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Iksuda Therapeutics announces first patient successfully dosed in phase 1 trial evaluating IKS03 in advanced B cell non-Hodgkin lymphomas
Iksuda Therapeutics announces first patient successfully dosed in phase 1 trial evaluating IKS03 in advanced B cell non-Hodgkin lymphomas

Business Wire

time3 days ago

  • Business
  • Business Wire

Iksuda Therapeutics announces first patient successfully dosed in phase 1 trial evaluating IKS03 in advanced B cell non-Hodgkin lymphomas

NEWCASTLE, England--(BUSINESS WIRE)--Iksuda Therapeutics (Iksuda), the developer of class-leading antibody drug conjugates (ADCs) with clinically validated tumour-selective payload release formats, today announces the completion of dosing of its first patient with IKS03, a CD19-directed ADC, in a phase 1, first-in-human, clinical trial in patients with advanced B cell non-Hodgkin lymphoma. This first-in-human study ( will evaluate the safety, tolerability, preliminary antineoplastic activity, pharmacokinetics and pharmacodynamics of increasing dose levels of IKS03, and determine the recommended dose for dose-expansion. Efficacy will be further evaluated in disease-specific expansion cohorts. The study is currently enrolling patients across clinical sites in Italy, Spain, Australia, United States and Canada. Dr Dave Simpson, Chief Executive Officer, Iksuda Therapeutics, said: 'With the first patient successfully completing the safety evaluation period with IKS03, Iksuda demonstrates its continued commitment to drive its differentiated ADCs through clinical proof of concept, further solidifying our position as a clinical-stage ADC-focused company. Although there have been advances in the treatment of non-Hodgkin lymphoma in recent years, there remains a significant unmet patient need, and we hope that IKS03 will be able to build on the potential benefit-risk profile suggested by the data generated in preclinical studies.' About IKS03 IKS03 is a best-in-class CD19-targeting ADC delivering a tumour-activated prodrug pyrrolobenzodiazepine (PBD) which was licensed from LigaChem Biosciences (formerly LegoChem Biosciences) ( Preclinical testing demonstrates best-in-class efficacy (vs in-clinic and marketed CD19-targeted therapies) in in vivo xenograft models and significantly raised maximum tolerated dose (MTD) in non-human primate disease models, demonstrating its potential to be the leading anti-CD19 therapy in B-cell cancers. About Iksuda Therapeutics: Iksuda Therapeutics is a clinical stage, UK-based biotechnology company focussed on the development of class leading antibody drug conjugates (ADCs) targeting difficult-to-treat haematological and solid tumours. Iksuda's pipeline of ADCs is centred on a portfolio of prodrug DNA and protein alkylating payloads in combination with stable conjugation chemistries including its proprietary PermaLink ® platform. The Company's design concepts for ADCs are now clinically validated to significantly improve the therapeutic index of this important modality and improve the outcomes for patients living with cancer.

Pfizer sets sights on Summit's bispecific in combo with its ADCs
Pfizer sets sights on Summit's bispecific in combo with its ADCs

