Xilio Therapeutics, Inc. | November 28, 2022
Xilio Therapeutics, Inc. a biotechnology company developing tumor-activated immuno-oncology therapies for people living with cancer, announced that the company will host a live virtual program on Thursday, December 1, 2022, at 12:30 p.m. ET spotlighting Xilio’s clinical-stage molecule XTX301, a tumor-activated, engineered IL-12.
The event will feature Diwakar Davar, MBBS, M.Sc., a key opinion leader and assistant professor of medicine and a medical oncologist/hematologist from UPMC Hillman Cancer Center. Dr. Davar will discuss the unmet medical need in treating patients with immunologically “cold” advanced solid tumors and the differences between “cold” and “hot” tumors in the tumor microenvironment as well as the potential for IL-12 as a compelling immunotherapy target across tumor types due to its ability to activate both the innate and adaptive immune system.
Xilio executives René Russo, Pharm.D., chief executive officer, Marty Huber, M.D., president and head of R&D, and Uli Bialucha, Ph.D., chief scientific officer, will discuss the company’s clinical-stage molecule, XTX301, a unique tumor-activated, engineered IL-12 designed to potently stimulate anti-tumor immunity and reprogram the TME of poorly immunogenic “cold” tumors towards an inflamed state, while limiting systemic toxicity. The Xilio team will also cover the adaptive design for the planned Phase 1 trial for XTX301 and anticipated clinical development timeline.
To register in advance for the webcast, please click here. A live webcast of the event will also be available under “Events and Presentations” in the Investors & Media section of Xilio’s.
Diwakar Davar, MBBS, M.Sc.
Dr. Davar is an assistant professor of medicine and a medical oncologist/hematologist at UPMC Hillman Cancer Center. He specializes in the management of advanced melanoma and the development of early phase studies to test novel immunotherapeutic approaches to treat advanced cancers. Dr. Davar is board-certified in internal medicine and medical oncology. He received his medical degree from National University of Singapore, and he completed both his residency and fellowship at UPMC. Dr. Davar is a member of many professional organizations, including the American Association for Cancer Research, American Society of Clinical Oncology, Allegheny County Medical Society, American College of Physicians, and Singapore Medical Association.
About XTX301, a Tumor-Activated, Engineered IL-12
XTX301 is an investigational tumor-activated, engineered IL-12 molecule designed to potently stimulate anti-tumor immunity and reprogram the TME of poorly immunogenic “cold” tumors towards an inflamed state. IL-12 plays a key role in bridging innate and adaptive cellular immunity, making it a compelling target for immunotherapy. However, life-threatening toxicity observed with systemically active IL-12, including severe liver toxicity, have limited the therapeutic potential of IL-12 agents. In November 2022, Xilio announced that the U.S. Food and Drug Administration cleared the company’s investigational new drug application for the evaluation of XTX301 as a potential treatment for patients with advanced solid tumors.
About the Planned Phase 1 Clinical Trial for XTX301
The planned Phase 1 clinical trial for XTX301 is a first-in-human, multi-center, open-label trial designed to evaluate the safety and tolerability of XTX301 as a monotherapy in patients with advanced solid tumors.
About Xilio Therapeutics
Xilio Therapeutics is a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology therapies with the goal of significantly improving outcomes for people living with cancer without the systemic side effects of current I-O treatments. The company is using its proprietary platform to build a pipeline of novel, tumor-activated molecules, including cytokines and other biologics, which are designed to optimize their therapeutic index and localize anti-tumor activity within the tumor microenvironment. Xilio is currently advancing multiple programs for tumor-activated I-O treatments in clinical development, as well as programs in preclinical development.
CELL AND GENE THERAPY
CBC Group | November 21, 2022
RVAC Medicines Pte. Ltd. a messenger RNA technology platform company incubated by CBC Group, a healthcare-dedicated asset management firm headquartered in Singapore, and the Agency for Science, Technology and Research (A*STAR) today announced the signing of a master research collaboration agreement to jointly study and develop solutions to build mRNA manufacturing and analytics capabilities in Singapore.
With this collaboration, RVAC and A*STAR will set up a joint laboratory based at A*STAR's Bioprocessing Technology Institute (BTI) to develop a preclinical manufacturing platform, which will facilitate the generation of novel raw materials and potentially clinical-grade assets for the development of mRNA vaccines and therapeutics targeting infectious diseases and other conditions with unmet needs.
Leveraging BTI's deep expertise in processing technologies and analytical sciences for biotherapeutics and the strong translational research in biomedical technologies across multiple research institutes in A*STAR, this collaboration seeks to enable local ecosystem innovators and global manufacturers to access the manufacturing platform to aid in preclinical asset development.
