Fruquintinib

Phase 2 data demonstrated 17.5-month median overall survival in advanced, chemo-refractory patients with microsatellite stable colorectal cancer (MSS-CRC) Company closed $22M financing to support randomized Phase 2b trial; IND cleared and study initiated; Interim results anticipated in late 2026; topline data expected in H2/2027 MODI'IN, Israel, Jan. 8, 2026 /PRNewswire/ -- KAHR Bio (KAHR or the Company), a clinical-stage biotechnology company developing DSP107, a first-in-class, bispecific 4-1BB–targeted, next-generation T-cell engager, today announced topline results from its Phase 2a dose-expansion cohort in late-line metastatic microsatellite stable colorectal cancer (MSS-CRC). DSP107 was evaluated in combination with atezolizumab (Tecentriq®), an anti–PD-L1 therapy. The combination demonstrated favorable safety, clinical evidence of antitumor activity, and extended survival, including in patients with liver metastases. KAHR also announced the closing of a $22 million round in equity financing. The equity investment was led by Flerie AB, Peregrine Ventures, Oriella Ltd. of the Consensus Business Group, aMoon Growth Fund, and the Cancer Focus Fund, with participation from certain additional existing investors and new investors including SPRIM Global Investments. The proceeds are expected to fully fund KAHR's randomized, controlled Phase 2b trial of DSP107 in combination with atezolizumab versus fruquintinib (Fruzaqla®) in fourth-line metastatic MSS-CRC. The trial was initiated in December 2025 following the U.S. Food and Drug Administration (FDA) investigational new drug (IND) clearance. In addition to the equity financing, KAHR has entered into a $10 million on-demand debt facility with SPRIM Global Investments, which the Company can draw down based on eligible research and development (R&D) activity under the Australian Government's R&D tax rebate scheme. Additional equity commitments are under discussion as the Company continues to attract new investor interest. The topline Phase 2a (NCT04440735) data demonstrated a median overall survival of 17.5 months, exceeding outcomes reported for currently approved therapies in this setting (6.4–10.8 months). Notably, approximately 75% of enrolled patients had liver metastases, a population historically refractory to immunotherapy. Across more than 130 patients treated with DSP107 to date in a variety of solid tumors and hematological malignancies, the therapy continues to demonstrate a favorable safety and tolerability profile. Based on these encouraging results, KAHR has initiated a randomized, controlled, multicenter Phase 2b clinical trial in fourth-line metastatic, chemo-refractory MSS-CRC. The trial is expected to enroll at 18 sites across Australia and the United States, with the first patient having been enrolled in December 2025. Interim results are expected in late 2026, with topline data anticipated in the second half of 2027. Additional information about the study is available at clinicaltrials.gov (NCT07235293). Anwaar Saeed, M.D., Chief of GI Oncology at the University of Pittsburgh and Co-Leader of the Cancer Therapeutics Program at UPMC Hillman Cancer Center, who co-led the Phase 2a trial said, "Observing efficacy with an immunotherapy approach in late line MSS-CRC patients with liver metastases is unexpected. DSP107's mechanism is particularly suited to this setting as it utilizes CD47 overexpression on cancer cells to anchor a 4-1BB ligand to those cells, thereby attracting and activating T cells. CD47 expression increases in liver metastases following chemotherapy, creating a therapeutic window uniquely addressable by DSP107." "Following these compelling topline results demonstrating anti-tumor activity and meaningful survival outcomes in heavily pretreated MSS-CRC patients, including those with liver metastases, we have made MSS-CRC our primary development focus and look forward to advancing the Phase 2b trial," said Yaron Pereg, Ph.D., Chief Executive Officer of KAHR. Dr. Pereg added, "We highly appreciate the continued support from our existing and new investors. Their commitment reflects confidence in the clinical potential of DSP107 and the opportunity to meaningfully improve outcomes in MSS-CRC, a disease with a significant unmet medical need, and in our team's ability to execute as we move toward our next milestones." About DSP107 DSP107, KAHR Bio's lead drug candidate, is a