Yahoo

time24-02-2025

  • Business
  • Yahoo

Pfizer sets sights on Summit's bispecific in combo with its ADCs

Pfizer has signed a deal with Summit Therapeutics to assess the efficacy of Summit's Keytruda-challenging ivonescimab in combination with several of its antibody-drug conjugates (ADCs). Under the agreement, Summit will supply ivonescimab – an investigational PD-1/VEGF bispecific antibody – for the studies, while Pfizer will oversee study operations. Both companies will jointly supervise the trials and retain their respective product rights. The initiation of these studies is scheduled for mid-2025. Following the announcement, Summit's share price rose 2.6% at market open on 24 January. Shares in the company dropped soon after, however, on the back of increased net losses for 2024 reported on the same day. The planned studies will evaluate the combination of ivonescimab with Pfizer's vedotin-based ADCs in several solid tumour settings. ADCs have gained prominence in oncology, with numerous pharmaceutical companies pursuing collaborations and acquisitions to bolster their pipelines with the promising modality. Pfizer's portfolio includes multiple ADCs, supported by its acquisition of ADC-focused company Seagen in March 2023 for $43bn. Pfizer has made it clear that it is committed to advancing its oncology portfolio. At the JP Morgan Healthcare Conference last month, Pfizer CEO Albert Bourla highlighted oncology and metabolic diseases as key areas for innovation. Summit hit the headlines in September 2024 when it reported that ivonescimab significantly reduced the risk of disease progression or death by 49% compared to MSD's blockbuster Keytruda (pembrolizumab) in a Phase III trial involving patients with advanced non-small cell lung cancer (NSCLC). The trial, known as HARMONi-2 (NCT05499390), enrolled 398 patients in China with PD-L1-positive advanced NSCLC. Results demonstrated a median progression-free survival of 11.14 months for ivonescimab recipients versus 5.82 months for those on Keytruda. This marked the first instance of a therapy showing a statistically significant improvement over Keytruda in this patient population. Keytruda, a PD-1 checkpoint inhibitor, generated $29.5bn in 2024, as per MSD's financials. This revenue flow is expected to continue growing with GlobalData predicting that the blockbuster will pull in $34.9bn in 2028, the year in which key Keytruda patents are set to expire. Summit acquired rights to ivonescimab in December 2022 through a $500m agreement with China-based Akeso, covering territories including the US and Europe. If approved, the antibody could generate up to $1.2bn in sales in 2030, as per GlobalData analysis. GlobalData is the parent company of Pharmaceutical Technology. "Pfizer sets sights on Summit's bispecific in combo with its ADCs" was originally created and published by Pharmaceutical Technology, 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. Sign in to access your portfolio

Lantern Pharma Unveils Innovative AI-Powered Module to Improve the Precision, Cost and Timelines of Antibody-Drug Conjugate (ADC) Development for Cancer
Lantern Pharma Unveils Innovative AI-Powered Module to Improve the Precision, Cost and Timelines of Antibody-Drug Conjugate (ADC) Development for Cancer

Yahoo

time27-01-2025

  • Business
  • Yahoo

Lantern Pharma Unveils Innovative AI-Powered Module to Improve the Precision, Cost and Timelines of Antibody-Drug Conjugate (ADC) Development for Cancer

