drug for an eye condition called retinitis pigmentosa and a Phase 1/2 assessment has restarted. An initial read-out from the research is expected by the middle of the year.

Flying in from London as well to deliver a lecture is Lisa Anson, CEO of Redx Pharma Plc (LOND:REDX) and the former president of AstraZeneca PLC’s (LON:AZN) UK division. The AIM-quoted biotech Redx specializes in developing cancer and fibrosis-fighting drugs.

Its flagship drug is RXC004, a porcupine inhibitor, a new and potentially breakthrough method of fighting cancer. Porcupine inhibitors work by targeting cancer stem cells that can often lie dormant after traditional treatment and are associated with a recurrence of the illness. Anson’s presentation will take place at 3 pm (PST) on Tuesday, January 8 (Yosemite A – Ballroom level).

READ: ChemioCare gets DEA clearance to introduce dronabinol patch for cancer patients

A presentation is expected too from Pedro Lichtinger, CEO of ChemioCare USA, a privately held biotech company that focuses on cancer care. Based in New York, the company specializes in neutralizing chemotherapy-induced nausea and vomiting through its own transdermal patch technology. Its management is looking to take the company public in the first half of this year.

Additional panel discussions to be aired at the conference include a retrospective look at the biotech sector with former analysts on January 7 at 4 pm (Imperial Ballroom) and a Reexamination of Alzheimer’s: Is it a singular disease? on January 8 at 8 am (Yosemite C).

Contact Ellen Kelleher at ellen@proactiveinvestors.com

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Fri, 04 Jan 2019 13:05:00 -0500 https://www.proactiveinvestors.com/companies/news/211991/biotech-ceos-gather-in-san-francisco-to-mull-2019-outlook-211991.html
<![CDATA[Media files - Orgenesis to present at Biotech Showcase in San Francisco next week ]]> https://www.proactiveinvestors.com/companies/stocktube/11698/orgenesis-to-present-at-biotech-showcase-in-san-francisco-next-week-11698.html Thu, 03 Jan 2019 12:02:00 -0500 https://www.proactiveinvestors.com/companies/stocktube/11698/orgenesis-to-present-at-biotech-showcase-in-san-francisco-next-week-11698.html <![CDATA[News - Orgenesis collaborates with MangoGen Pharma for advanced gene delivery platform ]]> https://www.proactiveinvestors.com/companies/news/211435/orgenesis-collaborates-with-mangogen-pharma-for-advanced-gene-delivery-platform-211435.html Orgenesis Inc (NASDAQ:ORGS), a developer of advanced cell therapies, said Tuesday that it had forged a collaboration with MangoGen Pharma Inc, initially focused on the pre-clinical development of insulin producing cells (IPCs), using MangoGen’s advanced gene delivery platform.

Under the initial terms of the collaboration, the companies will work together to develop a “complete solution” for the delivery of insulin-producing cells.

The company has been awarded a grant from the Canada-Israel Industrial R&D Foundation (CIIRDF) to fund the project.

The technology potentially allows the Germantown, Maryland-based company to reduce the cost and complexity of manufacturing its cell therapy programs.

“We look forward to working with MangoGen, which has developed an innovative virus vector for the delivery of DNA utilizing baculoviruses. We believe that the MangoGen baculoviral delivery and encapsulation system has the potential to increase the potency and performance of our transdifferentiation technology, as well as other cell therapies we are developing and those of our customers,” Vered Caplan, CEO of Orgenesis, said in a statement. 

Orgenesis’ subsidiary MaSTherCell is a global contract development and manufacturing organization, or CDMO.

READ: Orgenesis CEO Vered Caplan says it's a 'very exciting time' for cell therapy in Fox interview

“Baculoviral systems have a number of advantages over other vectors due to the fact that they do not integrate into the hosts DNA and are therefore unlikely to cause problems with mutation or immunogenicity. By using MangoGen’s baculovirus, it could potentially enhance manufacturing processes and reduce the cost of goods for Orgenesis’ IPCs and other cell therapies,” said Caplan.

Orgenesis is also a pioneer in transdifferentiation, which simply means cell reprograming. 

