Latest news with #ESMOGI
Yahoo
3 days ago
- Health
- Yahoo
Natera Presents Data at ESMO GI on its Tissue-Free Latitude™ MRD* Assay, Demonstrating Excellent Overall Performance in Colorectal Cancer
AUSTIN, Texas, July 07, 2025--(BUSINESS WIRE)--Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced data from a colorectal cancer (CRC) study of its tissue-free Latitude™ MRD assay, which were presented at the 2025 European Society for Medical Oncology GI Congress (ESMO GI). The clinical performance of the assay was analyzed in a cohort of ~200 patients (>1,300 plasma samples) with resectable stage I-IV colorectal cancer. Samples were derived from the GALAXY arm of the CIRCULATE-Japan study, one of the largest and most comprehensive prospective studies of MRD testing in resectable CRC. Key results include: Excellent clinical sensitivity to recurrence: The Latitude assay detected recurrence with 58% sensitivity in the post-surgical MRD window and 81% sensitivity in the surveillance setting, with median diagnostic lead time of 4.6 months. High clinical specificity: In the surveillance setting, patient-level specificity was 92%, and sample-level specificity was 97%. Highly prognostic of recurrence risk: MRD positivity was significantly associated with inferior outcomes during both the MRD (HR: 10, p<0.001) and surveillance (HR: 18, p<0.001) windows. Highly predictive of adjuvant chemotherapy (ACT) benefit: Among high-risk stage II and stage III patients, those who were MRD-positive after surgery derived significant benefit from ACT (p<0.001), while no significant treatment benefit was observed in MRD-negative patients (p=0.54). "This study demonstrates strong clinical potential for Natera's tissue-free MRD assay," said Yoshiaki Nakamura, M.D., Ph.D., principal investigator of the study. "We clearly observed the prognostic and predictive value of the assay, seeing strong correlation of recurrence risk and adjuvant treatment outcomes." "These results reinforce the data previously presented at ASCO GI, where our tissue-free Latitude MRD assay demonstrated high overall concordance to Signatera™ as well as strong standalone clinical performance," said Alexey Aleshin, M.D., corporate chief medical officer and general manager of oncology at Natera. "When offered alongside Signatera, our tissue-free assay gives patients and providers the latitude to get a reliable MRD assessment even when tissue is unavailable." Notes*MRD = Molecular residual disease About Natera Natera™ is a global leader in cell-free DNA and genetic testing, dedicated to oncology, women's health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard-of-care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera's tests are supported by more than 300 peer-reviewed publications that demonstrate excellent performance. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos, California. For more information, visit Forward-Looking Statements All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera's plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera's expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy and performance of our tests, or of the benefits of our tests and product offerings to patients, providers and payers. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera's recent filings on Forms 10-K and 10-Q and in other filings Natera makes with the SEC from time to time. These documents are available at and View source version on Contacts Investor Relations: Mike Brophy, CFO, Natera, Inc., investor@ Media: Lesley Bogdanow, VP of Corporate Communications, Natera, Inc., pr@ 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
Business Wire
3 days ago
- Health
- Business Wire
Natera Presents Data at ESMO GI on its Tissue-Free Latitude™ MRD * Assay, Demonstrating Excellent Overall Performance in Colorectal Cancer
AUSTIN, Texas--(BUSINESS WIRE)-- Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced data from a colorectal cancer (CRC) study of its tissue-free Latitude™ MRD assay, which were presented at the 2025 European Society for Medical Oncology GI Congress (ESMO GI). The clinical performance of the assay was analyzed in a cohort of ~200 patients (>1,300 plasma samples) with resectable stage I-IV colorectal cancer. Samples were derived from the GALAXY arm of the CIRCULATE-Japan study, one of the largest and most comprehensive prospective studies of MRD testing in resectable CRC. Key results include: Excellent clinical sensitivity to recurrence: The Latitude assay detected recurrence with 58% sensitivity in the post-surgical MRD window and 81% sensitivity in the surveillance setting, with median diagnostic lead time of 4.6 months. High clinical specificity: In the surveillance setting, patient-level specificity was 92%, and sample-level specificity was 97%. Highly prognostic of recurrence risk: MRD positivity was significantly associated with inferior outcomes during both the MRD (HR: 10, p<0.001) and surveillance (HR: 18, p<0.001) windows. Highly predictive of adjuvant chemotherapy (ACT) benefit: Among high-risk stage II and stage III patients, those who were MRD-positive after surgery derived significant benefit from ACT (p<0.001), while no significant treatment benefit was observed in MRD-negative patients (p=0.54). 