A Phase 1b Study of the Multi-Kinase Inhibitor Regorafenib in Combination With the BCL-2 Inhibitor Venetoclax Plus Azacitidine in Patients With Relapsed/Refractory Acute Myeloid Leukemia

This phase Ib trial tests the safety, side effects, best dose and effectiveness of regorafenib in combination with venetoclax and azacitidine in treating patients with acute myeloid leukemia (AML) that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Regorafenib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps to slow or stop the spread of cancer cells. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking BCL-2, a protein needed for cancer cell survival. Azacitidine is in a class of medications called demethylation agents. It works by helping the bone marrow to produce normal blood cells and by killing abnormal cells. Giving regorafenib in combination with venetoclax and azacitidine may be safe, tolerable and/or effective in treating patients with relapsed or refractory AML.

Start Date20 Mar 2025

Sponsor / Collaborator

City of Hope National Medical Center

[+1]

NCT06682611

/ Not yet recruitingPhase 1/2

An, Phase Ib/II Clinical Trial to Evaluate the Safety and Efficacy of SYHA1813 Single Agent or in Combination With Different Regimens in Unresectable Locally Advanced or Metastatic Solid Tumors.

This is an open-label, multi-center, multi-cohort, phase Ib/II clinical trial, divided into 8 cohorts according to tumor types. Cohorts 1-4 are SYHA1813 combined with different regimens, including safety run-in stage and cohort expansion stage. Cohorts 5-8 are SYHA1813 monotherapy and only include the expansion cohorts. The primary objective was to evaluate the safety and efficacy of SYHA1813 single agent or in combination with different regimens in unresectable locally advanced or metastatic solid tumors.

Start Date13 Nov 2024

Sponsor / Collaborator

Shanghai Runshi Pharmaceutical Technology Co., Ltd.

NCT06575725

/ WithdrawnPhase 2IIT

A Phase 2 Study of Botensilimab, Balstilimab and Regorafenib in Patients With Microsatellite Stable Colorectal Cancer

This phase II trial studies how well the combination of botensilimab, balstilimab and regorafenib works compared to botensilimab and balstilimab in treating patients with microsatellite stable colorectal cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as botensilimab and balstilimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Regorafenib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals tumor cells to multiply. This helps to slow or stop the spread of tumor cells. The combination of botensilimab, balstilimab and regorafenib or botensilimab and balstilimab may be a safe and effective treatment for advanced or metastatic microsatellite stable colorectal cancer.

Start Date01 Nov 2024

Sponsor / Collaborator

City of Hope National Medical Center

[+1]

100 Clinical Results associated with Regorafenib

100 Translational Medicine associated with Regorafenib

100 Patents (Medical) associated with Regorafenib

2,050

Literatures (Medical) associated with Regorafenib

01 Feb 2025·JOURNAL OF ETHNOPHARMACOLOGY

Safety assessment and exploration of the mechanism of toxic effects of diallyl trisulfide: Based on acute and subacute toxicity and proteomics experiments

Article

Author: Wang, Yihao ; Ma, Zengchun ; Wu, Zhenhui ; Shen, Pan ; Li, Shubei ; Tu, Bodan ; Zhou, Wei ; Gao, Yue ; Tang, Xianglin ; Chen, Junru ; Xiao, Chengrong

ETHNOPHARMACOLOGICAL RELEVANCE:

Garlic (Allium sativum L.) is a widely consumed spice and condiment around the world, applied both as a food and as a traditional medicine, and is a natural strengthening agent for the body's circulatory and nervous systems. Diallyl trisulfide (DATS) is the major volatile organosulfur phytochemical found in garlic, with antithrombotic, anticoagulant, and antiplatelet activities as well as antioxidant, anti-infective, and other pharmacological effects. However, the safe dose and the underlying mechanisms of its toxic effects remain elusive.

AIM OF THE STUDY:

DATS, an important pharmacologically active compound found in garlic, has garnered attention for its ability to fight cancer, antioxidant, anti-infective, and cardioprotective. The aim of this study was to evaluate the safety of DATS and to elucidate the potential mechanisms of its toxicity.

MATERIALS AND METHODS:

In this study, ICR mice were selected for acute and subacute toxicity experiments according to OECD guidelines. The toxicity profile of DATS was analyzed by computer prediction software. Also, key differential proteins in spleen and serum were analyzed by proteomics. The binding stability of DAST to differential proteins was analyzed by molecular docking. Additionally, the regulatory relationship between DATS and differential proteins was verified by Western blot and ELISA experiments.

RESULTS:

The results showed that the LD₅₀ value of DATS in acute toxicity was 188.67 mg/kg. In subacute toxicity, water consumption and food intake were reduced in both male and female mice. In addition, the spleen and small intestinal organ coefficients were significantly elevated in male mice at the high dose of DATS; the blood biochemical indices ALB and TP were also significantly elevated. HE staining results showed significant damage to the spleen, liver, small intestine, and kidney of mice at high doses of DATS. Spleen and serum proteomics analyses showed that DATS significantly inhibited ZBP1 expression and upregulated TEC. ADMETlab 2.0 software predictions identified DATS as having potential genotoxicity, dermal sensitization, carcinogenicity, and respiratory and ocular toxicity. Docking results showed that the binding energies between DATS and TEC protein (PDB: 6F3F) and ZBP1 protein (PDB: 4KA4) were -3.7 kcal/mol, -2.4 kcal/mol, respectively. Western blot results showed that DATS-H significantly inhibited the expression of ZBP1 (only in male mice) and Bcl-2 proteins. ELISA results showed that DATS-H significantly increased the level of TEC protein both in male and female mice.

