A Phase II Study of TPEx (Taxotere-platinum-cetuximab) Followed by a Maintenance With Avelumab and Cetuximab in First Line Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (TATIANA)

The main objective of this research is to increase the life expectancy of patients with advanced mouth and throat cancer, by adding avelumab to the standard TPEx treatment.
All participants in this research will receive the same treatment which will take place in two phases:
* 1st phase chemotherapy + immunotherapy: standard reference treatment (Docetaxel + cisplatin or carboplatin + cetuximab)
* 2nd phase immunotherapy: cetuximab combined with avelumab which is the treatment under study.

Start Date02 Dec 2024

Sponsor / Collaborator-

NCT06585488 / Not yet recruitingPhase 1

A Phase 1a/1b Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-53038, a Pan-KRAS Inhibitor, As Monotherapy or in Combinations in Patients with Advanced or Metastatic Solid Tumors with KRAS Mutations or Amplifications

This is a first-in-human (FIH), open-label, multicenter, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BGB-53038 as monotherapy in participants with advanced or metastatic solid tumors harboring KRAS mutations or amplification, as well as when used in combination with tislelizumab (also known as BGB-A317) in participants with nonsquamous non-small cell lung cancer (NSCLC) and used in combination with cetuximab in participants with colorectal cancer (CRC). The study consists of 2 phases: Phase 1a Dose Escalation and Safety Expansion and Phase 1b Dose Expansion.

Start Date01 Dec 2024

Sponsor / Collaborator

BeiGene Ltd.

NCT06448026 / Not yet recruitingPhase 2

Cemiplimab and Cetuximab Prior Salvage Surgery in Patients With Recurrent Oral Cavity Squamous Cell Carcinoma (OCSCC).

To learn if giving cemiplimab and cetuximab before salvage surgery can help to control recurrent oral cavity squamous cell carcinoma.

Start Date29 Nov 2024

Sponsor / Collaborator

Regeneron Pharmaceuticals, Inc.

100 Clinical Results associated with Cetuximab

100 Translational Medicine associated with Cetuximab

100 Patents (Medical) associated with Cetuximab

7,434

Literatures (Medical) associated with Cetuximab

31 Dec 2024·mAbs

Antibody-epitope conjugates deliver immunogenic T-cell epitopes more efficiently when close to cell surfaces

Article

Author: Heemskerk, M H M ; Guelen, L ; Schuurman, J ; van der Wulp, W ; Ressing, M E ; Hoeben, R C ; Luu, W ; van Kasteren, S I ; Bleijlevens, B

Antibody-mediated delivery of immunogenic viral CD8⁺ T-cell epitopes to redirect virus-specific T cells toward cancer cells is a promising new therapeutic avenue to increase the immunogenicity of tumors. Multiple strategies for viral epitope delivery have been shown to be effective. So far, most of these have relied on a free C-terminus of the immunogenic epitope for extracellular delivery. Here, we demonstrate that antibody-epitope conjugates (AECs) with genetically fused epitopes to the N-terminus of the antibody can also sensitize tumors for attack by virus-specific CD8⁺ T cells. AECs carrying epitopes genetically fused at the N-terminus of the light chains of cetuximab and trastuzumab demonstrate an even more efficient delivery of the T-cell epitopes compared to AECs with the epitope fused to the C-terminus of the heavy chain. We demonstrate that this increased efficiency is not caused by the shift in location of the cleavage site from the N- to the C-terminus, but by its increased proximity to the cell surface. We hypothesize that this facilitates more efficient epitope delivery. These findings not only provide additional insights into the mechanism of action of AECs but also broaden the possibilities for genetically fused AECs as an avenue for the redirection of multiple virus-specific T cells toward tumors.

