Collaborative Research Initiative to Advance Innovation in Oncology

JEAN-CHARLES SORIA | May 31, 2019 | 48 views

Collaboration is core to our science and evident in everything we do – from the papers we publish, to the operational tone in our labs, to the partnerships we establish across industry and academia worldwide. And starting in 2019, AstraZeneca is doubling down on its commitment to collaboration – in a very big way.

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JAPARA HEALTHCARE LIMITED

Japara commenced business in 2005 as privately owned company and proceed to grow into one of Australia’s largest private sector operators of residential aged care facilities until publicly listing on the Australian Stock Exchange as Japara Healthcare Limited on the 17th April 2014.

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How to Choose a Reliable Biotech Clinical Trial Management System?

Article | July 20, 2022

Introduction The medical and life-science industries are experiencing a robust transformation with the increasing prevalence of various types of diseases, including infectious diseases, chronic disorders, and acute conditions around the world. As a result, a significant rise in demand for more effective therapeutic drugs and bionics is being witnessed, leading to a swift increase in the number of clinical trials. For a successful trial, it is important for biotech companies to ensure the data submitted to regulatory bodies regarding clinical trials is accurate, reliable, and definitive from an ethical point of view. A reliable clinical trial management system plays a vital role in collecting, monitoring, and managing clinical data. The availability of high-quality clinical data also helps clinical research institutions make efficient treatment decisions and provide proper patient care. Hence, a number of biotech companies and research organizations are focusing on leveraging innovative clinical trial management solutions to handle a large amount of data, particularly in multi-center trials, and generate reliable, high-quality, and statistically sound data from clinical trials. However, selecting the most appropriate and reliable clinical trial management system is vital for the clinical trial's success. Let's see some of the steps that will assist these firms in choosing the right CTMS. Key Steps for Selecting Right Biotech Clinical Trial Management System Prioritize Study Needs Considering and prioritizing study needs is a crucial step in choosing the most reliable clinical trial management system for biotech companies. Prioritizing helps them to identify a solution that improves the study's quality and removes uncertainty for researchers when faced with difficult choices. Hence, biotech and life-science organizations should choose a clinical trial system that is simple to use, well-organized, and suitably designed to minimize the number of clicks required to complete a task. Select CTMS with Multiple Integrations Integrated clinical trial management systems provide the best value for the companies’ funds as they guarantee the smooth functioning of research protocols. In addition, integrations are necessary to fully understand the importance and advantages of clinical trial management software for ensuring smooth transitions between site management and data collection. Biotech and clinical research should look for CTMS platforms that can integrate with electronic medical record (EMR) platforms and clinical research process content (CRPC) billing grids. This will allow them to use the same billing designations and ensure compliance while minimizing the need for duplicate processes. Ensure System Compliance and Security Clinical research organizations need to adhere to a plethora of complex regulations in order to ensure compliance with one of the most challenging environments of principles, which is information security and privacy. Security and system compliance are vital aspects of choosing the right CTMS solutions for biotech firms as they assist in building trust and form a part of the system’s duties. While selecting CTMS systems, it is essential for companies engaged in clinical research to ensure that these platforms are able to configure both, group and individual permissions, along with having a data backup and recovery plan for hosted systems. This will allow companies to assess the privacy and security implications of research and anticipate complications that may arise in each phase of the project. Assess the Scalability Choosing a scalable CTMS that can accommodate various types of fluctuations and expansions enables biotech and clinical firms to quickly adapt to fast-changing trends and demand spikes while reducing maintenance costs and enhancing user agility. As scalability also means secure and expanded data storage, these businesses should instead use SaaS solutions than manually manage an ever-growing collection of hard drives. The right CTMS ensures accommodating the firm’s availability requirements without incurring the capital costs associated with expanding a physical infrastructure. The Closing Thought A well-executed and successful clinical trial involves multiple stages and processes. Several quality controls and stringent adherence to regulations are essential for the steps, along with efficient cross-departmental processes and procedures. Incorporating the right CTMS paves the way for paperless data collection, regulatory filing, and fiscal management tools for biotech researchers and administrative personnel.

