A Randomized Phase 2 Study of Casdozokitug in Combination With Toripalimab Plus Bevacizumab in Participants With Unresectable and/or Locally Advanced or Metastatic Hepatocellular Carcinoma

The main goals of this study are to evaluate the safety and efficacy of casdozokitug in combination with toripalimab plus bevacizumab and to define a recommended dose for casdozokitug in combination with toripalimab plus bevacizumab.

Start Date20 Dec 2024

Sponsor / Collaborator

Coherus Oncology, Inc.

NCT05359861

/ Active, not recruitingPhase 2

A Randomized Phase 2 Trial of Atezolizumab and Bevacizumab in Combination With SRF388 or Placebo in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma

This is a Phase 2 trial composed of an open label Lead-In followed by a Randomized Phase designed to evaluate the efficacy and safety of SRF388 in combination with atezolizumab plus bevacizumab compared to placebo (inactive substance) in combination with atezolizumab plus bevacizumab in patients with first-line advanced or metastatic HCC.

Start Date12 Apr 2022

Sponsor / Collaborator

Coherus Oncology, Inc.

NCT04374877

/ Active, not recruitingPhase 1

A Phase 1/1b Study of CHS-388 (Formerly Known as SRF388) in Patients With Advanced Solid Tumors

This is a Phase 1/1b, open-label, first-in-human, dose-escalation and expansion study of CHS-388, a monoclonal antibody that targets IL-27, as a monotherapy and in combination in patients with solid tumors.

Start Date22 Apr 2020

Sponsor / Collaborator

Coherus Oncology, Inc.

[+1]

100 Clinical Results associated with Casdozokitug

100 Translational Medicine associated with Casdozokitug

100 Patents (Medical) associated with Casdozokitug

Literatures (Medical) associated with Casdozokitug

01 Aug 2023·International immunopharmacology

IL-27 enhances peripheral B cell glycolysis of rheumatoid arthritis patients via activating mTOR signaling.

Article

Author: Liu, Jiaqing ; Huang, Huina ; Zhao, Xiangge ; Qi, Jingjing ; Tang, Yawei ; Li, Xia

Our previous study found that increased serum IL-27 could promote rheumatoid arthritis (RA) B cell dysfunction via activating mTOR signaling pathway. This study aimed to explore the effects of IL-27 on B cell metabolism and clarify the mechanisms via which IL-27 enhancing glycolysis to induce B cells hyperactivation. Peripheral CD19⁺ B cells were purified from healthy controls (HC) and RA patients and then cultured with or without anti-CD40/CpG and glycolysis inhibitor 2-deoxy-D-glucose (2-DG) or mTOR inhibitor rapamycin. Furthermore, the isolated CD19⁺ B cells were treated by HC serum or RA serum in the presence and absence of recombinant human IL-27 or anti-IL-27 neutralizing antibodies or 2-DG or rapamycin. The B cell glycolysis level, proliferation, differentiation and inflammatory actions were detected by qPCR, flow cytometry or ELISA. We found that the glycolysis in RA B cells was increased significantly compared with HC B cells. Glycolysis inhibition downregulated the proliferation, differentiation, and inflammatory actions of RA B cells. RA serum and IL-27 promoted B cell glycolysis, which could be obviously rescued by anti-IL-27 antibodies or mTOR inhibitor rapamycin. Our results suggest that the enhanced cellular glycolysis of RA B cells induced by IL-27 may contribute to B cells hyperactivation through activating the mTOR signaling pathway.