31 Dec 2024·CANCER BIOLOGY & THERAPY

MiR-135b-5p promotes cetuximab resistance in colorectal cancer by regulating FOXN3

Article

Author: Li, Xiaoqing ; Yao, Yuhui ; Peng, Chun ; Zhu, Chuandong ; Nie, Yu ; Fan, Lingyao

Despite advances in targeted therapies, primary and acquired resistance make the treatment of colorectal cancer (CRC) a pressing issue to be resolved. According to reports, the development of CRC is linked to miRNA dysregulation. Multiple studies have demonstrated that miR-135b-5p has an aberrant expression level between CRC tissues and adjacent tissues. However, it is unclear whether there is a correlation between miR-135b-5p and cetuximab (CTx) resistance in CRC. Use the GEO database to measure miR-135b-5p expression in CRC. Additionally, RT-qPCR was applied to ascertain the production level of miR-135b-5p in three human CRC cells and NCM460 cells. The capacity of cells to migrate and invade was examined utilizing the wound-healing and transwell assays, while the CCK-8 assay served for evaluating cell viability, as well as colony formation assays for proliferation. The expected target protein of miR-135b-5p in CRC cell cetuximab resistance has been investigated using western blot. Suppression of miR-135b-5p could increase the CTx sensitivity of CTx-resistant CRC cells, as manifested by the attenuation of proliferation, migration, and invasion ability. Mechanistic studies revealed miR-135b-5p regulates the epithelial-to-mesenchymal transition (EMT) process and Wnt/β-catenin signaling pathway through downgulating FOXN3. In short, knockdowning miR-135b-5p could increase FOXN3 expression in CRC cells, promote the EMT process, and simultaneously activate the Wnt/β-catenin signaling pathway to elevate CTx resistance in CRC cells.

31 Dec 2024·mAbs

Impact of antibody architecture and paratope valency on effector functions of bispecific NKp30 x EGFR natural killer cell engagers

Article

Author: Toleikis, Lars ; Xiao, Yanping ; Pekar, Lukas ; Koep, Katharina ; Zielonka, Stefan ; Evers, Andreas ; Klausz, Katja ; Lipinski, Britta ; Rabinovich, Brian ; Boje, Ammelie Svea ; Gehlert, Carina Lynn ; Poetzsch, Sven ; Krah, Simon ; Krohn, Steffen ; Zaynagetdinov, Rinat ; Peipp, Matthias

Natural killer (NK) cells emerged as a promising effector population that can be harnessed for anti-tumor therapy. In this work, we constructed NK cell engagers (NKCEs) based on NKp30-targeting single domain antibodies (sdAbs) that redirect the cytotoxic potential of NK cells toward epidermal growth factor receptor (EGFR)-expressing tumor cells. We investigated the impact of crucial parameters such as sdAb location, binding valencies, the targeted epitope on NKp30, and the overall antibody architecture on the redirection capacity. Our study exploited two NKp30-specific sdAbs, one of which binds a similar epitope on NKp30 as its natural ligand B7-H6, while the other sdAb addresses a non-competing epitope. For EGFR-positive tumor targeting, humanized antigen-binding domains of therapeutic antibody cetuximab were used. We demonstrate that NKCEs bivalently targeting EGFR and bivalently engaging NKp30 are superior to monovalent NKCEs in promoting NK cell-mediated tumor cell lysis and that the architecture of the NKCE can substantially influence killing capacities depending on the NKp30-targeting sdAb utilized. While having a pronounced impact on NK cell killing efficacy, the capabilities of triggering antibody-dependent cellular phagocytosis or complement-dependent cytotoxicity were not significantly affected comparing the bivalent IgG-like NKCEs with cetuximab. However, the fusion of sdAbs can have a slight impact on the NK cell release of immunomodulatory cytokines, as well as on the pharmacokinetic profile of the NKCE due to unfavorable spatial orientation within the molecule architecture. Ultimately, our findings reveal novel insights for the engineering of potent NKCEs triggering the NKp30 axis.

