Pfizer Raises Gene Therapy Stake with 500M Dollars Sanford, NC, Expansion

GEN | August 22, 2019

Pfizer will expand its manufacturing of gene therapies in North Carolina, where the pharma giant joined Gov. Roy Cooper in announcing plans for a 500 million dollars facility expansion in Sanford that is expected to add 300 jobs to its local workforce of 650. The planned expansion which will grow its Sanford workforce by nearly 50 Percent comes three years to the month that Pfizer expanded into gene therapy by acquiring Bamboo Therapeutics for up to 645 million dollars. The following year, Pfizer raised its proverbial bet on gene therapy with a $100 million, 40-job expansion to the company’s vaccine manufacturing plant in Sanford. “Our purpose is to deliver breakthroughs that change patients’ lives. And expanding these end-to-end capabilities that we have here in Sanford in gene therapy is exactly how we are going to make this happen,” Angela Hwang, Group President, Pfizer Biopharmaceuticals Group, said yesterday at a ceremony at the Sanford facility, according to a video of the event posted by WRAL TechWire. Hwang and other Pfizer executives joined Cooper at the ceremony, which also marked the completion of the first phase of the expansion. Pfizer said the expansion will advance its ability to produce potentially one-time gene therapies that use custom-made recombinant adeno-associated virus (rAAV) vectors—thus strengthening its ability to supply both clinical- and commercial-scale quantities of the treatments.

Spotlight

Global potential artificial blood substitutes market is expected to be valued at $5,204 million by 2022 and is expected to grow by a CAGR of 27.8 percent to assume a value of $17,775 million by 2027

Spotlight

Global potential artificial blood substitutes market is expected to be valued at $5,204 million by 2022 and is expected to grow by a CAGR of 27.8 percent to assume a value of $17,775 million by 2027

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MEDTECH

With "Prodrugs for Cancer Treatment" Patent, Gatc Health Enters Oncology Medicine Market

GATC Health Corp | April 22, 2022

GATC Health, a biotech company that uses artificial intelligence and advanced multiomics to revolutionize drug discovery and disease prediction, announced that it filed a patent application for an innovative new prodrug designed to safely cross the blood-brain barrier (BBB) for cancer treatment. GATC Health's entry into the oncology drug discovery market is marked by this breakthrough, which was made possible by the company's innovative Multiomics Advanced TechnologyTM AI platform. Prodrugs are physiologically inactive chemicals that are converted to drugs in the body. Aspirin, Plavix, and Prednisone are just a few examples. The novel new prodrug developed by GATC Health is meant to trigger programmed cell death in malignant cancer tissues and could be used to treat glioblastoma brain tumors. Due to the difficulty of delivering and selecting drug-target interactions, this unique technique of treatment has not been conceivable before, but it has the potential to improve safety and selectivity. Furthermore, this new prodrug formulation has the potential to significantly lessen the collateral harm produced by past iterations of chemical agents employed to treat cancer. This style, according to the business, will lead to many more advances in innovative cancer therapies. I am very excited that we are continuing to expand our portfolio at GATC Health and entering in oncology with this innovative platform to meet unmet needs of cancer patients, Glioblastoma accounts for half of all the cancerous brain tumors in adults. We see about 12 to 18 months average survival time for these patients with only 5% of patients surviving more than five years, highlighting the unmet need for innovation for these patients. Our new prodrug has the potential to differentiate between glioblastoma cells and healthy neuron growth, preventing replication of cancer cells for glioblastoma. This new technology may also be used for other tumors. Global spending on therapeutics and supportive care of cancer is continuing to grow and be is expected to reach $200 billion in 2022. With growing incidence of cancer in patients, oncology is the focus area for the 10 largest pharma companies, and we are looking forward to partnering with them to bring glioblastoma patients and other cancer patients a safe, effective cure." Preetaman Wadhwa, the company's Chief Marketing Officer.

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MEDTECH

FDA Grants ILiAD Biotechnologies Fast Track Designation for Next Generation Pertussis Vaccine BPZE1