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Top 3 Biotech Clinical Data Management Trends to Watch in 2022

Article | July 11, 2022

Introduction The administration of medical records and data has advanced significantly during the past few decades. Clinical data management, which was once only a small subset of biotech research organizations, has now developed into a mission-critical, specialized unit. In the late 1990s, electronic data capture (EDC) began to alter the traditional function of clinical data management. After that, the data configuration and management of data queries for the EDC system fell under the purview of clinical data management services. Today, clinical data management is not only responsible for managing the clinical data configuration and data queries but also developing and implementing data administration plans, ensuring data accuracy and completeness, and maintaining optimum data security. In recent years, as digital technologies have gained acceptance around the globe, data has become a vital aspect in decision-making across numerous industries, and the life sciences and biotechnology sectors are no exception. Using data has provided granular insights to biotech organizations, assisting them in creating breakthroughs in drug development and medical research and signifying the importance of clinical trial management systems in these medical verticals. The Biggest Biotech Clinical Data Management Trends to Know About Today The future of clinical data management is contingent upon the implementation of systems and regulations. It is imperative for all organizations participating in a medical or life science trial to have transparent rules in place for sharing and retaining patient data. Also, there is a need to have a standardized format for maintaining these records and documents related to trials. This assists biotech organizations in reducing the chances of ambiguity regarding who owns what kind of data or paperwork at any given time. Over the past couple of years, the focus of the life science and biotechnology industries has shifted towards developing more effective medications and therapies, implementing personalized treatment, and finding cures for diseases such as cancer and AIDS. In response to this, a substantial rise in the number of clinical trials is being witnessed globally. As the number of clinical trials continues to accelerate, the spending on these trials rises as well. In response to this, the worldwide cost of conducting clinical trials is anticipated to reach US$ 49.80 billion in 2022. With the transition of the world from traditional to digital, medical professionals and biotech businesses are increasingly shifting towards adopting high-tech and reliable clinical trial management systems for various applications, starting from diagnosis and clinical trials to patient data documentation. But, what are the future trends in biotechnology clinical data management? Let’s discuss. Cloud-Based Clinical Metadata Repositories Automation is emerging as a new frontier in the biotech clinical data management domain, along with other innovative technologies such as artificial intelligence and machine learning. Because of this, life science establishments are witnessing a huge shift from paper-based documentation toward data-based documentation, which is creating mountains of research, compliance, and clinical data. The growing demand for new and more effective medications and drugs is augmenting the need to expedite clinical trials. This is resulting in an increased number of initiatives aimed at optimizing clinical trial processes to prepare and launch successful trials. However, pharmaceutical and biotechnology laboratories are encountering several challenges in collecting, managing, and analyzing metadata due to its complexities. So, what is the best solution to this problem? The answer to this is cloud-based clinical metadata repositories. Clinical research facilities are leveraging advanced, all-in-one, cloud-based clinical metadata repositories to assist them in centralizing and managing metadata; increasing metadata quality, consistency, and accuracy; and speeding up clinical trial management, documentation, and compliance processes. Shift Towards Digital Solutions Electronic Case Report Form Adequate research and accurate data are crucial for a clinical trial to succeed. Whether developing new drugs, medication, or therapies; conducting life science research; or studying the latest clinical trial systems, it is best to use electronic solutions as it reduces the room for mistakes during the transition of clinical data from paper-based format. Realizing this, biotech organizations are shifting towards using electronic case report forms to speed up record retrieval, improve record security, and cut down on operational costs associated with running clinical trials. The electronic case report form assists in lowering the failure rate of the clinical trial, enhancing efficiency, and optimizing security along with improving clinical trial documentation and productivity, further driving its adoption in the medical space. Electronic Clinical Outcome Assessment Electronic clinical outcome assessment is surfacing as one of the fast-growing future trends in biotechnology. It allows clinical trial facilities to automate data entry and improve the reliability of the collected information. The technology enables clinical trial institutions to automatically record patient-provided information about side effects, symptoms, drug timing, and other aspects during the clinical trial for increased precision. It also helps these institutions analyze the results of medication or therapy in clinical trials and lets clinical researchers use medical technologies like biosensor-enabled devices, self-service applications, and medical wearables for evaluation. Hence, biotech clinical facilities are