'This study demonstrates strong clinical potential for Natera's tissue-free MRD assay,' said Yoshiaki Nakamura, M.D., Ph.D., principal investigator of the study. 'We clearly observed the prognostic and predictive value of the assay, seeing strong correlation of recurrence risk and adjuvant treatment outcomes.' 'These results reinforce the data previously presented at ASCO GI, where our tissue-free Latitude MRD assay demonstrated high overall concordance to Signatera™ as well as strong standalone clinical performance,' said Alexey Aleshin, M.D., corporate chief medical officer and general manager of oncology at Natera. 'When offered alongside Signatera, our tissue-free assay gives patients and providers the latitude to get a reliable MRD assessment even when tissue is unavailable.' Notes * MRD = Molecular residual disease About Natera Natera™ is a global leader in cell-free DNA and genetic testing, dedicated to oncology, women's health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard-of-care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera's tests are supported by more than 300 peer-reviewed publications that demonstrate excellent performance. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos, California. For more information, visit Forward-Looking Statements All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera's plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera's expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy and performance of our tests, or of the benefits of our tests and product offerings to patients, providers and payers. Additional risks and uncertainties are discussed in greater detail in 'Risk Factors' in Natera's recent filings on Forms 10-K and 10-Q and in other filings Natera makes with the SEC from time to time. These documents are available at and
Business Upturn
02-07-2025
- Business
- Business Upturn
I-Mab Presents Positive Givastomig Phase 1b Dose Escalation Data in Combination with Immunochemotherapy in Patients with 1L Gastric Cancers at ESMO GI 2025
Data show confirmed ORR of 83% (10/12) at doses selected for ongoing expansion study Median follow-up of 9.0 months as of the updated data cutoff Responses observed in patients with low PD-L1 and/or CLDN18.2 expression Company to host investor event on Tuesday, July 8 th ROCKVILLE, Md., July 02, 2025 (GLOBE NEWSWIRE) — I-Mab (NASDAQ: IMAB) (the Company), a U.S.-based, global biotech company, focused on the development of precision immuno-oncology agents for the treatment of cancer, today announced the presentation of positive Phase 1b combination data for givastomig, in combination with nivolumab and mFOLFOX6, at the European Society for Medical Oncology Gastrointestinal Cancers Congress 2025 (ESMO GI 2025) in Barcelona (abstract #388MO) . Givastomig is a bispecific antibody targeting Claudin 18.2 and 4-1BB. I-Mab plans to host a virtual investor event on Tuesday, July 8th (register here) to review these data. The Phase 1b data (NCT04900818) show a confirmed objective response rate (ORR) of 71% across all doses (12/17), and 83% (10/12) at doses selected for the ongoing dose expansion study (8 mg/kg and 12 mg/kg). Responses occurred in tumors with low levels of PD-L1 expression and/or Claudin 18.2 (CLDN18.2) expression, with favorable overall tolerability. There were no Grade 3 or greater events for nausea and vomiting, and only one Grade 3 TRAE for increased liver enzymes. The data are based on the results of the dose escalation part of a Phase 1b study evaluating the givastomig combination as first line therapy (1L) in patients with Claudin 18.2-positive gastric cancers (≥1+ IHC staining intensity in ≥1% of tumor cells). The primary endpoint is safety. The study enrolled only patients in the U.S. 'The positive Phase 1b combination data presented at ESMO GI bolster our confidence in givastomig's potential to be a best-in-class Claudin 18.2 directed therapy. Givastomig has been well tolerated when combined with immuno-oncology and chemotherapy, has shown a high objective response rate, with rapid onset and durable responses that have deepened over time, supported by consistent pharmacokinetic data and soluble 4-1BB induction,' said Phillip Dennis, MD, PhD, Chief Medical Officer of I-Mab. 