01 Oct 2022·Cell reports

Structural basis of activation and antagonism of receptor signaling mediated by interleukin-27

Article

Author: Składanowska, Katarzyna ; Hunter, Christopher A ; Hua, Jing ; Logan, Derek T ; Soete, Arne ; Aldridge, Daniel ; Bazan, J Fernando ; Bloch, Yehudi ; Welin, Martin ; White, Kerry F ; Hill, Jonathan A ; Savvides, Savvas N ; Strand, Jamie ; Merceron, Romain ; Murphy, Casey ; Provost, Mathias

Interleukin-27 (IL-27) uniquely assembles p28 and EBI3 subunits to a heterodimeric cytokine that signals via IL-27Rα and gp130. To provide the structural framework for receptor activation by IL-27 and its emerging therapeutic targeting, we report here crystal structures of mouse IL-27 in complex with IL-27Rα and of human IL-27 in complex with SRF388, a monoclonal antibody undergoing clinical trials with oncology indications. One face of the helical p28 subunit interacts with EBI3, while the opposite face nestles into the interdomain elbow of IL-27Rα to juxtapose IL-27Rα to EBI3. This orients IL-27Rα for paired signaling with gp130, which only uses its immunoglobulin domain to bind to IL-27. Such a signaling complex is distinct from those mediated by IL-12 and IL-23. The SRF388 binding epitope on IL-27 overlaps with the IL-27Rα interaction site explaining its potent antagonistic properties. Collectively, our findings will facilitate the mechanistic interrogation, engineering, and therapeutic targeting of IL-27.

01 Feb 2019·HaematologicaQ1 · MEDICINE

The TLR7 ligand R848 prevents mouse graft-versus-host disease and cooperates with anti-interleukin-27 antibody for maximal protection and regulatory T-cell upregulation

Q1 · MEDICINE

Article

Author: Dumoutier, Laure ; Van Snick, Jacques ; Coutelier, Jean-Paul ; Uyttenhove, Catherine ; Gaignage, Mélanie ; Marillier, Reece G ; Cochez, Perrine M

In spite of considerable therapeutic progress, acute graft-versus-host disease still limits allogeneic hematopoietic cell transplantation. We recently reported that mouse infection with nidovirus lactate dehydrogenase elevating virus impairs disease in non-conditioned B6D2F1 recipients of parental B6 spleen cells. As this virus activates TLR7, we tested a pharmacological TLR7 ligand, R848, in this model and observed complete survival if donor and recipients were treated before transplantation. Mixed lymphocyte culture performed 48 h after R848-treatment of normal mice demonstrated that both T-cell allo-responsiveness and antigen presentation by CD11b⁺ and CD8α⁺ dendritic cells were inhibited. These inhibitions were dependent on IFNAR-1 signaling. In the B6 to B6D2F1 transplantation model, R848 decelerated, but did not abrogate, donor T-cell implantation and activation. However, it decreased interferon-gamma, tumor necrosis factor-alpha and interleukin-27 while upregulating active transforming growth factor-beta 1 plasma levels. In addition, donor and recipient Foxp3⁺ regulatory T-cell numbers were increased in recipient mice and their elimination compromised disease prevention. R848 also strongly improved survival of lethally irradiated BALB/c recipients of B6 hematopoietic cells and this also correlated with an upregulation of CD4 and CD8 Foxp3⁺ regulatory T cells that could be further increased by inhibition of interleukin-27. The combination of anti-interleukin-27p28 mono -clonal antibody and R848 showed strong synergy in preventing disease in the B6 to B6D2F1 transplantation model when recipients were sublethally irradiated and this also correlated with upregulation of regulatory T cells. We conclude that R848 modulates multiple aspects of graft-versus-host disease and offers potential for safe allogeneic bone marrow transplantation that can be further optimized by inhibition of interleukin-27.

News (Medical) associated with Casdozokitug

30 May 2025

·www.globenewswire.com

Coherus Completes Strategic Transformation to Coherus Oncology, Focusing Exclusively on Innovative Cancer Therapeutics

