Latest news with #Tecentriq
Yahoo
7 hours ago
- Health
- Yahoo
Natera pursues ctDNA assay approval after Phase III victory
Natera's Signatera assay has been found to accurately predict if a patient with muscle-invasive bladder cancer (MIBC) will benefit from adjuvant cancer immunotherapy, Tecentriq (atezolizumab) post-surgery in a Phase III trial. Top-line results of the IMvigor011 study (NCT04660344) revealed that patients given Roche's Tecentriq after testing positive through the in vitro companion diagnostic (IVD) experienced significant improvements in both disease-free survival (DFS) and overall survival (OS). Meanwhile, a preliminary analysis found that patients who remained Signatera-negative post-operation had positive outcomes without adjuvant treatment, with 88% of patients being disease-free 18 months after surgery. This is the first Phase III study in this indication to use a personalised approach to treatment guided by the presence of circulating tumour DNA (ctDNA), a key biomarker of molecular residual disease (MRD) – which is often associated with an increased risk of relapse. According to the study's principal investigator, Professor Thomas Powles, the results of the IMvigor011 trial could 'open the door for a new treatment paradigm' in MIBC, helping physicians to more accurately determine if adjuvant treatment is necessary by monitoring the presence of cancer on a molecular level. This contrast could mark a step up from the previous standard of care (SoC) disease-monitoring techniques such as imaging and bladder endoscopy, which can often at times miss early-stage recurrence events due to their inability to detect MRD in patients. Following the trial's positive outcome, Natera is finalising its premarket approval application to the US Food and Drug Administration (FDA) for Signatera's use as a companion diagnostic. If given the go-ahead, Signatera could prevent patients who have no detectable MRD from enduring potentially severe immune-related side effects commonly associated with PD-L1 blockers such as Tecentriq. It would also allow physicians to prescribe treatment in the early stages of relapse. This is welcome news for the company, as Signatera was previously turned down by the UK's National Institute for Health and Care Excellence (NICE) for use in the National Health Service (NHS) as a routine MRD test for solid tumours in 2022. This was due to the lack of clinical evidence to support its use when assessing its cost-benefit ratio. The development also follows Natera's involvement in one of the largest false advertising verdicts in history, which saw Guardant Health claim $292.5m – including $175.5m in punitive damages – from the company after it falsely advertised the benefits of Signatera over Guardant's MRD assay, Guardant Reveal. "Natera pursues ctDNA assay approval after Phase III victory " was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Yahoo
11 hours ago
- Business
- Yahoo
Genprex Receives Notice of Allowance for Multiple Patents for Reqorsa® Gene Therapy with PD-L1 and PD-1 Antibodies to Treat Cancers
Strengthens Intellectual Property Estate for REQORSA Oncology Program with Immune Checkpoint Inhibitors AUSTIN, Texas, Aug. 18, 2025 /PRNewswire/ -- Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced that the U.S. Patent and Trademark Office has issued a Notice of Allowance for a patent to Genprex that covers the use of the Company's lead drug candidate, Reqorsa® Gene Therapy, in combination with PD-L1 antibodies, such as Tecentriq®. Similarly, the European Patent Office has issued a Notice of Allowance to Genprex for a patent covering the use of REQORSA in combination with PD-1 antibodies. Both patents will expire in 2037 at the earliest. "We are very proud to continue building a fortress of intellectual property protection around our oncology program for REQORSA, and these newly granted patents strengthen and expand our intellectual property estate for REQORSA in combination with immune checkpoint inhibitors applicable to our Acclaim-3 clinical trial," said Thomas Gallagher, Esq., Senior Vice President of Intellectual Property and Licensing at Genprex. Genprex has been granted patents for the use of REQORSA in combination with PD-L1 antibodies in Korea. Genprex is pursuing additional patent applications in Europe, Canada, Brazil, China and Israel. Should these applications grant, they would be applicable to Genprex's Acclaim-3 clinical trial. Genprex has been granted patents for the use of REQORSA in combination with PD-1 antibodies in the U.S., Japan, Mexico, Russia, Australia, Chile, China, Korea and Singapore. PD-L1 and PD-1 antibodies are a type of targeted immunotherapy and a part of a group of checkpoint inhibitor anti-cancer drugs that block the activity of PD-L1 and PD-1 immune checkpoint proteins present on the surface of cells. The Acclaim-3 study is a Phase 1/2 clinical trial that uses a combination of REQORSA and Genentech's Tecentriq® as maintenance therapy for patients with extensive stage small cell lung cancer (ES-SCLC) who are candidates for maintenance therapy after receiving Tecentriq and chemotherapy as initial standard treatment. The Acclaim-3 clinical trial has received U.S. Food and Drug Administration (FDA) Fast Track Designation for this patient population, and Acclaim-3 has received FDA Orphan Drug Designation. About Genprex, Inc. is a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes. Genprex's technologies are designed to administer disease-fighting genes to provide new therapies for large patient populations with cancer and diabetes who currently have limited treatment options. Genprex works with world-class institutions and collaborators to develop drug candidates to further its pipeline of gene therapies in order to provide novel treatment approaches. Genprex's oncology program utilizes its systemic, non-viral Oncoprex® Delivery System which encapsulates the gene-expressing plasmids using lipid-based nanoparticles in a lipoplex form. The resultant product is administered intravenously, where it is taken up by tumor cells that then express tumor suppressor proteins that were deficient in the tumor. The Company's lead product candidate, Reqorsa® Gene Therapy (quaratusugene ozeplasmid), is being evaluated in two clinical trials as a treatment for NSCLC and SCLC. Each of Genprex's lung cancer clinical programs has received a Fast Track Designation from the FDA for the treatment of that patient population, and Genprex's SCLC program has