increasingly deploying advanced electronic clinical outcome assessment systems to ensure adherence to protocols and regulations. Clinical Trial Customization The success of a new drug is determined by numerous factors other than its effectiveness, safety, and creativity of its developers, such as a successful clinical trial. Each clinical trial involves a number of decision-making points, and one wrong choice in any of these aspects can jeopardize the success of the entire endeavor. A crucial component of making well-informed decisions is data management, which is a part of clinical study as a whole. Clinical trial customization is emerging as one of the most prominent biotech clinical trial management trends. Every clinical trial is unique and needs a tailored approach to be successful. With the emergence of the trend of personalized treatment around the globe, biotech and pharmaceutical organizations are adopting innovative customized clinical trial management solutions to accelerate the pace of clinical trials and approvals. This is giving clinical researchers innovative ways to come up with new medicines for patients and streamline the clinical data as per the requirements for faster approvals. What Are the Key Clinical Data Management Challenges Faced by Biotech Companies? Groundbreaking medical interventions are of no use without reliable, accurate, and extensive clinical trial data. Without the data, biotech and pharmaceutical companies will not be able to provide the assurance of safety and efficacy required to bring the medication to market. Regulatory bodies such as the Food and Drug Administration (FDA), the Medicines and Healthcare Products Regulatory Agency (MHRA), and others are putting stricter rules in place to ensure the quality of clinical data. In addition, the fast-changing clinical development environment is creating more obstacles for biotech and medical spaces to ensure the accuracy, standard, and completeness of the clinical trial data. Hence, clinical teams are spending valuable time cleaning up data instead of analyzing it. Time spent trying to figure out issues with clinical trial data is detrimental and expensive but also mission-critical. This is because a small issue in the data can lead to numerous consequences, from small delays to calamitous setbacks, making it necessary to rerun clinical trials. This problem will only get more challenging to address as the volume of data and the types of data sources continue to grow. Here are some of the major clinical data management challenges that biotech firms encounter Standardization of Clinical Metadata Stringent Regulatory Compliance Increased Clinical Trial Complexity Mid-Study Changes Why Are Clinical Data Management Systems Garnering Popularity in the Biotech Industry? With the changing regulatory and clinical landscape, biotech and pharmaceutical companies are facing several obstacles in the management of clinical data and clinical trials. In addition, regulatory agencies are moving toward integrated electronic systems, which is making it more and more important for clinical laboratories to change the format of their submissions. Because of this, several biotech clinical labs are focusing on adopting innovative laboratory solutions, such as biotech clinical data management systems, to meet the need for standardized data inputs and replace all manual ways of working with electronic systems. A clinical data management system establishes the framework for error-free data collection and high-quality data submission, resulting in speedier drug discovery and shorter time-to-market. These solutions are gaining huge traction among biotech and pharmaceutical companies, owing to their ability to effectively manage clinical data, accelerate clinical trials, and ensure compliance. Let’s see some of the features of biotech clinical data management software that are most sought after by life-science companies Controlled, standardized data repository. Centralized data analysis and administration. Reduced operational expenditures for clinical data processes. Enhanced process effectiveness. Superior submission quality Compliance with predefined standards. Clinical Data Management Systems: The Future The role of clinical data management systems is evolving at a rapid pace as the life science and medical industries continue to incorporate digital solutions for diverse operations. These systems are being used in a variety of biotech clinical settings, ranging from clinical data compliance to data science and analytics, to help them analyze large and growing volumes of clinical data. Hence, a number of high-tech medical companies are aiming at integrating innovative technologies, such as artificial intelligence and machine learning, into clinical data management software to automate clinical data management tasks, improve clinical data submission, and enhance data quality. These new biotech clinical management technologies are anticipated to help life science laboratories gain a better understanding of diseases and speed up clinical trials in the coming years. FAQ What is a clinical data management system? A clinical data management system (CDMS) is a tool used in clinical research to track, record, and manage clinical trial data across medical establishments such as biotech laboratories. What are the key functions of the biotech clinical data management system? Some of the key functions of biotech clinical data management system are Documentation of Protocols and Regulations Patient Recruitment Real-time Clinical Study Analytics Reporting Investigator Relationship Management Electronic Visit Report Why is a clinical data management system needed for clinical trials today? A clinical data management system helps shorten the time from drug development to marketing by assisting in the collection of high-quality, statistically sound, and accurate data from clinical trials.