CONCLUSIONS:

Long-term administration of high-dose DATS may carry some risk of toxicity. Based on the amount of DATS in garlic, it is recommended that adults should not take more than 359 mg of DATS and 84.5 g of garlic per day. The mechanism of toxicity may be related to the fact that DATS significantly inhibits ZBP1 expression, upregulates TEC, and promotes apoptosis. This study provides valuable toxicological data for the effective evaluation of the long-term toxicity of DATS and offers an additional experimental basis for developing DATS as a healthy food or drug.

01 Jan 2025·Nature Reviews Clinical Oncology

Late-line options for patients with metastatic colorectal cancer: a review and evidence-based algorithm

Review

Author: Cremolini, Chiara ; Ciracì, Paolo ; Studiale, Vittorio ; Antoniotti, Carlotta ; Taravella, Ada

Over the past few years, several novel systemic treatments have emerged for patients with treatment-refractory metastatic colorectal cancer, thus making selection of the most effective later-line therapy a challenge for medical oncologists. Over the past decade, regorafenib and trifluridine-tipiracil were the only available drugs and often provided limited clinical benefit compared to best supportive care. Results from subsequent practice-changing trials opened several novel therapeutic avenues, both for unselected patients (such as trifluridine-tipiracil plus bevacizumab or fruquintinib) and for subgroups defined by the presence of actionable alterations in their tumours (such as HER2-targeted therapies or KRAS^G12C inhibitors) or with no acquired mechanisms of resistance to the previously received targeted agents in circulating tumour DNA (such as retreatment with anti-EGFR antibodies). In this Review, we provide a comprehensive overview of advances in the field over the past few years and offer a practical perspective on translation of the most relevant results into the daily management of patients with metastatic colorectal cancer using an evidence-based algorithm. Finally, we discuss some of the most appealing ongoing areas of research and highlight approaches with the potential to further expand the therapeutic armamentarium.

31 Dec 2024·JOURNAL OF MEDICAL ECONOMICS

Budget impact analysis of introducing fruquintinib for metastatic colorectal cancer previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy and biologics in the United States from the payer perspective

Article

Author: Asfaw, Alemseged Ayele ; Hernandez, Luis ; Li, Shujun ; Zou, Denise ; Khanduri, Pratishtha ; Paly, Victoria Federico

AIMS:

Fruquintinib is a selective small molecule tyrosine kinase inhibitor of vascular endothelial growth factor receptor (VEGFR)-1, -2, and -3 recently approved in the United States (US) for the treatment of adult patients with metastatic colorectal cancer (CRC) who have previously been treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type and medically appropriate, anti-epidermal growth factor receptor therapy. This study aimed to estimate the 5-year budget impact of fruquintinib from a US payer perspective (commercial and Medicare).

MATERIALS AND METHODS:

A budget impact model was developed to compare two scenarios: a reference scenario in which patients received regorafenib, trifluridine/tipiracil, or trifluridine/tipiracil with bevacizumab and an alternative scenario in which patients received reference scenario treatments or fruquintinib. Market shares were evenly divided across available options. A 5-year time horizon and a hypothetical health plan of 1 million members was assumed. The model included epidemiological inputs to estimate the eligible population; clinical inputs for treatment duration, progression-free survival, overall survival, and adverse event (AE) frequency; and cost inputs for treatment, AEs, disease management, subsequent therapy, and terminal care costs. Budget impact was reported as total, per member per year (PMPY), and per member per month (PMPM).

RESULTS:

The model estimated an eligible population of 194 patients (39 per year) over 5 years. In the base case, the estimated 5-year budget impact of fruquintinib was $4,077,073 ($0.82 PMPY and 0.07 PMPM) for a commercial health plan. During the first year, the estimated budget impact was $627,570 ($0.63 PMPY and 0.05 PMPM). Results were robust across sensitivity analyses. PMPM costs from the Medicare perspective were greater than the base-case (commercial) ($0.17 vs. $0.07) due to higher incidence of CRC in that population.

CONCLUSIONS:

Fruquintinib is associated with a low budget impact for payers based on proposed thresholds in the US.