The collaboration utilizes RVAC's extensive capabilities in mRNA, vaccine, and drug delivery technologies, as well as knowledge and expertise in biopharmaceutical manufacturing, research and development clinical development, and commercialization. RVAC develops mRNA-based vaccines targeting infectious diseases such as COVID-19, for which it initiated a first-in-human vaccine clinical trial in September 2022. Additional RVAC pipeline assets in development include vaccines targeting respiratory syncytial virus and Clostridioides difficile infections. Since its founding in June 2021, RVAC has recruited a team of more than 80 top-tier scientists and experienced industry veterans, and has established R&D centres in Boston, MA, USA and Shanghai, PRC.
"Our collaboration with A*STAR brings together innovative research and development experience from some of the world's leading mRNA researchers. We are committed to providing the staff, equipment, and technological expertise, with support from our R&D teams around the world, to this endeavour. Combined with A*STAR's knowledge and experience, this partnership has the potential to continue the advancement of mRNA as a new class of medicines."
Dr Sean Fu, Chief Executive Officer of RVAC
Professor Ng Huck Hui, Assistant Chief Executive, Biomedical Research Council, A*STAR, said, "Public-private partnerships are key enablers in translating science into impact. A*STAR's multidisciplinary R&D capabilities in infectious diseases, artificial intelligence, analytics and protein engineering, coupled with RVAC's expertise, will advance the development of mRNA vaccines and therapeutics and contribute to better health outcomes for Singapore and beyond."
Fu Wei, Chief Executive Officer, CBC Group added, "The collaboration between RVAC and A*STAR is a significant step in supporting the growth of innovative R&D that will ultimately drive the development of advanced vaccines and therapeutics to benefit more patients. This is aligned with CBC's mission of delivering quality and accessible medical innovation across Asia and beyond. The collaboration will also enhance the technological capability of our ecosystem, which fits well with Singapore's commitment to mission-oriented and curiosity-driven R&D."
About RVAC Medicines
RVAC Medicines is an mRNA platform company headquartered in Singapore with R&D centers in Boston and Shanghai. Leveraging its mRNA technology and strategic partnerships, the company is building a pipeline of novel mRNA vaccines and therapeutics to address unmet medical needs, particularly in emerging markets. The company is led by an experienced management team, supported by a world-renowned scientific advisory board.
About CBC Group
Headquartered in Singapore, CBC Group is Asia's largest healthcare-dedicated asset management firm, focusing on platform-building, buyout, credit/royalty, and real estate across the healthcare space, including pharmaceutical and biotech, medical technology and healthcare services. CBC is committed to creating lasting value by integrating global innovations and talents. Partnering with the world's top entrepreneurs and scientists, its unique "investor-operator" approach has empowered leading healthcare companies to widen access to affordable medical care, catalyse innovations and improve efficiency in fulfilling unmet medical needs worldwide. Founded in 2014, CBC has built a world class team of investment, industry and portfolio management professionals, headquartered in Singapore with locations in Shanghai, Beijing, Hong Kong, New York, London, and Seoul.
About the Agency for Science, Technology and Research
The Agency for Science, Technology and Research is Singapore's lead public sector R&D agency. Through open innovation, we collaborate with our partners in both the public and private sectors to benefit the economy and society. As a Science and Technology Organisation, A*STAR bridges the gap between academia and industry. Our research creates economic growth and jobs for Singapore, and enhances lives by improving societal outcomes in healthcare, urban living, and sustainability. A*STAR plays a key role in nurturing scientific talent and leaders for the wider research community and industry. A*STAR's R&D activities span biomedical sciences to physical sciences and engineering, with research entities primarily located in Biopolis and Fusionopolis.
CELL AND GENE THERAPY
Delfi Diagnostics | September 12, 2022
Delfi Diagnostics, a pioneering developer of a new class of high-performance, accessible liquid biopsy tests for early cancer detection and monitoring, has been selected as the liquid lung cancer biopsy partner in Europe's multi-national, randomized, prospective lung cancer screening trial known as 4-IN-THE-LUNG-RUN, or 4ITLR.
Through 4ITLR, European investigators are studying how often – every year, or every other year – individuals should get screened if their initial CT scan is negative. Delfi's technology is paired to the study objectives by measuring whether Delfi can identify individuals in Europe's screen-eligible population who are most likely to benefit from a CT scan. The collaboration, initiated and facilitated through a partnership between the Netherlands Cancer Institute ((NKI), with Dr. D. van den Broek as PI) and the institute for DiagNostic Accuracy (iDNA), includes Delfi analyzing the first 9,000 subjects enrolled through the trial in the Netherlands and France (Gustave Roussy) - generating data that can support Delfi's research and subsequent implementation within the European Union.
"One of the goals of our study is to examine how a liquid biopsy test might improve screening in a manner that is cost-effective. We are eager to explore how a low-cost liquid biopsy platform could help us screen more high-risk Europeans."
prof. Matthijs Oudkerk, MD, PhD, Chief Scientific Officer at iDNA and leading the Radiology and AI readings of 4ITLR
Based on the results of the NELSON trial, the European Union is expected to initiate a European lung cancer screening program for individuals at risk due to their smoking and age.
