Latest news with #MSS-CRC
Yahoo
3 days ago
- Business
- Yahoo
KAHR Bio Announces Positive Phase 2 Results of DSP107 in Combination with anti-PD-L1 in Colorectal Cancer
- Findings presented in an oral presentation at the 2025 ASCO Annual Meeting - DSP107 in combination with atezolizumab in 3rd line microsatellite stable colorectal cancer (MSS-CRC) patients elicits anti-tumor activity and extends survival including in patients with liver metastases MODI'IN, Israel, June 2, 2025 /PRNewswire/ -- KAHR, a clinical-stage biotech company developing DSP107, a first-in-class bi-specific 4-1BB T-cell engager that activates innate and adaptive immunity to treat solid tumors, today announced positive results from the Phase 2 dose expansion cohort of DSP107 in combination with atezolizumab (Tecentriq®), an anti-PD-L1 cancer immunotherapy, in patients with 3rd line microsatellite stable metastatic colorectal cancer (MSS-CRC). In addition to its favorable safety profile, the combination has shown anti-tumor activity and extended survival including in patients with liver metastases. The results were presented in an oral presentation by Anwaar Saeed, MD, Associate Professor of Medicine, University of Pittsburgh Medical Center and Director, Gastrointestinal Disease Center, UPMC Hillman Cancer Center at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting, May 30 – June 3, 2025, in Chicago, IL. "Colorectal cancer, the second largest cause of cancer deaths worldwide, is considered a 'cold' tumor that usually does not elicit an efficient immune response," said Dr. Saeed. "This immunotherapy combination showed durable results in MSS-CRC patients. Not only is the median survival of DSP107 with atezolizumab longer than current standard treatments, it is also very well tolerated by patients, without the severe, sometimes life-threatening side effects of chemotherapy in such advanced lines of treatment. Importantly, the majority of patients in the combination cohort had active liver metastases and the activity and survival benefit were also seen in these patients, who are very difficult to treat, suggesting that DSP107 in combination with a PD1/PD-L1 checkpoint inhibitor may become an effective immunotherapy treatment option for this patient population." Yaron Pereg, Ph.D., Chief Executive Officer of KAHR, said, "We are extremely encouraged by the dose expansion data, showing objective responses and extended survival in response to DSP107 in combination with atezolizumab in patients with 3rd line MSS-CRC. We look forward to initiating a Phase 2b, randomized, controlled study to confirm these promising efficacy signals. In addition, we expect data in 2026 from a Phase 2 dose expansion cohort in Non-small Cell Lung Cancer (NSCLC), the leading cause of cancer deaths worldwide." Results from the completed dose expansion cohort show that DSP107 monotherapy and combination treatment with atezolizumab were well tolerated with no dose limiting toxicities. The median OS from the efficacy-evaluable patients who received DSP107 monotherapy (n=19) and combination therapy with atezolizumab (n=21) has not been reached, but currently (May 2025 cutoff) stands at 8.1 and 17 months, respectively. Disease control was demonstrated in 21% (monotherapy) and 62% (combination) of evaluable patients including a patient who achieved a complete response (> 2.5 years) and a patient with a deep (86% target lesion reduction) and durable (> 16 months) confirmed partial response and disappearance of pulmonary and hepatic metastases. Immunofluorescence analysis of baseline tumor biopsies demonstrated very high levels of CD47 expression, the DSP107 target, in all samples collected from liver metastases. The MSS-CRC dose expansion phase of the study was an open label, multi-center trial (NCT04440735) that enrolled patients with 3rd line MSS colorectal cancer patients, treated weekly with 10 mg/kg DSP107 infusions and atezolizumab (1200 mg) every three weeks, until disease progression. The primary objective was to determine the safety and tolerability of DSP107 in combination with atezolizumab. The secondary objective was to assess the preliminary efficacy of DSP107 in combination with atezolizumab. Presentation information: Abstract Title: Phase 2 dose expansion study of DSP107, a first-in-class bi-specific 4-1BB T-cell engager, with and without atezolizumab in metastatic MSS colorectal cancer patients. Abstract Number for Publication: 3517 About DSP107 KAHR's lead drug candidate, DSP107, is a first-in-class bi-specific 4-1BB T-cell engager utilizing CD47 overexpression as a tumor anchor. DSP107 binds to CD47 that cancer cells express on their cell surface. Once bound, DSP107 converts the CD47 signal, which cancer uses to camouflage itself from the innate immune system, into a 4-1BB signal, which attracts and activates adaptive immune cells, primarily cancer cytotoxic CD8 T-cells. In this way, DSP107 engages both parts of the immune system in a wholistic anti-cancer response. This is particularly relevant in colorectal cancer, where 70%+ of the metastatic patients have metastases in the liver, and where liver metastases highly express CD47 in response to first- and second-line chemotherapy treatments. Previous attempts to treat colorectal cancer with immunotherapy have failed as there is a lack of immune cells in the tumor. DSP107 is unique in that it takes advantage of CD47 expression to drive immune cells into the tumor. DSP107 is also being tested in Phase 2 expansion cohort in 2L/3L PD1-experienced NSCLC. About microsatellite stable metastatic colorectal cancer (MSS-CRC) Microsatellite stable metastatic colorectal cancer (MSS-CRC) is a subtype of colorectal cancer that lacks deficiencies in the DNA mismatch repair system, resulting in stable microsatellite regions within the genome. Unlike microsatellite instability-high (MSI-H) tumors, MSS-CRC exhibits lower tumor mutational burden and is less responsive to immunotherapy. MSS tumors represent the majority of colorectal cancer cases and are typically more challenging to treat. Standard treatment for metastatic MSS-CRC often involves a combination of chemotherapy, targeted therapy, and in select cases, surgical intervention. About KAHR KAHR develops novel, dual-targeting fusion protein therapeutics engineered to activate both the innate and adaptive immune systems simultaneously and localize that response in the tumor microenvironment. The Company is developing multifunctional fusion proteins that boost the immune systems' response to cancer. KAHR Bio was founded based on technology developed at the University of Pennsylvania and Thomas Jefferson University. For more information, please visit Media contact:Tsipi HaitovskyGlobal Media LiaisonKAHR +972-52-598-9892Tsipihai5@ View original content: SOURCE KAHR Medical 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
6 days ago
- Business
- Business Wire
Parabilis Medicines to Present Overview of Ongoing Phase 1/2 Study of FOG-001, a β-catenin
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Parabilis Medicines, a clinical-stage biopharmaceutical company committed to creating extraordinary medicines for people living with cancer, today announced the presentations of trial-in-progress posters on the Company's first-in-human clinical trial evaluating FOG-001, the first and only direct inhibitor of β-catenin TCF4, at the ASCO Annual Meeting, which begins on May 30 in Chicago, Illinois, and the ESMO Gastrointestinal Cancers Congress 2025, which begins on July 2 in Barcelona, Spain. FOG-001 is being evaluated in a Phase 1/2 trial (NCT05919264). The multicenter, open-label, non-randomized trial aims to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of FOG-001 in patients with solid tumors with Wnt pathway activating mutations (WPAM+), including colorectal cancer (CRC) and desmoid tumors. More than 65 patients with locally advanced or metastatic tumors have been dosed with FOG-001 to date, and early clinical data demonstrate monotherapy antitumor activity and in-tumor target engagement. Phase 1/2 data are expected to be shared publicly in 2025. The trial is currently enrolling patients with desmoid tumors in its monotherapy arm. It is also enrolling multiple cohorts of microsatellite-stable CRC (MSS-CRC) patients to evaluate combination regimens of FOG-001, supported by strong scientific rationale: Combinations with FOLFOX+bevacizumab and trifluridine/tipiracil+bevacizumab: Paired biopsy data from the ongoing FOG-001 trial indicate that FOG-001 drives reduction in markers of stemness and upregulation of the angiogenesis pathway, pointing to potentially greater susceptibility to both chemotherapy and bevacizumab. Preclinical studies employing patient-derived xenograft (PDX) mouse models indicate FOG-001 can significantly deepen and extend the benefit of both chemotherapy backbone agent 5-FU and bevacizumab. A second combination regimen, pairing FOG-001 with PD-1 checkpoint inhibitors, is supported by paired biopsy data from the ongoing trial indicating that FOG-001 induces the Merck tumor inflammation signature in otherwise immunologically 'cold' tumors. Preclinical studies in MC38 mouse models suggest this potential, demonstrating synergistic combination efficacy between FOG-001 and PD-1 checkpoint inhibitors. These observations indicate that FOG-001 could improve CRC responses to immunotherapy, which currently has minimal to no monotherapy efficacy in MSS-CRC. ASCO poster information: Title: 'A Phase 1/2 study of FOG-001, a first-in-class direct β-catenin:TCF inhibitor, in patients with colorectal cancer (CRC) and other locally advanced or metastatic solid tumors' Abstract Number: TPS3169 Date and Time: June 2, 2025, 1:30-4:30 p.m. CDT Session: Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology Location: Hall A – Posters and Exhibits ESMO GI poster information: Title: 'FOG-001 – a first-in-class direct β-catenin:TCF inhibitor, in patients with colorectal cancer (CRC) and other locally advanced or metastatic solid tumors: Phase 1/2 study design' Presentation Number: 145TiP Date and Time: July 3, 2025, 3:30-4:30 p.m. CET Session: Poster display session Location: Foyer About FOG-001 FOG-001 is an investigational first-in-class competitive inhibitor of β-catenin interactions with the T-cell factor (TCF) family of transcription factors, and is currently in clinical development. By directly targeting the β-catenin TCF4 protein-protein interaction, FOG-001 is intended to block the Wnt signaling pathway irrespective of the various APC and beta-catenin mutations that typically drive disease. FOG-001 combines key features that distinguish it from previously reported Wnt/β-catenin pathway modulators: FOG-001 acts inside the cell where it binds directly to the key oncogenic driver β-catenin; and FOG-001 blocks the Wnt pathway at the most downstream node, disrupting the interaction between β-catenin and the transcription factor TCF, thereby abrogating the signal transmission by which Wnt pathway mutations are believed to drive oncogenesis. FOG-001 is currently being evaluated in a first-in-human Phase 1/2 clinical trial in patients with locally advanced or metastatic solid tumors. About Parabilis Medicines Parabilis Medicines is a clinical-stage biopharmaceutical company dedicated to creating extraordinary medicines for people living with cancer. Through its Helicon discovery platform, Parabilis is engineering precisely tuned, stabilized helical peptide therapeutics that have the potential to unlock a large number of traditionally undruggable targets. This versatile platform enables applications for Helicons across three main areas: functional inhibitors of intracellular protein-protein interactions, targeted protein degraders, and targeted radiopharmaceuticals. Parabilis is advancing a pipeline of first-in-class programs across these three domains, led by FOG-001, its clinical-stage β-catenin TCF4 inhibitor. Parabilis is headquartered in Cambridge, Mass., and is well-capitalized, with more than $500 million raised to date from leading life sciences investors. For more information, please visit:
