CELL AND GENE THERAPY

Discovery Life Sciences Launches GMP Compliant Discovery Leukopaks™ to Accelerate Research and Development of Cell and Gene Therapies

Discovery Life Sciences | October 28, 2020

Discovery Life Sciences™ (Discovery), a global leader in biospecimen, genomic sequencing, cell, and immunohistochemistry (IHC) services, announces the launch of GMP-compliant Discovery Leukopaks™ and other cell-based products for use in human cell and gene therapy research, development and manufacturing programs. Cell and gene therapies have revolutionized treatment approaches to cancer and other complex diseases. Acceleration of the manufacturing and development of these novel therapies requires fast and reliable access to high quality, well-characterized human cellular raw materials.  Discovery's reputation for speed and quality will be a boon to researchers around the globe. Discovery's launch of GMP-compliant Discovery Leukopaks and derivatives adds to Discovery's existing RUO (research-use-only) fresh and cryopreserved leukopaks and isolated immune cell populations.  Discovery's next-generation short and long read sequencing and flow cytometry services can be incorporated to provide highly characterized, reliable human cellular materials for research, development, and GMP manufacturing.

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CELL AND GENE THERAPY

Bicycle Therapeutics Announces Continued Clinical Progress and Updates to Management Team

Bicycle Therapeutics | January 06, 2022

Bicycle Therapeutics plc, a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide technology, announced continued progress in its ongoing Phase I/II clinical trials of BT8009, BT5528 and BT7480. “Last quarter, we reported interim clinical results from ongoing trials of two of our Bicycle toxin conjugates, BT8009 and BT5528, demonstrating preliminary anti-tumor activity in two tumor types, and announced the first patient dosed in the Phase I clinical trial of BT7480, our first tumor-targeted immune cell agonist to enter the clinic. In our trial of BT8009, we are pleased to confirm the preliminary activity and see that these patients remain on trial. We look forward to presenting interim BT8009 Phase I results at a medical meeting and initiating the BT5528 expansion cohorts this year. We are also pleased with our progress advancing BT7480 in the ongoing Phase I clinical trial and look forward to sharing additional details regarding the potential for Bicycles beyond our toxin conjugates as we strive to become a leader in the development of targeted oncology therapeutics.” Kevin Lee, Ph.D., Chief Executive Officer Bicycle Toxin Conjugates® (BTCs) BT8009 and BT5528 In the ongoing Phase I portion of the Phase I/II clinical trial of BT8009, a second-generation BTC™ targeting Nectin-4, four out of 11 patients were previously reported to have a partial response under Response Evaluation Criteria in Solid Tumors version 1.1, including one out of four (25%) in the 2.5mg/m2 dose and three out of seven (43%) at the 5.0 mg/m2 cohorts. All four patients previously reported as responders have since received at least one subsequent scan, and all have been confirmed as ongoing RECIST 1.1 responses. One patient in the 5.0 mg/m2 cohort, who previously was reported to have a partial response with an 89% tumor reduction, has now received two subsequent scans, which each showed that total tumor volume has been reduced by 100%, constituting a confirmed complete response. All four patients previously reported to have a RECIST 1.1 clinical response remain on therapy. The tolerability profile of the 2.5mg/m2 and 5.0 mg/m2 cohorts remains consistent with that previously reported. Dose escalation in the BT8009 Phase I trial remains ongoing, with patients currently being dosed at 7.5mg/m2 weekly or every-other-week. Bicycle intends to present interim Phase I results from the ongoing clinical trial at a medical meeting this year. The Phase I/II trial of BT5528, Bicycle’s second-generation BTC targeting EphA2, is also ongoing, with plans remaining on track to initiate the expansion cohorts this year, with an expected recommended Phase II dose of 6.5mg/m2 every-other-week. Bicycle tumor-targeted immune cell agonist™ (Bicycle TICA™) BT7480 Bicycle also initiated a Phase I clinical trial of BT7480, a novel, fully synthetic Bicycle TICA targeting Nectin-4 and agonizing CD137, in the fourth quarter of 2021, and dose escalation in that trial remains ongoing. BT7480 and other Bicycle TICAs, including a novel NK-cell-engaging molecule, were the subjects of four posters at SITC in November 2021. Management Team Updates Bicycle is also announcing the expansion of and transition in its management team. Michael Skynner, Ph.D., the company’s Chief Operating Officer has been appointed to the newly created position of Chief Technology Officer, effective January 3, 2022, to focus on leading and overseeing the growth of Bicycle’s proprietary phage display discovery platform in oncology, as well as on creating innovative opportunities for the platform outside of oncology. Dr. Skynner joined the company in January 2016 as Vice President, Operations and Discovery and had served as COO since March 2018. Alistair Milnes, who has served as the company’s Vice President, Human Resources and Communications since January 2021, has assumed the COO role. Mr. Milnes previously led human resources and communications at multinational energy and mineral companies. Both Dr. Skynner and Mr. Milnes are based in the United Kingdom. “We are delighted to announce our recent management team appointments, with Mike Skynner becoming our new CTO and Alistair Milnes moving to the COO role. Mike has been an invaluable contributor to Bicycle’s success to date and has led our platform discovery efforts since joining in early 2016. Following recent promising clinical progress, we believe it is time to focus on accelerating the growth of our proprietary oncology pipeline and on identifying innovative ways to potentially capitalize on our unique technology beyond our current therapeutic focus. I am confident that Mike can help us achieve these objectives.” Dr. Lee added, “I am similarly enthusiastic about Alistair’s appointment as COO and believe his operational experience and track record of successfully identifying, recruiting, and retaining key talent at large, multinational companies will be instrumental in helping guide Bicycle through our next phase of growth.” About Bicycle Therapeutics Bicycle Therapeutics is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycles, for diseases that are underserved by existing therapeutics. Bicycles are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry. This constraint facilitates target binding with high affinity and selectivity, making Bicycles attractive candidates for drug development. Bicycle is evaluating BT5528, a second-generation Bicycle Toxin Conjugate targeting EphA2; BT8009, a second-generation BTC targeting Nectin-4, a well-validated tumor antigen; and BT7480, a Bicycle TICA™ targeting Nectin-4 and agonizing CD137, in company-sponsored Phase I/II trials. In addition, BT1718, a BTC that targets MT1-MMP, is being investigated in an ongoing Phase I/IIa clinical trial sponsored by the Cancer Research UK Centre for Drug Development. Bicycle is headquartered in Cambridge, UK, with many key functions and members of its leadership team located in Lexington, MA.

