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Yahoo
23-04-2025
- Business
- Yahoo
Cullinan Therapeutics to Present Results from REZILIENT1, a Phase 1/2 Trial of Zipalertinib in Patients with Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations Who Have Received Prior Therapy, at ASCO 2025
Cullinan and Taiho previously announced the Phase 2b portion of the study met the primary endpoint of overall response rate CAMBRIDGE, Mass., April 23, 2025 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, today announced that results from the REZILIENT1 study of zipalertinib in non-small cell lung cancer (NSCLC) patients with EGFR exon 20 insertion mutations (ex20ins) who have received prior therapy will be presented in an oral abstract session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting taking place in Chicago from May 30–June 3, 2025. The data will include results from the Phase 2b portion of the study, which explored zipalertinib monotherapy in patients with advanced or metastatic EGFR ex20ins NSCLC who progressed after prior treatment with platinum-based chemotherapy with or without amivantamab and other ex20ins-targeted therapies. 'Despite an evolving treatment landscape, patients with non-small cell lung cancer with EGFR exon 20 insertion mutations continue to have limited treatment options and poor disease outcomes,' said Jeffrey Jones, MD, MBA, Chief Medical Officer, Cullinan Therapeutics. 'The results from REZILIENT1 show zipalertinib demonstrated clinically meaningful efficacy and a manageable safety profile in patients who have received prior platinum-based chemotherapy, including those who were treated with amivantamab, and zipalertinib has the potential to address significant unmet need in these patient settings. We look forward to sharing these important results with the lung cancer community through our oral presentation at the 2025 ASCO Annual Meeting.' The details of the presentation include: Presentation Title: Efficacy of zipalertinib in NSCLC patients with EGFR exon 20 insertion mutations who received prior platinum-based chemotherapy with or without amivantamabPresenting Author: Helena A. Yu, MD, Memorial Sloan Kettering Cancer CenterAbstract Number: 8503Session: Oral Abstract Session – Lung Cancer – Non-Small Cell MetastaticPresentation Date and Time: Sunday, June 1, 2025, 8:00 AM-11:00 AM CDT Live and Virtual Investor EventCullinan will host an in-person event for analysts and institutional investors on Sunday, June 1, 2025, at 6:30 PM CDT, during which Danny Nguyen, MD, Assistant Clinical Professor, City of Hope National Medical Center, will participate in a discussion of the zipalertinib data shared at the 2025 ASCO Annual Meeting with members of Cullinan management. Participants from Cullinan Therapeutics include Nadim Ahmed, Chief Executive Officer, and Jeffrey Jones, MD, MBA, Chief Medical Officer. Investors and analysts are invited to register to attend in person by emailing Nick Smith, Head of Investor Relations (nsmith@ A webcast will be available via the events page of the Company's investor relations website at About Zipalertinib Zipalertinib (CLN-081/TAS6417) is an orally available small molecule designed to target activating mutations in EGFR. The molecule was engineered to inhibit EGFR variants with exon 20 insertion mutations, while sparing wild-type EGFR. Zipalertinib is designed as a next generation, irreversible EGFR inhibitor for the treatment of a genetically defined subset of patients with non-small cell lung cancer. Zipalertinib has received Breakthrough Therapy Designation from the FDA. Zipalertinib is being developed by Taiho Oncology, Inc., its parent company, Taiho Pharmaceutical Co., Ltd., and Cullinan Therapeutics, Inc. About Cullinan Therapeutics Cullinan Therapeutics, Inc. (Nasdaq: CGEM) is a biopharmaceutical company dedicated to creating new standards of care for patients. Cullinan has strategically built a diversified portfolio of clinical-stage assets that inhibit key drivers of disease or harness the immune system to eliminate diseased cells in both autoimmune diseases and cancer. Cullinan's portfolio encompasses a wide range of modalities, each with the potential to be best and/or first in class. Anchored in a deep understanding of oncology, immunology, and translational medicine, we create differentiated ideas, identify the most appropriate targets, and select the optimal modality to develop transformative therapeutics across a wide variety of autoimmune and cancer indications. We push conventional boundaries from candidate selection to differentiated therapeutic, applying rigorous go/no go criteria at each stage of development to fast-track only the most promising molecules to the clinic and, ultimately, commercialization. With deep scientific expertise, our teams exercise creativity and urgency to deliver on our promise to bring new therapeutic solutions to patients. Learn more about Cullinan at and follow us on LinkedIn and X. Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements regarding the company's beliefs and expectations regarding our plans regarding future data presentations, the clinical development and regulatory filing plan and timeline of zipalertinib, the safety and efficacy profile of zipalertinib and its potential to address this unmet need, and other statements that are not historical facts. The words 'believe,' 'continue,' 'could,' 'estimate,' 'expect,' 'intends,' 'may,' 'plan,' 'potential,' 'project,' 'pursue,' 'will,' and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs of future events and are subject to known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks include, but are not limited to, the following: uncertainty regarding the timing and results of regulatory submissions; the risk that any INDs or other global regulatory submissions we may file with the United States Food and Drug Administration or other global regulatory agencies are not cleared on our expected timelines, or at all; the success of our clinical trials and preclinical studies; the risks related to our ability to protect and maintain our intellectual property position; the risks related to manufacturing, supply, and distribution of our product candidates; the risk that any one or more of our product candidates, including those that are co-developed, will not be successfully developed and commercialized; the risk that the results of preclinical studies or clinical studies will not be predictive of future results in connection with future studies; and the success of any collaboration, partnership, license or similar agreements. These and other important risks and uncertainties discussed in our filings with the Securities and Exchange Commission, including under the caption 'Risk Factors' in our most recent Annual Report on Form 10-K and subsequent filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change, except to the extent required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Moreover, except as required by law, neither the company nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements included in this press release. Any forward-looking statement included in this press release speaks only as of the date on which it was made. Contacts: Investors Nick Smith +1 401.241.3516 nsmith@ MediaRose Weldon+1 215.801.7644rweldon@ in to access your portfolio
Yahoo
18-03-2025
- Business
- Yahoo
Taiho Pharmaceutical to acquire Araris Biotech for up to $1.14 billion
-- On Monday, Taiho Pharmaceutical (TADAWUL:2070) Co., Ltd. announced a definitive agreement to acquire Araris Biotech AG, a Swiss biotech company specializing in next-generation antibody drug conjugates (ADCs). The $400 million deal, with additional milestone payments up to $740 million, is set to be completed in the first half of 2025. The agreement follows a research collaboration initiated in November 2023 between the two companies. Araris, emerging from the Paul-Scherrer-Institute in Switzerland, is known for its innovative ADCs which offer improved design, high linker solubility, and simpler manufacturing. These advancements aim to overcome the limitations of existing ADCs. Their proprietary ADC linker platform, AraLinQ™, has produced ADC candidates that are more uniform, stable, and potent, showing greater safety and antitumor effects in preclinical studies. Araris is also progressing three preclinical-stage products for hematological and solid tumors, expected to enter clinical trials between 2025 and 2026. Taiho Pharmaceutical, recognized for its antimetabolites and small molecule drug discovery platform Cysteinomix, aims to enhance cancer treatment and patient care. The acquisition of Araris will complement Taiho's portfolio, particularly in oncology drug discovery. Masayuki Kobayashi, President of Taiho Pharmaceutical, expressed confidence that Araris' expertise and technology will significantly enhance Taiho's drug discovery capabilities. Dima Kuzmin of 4BIO Capital commended the acquisition, emphasizing Taiho's capability to expedite the development of Araris' treatments. "We are proud to combine with Taiho and aim to turbo-charge the clinical development of our potent antibody-drug conjugate (ADC) candidates in hematological and solid tumors," Dragan Grabulovski, Ph.D., CEO and co-founder of Araris Biotech, told following the annoucement. "The Araris approach is unique because it creates smart missile ADCs by attaching multiple cancer-fighting payloads to a single antibody in