'In addition, we are optimistic about the results from the 8 mg/kg and 12 mg/kg doses. These doses showed an ORR of 83%, with consistent responses across PD-L1 and Claudin 18.2 expression levels, and a favorable overall safety profile. These data further our conviction in the ongoing Phase 1b dose expansion study. We believe givastomig has broad potential in a number of gastric cancer settings and look forward to continued advancement of the program.' 'I am encouraged by the response rates, as well as the deepening of responses over time, demonstrated by the givastomig combination regimen in the Phase 1b dose escalation study that we presented today at ESMO GI. Despite approved therapies, targeted treatment options for gastric cancers continue to be limited. While the data are early, givastomig combination therapy demonstrates a high response rate across Claudin 18.2 and PD-L1 expression levels,' said Samuel J Klempner, MD, Associate Professor of Medicine at Massachusetts General Hospital. 'In addition, I have been pleased to observe that givastomig has a favorable overall tolerability profile with a low level of gastrointestinal side effects — especially important for patients with gastric cancer. I look forward to participating in the ongoing givastomig clinical development program, and hope we may be able to expand the population of patients who may benefit from Claudin 18.2 directed agents.' Virtual Investor Event: Register (here) for the Post-ESMO GI 2025 Investor Event to be held on Tuesday, July 8th at 2:00 PM EDT. A replay of the webinar will be accessible on the Events page of the I-Mab website for 90 days. Fireside Chat Event with Lucid Capital Markets to Recap the Presentation: Tune in (here) for a fireside chat sponsored by Christopher Liu, PharmD, Managing Director at Lucid Capital Markets that will be accessible today at 2:00pm EDT on the Events page of the I-Mab website. A replay of the fireside chat will be available for 90 days. ESMO GI Presentation Details: A full copy of the ESMO GI presentation is available on the Publications and Presentations page of the I-Mab website here. Givastomig Phase 1b Dose Escalation Data Summary in 1L Gastric Cancers 17 advanced metastatic gastric cancer patients were treated with givastomig across the 5 mg/kg (n=5), 8 mg/kg (n=6), and 12 mg/kg (n=6) dose levels as of the May 15, 2025 data cutoff. All patients were efficacy evaluable Patient Characteristics: The 17 patients enrolled in the study were treatment naïve metastatic gastric, esophageal or gastroesophageal adenocarcinomas Patients were HER2-negative, Claudin 18.2-positive (defined as ≥1+ IHC staining intensity in ≥1% of tumor cells), regardless of PD-L1 expression levels All patients were enrolled at sites within the United States Efficacy Results: Confirmed Objective Response Rates (ORRs): 71% of patients (12/17) achieved a partial response (PR) per RECIST v1.1 5 mg/kg (2/5) 8 mg/kg (5/6) 12 mg/kg (5/6) At the doses selected for dose expansion (8 and 12 mg/kg), 83% (10/12) of patients achieved PRs 80% of patients (4/5) with CLDN18.2 expression below 75% (CLDN-Low) achieved a PR. The CLDN-Low response rate increased to 100% of patients (3/3) in the doses selected for expansion (8 and 12 mg/kg) The disease control rate (DCR) was 100% across the three dose levels Dose-dependent pharmacokinetics (PK) were observed, similar to monotherapy PK Patients also experienced a dose dependent induction of soluble 4-1BB, a positive indicator of T cell activation and engagement ORR: % (n) All (n=17) Cohorts Chosen for Expansion (8 and 12 mg/kg) (n=12) PD-L1 Any 71 (12/17) 83 (10/12) ≥5 82 (9/11) 89 (8/9) <5 50 (3/6) 67 (2/3) ≥1 73 (11/15) 82 (9/11) <1 50 (1/2) 100 (1/1) CLDN18.2 ≥75 67 (8/12) 78 (7/9) <75 80 (4/5) 100 (3/3) ORR: % (n) PD-L1 ≥ 5 PD-L1 < 5 CLDN18.2 ≥ 75 80 (8/10) 0 (0/2) CLDN18.2 < 75 100 (1/1) 75 (3/4) Durability: 8 of 17 patients remained on study treatment and the longest treatment duration was 13.3 months as of the data cutoff Median follow-up was 9.0 months across all dose levels as of the data cutoff Safety: Treatment-related adverse events (TRAEs) leading to discontinuation of any treatment were 12% (two patients), five patients had progressive disease, two patients withdrew from the study for social reasons No dose limiting toxicities (DLT) were observed and a maximum tolerated dose (MTD) was not reached Common TRAEs (≥10% of patients) were generally Grade 1 or Grade 2 including nausea, vomiting, infusion related reaction, fatigue, decreased appetite, diarrhea, abdominal pain, chills, dyspepsia and gastritis Grade 3 TRAEs attributed to givastomig were rare, with single cases of abdominal pain, ALT/AST increases, gastritis, and infusion related reaction Four cases of Grade 3 and two cases of Grade 4 treatment-related neutropenia were observed driven by an early restriction on prophylaxis use of G-CSF, which has been subsequently lifted. The neutropenia cases were primarily attributed to mFOLFOX6 in the 8 mg/kg cohorts No Grade 5 TRAEs were reported About Givastomig Givastomig (TJ033721 / ABL111) is a bispecific antibody targeting Claudin 18.2 (CLDN18.2)-positive tumor cells. It conditionally activates T cells through the 4-1BB signaling pathway in the tumor microenvironment where CLDN18.2 is expressed. Givastomig is being developed for first line (1L) metastatic gastric cancers, with further potential in other solid tumors. In Phase 1 trials, givastomig has shown promising anti-tumor activity attributable to a potential synergistic effect of proximal interaction between CLDN18.2 on tumor cells and 4-1BB on T cells in the tumor microenvironment, while minimizing toxicities commonly seen with other 4-1BB agents. An ongoing Phase 1b study is evaluating givastomig for the treatment of gastric cancer in the 1L setting in combination with standard of care, nivolumab (an anti-PD-1 checkpoint inhibitor) plus chemotherapy, in dose escalation and dose expansion cohorts. Dose escalation is complete, and enrollment in the first dose expansion cohort (n=20) finished ahead of schedule. Enrollment continues to progress ahead of schedule in the second dose expansion cohort (n=20). The study builds on positive Phase 1 monotherapy data. Givastomig is being jointly developed through a global partnership with ABL Bio, in which I-Mab is the lead party and shares worldwide rights, excluding Greater China and South Korea, equally with ABL Bio. About I-Mab I-Mab (NASDAQ: IMAB) is a U.S.-based, global biotech company, focused on the development of precision immuno-oncology agents for the treatment of cancer. The Company's differentiated pipeline is led by givastomig, a potential best-in-class, bispecific antibody (Claudin 18.2 x 4-1BB) designed to treat Claudin 18.2-positive gastric cancers. Givastomig conditionally activates T cells via the 4-1BB signaling pathway in the tumor microenvironment where Claudin 18.2 is expressed. Givastomig is being developed for first-line metastatic gastric cancers, with additional potential in other solid tumors. In Phase 1 trials, givastomig was observed to maintain strong tumor-binding and anti-tumor activity, attributable to a potential synergistic effect of proximal interaction with Claudin 18.2 and 4-1BB, while minimizing toxicities commonly seen with other 4-1BB agents. For more information, please visit and follow us on LinkedIn and X. I-Mab Forward Looking Statements This announcement contains forward-looking statements. These statements are made under the 'safe harbor' provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as 'will', 'expects', 'believes', 'designed to', 'anticipates', 'future', 'intends', 'plans', 'potential', 'estimates', 'confident', and similar terms or the negative thereof. I-Mab may also make written or oral forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission (the SEC), in its annual report to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Statements that are not historical facts, including statements about I-Mab's beliefs and expectations, are forward-looking statements. Forward-looking statements in this press release include, without limitation, statements regarding: the Company's pipeline and clinical development of I-Mab's drug candidates, including givastomig; the projected advancement of the Company's portfolio and anticipated milestones and related timing; the Company's expectations regarding the impact of data from ongoing and future clinical trials; the timing and progress of studies and trials (including with respect to patient enrollment); the potential benefits of givastomig; and the availability of data and information from ongoing studies and trials. Forward-looking statements involve inherent risks and uncertainties that may cause actual results to differ materially from those contained in these forward-looking statements, including but not limited to the following: I-Mab's ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may or may not support further development or New Drug Application/Biologics License Application (NDA/BLA) approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of I-Mab's drug candidates; I-Mab's ability to achieve commercial success for its drug candidates, if approved; I-Mab's ability to obtain and maintain protection of intellectual property for its technology and drugs; I-Mab's reliance on third parties to conduct drug development, manufacturing and other services; and I-Mab's limited operating history and I-Mab's ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates, as well as those risks more fully discussed in the 'Risk Factors' section in I-Mab's annual report on Form 20-F filed with the SEC on April 3, 2025, as well as the discussions of potential risks, uncertainties, and other important factors in I-Mab's subsequent filings with the SEC. All forward-looking statements are based on information currently available to I-Mab. I-Mab undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law. I-Mab Investor & Media ContactsPJ KelleherLifeSci Advisors+1-617-430-7579 [email protected] [email protected]