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INDUSTRIAL IMPACT

Canopy Biosciences Launches Next-Generation ChipCytometry™ Instrument for Spatial Biology with Sub-Cellular Resolution

Canopy Biosciences | March 04, 2022

Canopy Biosciences, a Bruker Company, announced the commercial launch of the CellScapeTM system, the next generation in ChipCytometryTM instrumentation, advancing the cutting-edge for quantitative in situ spatial phenotyping. ChipCytometry delivers single-cell targeted spatial proteomics for complex whole-tissue analysis of the tumor microenvironment, as well as deep immune profiling for applications in immunology, neuroscience, and infectious disease. The new benchtop CellScape system builds on the existing core strengths of the original ChipCytometry instrument, the ZellScannerONE™, which has enabled spatial biology research with sub-cellular resolution and a large field of view suitable for whole slide pathology imaging, on both tissue samples and cell suspensions since 2016. The CellScape system , with its multiplexed fluidics integration, adds complete walk-away automation, improved optical performance, sub-cellular resolution and massively increased throughput for whole slide imaging of millions of cells, while maintaining the key features of the core ChipCytometry technology, including high-plex phenotyping with single-cell resolution, very high dynamic range imaging for detection and quantification of both high- and low-expressing targets, and compatibility with standard commercially available fluorescently labelled antibodies, requiring no proprietary antibody conjugation. This powerful combination of features will significantly improve researchers’ workflow, accelerate spatial biology discovery, and drive broader adoption of high-plex spatial omics for translational and clinical applications. “The ChipCytometry platform has been a great tool for us in developing high content staining approaches for in-depth spatial immune profiling of human tissue samples. The improvements to throughput and automation of the CellScape system gives the opportunity to scale up studies and explore larger cohorts – and accelerate studies aimed at improving patient care.” Paul Klenerman, Ph.D., Professor of Gastroenterology at The University of Oxford “Following the acquisition of Canopy Biosciences by Bruker in 2020, we were able to leverage Bruker’s advanced fluorescence microscopy expertise to design the CellScape instrument as an integrated, multiplexed imaging system that is highly optimized for the application of high-throughput quantitative spatial omics with sub-cellular resolution,” added Thomas Campbell, Ph.D., Product Manager at Canopy Biosciences. “The improved optical performance of the system builds on the high resolution and high dynamic range that was already best-in-class with our ChipCytometry technology.” About the CellScape Instrument Through enhanced optics and automation, the throughput of CellScape is markedly improved compared to the previous generation of ChipCytometry instrumentation. Combined with multi-sample automated processing, which is available standard with every CellScape, the platform will have among the highest throughput of any highly multiplexed spatial proteomics system available today. CellScape will also be available with an optional FalconFastTM configuration, which provides an even greater increase in throughput, bringing into reach large-scale clinical studies that have previously not been possible at a high plex. About Canopy Biosciences, a Bruker Company Canopy Biosciences was formed in 2016 and rapidly built a comprehensive portfolio of products and services for spatial biology, multi-omics, and bioprocessing. Canopy offers its ChipCytometry technology for precise spatial multiplexing in cells and tissue samples, along with other technologies of ultrasensitive DNA sequencing (RareSeq), RNA-Seq, and gene expression analysis for services. Canopy Biosciences is headquartered in St. Louis, Missouri, with a CLIA site in California, and a site in Germany to serve researchers at universities, research institutions, and biotechnology and pharmaceutical companies worldwide. Canopy was acquired by Bruker Corporation in 2020.

