Latest news with #ADCs
Business Wire
3 days ago
- Business
- Business Wire
Kivu Bioscience Selects Sterling Pharma Solutions for cGMP Manufacturing of Lead Oncology Antibody-Drug Conjugate KIVU-107
SAN FRANCISCO--(BUSINESS WIRE)-- Kivu Bioscience, a biotech company developing next-generation antibody-drug conjugates, announced today a manufacturing partnership with Sterling Pharma Solutions, a global contract development and manufacturing organisation, to produce cGMP-quality material for Phase 1 clinical trials of its lead oncology antibody-drug conjugate (ADC) candidate, KIVU-107. Under the agreement, Sterling will manufacture cGMP clinical material for KIVU-107 at its dedicated bioconjugation facility in Deeside, UK. The collaboration includes process familiarisation, analytical development, process optimisation, and scale-up activities in preparation for a cGMP manufacturing campaign. 'We chose Sterling as our manufacturing partner based on their deep expertise in ADC development, proven track record of clinical supply, and commitment to quality,' said Mohit Trikha, Ph.D., President and Chief Operating Officer, Kivu Bioscience. 'This partnership marks an important milestone as we advance KIVU-107 toward first-in-human studies and deliver on our mission to bring kinder, gentler and efficacious next-generation ADC therapies to patients.' KIVU-107 is a potential first-in-class antibody-targeted conjugate which enables site-specific conjugation. The resulting structure positions the linker-payload in a natural cavity in the antibody, providing excellent stability, reduced hydrophobicity, and an increased therapeutic index relative to first-generation ADC therapies. 'Our team at Deeside has extensive experience supporting complex ADC programs from early development through clinical manufacturing,' said Chad Telgenhof, Chief Commercial Officer at Sterling Pharma Solutions. 'We're excited to support Kivu to bring this promising new oncology candidate into the clinic, leveraging our expertise and investment in world-class ADC development and clinical manufacturing capabilities.' Sterling's 6,500-square-metre Deeside facility offers a range of ADC services, from discovery-stage development through to clinical supply. In October 2024, Sterling announced a £10 million investment at the site to double its GMP manufacturing capacity, as the second phase of an ongoing strategy to increase the capabilities that it can offer customers. About Kivu Bioscience Kivu Bioscience is pioneering next-generation antibody-drug conjugates (ADCs) in oncology. The company's proprietary linker-payload technology delivers enhanced safety and efficacy, minimizing off-target effects to improve patient outcomes. With multiple ADC programs in development and a team of industry veterans, Kivu is advancing its lead candidates to clinical trials. The company is headquartered in San Francisco, CA. For more information, visit About Sterling Pharma Solutions Sterling Pharma Solutions is a global contract development and manufacturing organisation (CDMO) with more than 50 years' experience in providing small molecule API development and manufacturing services to the pharmaceutical industry, specialising in handling challenging chemistries. Sterling manages the most complex API challenges from proof-of-concept to commercial manufacture, as well as antibody-drug conjugate (ADC) research and development bioconjugation services. Sterling has six facilities employing more than 1,350 people: its HQ in Dudley, Northumberland, UK; a chemistry services business in Newcastle upon Tyne, UK; a site in Ringaskiddy, Co. Cork, Ireland; a dedicated bioconjugation and ADC facility in Deeside, North Wales, UK; and two sites in the US, in Cary, North Carolina and Germantown, Wisconsin. Find out more
Yahoo
3 days ago
- Business
- Yahoo
ADC Therapeutics Makes Grants to New Employees Under Inducement Plan
LAUSANNE, Switzerland, June 2, 2025 /PRNewswire/ -- ADC Therapeutics SA (NYSE: ADCT), a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs), today announced that the Company has made grants of options to purchase an aggregate of 107,550 of the Company's common shares to two new employees on June 2, 2025 (each, a "Grant"). The Grants were offered as material inducement to the employees' employment. The grants were approved by the Compensation Committee of the Company's Board of Directors pursuant to the Company's Inducement Plan to motivate and reward the recipients to perform at the highest levels and contribute significantly to the success of the Company. The Grants were made in reliance on the employment inducement exemption under the NYSE's Listed Company Manual Rule 303A.08. The Company is issuing this press release pursuant to Rule 303A.08. The Grants shall vest and become exercisable 25% on the first anniversary of the grant date, and 1/48th of the aggregate number of shares subject to