received an FDA Orphan Drug Designation. Genprex's diabetes gene therapy approach is comprised of a novel infusion process that uses an AAV vector to deliver Pdx1 and MafA genes directly to the pancreas. In models of Type 1 diabetes, GPX-002 transforms alpha cells in the pancreas into functional beta-like cells, which can produce insulin but may be distinct enough from beta cells to evade the body's immune system. In a similar approach for Type 2 diabetes, where autoimmunity is not at play, GPX-002 is believed to rejuvenate and replenish exhausted beta cells. Interested investors and shareholders are encouraged to sign up for press releases and industry updates by visiting the Company Website, registering for Email Alerts and by following Genprex on Twitter, Facebook and LinkedIn. Cautionary Language Concerning Forward-Looking StatementsStatements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of management, are not guarantees of performance and are subject to significant risks and uncertainty. These forward-looking statements should, therefore, be considered in light of various important factors, including those set forth in Genprex's reports that it files from time to time with the Securities and Exchange Commission and which you should review, including those statements under "Item 1A – Risk Factors" in Genprex's Annual Report on Form 10-K for the year ended December 31, 2024. Because forward-looking statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: Genprex's ability to advance the clinical development, manufacturing and commercialization of its product candidates in accordance with projected timelines and specifications; the timing and success of Genprex's clinical trials, its intended regulatory submissions and any resulting regulatory approvals; the effect of Genprex's product candidates, alone and in combination with other therapies, on cancer and diabetes; Genprex's future growth and financial status, including Genprex's ability to maintain compliance with the continued listing requirements of The Nasdaq Capital Market and to continue as a going concern and to obtain capital to meet its long-term liquidity needs on acceptable terms, or at all; Genprex's commercial and strategic partnerships, including those with its third party vendors, suppliers and manufacturers and their ability to successfully perform and scale up the manufacture of its product candidates; Genprex's intellectual property and licenses, including the potential for future grants of patent applications globally; and Genprex's current expectations, estimates, forecasts and projections about the industry and markets in which it operates. These forward-looking statements should not be relied upon as predictions of future events and Genprex cannot assure you that the events or circumstances discussed or reflected in these statements will be achieved or will occur. If such forward-looking statements prove to be inaccurate, the inaccuracy may be material. You should not regard these statements as a representation or warranty by Genprex or any other person that Genprex will achieve its objectives and plans in any specified timeframe, or at all. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Genprex disclaims any obligation to publicly update or release any revisions to these forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this press release or to reflect the occurrence of unanticipated events, except as required by law. Genprex, Inc.(877) 774-GNPX (4679) GNPX Investor Relationsinvestors@ GNPX Media ContactKalyn Dabbsmedia@ View original content to download multimedia: SOURCE Genprex, Inc. Error while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
Economic Times
11-08-2025
- Health
- Economic Times
India clears Roche's 7-minute cancer injection Tecentriq for patients, with Phase IV trial condition
Synopsis Roche has received clearance to import and market Atezolizumab injection (Tecentriq) for subcutaneous administration in India, potentially reducing cancer treatment time and costs. The approval, granted by a technical committee, requires Roche to conduct a Phase IV clinical trial in India. This new route offers a faster, more convenient option for patients, with administration possible outside of hospitals. Roche Gets Approval to Import Key Cancer Injection for Domestic Mkt New Delhi: The technical committee constituted for supervising clinical trials on new chemical entities has cleared Swiss drug major Roche to import and market cancer drug Atezolizumab injection (Tecentriq) through subcutaneous (SC) route-under the skin injection for Indian decisions is expected to provide relief to patients in the contry as the new subcutaneous injections will cut treatment time to nearly seven minutes from the 30-60 minutes in the standard intravenous (IV) infusion, besides saving on costs. The panel's permission has been given with a condition that the company would conduct a Phase IV clinical trial in India. "Switching from intravenous (IV) to subcutaneous (SC) administration of Atezolizumab can potentially reduce costs due to decreased healthcare professional time and improved patient convenience," a government official told ET. "Tecentriq may be administered by a healthcare professional outside of the hospital, in a community care setting or at a patient's home," he added. Atezolizumab is an immunotherapy called an immune checkpoint inhibitor, which blocks the immune system's natural brakes to help immune cells fight technical committee under the Director General of Health Services (DGHS) was formed in 2013 following the directions of the Supreme a recent meeting, Roche presented the proposal for grant of permission to import and market the drug product Atezolizumab injection (Tecentriq®) 1875 mg/15 mL vial for subcutaneous administration for the following indications with the request of local Phase III clinical trial waiver and commitment to conduct a Phase IV trial in is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy. It is a monotherapy for the first line treatment of patients of metastatic committee noted the pharmacokinetic-pharmacodynamic or PK/PD results of Asian & non-Asian population from the global clinical study for the ethnic differences in the PK parameters in the study. The committee further noted that firm has received the USFDA approval for the SC route on committee also asked the company to submit Phase IV clinical trial protocol to CDSCO within three months of grant of marketing authorisation.