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MEDTECH

Top 10 biotech IPOs in 2019

Article | September 22, 2022

The big question at the start of 2019 was whether the IPO window would stay open for biotech companies, particularly those seeking to pull off ever-larger IPOs at increasingly earlier stages of development. The short answer is yes—kind of. Here’s the long answer: In the words of Renaissance Capital, the IPO market had “a mostly good year.” The total number of deals fell to 159 from 192 the year before, but technology and healthcare companies were standout performers. The latter—which include biotech, medtech and diagnostics companies—led the pack, making up 43% of all IPOs in 2019. By Renaissance’s count, seven companies went public at valuations exceeding $1 billion, up from five the year before

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Cell Out? Lysate-Based Expression an Option for Personalized Meds

Article | February 18, 2020

Cell-free expression (CFE) is the practice of making a protein without using a living cell. In contrast with cell line-based methods, production is achieved using a fluid containing biological components extracted from a cell, i.e., a lysate. CFE offers potential advantages for biopharma according to Philip Probert, PhD, a senior scientist at the Centre for Process Innovation in the U.K.

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JAPARA HEALTHCARE LIMITED

Japara commenced business in 2005 as privately owned company and proceed to grow into one of Australia’s largest private sector operators of residential aged care facilities until publicly listing on the Australian Stock Exchange as Japara Healthcare Limited on the 17th April 2014.

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INDUSTRIAL IMPACT

Bicycle Therapeutics Announces Expansion of Genentech Immuno-Oncology Collaboration

Bicycle Therapeutics | October 26, 2021

Bicycle Therapeutics plc a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) technology, today announced that Genentech, a member of the Roche Group, has exercised an option to initiate a new program, expanding the exclusive strategic collaboration agreement with Bicycle to discover, develop and commercialize novel Bicycle®-based immuno-oncology therapies. Bicycle and Genentech are collaborating on the discovery and pre-clinical development of novel Bicycle-based immunotherapies against multiple targets. Pursuant to the terms of the February 2020 agreement, Genentech has exercised an option to include a new program under the agreement, triggering a $10 million payment to Bicycle. None of the compounds in Bicycle’s wholly owned oncology pipeline, including its immuno-oncology candidates, are included in the collaboration. “We are pleased both with the progress achieved so far in our ongoing work with Genentech and that Genentech has elected to exercise an option to add a new program under the collaboration. We believe the expansion of our collaboration underscores the potential utility of Bicycles compared to other modalities, as well as the potential broad applicability of Bicycles in a wide-range of targets “We look forward to continuing to work closely with the preeminent immuno-oncology team at Genentech to develop potential new cancer treatments based on Bicycles.” Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics About Bicycle Therapeutics Bicycle Therapeutics (NASDAQ: BCYC) 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 (BTC™) targeting EphA2, and BT8009, a second-generation BTC™ targeting Nectin-4, a well-validated tumor antigen, 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 Centre for Drug Development of Cancer Research UK. Bicycle is headquartered in Cambridge, UK, with many key functions and members of its leadership team located in Lexington, MA. For more information, visit bicycletherapeutics.com. Forward Looking Statements This press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding Bicycle’s collaboration with Genentech; the discovery, development and potential commercialization of potential product candidates using Bicycle’s technology and under the collaboration agreement; the therapeutic potential for Bicycles in immuno-oncology and other applications; and the potential to receive milestone payments and royalties under the strategic collaboration agreement. Bicycle may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: the risk that Bicycle may not realize the intended benefits of its technology or of the collaboration agreement with Genentech, including that Bicycle and Genentech may not successfully identify, develop and commercialize additional product candidates; the risk that Bicycle may not be able to maintain its collaboration with Genentech and realize the benefits thereof; and other important factors, any of which could cause Bicycle’s actual results to differ from those contained in the forward-looking statements, are described in greater detail in the section entitled “Risk Factors” in Bicycle’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 5, 2021, as well as in other filings Bicycle may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and Bicycle expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