397

News (Medical) associated with Cetuximab

12 Nov 2024

·www.globenewswire.com

NANOBIOTIX Provides Third Quarter 2024 Update and Progress on Nanotherapeutics Platforms

Transferred US sponsorship of global Phase 3 NANORAY-312 head and neck cancer study, a key step in the preparation for potential NBTXR3 regulatory submissionAdded expert industry leaders to Supervisory Board, further strengthening support for the Company’s long-term growth strategyNBTXR3 program update from pancreatic cancer study and lung cancer study with MD Anderson expected 4Q 2024 and 1H 2025, respectivelyUpdate on expansion of product portfolio to include disruptive nanotherapeutic platform Curadigm expected 4Q 2024€53.2 million in cash and cash equivalents as of September 30, 2024 with cash runway into 4Q 2025 PARIS and CAMBRIDGE, Mass., Nov. 12, 2024 (GLOBE NEWSWIRE) -- NANOBIOTIX (Euronext: NANO - NASDAQ: NBTX - the “Company”), a late-clinical stage biotechnology company pioneering nanoparticle-based approaches to expand treatment possibilities for patients with cancer and other major diseases, provided an update on operational progress and reported financial results for the third quarter of 2024. “Our strong momentum continues as we further execute across initiatives designed to advance our potentially first-in-class nanoparticle-based therapeutic platforms for millions of patients worldwide. In the NBTXR3 program, we began sponsorship transfer of our global, pivotal NANORAY-312, which is a key step for the potential regulatory submission of NBTXR3 and the promise of our lead candidate to help address the unmet needs of 12 million patients with solid tumors globally who receive radiotherapy each year,” said Laurent Levy, co-founder of Nanobiotix and chairman of the executive board. “We were also pleased to expand our Supervisory Board to include leading experts in both the scientific and financial communities to help foster sustainable long-term growth across our platforms. In the fourth quarter, we expect updated dose escalation data for NBTXR3 in pancreatic cancer from our MD Anderson collaboration, as well as an update to our Curadigm program, which is the next-wave of nanoparticle-based platforms from Nanobiotix.” Third Quarter 2024 Operational Highlights In an important step forward for the potential NBTXR3 regulatory pathway, Nanobiotix and Janssen Pharmaceutica NV, a Johnson & Johnson Company (“Janssen”), have initiated the planned sponsorship transfer of NANORAY-312, a global Phase 3 study evaluating radiotherapy-activated NBTXR3 for patients with head and neck cancer ineligible for cisplatin, from Nanobiotix to Janssen. Nanobiotix has transferred the sponsorship of the study in the United States to Janssen as planned. The process of transferring the remaining global regions is ongoing. Nanobiotix estimates this process will require several quarters to complete. Janssen is the global licensee for NBTXR3 co-development and commercialization. Accountability for the NANORAY-312 sponsorship will enable the licensee to submit NBTXR3 for global registration in the event of positive trial results. The Company strengthened its Supervisory Board with the nominations of Dr. Margaret A. Liu and Ms. Anat Naschitz as board observers, two key additions intended to further equip the Company for sustainable long-term growth. Dr. Liu brings a wealth of experience in US and international academia, pharmaceuticals, biotechnology and public policy, and Ms. Naschitz brings world-class expertise in raising and deploying capital to support disruptive innovation for the benefit of patients, healthcare professionals and investors. Upcoming Milestones Janssen License Agreement Locally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC): Nanobiotix continues to expect the interim analysis for NANORAY-312 after the required number of events and last patient recruited in 1H 2026 MD Anderson Collaboration Pancreatic Cancer: Updated Phase 1b dose escalation data expected 4Q 2024NSCLC: Initial Phase 1 dose escalation data in inoperable, recurrent NSCLC amenable to re-irradiation expected 1H 2025Esophageal Cancer: Presentation of first Phase 1b/2 data expected in 2025 Preclinical Nanoparticle-Based Platforms Curadigm Nanoprimer: Program update on the disruptive potential of Curadigm and the platform’s opportunity to redefine the discovery and design of next-gen therapies expected 4Q 2024 Third Quarter Financial Updates Nanobiotix reported cash and cash equivalents of €53.2 million (unaudited) as of September 30, 2024. Based on the current operating plan and financial projections, Nanobiotix