The process involves direct reprogramming of an adult tissue or cell into another type of specialized cell, with its distinct phenotype and function. Transdifferentiation potentially provides the use of a patient's own adult tissues to restore any damaged organs or tissue. This ability to convert one cell type to another holds great promise in the stem cell field.  

Professor Sarah Ferber, founder and chief scientific officer at Orgenesis, is the inventor of the company’s groundbreaking transdifferentiation (TD) platform technology, which has potential applications across multiple health conditions.

Orgenesis CEO Caplan said the grant from CIIRDF was a “validation of the technology” and could “accelerate research.”

“We are delighted to partner with Orgenesis on this exciting project to further enhance the efficacy and manufacturability of Orgenesis’ transdifferentiation technology through our baculoviral gene-delivery and encapsulation technology,” said MangoGen Pharma CEO Paul Plested.

“We see broad potential for this platform technology within the cell therapy and regenerative medicine markets.  Orgenesis is an ideal partner given their broad expertise and capabilities as both a developer of advanced cell therapies and leading contract development and manufacturing organization,” added Plested.

 

Contact Uttara Choudhury at uttara@proactiveinvestors.com

Follow her on Twitter: @UttaraProactive

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Tue, 18 Dec 2018 14:57:00 -0500 https://www.proactiveinvestors.com/companies/news/211435/orgenesis-collaborates-with-mangogen-pharma-for-advanced-gene-delivery-platform-211435.html
<![CDATA[News - Orgenesis CEO Vered Caplan says it's a 'very exciting time' for cell therapy in Fox interview ]]> https://www.proactiveinvestors.com/companies/news/211174/orgenesis-ceo-vered-caplan-says-it-s-a--very-exciting-time--for-cell-therapy-in-fox-interview-211174.html Vered Caplan, the CEO of Orgenesis Inc (NASDAQ:ORGS), a developer of advanced cell therapies, said her business is undergoing a “very exciting time” thanks to regulators working together to get cell therapies to patients, according to a Fox Business Network interview on the program “Mornings with Maria” held on Thursday.

“I think it’s very impressive how globally regulatory agencies have taken on the challenge of finding a way to get these drugs to patients,” Caplan said on the program.

"It’s exciting to see how scientists and regulatory people around the world are working together. Even a bone marrow transplantation is a cell therapy,” added Caplan.

READ: Orgenesis seals pact with Ben-Gurion University to develop dissolvable carriers for cell culturing

Developing cell therapies offers up challenges as it’s impossible to devise them as you would a plastic or a chemical material. “Making these drugs, making these products is the biggest engineering challenge so to speak,” Caplan said on Fox. “This is living material. These are the cells of our body.”

A developer and manufacturer of advanced cell therapies, Orgenesis is building a unique and fundamental base platform of know-how and expertise for a multitude of cell types and for the regenerative medicine industry. Based in Germantown, Maryland, the company conducts much of its research in Belgium and has also recently opened an operation in Korea. 

Orgenesis shares held steady at $5.17 in Thursday’s morning trading session.

 

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Thu, 13 Dec 2018 10:45:00 -0500 https://www.proactiveinvestors.com/companies/news/211174/orgenesis-ceo-vered-caplan-says-it-s-a--very-exciting-time--for-cell-therapy-in-fox-interview-211174.html
<![CDATA[News - Orgenesis seals pact with Ben-Gurion University to develop dissolvable carriers for cell culturing ]]> https://www.proactiveinvestors.com/companies/news/211072/orgenesis-seals-pact-with-ben-gurion-university-to-develop-dissolvable-carriers-for-cell-culturing-211072.html Orgenesis Inc (NASDAQ:ORGS), a developer and manufacturer of advanced cell therapies, announced Wednesday that it has entered into a licensing and collaboration agreement with Israel-based Ben-Gurion University for the development of dissolvable carriers for cell culturing.

The technology was developed by Professor Smadar Cohen, founder and director of The Regenerative Medicine and Stem Cell (RMSC) Research Center at Ben-Gurion University.

Under the license agreement, the Germantown, Maryland, company has received exclusive, worldwide rights to make, develop and commercialize technologies utilizing the dissolvable carriers for cell culturing. The technology potentially allows Orgenesis to reduce the cost and complexity of manufacturing its cell therapy programs.