the award on each monthly anniversary of the grant date thereafter, such that the entire award will be vested as of the fourth anniversary of the grant date, subject to continued employment with the Company. About ADC Therapeutics ADC Therapeutics (NYSE: ADCT) is a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs). The Company is advancing its proprietary ADC technology to transform the treatment paradigm for patients with hematologic malignancies and solid tumors. ADC Therapeutics' CD19-directed ADC ZYNLONTA (loncastuximab tesirine-lpyl) received accelerated approval by the FDA and conditional approval from the European Commission for the treatment of relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy. ZYNLONTA is also in development in combination with other agents and in earlier lines of therapy. In addition to ZYNLONTA, ADC Therapeutics has multiple ADCs in ongoing clinical and preclinical development. ADC Therapeutics is based in Lausanne (Biopôle), Switzerland, and has operations in London and New Jersey. For more information, please visit and follow the Company on LinkedIn. ZYNLONTA® is a registered trademark of ADC Therapeutics SA. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. In some cases you can identify forward-looking statements by terminology such as "may", "will", "should", "would", "expect", "intend", "plan", "anticipate", "believe", "estimate", "predict", "potential", "seem", "seek", "future", "continue", or "appear" or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to: whether future LOTIS-7 clinical trial results will be consistent with or different from the LOTIS-7 data presented at EHA and ICML, the timing of the PFS events for LOTIS-5 and the results of the trial, the expected cash runway into the second half of 2026 which assumes use of minimum liquidity amount required to be maintained under its loan agreement covenants; the Company's ability to grow ZYNLONTA® revenue in the United States; the ability of our partners to commercialize ZYNLONTA® in foreign markets, the timing and amount of future revenue and payments to us from such partnerships and their ability to obtain regulatory approval for ZYNLONTA® in foreign jurisdictions; the timing and results of the Company's or its partners' research and development projects or clinical trials including LOTIS 5 and 7, as well as early research in certain solid tumors with different targets, linkers and payloads; the timing and results of investigator-initiated trials including those studying FL and MZL and the potential regulatory and/or compendia strategy and the future opportunity; the timing and outcome of regulatory submissions for the Company's products or product candidates; actions by the FDA or foreign regulatory authorities; projected revenue and expenses; the Company's indebtedness, including Healthcare Royalty Management and Blue Owl and Oaktree facilities, and the restrictions imposed on the Company's activities by such indebtedness, the ability to comply with the terms of the various agreements and repay such indebtedness and the significant cash required to service such indebtedness; and the Company's ability to obtain financial and other resources for its research, development, clinical, and commercial activities. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K and in the Company's other periodic and current reports and filings with the U.S. Securities and Exchange Commission. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this document. CONTACTS:InvestorsMarcy GrahamADC 650-667-6450 MediaNicole RileyADC 862-926-9040 View original content to download multimedia: SOURCE ADC Therapeutics SA Sign in to access your portfolio
Yahoo
3 days ago
- Business
- Yahoo
Defence Therapeutics Opens U.S. Laboratory in Boston-Cambridge Biotech Hub
Montreal, Quebec--(Newsfile Corp. - June 2, 2025) - Defence Therapeutics Inc. (CSE: DTC) (OTCQB: DTCFF) (FSE: DTC) ("Defence" or the "Company"), a leading biotechnology company specializing in advanced endosomal escape technologies, is pleased to announce the opening of its first U.S. laboratory in the Boston-Cambridge area. This strategic expansion marks Defence Therapeutics' initial physical presence in the United States, reinforcing its commitment to advancing cutting-edge research and development in one of the world's foremost biotech clusters. The new laboratory, located at Cambridge Scientific Labs in Watertown, will allow Defence Therapeutics to further develop and optimize its proprietary Accum® technology for antibody-drug conjugates ("ADCs"). Establishing a presence in the Boston-Cambridge area provides the company with access to top-tier scientific resources and opportunities for collaboration within the region's renowned biotech ecosystem. The Cambridge Scientific Labs location will serve as a short-term base while Defence Therapeutics evaluates options for a long-term facility