REDWOOD CITY, Calif., May 30, 2025 (GLOBE NEWSWIRE) -- Coherus Oncology, Inc. (Coherus Oncology, Nasdaq: CHRS), a commercial-stage innovative oncology company, formerly named Coherus BioSciences Inc., announced its name change today to better align with its exclusive focus on proprietary innovative immuno-oncology medicines. “The field of cancer immunotherapy has been reinvigorated by the promise and power of combination therapies. Coherus Oncology has the expertise and pipeline to become a significant player in this dynamic space and unlock the potential of these next-generation therapeutic approaches,” said Jill O’Donnell-Tormey, Ph.D., Coherus Oncology board member. Dr. O’Donnell-Tormey is a Senior Advisor to the Cancer Research Institute and its former CEO. “The next wave of breakthroughs in cancer immunotherapy will come from new mechanistic orthogonal approaches that synergize for optimal clinical efficacy. CCR8+ Tregs represent one of the most promising targets in cancers, enabling selective depletion of tumor immune suppression while mitigating the risk of breaking tolerance and leading to severe autoimmunity,” said Alexander Rudensky, Ph.D., Coherus Scientific Advisory Board Co-Chair, Chairman and Member, Immunology Program, Sloan Kettering Institute, Lloyd Old Chair in Clinical Investigation Investigator, Howard Hughes Medical Institute Director, Ludwig Center for Cancer Immunotherapy Tri-Institutional Professor at MSKCC, The Rockefeller University and Cornell University. “Coherus Oncology is firmly committed to the oncology community and developing the next generation of therapies focused on extending survival of cancer patients and improving their quality of life,” said Theresa LaVallee, Ph.D., Chief Scientific and Development Officer of Coherus Oncology. “Our objective is to set new standards of cancer care with novel combinations that broadly target the immune system and resistance.” Our Novel Oncology Pipeline Coherus Oncology is developing a portfolio of novel combination therapies with the aim of unlocking immune resistance to current therapies. LOQTORZI® (toripalimab-tpzi), a next-generation PD-1 inhibitor, is the foundation of our immuno-oncology franchise. LOQTORZI is the only available FDA-approved treatment indicated in combination with chemotherapy for recurrent or metastatic nasopharyngeal carcinoma (NPC), and it is in development for the treatment of additional tumor types with the goal of being the PD-1/ICI backbone of future treatment combinations that may extend survival for patients. CHS-114 is a highly selective cytolytic CCR8 antibody that specifically binds and preferentially depletes CCR8+ tumor regulatory T cells (Tregs) with no off-target binding. CHS-114 is currently being evaluated in combination with toripalimab in Phase 1b studies in patients with advanced solid tumors, including second-line head and neck squamous cell carcinoma and second-line gastric cancer. Casdozokitug is a first-in-class, clinical-stage IL-27 antagonist, with demonstrated monotherapy activity in treatment-refractory NSCLC and clear cell renal cell carcinoma (ccRCC) and combination activity in hepatocellular carcinoma (HCC). A randomized Phase 2 study is underway evaluating casdozokitug in combination with toripalimab and bevacizumab, versus toripalimab and bevacizumab, in patients with first-line advanced metastatic HCC. Squamous NSCLC continues as an area of clinical focus and future development. Our Oncology Team & Board Coherus Oncology is led and advised by a world-class team with deep expertise in oncology drug development and commercialization. The Scientific Advisory Board includes pioneers in the fields of Treg immunology, T cell exhaustion, and cytokine biology. The Board of Directors is comprised of industry leaders from the Cancer Research Institute, Merck, United Healthcare, Bristol Myers Squibb, as well as others. The breadth and depth of these perspectives provide Coherus Oncology with valuable insights to navigate the rapidly evolving oncology landscape and drive innovation to advance patient benefit and shareholder value. Learn more about our executive team, Board of Directors, Scientific Advisory Board, and Strategic Advisors here: https://www.coherus.com/leadership/ About Coherus Oncology Coherus Oncology is a fully integrated commercial-stage innovative oncology company with an approved next-generation PD-1 inhibitor, LOQTORZI, and a promising pipeline that includes two mid-stage clinical candidates targeting