CELL AND GENE THERAPY, INDUSTRIAL IMPACT
Lineage Cell Therapeutics, Inc. | February 23, 2023
On February 22, 2023, Lineage Cell Therapeutics, Inc., a clinical-stage biotechnology firm focused on the development of allogeneic cell therapies to restore and replace specific cell types of the human body, announced that it has entered into an exclusive option and license agreement with Eterna Therapeutics Inc. (Eterna) for the development of innovative beta 2 microglobulin (B2M)-deficient induced pluripotent stem cell (iPSC) lines that Lineage will assess for the creation of unique, differentiated cell transplant therapies.
These new cell lines to be developed by Eterna are expected to help Lineage generate more product candidates for the treatment of central nervous system (CNS) conditions and other neurology indications. Eterna holds the exclusive license for the crucial intellectual property associated with this partnership, which it obtained from its discovery partner Factor Bioscience.
Following the agreement, Eterna intends to perform specific gene-editing activities and furnish materials to Lineage for assessment. In addition, the agreement grants Lineage the option to obtain an exclusive license to use and sublicense the new gene-edited cell lines for clinical, preclinical, and commercial purposes in the field of CNS diseases. A distinctive feature of the starting cell line is the targeted elimination of the B2M gene, which is aimed at minimizing the immunogenicity of product candidates generated from the cell lines by inhibiting rejection by CD8+ T cells.
Lineage anticipates that this attribute will enhance the overall usefulness of the edited cell lines, including non-immune privileged or non-human leukocyte antigen (HLA) matched indications. Other proposed gene modifications may additionally differentiate the cell line from those currently utilized by competitors. No details of the financial agreement were disclosed.
About Lineage Cell Therapeutics, Inc.
Founded in 1990, Lineage Cell Therapeutics is a clinical-stage biotechnology company focused on developing novel cell therapies to address unmet medical needs. The company's programs are based on its proprietary cell-based therapy platform and related development and manufacturing capabilities. By using this platform, it specializes in the development and manufacture of specialized, terminally-differentiated human cells from its progenitor and pluripotent cell starting materials. These differentiated cells are intended to either support or replace cells that are dysfunctional or absent due to degenerative disease or traumatic injury and can also be administered to help the body mount an effective immune response to cancer.
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.
CELL AND GENE THERAPY, INDUSTRIAL IMPACT
Scientist.com | February 02, 2023
On February 1, 2023, Scientist.com, the biopharma industry's largest R&D marketplace, announced the release of a new iOS mobile app. The app provides a new, easy-to-use, on-the-go experience for purchase request approvals and compliance. In addition, iPhone users receive untethered notifications for accepting, delegating, and clarifying requests without needing to use their computers. The result is speedier approvals and fewer delays in scientific discovery.
Scientist.com has spent the past fourteen years developing a digital marketplace that allows scientists to devote more time to science and less time to paperwork. The platform enables researchers to test more ideas in less time and at a lesser cost. It digitizes a company's complete research activities, automatically tracking purchases, contract management, payment processing, and generating business intelligence reports.
Scientist.com Founder and CTO Chris Petersen commented, "One of the major barriers to drug discovery is the time it takes to ensure all compliance measures are met for a given research project, and understandably so." He added, "Our goal in building the Compliance Mobile App is to put compliance in the pocket of approvers, therefore minimizing the time it takes for researchers to move through the R&D process."
(Source – Business Wire)
Registered users of the Scientist.com platform can now get the Compliance Mobile App free from the Apple App Store
Founded in 2007, Scientist.com is the world's largest medical research marketplace. Its digital research platform combines a custom-built, cloud-native technology stack with a white-glove customer and scientific support, helping pharmaceutical scientists discover life-saving drugs in less time and at a lower cost. As a result, Scientist.com is accelerating and lowering the cost of medical research by connecting scientists and allowing them to exchange ideas and transact online effortlessly. The company now has a presence in enterprise marketplaces for 20 of the world's top 30 pharmaceutical firms, 80 biotechnology enterprises, and the National Institutes of Health in the United States (NIH).