103

News (Medical) associated with Regorafenib

07 Nov 2024

·mendus.com

Mendus to present preclinical data supporting the combination potential of ilixadencel with the immune checkpoint inhibitor avelumab at SITC 2024

Press Release Stockholm, Sweden, November 7, 2024 Mendus AB ("Mendus" publ; IMMU. ST), a biopharmaceutical company focused on immunotherapies targeting tumor recurrence, announces that it will present preclinical data demonstrating immune priming synergies between the intratumoral primer ilixadencel and avelumab, an immune checkpoint inhibitor approved for multiple solid tumor indications, at the SITC 2024 conference. Mendus will present preclinical data demonstrating that ilixadencel and avelumab act synergistically in intratumoral priming of the immune system during the 39th annual meeting of the Society for Immunotherapy of Cancer (SITC), held November 6-10, 2024 (SITC 2024). Addition of avelumab leads to stronger natural killer cell activation by ilixadencel, enhances production of proinflammatory cytokines and chemokines in ilixadencel-stimulated peripheral blood mononuclear cells and leads to improved maturation of bystander dendritic cells. The presented data indicate that ilixadencel and avelumab act synergistically to promote a pro-inflammatory tumor microenvironment required for effective anti-tumor immune responses. The data will be presented by Mendus’ Director Research Dr Satwinder Kaur Singh on Friday, November 8, at 12.15 CST. Abstracts are available online on the SITC website Titles and Publications – SITC 2024 . Please find below the details of the abstract to be presented by Mendus: Abstract Number 761; Title: The intratumoral immune primer ilixadencel acts synergistically with the anti-PD-L1 antibody avelumab; Date: Friday, November 8, 2024; Presentation Time: 12.15-1.45 pm CST; Location poster session: Exhibit Halls A B, George R. Brown Convention Center, Houston, Texas, USA In July, Mendus announced a collaboration with Institut Bergonié, a leading cancer research centre based in Bordeaux, France, to study ilixadencel in soft tissue sarcomas as part of the REGOMUNE trial, a multicenter, prospective open-labeled phase 1/2 trial combining regorafenib, a tyrosine kinase inhibitor (TKI), and avelumab, an immune checkpoint inhibitor, in solid tumors. Mendus will support the REGOMUNE trial by supplying ilixadencel as study drug to treat up to 43 soft tissue sarcoma (STS) patients. Ilixadencel is an off-the-shelf intratumoral immune primer consisting of pro-inflammatory monocyte-derived dendritic cells (DCs) from allogeneic healthy donor material. Upon administration, ilixadencel promotes a local pro-inflammatory environment, activation of NK cells and cross-presentation of tumor antigens by recruited and activated endogenous DCs in the tumor microenvironment. In clinical trials, ilixadencel has demonstrated promising signs of efficacy in hard-to-treat solid tumors and was shown to be safe in combination with tyrosine kinase inhibitors and immune checkpoint inhibitors. The data presented at SITC support clinical evaluation of ilixadencel in combination with avelumab, the immune checkpoint inhibitor used in the REGOMUNE trial. For more information, please contact: Erik MantingChief Executive OfficerE-mail: ir@mendus.com About Mendus AB (publ) Mendus is dedicated to changing the course of cancer treatment by addressing tumor recurrence and improving long-term survival for cancer patients, while preserving health and quality of life. We leverage our understanding of dendritic cell biology to develop an advanced clinical pipeline of immunotherapies which combine clinical efficacy with a benign safety profile. Based in Sweden and The Netherlands, Mendus is publicly traded on the Nasdaq Stockholm under the ticker IMMU.ST. https://www.mendus.com/ Attachments241107 Mendus SITC 2024 ENG

ImmunotherapyClinical StudyClinical Result

06 Nov 2024

·www.businesswire.com

Arcus Biosciences Reports Third-Quarter 2024 Financial Results and Provides a Pipeline Update