in the area. "Our expansion into the Boston-Cambridge area is a significant milestone for Defence Therapeutics," said Sebastien Plouffe, CEO of Defence Therapeutics. "Establishing a U.S. laboratory positions us at the heart of the global biotech community and supports our mission to advance the Accum® platform for next-generation ADCs. We look forward to deepening our presence in the region as we continue to grow and pursue a long-term facility in this dynamic market." About Defence: Defence Therapeutics is a publicly-traded clinical-stage biotechnology company developing and engineering the next generation of radio-immuno-conjugate and ADC products using its proprietary platform. The core of Defence Therapeutics platform is the ACCUM® technology, which enables precision delivery of radio-immuno-conjugates or ADCs in their intact form to target cells. As a result, increased efficacy and potency can be reached against cancer. For further information: Sebastien Plouffe, President, CEO and DirectorP: (514) 947-2272Splouffe@ Cautionary Statement Regarding "Forward-Looking" Information This release includes certain statements that may be deemed "forward-looking statements". All statements in this release, other than statements of historical facts, that address events or developments that the Company expects to occur, are forward-looking statements. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects", "potential" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should" occur. Although the Company believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results may differ materially from those in the forward-looking statements. Factors that could cause the actual results to differ materially from those in forward-looking statements include regulatory actions, market prices, and continued availability of capital and financing, and general economic, market or business conditions. Investors are cautioned that any such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking statements. Forward-looking statements are based on the beliefs, estimates and opinions of the Company's management on the date the statements are made. Except as required by applicable securities laws, the Company undertakes no obligation to update these forward-looking statements in the event that management's beliefs, estimates or opinions, or other factors, should change. Neither the CSE nor its market regulator, as that term is defined in the policies of the CSE, accepts responsibility for the adequacy or accuracy of this release. To view the source version of this press release, please visit Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Associated Press
29-05-2025
- Business
- Associated Press
Akari Therapeutics Releases 'Meet the Team' Video Featuring Recently Appointed Mark F. Kubik, Head of Business Development
Access the video here BOSTON and LONDON, May 29, 2025 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), an oncology biotechnology company developing novel payload antibody drug conjugates (ADCs), today announced the release of a 'Meet the Team' video featuring newly appointed Mark F. Kubik, Head of Business Development – Oncology. The video is now available on the Presentations page under the Investors section of the Company's website ( ). About Akari Therapeutics Akari Therapeutics is an oncology biotechnology company developing next-generation spliceosome payload antibody drug conjugates (ADCs). Utilizing its innovative ADC discovery platform, the Company has the ability to generate ADC candidates and optimize them based on the desired application to any target of interest. Akari's lead candidate, AKTX-101, targets the Trop2 receptor on cancer cells and with a proprietary linker, delivers its novel PH1 payload directly into the tumor. Unlike current ADCs that use tubulin inhibitors and DNA damaging agents as their payloads, PH1 is a novel payload that is a spliceosome inhibitor designed to disrupt RNA splicing within cancer cells. This splicing inhibition has been shown in preclinical animal models to induce cancer cell death while activating immune cells to drive robust and durable activity. In preclinical studies, AKTX-101 has shown to have significant activity and prolonged survival, relative to ADCs with traditional payloads. Additionally, AKTX-101 has the potential to be synergistic with checkpoint inhibitors and has demonstrated prolonged survival as both a single agent and in combination with checkpoint inhibitors, as compared to appropriate controls. The Company is generating validating data on its novel payload PH1 to continue advancing its lead asset, as well as other undisclosed targets with this novel payload. For more information about the Company, please visit and connect on X and LinkedIn. Cautionary Note Regarding Forward-Looking Statements This press release includes express or implied 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, about