liver, lung, head & neck, and other cancers. Our strategy is to expand the use of LOQTORZI in NPC and advance the development of new indications for LOQTORZI in combination with both our pipeline candidates as well as our industry partners, driving synergies from proprietary combinations, including first-in-class anticancer agents. For more information about LOQTORZI, including the U.S. Prescribing Information and important safety information, please visit www.loqtorzi.com. Forward-Looking Statements The statements in this press release include express or implied forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act about Coherus Oncology that involve risks and uncertainties relating to future events and the future performance of Coherus Oncology. Forward-looking statements relate to expectations, beliefs, projections, future plans and strategies, anticipated events or trends and similar expressions concerning matters that are not historical facts. Words such as “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “future,” “opportunity,” “likely,” “target,” variations of such words, and similar expressions or negatives of these words are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. You can also identify forward-looking statements by discussions of strategy, plans or intentions. Examples of such forward-looking statements include, but are not limited to, express or implied statements regarding: the ability of Coherus Oncology’s product candidates to enhance outcomes for cancer patients; expectations about future synergies; expectations for how promising the targets are for our product candidates; projections about the expansion of indications for LOQTORZI; and the assumptions underlying or relating to such statements. These forward-looking statements are based on Coherus Oncology’s current plans, estimates and projections. By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific, assumptions and changes in circumstances, many of which are beyond the control of Coherus Oncology. A number of important factors, including those described in this press release, could cause actual results to differ materially from those contemplated in any forward-looking statements. Factors that may affect future results and may cause these forward-looking statements to be inaccurate include, without limitation: uncertainties about the potential impact of unforeseen liabilities, future capital expenditures, revenues, costs, expenses, earnings, economic performance, indebtedness and losses on Coherus Oncology’s prospects, business and operations in the future; risks and uncertainties in executing collaboration agreements and other joint ventures; risks and uncertainties of conducting clinical trials; the risks of Coherus Oncology’s dependence on an ability to raise funds, which may not be available on acceptable terms or at all; and risks and uncertainties of any litigation, regulatory actions and other legal proceedings. While the foregoing list of factors presented here is considered representative, no list should be considered to be a complete statement of all potential risks and uncertainties. There can be no assurance that the transaction described above will in fact be consummated in the manner described or at all. For a further discussion of these and other factors that could cause Coherus Oncology’s future results to differ materially from any forward-looking statements see the section entitled “Risk Factors” in Coherus Oncology’s Quarterly Report on Form 10-Q for the period ended March 31, 2025, filed with the Securities and Exchange Commission (SEC) on May 12, 2025, as updated by Coherus Oncology’s subsequent reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are made based on the current good faith beliefs and judgments of Coherus Oncology’s management, and the reader is cautioned not to rely on any forward-looking statements made by Coherus Oncology. Unless required by law, Coherus Oncology is not under any duty and undertakes no obligation to publicly update or revise any forward-looking statement to reflect changes in underlying assumptions or factors, of new information, data or methods, future events or other changes. LOQTORZI® is a registered trademark of Coherus Oncology, Inc. ©2025 Coherus Oncology, Inc. All rights reserved. Coherus Oncology Contact Information:For Investors:Jodi SieversVP, Investor Relations & Corporate CommunicationsIR@coherus.com For Media:Argot Partners(212) 600-1902coherus@argotpartners.com

