Johns Hopkins researchers develop anti-cancer compound

Pharmaceutical Technology | November 11, 2019

Researchers at Johns Hopkins Medicine in the US have developed a compound to block glutamine metabolism, slowing tumour growth, altering the tumour microenvironment and boosting the anti-tumour T-cell generation. The compound, JHU083, is a prodrug version of glutamine antagonist, DON, designed to become active and functional within the tumour. As glutamine is necessary for tumour metabolism, JHU083 is expected to help treat various cancers. Researchers added that the drug selectively targets tumour cells. Johns Hopkins Kimmel Cancer Center Bloomberg Kimmel Institute for Cancer Immunotherapy associated director Jonathan Powell said: “By targeting glutamine metabolism, we were not only able to inhibit tumour growth and change the tumour microenvironment but also alter the T-cells in a way that we markedly enhanced immunotherapy for cancer.” When tested in mice models of colon cancer, lymphoma and melanoma, the drug candidate was able to significantly reduce tumour growth and improve survival by targeting tumour cell metabolism and tumour microenvironment.

Spotlight

With complex development processes and stringent regulatory requirements, the path to developing a combination product can seem uncertain and fraught with risk. All elements of the delivery system must comply with the highest quality and regulatory standards.

Spotlight

With complex development processes and stringent regulatory requirements, the path to developing a combination product can seem uncertain and fraught with risk. All elements of the delivery system must comply with the highest quality and regulatory standards.

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BUSINESS INSIGHTS, PHARMACY MARKET

COEUS Holdings Announces Rebranding to Reflect the Unification of Each Business Unit Into One Entity

Businesswire | May 02, 2023

COEUS, a leading healthcare communications, technology, talent, and consulting firm delivering a variety of services and platforms to all stakeholders in the healthcare ecosystem, announced today that it has completed a major rebranding. Following nearly 14 years of both organic growth and acquisitions, all business units have been combined to form one entity: COEUS. Since the company’s inception in 2009, the company sought to build a suite of services capable of providing end-to-end solutions for drug and therapy manufacturers ranging from preapproval, through launch, and eventual loss of exclusivity. “A little over 13 years ago, we started this company with just one employee. After a series of acquisitions, the hiring of more than 140 people, and the creation of numerous distinct business units all coming online at different times, we felt it was a necessary part of our evolution to consolidate the business units to one entity capable of servicing all clients,” stated Marc Hixson, CEO, COEUS. “Our clients have routinely told us that our experts, our strategic vision of what healthcare should be, and our commitment to leveraging — and building — technologies that improve the biotech, pharmaceutical, and payer audiences truly sets COEUS apart. It’s time to let the rest of the industry in on it.” Through the rebranding, the company has redesigned its logo, launched an entirely new website and reinvented all its marketing collateral to reflect the company’s new identity. As part of the consolidation, COEUS has appointed Jodie McVan to the position of Chief Commercial Officer. In her new role, Jodie will oversee the day-to-day operations, staffing, and the management of existing offerings, as well as drive the creation of new services and products for the consulting and agency business. “With the combination of end-to-end service offerings for manufacturers, our technology platforms and services for manufacturers and payers alike, and industry leading talent and deep subject matter expertise, COEUS is well-positioned to efficiently deliver world-class service to our clients,” stated Jodie McVan, Chief Commercial Officer, COEUS. Visit 1COEUS.com to explore the new website and brand. About COEUS Established in 2009, COEUS is a leading healthcare consulting, communications, technology, and talent firm. The company offers clients a variety of services, as well as SaaS technology platforms, for various stakeholders throughout the healthcare ecosystem including all payers and emerging or more established drug manufacturers. Leveraging the deep knowledge and experience of the company’s many subject matter experts, COEUS works on all drug types with a particular focus on cell and gene therapies, rare diseases, and oncology. The company also has unique expertise in the creation and management of value-based agreements by leveraging COEBRA™, the company’s evidence and outcomes adjudication platform. In its 13-year history, the company has supported the launch of more than 120 pharmaceutical brands and has worked with more than 300 pharma clients including many top global pharmaceutical manufacturers.

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PHARMACY MARKET

Asieris Deepens Strategic Partnership with UroViu to Further Develop Integrated Diagnosis and Treatment Platform for Bladder Cancer