first-in-class, bispecific CD47×4-1BB targeting, next-generation T-cell engager. DSP107 utilizes tumor-expressed CD47 as an anchor, selectively binding CD47 on cancer cells while sparing red blood cells, thereby overcoming the safety challenges previously seen with other CD47-directed agents. Once bound, DSP107 converts the tumor's immune-evasion signal into a potent 4-1BB co-stimulatory activation signal, recruiting and activating CD8 cytotoxic T cells and orchestrating engagement of both the innate and adaptive immune systems to generate a coordinated anti-tumor response. This approach is particularly relevant in colorectal cancer, where more than 70% of metastatic patients develop liver metastases that commonly upregulate CD47 following earlier-line chemotherapy. Unlike prior immunotherapy approaches in MSS-CRC, which have demonstrated limited benefit due to poor immune cell infiltration and low immunogenicity, DSP107 is designed to leverage tumor CD47 overexpression to enhance immune engagement within the tumor microenvironment, transforming it from immunosuppressive to immune-responsive and enabling productive anti-tumor immunity. About Microsatellite Stable Metastatic Colorectal Cancer Colorectal cancer (CRC) is one of the most common cancers worldwide and a leading cause of cancer mortality. Globally, CRC ranks among the top three most frequently diagnosed cancers, with approximately 1.9 million new cases and nearly 900,000 deaths annually, making it the second leading cause of cancer-related death and the third most common cancer overall. Among metastatic colorectal cancer (mCRC) cases, approximately 85–90 % are microsatellite stable (MSS). MSS-CRC is characterized by low tumor mutational burden and limited inherent immune activation, and as a result, tumors are typically unresponsive to current immunotherapies, including immune checkpoint inhibitors. Standard treatment for MSS-CRC continues to rely on cytotoxic chemotherapy, targeted agents, and VEGF inhibition. Despite advances in systemic therapy, there remains a significant unmet medical need for more effective treatment options, and ongoing research is focused on novel approaches, including immune-based and mechanism-driven combination strategies, to improve outcomes for patients with this challenging disease. About KAHR Bio KAHR Bio develops dual-targeting fusion protein therapeutics designed to activate both the innate and adaptive immune systems while localizing activity within the tumor microenvironment. The Company's multifunctional fusion proteins aim to drive coordinated and durable anticancer responses. For more information, visit us at or contact us at [email protected] . Media contact: Tsipi Haitovsky Global Media Liaison KAHR Bio +972-52-598-9892 [email protected] SOURCE KAHR Medical 21% more press release views with Request a Demo

TABOSUN® (ipilimumab N01 injection) has been approved in combination with TYVYT® (sintilimab injection) for the neoadjuvant treatment of patients with stage IIB-III resectable microsatellite instability-high or mismatch repair deficient (MSI-H/dMMR) colon cancer. The TABOSUN® and TYVYT® combination therapy significantly improved pathological complete response (pCR) rates and enabled most patients to avoid the burden of postoperative adjuvant chemotherapy. This therapy is the first and only dual-IO regimen approved globally for neoadjuvant treatment of colon cancer[i], filling a critical gap in neoadjuvant treatment of colon cancer and benefiting more patients with MSI-H/dMMR colon cancer. SAN FRANCISCO and SUZHOU, China, Dec. 25, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces that the New Drug Application (NDA) for TABOSUN® (ipilimumab N01 injection; R&D Code: IBI310), the first domestic cytotoxic lymphocyte-associated antigen-4 (CTLA-4) monoclonal antibody (mAb), has been approved by China's National Medical Products Administration (NMPA), in combination with sintilimab as neoadjuvant treatment for stage IIB-III resectable microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colon cancer. TABOSUN® (ipilimumab N01 injection) is the world's first approved CTLA-4 mAb for neoadjuvant treatment of colon cancer. Short-term neoadjuvant treatment with the ipilimumab N01 and sintilimab combination demonstrated a substantial improvement in pathological complete response, offering the potential to benefit a broader population of patients with MSI-H/dMMR colon