National Comprehensive Cancer Network | October 16, 2020
The National Comprehensive Cancer Network® (NCCN®) Oncology Research Program (ORP) today announced plans to evaluate neratinib, a type of tyrosine kinase inhibitor (TKI) that works as a dual inhibitor of the epidermal growth factor receptor 1 (EGFR) and human epidermal growth factor receptor 2 (HER2). The research funding is supported by a $2-million grant from Puma Biotechnology, Inc. Projects may include pre-clinical, translational and clinical trials. They will focus on treatment of: Pediatric tumors(including neurofibromatosis Type 2 and progressive Vestibular Schwannoma). Early-stage and metastatic breast cancer, including those with HER2+ brain metastases. Other HER2-amplified tumors. EGFR-mutated glioblastoma multiforme. Specific research areas will be determined by a group of cancer research experts from NCCN Member Institutions who form a Request for Proposals (RFP) Development Team.
Be Bio | May 20, 2022
Be Biopharma, Inc. (“Be Bio”) and National Resilience, Inc. (Resilience) today announced a strategic collaboration to advance initial programs in Be Bio’s rare disease pipeline. Be Bio’s proprietary engineered B Cell Medicines (BeCM) platform is harnessing the power of the human B cell to create a new class of autologous and allogeneic cellular medicines that durably and redosably produce therapeutic proteins in vivo without toxic pre-conditioning.
The two companies are investing to drive innovation and reliability in cell therapy manufacturing, a critical success factor for broad and meaningful patient impact. As part of this unique partnership, Resilience will dedicate personnel solely to produce and supply Good Manufacturing Practices (GMP)-grade viral vector and cell therapy drug product for the initial programs in Be Bio’s rare disease pipeline. Through a creative cost and risk-sharing model, Resilience will be responsible for manufacturing costs and receive potential future milestones and royalties.
Over the past year, Be Bio has built a strong foundation with our BeCM platform, pipeline, team, and recent $130 million financing. Manufacturing is critical to rapidly progress our BeCMs to the clinic and we have built non-GMP manufacturing capabilities in our Cambridge facility. This deal allows us to drive GMP manufacturing with an outstanding partner, and in a capital efficient manner, Resilience’s broad manufacturing capabilities, strong collaborative spirit and dedicated resources to our platform, make them an ideal partner for our BeCM programs.”
Joanne Smith-Farrell, Ph.D., Chief Executive Officer at Be Bio.
Resilience will lead clinical GMP manufacturing of both the viral vector and the cell therapy drug product for Be Bio’s initial rare disease programs to support first-in-human clinical trials. Resilience will apply its pioneering bioprocessing solutions and network of cell therapy sites, including facilities in Research Triangle Park, NC, Philadelphia, PA, Waltham, MA and Marlborough, MA to conduct the work.
This collaboration shows our excitement for the promising science of Be Bio’s proprietary BeCM platforms, and our confidence in their expertise to deliver transformative cell therapies, By working alongside Be Bio early in the drug development process, we aim to accelerate the development of their B cell medicines with the potential to unlock a pipeline of product candidates across a variety of serious diseases.”
Rahul Singhvi, Sc.D., Chief Executive Officer of Resilience.
About B Cells – A New Class of Cellular Medicines
Imagine what could “Be?” In nature, a single B cell engrafts in the bone marrow and can produce thousands of proteins per second at constant levels over decades. B cells are nature’s exquisite medicine factories, manufacturing proteins to fight disease and maintain health. Unleashing the power of B cells is driving a new class of cellular medicines – Engineered B Cell Medicines (BeCM). BeCMs have the potential to be durable, allogeneic, redosable and administered without toxic conditioning. The promise of BeCMs could transform therapeutic biologics with broad application — across protein classes, patient populations and therapeutic areas.
About Be Biopharma
Be Biopharma (“Be Bio”) is pioneering Engineered B Cell Medicines (BeCM) to dramatically improve patients’ lives who are living with cancer, rare diseases and other serious conditions. With eyes locked on the patient, our team of purpose-driven scientists, technologists, manufacturing experts and business builders collaborate to create a bold new class of cell therapies. Be Bio was founded in October 2020 by Longwood Fund and B cell engineering pioneers David Rawlings, M.D., and Richard James, Ph.D. from Seattle Children’s Research Institute. Be Bio is backed by ARCH Venture Partners, Atlas Venture, RA Capital Management, Alta Partners, Longwood Fund, Bristol Myers Squibb and Takeda Ventures. Since our founding, Be Bio’s investors have committed over $180 million to enable the Company to re-imagine medicine based on the power of B cell therapy.