anticipates that the cash and cash equivalents of €53.2 million as of September 30, 2024 to fund operations into Q4 2025. About NBTXR3 NBTXR3 is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. Its proof-of-concept was achieved in soft tissue sarcomas for which the product received a European CE mark in 2019. The product candidate’s physical mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes that NBTXR3 could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly immune checkpoint inhibitors. Radiotherapy-activated NBTXR3 is being evaluated across multiple solid tumor indications as a single agent or in combination with anti-PD-1 immune checkpoint inhibitors, including in NANORAY-312—a global, randomized Phase 3 study in locally advanced head and neck squamous cell cancers. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of NBTXR3 activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy—the same population being evaluated in the Phase 3 study. Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a collaboration strategy to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several Phase 1 and Phase 2 studies evaluating NBTXR3 across tumor types and therapeutic combinations. In 2023, Nanobiotix announced a license agreement for the global co-development and commercialization of NBTXR3 with Janssen Pharmaceutica NV. About NANOBIOTIX Nanobiotix is a late-stage clinical biotechnology company pioneering disruptive, physics-based therapeutic approaches to revolutionize treatment outcomes for millions of patients; supported by people committed to making a difference for humanity. The Company’s philosophy is rooted in the concept of pushing past the boundaries of what is known to expand possibilities for human life. Incorporated in 2003, Nanobiotix is headquartered in Paris, France and is listed on Euronext Paris since 2012 and on the Nasdaq Global Select Market in New York City since December 2020. The Company has subsidiaries in Cambridge, Massachusetts (United States) amongst other locations. Nanobiotix is the owner of more than 25 patent families associated with three (3) nanotechnology platforms with applications in 1) oncology; 2) bioavailability and biodistribution; and 3) disorders of the central nervous system. For more information about Nanobiotix, visit us at www.nanobiotix.com or follow us on LinkedIn and Twitter Disclaimer This press release contains “forward-looking” statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the use of proceed therefrom, and the period of time through which the Company’s anticipates its financial resources will be adequate to support operations. Words such as “expects”, “intends”, “can”, “could”, “may”, “might”, “plan”, “potential”, “should” and “will” or the negative of these and similar expressions are intended to identify forward-looking statements. These forward-looking statements, which are based on our management’s current expectations and assumptions and on information currently available to management. These forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially from those implied by the forward-looking statements, including risks related to Nanobiotix’s business and financial performance, which include the risk that assumptions underlying the Company’s cash runway projections are not realized. Further information on the risk factors that may affect company business and financial performance is included in Nanobiotix’s Annual Report on Form 20-F filed with the SEC on April 24, 2024 under “Item 3.D. Risk Factors”, in Nanobiotix’s 2023 universal registration document filed with the AMF on April 24, 2024, in Nanobiotix’ 2024 semi-annual report under the caption “Supplemental Risk Factor” filed with the SEC on Form 6-K and with AMF on September 18 2024, and subsequent filings Nanobiotix makes with the SEC from time to time which are available on the SEC’s website at www.sec.gov. The forward-looking statements included in this press release speak only as of the date of this press release, and except as required by law, Nanobiotix assumes no obligation to update these forward-looking statements publicly. Contacts NanobiotixCommunications DepartmentBrandon OwensVP, Communications+1 (617) 852-4835contact@nanobiotix.comInvestor Relations DepartmentCraig WestSVP, Investor Relations+1 (617) 583-0211investors@nanobiotix.comMedia RelationsFR – Ulysse CommunicationLaurent Wormser+ 33 (0)6 13 12 04 04lwormser@ulysse-communication.com Global – LifeSci AdvisorsKevin Gardner+1 (617) 283-2856kgardner@lifesciadvisors.com Attachment 2024-11-12 -- NBTX -- 3Q24 Financial Results -- FINAL