READ: Orgenesis teams up with New York Blood Center for US cell therapy development program

“We are honored to continue our strategic partnership with leading scientists at Ben-Gurion University who have developed this unique dissolvable carrier for cell culturing,” said Orgenesis CEO Vered Caplan. “These breakthrough carriers are the basis for our development of an automated adherent cell culturing system allowing seamless seeding, harvesting and passaging of cells in closed bioreactors. We are excited about the potential of this technology and its abilities to advance adherent cell culturing for cell therapies.”

Professor Smadar Cohen said the Regenerative Medicine and Stem Cell Research Center would work with “skilled” scientists at Orgenesis to accelerate research.

“The research and development of resolvable carriers for cells contains the potential to produce higher quality cells and the technology allows dissolving of carriers and automatic seeding of new ones,” said Cohen. “We believe that Orgenesis has developed a highly scalable and cost-effective platform for cell therapies, which could help accelerate the development of this technology,” said Cohen.

Shares in Orgenesis were up 3.9% to $ 5.35 in morning trading in the US.

 

Contact Uttara Choudhury at uttara@proactiveinvestors.com

Follow her on Twitter: @UttaraProactive 

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Wed, 12 Dec 2018 09:36:00 -0500 https://www.proactiveinvestors.com/companies/news/211072/orgenesis-seals-pact-with-ben-gurion-university-to-develop-dissolvable-carriers-for-cell-culturing-211072.html
<![CDATA[News - Orgenesis subsidiary Masthercell Global unveils new production wing at Belgian plant ]]> https://www.proactiveinvestors.com/companies/news/210320/orgenesis-subsidiary-masthercell-global-unveils-new-production-wing-at-belgian-plant-210320.html Masthercell Global, a subsidiary of Orgenesis Inc (NASDAQ:ORGS), the developer and manufacturer of advanced cell therapies, has unveiled a new production wing at its Belgium site.

The expansion of its current Belgium plant gives Masthercell, which is a cell therapy-focused contract development and manufacturing organization, five additional state-of-the-art clean rooms. The new wing also includes two development laboratories, a quality control laboratory and additional warehouse capabilities.

READ: Orgenesis CEO says companies looking for ways to get costs of medicine down

Maggie De Block, Belgium’s Public Health and Social Affairs minister, and Willy Borsus, the minister-president of Wallonia were in attendance for the launch of the new facility.

“The cell therapy industry, and specifically our partners, are eager to have access to reliable and additional state-of-the-art facilities for their commercial projects,” said Dr Denis Bedoret, managing director of Masthercell in a statement.

“Our objective is to help them access the market faster with tailor-made capabilities. Today, we are pleased to offer these key assets to our partners and more widely to any cell therapy company facing a lack of production or development capacities,” Bedoret added.

Masthercell is also backed by Great Point Partners LLC, a healthcare investment firm based in Greenwich, Connecticut.

Orgenesis is a biopharmaceutical company focused on cell-therapy development and support services.

Via its Masthercell Global subsidiary, Orgenesis works with cell therapy organizations to provide business modeling as well as help with manufacturing and technology selection in a bid to speed up the arrival of their therapies to the market.

Each clean room of the new production wing is 30 square meters and boasts independent HVAC systems while the new production wing is 600 square meters.

Orgenesis shares jumped 9.1% to finish Thursday at $6.23.

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Fri, 30 Nov 2018 09:22:00 -0500 https://www.proactiveinvestors.com/companies/news/210320/orgenesis-subsidiary-masthercell-global-unveils-new-production-wing-at-belgian-plant-210320.html
<![CDATA[News - Orgenesis teams up with New York Blood Center for tissue collection, biobanking US cell therapy development program ]]> https://www.proactiveinvestors.com/companies/news/209693/orgenesis-teams-up-with-new-york-blood-center-for-tissue-collection-biobanking-us-cell-therapy-development-program-209693.html Germantown, Maryland-based Orgenesis Inc (NASDAQ:ORGS), a developer and manufacturer of advanced cell therapies announced Wednesday that it had entered into a collaboration agreement with the New York Blood Center (NYBC), one of the largest community-based blood collection and distribution centers in the United States.

