NEW YORK, Dec. 07, 2024 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel radioimmunotherapy and antibody-based therapeutic products for the treatment of cancer, today announced the presentation of CD38-SADA in Non-Hodgkin Lymphoma (NHL) preclinical data and trial in progress posters at the 66 th American Society of Hematology (ASH) Annual Meeting & Exposition being held on December 7 –10, 2024, in San Diego, California. A poster titled “ CD38-SADA, a S elf- A ssembling and D is- A ssembling Bispecific Fusion Protein for Two-Step Pretargeted Radioimmunotherapy of Non-Hodgkin Lymphoma ” characterizes the selective binding of CD38-SADA to DOTA-chelated lanthanide metals and high-avidity binding to CD38, a tumor specific antigen overexpressed across a range of lymphoma cells. Data from this poster demonstrate anti-tumor efficacy of CD38-SADA when used with Lutetium 177 (Lu 177 )-DOTA in a two-step approach to pre-targeted radioimmunotherapy (“PRIT”). Tumor responses in a xenograft mouse model were rapid and dose-dependent, further supporting the clinical development of CD38-SADA PRIT in patients with CD38-positive lymphoid malignancies. “This preclinical analysis provides important insights into the unique pharmacology of CD38-SADA and its therapeutic potential for NHL,” said Brian H. Santich, Ph.D., the lead author and co-inventor of the SADA PRIT technology platform. “The anti-tumor efficacy positively correlated with increasing doses of Lu 177 -DOTA and CD38-SADA, which informed the study design and initial dosing regimen of our Trial 1201 in patients with NHL.” In addition, Y-mAbs presents a trial-in-progress poster from its ongoing Phase 1 (Trial 1201) clinical study evaluating the safety and tolerability of CD38-SADA PRIT with Lu 177 -DOTA in adults with relapsed or refractory NHL. Trial 1201 is a first-in-human, dose-escalation, open-label, multicenter study composed of two parts. Part A includes dose escalation of the CD38-SADA bispecific fusion protein to define the optimal safe dose of the CD38-SADA protein, the administration interval between CD38-SADA and Lu 177 -DOTA, and the Lu 177 -DOTA dose for tumor imaging. In Part B, dose escalation of Lu 177 -DOTA will establish the optimal therapeutic dose of the radioactive payload. For each part, the escalation is based on a 3+3 trial design of 4 planned dose levels. “We are pleased to share the details of this Phase 1 clinical trial, which is investigating a potentially transformative approach to pre-targeted radioimmunotherapy for patients with relapsed and refractory NHL,” said Vignesh Rajah, MBBS, DCH, MRCP (UK), Chief Medical Officer. “This is our second clinical program evaluating the SADA PRIT technology platform and our first in hematological malignancies.” The abstract details are below: Abstract Title: “ CD38-SADA, a Self-Assembling and Dis-Assembling Bispecific Fusion Protein for Two-Step Pretargeted Radioimmunotherapy of Non-Hodgkin Lymphoma” Format : Poster Presentation, ID: 1599 Date and Time: Saturday, December 7, 2024, 5:30 PM-7:30 PM Abstract Title: “ CD38-SADA Pretargeted Radioimmunotherapy (PRIT) with Lutetium 177 (Lu177)-DOTA in Adult Patients with Relapsed or Refractory Non-Hodgkin Lymphoma: A First-in-Human Phase 1 Trial” Format : Poster Presentation, ID: 4434.1 Date and Time: Monday, December 9, 2024, 6:00 PM-8:00 PM Researchers at Memorial Sloan Kettering Cancer Center (MSK), including Dr. Nai-Kong Cheung, developed the SADA technology for radioimmunotherapy, which is exclusively licensed by MSK to Y-mAbs. Dr. Cheung has intellectual property rights and interests in the technology, and as a result of this licensing arrangement, MSK has institutional financial interests in the technology. About Y-mAbs Y-mAbs is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, radioimmunotherapy and antibody-based therapeutic cancer products. The Company’s technologies include its investigational Self-Assembly DisAssembly (“SADA”) Pretargeted Radioimmunotherapy Platform (“PRIT”) and bispecific antibodies generated using the Y-BiClone platform. The Company’s broad and advanced product pipeline includes the anti-GD2 therapy DANYELZA® (naxitamab-gqgk), the first FDA-approved treatment for patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow after a partial response, minor response, or stable disease to prior therapy. About CD38-SADA PRIT CD38-SADA is a bispecific fusion protein that tightly binds to the CD38 antigen and to select radionuclides chelated to tetraxetan (or “DOTA”). CD38-SADA contains a p53-derived domain that drives the self-assembly of CD38-SADA tetramers, which possess four distinct binding sites for CD38. In the first step of pre-targeted radiotherapy, non-radiolabeled-CD38-SADA tetramers are infused and bind with high avidity to CD38-positive