BOTHELL, Wash., Sept. 21, 2020 /PRNewswire/ -- BioLife Solutions. (NASDAQ: BLFS)("BioLife" or the "Company"), a leading developer and supplier of a portfolio of class-defining bioproduction tools for cell and gene therapies, today announced it has entered into a definitive agreement to acquire SciSafe, a privately held multi-facility provider of biological materials storage to the cell and gene therapy and pharmaceutical industries. The transaction is expected to close on September 30th.

SciSafe had 2019 unaudited revenue of $6 million and positive EBITDA and is anticipated to be accretive during 2021.

Under the terms of the agreement, BioLife will pay $15 million in cash and $15 million in newly issued shares of BioLife common stock for 100% of the outstanding shares of SciSafe. SciSafe's shareholders are also eligible over the next four years to receive up to 626,000 additional shares of BioLife common stock based on the achievement of annual revenue milestones.

Mike Rice, Chief Executive Officer of BioLife Solutions, commented, "This acquisition enables BioLife to offer even more value to our cell and gene therapy customers through an established business with an excellent reputation, marquee customers and seasoned team. Through SciSafe, we are accelerating profitable growth by expanding into the high growth biostorage segment with a robust quality system, a scalable business model and strong financial performance. We anticipate several vertical integration cost synergies including using SciSafe facilities for cGMP storage of our biopreservation media products, leveraging our CBS facility to manufacture walk-in freezer rooms for SciSafe and deploying our evo Smart Shippers and evoIS cloud app for the thousands of annual inbound and outbound biologic materials shipments managed by SciSafe."

Garrie Richardson, President of SciSafe, remarked, "I'm thrilled to be joining forces with BioLife. With BioLife's stellar reputation in the cell and gene therapy market, key customer relationships, financial resources and commitment to fund our growth, the SciSafe team is poised to deliver significant high-margin incremental revenue to BioLife's growing enterprise."

Benefits of the Transaction

Entry into the fast-growing biostorage segment

Cross-selling opportunities

Potential vertical integration cost synergies

Financial Impact of SciSafe Acquisition

BioLife expects the acquisition of SciSafe to impact the Company's financial performance as follows:

About SciSafeFounded in 2010, SciSafe offers dedicated pharmaceutical and biological specimen storage in its four fully cGMP-compliant state-of-the-art sample management facilities. SciSafe has built flourishing relationships with over 300 of the world's leading and most admired organizations. Clients have repeatedly chosen to store their most valued and irreplaceable biological samples because they trust SciSafe to care for them as if they were their own. SciSafe values and respects its long-term client relationships. With over 60 years combined experience specifically in life sciences, SciSafe personnel fully appreciate the vital requirements of all areas of specimen storage and cold chain management. For more information, please visit http://www.scisafe.com.

About BioLife SolutionsBioLife Solutions is a leading supplier of a portfolio of class-defining cell and gene therapy bioproduction tools and services. Our tools portfolio includes our proprietaryCryoStorfreeze media and HypoThermosolshipping and storage media, ThawSTARfamily of automated, water-free thawing products, evocold chain management system, and Custom Biogenic Systemshigh capacity storage freezers. Services include SciSafe biologic and pharmaceutical materials storage. For more information, please visit http://www.biolifesolutions.com, and follow BioLife on Twitter.

Cautions Regarding Forward Looking Statements Except for historical information contained herein, this press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements concerning the expected financial performance of the company following the completion of its acquisition of SciSafe, the expected synergies between the company and SciSafe, the company's ability to realize all or any of the anticipated benefits associated with the acquisition of SciSafe, the company's ability to implement its business strategy and anticipated business and operations, including following the acquisition of SciSafe, the potential utility of and market for the company's and SciSafe's products and services, guidance for financial results for 2020 and 2021, including regarding SciSafe's revenue, and potential revenue growth and market expansion, including with consideration to our acquisition of SciSafe. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including among other things, uncertainty regarding unexpected costs, charges or expenses resulting from the company's acquisition of SciSafe or the 2019 acquisitions, charges or expenses resulting from the acquisition of SciSafe; market adoption of the company's products (including the company's recently acquired products) or SciSafe's products; the ability of the SciSafe acquisition to be accretive on the company's financial results; the ability of the company to implement its business strategy; uncertainty regarding third-party market projections; market volatility; competition; litigation; the impact of the COVID-19 pandemic; and those other factors described in our risk factors set forth in our filings with the Securities and Exchange Commission from time to time, including our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. We undertake no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable law.