HAYWARD, Calif.--( BUSINESS WIRE )--Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for patients with cancer, today reported financial results for the third quarter ended September 30, 2024, and provided a pipeline update on its clinical-stage investigational molecules — targeting TIGIT, HIF-2a, CD73, the A2a/A2b receptors, CD-39, AXL and PD-1 — across multiple common cancers. “ Through the course of this year, we have presented multiple compelling datasets at medical conferences that we believe have de-risked several programs and support potential best-in-class profiles for our molecules, including our HIF-2a inhibitor casdatifan in ccRCC and our Fc-silent anti-TIGIT antibody domvanalimab in lung and upper gastrointestinal cancers,” said Terry Rosen, Ph.D., chief executive officer of Arcus. “ Meanwhile, in addition to our rapidly approaching first Phase 3 readout for domvanalimab in gastric cancer, we are aggressively pursuing our development plan for casdatifan, including in the IO-naive ccRCC setting in collaboration with AstraZeneca, and in the post-IO setting with the initiation of our Phase 3 PEAK-1 study in the first half of next year.” Corporate Updates: In October 2024, Arcus announced a clinical collaboration with AstraZeneca to evaluate casdatifan in combination with volrustomig, AstraZeneca’s investigational PD-1/CTLA-4 bispecific antibody, in IO-naive patients with ccRCC. AstraZeneca will operationalize the study. This is the second clinical collaboration between Arcus and AstraZeneca. Gilead retains the right to opt in to the development and commercialization for casdatifan after delivery of a qualifying data package. Pipeline Highlights: Casdatifan (HIF-2a inhibitor) Casdatifan Updates: First clinical data from the casdatifan 100mg and 50mg expansion cohorts of ARC-20, a Phase 1/1b study in metastatic ccRCC, were presented in an oral plenary session at the 2024 EORTC-NCI-AACR Symposium in October. Observations from the 100mg daily expansion cohort included: An objective response rate (ORR) of 34% (2 responses are pending confirmation; 25% confirmed ORR), a low rate of primary progression of 19% and a high disease control rate of 81%. The median progression-free survival (PFS) had not been reached at the time of the data cutoff. Together, these data support the potential for casdatifan to be a best-in-class HIF-2a inhibitor for the treatment of ccRCC. In the third quarter, Arcus had a successful Type B meeting with the U.S. Federal Drug Administration (FDA) to discuss its first Phase 3 study for casdatifan, PEAK-1, which will evaluate casdatifan in combination with cabozantinib versus cabozantinib in post-IO patients with ccRCC. Arcus is moving rapidly toward the initiation of PEAK-1 in the first half of 2025. Upcoming Casdatifan Milestones: Multiple expansion cohorts of ARC-20 evaluating casdatifan in ccRCC as a monotherapy and in combination with cabozantinib in ccRCC are underway with additional data presentations expected in the next 12 months. 100mg (50mg twice daily (BID), capsules) and 50mg expansion cohorts: Updated data, including median PFS, are expected to be presented in the first quarter of 2025. 150mg and 100mg (once daily (QD), tablets) expansion cohorts: Initial data are expected to be presented in 2025. 100mg of casdatifan plus cabozantinib: Safety data are expected to be presented in 2025. Domvanalimab (Fc-silent anti-TIGIT antibody) plus Zimberelimab (anti-PD-1 antibody) Domvanalimab-Zimberelimab Updates: Data from Part 1 of ARC-10, a randomized study evaluating domvanalimab plus zimberelimab in PD-L-1 high NSCLC are being presented at the SITC Annual Meeting in November. Domvanalimab plus zimberelimab was associated with greater PFS, overall survival, and objective response rate compared with zimberelimab or chemotherapy. A 36% reduction in risk of death (hazard ratio [HR]=0.64) was observed for domvanalimab plus zimberelimab compared to that of zimberelimab alone. Zimberelimab reached a median overall survival of 2 years, and the median overall survival for domvanalimab plus zimberelimab was not reached. Treatment-related adverse events leading to treatment discontinuation were low (10.5%) for the combination of domvanalimab and zimberelimab. Data from an investigator-sponsored trial evaluating domvanalimab plus zimberelimab in anti-PD-(L)1 refractory hepatocellular carcinoma will be presented in an oral session at the SITC Annual Meeting. Upcoming Domvanalimab-Zimberelimab Milestones: Overall survival data from the Phase 2 EDGE-Gastric study, evaluating domvanalimab plus zimberelimab and chemotherapy in upper gastrointestinal (GI) adenocarcinomas, are expected to be presented in 2025. CD73-Adenosine Axis: Quemliclustat (small-molecule CD73 inhibitor) and Etrumadenant (A2a/A2b receptor antagonist) Quemliclustat Arcus has initiated PRISM-1, a Phase 3 trial of quemliclustat combined with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel in pancreatic cancer. Etrumadenant Biomarker data from cohort B of ARC-9, a randomized Phase 1b/2 study evaluating etrumadenant plus zimberelimab, FOLFOX chemotherapy and bevacizumab (EZFB) versus regorafenib in third-line metastatic colorectal cancer (mCRC), are being presented at SITC in November. Early Clinical Programs Evaluation of AB801, a potent and highly selective small-molecule AXL inhibitor, in the dose-escalation phase of a Phase 1/1b study in patients is ongoing. Arcus anticipates advancing this molecule into expansion cohorts in NSCLC in early 2025. Financial Results for Third Quarter 2024: Cash, Cash