Latest news with #EPO
Globe and Mail
2 days ago
- Business
- Globe and Mail
Lantern Pharma Secures EU Patent Allowance for LP-284, Bolstering Global IP Position for AI-Developed Cancer Therapy
Lantern Pharma Inc. (NASDAQ: LTRN), a clinical-stage oncology company leveraging its proprietary RADR ® artificial intelligence (AI) platform to accelerate drug discovery, today announced that the European Patent Office (EPO) has issued a notice of allowance for a composition of matter patent covering its drug candidate LP-284. This patent, expected to be granted in the coming months with exclusivity through early 2039, strengthens Lantern's global intellectual property (IP) portfolio and supports the development and commercialization path for LP-284, a novel therapy in development for relapsed or refractory non-Hodgkin's lymphoma (NHL), including mantle cell lymphoma (MCL) and high-grade B-cell lymphomas (HGBL). LP-284, a next-generation acylfulvene, was optimized using Lantern's RADR ® platform, which identified its synthetically lethal mechanism targeting cancer cells with DNA damage repair deficiencies. Currently in a Phase 1 clinical trial (NCT06132503), LP-284 has demonstrated preclinical potential in addressing aggressive NHL subtypes, including MCL and double-hit lymphoma (DHL). The drug candidate has earned Orphan Drug Designations from the U.S. FDA for both MCL and HGBL, highlighting its role in tackling rare cancers with significant unmet needs. Expanding Global Patent Protection The EU patent complements a composition of matter patent granted in Japan (June 2024) and the U.S. (April 2023), with additional patent allowances grants in India and Mexico, and applications pending in China, Australia, Canada, and Korea. This expanding international IP portfolio positions LP-284 for global commercialization and strategic partnerships. "The EU patent allowance for LP-284 is a critical milestone that enhances our ability to deliver this AI-advanced therapy to patients globally," said Panna Sharma, President and CEO of Lantern Pharma. "Our RADR ® platform enabled us to rapidly advance LP-284's unique mechanism, achieving clinical trial readiness in under three years at a cost of approximately $1.5 to $2.0 million. This patent reinforces our commitment to precision oncology and creates opportunities for strategic collaborations with biotech partners." Addressing Significant Market Need LP-284 targets a global market estimated at $4 billion annually for blood cancers, driven by the rising incidence of NHL globally. Nearly all patients diagnosed with aggressive NHL subtypes like MCL will relapse after treatment, creating an urgent need for novel therapeutic approaches. Lantern's RADR ® platform, powered by over 200 billion oncology-focused data points and 200+ machine learning algorithms, has streamlined LP-284's development, reducing timelines and costs compared to traditional drug discovery. This efficiency and capability positions Lantern to attract investment and partnerships with biotech and pharma companies seeking innovative oncology solutions. About LP-284 LP-284 is an investigational next-generation acylfulvene designed to exploit synthetic lethal interactions in cancer cells with DNA damage repair deficiencies. Developed with guidance from Lantern's AI platform RADR ®, LP-284 represents a novel therapeutic approach for treating relapsed or refractory non-Hodgkin's lymphoma and other hematologic malignancies. The compound is currently being evaluated in a Phase 1 clinical trial (NCT06132503) to determine its safety profile, optimal dosing, and preliminary efficacy in patients with aggressive NHL subtypes who have failed standard therapies. LP-284 has received multiple Orphan Drug Designations from the U.S. FDA, including designations for mantle cell lymphoma and high-grade B-cell lymphomas, recognizing its potential to address significant unmet medical needs in rare cancer populations. About Lantern Pharma Lantern Pharma (NASDAQ: LTRN) is an AI-driven biotechnology company focused on accelerating and optimizing the discovery, development, and commercialization of cancer therapies. Its RADR ® platform leverages artificial intelligence and machine learning to uncover novel therapeutic opportunities, accelerate drug development, and improve patient outcomes. Please find more information at: Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include, among other things, statements relating to: future events or our future financial performance; the potential advantages of our RADR ® platform in identifying drug candidates and patient populations that are likely to respond to a drug candidate; our strategic plans to advance the development of our drug candidates and antibody drug conjugate (ADC) development program; estimates regarding the development timing for our drug candidates and ADC development program; expectations and estimates regarding clinical trial timing and patient enrollment; our research and development efforts of our internal drug discovery programs and the utilization of our RADR ® platform to streamline the drug development process; our intention to leverage artificial intelligence, machine learning and genomic data to streamline and transform the pace, risk and cost of oncology drug discovery and development and to identify patient populations