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MEDICAL

Anixa Biosciences Announces the Initiation of its Ovarian Cancer CAR-T Phase 1 Trial at Moffitt Cancer Center

Anixa | March 31, 2022

Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, today announced the initiation of a Phase 1 trial evaluating its novel chimeric antigen receptor T-cell (CAR-T) therapy in ovarian cancer. The CAR-T approach used for Anixa's therapy is known as chimeric endocrine receptor T-cell (CER-T) since the target of the engineered T-cells is an endocrine receptor. The Phase 1 trial at Moffitt Cancer Center will evaluate the safety and efficacy of Anixa's therapy in patients with ovarian cancer. Anixa holds an exclusive, worldwide license for the technology, which was developed at the Wistar Institute. While CAR-T therapy has shown efficacy in some hematological tumors, reproducing the same results with solid tumors, such as ovarian cancer, has proven challenging. One of the reasons for this difficulty is that effective CAR-T therapy needs a specific antigen to recognize that is only present on target cancer cells in order to avoid negatively affecting healthy cells. The CER-T therapy being evaluated in Anixa's Phase 1 study differs from traditional CAR-T in that it targets the follicle stimulating hormone receptor (FSHR), which research indicates is exclusively expressed on ovarian cells in healthy adult females. We are thrilled to have partnered with world-class scientists at Moffitt Cancer Center to advance our CER-T platform and feel that this partnership provides a critical opportunity to make a significant impact on the treatment of solid tumors, We strongly believe that our unique targeting approach differentiates our CER-T platform from traditional CAR-T approaches and that CER-T has potential to work in solid tumors where other therapies have failed." Dr. Amit Kumar, President, CEO and Chairman of Anixa Biosciences. CAR-T therapies are rapidly becoming an important player in cancer therapy, and our lab has developed a technology that has the potential to target tumors by using an existing biological mechanism that is well understood. If our CER-T approach is successful, it could serve as a model for future targeted CAR-T therapies in other cancer types. The goal in cancer therapy has always been to kill cancer cells with limited damage to healthy tissue, and we look forward to seeing how this CER-T therapy may be able to accomplish that in solid tumors, which have historically proven challenging to eradicate with cell therapy." Jose R. Conejo-Garcia, M.D., Ph.D., Chair of the Department of Immunology at Moffitt Cancer Center and co-inventor of the CER-T technology. About Anixa's CER-T Approach (Follicle Stimulating Hormone Receptor-Mediated CAR-T technology) Anixa's chimeric antigen receptor T-cell (CAR-T) technology approach is an autologous cell therapy comprised of engineered T-cells that target the follicle stimulating hormone receptor (FSHR). FSHR is found at immunologically relevant levels exclusively on the granulosa cells of the ovaries. Since the target is a hormone (chimeric endocrine) receptor, and the target-binding domain is derived from its natural ligand, this technology is known as CER-T (chimeric endocrine receptor T-cell) therapy, a new type of CAR-T. About Anixa Biosciences, Inc. Anixa is a clinical-stage biotechnology company with a number of programs addressing cancer and infectious disease. Anixa's portfolio of therapeutics includes a cancer immunotherapy program being developed in collaboration with Moffitt Cancer Center, which uses a novel type of CAR-T, known as chimeric endocrine receptor T-cell (CER-T) technology, and, with partner MolGenie GmbH, a COVID-19 program focused on compounds targeting the Mpro enzyme of SARS-CoV-2, which is largely conserved across all recently identified variants like Delta and Omicron. The company's vaccine portfolio includes a novel vaccine being developed in collaboration with Cleveland Clinic to prevent breast cancer – specifically triple negative breast cancer (TNBC), the most lethal form of the disease – as well as a vaccine to prevent ovarian cancer. These vaccine technologies focus on immunizing against "retired" proteins that have been found to be expressed in certain forms of cancer. Anixa's unique business model of partnering with world-renowned research institutions on clinical development allows the company to continually examine emerging technologies in complementary fields for further development and commercialization