one step that mimic successful chemotherapy combinations in a targeted fashion to overcome persistent challenges of cancer resistance. Araris' ADCs can potentially be safer and more efficacious than other ADCs because their proprietary conjugation technology AraLinQ™ connects the linker-payload to the antibody with exceptional stability, resulting in precise payload delivery to the tumor target and less toxicity in the bloodstream." Grabulovski added, "We have been able to build a strong relationship with the Taiho team starting with our research collaboration that began in November 2023. In the course of this research collaboration, ADCs were created using Araris' technology using antibodies to undisclosed targets. We look forward to working together to advance the future of cancer care." Post-acquisition, Araris will operate as a fully owned subsidiary of Taiho Pharmaceutical, continuing its operations and research in Zurich, Switzerland. Their AraLinQ™ technology is notable for its site-specific payload attachment, maintaining antibody performance and exceptional stability, while improving solubility and enabling the delivery of multiple payloads. MTS Health Partners, L.P, Wilson Sonsini Goodrich&Rosati PC, and Homburger AG are advising Taiho Pharmaceutical, while Centerview Partners UK LLP, Cooley LLP, and BGPartner Ltd are advising Araris on the transaction. Related Articles Taiho Pharmaceutical to acquire Araris Biotech for up to $1.14 billion Alphabet to buy Wiz for $32 billion in its biggest deal to boost cloud security .P. Morgan sees 20% upside in Rio Tinto, rates stock Overweight on copper growth Sign in to access your portfolio
Yahoo
17-03-2025
- Business
- Yahoo
Taiho outlays $1.14bn to acquire ADC specialist Araris
Taiho Pharmaceutical has agreed to acquire Swiss-based antibody-drug-conjugate (ADC) specialist Araris Biotech for up to $1.14bn, representing another big-dollar deal for the promising cancer treatment modality. The purchase agreement comprises a $400m upfront payment, with a further $740m in milestone payments. The deal is expected to be completed in the first half of 2025. Taiho is already familiar with Araris's technology, having worked with the biotech since 2023 via an ADC collaboration targeting undisclosed oncological targets. This acquisition will see Taiho gain access to Araris's entire ADC infrastructure, with the biotech becoming a wholly owned subsidiary. A spin-off from the Paul Scherrer Institute (PSI) and ETH Zurich, Araris has developed linker technology that allows attachment of payloads to 'off-the-shelf' antibodies in a single step. The key differentiator of the biotech's platform, called AraLinQ, allows the conjugation of two or three cytotoxic payloads simultaneously. ADCs have become a promising therapeutic modality in oncology and are one of the fastest-growing areas in cancer drug research. Araris claims its peptide linker technology overcomes limitations in current ADC technologies such as heterogeneity, aggregation in blood, and high costs. Araris states preclinical studies have demonstrated a wider range of safety and increased antitumour effects among its candidates compared to conventional ADCs. The Swiss biotech has three candidates at the preclinical stage that are anticipated to enter clinical trials between 2025 and 2026. Araris's CEO Dragan Grabulovski told Pharmaceutical Technology earlier this year that nectin-four and NaPi2b are targets for two of the internal programmes; the third has not been disclosed. '[Taiho's] significant cancer expertise will support us in turbo-charging the clinical development of our potent ADC candidates in haematological and solid tumours,' Grabulovski said in a statement following the acquisition agreement. Taiho's president Masayuki Kobayashi commented: 'We are confident that the addition of Araris's knowledge, experience and technology platform in ADC drug discovery, as well as its development pipeline, will lead to further expansion and strengthening of Taiho's drug discovery capabilities and portfolio.' Taiho is not the only Japanese pharma company to tap Araris's linker technology – Chugai Pharmaceutical penned a research collaboration, including a licence agreement with the biotech for up to $780m in January 2025. Taiho's acquisition of Araris is just the latest in a long line of deals in the ADC space, though it is still a long way short of some of the money being spent by big pharma. Pfizer – which is also researching multi-payload ADCs - acquired Seagen for $43bn in December 2023 while MSD and AbbVie have also completed $10.8bn and $10.1bn deals in recent years. "Taiho outlays $1.14bn to acquire ADC specialist Araris" 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.