Time of India
11-08-2025
- Health
- Time of India
India clears Roche's 7-minute cancer injection Tecentriq for patients, with Phase IV trial condition
New Delhi: The technical committee constituted for supervising clinical trials on new chemical entities has cleared Swiss drug major Roche to import and market cancer drug Atezolizumab injection ( Tecentriq ) through subcutaneous (SC) route-under the skin injection for Indian patients. The decisions is expected to provide relief to patients in the contry as the new subcutaneous injections will cut treatment time to nearly seven minutes from the 30-60 minutes in the standard intravenous (IV) infusion, besides saving on costs. The panel's permission has been given with a condition that the company would conduct a Phase IV clinical trial in India. "Switching from intravenous (IV) to subcutaneous (SC) administration of Atezolizumab can potentially reduce costs due to decreased healthcare professional time and improved patient convenience," a government official told ET. "Tecentriq may be administered by a healthcare professional outside of the hospital, in a community care setting or at a patient's home," he added. Atezolizumab is an immunotherapy called an immune checkpoint inhibitor, which blocks the immune system's natural brakes to help immune cells fight cancer. The technical committee under the Director General of Health Services (DGHS) was formed in 2013 following the directions of the Supreme Court. In a recent meeting, Roche presented the proposal for grant of permission to import and market the drug product Atezolizumab injection (Tecentriq®) 1875 mg/15 mL vial for subcutaneous administration for the following indications with the request of local Phase III clinical trial waiver and commitment to conduct a Phase IV trial in India. Atezolizumab is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy. It is a monotherapy for the first line treatment of patients of metastatic NSCLC. The committee noted the pharmacokinetic-pharmacodynamic or PK/PD results of Asian & non-Asian population from the global clinical study for the ethnic differences in the PK parameters in the study. The committee further noted that firm has received the USFDA approval for the SC route on 12.09.2024. The committee also asked the company to submit Phase IV clinical trial protocol to CDSCO within three months of grant of marketing authorisation.
New Indian Express
14-07-2025
- New Indian Express
Capital's deadly dose of deception
Delhi has long stood as a beacon of modern healthcare. The national capital is home to gleaming hospitals, internationally trained specialists and cutting-edge treatments. Its medical tourism industry draws patients from every corner of India and beyond. Cancer care in the city is considered among the best in the country, renowned for its precise surgical procedures, immunotherapy, targeted drugs, multidisciplinary tumor boards and clinical trials. For many, the city offers hope where once only despair ruled. But behind the shiny facades of these world-class medical institutions lies a dangerous and dark underbelly: a sprawling counterfeit drug network that has infiltrated the very supply chains that patients trust with their lives. These are not mere cheap knock-offs; these are criminal deceptions that put patients at grave risk, especially those battling life-threatening illnesses like cancer.. The Crackdown In June, the Delhi drugs control department executed a citywide operation that uncovered the depth of the problem. Over 160 samples of suspected cancer medications were seized—many lacked proper documentation or bore suspicious markings. This comes as a suo motu action after Delhi Police busted a well-organized racket allegedly responsible for selling fake and unauthorised cancer drugs to patients. Within days, six individuals were arrested. The raids took place in Laxmi Nagar, Budh Vihar, and Chandni Chowk—areas selected for their proximity to major medical institutions such as AIIMS, Safdarjung, Lok Nayak, and Rajiv Gandhi hospitals. The haul recovered from one raid included vials worth `2.15 crore, 519 empty vials labelled as Keytruda, Infinzi, Tecentriq, Perjeta, Opdyta, Darzalex; 864 empty packaging cartons; along with packets of counterfeit solutions.