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CELL AND GENE THERAPY

SOPHiA GENETICS Launches New Deep Learning Capabilities to Support the Detection of Homologous Recombination Deficiencies

SOPHiA GENETICS | March 08, 2022

SOPHiA GENETICS (Nasdaq: SOPH), a leader in Data-Driven Medicine, announced today the launch of their SOPHiA DDM Homologous Recombination Deficiency (HRD) Solution, opening new doors for cancer research. The application provides a unique approach for molecular cancer testing by combining the identification of HRD-causing mutations with the analysis of HRD-induced genomic instability across the whole genome of tumor samples. HRD is caused by a cell's impaired ability to repair DNA double-stranded breaks through the homologous recombination repair (HRR) pathway and is linked with the development of certain cancers. It is also an important predictor of tumor response to treatment with PARP inhibitors. Molecular testing of tumor samples using SOPHiA DDM enables simultaneous detection of both HRR mutations that can cause HRD, including those in the BRCA1 and BRCA2 genes, and the accumulated damage to genomic integrity that can result from them, using shallow whole-genome Next Generation Sequencing. SOPHiA GENETICS is collaborating with AstraZeneca, aiming to expand access to in-house HRD testing across European laboratories and institutions. Providing laboratories with innovative solutions to enable locally-delivered HRD testing is critically important, particularly in settings such as advanced ovarian cancer, where approximately half of all newly diagnosed patients have HRD-positive tumors, We are pleased to work with SOPHiA GENETICS in their mission to empower their laboratory customers and increase the range of options available for HRD detection." Kristina Rodnikova, SVP Global Oncology Diagnostics at AstraZeneca. To combat current challenges with HRD detection offerings, the SOPHiA DDM HRD Solution provides laboratories and institutions with a decentralized approach to HRD testing for tumor samples. The SOPHiA DDM HRD Solution allows the user to retain full ownership of their data and save time and expenses, while also offering comprehensive genomic insights powered by deep learning algorithms. We at SOPHiA GENETICS have always been on a mission to improve health outcomes by advancing data-driven medicine, which is why I am extremely excited to announce the launch of our new HRD research solution, Our SOPHiA DDM HRD Solution will provide researchers and other healthcare professionals with a decentralized approach to fully integrated HRD testing, enabling the HRD status of more advanced ovarian cancer cases to be determined without reliance on send-out testing solutions." Dr. Jurgi Camblong, Co-founder and CEO of SOPHiA GENETICS. About SOPHiA GENETICS SOPHiA GENETICS (Nasdaq: SOPH) is a healthcare technology company dedicated to establishing the practice of data-driven medicine as the standard of care and for life sciences research. It is the creator of the SOPHiA DDM™ Platform, a cloud-based SaaS platform capable of analyzing data and generating insights from complex multimodal data sets and different diagnostic modalities. The SOPHiA DDM™ Platform and related solutions, products and services are currently used by more than 790 hospital, laboratory, and biopharma institutions globally.

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Clinical Pharmaceutical Biotech Clinical & Healthcare • Protocols, patient information and informed consents • Marketing authorisation applications • Patient diaries with Cognitive Debriefing and ReadabilityTesting Publication & Education • Conference presentations • Publications for biomedical journals and text books • Academic manuscripts

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