Equivalents and Marketable Securities were $1.1 billion as of September 30, 2024, compared to $866 million as of December 31, 2023. The increase during the period is primarily due to the receipt of $320 million in cash from Gilead for their January 2024 equity investment, the receipt of the $100 million option continuation payment from Gilead in July 2024 and proceeds from our $50 million term loan, partially offset by the use of cash in research and development activities. We believe our cash, cash equivalents and marketable securities on-hand will be sufficient to fund operations into mid-2027. Cash, cash equivalents and marketable securities are expected to be between $950 million and $985 million at the end of 2024. Revenues were $48 million for the third quarter 2024, compared to $32 million for the same period in 2023. In the third quarter 2024, Arcus recognized $41 million in license and development services revenue related to the advancement of programs and Taiho's exercise of its option for the license of quemliclustat for the Taiho Territory of $15 million, as well as $7 million in other collaboration revenue primarily related to Gilead’s ongoing rights to access Arcus’s research and development pipeline in accordance with the Gilead collaboration agreement. Research and Development (R&D) Expenses were $123 million for the third quarter 2024, compared to $82 million for the same period in 2023. The net increase of $41 million was primarily driven by higher clinical trial and headcount-related costs associated with our late-stage development program activities. Non-cash stock-based compensation expense was $9 million for the third quarter 2024, compared to $8 million for the same period in 2023. For the third quarter 2024 and 2023, Arcus recognized gross reimbursements of $37 million and $33 million, respectively, for shared expenses from its collaborations, primarily the Gilead collaboration. R&D expense by quarter may fluctuate due to the timing of clinical manufacturing and standard-of-care therapeutic purchases with a corresponding impact on reimbursements. General and Administrative (G&A) Expenses were flat for the third quarter 2024, compared to the same period in 2023. Non-cash stock-based compensation expense was $10 million for each of the third quarter 2024 and 2023. Net Loss was $92 million for the third quarter 2024, compared to $71 million for the same period in 2023. Conference Call Information: Arcus will host a conference call and webcast today, November 6, at 2:00 PM PT/5:00 PM ET to discuss its third-quarter 2024 financial results and pipeline updates. To access the call, please dial +1 (404) 975-4839 (local) or +1 (833) 470-1428 (toll-free), using Access Code: 940081. Participants may also register for the call online using the following link: https://www.netroadshow.com/events/login?show=4818aee3&confId=72838 . To access the live webcast and accompanying slide presentation, please visit the “Investors & Media” section of the Arcus Biosciences website at www.arcusbio.com . A replay of the webcast will be available following the live event. Arcus Ongoing and Announced Clinical Studies: Trial Name Arms Setting Status NCT No. Lung Cancer STAR-121 dom + zim + chemo vs. pembro + chemo 1L NSCLC (PD-L1 all-comers) Ongoing Registrational Phase 3 NCT05502237 PACIFIC-8 dom + durva vs. durva Unresectable Stage 3 NSCLC Ongoing Registrational Phase 3 NCT05211895 ARC-7 zim vs. dom + zim vs. etruma + dom + zim 1L NSCLC (PD-L1 ≥ 50%) Ongoing Randomized Phase 2 NCT04262856 EDGE-Lung dom +/- zim +/- quemli +/- chemo 1L/2L NSCLC (lung cancer platform study) Ongoing Randomized Phase 2 NCT05676931 VELOCITY-Lung dom +/- zim +/- etruma +/- sacituzumab govitecan-hziy or other combos 1L/2L NSCLC (lung cancer platform study) Ongoing Randomized Phase 2 NCT05633667 Upper Gastrointestinal Cancers STAR-221 dom + zim + chemo vs. nivo + chemo 1L Gastric, GEJ and EAC Ongoing Registrational Phase 3 NCT05568095 EDGE-Gastric (ARC-21) dom +/- zim +/- quemli +/- chemo 1L/2L Upper GI Malignancies Ongoing Randomized Phase 2 NCT05329766 Colorectal Cancer ARC-9 etruma + zim + mFOLFOX vs. SOC 2L/3L/3L+ CRC Ongoing Randomized Phase 2 NCT04660812 Pancreatic Cancer PRISM-1 quemli + gem/nab-pac vs. gem/nab-pac 1L PDAC Ongoing Phase 3 NCT06608927 ARC-8 quemli + zim + gem/nab-pac vs. quemli + gem/nab-pac 1L, 2L PDAC Ongoing Randomized Phase 1/1b NCT04104672 Kidney Cancer PEAK-1 cas + cabo vs. cabo Post-IO ccRCC Planned Phase 3 TBD ARC-20 cas, cas + cabo Cancer Patients/ccRCC Ongoing Phase 1/1b NCT05536141 Other ARC-25 AB598 Advanced Malignancies Ongoing NCT05891171 ARC-27 AB801 Advanced Malignancies Ongoing NCT06120075 cabo: cabozantinib; cas: casdatifan; dom: domvanalimab; durva: durvalumab; etruma: etrumadenant; gem/nab-pac: gemcitabine/nab-paclitaxel; nivo: nivolumab; pembro: pembrolizumab; quemli: quemliclustat; SOC: standard of care; zim: zimberelimab; ccRCC: clear cell renal cell carcinoma; CRC: colorectal cancer; EAC: esophageal adenocarcinoma; GEJ: gastroesophageal junction; GI: gastrointestinal; NSCLC: non-small cell lung cancer; PDAC: pancreatic ductal adenocarcinoma About the Gilead Collaboration In May 2020, Arcus established a 10-year collaboration with Gilead to strategically advance our portfolio. Under this collaboration, Gilead obtained time-limited exclusive option rights to all of our clinical programs arising during the collaboration term. Arcus and Gilead are co-developing four investigational products, including zimberelimab (Arcus’s anti-PD-1 molecule), domvanalimab (Arcus’s