Under the terms of the agreement, NYBC will be responsible for establishing the infrastructure to collect, process, test, cryopreserve and bio-bank sampling materials, including liver biopsies. The samples are intended for use as the source of autologous insulin-producing (AIP) cells for patients that may be eligible for future clinical trials.

Through its Israeli subsidiary, Orgenesis Limited, Orgenesis is developing technology designed to successfully reprogram human liver cells into glucose-responsive, insulin-producing cells. Converting the diabetic patient's own tissue into insulin-producing cells through the groundbreaking technology has the potential to overcome the significant issues of donor shortage, cost and exposure to chronic immunosuppressive therapy associated with islet cell transplantation.

Through its Masthercell Global subsidiary, a global contract development and manufacturing organization (CDMO), Orgenesis also focuses on the development and manufacture of cell therapies for advanced medicinal products in the regenerative medicine industry. It helps cell therapy organizations speed up the arrival of their therapies onto the market.

READ: Orgenesis CEO says companies looking for ways to get costs of medicine down

“This agreement marks an important milestone toward initiating our US clinical activities. We have utilized human biopsy samples in a wide range of animal trials, and this agreement will now enable us to collect the biopsies from patients for potential clinical use once we receive the appropriate regulatory approvals,” said Professor Sarah Ferber, founder and Chief Scientific Officer at Orgenesis.

Orgenesis has invested significant time and effort in developing processes that include effective processing of liver biopsies and manufacturing of batch sizes that may be utilized for human clinical trials. It has leveraged the technologies developed by Ferber, a thought leader in the field of cell therapy.

She is the inventor of the company’s transdifferentiation (TD) platform technology, which direct reprograms adult cells into cells of alternate function. The technology has potential applications across multiple indications.

The first indication the company is pursuing is for the treatment of severe diabetes following Total Pancreatectomy, a surgical procedure performed to treat chronic pancreatitis when other treatment methods are unsuccessful. The company also plans to target insulin-dependent diabetes. Both these therapies involve the use of the TD technology that transforms the patient's own liver cells into functional and physiologically glucose-responsive insulin-producing cells, with the goal of providing long-term insulin independence. 

“We view the New York Blood Center as an ideal strategic partner for the expansion of our activity in the US. NYBC is well equipped to provide the necessary infrastructure to collect, process and biobank materials for both our diabetes program as well as for other development programs,” said Orgenesis CEO Vered Caplan.

“They have well established relationships with hundreds of hospitals in the US, which will be valuable during both the development and the commercial phases of our programs. Moreover, this infrastructure provided by NYBC and their expert development team complements our cell collection and processing activities for research purposes in Belgium, Israel and South Korea, where we have set up similar programs,” she added.

Beth Shaz, executive vice president at NYBC, said they looked forward to leveraging both their infrastructure and hospital relationships to help “accelerate the path to market.”

“We are delighted to partner with Orgenesis in advancing these disruptive cell therapies,” said Shaz.

Shares in Orgenesis climbed 1.5% to $5.58.

 

Contact Uttara Choudhury at uttara@proactiveinvestors.com

Follow her on Twitter: @UttaraProactive 

 

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Wed, 21 Nov 2018 10:11:00 -0500 https://www.proactiveinvestors.com/companies/news/209693/orgenesis-teams-up-with-new-york-blood-center-for-tissue-collection-biobanking-us-cell-therapy-development-program-209693.html
<![CDATA[Media files - Orgenesis teams up with HemoGenyx in second collaboration to push cancer cell replacement product to clinical trials ]]> https://www.proactiveinvestors.com/companies/stocktube/11105/orgenesis-teams-up-with-hemogenyx-in-second-collaboration-to-push-cancer-cell-replacement-product-to-clinical-trials-11105.html Mon, 05 Nov 2018 11:09:00 -0500 https://www.proactiveinvestors.com/companies/stocktube/11105/orgenesis-teams-up-with-hemogenyx-in-second-collaboration-to-push-cancer-cell-replacement-product-to-clinical-trials-11105.html <![CDATA[Media files - Orgenesis teams up with HemoGenyx to develop its AHC platform in ‘exciting’ deal ]]> https://www.proactiveinvestors.com/companies/stocktube/11104/orgenesis-teams-up-with-hemogenyx-to-develop-its-ahc-platform-in-exciting-deal-11104.html Mon, 05 Nov 2018 11:02:00 -0500 https://www.proactiveinvestors.com/companies/stocktube/11104/orgenesis-teams-up-with-hemogenyx-to-develop-its-ahc-platform-in-exciting-deal-11104.html <![CDATA[News - Orgenesis CEO says companies looking for ways to get costs of medicine down ]]> https://www.proactiveinvestors.com/companies/news/208450/orgenesis-ceo-says-companies-looking-for-ways-to-get-costs-of-medicine-down-208450.html The chief executive of Orgenesis Inc (NASDAQ:ORGS) said on Friday biotech companies are looking for ways to lower the cost of drugs.

