CELL AND GENE THERAPY

Zhongchao Inc. Announces its New Strategy Extension Focusing on the Oncology and Other Major Disease Management

Zhongchao Inc. | September 02, 2022 | Read time : 03:00 min

Zhongchao Inc.
Zhongchao Inc. an internet technology company offering healthcare professionals the online healthcare information, professional training and educational services platform and patient management service, today announced its newly added business section of  oncology and other major disease management which is a part of its development strategy to extend its business model from "Medical-Pharmaceutical" to  "Medical-Pharmaceutical-Patient." Utilizing its accumulated experiences in medical education and innovation, and extensive resources with medical professionals and pharmaceuticals, Zhongchao is well positioned to become a platform that provides patients with major disease management services.

The Company has implemented several strategic initiatives to transform to the new "Medical-Pharmaceutical-Patient" model. In 2021, Zhongchao launched patient management business focusing on the professional field of tumor and rare disease through its subsidiary Shanghai Zhongxin Medical Technology Co., Ltd. which was the important first step of the transform. The strategy to extend business model was driven by the increased demands of "patient-oriented" healthcare in China. Management have been closely observing and monitoring such service model that is to provide medical services and disease management tailored to individual patient and allow patient to actively initiate and participate in health management and disease treatment since its appearance in 2021. It is worth to mention that the Company's self-developed patient management system successfully improved Duration of Therapy ("DOT") by 40.4% for liver cancer patients, contributing to the maximum efficiency of drugs, successful treatment and longer patient survival terms, as compared to patients without using the management system, based on the data collected by the Company during a period from November 2017 to September 2021. As a result, the Company plans to continue the development of patient management services through Zhongxin.

As of now, Zhongxin provides comprehensive disease education and management services for tumor patients receiving treatment. Through services such as drug aids, disease follow-up visits, medication management, and cancer education promotion, Zhongxin helps tumor patients reduce the economic burden of treatment and promote the completion the treatment process, resulting in the best treatment effect and improvement the quality of life for the patients. As of now, more than hundreds of thousand oncology Patients have used either the application developed by Zhongxin or WeChat network service platform to connect patients with Zhongxin's hotline center and service commissioner system and received disease management support.

"As a digital platform for medical education in China, Zhongchao continues to provide scientific and reliable medical information to patients and healthcare professionals. We are committed to driving digital innovation in healthcare and patient services, and gradually extending our business model to "Medical-Pharmaceutical-Patient " for oncology and other major disease management services. We believe that our new business model will enable more effective treatment systems for individual well-being, improved patient experience, optimal allocation of resources and bring more values to our shareholders going forward."

Weiguang Yang, Chairman and Chief Executive Officer of Zhongchao

About Zhongchao Inc.
Zhongchao Inc. is an offshore holding company incorporated in the Cayman Islands. It conducts operations in China through the contractual arrangements between its wholly owned subsidiary and PRC operating entities. The PRC operating entities provide online healthcare information, professional training and educational services to healthcare professionals under their "MDMOOC" platform (www.mdmooc.org), offer patient management service on the professional field of tumor and rare diseases, and operate an online information platform, Sunshine Health Forums, to general public.

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MEDTECH, INDUSTRIAL IMPACT

Generate Biomedicines Expands Leadership Team with Chief Digital Officer

Generate Biomedicines | December 07, 2022

Generate Biomedicines announced that Dimitris Agrafiotis, Ph.D., FRSC, has been appointed Chief Digital Officer. He will lead multidisciplinary teams across technology, data science, automation, and digital transformation to support the rapid growth of the machine learning-powered biotech. Dr. Agrafiotis brings deep expertise at the intersection of digital technology, data science, and life sciences spanning the entire R&D continuum across venture-funded biotech, big pharma, and the services industry. He was Vice President at Pfizer Digital, where he was responsible for the digital strategy and portfolio for Pfizer’s Worldwide Research, Development and Medical organization. Prior to that, he served as Chief Information Officer of the Novartis Institutes for Biomedical Research leading Novartis’ global digital and informatics organization for its research and early development division. “We’re delighted and proud to welcome Dimitris to the Generate team to help us expand and scale our technology and generative biology platform as we enter this exciting new phase in the company’s evolution. Dimitris’ unique blend of digital, data, and life science experience and impressive record of innovation will help us revolutionize drug discovery and development and create life-saving treatments for some of the world’s most pressing medical needs.” Mike Nally, Chief Executive Officer of Generate Biomedicines Dr. Agrafiotis pointed out, “I’m thrilled and honored to be part of this supremely talented team that combines generative AI with leading-edge automation and wet-lab science to reprogram human biology and transform the discovery and development of protein therapeutics at a speed and scale never seen before in our industry.” Dr. Agrafiotis has co-authored more than 100 peer-reviewed publications and book chapters, and he holds 18 U.S.-issued patents. In 2012 he was elected Fellow of the Royal Society of Chemistry for his contributions to chemical and pharmaceutical research, and in 2016 he was named one of Computerworld’s Premier 100 Technology Leaders for his technology leadership and innovative approaches to business challenges. Dr. Agrafiotis received a bachelor’s degree in chemistry from the University of Patras in 1985 and a doctorate degree in theoretical organic chemistry from Imperial College London in 1988. He held postdoctoral fellowships at the University of California, Berkeley and Harvard, where he worked with Nobel laureate EJ Corey. About Generate Biomedicines Generate Biomedicines is the first drug generation company, pioneering a machine learning-powered generative biology platform with the ability to generate new drugs on demand across a wide range of biologic modalities. The platform can drastically improve the speed at which targets and therapeutics are identified and validated, the specificity of target engagement by generated proteins, and the cost of identifying and developing clinical candidates. The company’s platform represents a potentially fundamental shift in what’s possible in the field of therapeutic development, addressing key challenges of drug discovery and drastically expanding the available search space for novel biomedicines. Generate Biomedicines was founded by Flagship Pioneering after two years of foundational research in its Labs unit and launched in 2020.