tumors, while unbound CD38-SADA disassembles into low molecular weight monomers that are removed by the kidney. The second infusion delivers the “radioactive payload,” which binds to the CD38-SADA on tumor cells for localized irradiation. CD38-SADA PRIT with Lutetium 177 (Lu 177)-DOTA is now under clinical investigation in Trial 1201 (NCT05994157). Forward-Looking Statements Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, statements about our business model, including financial outlook for 2024 and beyond, including estimated operating expenses, use of cash and cash equivalents and DANYELZA product revenue and sufficiency of cash resources and related assumptions; expectations with respect to the Company’s future financial performance; implied and express statements regarding the future of the Company’s business, including with respect to expansion and its goals; expectations with respect to the Company’s plans and strategies, development, regulatory, commercialization and product distribution plans, including the timing thereof; expectations with respect to the Company’s products and product candidates, including potential territory and label expansion of DANYELZA and the potential market opportunity related thereto and potential benefits thereof, and the potential of the SADA PRIT technology and potential benefits and applications thereof; expectations relating to key anticipated development milestones, including potential expansion and advancement of commercialization and development efforts, including potential indications, applications and geographies, and the timing thereof; expectations with respect to current and future clinical and pre-clinical studies and the Company’s research and development programs, including with respect to timing and results; expectations regarding collaborations or strategic partnerships and the potential benefits thereof; and other statements that are not historical facts. Words such as ‘‘anticipate,’’ ‘‘believe,’’ “contemplate,” ‘‘continue,’’ ‘‘could,’’ ‘‘estimate,’’ ‘‘expect,’’ “hope,” ‘‘intend,’’ ‘‘may,’’ ‘‘might,’’ ‘‘plan,’’ ‘‘potential,’’ ‘‘predict,’’ ‘‘project,’’ ‘‘should,’’ ‘‘target,’’ “will,” ‘‘would’,’ “guidance,” “goal,” “objective,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Our product candidates and related technologies are novel approaches to cancer treatment that present significant challenges. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors, including but not limited to: risks associated with the Company’s financial condition and need for additional capital; the risks that actual results of the Company’s restructuring plan and revised business plan will not be as expected; risks associated with the Company’s development work; cost and success of the Company’s product development activities and clinical trials; the risks of delay in the timing of the Company’s or its partners’ regulatory submissions or failure to receive approval of its drug candidates; the risks related to commercializing any approved pharmaceutical product including the rate and degree of market acceptance of product candidates; development of sales and marketing capabilities and risks associated with failure to obtain sufficient reimbursement for products; risks related to the Company’s dependence on third parties including for conduct of clinical testing and product manufacture as well as regulatory submissions; the Company’s ability to enter into new partnerships or to recognize the anticipated benefits from its existing partnerships; risks related to government regulation; risks related to market approval, risks associated with protection of the Company’s intellectual property rights; risks related to employee matters and managing growth; risks related to the Company’s common stock, risks associated with macroeconomic conditions, including the conflict between Russia and Ukraine and sanctions related thereto, the state of war between Israel and Hamas and the related risk of a larger regional conflict, inflation, increased interest rates, uncertain global credit and capital markets and disruptions in banking systems; and other risks and uncertainties affecting the Company including those described in the “Risk Factors” section included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, and the Company’s Quarterly Report on Form 10-Q for the quarterly periods ended March 31, 2024, and September 30, 2024, and future filings and reports by the Company. Any forward-looking statements contained in this press release speak only as of the date hereof, and the Company undertakes no obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. SADA®, SADA PRIT®, DANYELZA® and Y-mAbs® are registered trademarks of Y-mAbs Therapeutics, Inc. Investor Contact: Courtney Dugan VP, Head of Investor Relations cdu@ymabs.com
