INDUSTRIAL IMPACT, MEDICAL
Globenewswire | March 27, 2023
Iovance Biotherapeutics, Inc. a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, announced it has completed its rolling Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA) for lifileucel. Lifileucel is a tumor infiltrating lymphocyte (TIL) therapy intended as a treatment for patients with advanced melanoma who progressed on or after prior anti-PD-1/L1 therapy and targeted therapy, where applicable. There are no FDA approved therapies in this treatment setting.
Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive Officer of Iovance, stated, “Completing our BLA submission for lifileucel is a critical step forward in our journey to deliver the first individualized, one-time cell therapy for a solid tumor. I would like to acknowledge the patients and physicians who participated in the C-144-01 clinical trial and the FDA review team for their commitment and support, as well as our internal team for their tremendous effort in completing the first BLA submission for Iovance. Our preparations for commercialization remain on track to support a launch later this year. We look forward to continued collaboration with the FDA as they review this new class of treatment for advanced melanoma patients with limited options.”
The BLA submission for lifileucel is supported by positive clinical data from the C-144-01 clinical trial in patients with advanced post-anti-PD1 melanoma. Following a successful pre-BLA meeting with the FDA, Iovance is pursuing accelerated approval in this indication. Iovance also reached agreement with the FDA regarding the registrational trial design for the Phase 3 TILVANCE-301 trial of lifileucel in combination with pembrolizumab in frontline advanced melanoma. TILVANCE-301 is intended to support full approval of lifileucel in post-anti-PD-1 advanced melanoma and is also designed to support registration for lifileucel in combination with pembrolizumab as therapy for advanced melanoma in the frontline setting. Startup activities for TILVANCE-301 are ongoing and the trial is expected to be well underway at the time of potential accelerated approval for lifileucel in advanced post-anti-PD-1 melanoma.
Marc Hurlbert, Ph.D., CEO of the Melanoma Research Alliance (MRA), said, “MRA congratulates Iovance for completing the BLA submission and moving closer toward making TIL therapy an option for people with advanced melanoma who have progressed following prior treatments. We hope for an FDA approval as quickly as possible for patients with significant unmet need who have no approved treatment options.”
Following receipt of the complete rolling BLA submission for lifileucel, the FDA has 60 days to determine the acceptability of the BLA for review. The rolling BLA allowed Iovance to submit portions of the BLA to the FDA on an ongoing basis, enabling the FDA to begin review as early as possible as documents were received. The rolling BLA submission and eligibility for priority review are benefits available under the FDA’s guidance on expedited programs for serious conditions, which allow for an expedited six-month review from the time of BLA acceptance. In addition, the FDA previously granted a regenerative medicine advanced therapy (RMAT) designation for lifileucel in advanced melanoma.
About Iovance Biotherapeutics, Inc.
Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapies for patients with cancer. We are pioneering a transformational approach to cure cancer by harnessing the human immune system’s ability to recognize and destroy diverse cancer cells in each patient. Our lead late-stage TIL product candidate, lifileucel for metastatic melanoma, has the potential to become the first approved one-time cell therapy for a solid tumor cancer. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, that may extend and improve life for patients with cancer.
INDUSTRIAL IMPACT, DIAGNOSTICS
Globenewswire | April 10, 2023
Avid Bioservices, Inc. a dedicated biologics contract development and manufacturing organization working to improve patient lives by providing high quality development and manufacturing services to biotechnology and pharmaceutical companies, announced the completion of two expansions within the company’s mammalian cell facilities. The company expects that the first customer for the newly expanded CGMP mammalian cell suites will begin manufacture this month. To celebrate the launch of the newly expanded facilities, Avid is hosting an open house and tour for existing and prospective clients.
“We are proud to unveil our completed expansions and excited to kick off the first customer project within our latest, state-of-the-art mammalian cell manufacturing suites. These build-outs involved great complexity and required exemplary efforts from our entire team. I would like to acknowledge the tremendous work from everyone who played a role in completing these significant projects on schedule,” said Nick Green, president and chief executive officer of Avid Bioservices. “This launch could not be timed any better based on the significant demand we continue to see for our mammalian cell services, highlighted by significant new business wins and the largest backlog in the history of the company.”
The newly expanded manufacturing capacity includes both upstream and downstream CGMP manufacturing suites and serves as complement to Avid’s existing Myford facility, providing increased capacity to address the needs of both existing and future mammalian cell business customers. The addition of the capacity provided by the new manufacturing suites within the Myford facility has the potential to generate approximately an additional $100 million in annual revenue.