that would likely respond to a drug candidate; estimates regarding patient populations, potential markets and potential market sizes; sales estimates for our drug candidates and our plans to discover and develop drug candidates and to maximize their commercial potential by advancing such drug candidates ourselves or in collaboration with others. Any statements that are not statements of historical fact (including, without limitation, statements that use words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "model," "objective," "aim," "upcoming," "should," "will," "would," or the negative of these words or other similar expressions) should be considered forward-looking statements. There are a number of important factors that could cause our actual results to differ materially from those indicated by the forward-looking statements, such as (i) the risk that we may not be able to secure sufficient future funding when needed and as required to advance and support our existing and planned clinical trials and operations, (ii) the risk that observations in preclinical studies and early or preliminary observations in clinical studies do not ensure that later observations, studies and development will be consistent or successful, (iii) the risk that our research and the research of our collaborators may not be successful, (iv) the risk that we may not be successful in licensing potential candidates or in completing potential partnerships and collaborations, (v) the risk that none of our product candidates has received FDA marketing approval, and we may not be able to successfully initiate, conduct, or conclude clinical testing for or obtain marketing approval for our product candidates, (vi) the risk that no drug product based on our proprietary RADR ® AI platform has received FDA marketing approval or otherwise been incorporated into a commercial product, and (vii) those other factors set forth in the Risk Factors section in our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission on March 27, 2025. You may access our Annual Report on Form 10-K for the year ended December 31, 2024 under the investor SEC filings tab of our website at or on the SEC's website at Given these risks and uncertainties, we can give no assurances that our forward-looking statements will prove to be accurate, or that any other results or events projected or contemplated by our forward-looking statements will in fact occur, and we caution investors not to place undue reliance on these statements. All forward-looking statements in this press release represent our judgment as of the date hereof, and, except as otherwise required by law, we disclaim any obligation to update any forward-looking statements to conform the statement to actual results or changes in our expectations.
The Hindu
6 days ago
- Health
- The Hindu
Interview with Gardiner Harris, author of The Dark Secrets of Johnson & Johnson
It's difficult to read Gardiner Harris' book at a stretch, only, and only because there are portions where you have to set it down and take a breather, and sigh. It is because the events of the book haunt you, turn you inside out and sometimes have you bristling with anger, the pages shaking in your hand. The Dark Secrets of Johnson & Johnson, sometimes, is a drop down a rabbit hole on the dark side of the moon. The book is a hard hitting expose on what went on at J&J, the pharma major, and it uncovers the secrets across the company's repertoire of drugs and products from baby powder, Tylenol, Risperdal (antipsychotic), EPO (a cancer drug), metal-on-metal hip implants, among others, all adversely impacting the health of users. Chillingly, the company continued to market them, fully cognisant of the harmful effects. In a conversation, Harris, an investigative reporter himself, describes the Herculean task he took on, and what he was up against. In conversation with Gardiner Harris Among all the violations that you have chronicled, what did you think was the most egregious? J&J, early on, would find out that its product was dangerous, and would hide those dangers not only from the public, but from the FDA (Food and Drug Administration) and other regulatory agencies, knowing that it could result in a number of deaths. I estimate that at least 2 million Americans alone died from using J&J products. So it really is hard to rank order. But the worst of the worst, just in terms of sheer numbers, would probably be Risperdal. Epidemiological analysis shows that it is probably one of the most deadly drugs that has ever been sold in the U.S. It is sold to children, even though it causes boys to grow breasts and young girls to express milk. And again, the company hid those risks, lied about them in publications. You have written about how you grew up in a J&J town. How did you move on from that to investigating the company? I spent part of my growing up years in Princeton, New Jersey, right next to New Brunswick, where J&J is headquartered. There was a sense, growing up, that it was really a capitalistic ideal -- this was a company that both did well financially and did good in in society, and that it was seen as a sort of mom, apple pie and America all rolled into one. So when I first got the pharmaceutical beat, when I worked for The Wall Street Journal, I expected to have a wonderful time