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CELL AND GENE THERAPY

Through Cutting-Edge mRNA and AI Technology Platforms, I-Mab Expands Its Emerging Portfolio of Next-Generation Novel Oncology Therapeutics

I-Mab | July 12, 2021

I-Mab, a clinical-stage biopharmaceutical business dedicated to discovering, developing, and commercialization of novel biologics, announced today the signing of two new partnerships with Chinese emerging biotech firms to enhance its next-generation innovation pipeline. Collaborations with Immorna, an mRNA biotech company, and neoX Biotech, an AI-enabled R&D biotech company, provide I-Mab access to revolutionary technologies to search for new cancer treatments. I-Mab will create new anti-cancer antibody therapies using Immorna's ground-breaking self-replicating mRNA technology. Furthermore, I-Mab will collaborate with neoX Biotech on up to ten new biologics programs that will use neoX's unique artificial intelligence algorithm under a strategic partnership agreement. Today's announcement adds to the Company's existing collaboration agreements with Complix for a cell-penetrating antibody platform and Affinity for a masking antibody platform in March 2021, allowing it to continue expanding its globally competitive pipeline of next-generation antibody assets enabled by transformative technologies. The cooperation agreements specify that both partner firms will earn secret upfront and milestone payments. About I-Mab I-Mab is a global biotech business focused on discovering, developing and ultimate commercialization of new and highly distinct biologics in the immuno-oncology therapeutic space. Through drug discovery, the Company's goal is to deliver transformational medicines to patients all around the globe. I-internationally, Mab's competitive pipeline of more than 15 clinical and preclinical stage therapeutic candidates is driven by its internal R&D capabilities and global licensing agreements based on the Company's exclusive Fast-to-Proof-of-Concept and Fast-to-Market pipeline development methods. The Company is quickly transitioning from clinical-stage biotech to a fully integrated global biopharmaceutical company with cutting-edge global R&D capabilities, a world-class GMP manufacturing facility, and commercialization capacity. I-Mab has a global presence in Shanghai, Beijing, Hangzhou, Hong Kong in China, and Maryland and San Diego in the United States. About Immorna Immorna, founded in 2019, is a rapidly expanding biotech company focused on creating self-replicating and traditional mRNA-based therapeutics and vaccines. Immorna has developed a strong CMC platform for mRNA synthesis, purification, and analytical testing since its inception, and it is ideally suited for commercial development. In addition, Immorna has developed an arsenal of mRNA delivery vehicles using cutting-edge screening tools, including polymers and lipid nanoparticles containing multiple proprietary cationic lipids suited for intramuscular, intravenous, or tissue-targeting delivery. Immorna's pipeline is diverse, including cancer immunotherapy, infectious diseases, rare genetic disorders, and cosmetology. Immorna's oncology and infectious disease projects are nearing the clinical stage. Immorna's global presence includes Hangzhou, Shanghai in China, and Wilmington, DE in the United States. About neoX Biotech neoX Biotech is a next-generation biotech firm that focuses on computational design for novel drug research and development. neoX focuses on studying and developing macromolecular medicines and multi-specific drugs by combining artificial intelligence (AI), biophysics, and high-throughput experiments. neoX has created a highly transferable and sophisticated platform for early drug discovery via in-depth protein-protein interaction analysis (PPI). NeoX has shown preclinical success in a number of novel drug pipelines derived from this platform. Founded in 2018 by two physicians from MIT and Caltech, neoX has received over $100 million in funding from renowned venture capital firms such as Sequoia Capital China, 5Y Capital, Vision Plus Capital, Vertex Ventures, LYFE Capital, ZhenFund, and others.

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Researchers identify new way to make cancer self-destruct