ImmunotherapyDrug ApprovalPhase 2Phase 1

29 May 2025

·www.globenewswire.com

Coherus Announces Clinical Collaboration with STORM Therapeutics to Evaluate STC-15 in Combination with LOQTORZI® (toripalimab-tpzi)

– First patient dosed in a Phase 1b/2 study evaluating STC-15, a METTL3 inhibitor, in combination with LOQTORZI, a next-generation PD-1 inhibitor – May 27, 2025 -- Coherus BioSciences, Inc. (“Coherus,” NASDAQ: CHRS), today announced a clinical collaboration with STORM Therapeutics, Ltd. (“STORM”) to evaluate STC-15, a METTL3 inhibitor, in combination with LOQTORZI (toripalimab-tpzi), a next-generation PD-1 inhibitor, in a Phase 1b/2 study for the treatment of non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), melanoma and endometrial cancer. “We are excited to partner with STORM on the development of the LOQTORZI/STC-15 combination, with patient dosing underway in the Phase 1b/2 study,” said Theresa LaVallee, Ph.D., Chief Scientific and Development Officer of Coherus. “This collaboration is another example of our strategy for expanding potential LOQTORZI indications beyond NPC through cost-efficient drug supply agreements and evaluating LOQTORZI with novel mechanisms in prioritized tumor types such as NSCLC, HNSCC, and others.” The phase 1b study will evaluate STC-15, a METTL3 inhibitor, in combination with LOQTORZI to determine the safety and efficacy of the combination. The phase 2 portion of the study will evaluate expansion cohorts in NSCLC, HNSCC, endometrial cancer and melanoma, in up to 188 patients in the United States. (NCT06975293) Under the terms of the clinical trial collaboration and supply agreement, Coherus will provide LOQTORZI to STORM, which will be the sponsor of the Phase 1b/2 clinical combination trial. STORM and Coherus each retain all commercial rights to their respective compounds, including as monotherapies or as combination therapies. Coherus is a fully integrated commercial-stage innovative oncology company with an approved next-generation PD-1 inhibitor, LOQTORZI® (toripalimab-tpzi), growing revenues and a promising pipeline that includes two mid-stage clinical candidates targeting liver, lung, head & neck, and other cancers. Our strategy is to grow sales of LOQTORZI in nasopharyngeal carcinoma and advance the development of new indications for LOQTORZI in combination with both our pipeline candidates as well as our partners’, driving sales multiples and synergies from proprietary combinations. Coherus’ immuno-oncology pipeline includes multiple antibody immunotherapy candidates focused on enhancing the innate and adaptive immune responses to enable a robust antitumor response and enhance outcomes for patients with cancer. Casdozokitug is a novel IL-27 antagonistic antibody currently being evaluated in multiple Phase 1/2 and Phase 2 studies in patients with advanced solid tumors, including non-small cell lung cancer and hepatocellular carcinoma. CHS-114 is a highly selective cytolytic anti-CCR8 antibody currently in Phase 1b studies in patients with advanced solid tumors, including head and neck squamous cell carcinoma and gastric cancer. The content above comes from the network. if any infringement, please contact us to modify.

ImmunotherapyLicense out/in

28 Apr 2025

·pipelinereview.com

Coherus Presents Promising Early Clinical Data from Phase 1 Dose Expansion Study of CHS-114 in Patients with Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma at AACR 2025