"I think industry is dedicated to that. We certainly have a pivotal role I think in that space," Vered Caplan, the CEO of the company, said in an interview on Yahoo's Midday Movers..

She added: "If you look at the hospitals that are involved, the research institutes, they are all looking for a way from the science perspective how do we get the costs down."

US officials have criticized drug makers for the expensive drugs they make.

Shares of Orgenesis closed on Friday up 1.26% to $6.45.

READ: Orgenesis' cell therapy development business pushes into the US

Caplan said there is a technology issue where investments must be made in the development of cutting-edge drugs.

"Let us look at the drugs we make. These are the next-generation," she said.

She said women are "very well accepted" when asked about the fact that there are very few women in the top ranks of companies in the country.

Orgenesis is a manufacturer, service provider and developer of advanced cell therapies.

The company is based in Germantown, Maryland.

Reporting by Rene Pastor, contactable on rene.pastor@proactiveinvestors.com

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Fri, 02 Nov 2018 16:17:00 -0400 https://www.proactiveinvestors.com/companies/news/208450/orgenesis-ceo-says-companies-looking-for-ways-to-get-costs-of-medicine-down-208450.html
<![CDATA[Media files - Orgenesis' cell therapy development business pushes into the US ]]> https://www.proactiveinvestors.com/companies/stocktube/11058/orgenesis-cell-therapy-development-business-pushes-into-the-us-11058.html Wed, 31 Oct 2018 08:51:00 -0400 https://www.proactiveinvestors.com/companies/stocktube/11058/orgenesis-cell-therapy-development-business-pushes-into-the-us-11058.html <![CDATA[Media files - Orgenesis, Geneius to present at 'The Cellular Living Drug Revolution Summit' in New York ]]> https://www.proactiveinvestors.com/companies/stocktube/10974/orgenesis-geneius-to-present-at-the-cellular-living-drug-revolution-summit-in-new-york-10974.html Wed, 24 Oct 2018 16:42:00 -0400 https://www.proactiveinvestors.com/companies/stocktube/10974/orgenesis-geneius-to-present-at-the-cellular-living-drug-revolution-summit-in-new-york-10974.html <![CDATA[News - Orgenesis revenue nearly doubled in fiscal second quarter on CAR T-cell therapies ]]> https://www.proactiveinvestors.com/companies/news/200984/orgenesis-revenue-nearly-doubled-in-fiscal-second-quarter-on-car-t-cell-therapies-200984.html Orgenesis Inc (NASDAQ:ORGS), a manufacturer and developer of advanced cell therapies, today reported a widening in its net loss for its fiscal second quarter, but also saw its revenue nearly double in the period.

Revenue jumped 73% to US$4mln in the three months ended May 31, from the US$2.3mln in revenue it saw in the fiscal second quarter of last year.

Vered Caplan, chief executive of Orgenesis, attributed the sales growth to the expansion of its services, particularly in the area of CAR T-cell therapies.

CAR T-cell therapy is a type of treatment that involves a patient's T cells being changed in the lab so they will attack cancer cells.

“We attribute this growth to the continued addition of new customers and expansion of services among our existing customers, especially as it relates to manufacturing of CAR T-cell therapies,” she said in a statement.

Its net loss for the fiscal second quarter, meanwhile, swung lower to US$2.6mln, or $0.20 per diluted share, compared with US$2.5mln, or US$0.26 per diluted share, for the same period a year ago.