the Company that involve risks and uncertainties relating to future events and the future performance of the Company. Actual events or results may differ materially from these forward-looking statements. Words such as 'will,' 'could,' 'would,' 'should,' 'expect,' 'plan,' 'anticipate,' 'intend,' 'believe,' 'estimate,' 'predict,' 'project,' 'potential,' 'continue,' 'future,' 'opportunity' 'will likely result,' 'target,' variations of such words, and similar expressions or negatives of these words are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. Examples of such forward-looking statements include, but are not limited to, express or implied statements regarding the ability of the Company to advance its product candidates for the treatment of cancer and any other diseases, and ultimately bring therapies to patients; the Company's targets, plans, objectives or goals for future operations, including those related to its product candidates; financial projections; future economic performance; and the assumptions underlying or relating to such statements. These statements are based on the Company's current plans, estimates and projections. By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific. A number of important factors, including those described in this communication, could cause actual results to differ materially from those contemplated in any forward-looking statements. Factors that may affect future results and may cause these forward-looking statements to be inaccurate include, without limitation: the potential impact of unforeseen liabilities, future capital expenditures, revenues, costs, expenses, earnings, synergies, economic performance, indebtedness, financial condition and losses on the future prospects, business and management strategies for the management, expansion and growth of the business; risks related to global as well as local political and economic conditions, including interest rate and currency exchange rate fluctuations; potential delays or failures related to research and/or development of the Company's programs or product candidates; risks related to any loss of the Company's patents or other intellectual property rights; any interruptions of the supply chain for raw materials or manufacturing for the Company's product candidates, including as a result of potential tariffs; the nature, timing, cost and possible success and therapeutic applications of product candidates being developed by the Company and/or its collaborators or licensees; the extent to which the results from the research and development programs conducted by the Company, and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; uncertainty of the utilization, market acceptance, and commercial success of the Company's product candidates; risks related to competition for the Company's product candidates; and the Company's ability to successfully develop or commercialize its product candidates. While the foregoing list of factors presented here is considered representative, no list should be considered to be a complete statement of all potential risks and uncertainties. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the SEC, copies of which may be obtained from the SEC's website at The Company assumes no, and hereby disclaims any, obligation to update the forward-looking statements contained in this press release except as required by law. Investor Relations Contact JTC Team, LLC Jenene Thomas 908-824-0775 [email protected]
Business Wire
28-05-2025
- Business
- Business Wire
Nucleai to Showcase Expanded Suite of ADC Biomarker Scoring Solutions at ASCO 2025
CHICAGO--(BUSINESS WIRE)--Nucleai, an AI-powered spatial biomarker and diagnostics company, will showcase its expanded suite of solutions for antibody-drug conjugate (ADC) clinical trials at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, held this week from May 30-June 3 in Chicago, IL. Recent studies have demonstrated that AI-powered computational pathology and spatial biomarkers can predict ADC treatment response more accurately than standard pathological scores, enabling ADC developers to derisk their drug development programs by designing biomarker-informed clinical trials. Nucleai's commercially available ADC suite of solutions unlocks unparalleled granularity for ADC developers, including high sensitivity for low levels of biomarker expression as well as detecting subcellular protein expression. At ASCO, Nucleai will demo their OD-based quantitative biomarker scoring solution, which solves the challenges of manual visual scoring of immunohistochemistry (IHC) images by pathologists, which could lead to inconsistent results and an incomplete understanding of drug efficacy. The analysis suite also includes spatial biomarker scoring methods to model a drug's potential bystander effect, with implications for patient stratification and trial design. In