In addition to the launch of the newly expanded Myford facility, Avid also announced the completion of its mammalian cell process development expansion, which has doubled the company’s total process development capacity. Now operational, these new capabilities have the potential to support up to an additional $25 million in annual process development revenue.
With the completion of these mammalian cell capacity expansion projects, Avid’s sole ongoing expansion effort involves the build-out of its new cell and gene therapy facility which will support early-stage development through commercial manufacturing. The company has already launched analytical and process development capabilities at this viral vector facility and remains on track to launch the CGMP manufacturing suites by the end of the third quarter of calendar 2023.
Upon completion of the CGT Facility, we estimate that our combined facilities will have the potential to bring our total revenue generating capacity to up to approximately $400 million annually.
About Avid Bioservices, Inc.
Avid Bioservices an S&P SmallCap 600 company, is a dedicated contract development and manufacturing organization focused on development and CGMP manufacturing of biologics. The company provides a comprehensive range of process development, CGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries. With 30 years of experience producing monoclonal antibodies and recombinant proteins, Avid's services include CGMP clinical and commercial drug substance manufacturing, bulk packaging, release and stability testing and regulatory submissions support. For early-stage programs the company provides a variety of process development activities, including upstream and downstream development and optimization, analytical methods development, testing and characterization. The scope of our services ranges from standalone process development projects to full development and manufacturing programs through commercialization.
MEDICAL, INDUSTRY OUTLOOK
PRNewswire | May 16, 2023
PhenomeX Inc. the functional cell biology company, announced the launch of Beacon Select™ optofluidic system with Opto® B Discovery workflows for antibody discovery.
The Opto B Discovery workflows, with their cutting-edge technologies and features, enable scientists to find lead candidate antibodies tailored to their specific challenges and changing needs. Combined with the value-matched Beacon Select system, more customers may access these propriety antibody discovery applications, but with the optimum level of features that meet their research and budgetary needs. PhenomeX's optofluidic platform is now a standard to deliver optimal antibodies with speed, as highlighted recently in the high-impact journal Cell, where antibodies against COVID-19 variants were discovered on the Beacon system six months before Omicron emergence.
Beacon Select for Antibody Discovery Workflow Feature
Opto B Discovery workflows on the Beacon Select system enable scientists to accelerate antibody screening and hit generation to find lead candidate antibodies and are ideally suited for small- to mid-sized biopharma and CDMOs/CROs. This contrasts with the flagship four-chip Beacon system enabled for antibody discovery, optimized for the highest screening throughputs demanded by large biopharma and established CDMOs/CROs.
The Beacon Select system enables rapid function-first selection of single B cells with the best characteristics for any antibody application, including antibody therapeutics, diagnostics, and reagents. In addition, the Opto B Discovery workflows offer users highly customizable assays to assess antigen and epitope specificity, species or variant cross-reactivity, and functional properties, all in a single-day workflow. By selecting and recovering sequences of only the most desirable antibodies with favorable attributes, users can reduce overall bioprocessing costs, improve the probability of campaign success, and shorten timelines to lead candidates. When combined with PhenomeX's catalog of best-in-class reagents and consumables for mouse, human, and rabbit B cell repertoires, customers can do all this against even the hardest antigen targets, including G coupled-protein receptors (GPCRs) and ion channels, to accelerate antibody discovery beyond traditional methods available today.
PhenomeX participation at 19th Annual PEGS Boston Conference & Expo
PhenomeX is participating at the 19th annual Protein Engineering & Cell Therapy Summit (PEGS) conference and expo being held from May 15-19 at the Hynes Convention Center in Boston, Mass. At the conference, the Company will feature its optofluidic and proteomic platform technologies, including the new Beacon Select system, in booth #517 and present two posters and podium presentations. Attendees can explore demonstrations of the technology and learn more about how PhenomeX's products can advance and accelerate our understanding of cellular function along the continuum of scientific discovery, bioprocessing, clinical research, and immunotherapy development.
About PhenomeX Inc.
PhenomeX is empowering scientists to leverage the full potential of each cell and drive the next era of functional cell biology that will advance human health. We enable scientists to reveal the most complete insights on cell function and obtain a full view of the behavior of each cell. Our unique suite of proven high-throughput tools and services offer unparalleled resolution and speed, accelerating the insights that are key to advancing discoveries that can profoundly improve the prevention and treatment of disease. Our award-winning platforms are used by researchers across the globe, including those at the top 15 global pharmaceutical companies and approximately 85% of leading U.S. comprehensive cancer centers.