DALLAS, January 27, 2025--(BUSINESS WIRE)--Lantern Pharma Inc. (NASDAQ: LTRN), an artificial intelligence (AI) company dedicated to developing cancer therapies and transforming the cost, pace, and timeline of oncology drug discovery and development, today announced advancements in the application of its RADR® AI platform to accelerate and optimize the development of antibody-drug conjugates (ADCs). The global ADC market is projected to reach $30.4 billion by 2028, growing at a CAGR of 41.7%, with several recently approved ADCs achieving blockbuster status with annual sales exceeding $1 billion. Major biotech and pharmaceutical companies have recently completed ADC-focused acquisitions valued at over $10 billion, highlighting the sector's growing strategic importance. Lantern Pharma is actively advancing multiple ADC candidates through preclinical development, including a promising collaboration with the prestigious MAGICBULLET::Reloaded Initiative at the University of Bielefeld in Germany. In a peer-reviewed study published in PLOS ONE, Lantern Pharma researchers demonstrated how their AI-driven approach successfully identified 82 promising ADC targets and 290 target-indication combinations, while also validating 729 potential payload molecules from a screening of over 50,000 compounds. Notably, 22 of these targets have already been validated in clinical or preclinical settings, demonstrating the platform's ability to identify clinically relevant targets. The remaining 60 novel targets represent significant potential for new intellectual property, portfolio development of ADC candidates at Lantern Pharma and licensing opportunities with other biotech and pharma companies. The ADC module helped to characterize payload molecules with exceptional potency, exhibiting GI50 values from picomolar to 10 nM (nanomolar) ranges. These payload molecules can be further optimized by leveraging RADR's comprehensive molecular features database by mapping drug-response relationships with biochemical and molecular structure characteristics. This AI-driven optimization capability could potentially enhance both the selective targeting and therapeutic window of these ADC payload candidates. Lantern Pharma continues to advance the methods and automations outlined in the paper as part of it's RADR™ AI platform and further enhance the data and computational precision of the module. "This breakthrough demonstrates how AI can transform the traditionally costly and time-consuming process of ADC development," said Panna Sharma, CEO & President of Lantern Pharma. "By simultaneously analyzing multiple data types and integrating mutation profiles with target expression, our team was able to identify optimal therapeutic combinations that have the potential to be more effective and safer for specific patient populations. We believe that our data-driven and machine-learning ready approach could reduce ADC development timelines by 30 to 50% and cut associated costs by up to 60% compared to traditional methods of ADC development." The research leverages Lantern's proprietary RADR® platform to analyze complex datasets including transcriptomics, proteomics, and mutation profiles across 22 tumor types. The platform's ability to predict mutation-specific responses could enable more precise patient stratification in clinical trials, potentially increasing success rates and reducing development costs. This precision approach to ADC development could be valuable for biotech and pharmaceutical companies looking to advance their ADC portfolio in more targeted indications and is also being actively used by Lantern in the development and modeling of their ADC candidates in preclinical testing and optimization. "The implications of this research extend far beyond just expanding the repertoire of potential ADC targets," said Kishor Bhatia, Ph.D., Chief Scientific Officer at Lantern Pharma. "By leveraging our RADR® platform's advanced AI capabilities, we've created a systematic approach that could dramatically reduce both the time and cost of ADC development while increasing the probability of clinical success. Our platform is particularly well-suited for partnership opportunities with pharmaceutical companies looking to accelerate their ADC programs or expand their pipeline with novel targets." Key Highlights of the AI-powered ADC module include: Demonstrated platform validation through the successful identification of 22 clinically proven targets with established therapeutic potential Discovered 60 novel targets that present significant opportunities for new intellectual property development, portfolio expansion, and strategic licensing partnerships Developed proprietary mutation-specific targeting capabilities that enable improved clinical trial design, enhanced precision in indication selection, and more accurate patient response predictions Established a framework that could reduce ADC development costs by up to 60% and accelerate development timelines by 30-50% for both Lantern Pharma and its collaborators Created a highly scalable, machine-learning ready approach that leverages the RADR™ AI platform to systematically evaluate thousands of potential tumor sub-types and indications Designed a clear pathway to commercialization through strategic industry partnerships and collaborative development programs The complete research paper, titled "Expanding the repertoire of Antibody Drug Conjugate (ADC) targets with improved tumor selectivity and range of potent payloads through in-silico analysis," is available in PLOS ONE at The paper outlines the approach and initial data-sets used in the development of the AI-powered ADC development module which continues to be enhanced, and is being further validated by Lantern Pharma. About Lantern Pharma Lantern Pharma (NASDAQ: LTRN) is an AI company transforming the cost, pace, and timeline of oncology drug discovery and development. Our proprietary AI and machine learning (ML) platform, RADR®, leverages over 100 billion oncology-focused data points and a library of 200+ advanced ML algorithms to help solve billion-dollar, real-world problems in oncology drug development. By harnessing the power of AI and with input from world-class scientific advisors and collaborators, we have accelerated the development of our growing pipeline of therapies that span multiple cancer indications, including both solid tumors and blood cancers and an antibody-drug conjugate (ADC) program. Our lead development programs include a Phase 2 clinical program and multiple Phase 1 clinical trials. Our AI-driven pipeline of innovative product candidates is estimated to have a combined annual market potential of over $15 billion USD and have the potential to provide life-changing therapies to hundreds of thousands of cancer patients across the world. Please find more information at: Website: LinkedIn: X: @lanternpharma FORWARD LOOKING STATEMENT: 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 our research and the research of our collaborators may not be successful, (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 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, (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, 2023, filed with the Securities and Exchange Commission on March 18, 2024. You may access our Annual Report on Form 10-K for the year ended December 31, 2023 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. View source version on Contacts Investor Relationsir@ (972)277-1136

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