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Second quarter 2021 Results

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Pfizer reports Second-Quarter 2021 results

Almac Clinical Technologies and THREAD Partner to Eliminate Common Clinical Trial Delays

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.

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."

Bluebird Bio and Resilience Announce Strategic Alliance to Develop Next Generation Cell Therapies

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.

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.

Zion Pharma Raises $40 Million to Develop Therapies for Brain Metastases

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.