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INDUSTRIAL IMPACT

Xilio Therapeutics to Host Live Virtual Program Spotlighting XTX301, a Tumor-Activated IL-12

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. Webcast Information 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.

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INDUSTRIAL IMPACT, MEDICAL

BioVaxys and Procare Health Execute US Distribution Agreement for Papilocare Gel and Oral Immunocaps

BioVaxys Technology Corp. | December 20, 2022

BioVaxys Technology Corp. and Procare Health Iberia, of Barcelona, Spain announced that they have finalized and executed the United States Distribution Agreement for Papilocare® and Oral Immunocaps©. Following the binding Term Sheet executed by the two companies in early October 2022, the Distribution Agreement finalized all remaining aspects of the transaction. Developed by Procare Health, Papilocare® is the world's first and only patented vaginal gel product with clinical evidence to prevent and treat HPV-dependent cervical lesions. Immunocaps®, which can be used on its own or together with Papilocare®, is an oral over-the-counter nutritional supplement that supports immune function and vaginal microbiota to help re-epithelialization of cervical lesions. Yann Gaslain, Founder and CEO of Procare Health Iberia commented: "We are delighted with this agreement, and if Papilocare® is approved by the FDA, to be able to provide access to millions of American women to a new treatment for cervical lesions caused by HPV. Papilocare is already approved in Europe and is available in 46 countries worldwide. In several clinical trials involving more than 600 patients, Papilocare© showed consistent and significant efficacy in normalizing cervical cytology at three months and at six months in the total study population with 50% to 70% of High-Risk HPV clearance at six months." BioVaxys will immediately begin pursuit of regulatory approval for Papilocare® with the US Food and Drug Administration and anticipates US registration as a Class II medical device. As Immunocaps® is an OTC supplement, BioVaxys anticipates that regulatory approval will not be required, allowing the rapid build out of sales channels and revenue generation from the product. BioVaxys plans to begin stocking and distributing Immunocaps© in early 2023. As per the Term Sheet executed in October, BioVaxys and Procare Health will begin discussions on the Company's right-of-refusal in the United States for Ovosicare® and Libicare®, Procare Health's over-the-counter supplements to support fertility enhancement for late maternity or IVF processes and Menopausal symptoms improvements which includes low libido among women suffering menopausal changes. "We are delighted to have been selected by Procare Health to market Papilocare® and Immunocaps© in the US, and together with Procare Health we look forward to playing a major role in the treatment of cervical lesions caused by HPV and what we hope is an accompanying reduction in cases of cervical cancer." Kenneth Kovan, President & Chief Operating Officer at BioVaxys Founded in 2012, Procare Health is a leading privately held pharmaceuticals company in the Women's Health field based in Spain with several affiliates in Europe including France, Portugal, and the UK, and marketed products including Papilocare®, Libicare®, Palomacare®, Idracare®, Pronolis HD® and Ovosicare®. Procare Health commercializes its products within more than 60 countries in the world via distribution agreements with well-known and established pharmaceuticals company within the Women's Health field. Left untreated, HPV infection can lead up to cervical cancer. In Procare Health's PALOMA Phase IIb clinical trial for Papilocare, which results were recently published into the Journal of Lower Genital Tract Disease, Papilocare® showed consistent and significant efficacy in normalizing cervical cytology at 3 months and at 6 months in the total study population, with 50% to 70% of High-Risk HPV clearance at 6 months in six different international studies and more than 600 patients. HPV infection causes 528,000 cases of cervical cancer and 266,000 cervical cancer deaths each year.1 Papilocare® has a CE mark valid for the entire EU and is currently marketed as a Class IIa medical device in Spain, France, Portugal, Italy, the UK, Germany, Belgium, Luxembourg, Lithuania, Latvia, Poland, Czech Republic, Hungary, Bulgaria, Romania, Greece, Balkans, Ukraine, Mexico, Colombia, Vietnam, and Kenya. A "CE mark" indicates that a product and the manufacturer has been assessed by a Notify Body under the new MDR EU regulation and deemed to meet EU efficacy and safety, health, and environmental protection requirements. It is required for products manufactured anywhere in the world that are then marketed in the EU. Additionally, Procare Health has been granted the ISO 13485 Medical device certification and the MDSAP certification which recognizes the company as a validated worldwide manufacturer. About BioVaxys Technology Corp. Based in Vancouver, BioVaxys Technology Corp. is a British Columbia-registered, clinical stage biotechnology company that is developing viral and oncology vaccine platforms, as well as immuno-diagnostics. The Company is advancing vaccines for SARS-CoV-2, SARS-CoV-1, and a pan-sarbecovirus vaccine based on its haptenized viral protein technology, and is planning a clinical trial of its haptenized autologous cell vaccine used in combination with anti-PD1 and anti-PDL1 checkpoint inhibitors that will initially be developed for Stage III/Stage IV ovarian cancer. Also in development is CoviDTH™, a diagnostic for evaluating the presence or absence of a T cell immune response to SARS-CoV-2, the virus that causes COVID-19. BioVaxys has two issued US patents, and multiple US and international patent applications related to its cancer vaccines, antiviral vaccines, and diagnostic technologies.