covering J&J. But my interactions with them were just the opposite and it surprised me that they were the least open with reporters, the most secretive. When the AIDS crisis in Africa hit at the end of the 20th century and the beginning of the 21st century, the scandal around the pricing of drugs led many U.S. pharma companies to agree to allow generics companies to sell drugs in Africa. J&J was the only major manufacturer of AIDS drugs that refused to allow that. I couldn't believe it. I thought there must be some mistake, but in story after story, the image of this company ended up being entirely the opposite of what we had believed so long. It probably hit me hardest when my own first son was born. He was born early and ended up spending days in the NICU. Soon after, I got a whole bunch of documents on J&J's heartburn drug Propulsid. Even though the company had done 20 clinical trials in children and infants, each one of which had failed to show that there was a benefit; the company nonetheless underwrote a marketing programme to sell them to infants. Not only did this drug not help these children, but it caused a QT prolongation, which is a heart arrhythmia, and for newborns, and particularly for preemies, a heart arrhythmia can be fatal. What was J&J's response to the book? I did cover the company for many years, I knew a lot of the executives and I certainly knew how to reach out to the company. As soon as I got the contract for this book, I told them that I'm writing this book and I would love for them to participate in it. But J&J had the same reaction it had had throughout my career -- which is to stonewall, not talk to me, not participate, and hope the story goes away. Did you, at some time, feel a bit like Erin Brockovich? I never looked that good; it's tough competing with Julia Roberts! But what was difficult about this process was just how dark it was, and how depressing the work often was. I spent more than five years writing this book and I go to church quite regularly. I found that I really needed that outlet throughout this process, even more than normal because I found I needed to appeal to God to help me through this, because you can lose hope. For me, it's just a very dark tale and I am thrilled, and surprised, actually, that it's gotten as many readers as it has. Do you think that the FDA, as a regulatory agency, could have done better? The portrait I paint of the FDA is one of real feckless disregard for protecting the public. Unfortunately, the FDA is largely funded by drug makers by what are known as user fees. The result of that is that the FDA has become captive to the very industry that it regulates. When I talk about baby powder, for instance, people had petitioned the FDA repeatedly to mandate a cancer warning on all products with talcum powder, and this would have included Johnson's baby powder. The FDA refused to answer those petitions until finally J&J lost its first baby powder case, and then suddenly, the FDA had to answer these petitions; it did so in the negative and claimed that the baby powder was fine. In the U.S., it was the drug kingpin when it came to opioids and the FDA got a lot of criticism of its oversight of opioids. To deal with that criticism, the agency actually hired a former FDA commissioner who served on the board of directors for J&J for the previous dozen years. So, to advise the agency on how to deal with this crisis that was created by J&J, it hired a top J&J person! How did you decide on your chosen style for the book, an engaging, but investigative journalistic piece? I have to say, you know, as I said, the book was nearly twice as long and I ended up hiring an editor to help me not only on the decisions about which products to include in the end, but also about the style. The original version of the book had had more personal stuff and my years as a reporter covering the company. But my editors thought the reader needed a really neutral voice in telling this story. The only way that it can work is to be told in a very low-key, neutral way. In your view, was there was a turning point when J&J could have reversed things? I really think it was that period in the early 1980s and perhaps the late 1970s. It was Johnson's baby powder in particular, that provided the ladder down which the company itself descended into real darkness. The Dark Secrets of Johnson & Johnson Gardiner Harris Ebury Press ₹899
Malaysian Reserve
14-07-2025
- Business
- Malaysian Reserve
CARsgen Successfully Defends Its GPC3 CAR-T Patent at the EPO