ILiAD Biotechnologies | January 04, 2022

ILiAD Biotechnologies, a late stage biotech development company focused on global eradication of disease due to Bordetella pertussis, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to BPZE1, a next generation vaccine for active booster immunization against pertussis. BPZE1 is the most advanced next generation pertussis vaccine currently in clinical development. Developed in the laboratory of Camille Locht, PhD, at the Institut Pasteur de Lille and French National Institute of Health and Medical research BPZE1 is a live-attenuated intranasal vaccine designed to overcome deficiencies of current pertussis vaccines, including poor durability of protection and failure to prevent nasopharyngeal Bordetella pertussis infections that lead to escape mutants and transmission to vulnerable infants. Four clinical trials studying BPZE1 in healthy adults have been completed to date, including positive topline results from a 300-participant adult Phase 2b trial demonstrating that BPZE1 induced durable mucosal immunity and reduced nasal colonization — two key factors necessary for the prevention of transmission and reduction of epidemic pertussis cycles. Earlier this month, the Company also announced initiation and enrollment of the first participants in the BPZE1 SUPER Trial (Standing Up to PERtussis) – the fifth clinical BPZE1 study and the first study in school-age children. Section 506(b) of the FD&C Act provides for the designation of a drug as a Fast Track product “…if it is intended, whether alone or in combination with one or more other drugs, for the treatment of a serious or life-threatening disease or condition, and it demonstrates the potential to address unmet medical needs for such a disease or condition.” Fast Track provides opportunities for frequent Company interactions with the FDA and the potential for accelerated approval and priority review. “We are pleased that the FDA is aligned with ILiAD’s position that there is an unmet clinical need for a more effective pertussis vaccine and that the evidence to date supports the potential for BPZE1 to address the major gaps in protection against pertussis. We look forward to continuing to work with the FDA and other global Regulatory Agencies to further clinical development of BPZE1 and to safely and efficiently bring BPZE1 to US and global markets.” Dr. Keith Rubin, Chief Executive Officer of ILiAD. Dr. Rubin About Pertussis Pertussis is a life-threatening disease caused by the highly contagious respiratory bacterium Bordetella pertussis. According to U.S. Centers for Disease Control and Prevention, each year pertussis affects approximately 16 million people globally, accounting for nearly 200,000 deaths. Although estimated global vaccination coverage is 84%, current vaccines have failed to control epidemics. In addition, current vaccines do not fully protect infants under age 6 months, since immunization requires multiple injections, usually at 2, 4 and 6 months. About BPZE1 BPZE1 is a next-generation live-attenuated pertussis vaccine designed to induce comprehensive and durable protection against B. pertussis infection and disease. BPZE1 is being developed to block B. pertussis from colonizing adult and adolescent nasal passages, to protect adults and adolescents from whooping cough, and to potentially prevent transmission, including transmission to infants. While ILiAD is currently focused on developing a vaccine to directly protect adults and adolescents and to indirectly protect vulnerable infants, future development aims to immunize neonates directly. About Fast Track Designation Fast Track Designation by the U.S. FDA is a process designed to facilitate the development and expedite the review of investigational products to treat serious conditions and fill an unmet medical need, with the intent of getting important new products to the population in an expedited manner. Specifically, Fast Track Designation provides the option of licensure via the accelerated approval pathway, which allows licensure based on surrogate endpoints. Additionally, Fast Track designation facilitates meetings with the FDA to discuss all aspects of development to support licensure and provides the opportunity to submit sections of a BLA on a rolling basis as data become available. This permits the FDA to review modules of the BLA as they are received instead of waiting for the entire BLA submission. Priority review is an additional benefit that may potentially be available for BPZE1 as part of the Fast Track designation. About ILiAD Biotechnologies, LLC ILiAD Biotechnologies is a privately held, clinical stage biotechnology company dedicated to the prevention and treatment of human disease caused by Bordetella pertussis. The company is developing and acquiring key technologies, working with leading scientists to overcome the limitations of current vaccines, investigating the impact of B. pertussis in a range of human disease, and is focused on validating its proprietary vaccines in human clinical trials.

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INDUSTRIAL IMPACT

Legend Biotech Achieves Milestone Payments in BCMA CAR-T Collaboration with Janssen

Legend Biotech Corporation | February 14, 2022

Legend Biotech Corporation, a global, clinical-stage biotechnology company developing and manufacturing novel therapies, has achieved two milestones under its collaboration agreement with Janssen Biotech, Inc. for ciltacabtagene autoleucel (cilta-cel), resulting in aggregate payments to Legend Biotech of $50 million. Cilta-cel is a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T-cell (CAR-T) therapy. Legend Biotech entered into the agreement with Janssen to develop, manufacture and commercialize cilta-cel for the treatment of multiple myeloma. Under the agreement, Legend Biotech received an upfront payment of $350 million and is entitled to receive additional payments upon achievement of landmarks for development, production performance, regulatory and sales. The global agreement specifies a 50-50 cost and profit-sharing agreement in all markets, excluding Greater China, where the split is 70 percent for Legend and 30 percent for Janssen. Including the payments announced above, Legend has achieved $250 million in milestone payments during the collaboration. About Cilta-cel Cilta-cel is an investigational chimeric antigen receptor T cell (CAR-T) therapy, formerly identified as JNJ-4528 in the United States and Europe and LCAR-B38M CAR-T cells in China, that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed or refractory multiple myeloma and in earlier lines of treatment. The design consists of a structurally differentiated CAR-T with two BCMA-targeting single domain antibodies. In addition to a Breakthrough Therapy Designation (BTD) granted in the United States in December 2019, cilta-cel received a Priority Medicines (PRiME) designation from the European Commission in April 2019, and a BTD in China in August 2020. In addition, Orphan Drug Designation was granted for cilta-cel by the U.S. Food and Drug Administration (FDA) in February 2019, and by the European Commission in February 2020. A Biologics License Application seeking approval of cilta-cel was submitted to the U.S. FDA and a Marketing Authorization Application was submitted to the European Medicines Agency. About Legend Biotech Legend Biotech is a global, clinical-stage biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide. We are currently engaged in a strategic collaboration to develop and commercialize our lead product candidate, ciltacabtagene autoleucel, an investigational BCMA-targeted CAR-T cell therapy for patients living with multiple myeloma. Applications seeking approval of cilta-cel for the treatment of patients with RRMM are currently under regulatory review by several health authorities around the world, including the U.S. Food and Drug Administration and the European Medicines Agency.

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