4-1BB

The ESMO Gastrointestinal Cancers Congress to be held July 2-5 in BarcelonaROCKVILLE, Md., April 30, 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 that an abstract for a combination study of givastomig plus nivolumab and chemotherapy has been accepted for a mini-oral presentation at the ESMO Gastrointestinal Cancers Congress 2025, which will be held July 2-5 in Barcelona, Spain. “We are very pleased to receive confirmation that new clinical data for givastomig has been accepted as an oral presentation at the upcoming ESMO Gastrointestinal Cancers Congress 2025. As more information becomes available from the conference, we look forward to providing further details about the presentation,” said Phillip Dennis, MD, PhD, Chief Medical Officer of I-Mab. 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 combined effect of proximal interaction between CLDN18.2 and 4-1BB, while minimizing toxicities commonly seen with other 4-1BB agents. The 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 is progressing well 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. I-Mab has established operations in the U.S. in Rockville, Maryland, and Short Hills, New Jersey. For more information, please visit https://www.i-mabbiopharma.com 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 KelleherLifeSci Advisors+1-617-430-7579pkelleher@lifesciadvisors.comIR@imabbio.com

TAIPEI, Taiwan I April 29, 2025 I AP Biosciences, a clinical-stage biopharmaceutical company dedicated to transforming cancer therapy through innovative bispecific antibodies, today announced the presentation of new preclinical data for its lead asset, AP402, at the 2025 American Association for Cancer Research (AACR) Annual Meeting in San Diego, California. The data, presented in a poster titled “AP402, a bispecific antibody targeting p95HER2 and CD137, shows potent antitumor activity,” highlight the therapeutic potential of AP402 to address treatment-resistant HER2-positive cancers through conditional T-cell engagement. “The findings presented at AACR reinforce the rationale for advancing AP402 into clinical studies,” said Jeng Her, Ph.D., Founder and Chief Executive Officer of AP Biosciences. “By selectively targeting p95HER2—a truncated HER2 isoform implicated in therapeutic resistance—and conditionally activating CD137, AP402 offers a unique mechanism to recruit and stimulate immune effector cells while minimizing the risk of systemic toxicity. These data demonstrate the strength of our T-cube platform in delivering targeted immune activation precisely within the tumor microenvironment.” Results Summary In conclusion, the preclinical data show that AP402 effectively engages innate and adaptive immune responses, demonstrates robust antitumor activity in p95HER2-expressing tumor models, and is well tolerated in non-human primates. These findings support the continued development of AP402, which recently entered clinical evaluation in Australia ( NCT06669975 ). About AP402 AP402 is a first-in-class bispecific antibody developed by AP Biosciences to target p95HER2, a truncated variant of HER2 associated with resistance to Herceptin and poorer prognosis. This variant is present in approximately 30–40% of HER2-positive breast cancer patients. By leveraging p95HER2 recognition to cluster CD137, the design enables localized T-cell activation within the tumor microenvironment, helping to minimize systemic cytokine-related toxicity. The binding domains for p95HER2 and CD137 are strategically positioned on opposite ends to enhance bridging between HER2 variant-expressing cancer cells and CD137-expressing T-cells, ensuring efficient immune cell recruitment without spatial hindrance. This novel mechanism has positioned AP402 as a promising therapeutic approach to addressing tumors that have developed resistance to traditional anti-HER2 therapies, offering potential new hope for patients with refractory/recurrent cancers. About AP Biosciences AP Biosciences is a Taiwan-based clinical-stage biopharmaceutical company committed to developing innovative antibody-based therapies for cancer and other diseases. Applying its proprietary Omni-Mab and T-cube platforms, AP Biosciences is pioneering next generation bispecific antibodies that activate the immune system precisely where it’s needed, for both established and treatment-resistant cancers. SOURCE: AP Biosciences