anti-TIGIT antibody), etrumadenant (Arcus’s adenosine receptor antagonist) and quemliclustat (Arcus’s CD73 inhibitor). The collaboration was expanded in November 2021 and May 2023 to include research directed to two targets for oncology and two targets for inflammatory diseases. About Arcus Biosciences Arcus Biosciences is a clinical-stage, global biopharmaceutical company developing differentiated molecules and combination medicines for people with cancer. In partnership with industry collaborators, patients and physicians around the world, Arcus is expediting the development of first- or best-in-class medicines against well-characterized biological targets and pathways and studying novel, biology-driven combinations that have the potential to help people with cancer live longer. Founded in 2015, the company has expedited the development of multiple investigational medicines into clinical studies, including new combination approaches that target TIGIT, PD-1, HIF-2a, CD73, dual A2a/A2b receptor, CD39 and AXL. For more information about Arcus Biosciences’ clinical and preclinical programs, please visit www.arcusbio.com . Domvanalimab, etrumadenant, quemliclustat and zimberelimab are investigational molecules, and neither Gilead nor Arcus has received approval from any regulatory authority for any use globally, and their safety and efficacy have not been established. Casdatifan, AB598 and AB801 are also investigational molecules, and Arcus has not received approval from any regulatory authority for any use globally, and their safety and efficacy have not been established. Forward-Looking Statements This press release contains forward-looking statements. All statements regarding events or results to occur in the future contained herein are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, the statements in Dr. Rosen’s quote and statements regarding: Arcus’s expectation that its cash, cash equivalents and marketable securities on-hand are sufficient to fund operations into mid-2027; plans to disclose or present study analyses or data, including any analyses or data from ARC-20 or EDGE-Gastric; whether data and results from studies validate our pipeline or support further development of a program; the potency, efficacy or safety of Arcus’s investigational products, including their potential for a best-in-class profile; and the initiation, design of and associated timing for future studies, including statements about PEAK-1 and PRISM-1. All forward-looking statements involve known and unknown risks and uncertainties and other important factors that may cause Arcus’s actual results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: risks associated with preliminary and interim data not being guarantees that future data will be similar; the unexpected emergence of adverse events or other undesirable side effects in Arcus’s investigational products; difficulties or delays in initiating or conducting clinical trials due to difficulties or delays in the regulatory process, enrolling subjects or manufacturing or supplying product for such clinical trials; unfavorable global economic, political and trade conditions; Arcus’s dependence on the collaboration with third parties such as Gilead and Taiho for the successful development and commercialization of its optioned molecules; difficulties associated with the management of the collaboration activities or expanded clinical programs; changes in the competitive landscape for Arcus’s programs; and the inherent uncertainty associated with pharmaceutical product development and clinical trials. Risks and uncertainties facing Arcus are described more fully in the “Risk Factors” section of Arcus’s most recent periodic report filed with the U.S. Securities and Exchange Commission. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this press release. Arcus disclaims any obligation or undertaking to update, supplement or revise any forward-looking statements contained in this press release except to the extent required by law. The Arcus name and logo are trademarks of Arcus Biosciences, Inc. All other trademarks belong to their respective owners. ARCUS BIOSCIENCES, INC. Consolidated Statements of Operations (unaudited) (In millions, except per share amounts) Three Months Ended September 30, Nine Months Ended September 30, 2024 2023 2024 2023 Revenues: License and development services revenue $ 41 $ 22 $ 204 $ 58 Other collaboration revenue 7 10 28 28 Total revenues 48 32 232 86 Operating expenses: Research and development 123 82 347 247 General and administrative 30 30 92 88 Impairment of long-lived assets — — 20 — Total operating expenses 153 112 459 335 Loss from operations (105 ) (80 ) (227 ) (249 ) Non-operating income (expense): Interest and other income, net 14 12 40 30 Interest expense (1 ) (1 ) (2 ) (2 ) Total non-operating income, net 13 11 38 28 Loss before income taxes (92 ) (69 ) (189 ) (221 ) Income tax expense — (2 ) — (5 ) Net loss $ (92 ) $ (71 ) $ (189 ) $ (226 ) Net loss per share: Basic and diluted $ (1.00 ) $ (0.94 ) $ (2.11 ) $ (3.07 ) Shares used to compute net loss per share: Basic and diluted 91.4 74.6 89.6 73.6 Selected Consolidated Balance Sheet Data (unaudited) (In millions) September 30, 2024 December 31, 2023 (1) Cash, cash equivalents and marketable securities $ 1,091 $ 866 Total assets 1,252 1,095 Total liabilities 687 633 Total stockholders’ equity 565 462 (1) Derived from the audited financial statements for the quarter ended December 31, 2023, included in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 21, 2024.