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INDUSTRIAL IMPACT, MEDICAL

Can-Fite’s Partner Vetbiolix is Heading into a European Multicentric Clinical Trial with Piclidenoson for the Treatment of Pets’ Osteoarthritis

Can-Fite BioPharma | December 09, 2022

Can-Fite BioPharma Ltd. a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, today announced progress achieved in the development of Piclidenoson for` the treatment of osteoarthritis in dogs by the Company’s veterinary commercialization partner Vetbiolix, which is covering all costs associated with veterinary clinical development. The canine osteoarthritis market is projected to reach $3 billion by 2028. Vetbiolix completed dose-ranging pharmacokinetic studies in dogs and determined the optimal efficacy and safety dosage for its upcoming European multicentric clinical study. Piclidenoson was well tolerated, with the PK data proportional to dose. Pre-clinical studies were also conducted showing Piclidenoson has a very favorable safety profile. Based on these data, Vetbiolix has designed a European Multicentric Clinical study protocol for dogs with osteoarthritis which has been approved by an ethical committee. There is clear need in the market for a safe and effective canine osteoarthritis drug. Current treatments for canine osteoarthritis include oral non-steroidal anti-inflammatory drugs (NSAIDs) which only treat symptoms and carry significant harmful side effects and an injectable disease-modifying osteoarthritis drug that targets the progression of the disease. “As Piclidenoson advances into a European Multicentric Clinical study for canine osteoarthritis in 2023, we are hopeful that our lead drug candidate, which has produced very good safety and efficacy results in human autoimmune diseases, will do the same for dogs. This veterinary indication offers Can-Fite the opportunity to get Piclidenoson onto the market faster to benefit canines, while also potentially contributing near-term revenues. We are very pleased to work productively with the team at Vetbiolix.” Can-Fite CEO Dr. Fishman In June 2021, Can-Fite entered an agreement with Vetbiolix, a France-based veterinary biotech company, for the treatment of osteoarthritis in companion animals including dogs and cats. Vetbiolix has the exclusive right to Piclidenoson in the veterinary osteoarthritis market for two years, during which time Vetbiolix is conducting studies and covering all associated costs. If the efficacy study yields positive data and Vetbiolix exercises its option to obtain the license from Can-Fite, then Vetbiolix will be obligated to pay Can-Fite upfront and milestone payments, in addition to royalties on sales upon regulatory approval. About Piclidenoson Piclidenoson is a novel, first-in-class, A3 adenosine receptor agonist (A3AR) small molecule, orally bioavailable drug with an excellent safety and efficacy profile demonstrated in a Phase III clinical study in psoriasis. The drug’s mechanism of action entails inhibition of the inflammatory cytokines interleukin 17 and 23 (IL-17 and IL-23) and the induction of apoptosis of patients’ skin cell keratinocytes involved with the disease pathogenicity. About Can-Fite BioPharma Ltd. Can-Fite BioPharma Ltd. is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion dollar markets in the treatment of cancer, liver, and inflammatory disease. The Company's lead drug candidate, Piclidenoson recently reported topline results in a Phase III trial for psoriasis. Can-Fite's liver drug, Namodenoson, is being evaluated in a Phase IIb trial for the treatment of non-alcoholic steatohepatitis (NASH), and enrollment is expected to commence in a Phase III trial for hepatocellular carcinoma (HCC), the most common form of liver cancer. Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. CF602, the Company's third drug candidate, has shown efficacy in the treatment of erectile dysfunction. These drugs have an excellent safety profile with experience in over 1,500 patients in clinical studies to date.

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