– CHS-114 demonstrates clinical efficacy and proof of mechanism in HNSCC in combination with toripalimab – – Confirmed partial response in heavily pretreated PD-1 refractory patient supports expansion in HNSCC and gastric cancer in combination with toripalimab – – A second-line Phase 1 dose optimization study in HNSCC and gastric cancer is ongoing; results expected in the first half of 2026– – Coherus to host investor and analyst call with study investigator, Dr. Douglas Adkins, Washington University, today at 4:30 p.m. Eastern Time– REDWOOD CITY, CA, USA I April 28, 2025 I Coherus BioSciences, Inc. (“Coherus,” NASDAQ: CHRS), today announced data from its ongoing Phase 1 clinical trial evaluating CHS-114, a selective, cytolytic anti-CCR8 antibody, as monotherapy and in combination with toripalimab in patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) evaluating two pharmacologically active doses of CHS-114 for dose optimization. These data are being presented at the 2025 American Association for Cancer Research (AACR) Annual Meeting, taking place April 25-30, 2025, in Chicago, Illinois. The data showed a confirmed partial response in a heavily pretreated PD-1 refractory patient, a > 50% depletion in CCR8+ Treg, and an increase in CD8+ T cells, consistent with anti-tumor activity and demonstrating proof of mechanism. Importantly, the safety profile was consistent with advanced disease and the known safety profile of toripalimab. These data support continued evaluation of CHS-114 in combination with other therapies, including toripalimab. Results support advancement and ongoing enrolment in Part 3 of the study evaluating CHS-114 with toripalimab in HNSCC (n = 40). CHS-114 is an afucosylated CCR8 monoclonal antibody and is the only known selective molecule designed to exclusively target human CCR8 with no off-target binding and preferentially kills CCR8+ Tregs within the tumor microenvironment while preserving CD8+ effector T cells and Tregs in normal tissue. “The data to date demonstrate a robust depletion of Treg cells in tumors, with a manageable safety profile, and a patient with a meaningful clinical response, which is highly encouraging,” said Rosh Dias, M.D., Coherus’ Chief Medical Officer. “Furthermore, the profound increase in CD8+ T cells, making these tumors immunologically hot, is exciting as it supports CHS-114 being combined with several treatment modalities including T Cell Engagers. Head and neck cancer is an important strategic focus for Coherus, but CHS-114 has the potential, based on its mechanism of action, to treat many solid tumors, including non-small cell lung cancer and other large, underserved immuno-oncology indications, like colorectal cancer. We look forward to sharing further head and neck and gastric cancer data in the first half of next year.” “One of the biggest challenges in oncology has been finding a treatment that depletes Treg cells and relieves immune suppression in the tumor without causing collateral autoimmune disease or affecting antitumor T cells,” said Douglas Adkins, M.D., Professor of Medicine, Director, Section of Head and Neck and Thyroid Medical Oncology, Division of Medical Oncology, Washington University School of Medicine. “These early clinical results are exactly what we’ve been hoping for and demonstrate CHS-114’s ability to remodel the tumor microenvironment in favor of anti-tumor activity. I am looking forward to exploring this treatment combination for solid tumor patients, even beyond head and neck.” Results from Phase 1b dose expansion trial evaluating CHS-114 monotherapy and with toripalimab in HNSCC This open-label Phase 1b clinical trial evaluated CHS-114 as a single-agent and in combination with toripalimab in 21 patients with advanced solid tumors including HNSCC. Patients received either CHS-114 alone or in combination with toripalimab (240 mg) q3w. The primary endpoint of the study was to determine dose limiting toxicities (DLTs) and treatment emergent adverse events (TEAEs), with the goal of identifying two recommended doses for expansion. Key secondary endpoints included objective response rate (ORR) based on investigator review per RECIST v1.1 as well as pharmacokinetics and pharmacodynamics (PK/PD). As of the data cutoff date of January 24, 2025: These results support continued evaluation of CHS-114 in combination with other drugs including toripalimab, with broad potential applications in many solid tumors with a high density of CCR8+ Treg cells. A second-line HNSCC dose optimization study of CHS-114 in combination with toripalimab in HNSCC and gastric cancer patients is ongoing, with anticipated results in the first half of 2026 The current study design is expected to address the regulatory requirements under Project Optimus 1 and support the recommendation of a phase 2 dose by