Pep Guardiola denies rumours of a rift with Kevin De BruyneUS President Joe Biden on Sunday said deposed Syrian leader Bashar al-Assad should be "held accountable" but called the nation's political upheaval a "historic opportunity" for Syrians to rebuild their country. In the first full US reaction to Assad's overthrow by an Islamist-led coalition of rebel factions, Biden also warned that Washington will "remain vigilant" against the emergence of terrorist groups, announcing that US forces had just conducted fresh strikes against militants from the Islamic State organization. "The fall of the regime is a fundamental act of justice," Biden said, speaking from the White House. "It's a moment of historic opportunity for the long-suffering people of Syria." Asked by reporters what should happen to the deposed president, who reportedly has fled to Moscow, Biden said that "Assad should be held accountable." Biden -- set to step down in January and make way for Republican Donald Trump's return to power -- said Washington will assist Syrians in rebuilding. "We will engage with all Syrian groups, including within the process led by the United Nations, to establish a transition away from the Assad regime toward independent, sovereign" Syria "with a new constitution," he said. However, Biden cautioned that hardline Islamist groups within the victorious rebel alliance will be under scrutiny. "Some of the rebel groups that took down Assad have their own grim record of terrorism and human right abuses," Biden said. The United States had "taken note" of recent statements by rebels suggesting they had since moderated, he said, but cautioned: "We will assess not just their words, but their actions." Biden said Washington is "clear eyed" that the Islamic State extremist group, often known as ISIS, "will try to take advantage of any vacuum to reestablish" itself in Syria. "We will not let that happen," he said, adding that on Sunday alone, US forces had conducted strikes against ISIS inside Syria. The US military said the strikes were conducted by warplanes against Islamic State operatives and camps. Strikes were carried out against "over 75 targets using multiple US Air Force assets, including B-52s, F-15s, and A-10s," the US Central Command said on social media. Earlier, Biden met with his national security team at the White House to discuss the crisis. Assad's reported departure comes less than two weeks after the Islamist Hayat Tahrir al-Sham (HTS) group challenged more than five decades of Assad family rule with a lightning rebel offensive that broke long-frozen frontlines in Syria's civil war. They announced Sunday they had taken the capital Damascus and that Assad had fled, prompting celebrations nationwide and a ransacking of Assad's luxurious home. A Kremlin source told Russian news agencies that the deposed leader was now in Moscow, along with his family. The US military has around 900 troops in Syria and 2,500 in Iraq as part of the international coalition established in 2014 to help combat the Islamic State jihadist group. It has regularly struck targets in the country including those linked to Iranian-backed militias. Tehran was a major backer of Assad's government. Biden also confirmed US authorities believe the American journalist Austin Tice, who was abducted in Syria in 2012, still lives. "We believe he's alive," Biden said, but the US has yet "to identify where he is." bur-sms/mlm
NEW YORK, Dec. 07, 2024 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel radioimmunotherapy and antibody-based therapeutic products for the treatment of cancer, today announced the presentation of CD38-SADA in Non-Hodgkin Lymphoma (NHL) preclinical data and trial in progress posters at the 66 th American Society of Hematology (ASH) Annual Meeting & Exposition being held on December 7 –10, 2024, in San Diego, California. A poster titled “ CD38-SADA, a S elf- A ssembling and D is- A ssembling Bispecific Fusion Protein for Two-Step Pretargeted Radioimmunotherapy of Non-Hodgkin Lymphoma ” characterizes the selective binding of CD38-SADA to DOTA-chelated lanthanide metals and high-avidity binding to CD38, a tumor specific antigen overexpressed across a range of lymphoma cells. Data from this poster demonstrate anti-tumor efficacy of CD38-SADA when used with Lutetium 177 (Lu 177 )-DOTA in a two-step approach to pre-targeted radioimmunotherapy (“PRIT”). Tumor responses in a xenograft mouse model were rapid and dose-dependent, further supporting the clinical development of CD38-SADA PRIT in patients with CD38-positive lymphoid malignancies. “This preclinical analysis provides important insights into the unique pharmacology of CD38-SADA and its therapeutic potential for NHL,” said Brian H. Santich, Ph.D., the lead author and co-inventor of the SADA PRIT technology