Medicalxpress | July 01, 2019

For years, researchers have been trying to target a gene called MYC that is known to drive tumor growth in multiple cancer types when it is mutated or over-expressed, but hitting that target successfully has proven difficult. Now researchers in the Perelman School of Medicine of the University of Pennsylvania have identified a new pathway that works as a partner to MYC and may be its Achilles' Heel. The pathway involves a protein called ATF4, and when it's blocked, it can cause cancer cells to produce too much protein and die. These findings in cell lines and mouse models could point the way toward a new therapeutic approach as inhibitors that can block synthesis of ATF4 already exist. The journal Nature Cell Biology published the findings today. MYC is a gene that controls normal cell growth, but when it is mutated or amplified in cancer, it sets off a chain reaction that helps tumors grow uncontrollably. While there is currently no specific way to target it, previous research has focused on blocking other steps in the chain as a workaround to impede tumor growth. The team, led by Constantinos Koumenis, Ph.D., the Richard Chamberlain Professor of Radiation Oncology and vice chair and research division director of Radiation Oncology, have previously shown that in certain tumors, one of these steps is regulated by a kinase called PERK, which activates ATF4. However, in this new study, they've shown that blocking PERK does not always stop tumor growth because MYC actually controls a second process that can work in parallel as a redundancy in the system. This study identified this second kinase, which is called GCN2.

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INDUSTRIAL IMPACT

Bicycle Therapeutics Announces Expansion of Genentech Immuno-Oncology Collaboration

Bicycle Therapeutics | October 26, 2021

Bicycle Therapeutics plc a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) technology, today announced that Genentech, a member of the Roche Group, has exercised an option to initiate a new program, expanding the exclusive strategic collaboration agreement with Bicycle to discover, develop and commercialize novel Bicycle®-based immuno-oncology therapies. Bicycle and Genentech are collaborating on the discovery and pre-clinical development of novel Bicycle-based immunotherapies against multiple targets. Pursuant to the terms of the February 2020 agreement, Genentech has exercised an option to include a new program under the agreement, triggering a $10 million payment to Bicycle. None of the compounds in Bicycle’s wholly owned oncology pipeline, including its immuno-oncology candidates, are included in the collaboration. “We are pleased both with the progress achieved so far in our ongoing work with Genentech and that Genentech has elected to exercise an option to add a new program under the collaboration. We believe the expansion of our collaboration underscores the potential utility of Bicycles compared to other modalities, as well as the potential broad applicability of Bicycles in a wide-range of targets “We look forward to continuing to work closely with the preeminent immuno-oncology team at Genentech to develop potential new cancer treatments based on Bicycles.” Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics About Bicycle Therapeutics Bicycle Therapeutics (NASDAQ: BCYC) 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 (BTC™) targeting EphA2, and BT8009, a second-generation BTC™ targeting Nectin-4, a well-validated tumor antigen, 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 Centre for Drug Development of Cancer Research UK. Bicycle is headquartered in Cambridge, UK, with many key functions and members of its leadership team located in Lexington, MA. For more information, visit bicycletherapeutics.com. Forward Looking Statements This press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding Bicycle’s collaboration with Genentech; the discovery, development and potential commercialization of potential product candidates using Bicycle’s technology and under the collaboration agreement; the therapeutic potential for Bicycles in immuno-oncology and other applications; and the potential to receive milestone payments and royalties under the strategic collaboration agreement. Bicycle may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: the risk that Bicycle may not realize the intended benefits of its technology or of the collaboration agreement with Genentech, including that Bicycle and Genentech may not successfully identify, develop and commercialize additional product candidates; the risk that Bicycle may not be able to maintain its collaboration with Genentech and realize the benefits thereof; and other important factors, any of which could cause Bicycle’s actual results to differ from those contained in the forward-looking statements, are described in greater detail in the section entitled “Risk Factors” in Bicycle’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 5, 2021, as well as in other filings Bicycle may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and Bicycle expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

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CELL AND GENE THERAPY

Through Cutting-Edge mRNA and AI Technology Platforms, I-Mab Expands Its Emerging Portfolio of Next-Generation Novel Oncology Therapeutics