SHANGHAI, July 13, 2025 /PRNewswire/ — CARsgen Therapeutics Holdings Limited (Stock Code: a company focused on developing innovative CAR T-cell therapies, announces a favorable outcome in opposition proceedings before the European Patent Office (EPO) concerning its European patent EP3445407, which covers its GPC3-targeted CAR-T cell therapy. On July 3, 2025, a U.S.-based biotechnology — the sole appellant among the original two opponents — formally withdrew its appeal against the EPO Opposition Division's earlier decision to maintain the patent. This withdrawal renders the EPO's decision final and binding for the opponents, effectively concluding their part in the opposition process. The patent was granted by the EPO in 2022 and opposed by two parties in 2023. Following oral proceedings, the EPO Opposition Division issued a decision to maintain the patent in amended form, upholding key claims related to the use of GPC3 CAR-T cell therapy following cyclophosphamide and fludarabine lymphodepletion pretreatment, in the treatment of liver cancer, lung cancer, ovarian cancer, breast cancer, gastric cancer, and thyroid cancer. Following the decision, only one opponent filed an appeal within the allowable period. That appeal has now been withdrawn. Under EPO procedures, the opponents or any other third party can no longer challenge the patent at the EPO. This development further reinforces CARsgen's intellectual property position in the field of GPC3-targeted CAR-T therapies, a promising and innovative approach for the treatment of solid tumors. About CARsgen Therapeutics Holdings Limited CARsgen is a biopharmaceutical company focusing on developing innovative CAR T-cell therapies to address the unmet clinical needs including but not limited to hematologic malignancies, solid tumors and autoimmune diseases. CARsgen has established end-to-end capabilities for CAR T-cell research and development covering target discovery, preclinical research, product clinical development, and commercial-scale production. CARsgen has developed novel in-house technologies and a product pipeline with global rights to address challenges faced by existing CAR T-cell therapies. Efforts include improving safety profile, enhancing the efficacy in treating solid tumors, and reducing treatment costs, etc. CARsgen's mission is to be a global biopharmaceutical leader that provides innovative and differentiated cell therapies for patients worldwide and makes cancer and other diseases curable. Forward-looking Statements All statements in this press release that are not historical fact or that do not relate to present facts or current conditions are forward-looking statements. Such forward-looking statements express the Group's current views, projections, beliefs and expectations with respect to future events as of the date of this press release. Such forward-looking statements are based on a number of assumptions and factors beyond the Group's control. As a result, they are subject to significant risks and uncertainties, and actual events or results may differ materially from these forward-looking statements and the forward-looking events discussed in this press release might not occur. Such risks and uncertainties include, but are not limited to, those detailed under the heading 'Principal Risks and Uncertainties' in our most recent annual report and interim report and other announcements and reports made available on our corporate website, No representation or warranty is given as to the achievement or reasonableness of, and no reliance should be placed on, any projections, targets, estimates or forecasts contained in this press release. Contact CARsgen For more information, please visit
Yahoo
14-07-2025
- Business
- Yahoo
CARsgen Successfully Defends Its GPC3 CAR-T Patent at the EPO
SHANGHAI, July 13, 2025 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: a company focused on developing innovative CAR T-cell therapies, announces a favorable outcome in opposition proceedings before the European Patent Office (EPO) concerning its European patent EP3445407, which covers its GPC3-targeted CAR-T cell therapy. On July 3, 2025, a U.S.-based biotechnology — the sole appellant among the original two opponents — formally withdrew its appeal against the EPO Opposition Division's earlier decision to maintain the patent. This withdrawal renders the EPO's decision final and binding for the opponents, effectively concluding their part in the opposition process. The patent was granted by the EPO in 2022 and opposed by two parties in 2023. Following oral proceedings, the EPO Opposition Division issued a decision to maintain the patent in amended form, upholding key claims related to the use of GPC3 CAR-T cell therapy following cyclophosphamide and fludarabine lymphodepletion pretreatment, in the treatment of liver cancer, lung cancer, ovarian cancer, breast cancer, gastric cancer, and thyroid cancer. Following the decision, only one opponent filed an appeal within the allowable period. That appeal has now been withdrawn. Under EPO procedures, the opponents or any other third party can no longer challenge the patent at the EPO. This development further reinforces CARsgen's intellectual property position in the field of GPC3-targeted CAR-T therapies, a promising and innovative approach for the treatment of solid tumors. About CARsgen Therapeutics Holdings Limited CARsgen is a biopharmaceutical company focusing on developing innovative CAR T-cell therapies to address the unmet clinical needs including but not limited to hematologic malignancies, solid tumors and autoimmune diseases. CARsgen has established end-to-end capabilities for CAR T-cell research and development covering target discovery, preclinical research, product clinical development, and commercial-scale production. CARsgen has developed novel in-house technologies and a product pipeline with global rights to address challenges faced by existing CAR T-cell therapies. Efforts include improving safety profile, enhancing the efficacy in treating solid tumors, and reducing treatment costs, etc. CARsgen's mission is to be a