platform. “The anti-tumor efficacy positively correlated with increasing doses of Lu 177 -DOTA and CD38-SADA, which informed the study design and initial dosing regimen of our Trial 1201 in patients with NHL.” In addition, Y-mAbs presents a trial-in-progress poster from its ongoing Phase 1 (Trial 1201) clinical study evaluating the safety and tolerability of CD38-SADA PRIT with Lu 177 -DOTA in adults with relapsed or refractory NHL. Trial 1201 is a first-in-human, dose-escalation, open-label, multicenter study composed of two parts. Part A includes dose escalation of the CD38-SADA bispecific fusion protein to define the optimal safe dose of the CD38-SADA protein, the administration interval between CD38-SADA and Lu 177 -DOTA, and the Lu 177 -DOTA dose for tumor imaging. In Part B, dose escalation of Lu 177 -DOTA will establish the optimal therapeutic dose of the radioactive payload. For each part, the escalation is based on a 3+3 trial design of 4 planned dose levels. “We are pleased to share the details of this Phase 1 clinical trial, which is investigating a potentially transformative approach to pre-targeted radioimmunotherapy for patients with relapsed and refractory NHL,” said Vignesh Rajah, MBBS, DCH, MRCP (UK), Chief Medical Officer. “This is our second clinical program evaluating the SADA PRIT technology platform and our first in hematological malignancies.” The abstract details are below: Abstract Title: “ CD38-SADA, a Self-Assembling and Dis-Assembling Bispecific Fusion Protein for Two-Step Pretargeted Radioimmunotherapy of Non-Hodgkin Lymphoma” Format : Poster Presentation, ID: 1599 Date and Time: Saturday, December 7, 2024, 5:30 PM-7:30 PM Abstract Title: “ CD38-SADA Pretargeted Radioimmunotherapy (PRIT) with Lutetium 177 (Lu177)-DOTA in Adult Patients with Relapsed or Refractory Non-Hodgkin Lymphoma: A First-in-Human Phase 1 Trial” Format : Poster Presentation, ID: 4434.1 Date and Time: Monday, December 9, 2024, 6:00 PM-8:00 PM Researchers at Memorial Sloan Kettering Cancer Center (MSK), including Dr. Nai-Kong Cheung, developed the SADA technology for radioimmunotherapy, which is exclusively licensed by MSK to Y-mAbs. Dr. Cheung has intellectual property rights and interests in the technology, and as a result of this licensing arrangement, MSK has institutional financial interests in the technology. About Y-mAbs Y-mAbs is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, radioimmunotherapy and antibody-based therapeutic cancer products. The Company’s technologies include its investigational Self-Assembly DisAssembly (“SADA”) Pretargeted Radioimmunotherapy Platform (“PRIT”) and bispecific antibodies generated using the Y-BiClone platform. The Company’s broad and advanced product pipeline includes the anti-GD2 therapy DANYELZA® (naxitamab-gqgk), the first FDA-approved treatment for patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow after a partial response, minor response, or stable disease to prior therapy. About CD38-SADA PRIT CD38-SADA is a bispecific fusion protein that tightly binds to the CD38 antigen and to select radionuclides chelated to tetraxetan (or “DOTA”). CD38-SADA contains a p53-derived domain that drives the self-assembly of CD38-SADA tetramers, which possess four distinct binding sites for CD38. In the first step of pre-targeted radiotherapy, non-radiolabeled-CD38-SADA tetramers are infused and bind with high avidity to CD38-positive tumors, while unbound CD38-SADA disassembles into low molecular weight monomers that are removed by the kidney. The second infusion delivers the “radioactive payload,” which binds to the CD38-SADA on tumor cells for localized irradiation. CD38-SADA PRIT with Lutetium 177 (Lu 177)-DOTA is now under clinical investigation in Trial 1201 (NCT05994157). Forward-Looking Statements Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, statements about our business model, including financial outlook for 2024 and beyond, including estimated operating expenses, use of cash and cash equivalents and DANYELZA product revenue and sufficiency of cash resources and related assumptions; expectations with respect to the Company’s future financial performance; implied and express statements regarding the future of the Company’s business, including with respect to expansion and its goals; expectations with respect to the Company’s plans and strategies, development, regulatory, commercialization and product distribution plans, including the timing thereof; expectations with respect to the Company’s products and product candidates, including potential territory and label expansion of DANYELZA and the potential market opportunity related thereto and potential benefits thereof, and the potential of the SADA PRIT technology and potential benefits and applications thereof; expectations