I-Mab | July 12, 2021

I-Mab, a clinical-stage biopharmaceutical business dedicated to discovering, developing, and commercialization of novel biologics, announced today the signing of two new partnerships with Chinese emerging biotech firms to enhance its next-generation innovation pipeline. Collaborations with Immorna, an mRNA biotech company, and neoX Biotech, an AI-enabled R&D biotech company, provide I-Mab access to revolutionary technologies to search for new cancer treatments. I-Mab will create new anti-cancer antibody therapies using Immorna's ground-breaking self-replicating mRNA technology. Furthermore, I-Mab will collaborate with neoX Biotech on up to ten new biologics programs that will use neoX's unique artificial intelligence algorithm under a strategic partnership agreement. Today's announcement adds to the Company's existing collaboration agreements with Complix for a cell-penetrating antibody platform and Affinity for a masking antibody platform in March 2021, allowing it to continue expanding its globally competitive pipeline of next-generation antibody assets enabled by transformative technologies. The cooperation agreements specify that both partner firms will earn secret upfront and milestone payments. About I-Mab I-Mab is a global biotech business focused on discovering, developing and ultimate commercialization of new and highly distinct biologics in the immuno-oncology therapeutic space. Through drug discovery, the Company's goal is to deliver transformational medicines to patients all around the globe. I-internationally, Mab's competitive pipeline of more than 15 clinical and preclinical stage therapeutic candidates is driven by its internal R&D capabilities and global licensing agreements based on the Company's exclusive Fast-to-Proof-of-Concept and Fast-to-Market pipeline development methods. The Company is quickly transitioning from clinical-stage biotech to a fully integrated global biopharmaceutical company with cutting-edge global R&D capabilities, a world-class GMP manufacturing facility, and commercialization capacity. I-Mab has a global presence in Shanghai, Beijing, Hangzhou, Hong Kong in China, and Maryland and San Diego in the United States. About Immorna Immorna, founded in 2019, is a rapidly expanding biotech company focused on creating self-replicating and traditional mRNA-based therapeutics and vaccines. Immorna has developed a strong CMC platform for mRNA synthesis, purification, and analytical testing since its inception, and it is ideally suited for commercial development. In addition, Immorna has developed an arsenal of mRNA delivery vehicles using cutting-edge screening tools, including polymers and lipid nanoparticles containing multiple proprietary cationic lipids suited for intramuscular, intravenous, or tissue-targeting delivery. Immorna's pipeline is diverse, including cancer immunotherapy, infectious diseases, rare genetic disorders, and cosmetology. Immorna's oncology and infectious disease projects are nearing the clinical stage. Immorna's global presence includes Hangzhou, Shanghai in China, and Wilmington, DE in the United States. About neoX Biotech neoX Biotech is a next-generation biotech firm that focuses on computational design for novel drug research and development. neoX focuses on studying and developing macromolecular medicines and multi-specific drugs by combining artificial intelligence (AI), biophysics, and high-throughput experiments. neoX has created a highly transferable and sophisticated platform for early drug discovery via in-depth protein-protein interaction analysis (PPI). NeoX has shown preclinical success in a number of novel drug pipelines derived from this platform. Founded in 2018 by two physicians from MIT and Caltech, neoX has received over $100 million in funding from renowned venture capital firms such as Sequoia Capital China, 5Y Capital, Vision Plus Capital, Vertex Ventures, LYFE Capital, ZhenFund, and others.

Read More

Researchers identify new way to make cancer self-destruct

Medicalxpress | July 01, 2019

For years, researchers have been trying to target a gene called MYC that is known to drive tumor growth in multiple cancer types when it is mutated or over-expressed, but hitting that target successfully has proven difficult. Now researchers in the Perelman School of Medicine of the University of Pennsylvania have identified a new pathway that works as a partner to MYC and may be its Achilles' Heel. The pathway involves a protein called ATF4, and when it's blocked, it can cause cancer cells to produce too much protein and die. These findings in cell lines and mouse models could point the way toward a new therapeutic approach as inhibitors that can block synthesis of ATF4 already exist. The journal Nature Cell Biology published the findings today. MYC is a gene that controls normal cell growth, but when it is mutated or amplified in cancer, it sets off a chain reaction that helps tumors grow uncontrollably. While there is currently no specific way to target it, previous research has focused on blocking other steps in the chain as a workaround to impede tumor growth. The team, led by Constantinos Koumenis, Ph.D., the Richard Chamberlain Professor of Radiation Oncology and vice chair and research division director of Radiation Oncology, have previously shown that in certain tumors, one of these steps is regulated by a kinase called PERK, which activates ATF4. However, in this new study, they've shown that blocking PERK does not always stop tumor growth because MYC actually controls a second process that can work in parallel as a redundancy in the system. This study identified this second kinase, which is called GCN2.

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