Media & Investor RelationsRoderick de GreefChief Financial Officer(425) 686-6002rdegreef@biolifesolutions.com

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BioLife Solutions to Acquire SciSafe, a High-Growth Biostorage Service Provider to the Cell and Gene Therapy Industry - BioSpace

Xtalks Life Science Webinars

TORONTO (PRWEB) September 21, 2020

The International Organization for Standardization (ISO) has recently issued its eagerly awaited guidance on the transportation of cells for therapeutic use (ISO 21973). The ISO document is meant to provide general requirements and points to consider for transportation service providers, clients and senders to ensure cell quality, safety and efficacy during the transportation process. This webinar will discuss the key recommendations and changes that interested parties should review and evaluate when planning their clinical and commercial distribution strategies for cell and gene therapies. Some of the elements to be discussed are documentation, traceability, validation and qualification activities, temporary storage, as well as cleaning and disinfection.

Join Robert Jones, Vice President, BioServices, Cryoport Systems in a live webinar on Thursday, October 1, 2020 at 11am EDT (4pm BST/UK).

For more information or to register for this event, visit Addressing the Recent ISO 21973 Guidance: Considerations for Cell and Gene Therapy Distribution.

ABOUT CRYOPORT, INC.

Cryoport, Inc. is redefining temperature controlled supply chain support for the life sciences industry by providing a broad platform of temperature-controlled supply chain solutions, serving the Biopharma, Reproductive Medicine, and Animal Health markets. Our mission is to support life and health on earth by providing reliable and comprehensive solutions for the life sciences industry through our advanced technologies, global supply chain network and dedicated scientists, technicians and supporting team of professionals. Through our purpose-built, proprietary Cryoport Express Shippers; Cryoportal information technology; validated Global Logistics Centers; smart and sustainable temperature-controlled logistics solutions; and biostorage/biobanking services, Cryoport serves clients in life sciences research, clinical trials, and product commercializations. We support life-saving advanced cell and gene therapies and deliver vaccines, protein producing materials, and IVF materials in over 100 countries around the world. For more information, visit http://www.cryoport.com or follow @cryoport on Twitter at http://www.twitter.com/cryoport for live updates.

ABOUT XTALKS

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year thousands of industry practitioners (from life science, food and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

To learn more about Xtalks visit http://xtalks.comFor information about hosting a webinar visit http://xtalks.com/why-host-a-webinar/

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Addressing the Recent ISO 21973 Guidance: Considerations for Cell and Gene Therapy Distribution, Upcoming Webinar Hosted by Xtalks - PR Web

The first part of the CPhI Annual Report 2020, released ahead of the CPhI Festival of Pharma (taking place online October 5-16) predicts dramatic growth of new mAb production in China. It also forecasts capacity shortages for cell and gene therapies in the US, as well as widespread global adoption of single-use technologies, with only limited continuous bioprocessing.

In the document, CPhI experts from BioPlan Associates (Vicky Qing XIA, senior project manager; Leo Cai Yang, project manager; and Eric Langer, president and managing partner) delve into the rapidly evolving biologics markets. The report highlights implications for contract outsourcing and Chinas continually increasing presence emergence as a hub for both bio innovation and contract services.

The report predicts rapid bio growth in China to continue, forecasting that more than 10 new mAbs likely will be launched each year by 2025. Overall, the authors estimate the total market size will quadruple by 2025, reaching nearly $18b (120b RMB) by that point and rising to more than $28b (190b RMB) by 2030.

As most early-stage biotech in China lack manufacturing facilities, the need for contract manufacturing services is rising quickly, and has been accelerated further by the 2016 MAH reforms, XIA commented.

According to the report, bioprocessing outsourcing in China is currently highly stratified with four tiers and just one domestic company in tier one (WuXi Biologics), with a number of international CDMOs (including BI, Lonza and Merck).

However, by 2025 the report anticipates as many as five more domestic CDMOs may have reached tier one status, with US Food and Drug Administration (FDA) and EU facility approvals. Significantly, pending regulatory changes for contract vaccine production will likely spur further rapid growth amongst the existing tier one CDMOs.

WuXi Biologics in 2019 realized 35.3% of its total revenue of USD 0.57 billion from China, which is ~USD 0.2 billion and would translate to ~35% of the total biopharma outsourcing service market in China1. However, despite sizable growth in revenue, its overall share of the market will now fall, as the mAb market expands rapidly, added XIA.

Langer explained, Because preclinical and clinical pipeline products require flexible manufacturing, SUS lends itself to these scales, but many of these will fail as they progress through the pipeline. This means that while more commercial-scale biologics are going to be made in SUS platforms, or hybrid systems, over the next 2+ years, stainless platforms are, and will remain, critical to bioprocessing as well.

The report also suggested that in the US and European markets will likely ocme under a cell and gene therapy capacity crunch by 2025, seeing CDMOs investing in this area already expanding in an attempt to meet the pipelines impending demand.

However, capacity alone is not the biggest challenge as there is a shortage of both specialized platforms, and trained personnel to operate them. Significantly, for some facilities in these emerging areas the equipment required for expansion and up-scaling may not yet exist, nor are regulatory authorities fully aligned with issues around patient treatments which could slow approvals.

Tara Dougal, head of content at CPhI Festival of Pharma, explained, The cell and gene therapy space is hugely fast-moving and we will run a session on the potential for M&As as both manufacturers and CDMOs try to buy-in expertise rather than build. More generally, our report also points to sustained bio growth in China, almost universal adoption of single use technologies, with continuous processing growing but from a far lower base."

Dougal added that CPhI has engaged Jefferson Institute for Bioprocessing to expand on the topic, exploring current strategies and looking ahead at future approaches.

Langer is scheduled to participate in a panel discussion on M&A activity in the cell and gene sector, taking place at CPhI Festival of Pharma October 6, 2 to 3 pm CET.

The CPhI Festival of Pharma takes place digitally October 5 to 16. For more information about the program or to register, go to https://www.cphi.com/festival-of-pharma/en/home.html.

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CPhI: cell and gene therapy capacity shortages on the horizon - OutSourcing-Pharma.com

HEIDELBERG, Germany, Sept. 21, 2020 /PRNewswire/ -- GeneWerk GmbH, a cell and gene therapy testing laboratory focused on providing preclinical and clinical trial patient sample analysis services, today announced a majority investment from Ampersand Capital Partners, a private equity firm specializing in growth equity investments in the healthcare sector. Ampersand's growth investment will be used to expand GeneWerk's capabilities to meet rapidly growing demand for cell and gene therapy testing services.

GeneWerk provides cell and gene therapy sponsors with patient testing services in compliance with guidance by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The company is recognized as a leading provider of vector integration site analysis (ISA) services, a method that was developed by GeneWerk's founders and that the FDA and EMA recommend performing after the administration of both integrating and non-integrating cell and gene therapies. The company's test menu also includes vector persistence testing, gene edited off-target analysis, vector copy number (VCN), vector quality control, immune repertoire analysis, and dedicated bioinformatics studies. With a focus on vector safety, characterization, and functionality analysis, the company's 30 employees work in compliance with GCP and in line with GLP standards in a BSL-2 classified state-of-the-art genomics and bioinformatics laboratory in Heidelberg, Germany.

Annette Deichmann, Ph.D., Co-Founder and Co-CEO at GeneWerk commented, "With the benefit of Ampersand as our partner, GeneWerk will strengthen and expand its position in the U.S. and European markets while further investing in our testing capabilities to service cell and gene therapy sponsors and patients." Co-Founder and Co-CEO Manfred Schmidt, Ph.D., then added, "Our partnership with Ampersand solidifies GeneWerk's position in the space and will allow the company to continue to exceed our customers' expectations by facilitating the development of innovative cell and gene therapies. We are very pleased to have Ampersand on board as we take GeneWerk through its next phase of growth." Christof von Kalle, M.D., Co-Founder concluded, "This will greatly further GeneWerk's opportunities to contribute to medical breakthroughs and patient safety."

Marina Pellon-Consunji, Principal at Ampersand said, "GeneWerk is a leading company in its field. Given the exciting developments within the cell and gene therapy market and recent guidance by FDA and EMA, this is an excellent time for an investor with deep experience in cell and gene therapy to partner with the company. We are looking forward to working with the team at GeneWerk to accelerate and continue its success in delivering leading testing services to ensure the safety of patients receiving cutting edge cell and gene therapies."

About GeneWerk GmbHFounded in 2014 by Prof. Dr. Christof von Kalle, Dr. Manfred Schmidt, and Dr. Annette Deichmann with the participation of the German Cancer Research Center (DKFZ) Heidelberg, GeneWerk is a cell and gene therapy testing laboratory focused on providing preclinical and clinical trial patient sample analysis services. The company is recognized as a leading provider of vector integration site analysis (ISA) services, a method that was developed by the company's founders and that the FDA and EMA recommend performing after the administration of both integrating and non-integrating cell and gene therapies. For more information, please visit http://www.genewerk.com.

About Ampersand Capital PartnersFounded in 1988, Ampersand is a middle market private equity firm dedicated to growth-oriented investments in the healthcare sector. With offices in Boston and Amsterdam, Ampersand leverages its unique blend of private equity and operating experience to build value and drive superior long-term performance alongside its portfolio company management teams. Ampersand has helped build numerous market-leading companies across each of the firm's core healthcare sectors. Additional information about Ampersand is available at http://www.ampersandcapital.com.

SOURCE Ampersand Capital Partners

http://www.ampersandventures.com

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GeneWerk GmbH Announces Growth Equity Investment from Ampersand Capital Partners - PRNewswire

This article was originally published here

Curr Gene Ther. 2020;20(2):127-141. doi: 10.2174/1566523220999200731003206.

ABSTRACT

Suppression of TP53 function is nearly ubiquitous in human cancers, and a significant fraction of cancers have mutations in the TP53 gene itself. Therefore, the wild-type TP53 gene has become an important target gene for transformation research of cancer gene therapy. In 2003, the first anti-tumor gene therapy drug rAd-p53 (recombinant human p53 adenovirus), trade name Gendicine, was approved by the China Food and Drug Administration (CFDA) for treatment of head and neck squamous cell carcinoma (HNSCC) in combination with radiotherapy. The recombinant human TP53 gene is delivered into cancer cells by an adenovirus vector constructed to express the functional p53 protein. Although the only currently approved used of Gendicine is in combination with radiotherapy for treatment of HNSCC, clinical studies have been carried out for more than 20 other applications of Gendicine in treating cancer, including treatment of advanced lung cancer, advanced liver cancer, malignant gynecological tumors, and soft tissue sarcomas. Currently more than 30,000 patients have been treated with Gendicine. This review provides an overview of the clinical applications of Gendicine in China. We summarize a total of 48 studies with 2,561 patients with solid tumors, including 34 controlled clinical studies and 14 open clinical studies, i.e., clinical studies without a control group. There are 11 studies for head and neck cancer, 10 for liver cancer, 6 for malignant gynecological tumors, 4 for non-small cell lung cancer, 4 for soft tissue sarcoma, 4 for malignant effusion, 2 for gastrointestinal tumors, and 7 for other types of cancer. In all the reported clinical studies, the most common side effect was self-limited fever. Intratumoral injection and intra-arterial infusion were the most common routes of administration. Overall, Gendicine combined with chemotherapy, radiotherapy, or other conventional treatment regimens demonstrated significantly higher response rates compared to standard therapies alone. Some of the published studies also showed that Gendicine combination regimens demonstrated longer progression-free survival times than conventional treatments alone. To date, Gendicine has been clinically used in China for treatment of cancers other than HNSCC for more than ten years, mainly for patients with advanced or unresectable malignant tumors. However, the establishment of standard treatment regimens using TP53 gene therapy is still needed in order to advance its use in clinical practice.

PMID:32951572 | DOI:10.2174/1566523220999200731003206

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Applications of Recombinant Adenovirus-p53 Gene Therapy for Cancers in the Clinic in China - DocWire News

Management to Highlight Progress in Bone Marrow Transplant (BMT) and Chimeric Antigen Receptor T Cell (CAR T) Business Collaborations

Tel Aviv, Israel, Sept. 21, 2020 (GLOBE NEWSWIRE) -- Cellect Biotechnology Ltd. (NASDAQ: APOP), a developer of innovative technology which enables the functional selection of cells facilitating safer and more efficacious cell and gene therapies, today announced that the leadership will be presenting at the Cell & Gene Meeting on the Mesa, which is being held from October 12th 16th. In addition to providing an overview of the Company, the management team will provide a progress update on the clinical and development programs and an overview of the Companys business strategy. Management will be virtually meeting cell and gene therapy companies to support collaborations.

This is one of the most prestigious meetings for our industry, and despite it being virtual this year due to the COVID-19 pandemic, it will not dampen our enthusiasm commented Dr. Yarkoni. We have successfully adjusted our operations, and we continue to make significant progress with our Israel and U.S.-based clinical trials. We are also taking meaningful steps to accelerate nearer-term revenue opportunities as we are collaborating with several partners that are looking to leverage our technology platform to help improve their products, especially in high-growth areas such as CAR T, NK (natural killers) and MSCs. We are looking forward to sharing the progress we have made and also look forward to meeting with current and potential partners developing cell and gene therapies.

To schedule a meeting with the Companys Chief Executive Officer, Dr. Shai Yarkoni or Chief Operating Officer, Amos Ofer, please request a meeting through the meeting portal and/or contact the Company direct at shai@cellect.co or amoso@cellect.co. The presentation will be available on the Companys website prior to the commencement of the meeting. The Cell & Gene Meeting on the Mesa is the sectors foremost annual conference bringing together senior executives and top decision-makers in the industry to advance cutting-edge research into cures.

About Cellect Biotechnology Ltd.

Cellect Biotechnology (APOP) has developed a breakthrough technology, for the functional selection of cells that aims to improve the robustness, safety and efficacy of a variety of cell and gene therapies. The Companys technology can be used by researchers, clinical community and pharma companies in a wide variety of applications including next generation Car T, NK, MSC and gene therapies.

The Company is also developing its own product that is an improved BMT which is in a current clinical trial for cancer treatment.

Forward Looking Statements

This press release contains forward-looking statements about the Companys expectations, beliefs and intentions. Forward-looking statements can be identified by the use of forward-looking words such as believe, expect, intend, plan, may, should, could, might, seek, target, will, project, forecast, continue or anticipate or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. For example, forward-looking statements are used in this press release when we discuss Cellects expectations regarding timing of the commencement of its planned U.S. clinical trial and its plan to reduce operating costs. These forward-looking statements and their implications are based on the current expectations of the management of the Company only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In addition, historical results or conclusions from scientific research and clinical studies do not guarantee that future results would suggest similar conclusions or that historical results referred to herein would be interpreted similarly in light of additional research or otherwise. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: the Companys history of losses and needs for additional capital to fund its operations and its inability to obtain additional capital on acceptable terms, or at all; the Companys ability to continue as a going concern; uncertainties of cash flows and inability to meet working capital needs; the Companys ability to obtain regulatory approvals; the Companys ability to obtain favorable pre-clinical and clinical trial results; the Companys technology may not be validated and its methods may not be accepted by the scientific community; difficulties enrolling patients in the Companys clinical trials; the ability to timely source adequate supply of FasL; risks resulting from unforeseen side effects; the Companys ability to establish and maintain strategic partnerships and other corporate collaborations; the scope of protection the Company is able to establish and maintain for intellectual property rights and its ability to operate its business without infringing the intellectual property rights of others; competitive companies, technologies and the Companys industry; unforeseen scientific difficulties may develop with the Companys technology; the Companys ability to retain or attract key employees whose knowledge is essential to the development of its products; and the Companys ability to pursue any strategic transaction or that any transaction, if pursued, will be completed. Any forward-looking statement in this press release speaks only as of the date of this press release. The Company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. More detailed information about the risks and uncertainties affecting the Company is contained under the heading Risk Factors in Cellect Biotechnology Ltd.s Annual Report on Form 20-F for the fiscal year ended December 31, 2019 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SECs website, http://www.sec.gov, and in the Companys periodic filings with the SEC.

ContactCellect Biotechnology Ltd.Eyal Leibovitz, Chief Financial Officerwww.cellect.co+972-9-974-1444

Or

EVC Group LLCMichael Polyviou(732) 933-2754mpolyviou@evcgroup.com

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Cellect Biotechnology to Present at the 2020 Cell & Gene Meeting on the Mesa - GlobeNewswire

Cell and Gene Therapy Market Research Report is a Proficient and In-Depth Study on the Existing State of Cell and Gene Therapy Industry. This Report Focuses on the Major Drivers, Restraints, Opportunities and Threats for Key Players. It also Provides Granular Analysis of Market Share, Segmentation, Revenue Forecasts and Regional Analysis till 2025.

The recent study on Cell and Gene Therapy market offers an all-inclusive analysis of this vertical, with emphasis on the growth driving factors as well as facets such as consumption and production. Constraints and potential threats expected to restrain the expansion along with solutions to overcome the challenges are discussed at length. Moreover, insights of the market share along with estimates reflecting the CAGRs of the listed segments are highlighted in the document.

In hindsight of the COVID-19 pandemic, the report investigates the prevalent business strategies employed by leading organizations and offers tactics for stakeholders to adapt to the industry changes over the forecast period.

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Cell and Gene Therapy Market Report 2020 Industry Capacity, Manufactur - News by aeresearch

T-knife GmbH, a next-gen adoptive T-cell company, and Catalent, have signed an agreement to provide technology transfer and CGMP clinical manufacturing of T-knifes T1367 T-cell receptor (TCR) program.

T1367 is an autologous T-cell receptor-based cell therapy derived from T-knifes proprietary humanized T-cell receptor (HuTCR) mouse platform and specifically targets MAGE-A1 positive tumors in cancer patients. The therapy is expected to be manufactured for clinical trials in both the EU and U.S.

Catalent will undertake transfer of T-knifes platform process for T-cell receptor-based cell therapy at its site in Gosselies, Belgium, with the goal of manufacturing clinical batches for European trials in 2021. T-knife will also prepare for the transfer of the TCR manufacturing platform to Catalents Houston, TX, facility for clinical trials in North America in the future.

The product candidates based on our proprietary HuTCR platform require sophisticated, state-of-the-art manufacturing capabilities and deep cell and gene therapy know-how, said Michael Buchholz, Director Manufacturing of T-knife. We are convinced that Catalent is the right partner for T-knife to ensure premier manufacturing of our pipeline programs, covering all stages from clinical trials to market.

Catalent is well-suited to support T-knife with focused technology transfer and process industrialization in both Gosselies and Houston, commented Manja Boerman, Ph.D., President, Cell & Gene Therapy, Catalent. Emerging and innovative treatments like T1367 are moving rapidly to the clinic. Catalent is committed to continual investment and expansion to support our clients as they continue on the journey to commercialization.

Catalents 25,830 sq.-ft. facility in Gosselies, Belgium, provides clinical through commercial-scale cell therapy manufacturing, for both autologous and allogeneic cell therapy treatments. An additional large-scale commercial manufacturing plant is currently under construction at the site and expected to be fully commissioned in 2021. The companys clinical manufacturing site in Houston is under qualification and expected to be fully commissioned in 2020.

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T-knife, Catalent Sign Tech Transfer And Mfg. Pact For Cell Therapy - Contract Pharma

DUARTE, Calif.--(BUSINESS WIRE)--City of Hope, a world-renowned independent research and treatment center for cancer, diabetes and other life-threatening diseases, today announced that it has licensed intellectual property relating to its pioneering chlorotoxin chimeric antigen receptor (CLTX-CAR) T cell therapy to Chimeric Therapeutics Limited, an Australian biotechnology company.

The therapy is currently being used in a phase 1 clinical trial at City of Hope to treat glioblastoma (GBM), a type of brain tumor. The first patient in the trial was recently dosed; Behnam Badie, M.D., chief of City of Hopes Division of Neurosurgery and The Heritage Provider Network Professor in Gene Therapy, is leading this innovative, first-of-its-kind trial.

Chimeric has acquired the exclusive worldwide rights to develop and commercialize certain patents relating to City of Hopes CLTX-CAR T cells, as well as to further develop the therapy for other cancers.

City of Hope is excited to enter into this agreement with Chimeric as it supports our innovative research in CAR T cell therapy and our commitment to extend these therapies to more patients, particularly those with GBM and other solid tumors that are difficult to treat, said Christine Brown, Ph.D., The Heritage Provider Network Professor in Immunotherapy and deputy director of City of Hopes T Cell Therapeutics Research Laboratory. Chimeric shares our goal of providing effective CAR T cell therapies to more patients with current unmet medical needs.

Led by Brown and Michael Barish, Ph.D., chair of City of Hopes Department of Developmental and Stem Cell Biology, and Dongrui Wang, Ph.D., a recent graduate of City of Hopes Irell & Manella Graduate School of Biological Sciences, the team developed and tested the first CAR T cell therapy using CLTX, a component of scorpion venom, to direct T cells to target brain tumor cells. The research was published this past March in Science Translational Medicine.

Chimeric is excited to join City of Hope in its quest to find more effective cancer therapies. This is an exceedingly rare opportunity to acquire a promising technology in one of the most exciting areas of immuno-oncology today, said Paul Hopper, executive chairman of Chimeric. Furthermore, the CLTX-CAR T cell therapy has completed years of preclinical research and development, and recently enrolled its first patient in a phase 1 clinical trial for brain cancer.

CARs commonly incorporate a monoclonal antibody sequence in their targeting domain, enabling CAR T cells to recognize antigens and kill tumor cells. In contrast, the CLTX-CAR uses a synthetic 36-amino acid peptide sequence first isolated from death stalker scorpion venom and now engineered to serve as the CAR recognition domain.

In this recent study, City of Hope researchers used tumor cells in resection samples from a cohort of patients with GBM to compare CLTX binding with expression of antigens currently under investigation as CAR T cell targets. They found that CLTX bound to a greater proportion of patient tumors, and cells within these tumors.

CLTX binding included the GBM stem-like cells thought to seed tumor recurrence. Consistent with these observations, CLTX-CAR T cells recognized and killed broad populations of GBM cells while ignoring nontumor cells in the brain and other organs. The study team demonstrated that CLTX-directed CAR T cells are highly effective at selectively killing human GBM cells without off-tumor targeting and toxicity in cell-based assays and in animal models.

City of Hope, a recognized leader in CAR T cell therapies for GBM and other cancers, has treated more than 500 patients since its CAR T program started in the late 1990s. The institution continues to have one of the most comprehensive CAR T cell clinical research programs in the world it currently has 30 ongoing CAR T cell clinical trials, including CAR T cell trials for HER-2 positive breast cancer that has spread to the brain, and PSCA-positive bone metastatic prostate cancer. It was the first and only cancer center to treat GBM patients with CAR T cells targeting IL13R2, and the first to administer CAR T cell therapy locally in the brain, either by direct injection at the tumor site, through intraventricular infusion into the cerebrospinal fluid, or both. In late 2019, City of Hope opened a first-in-human clinical trial for patients with recurrent GBM, combining IL13R2-CAR T cells with checkpoint inhibitors nivolumab, an anti-PD1 antibody, and ipilimumab, blocking the CTLA-4 protein.

Both an academic medical center and a drug development powerhouse, City of Hope is known for creating the technology used in the development of human synthetic insulin and numerous breakthrough cancer drugs. Its unique research and development hybrid of the academic and commercial creates an infrastructure that enables City of Hope researchers to submit an average of 50 investigational new drug applications to the U.S. Food and Drug Administration each year. The institution currently holds more than 450 patent families.

"City of Hope is delighted to license this technology to Chimeric, said Sangeeta Bardhan Cook, Ph.D., City of Hope director of the Office of Technology Licensing. We are impressed with the ability of their executive team to push and bring therapies to market expeditiously. At City of Hope, our mission is to transform the future of health care. We believe Chimeric has the vision to offer innovative therapies to cancer patients.

About City of Hope

City of Hope is an independent biomedical research and treatment center for cancer, diabetes and other life-threatening diseases. Founded in 1913, City of Hope is a leader in bone marrow transplantation and immunotherapy such as CAR T cell therapy. City of Hopes translational research and personalized treatment protocols advance care throughout the world. Human synthetic insulin and numerous breakthrough cancer drugs are based on technology developed at the institution. A National Cancer Institute-designated comprehensive cancer center and a founding member of the National Comprehensive Cancer Network, City of Hope has been ranked among the nations Best Hospitals in cancer by U.S. News & World Report for 14 consecutive years. Its main campus is located near Los Angeles, with additional locations throughout Southern California. For more information about City of Hope, follow us on Facebook, Twitter, YouTube or Instagram.

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AUSTIN, Texas--(BUSINESS WIRE)--Genprex, Inc. (Genprex or the Company) (NASDAQ: GNPX), a clinical-stage gene therapy company developing potentially life-changing technologies for patients with cancer and diabetes, today announced it has named Thomas C. Gallagher, Esq. as the Companys Senior Vice President of Intellectual Property and Licensing. Mr. Gallagher has extensive experience in the area of biotechnology intellectual property (IP) law, business development, and licensing transactions with industry and academic institutions.