addition to these applications, biopharma partners developing ADC and immunotherapy combination therapy strategies can evaluate tumor immunogenicity and identify specific immune cell subsets in the tumor microenvironment using Nucleai's multimodal capabilities, which combine IHC data with hematoxylin and eosin (H&E) stained biopsy slides. Demand has continued to rise for AI-powered quantitative biomarker scoring, especially for ADC development, where the exact mechanism of action (MOA), treatment response, and resistance mechanisms have not been fully established. For example, in some studies, researchers have concluded that high levels of protein expression on the surface of tumor cells are correlated to patient outcomes, but in other studies, treatment response is correlated to higher expression of the protein in the cell's cytoplasm. On the other hand, in some indications, there is no clear correlation between protein expression levels in the patient and their response to the drug. In addition to supporting drug development, clinicians are also in need of better biomarkers to help guide the sequence of treatment in indications like hormone receptor (HR)-positive breast cancer, where multiple ADCs with similar cytotoxic payloads have been approved in recent years. Nucleai, which has pioneered the use of AI for spatial biomarker analysis, has been working with leading ADC developers to evaluate their trials with this expanded suite of capabilities. As an add-on to these capabilities, Nucleai will also unveil an AI-driven analysis studio that enables easier extraction of actionable MOA and biomarker insights from complex computational pathology and spatial biology data. With this advancement, biopharma partners now have faster access to actionable insights, which can be applied to clinical trials and companion diagnostics in the future. The expanded ADC suite also includes a novel spatial proteomics dataset with over 200 tumor and normal samples, across 30 biomarkers and 3 indications to profile ADCs, bispecific antibody targets, the tumor immune microenvironment, and for credentialing potential combination therapy strategies. "Biomarker exploration often stops at identifying correlations, but the promise of AI-based spatial biomarkers and diagnostics is to move beyond this limited understanding," said Avi Veidman, CEO and co-founder of Nucleai. "With this expanded suite of ADC solutions, researchers can shift from passive observation to active investigation with an interactive interface, helping to bridge the gap from correlation to causality. This approach enables our biopharma partners to accelerate development by deriving clinically meaningful insights from complex data." Next week at ASCO (booth #IH02), the Nucleai team will be sharing specific applications of the ADC solutions suite with demos that cover target identification, credentialing of bispecific targets and combination strategies, OD-based quantitative biomarker scoring, and spatial scoring to model a drug's potential bystander effect. The demos will show how Nucleai is reducing the burden on bioinformatics and pathology teams by providing intuitive tools for real-time interaction with data. Poster Presentation: Biomarkers of Immunotherapy Response in Melanoma Also at ASCO, Nucleai's AI-powered spatial biomarker technology combined with Lunaphore (a Bio-Techne brand)'s high-throughput, hyperplex COMET™ platform will be featured in a poster presentation in collaboration with Dr. Paolo A. Ascierto, Director of the Melanoma and Cancer Immunotherapy Unit at the National Cancer Institute in Naples. The poster, titled 'Application of a novel multiplex imaging-based immunotherapy panel and AI-powered analysis solution for predictive spatial biomarker identification on immunotherapy-treated melanoma patients,' will be presented on Sunday, June 1 from 9:00 AM – 12:00 PM CDT in Hall A - Posters and Exhibits. For more information, visit About Nucleai Nucleai is a leading AI-powered spatial biomarker and diagnostics company, advancing drug development and clinical decision-making through the analysis of cellular interactions and spatial relationships within tissue samples. By adapting geospatial analytical methods initially developed for military purposes, Nucleai applies these capabilities to biospatial analysis in oncology. This enables precise mapping of cellular interactions within tissue samples, which is needed for developing complex therapeutics such as bispecific antibodies and antibody-drug conjugates (ADCs). Nucleai's approach mitigates risks in drug development by improving the accuracy of biomarker identification, optimizing patient selection, and ultimately increasing the probability of clinical success. The company is backed by investors including Section 32, Sanofi Ventures, M Ventures, Vertex Ventures, and Debiopharm Innovation Fund. For more information, visit
