CELL AND GENE THERAPY, MEDICAL
PRNewswire | May 03, 2023
BioCentriq, Inc. and panCELLa, a Pluristyx Company, announced that they have signed a research agreement designed to evaluate the ability of panCELLa's genetically-engineered, induced Pluripotent Stem Cell derived, feeder cells to activate and positively impact the expansion rate, total yield and potency of manufactured NK cells.
BioCentriq, a contract development and manufacturing organization focused exclusively on accelerating the development and manufacturing of cell therapies, will expand and cryopreserve the feeder cell bank for use as a reagent to activate adult and iPSC-derived NK cells and evaluate viable cell yield and potency in static and dynamic culture conditions.
panCELLa developed the feeder line from proprietary, genetically-modified, iPSCs to serve as a critical raw material for easy adoption by therapy developers and their partners to overcome the challenges associated with making NK cell therapies. The panCELLa feeder line provides a stable and easily scalable platform that can be fine-tuned to maximize NK cell activation, expansion, and manufacturability. Companies wishing to utilize panCELLa's feeder line can access a research version for evaluation and a clinical-grade format for therapeutic use through panCELLa and its sub-licensees.
"We envision the panCELLa-provided feeder line as an effective tool in our quest to accelerate the manufacturing of NK cell therapies and can be added to BioCentriq's proprietary LEAP™ platform," said Alex Klarer, Vice President of Business Strategy and Innovation at BioCentriq. "Our LEAP-NK™ platform is specifically designed to help biotech companies with promising NK cell therapies advance from lab to clinic in half the time it would normally take by leveraging proven technology, completed development work and established processes ready for GMP production."
Mahendra Rao, Chief Scientific Officer at Pluristyx, said, "We are pleased that BioCentriq selected our feeder line technology to better serve their cell therapy clients in solving the challenges of NK cell commercial manufacturing. We look forward to working with BioCentriq to bring the next generation of customized cell products and service solutions to speed the transition of these revolutionary therapies from the benchtop to the bedside."
BioCentriq is a full-service, New Jersey-based CDMO for cell and gene therapy, focusing on all stages of process development and clinical manufacturing. It was purchased by GC of South Korea for $73M. With over 90 scientists, engineers, analysts, and manufacturing specialists, the company has established quality systems and the infrastructure required to support the release of autologous and allogeneic drug products.
PRNewswire | June 02, 2023
During this year's AAPS National biotechnology conference, Navigate BioPharma Services, Inc., a Novartis subsidiary and a leading provider of innovative biomarker solutions for drug development, announced the launch of its new multiplex digital PCR assays for comprehensive quantification of multiple chimeric antigen receptor (CAR) T cells, a type of cancer immunotherapy that involves genetically modifying T cells to recognize and destroy certain cancers. These assays are based on the Qiagen QIAcuity digital PCR System, which offers a powerful yet easy-to-use digital PCR experience through its unique nanoplate system.
The new multiplex digital PCR assay enables simultaneous measurement of the number, function and persistence of CAR-T cells in clinical blood and bone marrow samples, without the need for a standard curve. It can detect as low as 0.01% of CAR-T cells among normal T cells, with a turnaround time of less than two hours. These assays can measure up to five different CAR-T cell markers in a single reaction, using specific probes for different CAR targets, to quantitate multiple CAR-domains, or combinations of commonly used therapeutic targets for CAR-T therapies. The assay can help clinicians monitor response or safety events during clinical trials to enable the development of new therapies.
"CAR-T therapy is a promising and innovative approach to treat cancer, but it requires accurate and reliable quantification of CAR-T cells for successful drug development," said Dr. Nathan Riccitelli, Associate Director of Innovative Technologies at Navigate BioPharma Services, Inc. "Our new proprietary multiplex digital PCR assay provides a comprehensive and robust solution for measuring CAR-T cells in clinical samples with high sensitivity, specificity and reproducibility."
Navigate BioPharma Services, Inc. has developed this assay for use in sponsors-led clinical trials. If interested, contact them about how this assay can be used in upcoming clinical trial studies.
Navigate Biopharma Services, Inc.
Navigate BioPharma Services, Inc., an independently operating subsidiary within the Novartis group of companies, is a leading provider of innovative biomarker and specialty bioanalytic solutions for clinical development. Over the past decade, Navigate BioPharma has built and developed its exclusive library of assays, methodologies, and biomarker solutions. Their extensive expertise offers unique, accurate, reliable, and cost-effective solutions for its customers and partners.
Puma Biotechnology, Inc. | March 16, 2023
Puma Biotechnology, Inc., a biopharmaceutical company, recently announced the online publication of the Phase II TBCRC041 randomized clinical trial results in JAMA Oncology. The trial investigated the use of alisertib, an adenosine triphosphate–competitive and reversible inhibitor of aurora kinase A, alone or in combination with fulvestrant in postmenopausal women with endocrine-resistant, HER2-negative metastatic breast cancer who were previously treated with fulvestrant.
The Phase II randomized clinical trial was conducted via the Translational Breast Cancer Research Consortium and included patients previously treated with CDK 4/6 inhibitors and everolimus.
The trial enrolled 91 evaluable patients, with baseline characteristics balanced between the two arms of the trial. However, more patients in the alisertib plus fulvestrant arm had previously received chemotherapy for metastatic disease (47.8% in the alisertib alone arm vs. 68.9% in the alisertib plus fulvestrant arm). In each arm of the trial, all patients had earlier been treated with CDK 4/6 inhibitors. Everolimus was previously administered to 37% of patients in the alisertib alone arm and 57.8% in the alisertib plus fulvestrant arm.
The trial's efficacy results indicated that nine partial responses were observed in the 46 evaluable patients in the alisertib alone arm, leading to an overall response rate of 19.6%. The median duration of response was 15.1 months, with a clinical benefit rate of 41.3% at 24 weeks. The projected median progression-free survival (PFS) was 5.6 months. Nine of the 45 evaluable patients in the alisertib plus fulvestrant arm of the study responded, for an overall response rate of 20.0%. There was one patient who had a complete response and eight patients who showed partial responses. The median duration of response was 8.5 months, with a clinical benefit rate of 28.9% at 24 weeks. The median PFS was expected to be 5.4 months.
The most prevalent grade 3 or higher adverse events in the alisertib alone arm of the trial were neutropenia (43.4%), anemia (19.6%) and leukopenia (17.4%). The most prevalent grade 3 or higher adverse events in the alisertib plus fulvestrant arm of the study were neutropenia (42.2%), leukopenia (31.1%), lymphopenia (15.6%), fatigue (11.1%), and anemia (8.9%).
About Puma Biotechnology, Inc.
Puma Biotechnology, Inc. is a leading biopharmaceutical company specializing in the development and commercialization of innovative treatments for cancer. Its flagship product is Nerlynx (neratinib), an oral tyrosine kinase inhibitor approved by the USFDA for the extended adjuvant treatment of HER2-positive early-stage breast cancer. In addition to Nerlynx, it has a robust pipeline of product candidates in various stages of development. The company is firmly committed to research and development and collaborates with leading academic institutions and research organizations to advance the understanding of cancer and develop new therapies.