Phase 1License out/inPhase 3Fast Track

12 Nov 2024

·www.globenewswire.com

Fate Therapeutics Highlights Cancer-selective, HER2-Targeting Profile of FT825 / ONO-8250 CAR T-cell Product Candidate for Treatment of Advanced Solid Tumors at 2024 SITC Annual Meeting

Novel H2CasMab-2 Antigen Binding Domain Shown to Preferentially Target HER2 Expressed on Tumor Cells in Preclinical Studies Initial Low-Dose Cohort of FT825 / ONO-8250 as Monotherapy Shows Favorable Safety Profile in Phase 1 Solid Tumor Study Peripheral Blood from First Three Patients Demonstrates CAR T-cell Expansion with Maintenance of Activated State at Day 8 Following Treatment Nov. 09, 2024 -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune disorders, today presented initial clinical and new preclinical data for FT825 / ONO-8250, a multiplexed-engineered, chimeric antigen receptor (CAR) T-cell product candidate targeting human epidermal growth factor receptor 2 (HER2), at the 2024 Society of Immunotherapy of Cancer (SITC) 39th Annual Meeting being held in Houston, TX on November 6-10, 2024. FT825 / ONO-8250 incorporates a novel H2CasMab-2 binding domain targeting HER2 that is designed to overcome on-target, off-tumor toxicity and to recognize variants associated with poor clinical outcomes and tumor escape. In an ongoing Phase 1 study in advanced solid tumors, three patients were treated with FT825 / ONO-8250 in the first low-dose cohort as monotherapy, and no dose-limiting toxicities (DLTs) and no events of any grade of cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), or graft-versus-host disease (GvHD) were observed. The multi-center, Phase 1 study is currently being conducted under a strategic collaboration with Ono Pharmaceutical Co., Ltd. (Ono). “FT825 / ONO-8250 integrates seven novel synthetic controls of CAR T-cell function designed to overcome multiple mechanisms that impede the safe and effective treatment of solid tumors. We are very pleased with initial Phase 1 clinical observations from the first low-dose cohort, which showed a favorable safety profile, product expansion, and maintenance of an activated CAR T-cell state,” said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. “In addition, new preclinical data for FT825 / ONO-8250 presented today at SITC highlighted the cancer-selective recognition profile of its novel HER2 antigen binding domain, including its potential to target variants uniquely expressed on tumor cells. Under our collaboration with Ono, we are excited to further assess the potential of FT825 / ONO-8250 to benefit patients with hard-to-treat advanced solid tumors who currently have limited treatment options.” The Phase 1 study is designed to assess the safety, pharmacokinetics, and activity of FT825 / ONO-8250 as monotherapy and in combination with monoclonal antibody (mAb) therapy in patients with advanced solid tumors (NCT06241456). Three heavily pre-treated patients, all of whom were previously treated with at least five prior lines of therapy including HER2-targeted therapy, were administered conditioning chemotherapy and FT825 / ONO-8250 at the first dose level of 100 million cells as monotherapy. In all three patients, peak CAR T-cell expansion was observed at Day 8 following treatment. In addition, phenotyping of FT825 / ONO-8250 sourced from the patients’ peripheral blood on Day 8 was indicative of an activated state (as evidenced by high levels of Granzyme B expression and maintenance of CAR expression) with no evidence of exhaustion (as evidenced by low levels of PD-1 and TIM3 expression). As of a data cutoff date of October 25, 2024, FT825 / ONO-8250 was well-tolerated with no DLTs and no events of any grade of CRS, ICANS, or GvHD. Enrollment is currently ongoing at the second dose level of 300 million cells as monotherapy and at the first dose level of 100 million cells in combination with epidermal growth factor receptor (EGFR)-targeted mAb therapy. While HER2-directed therapies, such as trastuzumab (Herceptin) and trastuzumab deruxtecan (Enhertu), are effective in treating HER2-positive cancers, widespread HER2 expression in normal epithelial tissue can lead to significant off-tumor, on-target toxicities. At an oral presentation today at SITC entitled “Preferential targeting of HER2-expressing cancer cells by FT825 / ONO-8250, an off-the-shelf iPSC-derived CAR-T cell incorporating novel synthetic mechanisms for enhanced solid tumor activity”, scientists from the Company, Ono, Osaka University, and Tohoku University highlighted that FT825 / ONO-8250 demonstrated potent HER2-specific, anti-tumor activity in both in vitro and in vivo settings with limited cytolytic targeting of HER2+ normal cells. The on-tumor selectivity of FT825 / ONO-8250 was attributed to its incorporation of a novel HER2-targeted antigen binding domain, which was derived from a cancer-specific monoclonal antibody H2CasMab-2 (Kaneko et al., 2024), that was shown to differentially and preferentially recognize both locally misfolded HER2 and p95 truncation variants of HER2 as compared to trastuzumab. The scientists also presented preclinical data demonstrating that FT825 / ONO-8250 exhibits potent antibody-mediated cellular cytotoxicity (ADCC) through its high-affinity non-cleavable CD16 (hnCD16) Fc receptor, synergizing with trastuzumab to enhance clearance of HER2+ tumor cells and with cetuximab to enable multi-antigen targeting of HER2 and epidermal growth factor receptor (EGFR) expressed on cancer cells. Under the terms of its partnership with Ono for FT825 / ONO-8250, Fate and Ono are jointly responsible for development and commercialization in the U.S. and Europe, and Ono maintains exclusive development and commercialization rights in the rest of the world. The parties are also conducting preclinical development of an additional solid tumor program targeting an undisclosed tumor-associated antigen. Human induced pluripotent stem cells (iPSCs) possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Company’s proprietary iPSC product platform combines multiplexed-engineering of human iPSCs with single-cell selection to create clonal master iPSC lines. Analogous to master cell lines used to mass produce biopharmaceutical drug products such as monoclonal antibodies, the Company utilizes its clonal master iPSC lines as a starting cell source to manufacture engineered cell products which are well-defined and uniform in composition, can be stored in inventory for off-the-shelf availability, can be combined and administered with other therapies, and can potentially reach a broad patient population. As a result, the Company’s platform is uniquely designed to overcome numerous limitations associated with the manufacture of cell therapies using patient- or donor-sourced cells. Fate Therapeutics’ iPSC product platform is supported by an intellectual property portfolio of over 500 issued patents and 500 pending patent applications. Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune diseases. Using its proprietary iPSC product platform, the Company has established a leadership position in creating multiplexed-engineered master iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products. The Company’s pipeline includes iPSC-derived natural killer (NK) cell and T-cell product candidates, which are selectively designed, incorporate novel synthetic controls of cell function, and are intended to deliver multiple therapeutic mechanisms to patients. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com. The content above comes from the network. if any infringement, please contact us to modify.