cancer. Resectable MSI-H/dMMR colon cancer urgently requires effective neoadjuvant therapies to improve prognosis MSI-H/dMMR colon cancer accounts for around 15% of all resectable colon cancer cases[ii]. Due to its unique biological characteristics, this class of tumor shows limited sensitivity to chemotherapy and generally responds poorly[iii]. In recent years, immune checkpoint inhibitors have demonstrated significant efficacy in advanced MSI-H/dMMR colon cancer, but a gap remains in the neoadjuvant setting. For locally advanced MSI-H/dMMR colon cancer, the current standard of care is direct surgery followed by adjuvant chemotherapy. Under this regimen, approximately 10%-30% of patients experience disease recurrence or metastasis after surgery, while chemotherapy-related toxicities may negatively affect quality of life[iv]. Thus in the neoadjuvant setting, there remains an urgent need for more effective therapies to improve outcomes for patients with locally advanced MSI-H/dMMR colon cancer. The world ' s first dual-IO neoadjuvant therapy: TABOSUN ® (ipilimumab N01 injection) combined with TYVYT ® (sintilimab injection) markedly enhances pathological complete response rates Immune checkpoint blockade (ICB) therapy targeting PD-1 and CTLA-4 has transformed cancer treatment. The combination of DABOSUN® (ipilimumab N01 injection) and TYVYT® (sintilimab injection) as neoadjuvant therapy can significantly improve pathological complete response(pCR) rates and allow the majority of patients to avoid adjuvant chemotherapy. Previously, results from a randomized, controlled Phase 1b trial evaluating ipilimumab N01 plus sintilimab as neoadjuvant treatment for MSI-H/dMMR colon cancer were published in the top-tier journal Cancer Cell[i]. As of June 17, 2025, 101 patients were enrolled and randomized to receive ipilimumab N01 plus sintilimab (n=52) or sintilimab alone (n=49). In the per-protocol population, the pCR rate in the ipilimumab N01-plus-sintilimab arm was significantly higher than in the sintilimab-alone arm (80.0% vs 47.7%, p=0.0007). With median follow-up of 21.4 months, no patient experienced disease recurrence. Approval is based on results from the randomized, controlled, multicenter, pivotal Phase 3 clinical trial (NeoShot, NCT05890742), which evaluated the safety and efficacy of ipilimumab N01 combined with sintilimab as neoadjuvant therapy compared with direct radical surgery for MSI-H/dMMR colon cancer. The primary endpoints are pCR rate and event-free survival (EFS). Interim analysis by the Independent Data Monitoring Committee (IDMC) confirmed that the NeoShot trial met its primary endpoint. As of November 28, 2024, among the first 50 patients in the treatment arm, 41 achieved pathological complete response after neoadjuvant treatment, yielding a pCR rate of 82%. Neoadjuvant treatment with ipilimumab N01 combined with sintilimab did not significantly increase safety risks compared with direct surgery. Detailed results will be presented at future academic conferences or published in academic journals. The Principal Investigator of the NeoShot study, Academician of the Chinese Academy of Engineering, Prof. Ruihua Xu from Sun Yat-sen University Cancer Center, stated: "Achieving R0 resection remains challenging for certain patients with locally advanced colon cancer, who also face substantial surgical trauma and poor prognosis. Results from the FOxTROT study indicated that neoadjuvant chemotherapy provides limited benefit in MSI-H/dMMR colon cancer, with a pCR rate of only around 5%[v]. The NeoShot trial is the first randomized, controlled Phase 3 clinical trial to show promising efficacy of dual checkpoint inhibition as neoadjuvant therapy in MSI-H/dMMR colon cancer. Interim analysis suggests that ipilimumab N01 with sintilimab as short-term neoadjuvant treatment can lead to pathological complete response in 82% of treated patients. In addition, NeoShot Ph1b and Ph3 interim results both show the R0 resection under this regimen could reach 100% and spare patients from adjuvant chemotherapy. In NeoShot-1b, the dual-immunotherapy neoadjuvant regimen combining ipilimumab N01 and sintilimab significantly improved the pCR rate, which serves as a surrogate endpoint for long-term prognosis. Based on the existing data, this regimen shows promising potential to reduce recurrence risk and improve long-term survival outcomes. We look forward to observing continued