Phase 3Phase 2License out/inFinancial StatementClinical Result

08 Oct 2024

·mendus.com

Mendus announces industry conference participation in October-November

Press Release Stockholm, Sweden, October 8, 2024 Mendus AB ("Mendus" publ; IMMU. ST), a biopharmaceutical company focused on immunotherapies targeting tumor recurrence, announces that it will participate in the following upcoming industry and investor conferences in the period October-November 2024: LSX Nordic conferenceCopenhagen, Denmark, October 8-9 Mendus CEO Erik Manting will hold a company Showcase presentation on October 9, 11.00 CET. Dr Manting will also participate in a panel discussion titled “ATMPs and a New Paradigm Shift for Patients: Initiatives and Ambitions in the Nordics” on October 9, 14.50 CET. The panel focuses on how new advanced therapies (ATMPs) offer life-changing potential for many patients who battle with serious rare diseases and cancers. Mendus has entered into an ATMP manufacturing alliance with NorthX Biologics, to enable large-scale manufacturing of its lead product, vididencel. Biotech, Healthtech & Medtech Investment | LSX Nordic Congress (informaconnect.com) CONDOR SymposiumBordeaux, France, October 10-11 Mendus CMO Jeroen Rovers will participate in the annual symposium of the Precision Medicine and Immunotherapy of Sarcoma (CONDOR) program, held at Institut Bergonié, Bordeaux, France. Together with Institut Bergonié, Mendus is preparing to study the intratumoral primer ilixadencel in combination with regorafenib and avelumab as a novel treatment for soft tissue sarcoma as part of the REGOMUNE trial. See our July 23 press release of for more background Mendus announces collaboration with Institut Bergonié to study ilixadencel in soft tissue sarcomas – Mendus. For more information on the CONDOR program, please visit HOME – CONDOR PROGRAM – Therapeutic Management of STS EVENTS & MEETINGS – CONDOR PROGRAM – Management of STS BioEuropeStockholm, Sweden, November 4-6 Mendus CEO Erik Manting will participate for investor and industry meetings. BIO-Europe | Meet dealmakers from biotech, pharma and finance (informaconnect.com) SITC 2024Houston, Texas, USA, November 6-10 On November 8, Mendus will present preclinical data supporting the combination of its intratumoral primer ilixadencel with the immune checkpoint inhibitor avelumab at the 39th annual meeting of the Society for Immunotherapy of Cancer (SITC). SITC abstract titles are available via Titles and Publications – SITC 2024 (sitcancer.org), abstract number is 761. Together with Institut Bergonié, Mendus is preparing study ilixadencel in combination with avelumab and the tyrosine kinase inhibitor regorafenib in soft tissue sarcoma, as part of the REGOMUNE trial. Home – SITC 2024 (sitcancer.org) ALLG Scientific MeetingMelbourne, Australia, November 12-15 Mendus CMO Jeroen Rovers will participate in the biannual investigator meeting organized by the Australasian Leukaemia and Lymphoma Group (ALLG). Together with ALLG, Mendus will study its lead program vididencel as a novel maintenance therapy for acute myeloid leukemia (AML) in combination with oral azacitidine (aza) in the AMLM22-CADENCE trial. Mendus and ALLG are in the process of opening up to 9 clinical centres in 2024Q4 to support the first stage of the trial, which comprises 40 patients to study the safety of the vididencel + oral aza combination. This stage will be followed by another 100 patients to study efficacy of the combination versus oral aza, currently the only approved AML maintenance drug. November 2024 Scientific Meeting | The Australasian Leukaemia and Lymphoma Group (allg.org.au) Jefferies Healthcare ConferenceLondon, UK, November 19-21 Mendus CEO Erik Manting will participate for investor and industry meetings. Jefferies Global Healthcare Conference 2024 | Jefferies.com For more information, please contact: Erik MantingChief Executive OfficerE-mail: ir@mendus.com About Mendus AB (publ) Mendus is dedicated to changing the course of cancer treatment by addressing tumor recurrence and improving long-term survival for cancer patients, while preserving health and quality of life. We leverage our understanding of dendritic cell biology to develop an advanced clinical pipeline of immunotherapies which combine clinical efficacy with a benign safety profile. Based in Sweden and The Netherlands, Mendus is publicly traded on the Nasdaq Stockholm under the ticker IMMU.ST. https://www.mendus.com/ Attachments241008 Mendus Conferences OctNov ENG

ImmunotherapyClinical Study

100 Deals associated with Regorafenib

External Link

KEGG	Wiki	ATC	Drug Bank
-	Regorafenib	L01XE21	DB08896

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Liver Cancer	CN	Bayer AG	05 Dec 2017
Hepatocellular Carcinoma	EU	Bayer Pharma AG	26 Aug 2013
Hepatocellular Carcinoma	IS	Bayer Pharma AG	26 Aug 2013
Hepatocellular Carcinoma	LI	Bayer Pharma AG	26 Aug 2013
Hepatocellular Carcinoma	NO	Bayer Pharma AG	26 Aug 2013
Colorectal Cancer	JP	Bayer Yakuhin Ltd.	25 Mar 2013
Gastrointestinal Stromal Tumors	US	Bayer HealthCare Pharmaceuticals, Inc.	25 Feb 2013
Metastatic Colorectal Carcinoma	US	Bayer HealthCare Pharmaceuticals, Inc.	27 Sep 2012

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Colorectal Liver Metastases	Phase 3	CN	Sun Yat-Sen University	10 Jun 2023
Glioblastoma	Phase 3	DE	Bayer AG	06 Sep 2022
Esophageal Carcinoma	Phase 3	US	Bayer AG	01 Jun 2021
Esophageal Carcinoma	Phase 3	US	Bristol Myers Squibb Co.	01 Jun 2021
Esophageal Carcinoma	Phase 3	JP	Bristol Myers Squibb Co.	01 Jun 2021
Esophageal Carcinoma	Phase 3	JP	Bayer AG	01 Jun 2021
Esophageal Carcinoma	Phase 3	AU	Bayer AG	01 Jun 2021
Esophageal Carcinoma	Phase 3	AU	Bristol Myers Squibb Co.	01 Jun 2021
Esophageal Carcinoma	Phase 3	AT	Bristol Myers Squibb Co.	01 Jun 2021
Esophageal Carcinoma	Phase 3	AT	Bayer AG	01 Jun 2021

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03563157 (CTgov)	Phase 1/2	Metastatic Colorectal Carcinoma	2	SBRT+Aldoxorubicin Hydrochloride+GI-6301+GI-4000+ETBX-061+Cetuximab+ETBX-051+Leucovorin+ETBX-011+5-Fluorouracil+ALT-803+ETBX-021+nab-paclitaxel+CYCLOPHOSPHAMIDE+Avelumab+haNK+GI-6207+Regorafenib+Oxaliplatin+Capecitabine (NANT Colorectal Cancer (CRC) Vaccine)	dlomvrvsxr(mfuksrnjoe) = czxzhpivsj pjnhqimwma (sjlbtosrgs, swceyudvlc - byqmlrbhbv) View more	-	11 Dec 2024
				Regorafenib (Regorafenib)	azffuwsgqn(pbmgtbzuew) = mxkubwxriq tazdyluqzf (tzrpfkadbs, eifyjcsmjs - kedufeyomo) View more
JPRN-UMIN000040586 (OSERO study, ESMO_ASIA2024)	Not Applicable	Metastatic Colorectal Carcinoma Third line RAS status	386	Regorafenib-first (Group A)	vlrtqcajql(ctezvpdahj) = racvikimqn mqugrcrwcy (kvuudktyyc ) View more	Positive	07 Dec 2024
ESMO_ASIA2024	Not Applicable	Metastatic Colorectal Carcinoma Third line prognostic nutritional index (PNI)	87	regorafenib (High PNI level)	goglgzxmib(yiboamktgl) = oslrxhdqdh igirxmkwxx (vpyaunmmkv )	Positive	07 Dec 2024
				regorafenib (Low PNI level)	goglgzxmib(yiboamktgl) = amrfrjvmfq igirxmkwxx (vpyaunmmkv )
NCT04117945 (CTgov)	Phase 2	Adenocarcinoma of large intestine \| Colorectal Cancer, Hereditary Nonpolyposis, Type 1 \| Metastatic Colorectal Carcinoma	22	Regorafenib (Arm A (Regorafenib))	nkehtvqexe(eaplqrrrwl) = fkvdwxdhbs eqgtfictxu (ierloyncbi, zzzecjlcyy - xmlpwcfzey) View more	-	27 Sep 2024
				Cetuximab+Irinotecan+Panitumumab (Arm B (Cetuximab, Panitumumab, Irinotecan))	nkehtvqexe(eaplqrrrwl) = tkxnhpxcfq eqgtfictxu (ierloyncbi, ihcwwwogcp - tfkskniqrp) View more
ESMO2024 Manual	Not Applicable	Advanced Hepatocellular Carcinoma Second line	707	Regorafenib	rcmpipxcbz(iooqaquipi) = dydoztopym ebifqdsjmb (seztwuahom ) View more	Positive	16 Sep 2024
NCT03793361 (EREMISS, ESMO2024) Manual	Phase 2	Soft Tissue Sarcoma Maintenance	126	Regorafenib (REGO) 120 mg/d	dvdkvonfjr(xwigduxnao) = ozljwrbqtd alypidxbrj (rlpbjhhrls ) Met View more	Positive	16 Sep 2024
				Placebo (PBO)	dvdkvonfjr(xwigduxnao) = vyplkvtaot alypidxbrj (rlpbjhhrls ) Met View more
REGOMA-OSS (ESMO2024) Manual	Not Applicable	Recurrent Glioblastoma Second line	36	Regorafenib	ypijhordfm(ektxjtmzjf) = omovlagtdm chzngesfxj (msfqztevls ) View more	Negative	16 Sep 2024
ESMO2024 Manual	Not Applicable	Metastatic Colorectal Carcinoma	471	TAS-102+bevacizumab	nvbjcsorri(hpzocsxtub) = ouqplbyadf txxbtfvcoo (zfzzstbyjc ) View more	Positive	16 Sep 2024
				TAS-102	nvbjcsorri(hpzocsxtub) = fwvecnnqqa txxbtfvcoo (zfzzstbyjc ) View more
ReTrITA (ESMO2024)	Not Applicable	Refractory Colorectal Carcinoma	1,156	Regorafenib/Trifluridine-Tipiracil sequence	pnbjhptdtc(kmlwrwciaq) = adwvgilhlg xdvtwsdyce (aooxoxdgvr )	Positive	16 Sep 2024
				Trifluridine-Tipiracil/Regorafenib sequence	pnbjhptdtc(kmlwrwciaq) = mpactffaam xdvtwsdyce (aooxoxdgvr ) View more
ESMO2024 Manual	Phase 2	Melanoma KIT Mutation	8	Regorafenib	kvuxbdxfuy(zxqfegqudx) = NR [range 6-59w] bdjacgthek (jhljjpisua ) View more	Positive	14 Sep 2024

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

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