PRNewswire | May 19, 2023

Asieris Pharmaceuticals a global biopharma company specializing in discovering, developing and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases, announced a strategic collaboration with UroViu Corporation ("UroViu"). Asieris Pharmaceuticals will obtain exclusive global rights to UroViu's patented technology of portable single-use cystoscope in the field of fluorescent imaging. Under the agreement, Asieris Pharmaceuticals will use this patented technology in combination with specific optical imaging agents to conduct research on the application of non-white light imaging technology in the diagnosis and postoperative monitoring of None-Muscle Invasive Bladder Cancer (NMBC). At the same time, Asieris Pharmaceuticals will be responsible for the global commercialization of the sterile single-use fluorescent Cystoscope. Previously, Asieris Pharmaceuticals entered a cooperation agreement with UroViu in 2021 for the exclusive registration and commercialization rights of its portable single-use flexible white light cystoscopy system in mainland China, Taiwan, Hong Kong and Macau. "There is still a huge unmet need for more accessible and safer fluorescent cystoscopy in the diagnosis and surveillance of bladder cancer."Dr. Susan Wang, Senior Vice President of Global Business Development & Strategic Partnership of Asieris said, "We are thrilled to deepen and expand our collaboration with UroViu which enabling us not only to broaden our technology portfolio, but also to expedite the implementation of Asieris' integrated strategy for bladder cancer diagnosis and treatment, aiming to provide more effective disease management options for bladder cancer patients." "We are excited about the possibilities that our expanded Partnership with Asieris will create. Our unique and expanding portfolio of single use endoscopic products are fulfilling UroViu's promise to greatly improve both the patient and provider experience, elevate the standard of care in a field with rapidly advancing technologies," said Bruce OuYang, Founder and CEO of UroViu. About Asieris Asieris Pharmaceuticals founded in March 2010, is a global biopharma company specializing in the discovery, development and commercialization of innovative drugs that treat genitourinary tumors and other related diseases. We strive to improve human health and help people live a more dignified life. We aim to become a global pharma leader that integrates R&D, manufacturing, and commercialization in our areas of focus, as we provide best-in-class integrated diagnosis and treatment solutions for patients in China and worldwide. The company has been developing its proprietary R&D platform and core technologies, exploring new mechanisms of action, and efficiently screening and evaluating drug candidates. With a well-established in-house R&D system and expertise in global drug development, Asieris is committed to launching first-in-class drugs and other innovative products to address huge unmet needs in its areas of focus. Asieris is also enhancing its pipeline for genitourinary diseases via proprietary R&D and strategic partnerships, while closely following cutting-edge technologies and therapeutics. The company strives to discover and identify unmet medical needs, and adopts a forward-looking approach in product planning and life-cycle management. We aim to establish an outstanding portfolio that covers diagnosis and treatment in a bid to benefit more patients in China and globally.

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PHARMA TECH

Janssen Seeks European Commission Approval of a New Indication for CARVYKTI® for the Earlier Treatment of Patients with Relapsed and Refractory

Globenewswire | June 01, 2023

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a Type II variation application to the European Medicines Agency (EMA) seeking approval of a new indication for CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) for the treatment of adult patients with relapsed and lenalidomide-refractory multiple myeloma. “The previous European Commission approval recognised the potential for cilta-cel to positively impact outcomes for people living with relapsed and refractory multiple myeloma,” said Edmond Chan, MBChB M.D. (Res), Senior Director, EMEA Therapeutic Area Lead Haematology, Janssen-Cilag Limited. “Today’s submission to the EMA is an important step towards helping patients benefit from this CAR-T therapy earlier in their treatment journey. If approved, this will be the first and only CAR-T therapy available to treat relapsed and refractory multiple myeloma patients as early as second line.” The application is supported by data from the CARTITUDE-4 study the first randomised Phase 3 study evaluating the efficacy and safety profile of cilta-cel versus pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd) in the treatment of patients with relapsed and lenalidomide-refractory multiple myeloma who received one to three prior lines of therapy.1 The CARTITUDE-4 study results will be presented in a special session at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL on Monday 5 June 2023 at 16:45 CEST. “This submission is a testament to our relentless commitment to advance science, transform outcomes, challenge what a multiple myeloma diagnosis means for patients and ultimately, work towards our goal of one day curing this complex disease,” said Sen Zhuang, M.D., Ph.D., Vice President, Clinical Research and Development, Janssen Research & Development, LLC. “We look forward to collaborating with the EMA to bring this potential new indication for cilta-cel to the multiple myeloma community as soon as possible.” About Ciltacabtagene Autoleucel (cilta-cel) Cilta-cel received conditional marketing authorisation from the European Commission in May 2022, for the treatment of adults with relapsed and refractory multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy.3,4 In February 2022, the FDA approved cilta-cel for the treatment of adults with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.5 Cilta-cel is a B-cell maturation antigen (BCMA)-directed, genetically modified autologous T-cell immunotherapy, which involves reprogramming a patient’s own T-cells with a transgene encoding a chimeric antigen receptor (CAR) that identifies and eliminates cells that express BCMA.6 BCMA is primarily expressed on the surface of malignant multiple myeloma B-lineage cells, as well as late-stage B-cells and plasma cells.7,8 The cilta-cel CAR protein features two BCMA-targeting single domain antibodies designed to confer high avidity against human BCMA.6 The CAR-modified T-cells express fusion proteins of antigen receptors against tumour-associated surface antigens and T-cell activation domains, and upon binding to BCMA-expressing cells redirect the effector T-cells and enhance tumour-specific immunosurveillance.9 In December 2017, Janssen Biotech, Inc. (Janssen) entered into a worldwide license and collaboration agreement with Legend Biotech USA, Inc. to develop and commercialise cilta-cel.10 About Multiple Myeloma Multiple myeloma is an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.11 In multiple myeloma, these malignant plasma cells change and grow out of control.8 In Europe, more than 50,900 people were diagnosed with multiple myeloma in 2020, and more than 32,400 patients died.12 While some patients with multiple myeloma initially have no symptoms, others can have common signs and symptoms of the disease, which can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels, or kidney failure.13 About the Janssen Pharmaceutical At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular, Metabolism & Retina; Immunology; Infectious Diseases & Vaccines; Neuroscience; Oncology; and Pulmonary Hypertension.

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