ImmunotherapyClinical ResultASCOCell Therapy

07 Nov 2024

·www.prnewswire.com

Dragonfly Therapeutics to Present Preclinical Data on Clinical-Stage DF6215, its Engineered IL-2R alpha-active Agonist, and DF9001, its EGFR-targeting TriNKET®, at the Society for Immunotherapy of Cancer (SITC) Annual Conference

DF9001 is currently being evaluated for the treatment of Non-Small Cell Lung Cancer, Renal Cell Carcinoma and Head and Neck Squamous Cell CarcinomaDF6215 is currently being evaluated for the treatment of advanced solid tumors BOSTON, Nov. 7, 2024 /PRNewswire/ -- Dragonfly Therapeutics, Inc., a clinical-stage biotechnology company developing novel immunotherapies, today announced the company will deliver poster presentations at the Society for Immunotherapy of Cancer (SITC) Annual Conference , highlighting preclinical data supporting two clinical-stage assets, DF6215, its engineered IL-2 cytokine, and DF9001, its EGFR-targeting TriNKET, for the treatment of advanced solid tumors. DF6215 drives greater therapeutic benefit than a non-alpha IL-2 in the CT26 mouse tumor model DF6215 synergizes with PD-1 blockade in the “cold” B16F10 melanoma tumor model without adding toxicity DF9001 shows superior anti-tumor activity via EGFR signal inhibition compared to cetuximab in a xenograft mice model Even in the absence of EGFR signal inhibition, DF9001 induces potent in vivo efficacy via immune effector cells