"We know that LDCT screening is effective in reducing lung cancer mortality," said Peter B. Bach, Delfi Diagnostics Chief Medical Officer. "This study should lay the groundwork for widespread, cost efficient screening of those at risk in Europe. Delfi is honored to be part of it."
Lung cancer kills more than 380,000 Europeans each year, and more than half of all new lung cancer diagnoses in Europe occur at stage IV, when 5-year survival rates can be as low as 2 percent. But screening older heavy smokers with low-dose CT could save up to 80,000 lives in Europe per year.
About Delfi Diagnostics
Delfi is developing a new class of liquid biopsy tests for early detection based on altered genome-wide fragmentation profiles, also known as "fragmentomes," representing aberrant packaging of DNA in cancer cells. By applying advanced machine learning algorithms, these fragment patterns are detectable at a very low sequencing cost. Delfi is using this technology to develop highly sensitive and specific cancer detection assays intended for wide and cost-effective distribution and adoption.
About The Netherlands Cancer Institute (NKI) and CVV
The NKI is among the world's foremost comprehensive cancer centers, combining innovative fundamental, translational, and clinical research with dedicated patient care. Our research institute gratefully acknowledges funding from the Dutch Ministry of Health, Welfare and Sport, the Dutch Cancer Society, and individual donors. The NKI Center for Early Diagnostics is an initiative of the NKI. Our Center combines innovation and scientific research to provide certainty in an early stage for risk factors or signs that may indicate cancer.
iDNA is a Contract Research Organization specialized in early-stage lung cancer, and researching new technologies for the early detection and treatment of lung cancer, with comorbidities in cardiovascular diseases and COPD/emphysema. Key to the early detection of lung cancer are high quality lung cancer screening programs and therefore iDNA wants to set the ''golden standard'' for worldwide lung cancer screening. iDNA works with relevant, early-stage, asymptomatic, high- to medium-risk lung cancer (sub)populations, up to a large, multi-national scale. In addition, iDNA provides several services facilitating the required validation of liquid- and imaging biomarkers and/or therapeutics, while working with KOLs and research partners worldwide. iDNA thereby provides leading pharmaceutical, biotech and AI partners with the opportunity to implement their disruptive technology much quicker and more cost-effective, fully capitalizing on the current momentum within the lung cancer screening landscape.
About Gustave Roussy
Ranked as the leading European Cancer Centre and sixth in the world, Gustave Roussy is a centre with comprehensive expertise and is devoted entirely to patients suffering with cancer. The Institute is a founding member of the Paris Saclay Cancer Cluster. It is a source of diagnostic and therapeutic advances. It caters for almost 50,000 patients per year and its approach is one that integrates research, patient care and teaching. It is specialized in the treatment of rare cancers and complex tumors and it treats all cancers in patients of any age. Its care is personalized and combines the most advanced medical methods with an appreciation of the patient's human requirements. In addition to the quality of treatment offered, the physical, psychological and social aspects of the patient's life are respected. 4,100 professionals work on its two campuses: Villejuif and Chevilly-Larue.
CELL AND GENE THERAPY
Cimeio | November 29, 2022
Cimeio Therapeutics, a biotechnology company developing a novel approach to cell therapies, today announced the U.S. Patent Office has issued a key patent covering the company’s Shielded-Cell & Immunotherapy Pairs platform.
U.S. Patent No. 11,499,168 covers a method for in vivo selective depletion of edited primary hematopoietic cells or non-edited primary hematopoietic cells. This method was first discovered and developed in the lab of company founder Lukas Jeker, M.D., Ph.D., at the University of Basel, and is exclusively licensed to Cimeio.
“This comprehensive intellectual property provides broad protection for our platform. We believe this patent, along with those we’ve filed for our target antigen and immunotherapy portfolio, cements us as a leader in the emerging field of cell shielding and will enable the broad development of our SCIP platform.”
Cimeio CEO Thomas Fuchs
Cimeio uses genome editing to insert novel protein variants into hematopoietic stem cells or other types of cells, allowing the cells to maintain their function while making them resistant to paired immunotherapy depletion. Cimeio’s platform has effectively shielded cells from depletion mediated by antibodies, T-cell engagers, ADCs, and CAR-T cells in preclinical studies.
The company is advancing its first programs towards clinical development for genetic and malignant hematologic diseases. As previously disclosed, two posters for the company’s pipeline programs will be presented at the American Society of Hematology meeting in December 2022 in New Orleans.
Cimeio is an applied gene editing and immunotherapy company developing a portfolio of Shielded-Cell & Immunotherapy Pairs® which has the potential to transform hematopoietic stem cell transplant. Cimeio’s technology platform is based on the design and expression of modified variants of naturally occurring cell surface proteins in HSCs. These novel variants maintain their function but are resistant to depletion when targeted by a paired immunotherapy which has high affinity for the wild-type version of these proteins. This technology has significant therapeutic potential, which Cimeio is using to develop curative treatments for patients with genetic diseases, hematologic malignancies, and severe autoimmune disorders.