early 2026. AACR 2025 Presentation Details Title: Phase 1 study of anti-CCR8 antibody CHS-114 with and without anti-PD-1 antibody toripalimab in patients with advanced solid tumors Lead Author: Francis Worden, M.D., University of Michigan Abstract #: CT038 Poster Session: Phase 0 and Phase 1 Clinical Trials Poster Section 49: Poster board 17 Date and Time: Monday, April 28, 2025, 9:00 a.m. – 12:00 p.m. CDT Conference Call Information for Investors and Analysts Coherus Chief Development Officer, Dr. Theresa LaVallee, and Chief Medical Officer, Dr. Rosh Dias, will host a presentation and discussion of new clinical data from the Phase 1 study with CHS-114 with and without anti-PD-1 antibody toripalimab with study investigator, Dr. Douglas Adkins of Washington University. When: Monday, April 28, 2025, starting at 4:30 p.m. Eastern Time Investors and analysts are invited to listen into a live audio webcast of the presentation. To access the conference call, please pre-register through the following link to receive dial-in information and a personal PIN to access the live call: https://register-conf.media-server.com/register/BI5eb6be782f004f9bb4e652903aabafe4 Please dial in 15 minutes early to ensure a timely connection to the call. Webcast: https://edge.media-server.com/mmc/p/yawixgnq An archived webcast will be available on the “Investors” section of the Coherus website at https://investors.coherus.com/events-presentations . About the CHS-114 Phase 1 Study The Phase 1 study (NCT05635643) is a dose escalation, dose optimization, and expansion study evaluating CHS-114 as a monotherapy and in combination with toripalimab, a next-generation PD-1 inhibitor. Arm 1a (first-in-human dose escalation) enrolled 20 patients with advanced solid tumors including 2 patients with HNSCC and evaluated multiple dose levels (5-1200 mg) of CHS-114 monotherapy. Arm 1b evaluated two pharmacologically active doses of CHS-114 monotherapy in 12 HNSCC patients with paired tumor biopsies. Arm 2 evaluated two pharmacologically active doses of CHS-114 with toripalimab in 7 patients. Arm 3 is evaluating two pharmacologically active doses of CHS-114 with toripalimab in 40 patients with second-line HNSCC. Primary objectives are to optimize the CHS-114 dose(s) for expansion and evaluate the safety of CHS-114 with toripalimab. Secondary objectives were to evaluate the safety, PK, and antitumor activity of CHS-114 with and without toripalimab and assess biomarkers, including changes in regulatory T cells (Tregs) and CD8+ T cells in paired tumor biopsies and other immune biomarkers. About CHS-114 CHS-114, an afucosylated, cytolytic CCR8 monoclonal antibody, is designed to selectively target human CCR8 and preferentially kill CCR8+ Tregs within the tumor microenvironment while preserving CD8+ effector T cells and Tregs in normal tissue. In preclinical studies, CHS-114 induced antibody-dependent cellular cytotoxicity (ADCC) and/or antibody-dependent cellular phagocytosis (ADCP) to deplete tumoral CCR8+ Tregs. In addition, treatment with CHS-114 alone reduced tumor growth in murine models, and enhanced antitumor activity was observed in combination with anti-PD-1 treatment. CHS-114 is currently being evaluated in combination with toripalimab in two Phase 1b clinical trials in patients with advanced solid tumors, including head and neck cancer (NCT05635643) and gastric cancer (NCT06657144). About Coherus BioSciences Coherus is a fully integrated commercial-stage innovative oncology company with an approved next-generation PD-1 inhibitor, LOQTORZI ® (toripalimab-tpzi), growing revenues and a promising pipeline that includes two mid-stage clinical candidates targeting liver, lung, head & neck, and other cancers. Our strategy is to grow sales of LOQTORZI in nasopharyngeal carcinoma and advance the development of new indications for LOQTORZI in combination with both our pipeline candidates as well as our partners’, driving sales multiples and synergies from proprietary combinations. Coherus’ immuno-oncology pipeline includes multiple antibody immunotherapy candidates focused on enhancing the innate and adaptive immune responses to enable a robust antitumor response and enhance outcomes for patients with cancer. Casdozokitug is a novel IL-27 antagonistic antibody currently being evaluated in multiple Phase 1/2 and Phase 2 studies in patients with advanced solid tumors including in non-small cell lung cancer and in hepatocellular carcinoma. CHS-114 is a highly selective cytolytic anti-CCR8 antibody currently in Phase 1 studies in patients with advanced solid tumors, including head and neck squamous cell carcinoma and gastric cancer. For more information about LOQTORZI, including the U.S. Prescribing Information and important safety information, please visit www.loqtorzi.com . SOURCE: Coherus BioSciences