Lead development candidate, AMP-410, leverages proprietary Ampersand technology to block VEGF and allosterically activate 4-1BB signaling – unlike traditional bispecific molecules – driving both adaptive and innate anti-tumor activity In multiple preclinical models of hard-to-treat cancers, AMP-410 showed strong efficacy when compared to four other clinical-stage immunotherapies, including an anti-VEGF/PD-1 bispecific antibody; IND-enabling studies to begin this year AMP-410 was discovered and designed by Ampersand’s Address, Navigate, Determine (AND™) platform, highlighting its ability to create products that act only at the site of disease with maximal potency and improved tolerability BOSTON, MA, USA I April 28, 2025 I Ampersand Biomedicines, a multi-product platform company developing smarter medicines that act specifically at the site of disease and nowhere else, today announced preclinical data for one of its lead development candidates, AMP-410, a novel potential first-in-class bifunctional anti-VEGF/4-1BB AND-Body™ therapeutic. The data are being presented at the American Association for Cancer Research (AACR) Annual Meeting 2025, April 25-30, 2025, in Chicago. AMP‑410 was discovered and developed using the Ampersand platform to block VEGF, which then triggers allosteric activation of the 4‑1BB pathway selectively in tumors. This novel molecular mechanism is different from other bispecific molecules, and reprograms the tumor microenvironment with potent activation of both adaptive and innate immune responses and minimal systemic activity. AMP-410 was evaluated in multiple preclinical models of hard-to-treat cancers, including melanoma, colorectal, and lung cancer. Findings show that AMP-410 induced more durable anti-tumor immunity compared to four other classes of clinical immunotherapies. Notably, AMP-410 showed initial promising monotherapy efficacy compared to an anti-VEGF/PD-1 bispecific antibody in a non-small cell lung cancer (NSCLC) model, demonstrating its potential to treat tumors resistant to checkpoint inhibitors. AMP-410 monotherapy achieved 90% tumor-free survival in colorectal cancer and extended survival in melanoma models; when combined with anti-PD-1, it drove 100% tumor-free survival in colorectal cancer and further extended survival in melanoma. Additional mechanistic data demonstrate that the AND-Body’s unique bifunctional targeting and activity mechanisms not only enhanced immune cell infiltration of the tumor and prevented T cell exhaustion, but also led to durable anti-tumor immunity and improved tolerability. “Our Address, Navigate, Determine (AND)™ platform combines computational target identification with modular antibody engineering to generate programmable therapeutics that precisely localize potent biological activities to disease sites,” said Jason Gardner, D.Phil., CEO and Director of Ampersand Biomedicines and CEO-Partner at Flagship Pioneering. “We have evaluated AMP-410 against multiple clinical-stage assets using stringent criteria, and these data demonstrate that our approach can unleash powerful efficacy with enhanced tolerability, which is exactly our goal – to deliver unrivaled therapeutic indices for patients across multiple tumor types. We’re eager to advance AMP-410 into IND-enabling studies this year as a potential high-impact medicine, and to extend our precision platform to create best-in-class medicines in cancer and beyond.” Poster presentation details : Title : Anti-VEGF/4-1BB bifunctional AND-Body combines VEGF blockade and allosteric 4-1BB mechanism for sustained activation of adaptive and innate anti-tumor immunity Poster Number : 4794/30 Session Date/Time : Tuesday, April 29, 9:00 a.m. – 12:00 p.m. CDT About Ampersand Biomedicines Ampersand Biomedicines enables a new way of programming medicines that work precisely where needed in the body and nowhere else. The company’s computationally powered Address, Navigate, Determine (AND)™ Platform identifies ideal addresses for drug localization and informs the design of AND-Body™ Therapeutics that have the optimal therapeutic effect. AND-Body therapeutics combine a localizing element that enables disease-specific precision with an actuator specifically chosen for disease modification. The localizer’s primary function is to anchor these medicines in the diseased tissue. The actuator is responsible for inducing the desired therapeutic effect. This approach enables improved target engagement while sparing on-target, off-tissue side effects. Ampersand Biomedicines was founded by Flagship Pioneering in 2021. For more information, please visit www.ampersand.bio and follow us on LinkedIn . SOURCE: Ampersand Biomedicines