CELL AND GENE THERAPY, INDUSTRIAL IMPACT
Center for Breakthrough Medicines | February 27, 2023
Center for Breakthrough Medicines (CBM), a leading contract development and manufacturing organization dedicated to addressing the challenges of commercializing cell and gene therapies, and Virion Therapeutics, a clinical-stage biotech firm focused on developing accessible and adaptable CD8+ T cell-based technologies for cancer and infectious diseases, have recently announced a strategic collaboration agreement.
CBM will partner and manufacture with Virion Therapeutics on their checkpoint modifier clinical development programs, including the First-in-Human VRON-0200 immunotherapy, designed to treat chronic Hepatitis B Virus (HBV) infection.
The collaboration aims to develop VRON-0200, a pan-genotypic, global therapeutic immunotherapy that targets chronic HBV infection, which affects over 295 million people worldwide. HBV impairs CD8+ T cells, which results in the loss of viral control. VRON-0200 induces a broad CD8+ T cell response, which includes responses to the core and pol regions not generally induced by the infection. Therefore, VRON-0200 is designed to stimulate a highly functional immune response to help clear the virus.
CBM's Co-Founder and Chief Business Officer Audrey Greenberg commented, "Virion is working to revolutionize the immunotherapy treatment landscape, and we are honored to partner with them on this bold mission as we share a common goal – to create a future free of cancer and chronic infectious diseases." She further emphasized, "We have assembled best-in-field technical teams, supported by industry-leading product and process development, manufacturing, and testing capabilities, all located within a single, world-class manufacturing facility. We look forward to working with Virion to bring their life-saving therapies to the patients who need them most, as quickly as possible."
(Source – PR Newswire)
About Center for Breakthrough Medicines
The Center for Breakthrough Medicines is a pioneering contract development and manufacturing organization (CDMO) situated in the center of "Cellicon Valley," with a focus on cell and gene therapies. It offers an all-in-one solution to expedite the speed of delivering advanced treatments to the market. Its customer-oriented approach, combined with a culture that prioritizes the needs of patients, guarantees dependable and high-quality process and analytical development, GMP testing, viral vector manufacturing, plasmid production, cell therapy bioprocessing and cell banking services throughout the entire life cycle of a product.
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INDUSTRIAL IMPACT, DIAGNOSTICS
Prnewswire | April 26, 2023
PathAI, a global leader in AI-powered pathology, and ConcertAI, a leader in AI software-as-a-service technology and real-world evidence solutions for life sciences and healthcare, today announced a strategic partnership to launch a first-in-class quantitative histopathology and curated clinical real-world data (RWD) solution combining PathAI's PathExplore™ tumor microenvironment panel with ConcertAI's Patient360™ and RWD360™ products.
Utilizing real world H&E-stained samples from PathAI's pathology laboratory, PathExplore extracts quantitative measures of the tumor microenvironment, known as human interpretable features (HIFs), from whole slide images. These data are linked to Patient360's reference-standard abstracted clinical EMR, medical claims, and Social Determinants of Health data, allowing direct insights into current standards of care and treatment dynamics. Similarly, the data are also linked to RWD360, which provides scaled insights from structured EMR data, medical claims, and Social Determinants of Health for large populations.
"Real world data products include clinical and outcomes data, but are missing a critical component that links these, namely pathology, which has historically been non-standardized or with limited quantification," said Andy Beck, CEO and co-founder of PathAI. "Our collaboration with ConcertAI will offer access to a uniquely linked quantitative pathology dataset, allowing researchers to explore hypotheses far beyond the scope of small, controlled datasets, such as identifying and analyzing novel histological biomarkers correlated with patient treatment and outcomes."
"Analysis of tumor microenvironment characteristics is critical to understanding why certain patients respond to a specific therapy and others do not. It further allows the definition of clinical strategies that might increase the numbers of patients benefiting from current medicines and improve the effectiveness of new ones," said Jeff Elton, PhD, CEO of ConcertAI. "With PathAI we are creating the first large scale clinical datasets linking pathology HIFs with EMR-derived clinical data, greatly enhancing the armamentarium of the translational and clinical development research communities."
ConcertAI and PathAI will jointly offer these combined solutions to biopharma customers, including translational research and real-world data teams. The initial solutions focus on bladder cancer, colorectal cancer, prostate cancer, and melanoma. For more information, contact us at PathAI or ConcertAI, or visit us at PathAI's exhibit and ConcertAI's exhibit at ASCO in Chicago, IL, on June 2-6, 2023.
PathAI and PathExplore are a registered trademark and trademark respectively of PathAI. ConcertAI, Patient360, and RWD360 are registered trademarks or trademarks of ConcertAI. All rights reserved.
About ConcertAI
ConcertAI is a leader in Real-World Evidence (RWE) and AI Software-as-a-Service solutions for life sciences and healthcare. Our mission is to accelerate insights and advance clinical outcomes for patients through advanced AI technologies, multi-modal real-world data, and scientific expertise in partnership with the leading biomedical innovators, healthcare providers, and medical societies.
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INDUSTRY OUTLOOK
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.
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