Phase 1ImmunotherapyAACRClinical ResultPhase 2

100 Deals associated with Casdozokitug

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Hepatocellular Carcinoma	Phase 2	Hong Kong	Coherus Oncology, Inc.	20 Dec 2024
Non-Small Cell Lung Cancer	Phase 2	United States	Surface Oncology, Inc.	14 Apr 2022
Metastatic hepatocellular carcinoma	Phase 2	United States	Coherus Oncology, Inc.	12 Apr 2022
Metastatic hepatocellular carcinoma	Phase 2	Australia	Coherus Oncology, Inc.	12 Apr 2022
Metastatic hepatocellular carcinoma	Phase 2	South Korea	Coherus Oncology, Inc.	12 Apr 2022
Metastatic hepatocellular carcinoma	Phase 2	Taiwan Province	Coherus Oncology, Inc.	12 Apr 2022
Locally Advanced Malignant Solid Neoplasm	Phase 1	United States	Coherus Oncology, Inc.	22 Apr 2020
Locally Advanced Malignant Solid Neoplasm	Phase 1	Singapore	Coherus Oncology, Inc.	22 Apr 2020
Locally Advanced Malignant Solid Neoplasm	Phase 1	South Korea	Coherus Oncology, Inc.	22 Apr 2020
metastatic non-small cell lung cancer	Phase 1	United States	Coherus Oncology, Inc.	22 Apr 2020

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06679985 (CHS-388-202, ASCO2025)	Phase 2	Hepatocellular Carcinoma First line IL-27 activation signature	72	Tori 240 mg + Bev 15 mg/kg + Casdozo 700 mg	zbzdktvorb(upssaqosax) = gtunudagzh ghqbcohbsy (ofrohzfpfb ) View more	Positive	30 May 2025
NCT05359861 (ASCO_GI2025) Manual	Phase 2	Hepatocellular Carcinoma	30	Casdozo 10 mg/kg + Atezolizumab 1200 mg + Bevacizumab 15 mg/kg (RECIST1.1)	avqusahvro(kfedndobio) = rweqjfjozj nkenhftirf (bdmhsaqzad ) View more	Positive	23 Jan 2025
NCT05359861 (ASCO_GI2025) Manual	Phase 2	Hepatocellular Carcinoma	30	Casdozo 10 mg/kg + Atezolizumab 1200 mgAtezolizumab 1200 mg + Bevacizumab 15 mg/kg (mRECIST)	qfuuomxmly(buaxlgchvy) = zacncxiiwa yyrzpinaws (ydlxkwqraw ) View more	Positive	23 Jan 2025
NCT04374877 (ESMO_IO2024) Manual	Phase 1	Non-Small Cell Lung Cancer	45	Casdozokitug (casdozo, CHS-388) 10 mg/kg IV q4 wks	aewahmmbaj(lgmjfsvwzu) = hdunjyonnu pjsrgkkpjo (lurommuhnv ) View more	Positive	12 Dec 2024
NCT05359861 (ASCO_GI2024) Manual	Phase 2	Hepatocellular Carcinoma First line	30	Casdozokitug+atezolizumab+bevacizumab	rtjsjvyeuo(blhlaaxfoi) = brtljvymvg jsuyfoxzug (hebyglbckm ) View more	Positive	18 Jan 2024
NCT04374877 (GlobeNewswire) Manual	Phase 1/2	Solid tumor PD-L1	-	Casdozokitug (PD-L1 negative or low, squamous NSCLC)	iwyhbfncbm(klgpvieaua) = yntclerdzo vzcxknyswk (nwgnbwjxtf )	Positive	06 Dec 2023
NCT04374877 (GlobeNewswire) Manual	Phase 1/2	Solid tumor PD-L1	-	Casdozokitug (adenocarcinoma)	kegswvnozv(cmexcvvfyp) = levgulyzif bdoofaqdqa (qixhezmrpu )	Positive	06 Dec 2023
NCT04374877 (ASCO2022) Manual	Phase 1	HR-positive/HER2-low Solid Tumors	29	SRF388	kbwtyqmgxa(phwmpfpadr) = vahaibafrm mgdbsqtobg (yvanbsapwt ) View more	Positive	02 Jun 2022
NCT04374877 (ASCO2021)	Phase 1	HR-positive/HER2-low Solid Tumors	12	SRF388	zgmqfzniqp(klsbsnzkqj) = xeehcckqsv atiifkismc (zosbgfcxfj )	-	28 May 2021

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Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis