On July 28, 2021 Almac Clinical Technologies, a member of the contract and development organization, Almac Group, and THREAD, a technology and service provider enabling decentralized clinical trials (DCTs), and reported a strategic partnership (Press release, Almac, JUL 28, 2021, View Source [SID1234585447]). The market leaders will integrate their technologies to enable more efficient clinical trials that generate better outcomes.

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By integrating their proprietary technology platforms, Almac and THREAD will provide sponsors and contract research organizations (CROs) with a full range of tools to reduce the risk of trial delays. Almac’s IXRS solution and industry-leading services for randomization and clinical trial supply management will be available to THREAD customers and THREAD’s DCT solution will be available to Almac customers. The two companies will leverage single sign-on and application program interfaces (APIs) to integrate their technologies and automate DCT workflows across their respective platforms to:

• minimize duplicate data entry, particularly for research sites
• provide sponsors with integrated reports on trial progress
• preserve automation to ensure operational efficiency

Organizations interested in learning more can request more information here.

"We’re thrilled to be working with THREAD, an acknowledged leader in DCT technology," said George Tiger, vice president of Global Business Development, Almac Clinical Technologies. "As part of our growing Partnership and Alliance program, this specific partnership will enable us to offer an additional level of support to Almac clients as they seek to decentralize their clinical trials."

"A common pain point for research sites is the abundance of technologies they have to independently maintain for each clinical trial," said John Reites, chief executive officer of THREAD. "By integrating Almac within our comprehensive platform, sites and study teams will have a single DCT study experience. Almac is a longstanding global leader in clinical research, and we’re excited about this synergistic partnership."

On July 28, 2021 National Resilience, Inc. (Resilience) and bluebird bio, Inc. (NASDAQ: BLUE), reported a strategic alliance aimed to accelerate the early research, development and delivery of cell therapies (Press release, bluebird bio, JUL 28, 2021, View Source [SID1234585446]). As part of the agreement, Resilience will acquire bluebird’s Research Triangle (bRT) manufacturing facility located in North Carolina and retain all of the more than 100 highly skilled technical staff and administrators currently employed at the site. Resilience will continue to support vector supply for both bluebird bio and 2seventy bio, bluebird’s spin-off oncology cell therapy company that is expected to launch by the end of 2021. The two companies are also finalizing a definitive agreement to establish partner programs that will share expense and revenue for successful commercialized oncology products and in parallel establish a next-generation manufacturing R&D collaboration.

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The 125,000-square foot facility, located in Durham, North Carolina, is currently manufacturing lentiviral vector (LVV), a critical component for cell and gene therapies. The facility includes drug substance and drug product production suites, quality control testing laboratories and warehousing space as well as additional footprint for future expansion. Resilience will continue to invest in the advancement of new technologies and expand the workforce as part of the company’s mission to build a digitally connected, end-to-end biomanufacturing ecosystem. Upon completion of the acquisition, the Resilience network will include 10 sites in North America with more than 1 million square feet of manufacturing, development, and support space.

In consideration for the acquisition of the bRT facility upon the closing of the transaction, bluebird will receive $110 million from Resilience. bluebird and 2seventy will continue to benefit from flexible and guaranteed access to LVV manufacturing for their emerging pipeline programs and the facility will be the primary source of suspension LVV.

The two companies plan to collaborate on the next phase of 2seventy’s pipeline, each applying their respective innovations in cell therapy development and manufacturing through a risk-sharing model.

"This alliance supports our vision of innovative product participation business models and bluebird’s demonstrated leadership and expertise in the field of gene and cell therapy makes them an ideal partner for this next phase of growth," said Rahul Singhvi, Sc.D, Chief Executive Officer of Resilience. "Further, the acquisition of the bRT facility gives us an important strategic presence in the Research Triangle region with one of the largest and most technically advanced facilities focused exclusively on cell and gene therapy manufacturing. We look forward to working closely with bluebird as they continue to advance important therapies for patients."

"Our mission of developing the next generation of cell therapies requires a thoughtful balance of innovation from both a scientific, medical and regulatory perspective as well as manufacturing perspective. We believe Resilience is an optimal partner to help us achieve this mission as well as the ideal successor for the next phase of the bRT facility’s growth," said Nick Leschly, chief bluebird. "As we continue to pivot toward the planned separation of bluebird and 2seventy, this strategic partnership allows us to share risk, streamline our business operations, provide additional capital and importantly ensures uninterrupted access to vector supply as we develop additional transformative treatments."

The closing of the transaction will be subject to the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act, the negotiation of certain definitive agreements and other customary closing conditions.

On July 28, 2021 Zion Pharma of Hong Kong reported that it raised $40 million in a Series B financing led by OrbiMed to advance its small molecule cancer drugs (Press release, Zion Pharma, JUL 28, 2021, View Source [SID1234585445]). Founded in 2018, Zion is based on its expertise in DMPK that allows the company to develop drugs capable of crossing the blood-brain barrier. The company’s lead product in a tyrosine kinase receptor inhibitor targeting HER2 aimed at treating brain metastases accompanying HER2+ breast cancer. The candidate, ZN-A-104, has completed China and US initial trials. Zion is headquartered in Hong Kong with research operations in Shanghai and Suzhou.

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On July 28, 2021 Citryll reported that first in class antibody drug candidate CIT-013 for autoimmune and chronic inflammatory diseases is beginning its bioanalytical phase at Ardena, a specialist pharmaceutical contract development and manufacturing organisation (CDMO) (Press release, Citryll, JUL 28, 2021, View Source [SID1234585444]).

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In partnership with its client Citryll, based in Oss in the Netherlands, Ardena is preparing to support the clinical phase of development of a first in class therapeutic human antibody targeting Neutrophil Extracellular Traps (NET) formation and clearance. The first-in-human study will be a randomised, double blind, placebo controlled, single ascending dose study for Citryll’s lead candidate CIT-013.

"We are very pleased to be partnering with Ardena as part of Citryll’s development programme for CIT-013," said Helmuth van Es, CEO of Citryll. "We are entering new territory. CIT-013 has the potential to impact many diseases where NET biology is contributing to the pathology, such as lupus, rheumatoid arthritis, vasculitis, sepsis, a range of serious lung inflammatory conditions and the list is still growing. Ardena has the bioanalytical skills and knowledge needed to help us develop CIT-013 and take it to the next level," he explained.

"To be involved in such an innovative drug development programme is very exciting for us," said Melloney Dröge, Business Unit Director at Ardena Assen, The Netherlands. "CIT-013 targets and inhibits the source of auto-antigens and NET derived pro-inflammatory molecules instead of the traditional approach of broadly targeting acquired immunity or inflammation," she explained. "Inhibition of NET formation and promoting their systemic clearance could change the way autoimmune, chronic inflammatory diseases and inflammatory conditions in general are treated."

Ardena will be drawing on its extensive expertise, providing full bioanalytical support from the development of PK, immunogenicity, PD and safety assays, right up to the validation of the methods and subsequent bioanalytical clinical sample analysis. The study will be conducted in healthy volunteers both with and without an intravenous lipopolysaccharide challenge.

On July 28, 2021 Complix, a biopharmaceutical company developing a pipeline of transformative Alphabody therapeutics, reported that it has signed a global collaboration and license agreement with Jiangsu Nhwa Pharmaceutical Co., one of China’s leading CNS companies, to develop Cell Penetrating Alphabodies (CPABs) able to cross the blood brain barrier, for the improved treatment of diseases of the central nervous system (CNS) (Press release, Complix, JUL 28, 2021, View Source;utm_medium=rss&utm_campaign=complix-signs-global-drug-discovery-and-development-agreement-with-jiangsu-nhwa-pharmaceutical-co-to-develop-novel-alphabody-therapeutics-for-treatment-of-cns-diseases [SID1234585443]). This agreement is an important corporate milestone for Complix, as it seeks to apply its industry leading CPAB platform in yet another major disease area, beyond oncology, autoimmunity, and viral diseases.

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Jiangsu Nhwa Pharmaceutical Co. (Nhwa) is a leading CNS company in China, which has developed an innovative and differentiated pipeline in the areas of anesthesia, analgesia, psychiatry, and neurology via both its own in-house R&D and global partnerships. Nhwa has more than 4000 employees, with capabilities in research, clinical development, manufacturing, and commercialization of CNS drugs.

Complix and Nhwa will collaborate to develop novel biotherapeutics against two selected CNS targets. Complix will apply its proprietary CPAB technology, that enables biologics to traverse membrane systems and act with high affinity and precision on disease targets that are considered intractable by current drug formats. The novel compounds to be developed under this collaboration, will be designed to cross the blood brain barrier to address important disease targets in the central nervous system.

Under the terms of the agreement, Complix has granted an exclusive license to Nhwa to develop, manufacture and commercialize the CPABs resulting from this collaboration in Greater China. Both companies retain joint development and commercialization rights for these CPABs in the rest of the world.

Complix is entitled to upfront license payments and further milestone payments subject to the progress of clinical development and regulatory approval. Complix is also eligible for royalty payments based on the future commercial sales of the CPABs in China.

Mark Vaeck, CEO of Complix, said:
"We are thrilled to announce this exciting collaboration with Nhwa. We are confident that the unique targeting capabilities of our CPABs will allow us to jointly develop novel biotherapeutics that will deliver improved treatment outcomes for patients suffering from severe neurological diseases. We believe that partnering with an innovative company like Nhwa, specialized in the area of CNS diseases, is substantially value creating, as it provides access to significant research and clinical development expertise in the CNS area, as well as a strong commercial platform in China. I am confident that together we can deliver on our ambitions to develop innovative and highly needed solutions for patients with severe neurological conditions".

Jiaquan Sun, CEO of Jiangsu Nhwa added:
"We are pleased to collaborate with Complix to gain access to its highly innovative CPAB platform as we look to further strengthen our position as a market leader in CNS therapies in China. We are looking forward to working with the team at Complix as we tap into their world leading intracellular targeting expertise to generate novel therapeutics that can cross the blood brain barrier to address major unmet medical needs that still exist in the CNS disease area today’’.