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
Biocytogen | November 28, 2022
Biocytogen Pharmaceuticals Co., Ltd. announced that it has entered into an evaluation and option agreement with ADC Therapeutics SA. Biocytogen will grant ADC Therapeutics a license to evaluate Biocytogen’s proprietary antibodies against three tumor targets, with an option to license selected antibodies at a later date for global ADC development and commercialization. Biocytogen reserves all global rights for these antibodies beyond ADC development. Biocytogen will receive an upfront payment. For each option exercised, Biocytogen will be entitled to an option-exercise fee, and development and commercial milestone payments, which potentially total tens of millions of US dollars, as well as single-digit royalties on net sales.
Under the agreement, Biocytogen will provide ADC Therapeutics with monoclonal and/or biparatopic antibodies directed against three tumor targets, generated through Biocytogen’s Project Integrum. ADC Therapeutics will carry out feasibility studies and be responsible for further development and commercialization of the ADC products if the company exercises an option.
“ADC Therapeutics is a leader in the development and commercialization of ADCs. We believe this collaboration with ADC Therapeutics will underscore the value of Biocytogen’s proprietary antibody discovery and screening platforms. We’ve been dedicated to expanding the possibilities of antibody-based therapeutics in disease treatment, through the exploration of new types of targets and modalities through Project Integrum. The combination of Biocytogen’s strength in antibody development with ADC Therapeutics’ expertise and track record in payload and linker technology may lead to the generation of novel ADC medicines for unmet medical needs in the future.”
Dr. Yuelei Shen, President and CEO of Biocytogen
“We are pleased to enter this collaboration with Biocytogen as we continue expanding our toolbox to realize the full potential of our ADC platform,” said Patrick van Berkel, PhD, Chief Scientific Officer of ADC Therapeutics. “We look forward to evaluating the fully human antibodies from Biocytogen’s proprietary discovery platform, which have the potential to accelerate the development of our novel ADCs.”
Biocytogen is a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies. Using its proprietary RenMabTM /RenLite® mice platforms for fully human monoclonal and bispecific antibody development, Biocytogen has integrated its in vivo drug efficacy screening platforms and strong clinical development expertise to streamline the entire drug development process. Biocytogen is undertaking a large-scale project to develop first-in-class and/or best-in-class antibody drugs for more than 1000 targets, known as Project Integrum. This project has resulted in 28 drug co-development agreements and 16 RenMiceTM licensing agreements with companies around the world, including several partnerships with multinational pharmaceutical companies (MNCs). The company's pipeline includes 12 core products, among which two products are in phase II multi-regional clinical trials and two products are in phase I. Headquartered in Beijing, Biocytogen has branches in Haimen Jiangsu, Shanghai, Boston, USA and Heidelberg, Germany.
About ADC Therapeutics
ADC Therapeutics is a commercial-stage biotechnology company improving the lives of those affected by cancer with its next-generation, targeted antibody drug conjugates. The Company is advancing its proprietary PBD-based ADC technology to transform the treatment paradigm for patients with hematologic malignancies and solid tumors.
ADC Therapeutics’ CD19-directed ADC ZYNLONTA is approved by the FDA for the treatment of relapsed or refractory diffuse large b-cell lymphoma after two or more lines of systemic therapy. ZYNLONTA is also in development in combination with other agents. In addition to ZYNLONTA, ADC Therapeutics has multiple ADCs in ongoing clinical and preclinical development.
SpectrumX | November 25, 2022
SpectrumX, a UK-based healthcare and pharmaceutical company announces that following a constructive scientific advice meeting with the Medicines and Healthcare products Regulatory Agency on Monday, 14th November, the Company is prepared to move forward with the next stage in clinical development of its respiratory drug candidate SPX-001.
Per regulatory guidelines, SpectrumX will submit a combined Clinical Trial and Ethics Committee application for a placebo-controlled phase Ib influenza viral challenge study of SPX-001 in healthy volunteers to the MHRA in December 2022.
SPX-001 is SpectrumX’s nebulised respiratory infection drug candidate, based on the Company’s licensed hypochlorous acid based SPC-069 drug substance, which is believed to have broad-spectrum antipathogenic properties.
“We believe SPX-001 could be a significant new weapon in the fight against viral respiratory infections, and this is a critical milestone in progressing our drug candidate toward targeted market authorisation approval. We would like to thank the MHRA for their helpful guidance and responses to our initial proposal to begin human clinical trials, and we hope this brings us another step closer to trialling what we believe is a revolutionary treatment for respiratory infections.”
Commenting, Damien Hancox, CEO of SpectrumX
Dr Donna Lockhart, Consulting Head of Medicines at SpectrumX, said: “After productive discussions at a scientific advice meeting with the MHRA, during which we presented our lab-driven data, supporting evidence from existing literature, and key features of our novel solution, SPX-001, supporting its potential effects in combating respiratory infections, as well as our proposed clinical study protocol, I am pleased that we are one step closer to starting our clinical trial programme and the subsequent processes that are essential to market authorisation.”
If approved, this will the first in-human trial to deliver SPX-001 via a nebulizer to test its efficacy and safety versus a placebo treatment in healthy subjects infected with influenza. Following successful completion of the planned trial, SpectrumX will move forward with further trials in patients with respiratory infections to gather the additional necessary data for a market authorisation approval.
As previously announced, SpectrumX has already begun the production process for SPX-001, working with a GMP-certified partner, which will accelerate trial-readiness once requisite approvals have been received.
SpectrumX is a UK-based healthcare and pharmaceuticals company focused on bringing to market an innovative respiratory infection therapy and the roll-out of the most powerful hand sanitiser in the world to the NHS and other healthcare clients. Both products utilise unique, patent-pending HOCl formulations. HOCl is naturally occurring in human white blood cells and is a key contributor in the immune response to infection. HOCl also has direct killing activity against bacteria, viruses and fungi. It is well-tolerated in humans while also being the most effective known disinfectant when used on surfaces.