Resilience is a technology-focused biomanufacturing company dedicated to broadening access to complex medicines. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the treatments of today and tomorrow can be made quickly, safely, and at scale. Resilience seeks to free its partners to focus on the discoveries that improve patients’ lives by continuously advancing the science of biopharmaceutical manufacturing and development.
CELL AND GENE THERAPY
Helix | September 21, 2021
The Medical University of South Carolina (MUSC) and Helix have announced a strategic collaboration to develop a first-of-its-kind population genomics initiative in South Carolina called In Our DNA SC. The large-scale program is designed to improve health care outcomes by integrating genetic insights into clinical care and research. The statewide initiative will enroll 100,000 patients in genetic testing over the next four years at no cost to the patient.
The program will enable the use of genomic insights with an initial focus on actionable information regarding a patient's risk for certain forms of cancer and cardiovascular disease. The genetic reports will allow patients and their health providers to develop precision health care plans to proactively mitigate the conditions and take a more preventive approach to patient care. Patient enrollment in In Our DNA SC is expected to begin in the fall.
Medical University of South Carolina and Helix to develop a first-of-its-kind genomics initiative called In Our DNA SC.
In addition, MUSC and Helix will be developing a robust clinico-genomic dataset from consenting participants that will help researchers learn what can cause certain diseases, how we may be able to treat them more effectively and, possibly, improve the standard care for everyone. This is expected to lay the groundwork for a broader collaboration with other organizations across the health care value chain.
As South Carolina's only comprehensive academic health sciences center, delivering the highest quality care throughout the state is our top priority. Precision medicine is an emerging field that is going to transform the future delivery of health care. Being a leader and helping to define this path is core to our mission. We are excited to have the opportunity to partner with Helix to deploy this first-of-its-kind population genomic program for our patients. This collaboration will help drive preventive, precision health care for South Carolinians.
- David J. Cole, M.D., FACS, MUSC president
The strategic relationship with Helix allows MUSC to leverage Helix's unique Sequence Once, Query Often™ model and its end-to-end integration platform to enable immediate application and continual on-demand use of genetic insights throughout a patient's life. By working with South Carolina's only integrated academic health sciences center in the state, Helix gains access to thousands of providers and research staff dedicated to understanding how to deliver the highest quality patient care available to serve the people of South Carolina and beyond.
Enrollment in the program will initially be available to patients who sign up at select MUSC clinics and locations, later expanding to participants throughout the community and state in collaboration with MUSC's clinical affiliates and partners. Additionally, participants who consent to securely contribute their genetic data will help MUSC develop one of the largest clinico-genomic datasets in the country. Analyses from this platform will be used to pioneer and further advance genomics research.
About the Medical University of South Carolina
Founded in 1824 in Charleston, MUSC is home to the oldest medical school in the South as well as the state's only integrated academic health sciences center, with a unique charge to serve the state through education, research and patient care. Each year, MUSC educates and trains more than 3,000 students and nearly 800 residents in six colleges: Dental Medicine, Graduate Studies, Health Professions, Medicine, Nursing and Pharmacy. MUSC brought in more than $271 million in biomedical research funds in fiscal year 2020, continuing to lead the state in obtaining National Institutes of Health funding, with more than $129.9 million. As the clinical health system of the Medical University of South Carolina, MUSC Health is dedicated to delivering the highest quality and safe patient care while training generations of compassionate, competent health care providers to serve the people of South Carolina and beyond. Close to 25,000 care team members provide care for patients at 14 hospitals with approximately 2,500 beds and 5 additional hospital locations in development, more than 300 telehealth sites and nearly 750 care locations situated in the Lowcountry, Midlands, Pee Dee and Upstate regions of South Carolina. In 2021, for the seventh consecutive year, U.S. News & World Report named MUSC Health the No. 1 hospital in South Carolina.MUSC and its affiliates have collective annual budgets of $4.4 billion. The more than 25,000 MUSC team members include world-class faculty, physicians, specialty providers and scientists who deliver groundbreaking education, research, technology and patient care.
Helix is the leading population genomics company operating at the intersection of clinical care, research, and genomics. Its end-to-end platform enables health systems, life sciences companies, and payers to advance genomic research and accelerate the integration of genomic data into clinical care. Powered by one of the world's largest CLIA / CAP next-generation sequencing labs and the first and only FDA authorized whole exome sequencing platform, Helix supports all aspects of population genomics including recruitment and engagement, clinically actionable disease screening, return of results, and basic and translational research. In response to the COVID-19 public health crisis, Helix has launched a sensitive and scalable end-to-end COVID-19 test system to meet the needs of health systems, employees, governments, and other organizations across the country.