GRAIL | June 06, 2022
GRAIL, LLC, a healthcare company whose mission is to detect cancer early when it can be cured, today announced a broad strategic collaboration with AstraZeneca (LSE/STO/Nasdaq: AZN) to develop and commercialize companion diagnostic (CDx) assays for use with AstraZeneca’s therapies. The collaboration will initially focus on developing companion diagnostic tests to identify patients with high-risk, early-stage disease, with plans to embark on numerous studies across multiple indications over the next several years. The parties are additionally planning to use GRAIL’s technology to enable recruitment of patients with early-stage cancer for AstraZeneca’s clinical studies.
GRAIL has developed a novel approach to detect cancer signals in blood, regardless of whether or not the patient has clinical symptoms. We are excited to embark on this work with AstraZeneca to transform cancer outcomes through a broad, strategic collaboration, Through our collaboration, we hope to provide critical information to improve the identification of patients who may be eligible for clinical trials and change clinical paradigms for the treatment of early-stage cancers."
Sir Harpal Kumar, President, Biopharma Business and Europe at GRAIL.
Across the projects within this collaboration, GRAIL will use its methylation platform to perform testing for patients enrolled in AstraZeneca’s clinical trials. GRAIL will seek regulatory approval in key markets for the liquid biopsy companion diagnostics.
Identifying and treating cancer early is at the heart of this strategic collaboration. Combining GRAIL’s innovative blood-based methylation profiling platform with AstraZeneca’s leadership in Oncology, we hope to accelerate the adoption of circulating tumor DNA across clinical trials and make our cancer medicines available at an earlier stage of disease when there is greater potential to transform patient outcomes, and even cure.”
Susan Galbraith, Executive Vice President of Oncology R&D, AstraZeneca.
GRAIL is developing its proprietary methylation platform for use in multiple post-diagnostic settings to identify patients at high risk of future cancer recurrence, detect the presence or absence of residual disease, and to inform treatment decisions, including identifying patients with cancer who may be eligible for neoadjuvant or adjuvant therapy. GRAIL’s technology platform is designed to optimize circulating tumor DNA testing to enable detection of early stage disease and minimal residual disease (MRD).
GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. GRAIL, LLC, is a subsidiary of Illumina, Inc. (NASDAQ:ILMN) currently held separate from Illumina Inc. under the terms of the Interim Measures Order of the European Commission dated 29 October 2021.
Pfizer, BioNTech | May 10, 2021
Pfizer Inc. and BioNTech SE confirmed today the filing of a Biologics License Application (BLA) with the US Food and Drug Administration (FDA) for approval of their mRNA vaccine to prevent COVID-19 in people aged 16 and above. Companies will send data to help the BLA to the FDA on a rolling basis in the coming weeks, along with a proposal for Priority Review. If the BLA has been completed and duly approved for review by the FDA, the FDA will set a target date for a determination under the Prescription Drug User Fee Act (PDUFA).
The Pfizer-BioNTech COVID-19 Vaccine is now available in the United States under an Emergency Use Authorization (EUA) issued by the Food and Drug Administration (FDA) on December 11, 2020. Since then, the firms have distributed more than 170 million doses of the vaccine in the United States. The next step in the comprehensive FDA evaluation process is the submission of a BLA, which includes longer-term follow-up data for acceptance and approval.
Pfizer and BioNTech started the BLA process by providing the nonclinical and clinical data needed to justify the licensure of the COVID-19 vaccine for use in people aged 16 and up. This covers the most recent analyses from the pivotal Phase 3 clinical trial, in which the vaccine's effectiveness and safety profile were detected up to six months after the second dose. In the coming weeks, the companies will submit the required manufacturing and facility details for licensure, completing the BLA.
Pfizer and BioNTech have since submitted to expand the new EUA for their COVID-19 vaccine to cover individuals aged 12 to 15. The firms plan to send a supplemental BLA to facilitate vaccine licensure in this age group until the requisite data is available six months after the second vaccine dose.
BioNTech and Pfizer collaborated to create the Pfizer-BioNTech COVID-19 Vaccine, which is built on BioNTech's patented mRNA technology. BioNTech is the European Union's Marketing License Holder, as well as the holder of emergency use authorizations or similar in the United States (along with Pfizer), the United Kingdom, Canada, and other countries in advance of a planned application for full marketing authorizations in these countries.