ImmunotherapyAACR

100 Deals associated with Cetuximab

External Link

KEGG	Wiki	ATC	Drug Bank
D03455	Cetuximab	L01XC06	DB00002

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
RAS Wild Type Colorectal Cancer	JP	Merck Biopharma Co., Ltd.	01 Dec 2012
Head and Neck Neoplasms	US	Eli Lilly & Co.	01 Mar 2006
Metastatic Colorectal Carcinoma	EU	Merck Europe BV	29 Jun 2004
Metastatic Colorectal Carcinoma	IS	Merck Europe BV	29 Jun 2004
Metastatic Colorectal Carcinoma	LI	Merck Europe BV	29 Jun 2004
Metastatic Colorectal Carcinoma	NO	Merck Europe BV	29 Jun 2004
Squamous Cell Carcinoma of Head and Neck	EU	Merck Europe BV	29 Jun 2004
Squamous Cell Carcinoma of Head and Neck	IS	Merck Europe BV	29 Jun 2004
Squamous Cell Carcinoma of Head and Neck	LI	Merck Europe BV	29 Jun 2004
Squamous Cell Carcinoma of Head and Neck	NO	Merck Europe BV	29 Jun 2004
Colorectal Cancer	CH	Merck & Co., Inc.	01 Dec 2003

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
KRAS G12C mutant Colorectal Cancer	Phase 3	US	Mirati Therapeutics, Inc.	24 Jun 2021
KRAS G12C mutant Colorectal Cancer	Phase 3	AR	Mirati Therapeutics, Inc.	24 Jun 2021
KRAS G12C mutant Colorectal Cancer	Phase 3	AU	Mirati Therapeutics, Inc.	24 Jun 2021
KRAS G12C mutant Colorectal Cancer	Phase 3	AT	Mirati Therapeutics, Inc.	24 Jun 2021
KRAS G12C mutant Colorectal Cancer	Phase 3	BE	Mirati Therapeutics, Inc.	24 Jun 2021
KRAS G12C mutant Colorectal Cancer	Phase 3	BR	Mirati Therapeutics, Inc.	24 Jun 2021
KRAS G12C mutant Colorectal Cancer	Phase 3	CA	Mirati Therapeutics, Inc.	24 Jun 2021
KRAS G12C mutant Colorectal Cancer	Phase 3	CO	Mirati Therapeutics, Inc.	24 Jun 2021
KRAS G12C mutant Colorectal Cancer	Phase 3	CZ	Mirati Therapeutics, Inc.	24 Jun 2021
KRAS G12C mutant Colorectal Cancer	Phase 3	DK	Mirati Therapeutics, Inc.	24 Jun 2021