relating to key anticipated development milestones, including potential expansion and advancement of commercialization and development efforts, including potential indications, applications and geographies, and the timing thereof; expectations with respect to current and future clinical and pre-clinical studies and the Company’s research and development programs, including with respect to timing and results; expectations regarding collaborations or strategic partnerships and the potential benefits thereof; and other statements that are not historical facts. Words such as ‘‘anticipate,’’ ‘‘believe,’’ “contemplate,” ‘‘continue,’’ ‘‘could,’’ ‘‘estimate,’’ ‘‘expect,’’ “hope,” ‘‘intend,’’ ‘‘may,’’ ‘‘might,’’ ‘‘plan,’’ ‘‘potential,’’ ‘‘predict,’’ ‘‘project,’’ ‘‘should,’’ ‘‘target,’’ “will,” ‘‘would’,’ “guidance,” “goal,” “objective,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Our product candidates and related technologies are novel approaches to cancer treatment that present significant challenges. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors, including but not limited to: risks associated with the Company’s financial condition and need for additional capital; the risks that actual results of the Company’s restructuring plan and revised business plan will not be as expected; risks associated with the Company’s development work; cost and success of the Company’s product development activities and clinical trials; the risks of delay in the timing of the Company’s or its partners’ regulatory submissions or failure to receive approval of its drug candidates; the risks related to commercializing any approved pharmaceutical product including the rate and degree of market acceptance of product candidates; development of sales and marketing capabilities and risks associated with failure to obtain sufficient reimbursement for products; risks related to the Company’s dependence on third parties including for conduct of clinical testing and product manufacture as well as regulatory submissions; the Company’s ability to enter into new partnerships or to recognize the anticipated benefits from its existing partnerships; risks related to government regulation; risks related to market approval, risks associated with protection of the Company’s intellectual property rights; risks related to employee matters and managing growth; risks related to the Company’s common stock, risks associated with macroeconomic conditions, including the conflict between Russia and Ukraine and sanctions related thereto, the state of war between Israel and Hamas and the related risk of a larger regional conflict, inflation, increased interest rates, uncertain global credit and capital markets and disruptions in banking systems; and other risks and uncertainties affecting the Company including those described in the “Risk Factors” section included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, and the Company’s Quarterly Report on Form 10-Q for the quarterly periods ended March 31, 2024, and September 30, 2024, and future filings and reports by the Company. Any forward-looking statements contained in this press release speak only as of the date hereof, and the Company undertakes no obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. SADA®, SADA PRIT®, DANYELZA® and Y-mAbs® are registered trademarks of Y-mAbs Therapeutics, Inc. Investor Contact: Courtney Dugan VP, Head of Investor Relations cdu@ymabs.comIPL 2025 Mega Auction The TOI Entertainment Desk is a dynamic and dedicated team of journalists, working tirelessly to bring the pulse of the entertainment world straight to the readers of The Times of India. No red carpet goes unrolled, no stage goes dark - our team spans the globe, bringing you the latest scoops and insider insights from Bollywood to Hollywood, and every entertainment hotspot in between. We don't just report; we tell tales of stardom and stories untold. 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Read More Ethnic Statement Styles Inspired by Keerthy Suresh Stunning pictures of Nazriya Nazim Famous tea-tourism destinations in India 8 simple techniques to sharpen your eyesight Hansika Motwani's Indo-Western look sets the perfect bridesmaid style goals 8 South Indian delicacies that make for a light meal Sanya Malhotra radiates ethnic elegance in golden splendor Best boss Lady looks of Nita Ambani for your next boardroom meeting Radiant snaps of Helly ShahNVIDIA, a leading American technology company known for its graphics processing units (GPUs) and automotive electronics, is reportedly facing the possibility of a significant fine amidst regulatory scrutiny. The company's operations in China mainland have been a crucial source of revenue, contributing approximately 15% of its total revenue in the third quarter of the fiscal year.