reductions in recurrence with longer-term follow-up. The approval of this dual-immunotherapy regimen is expected to change clinical practice, fill a critical gap in neoadjuvant treatment of colon cancer and benefit more patients with MSI-H/dMMR colon cancer." Dr. Hui Zhou, Chief R&D Officer (Oncology) of Innovent, stated: "There remains a substantial unmet clinical need for neoadjuvant therapies for stage IIB-III resectable MSI-H/dMMR colon cancer in China. Interim analysis has shown that the NeoShot trial met its primary endpoint. Through Innovent's efficient and high-quality clinical development, ipilimumab N01 has become China's first domestically developed innovative CTLA-4 inhibitor approved by the NMPA, offering a new treatment option for patients in China with stage IIB-III resectable MSI-H/dMMR colon cancer." About Ipilimumab N01 Ipilimumab N01 (R&D code: IBI310) is a fully human monoclonal antibody injection independently developed by Innovent. Ipilimumab N01 specifically binds cytotoxic T lymphocyte-associated antigen 4 (CTLA-4), thereby blocking CTLA-4-mediated inhibition of T cell activity, promoting T cell activation and proliferation, improving tumor immune response, and achieving anti-tumor effects. [vi] The NDA for ipilimumab N01 in combination with sintilimab as neoadjuvant treatment for stage IIB-III resectable microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colon cancer has recently been approved by the NMPA. About Sintilimab Sintilimab, marketed as TYVYT® (sintilimab injection) in China, is a PD-1 immunoglobulin G4 monoclonal antibody co-developed by Innovent and Eli Lilly and Company. Sintilimab is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1 / PD-Ligand 1 (PD-L1) pathway, and reactivates T-cells to kill cancer cells.[vii] In China, sintilimab has been approved and included in the updated NRDL for eight indications. The updated NRDL reimbursement scope for TYVYT® (sintilimab injection) includes: For the treatment of relapsed or refractory classic Hodgkin's lymphoma after two lines or later of systemic chemotherapy; For the first-line treatment of unresectable locally advanced or metastatic non-squamous non-small cell lung cancer lacking EGFR or ALK driver gene mutations; For the treatment of patients with EGFR-mutated locally advanced or metastatic non-squamous non-small cell lung cancer who progressed after EGFR-TKI therapy; For the first-line treatment of unresectable locally advanced or metastatic squamous non-small cell lung cancer; For the first-line treatment of unresectable or metastatic hepatocellular carcinoma with no prior systematic treatment; For the first-line treatment of unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma; For the first-line treatment of unresectable locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma; and In combination with fruquintinib for the treatment of patients with advanced endometrial cancer with pMMR tumors that have failed prior systemic therapy and are not candidates for curative surgery or radiation. The NDA for sintilimab's ninth indication, in combination with ipilimumab N01 as neoadjuvant treatment for stage IIB-III resectable MSI-H/dMMR colon cancer is recently approved by the NMPA. The NDA for sintilimab's tenth indication, in combination with fruquintinib for the treatment of locally advanced or metastatic renal cell carcinoma who previously failed systematic treatment, has been accepted by the Center for Drug Evaluation (CDE) of NMPA. In addition, two clinical studies of sintilimab have met their primary endpoints: Phase 2 study of sintilimab monotherapy as second-line treatment of esophageal squamous cell carcinoma; and Phase 3 study of sintilimab monotherapy as second-line treatment for squamous non-small cell lung cancer with disease progression following platinum-based chemotherapy. About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 18 products in the market. It has 4 assets in Phase 3 or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Lilly, Sanofi, Incyte, LG Chem and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action" Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow Innovent on Facebook and LinkedIn. Disclaimer: Innovent does not recommend any off-label usage. Forward-Looking Statements This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions. Reference: SOURCE Innovent Biologics 21% more press release views with Request a Demo