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


SITC2024 Manual	Phase 1	Colorectal Cancer Proficient DNA Mismatch Repair (pMMR)	15	pre-A+E CBNK cells + cetuximab	plaskjxmlv(unyvjrrals) = None zesxgcvokk (kazrtplewc ) View more	Positive	05 Nov 2024
NCT04117945 (CTgov)	Phase 2	Colorectal Cancer, Hereditary Nonpolyposis, Type 1 \| Metastatic Colorectal Carcinoma	22	Regorafenib (Arm A (Regorafenib))	amnowkxjhb(kssdyetqaw) = nblgzzxvvx huuvcxgjbc (zorbvgwrpb, wbwbodbwch - dtfiojfsmh) View more	-	27 Sep 2024
				Cetuximab+Irinotecan+Panitumumab (Arm B (Cetuximab, Panitumumab, Irinotecan))	amnowkxjhb(kssdyetqaw) = fsznepxgmt huuvcxgjbc (zorbvgwrpb, btdwrzyzcd - lvyditdksj) View more
NCT04262635 (C-CLASSIC, ESMO2024) Manual	Phase 3	RAS/BRAF Wild Type Colorectal Cancer Maintenance RAS/BRAF wild type	80	Cetuximab + Capecitabine	gaipppfhlc(mvzinufkee) = nkaujrnmnn ouklelupxg (cjpghfphcy, 5.32 - 11.24) View more	Positive	16 Sep 2024
				Cetuximab	gaipppfhlc(mvzinufkee) = tnuayqbszo ouklelupxg (cjpghfphcy, 3.02 - 7.46) View more
NCT04278092 (pace ace, ESMO2024) Manual	Phase 2	Head and Neck Neoplasms Second line	57	Paclitaxel+cetuximab	mygumntsbc(csabnsehll) = mdqdmwudbx xqswkbizwm (eenwwdddxd, 34.0 - 61.0) View more	Positive	14 Sep 2024
CITRIC (ESMO2024) Manual	Phase 2	Metastatic Colorectal Carcinoma	114	Cetuximab and irinotecan	ahmwaoslzp(uwlwbksjrg) = gboynlodsy bcvfxkzndr (ncvzfckshu ) View more	Positive	14 Sep 2024
				Investigator's choice (excluding anti-EGFR)	ahmwaoslzp(uwlwbksjrg) = huwcttkmvd bcvfxkzndr (ncvzfckshu ) View more
NCT04607421 (BREAKWATER, ESMO2024) Manual	Phase 3	BRAF V600E mutant Colorectal Cancer Second line \| First line BRAF V600E	30	Encorafenib + cetuximab + FOLFIRI (1L)	xneutvbpck(rwlsnkopyq) = none vigvcjgsjk (yvpxlfqmqm ) View more	Positive	14 Sep 2024
				Encorafenib + cetuximab + FOLFIRI (2L)
NCT02999087 (GORTEC 2017-01 REACH, ESMO2024) Manual	Phase 3	Locally Advanced Head and Neck Squamous Cell Carcinoma	701	IMRT 70 Gy / 6.5 weeks+ cetuximab+avelumab (unfit for cisplatin)	lseovnqcaj(klphnsurbs) = viygpanpin mcrfymxinv (psfsigmbtc, 26.2 - 42.2)	Negative	14 Sep 2024
				IMRT 70 Gy / 6.5 weeks+cetuximab (unfit for cisplatin)	lseovnqcaj(klphnsurbs) = rpbapxprdi mcrfymxinv (psfsigmbtc, 12.5 - 26.1)
NCT04856631 (ESMO2024) Manual	Phase 1/2	Squamous Cell Carcinoma of Head and Neck First line PD-L1 Positive	43	Toripalimab+cetuximab	zuzmjydatl(doydhqaofv) = pzrixaaekz ojiqawbmde (nrkthipeam, 27.0 - 57.9) View more	Positive	14 Sep 2024
ESMO2024	Not Applicable	Locally Advanced Head and Neck Squamous Cell Carcinoma	-	Cetuximab/RT	stjxqjnrma(hslzmvyanq) = dofsclynko xrxfjucqts (uttsybhtwr )	-	14 Sep 2024
				Cisplatin/RT	stjxqjnrma(hslzmvyanq) = abgqxknyfm xrxfjucqts (uttsybhtwr )
NCT03387111 (CTgov)	Phase 1/2	Squamous Cell Carcinoma	4	SBRT+Aldoxorubicin HCl+GI-6301+GI-4000+cetuximab+ETBX-061+ETBX-051+ETBX-011+Necitumumab+fluorouracil+N-803+ETBX-021+nab-paclitaxel+Cyclophosphamide+Avelumab+haNK for infusion+Leucovorin+GI-6207+Cisplatin+Bevacizumab+Capecitabine	fifxybujmz(pulhztlchh) = dzyukafiyf jbqzhasiff (ivxbjsvinu, ycozcibasw - xjigpkclvy) View more	-	05 Aug 2024

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