The Pfizer-BioNTech COVID-19 Vaccine has not been authorized or licensed by the United States Food and Drug Administration (FDA), but it has been authorized for emergency use by the FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in people aged 16 and up. The emergency use of this product is only permitted for the duration of the declaration the circumstances justify the authorization of emergency use of the medical product under Section 564 (b) (1) of the FD&C Act until the declaration is terminated or the authorization is revoked sooner.
At Pfizer, they utilize science and its global resources to deliver treatments to patients that significantly extend and change their lives. In the discovery, development, and manufacture of health care products, including innovative medicines and vaccines, they aim to set the benchmark for consistency, safety, and value. Every day, Pfizer colleagues collaborate in developing and emerging markets to advance wellness, prevention, treatments, and remedies for today's most feared diseases. As one of the world's leading innovative biopharmaceutical firms, they partner with health care providers, governments, and local communities to promote and improve access to reliable and affordable health care around the world.
Biopharmaceutical New Technologies is a next-generation immunotherapy firm that is developing novel cancer and other severe disease therapies. For the accelerated production of new biopharmaceuticals, the company makes use of a diverse set of computational discovery and therapeutic drug platforms. Its oncology product candidates include individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies, and small molecules from Fosun Pharma and Pfizer.
CELL AND GENE THERAPY
Kite, Shoreline Biosciences | June 18, 2021
Kite, a Gilead Company, and Shoreline Biosciences, Inc., a biotechnology firm developing intelligently designed allogeneic off-the-shelf, standardized, and targeted natural killer (NK) and Macrophage cellular immunotherapies achieved from induced pluripotent stem cells (iPSC) for cancer and other serious diseases, announced a strategic partnership today to develop novel cell therapies across a variety of indications.
The collaboration will combine Shoreline’s profound experience in iPSC differentiation and genetic reprogramming with Kite’s extensive cell therapy development, commercialization, and manufacturing capabilities to develop new allogeneic candidates for a variety of hematologic malignancies. The collaboration will initially focus on chimeric antigen receptor (CAR) NK targets, with Kite having the option to expand the partnership to include an iPSC CAR Macrophage program for an undisclosed target to be picked after the deal is completed. This agreement comes on the back of Kite’s investment in Shoreline’s recent Series A financing.
“As the pioneer in cell therapy, we are focused on investing in and delivering on the most promising possibilities to improve cell therapy’s therapeutic potential further,” said Mert Aktar, Kite’s Vice President of Corporate Development and Strategy. “We are excited about the potential of Shoreline’s next-generation approach to allogeneic development, as well as how our partnership might accelerate this research across various leukemias and lymphomas.”
“Through this strong partnership, we are thrilled to strengthen our relationship with Kite, which is at the forefront of cancer immunotherapy for more than ten years,” said Kleanthis G. Xanthopoulos, Ph.D., Shoreline Co-Founder, Chairman, and CEO. “The combination of Kite’s experience in CAR T-cell therapies with our cutting-edge iPSC platform has the potential to accelerate Shoreline’s timeline to the clinic, expand our pipeline opportunities, and offer transformative cancer treatment options.”
According to the terms of the agreement, Shoreline will get an initial payment and will be eligible for further payments totaling more than $2.3 billion, as well as royalties based on the accomplishment of specific development and commercial milestones.
About Shoreline Biosciences
Shoreline is a biotechnology firm committed to developing intelligently designed allogeneic off-the-shelf, targeted, and standardized cellular immunotherapies for cancer and other severe illnesses. Shoreline is building a pipeline of natural killer (NK) cell and macrophage-cell treatment options based on its extensive knowledge of iPSC differentiation methods and genetic reprogramming of disease-relevant pathways.
Kite, a Gilead Company, is a biopharmaceutical company headquartered in Santa Monica, California, with commercial manufacturing facilities in North America and Europe. Kite’s sole focus is on cell therapy to treat and possibly cure cancer. As the pioneer in cell therapy, Kite has more authorized CAR T indications to help more patients than any other company.