The biopharmaceutical company, which is based in Germantown, Maryland, finished the quarter with US$4.5mln worth of cash and roughly US$26mln in shareholders’ equity.

Making strides

As part of its quarterly announcements, Orgenesis announced it has formed a strategic partnership with Great Point Partners LLC, which will invest up to US$25mln in its MaSTherCell subsidiary, a contract development and manufacturing organization. “This partnership and investment will allow us to expand our services as well as enter the US market,” said Caplan in a statement.

The company also announced the acquisitions of two of its partners: Atvio Biotech Ltd in Israel and Curecell Co. Ltd in South Korea.

Orgenesis is developing its own proprietary cell therapies. Through its Israeli subsidiary, Orgenesis Ltd, Orgenesis is developing technology that is designed to successfully reprogram human liver cells into glucose-responsive and fully functional insulin-producing cells.

Orgenesis shares were trading 2% lower at US$8.05 in late afternoon trade.

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Tue, 17 Jul 2018 15:00:00 -0400 https://www.proactiveinvestors.com/companies/news/200984/orgenesis-revenue-nearly-doubled-in-fiscal-second-quarter-on-car-t-cell-therapies-200984.html
<![CDATA[News - Orgenesis to conduct clinical trials for Type 1 diabetes treatment in Russia ]]> https://www.proactiveinvestors.com/companies/news/119663/orgenesis-to-conduct-clinical-trials-for-type-1-diabetes-treatment-in-russia-119663.html Orgenesis (OTCMKTS:ORGS), a cell therapy and regenerative medicine company, signed a collaboration agreement with Russian company, Biosequel LLC on conducting clinical trials in Russia.

The collaboration will start with the opening of the new Yauza Medical Center on November 24, the Germantown, Maryland-based company said in a statement.

"Orgenesis is on the cutting edge of medical development in driving the industry towards a practical cure for Type 1 Diabetes and we are honored to work with them in Russia to facilitate the human clinical trials in this country," the company cites Dr. Vitaly Shabadash, Biosequel founder and practicing Israeli physician, as saying.

Orgenesis is a company that is committed to developing a cure for Type 1 Diabetes.

The company has developed and patented a novel technology called "cellular trans-differentiation" that turns an insulin-dependent patient's own liver cells into functional insulin producing cells.

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Tue, 24 Nov 2015 11:41:00 -0500 https://www.proactiveinvestors.com/companies/news/119663/orgenesis-to-conduct-clinical-trials-for-type-1-diabetes-treatment-in-russia-119663.html
<![CDATA[News - Orgenesis forms strategic collaboration with Lyfebulb ]]> https://www.proactiveinvestors.com/companies/news/119577/orgenesis-forms-strategic-collaboration-with-lyfebulb-119577.html Orgenesis (OTCMKTS:ORGS), a cell therapy and regenerative medicine company that is committed to developing a cure for Type 1 Diabetes, has entered into an advisory and consulting agreement with Lyfebulb.

Lyfebulb is a patient-centric organization whose mission is to improve the quality of life for people living with chronic disease.

Lyfebulb said in a statement on Monday that it will help Orgenesis identify and incorporate insights that are unique and important to Type 1 Diabetes patients into the design and conduct of the company's clinical development plans.

Lyfebulb will also advise the Germantown, Maryland-based company on its commercialization strategies to ensure optimal patient access and market acceptance if and when its products are approved for clinical use.

The Orgenesis 'cellular trans-differentiation' technology is at the forefront of realizing the promise a practical cure for Type 1 Diabetes, Lyfebulb said.

"Lyfebulb closely aligns with our goals of helping to ease, if not erase, the burden of chronic disease," Vered Caplan, CEO of Orgenesis, was quoted in the statement as saying.

"We hope to introduce new personalized and practical solutions for individuals struggling with chronic conditions such as Type 1 Diabetes."

Lyfebulb also plans to host a Lyfebulb Connect Event with Orgenesis, scheduled for December 8, 2015 in New York City.

Shares of Orgenesis closed flat at $0.335 on Friday, leaving the company with a market value of $33mln.

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Mon, 23 Nov 2015 08:16:00 -0500 https://www.proactiveinvestors.com/companies/news/119577/orgenesis-forms-strategic-collaboration-with-lyfebulb-119577.html