Mr. Gallagher will play a critical role in advancing our expanding intellectual property estate by spearheading IP strategy, which is an important element of the Companys overall success and value creation. A seasoned biotech executive, he will provide significant support as we execute on broadening our research and development programs, explore opportunities for partnerships on our existing programs, and opportunistically acquire new technologies to further expand our pipeline, said Rodney Varner, President and Chief Executive Officer of Genprex.

Mr. Gallagher has more than 20 years of experience as an intellectual property attorney. Prior to joining Genprex, he served as Principal at the Fenagh Group, an IP and licensing consultancy providing clients in the healthcare sector guidance on all aspects of patent and trademark portfolio management, intellectual property due diligence, freedom-to-operate analysis and related transactional work. He has also served as Senior Vice President of Intellectual Property and Licensing at Kadmon Corporation, LLC, a biopharmaceutical company based in Manhattan. Prior to joining Kadmon, he served as in-house IP counsel at Neostem Inc. (now Caladrius Biosciences, Inc.), a company focused on stem cell biology. Previously, he held several positions at ImClone Systems Incorporated, most recently as Vice President of Intellectual Property and Licensing. While at ImClone, he was responsible for all aspects of intellectual property and led the IP function in multiple due diligence undertakings by major pharmaceutical companies, which resulted in a $2 billion strategic investment, the highest-valued biotech deal ever at the time, and the eventual sale of the company to Eli Lilly and Company for $6.5 billion.

Mr. Gallagher is experienced in both patent prosecution and litigation, as well as intellectual property issues relating to business development and licensing matters. His patent litigation experience includes European litigation and opposition proceedings. In addition to a law degree, Mr. Gallagher holds a Masters degree in molecular biology. Before becoming an attorney, Mr. Gallagher worked as a molecular biologist in France, Spain and the United States.

About Genprex, Inc.

Genprex, Inc. is a clinical-stage gene therapy company developing potentially life-changing technologies for patients with cancer and diabetes. Genprexs technologies are designed to administer disease-fighting genes to provide new treatment options for large patient populations with cancer and diabetes who currently have limited treatment options. Genprex works with world-class institutions and collaborators to develop drug candidates to further its pipeline of gene therapies in order to provide novel treatment approaches. The Companys lead product candidate, GPX-001 (quaratusugene ozeplasmid), is being evaluated as a treatment for non-small cell lung cancer (NSCLC). GPX-001 has a multimodal mechanism of action that has been shown to interrupt cell signaling pathways that cause replication and proliferation of cancer cells; re-establish pathways for apoptosis, or programmed cell death, in cancer cells; and modulate the immune response against cancer cells. GPX-001 has also been shown to block mechanisms that create drug resistance. In January 2020, the U.S. Food and Drug Administration granted Fast Track Designation for GPX-001 for NSCLC in combination therapy with osimertinib (AstraZenecas Tagrisso) for patients with EFGR mutations whose tumors progressed after treatment with osimertinib alone. For more information, please visit the Companys web site at http://www.genprex.com or follow Genprex on Twitter, Facebook and LinkedIn.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the effect of Genprexs product candidates, alone and in combination with other therapies, on cancer and diabetes, regarding potential, current and planned clinical trials, regarding the Companys future growth and financial status and regarding our commercial partnerships and intellectual property licenses. Risks that contribute to the uncertain nature of the forward-looking statements include the presence and level of the effect of our product candidates, alone and in combination with other therapies, on cancer; the timing and success of our clinical trials and planned clinical trials of GPX-001, alone and in combination with targeted therapies and/or immunotherapies, and whether our other potential product candidates, including GPX-002, our gene therapy in diabetes, advance into clinical trials; the success of our strategic partnerships, including those relating to manufacturing of our product candidates; the timing and success at all of obtaining FDA approval of GPX-001 and our other potential product candidates including whether we receive fast track or similar regulatory designations; costs associated with developing our product candidates, whether we identify and succeed in acquiring other technologies and whether patents will ever be issued under patent applications that are the subject of our license agreements or otherwise. These and other risks and uncertainties are described more fully under the caption Risk Factors and elsewhere in our filings and reports with the United States Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. We undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

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Genprex Names Seasoned IP Executive, Thomas C. Gallagher, as Senior Vice President of Intellectual Property and Licensing - Business Wire