global biopharmaceutical leader that provides innovative and differentiated cell therapies for patients worldwide and makes cancer and other diseases curable. Forward-looking Statements All statements in this press release that are not historical fact or that do not relate to present facts or current conditions are forward-looking statements. Such forward-looking statements express the Group's current views, projections, beliefs and expectations with respect to future events as of the date of this press release. Such forward-looking statements are based on a number of assumptions and factors beyond the Group's control. As a result, they are subject to significant risks and uncertainties, and actual events or results may differ materially from these forward-looking statements and the forward-looking events discussed in this press release might not occur. Such risks and uncertainties include, but are not limited to, those detailed under the heading "Principal Risks and Uncertainties" in our most recent annual report and interim report and other announcements and reports made available on our corporate website, No representation or warranty is given as to the achievement or reasonableness of, and no reliance should be placed on, any projections, targets, estimates or forecasts contained in this press release. Contact CARsgen For more information, please visit View original content to download multimedia: SOURCE CARsgen Therapeutics
Associated Press
14-07-2025
- Business
- Associated Press
CARsgen Successfully Defends Its GPC3 CAR-T Patent at the EPO
SHANGHAI, July 13, 2025 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: a company focused on developing innovative CAR T-cell therapies, announces a favorable outcome in opposition proceedings before the European Patent Office (EPO) concerning its European patent EP3445407, which covers its GPC3-targeted CAR-T cell therapy. On July 3, 2025, a U.S.-based biotechnology — the sole appellant among the original two opponents — formally withdrew its appeal against the EPO Opposition Division's earlier decision to maintain the patent. This withdrawal renders the EPO's decision final and binding for the opponents, effectively concluding their part in the opposition process. The patent was granted by the EPO in 2022 and opposed by two parties in 2023. Following oral proceedings, the EPO Opposition Division issued a decision to maintain the patent in amended form, upholding key claims related to the use of GPC3 CAR-T cell therapy following cyclophosphamide and fludarabine lymphodepletion pretreatment, in the treatment of liver cancer, lung cancer, ovarian cancer, breast cancer, gastric cancer, and thyroid cancer. Following the decision, only one opponent filed an appeal within the allowable period. That appeal has now been withdrawn. Under EPO procedures, the opponents or any other third party can no longer challenge the patent at the EPO. This development further reinforces CARsgen's intellectual property position in the field of GPC3-targeted CAR-T therapies, a promising and innovative approach for the treatment of solid tumors. About CARsgen Therapeutics Holdings Limited CARsgen is a biopharmaceutical company focusing on developing innovative CAR T-cell therapies to address the unmet clinical needs including but not limited to hematologic malignancies, solid tumors and autoimmune diseases. CARsgen has established end-to-end capabilities for CAR T-cell research and development covering target discovery, preclinical research, product clinical development, and commercial-scale production. CARsgen has developed novel in-house technologies and a product pipeline with global rights to address challenges faced by existing CAR T-cell therapies. Efforts include improving safety profile, enhancing the efficacy in treating solid tumors, and reducing treatment costs, etc. CARsgen's mission is to be a global biopharmaceutical leader that provides innovative and differentiated cell therapies for patients worldwide and makes cancer and other diseases curable. Forward-looking Statements All statements in this press release that are not historical fact or that do not relate to present facts or current conditions are forward-looking statements. Such forward-looking statements express the Group's current views, projections, beliefs and expectations with respect to future events as of the date of this press release. Such forward-looking statements are based on a number of assumptions and factors beyond the Group's control. As a result, they are subject to significant risks and uncertainties, and actual events or results may differ materially from these forward-looking statements and the forward-looking events discussed in this press release might not occur. Such risks and uncertainties include, but are not limited to, those detailed under the heading 'Principal Risks and Uncertainties' in our most recent annual report and interim report and other announcements and reports made available on our corporate website, No representation or warranty is given as to the achievement or reasonableness of, and no reliance should be placed on, any projections, targets, estimates or forecasts contained in this press release. Contact CARsgen For more information, please visit View original content to download multimedia: SOURCE CARsgen Therapeutics