Associated Press
02-07-2025
- Business
- Associated Press
I-Mab Presents Positive Givastomig Phase 1b Dose Escalation Data in Combination with Immunochemotherapy in Patients with 1L Gastric Cancers at ESMO GI 2025
Data show confirmed ORR of 83% (10/12) at doses selected for ongoing expansion study Median follow-up of 9.0 months as of the updated data cutoff Responses observed in patients with low PD-L1 and/or CLDN18.2 expression Company to host investor event on Tuesday, July 8th ROCKVILLE, Md., July 02, 2025 (GLOBE NEWSWIRE) -- I-Mab (NASDAQ: IMAB) (the Company), a U.S.-based, global biotech company, focused on the development of precision immuno-oncology agents for the treatment of cancer, today announced the presentation of positive Phase 1b combination data for givastomig, in combination with nivolumab and mFOLFOX6, at the European Society for Medical Oncology Gastrointestinal Cancers Congress 2025 (ESMO GI 2025) in Barcelona (abstract #388MO) . Givastomig is a bispecific antibody targeting Claudin 18.2 and 4-1BB. I-Mab plans to host a virtual investor event on Tuesday, July 8th (register here ) to review these data. The Phase 1b data (NCT04900818) show a confirmed objective response rate (ORR) of 71% across all doses (12/17), and 83% (10/12) at doses selected for the ongoing dose expansion study (8 mg/kg and 12 mg/kg). Responses occurred in tumors with low levels of PD-L1 expression and/or Claudin 18.2 (CLDN18.2) expression, with favorable overall tolerability. There were no Grade 3 or greater events for nausea and vomiting, and only one Grade 3 TRAE for increased liver enzymes. The data are based on the results of the dose escalation part of a Phase 1b study evaluating the givastomig combination as first line therapy (1L) in patients with Claudin 18.2-positive gastric cancers (≥1+ IHC staining intensity in ≥1% of tumor cells). The primary endpoint is safety. The study enrolled only patients in the U.S. 'The positive Phase 1b combination data presented at ESMO GI bolster our confidence in givastomig's potential to be a best-in-class Claudin 18.2 directed therapy. Givastomig has been well tolerated when combined with immuno-oncology and chemotherapy, has shown a high objective response rate, with rapid onset and durable responses that have deepened over time, supported by consistent pharmacokinetic data and soluble 4-1BB induction,' said Phillip Dennis, MD, PhD, Chief Medical Officer of I-Mab. 'In addition, we are optimistic about the results from the 8 mg/kg and 12 mg/kg doses. These doses showed an ORR of 83%, with consistent responses across PD-L1 and Claudin 18.2 expression levels, and a favorable overall safety profile. These data further our conviction in the ongoing Phase 1b dose expansion study. We believe givastomig has broad potential in a number of gastric cancer settings and look forward to continued advancement of the program.' 'I am encouraged by the response rates, as well as the deepening of responses over time, demonstrated by the givastomig combination regimen in the Phase 1b dose escalation study that we presented today at ESMO GI. Despite approved therapies, targeted treatment options for gastric cancers continue to be limited. While the data are early, givastomig combination therapy demonstrates a high response rate across Claudin 18.2 and PD-L1 expression levels,' said Samuel J Klempner, MD, Associate Professor of Medicine at Massachusetts General Hospital. 'In addition, I have been pleased to observe that givastomig has a favorable overall tolerability profile with a low level of gastrointestinal side effects -- especially important for patients with gastric cancer. I look forward to participating in the ongoing givastomig clinical development program, and hope we may be able to expand the population of patients who may benefit from Claudin 18.2 directed agents.' Virtual Investor Event: Register ( here ) for the Post-ESMO GI 2025 Investor Event to be held on Tuesday, July 8th at 2:00 PM EDT. A replay of the webinar will be accessible on the Events page of the I-Mab website for 90 days. Fireside Chat Event with Lucid Capital Markets to Recap the Presentation: Tune in ( here ) for a fireside chat sponsored by Christopher Liu, PharmD, Managing Director at Lucid Capital Markets that will be accessible today at 2:00pm EDT on the Events page of the I-Mab website. A replay of the fireside chat will be available for 90 days. ESMO GI Presentation Details: A full copy of the ESMO GI presentation is available on the Publications and Presentations page of the I-Mab website here. Givastomig Phase 1b Dose Escalation Data Summary in 1L Gastric Cancers Patient Characteristics: Efficacy Results: Durability: Safety: About Givastomig Givastomig (TJ033721 / ABL111) is a bispecific antibody targeting Claudin 18.2 (CLDN18.2)-positive tumor cells. It conditionally activates T cells through the 4-1BB signaling pathway in the tumor microenvironment where CLDN18.2 is expressed. Givastomig is being developed for first line (1L) metastatic gastric cancers, with further potential in other solid tumors. In Phase 1 trials, givastomig has shown promising anti-tumor activity attributable to a potential synergistic effect of proximal interaction between CLDN18.2 on tumor cells and 4-1BB on T cells in the tumor microenvironment, while minimizing toxicities commonly seen with other 4-1BB agents. An ongoing Phase 1b study is evaluating givastomig for the treatment of gastric cancer in the 1L setting in combination with standard of care, nivolumab (an anti-PD-1 checkpoint inhibitor) plus chemotherapy, in dose escalation and dose expansion cohorts. Dose escalation is complete, and enrollment in the first dose expansion cohort (n=20) finished ahead of schedule. Enrollment continues to progress ahead of schedule in the second dose expansion cohort (n=20). The study builds on positive Phase 1 monotherapy data. Givastomig is being jointly developed through a global partnership with ABL Bio, in which I-Mab is the lead party and shares worldwide rights, excluding Greater China and South Korea, equally with ABL Bio. About I-Mab I-Mab (NASDAQ: IMAB) is a U.S.-based, global biotech company, focused on the development of precision immuno-oncology agents for the treatment of cancer. The Company's differentiated pipeline is led by givastomig, a potential best-in-class, bispecific antibody (Claudin 18.2 x 4-1BB) designed to treat Claudin 18.2-positive gastric cancers. Givastomig conditionally activates T cells via the 4-1BB signaling pathway in the tumor microenvironment where Claudin 18.2 is expressed. Givastomig is being developed for first-line metastatic gastric cancers, with additional potential in other solid tumors. In Phase 1 trials, givastomig was observed to maintain strong tumor-binding and anti-tumor activity, attributable to a potential synergistic effect of proximal interaction with Claudin 18.2 and 4-1BB, while minimizing toxicities commonly seen with other 4-1BB agents. For more information, please visit and follow us on LinkedIn and X. I-Mab Forward Looking Statements This announcement contains forward-looking statements. These statements are made under the 'safe harbor' provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as 'will', 'expects', 'believes', 'designed to', 'anticipates', 'future', 'intends', 'plans', 'potential', 'estimates', 'confident', and similar terms or the negative thereof. I-Mab may also make written or oral forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission (the SEC), in its annual report to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Statements that are not historical facts, including statements about I-Mab's beliefs and expectations, are forward-looking statements. Forward-looking statements in this press release include, without limitation, statements regarding: the Company's pipeline and clinical development of I-Mab's drug candidates, including givastomig; the projected advancement of the Company's portfolio and anticipated milestones and related timing; the Company's expectations regarding the impact of data from ongoing and future clinical trials; the timing and progress of studies and trials (including with respect to patient enrollment); the potential benefits of givastomig; and the availability of data and information from ongoing studies and trials. Forward-looking statements involve inherent risks and uncertainties that may cause actual results to differ materially from those contained in these forward-looking statements, including but not limited to the following: I-Mab's ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may or may not support further development or New Drug Application/Biologics License Application (NDA/BLA) approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of I-Mab's drug candidates; I-Mab's ability to achieve commercial success for its drug candidates, if approved; I-Mab's ability to obtain and maintain protection of intellectual property for its technology and drugs; I-Mab's reliance on third parties to conduct drug development, manufacturing and other services; and I-Mab's limited operating history and I-Mab's ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates, as well as those risks more fully discussed in the 'Risk Factors' section in I-Mab's annual report on Form 20-F filed with the SEC on April 3, 2025, as well as the discussions of potential risks, uncertainties, and other important factors in I-Mab's subsequent filings with the SEC. All forward-looking statements are based on information currently available to I-Mab. I-Mab undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law. I-Mab Investor & Media Contacts PJ Kelleher LifeSci Advisors +1-617-430-7579 [email protected] [email protected]
Business Wire
01-07-2025
- Business
- Business Wire
Natera to Present Clinical and Economic Utility of Signatera at ESMO GI, Highlights Innovations in MRD
AUSTIN, Texas--(BUSINESS WIRE)-- Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, announced new data that will be presented at the 2025 European Society for Medical Oncology GI Congress (ESMO GI) in Barcelona, Spain. These presentations reinforce the strong clinical and economic utility of Signatera™ monitoring across colon and rectal cancers (CRC), as well as new clinical validation data on its tissue-free MRD assay. Signatera in CRC surveillance Data on >3,000 CRC patients will be shared in an oral presentation, concluding that adding Signatera ctDNA * monitoring to the current standard of care in surveillance can better identify patients who are candidates for metastasis-directed therapy (MDT). Results indicated that Signatera-positive patients were up to 20x more likely to receive curative-intent MDT than Signatera-negative patients. By comparison, CEA positivity led to only a 2x increase, with no added value in stage IV. Signatera Genome in rectal cancer An analysis will be presented from the MD Anderson INTERCEPT study (n=31) that used serial Signatera Genome testing in patients with locally advanced rectal cancer after neoadjuvant therapy. Results demonstrated 100% specificity/PPV, with surveillance sensitivity of 100% in the surgical cohort and 88% (7/8) overall. Economic utility of Signatera-guided therapy in adjuvant CRC A budget impact model from BUPA, a multinational health insurance provider with over 60 million customers, will outline a 43% expected reduction in healthcare costs using Signatera-guided adjuvant treatment versus standard of care in stage II-III CRC. 'We're excited to present these new findings that continue to support the utility of Natera's products across GI cancers,' said Adham Jurdi, M.D., senior medical director of oncology at Natera. 'These data highlight our commitment to improving outcomes and driving innovation in MRD detection.' Full list of data featuring Natera's technology at ESMO GI: July 4, 16:40-16:50 CET | FPN: 20 | Signatera (Oral Presentation) Presenter: Arvind Dasari, M.D., MS Clinical utility of including circulating tumor DNA (ctDNA) monitoring in standard of care (SoC) colorectal cancer (CRC) surveillance July 4, 16:50-17:00 CET | FPN: 30 | Signatera (Oral Presentation) Presenter: Hideaki Bando, M.D. Association of ctDNA Clearance with Disease-Free Survival and Safety and Quality of Life from ctDNA-Directed Therapy: Findings from the ALTAIR Study July 4, 15:30-16:30 CET | FPN: 102P | Signatera (Poster Presentation) Presenter: Christos Mikropoulos, MBBS, MSc, M.D. (Res), MRCP, FRCR Direct cost of healthcare analysis of Signatera ctDNA testing in the adjuvant setting for a hypothetical cohort of stage II and stage III colorectal cancer (CRC) patients: a UK private payer perspective July 4, 15:30-16:30 CET | FPN: 243P | Signatera Genome (Poster Presentation) Presenter: Arvind Dasari, M.D., MS Clinical performance of Signatera Genome assay in a sub-cohort of locally advanced rectal cancer (LARC) patients (pts) in the MD Anderson INTERCEPT program July 4, 15:30-16:30 CET | FPN: 93P | Tissue-free MRD (Poster Presentation) Presenter: Yoshiaki Nakamura, M.D., Ph.D. Clinical validation of a methylation-based, tissue-free colorectal cancer test for the detection of molecular residual disease by circulating tumor DNA July 4, 15:30-16:30 CET | FPN: 89P | Early Cancer Detection (Poster Presentation) Presenter: John P.Y. Shen, M.D. Development of methylation-based biomarkers to predict metastases, treatment effect, and microsatellite status in colorectal cancer Notes * Circulating tumor DNA About Natera Natera™ is a global leader in cell-free DNA and genetic testing, dedicated to oncology, women's health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard-of-care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera's tests are supported by more than 300 peer-reviewed publications that demonstrate excellent performance. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos, California. For more information, visit Forward-Looking Statements All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera's plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera's expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy and performance of our tests, or of the benefits of our tests and product offerings to patients, providers and payers. Additional risks and uncertainties are discussed in greater detail in 'Risk Factors' in Natera's recent filings on Forms 10-K and 10-Q and in other filings Natera makes with the SEC from time to time. These documents are available at and
