RegulationPriority Review (US), Fast Track (US), Orphan Drug (EU), Priority Review (CN), Conditional marketing approval (CN), Orphan Drug (AU), Priority Review (SG), Breakthrough Therapy (US), Orphan Drug (US)

Gene Sequence

Sequence Code 453640391L

Source: *****

Sequence Code 524455911H

Source: *****

498

Clinical Trials associated with Toripalimab

NCT06657144 / Not yet recruitingPhase 1

A Phase 1B, Multicenter, Open-Label Study of the Safety and Efficacy of CHS-114 in Combination With Toripalimab With or Without Other Treatments in Participants With Advanced or Metastatic Solid Tumors

The main purpose of this study is to evaluate the safety and preliminary efficacy of CHS-114 in combination with toripalimab and/or other standard of care (SOC) compound(s) in participants with advanced or metastatic solid tumors.

Start Date01 Mar 2025

Sponsor / Collaborator

Coherus BioSciences, Inc.

NCT06389526 / Not yet recruitingPhase 1

A Phase 1, Multicenter, Open-Label Study of CHS-1000 as a Single Agent and in Combination With Toripalimab-tpzi in Participants With Advanced or Metastatic Solid Tumors

The primary purpose of this trial is to assess the tolerability and safety of CHS-1000 alone and in combination with toripalimab-tpzi in participants with advanced solid tumors.

Start Date15 Feb 2025

Sponsor / Collaborator

Coherus BioSciences, Inc.

NCT05479045 / Not yet recruitingPhase 2IIT

A Combination Therapy Strategy to Prevent Anti-PD-1 Therapy Resistance in Metastatic Ovarian Cancer Patients

This is an open label, non-randomized, 2-stage phase II, single arm study to determine the efficacy of New York esophageal squamous cell carcinoma 1 (NY-ESO-1) peptide vaccine as a priming mechanism to prevent anti-PD1 resistance in patients with platinum-refractory stage III/IV ovarian cancer (OC).

Start Date01 Jan 2025

Sponsor / Collaborator

Georgetown University

[+1]

100 Clinical Results associated with Toripalimab

100 Translational Medicine associated with Toripalimab

100 Patents (Medical) associated with Toripalimab

471

Literatures (Medical) associated with Toripalimab

01 Dec 2024·ORAL ONCOLOGY

Immune checkpoint expression on tumor-infiltrating lymphocytes (TIL) is dependent on HPV status in oropharyngeal carcinoma (OPSCC) – A single-cell RNA sequencing analysis

Article

Author: Kraus, Johann M ; King, Emma V ; Ottensmeier, Christian H ; Doescher, Johannes ; Hoffmann, Thomas K ; Schuler, Patrick J ; Thomas, Jaya ; Kestler, Hans A ; Laban, Simon ; Ezić, Jasmin ; Vahl, Julius M ; Grages, Ayla ; Brunner, Cornelia ; von Witzleben, Adrian

INTRODUCTION:

A substantial proportion of head and neck squamous cell carcinoma (HNSCC), particularly oropharyngeal squamous cell carcinoma (OPSCC), is associated with human papillomavirus (HPV), resulting in distinct molecular phenotypes. In this study, we investigated differential immune checkpoint molecule (ICM) expression by HPV status using RNA sequencing data to identify additional ICM targets that may complement anti-PD1 antibodies.

MATERIAL AND METHODS:

RNA sequencing was performed on 51 OPSCC cases and validated using the TCGA HNSCC dataset. Unsupervised clustering and differential gene expression analyses in R were conducted based on HPV status. Additionally, a published single-cell RNA sequencing (scRNA) dataset of tumor-infiltrating lymphocytes (TIL) and peripheral immune cells (PBMC) (GSE139324) was analyzed with a Seurat pipeline grouped by HPV status.

RESULTS:

Our study identified a significant upregulation of all examined ICM in HPV-positive OPSCC through bulk RNA sequencing, validated by the TCGA cohort. Unsupervised clustering revealed a strong association between HPV-positive/-negative and high/low ICM expression cases respectively, indicating overlap between ICM and HPV status. In scRNA analysis, CD27, PD-1, OX-40, and BTLA were significantly more highly expressed on TILs of HPV-positive OPSCC. Conversely, VSIR was increased in PBMC and TILs of HPV-negative OPSCC, while LAG3 expression on PBMC was reduced in HPV-negative OPSCC.

CONCLUSION:

Our study unveils the intricate interplay of ICMs in OPSCC, emphasizing the necessity for personalized therapeutic approaches based on HPV status and immune profiles. The identified ICMs, including PD1, CD27, and CTLA4, are promising candidates for further investigation and may enhance immunotherapeutic interventions in the HPV-dependent treatment strategies for OPSCC.

01 Dec 2024·LANCET ONCOLOGY

Neoadjuvant and adjuvant toripalimab for locoregionally advanced nasopharyngeal carcinoma: a randomised, single-centre, double-blind, placebo-controlled, phase 2 trial

Article

Author: Luo, Mei-Juan ; Guo, Ling ; Yang, Zhen-Chong ; Sun, Xue-Song ; Li, Yi-Fu ; Mai, Hai-Qiang ; Yang, Qi ; Lan, Kai-Qi ; Wen, Dong-Xiang ; Tang, Lin-Quan ; Luo, Dong-Hua ; Wang, Pan ; Jia, Guo-Dong ; Liu, Sai-Lan ; Mo, Hao-Yuan ; Yang, Jin-Hao ; Xie, Si-Yi ; Liang, Yu-Jing ; Li, Ru ; Xu, Rui-Hua ; Guo, Shan-Shan ; Li, Ji-Bin ; Li, Xiao-Yun ; Liu, Qing ; Lv, Xiao-Fei ; Chen, Qiu-Yan ; Sun, Rui ; Zhao, Chong ; Liu, Li-Ting

BACKGROUND:

Patients with locoregionally advanced nasopharyngeal carcinoma with a high pretreatment plasma concentration of Epstein-Barr virus (EBV) DNA remain at high risk for recurrence after concurrent chemoradiotherapy. This study aimed to compare the efficacy and safety of neoadjuvant-adjuvant treatment with the PD-1 inhibitor toripalimab and concurrent chemoradiotherapy versus placebo and concurrent chemoradiotherapy in patients with locoregionally advanced nasopharyngeal carcinoma.

METHODS:

This randomised, single-centre, double-blind, placebo-controlled, phase 2 trial was conducted at Sun Yat-sen University Cancer Centre in Guangzhou, China. Adult patients (aged 18-65 years) with newly diagnosed high-risk stage III-IVa locoregionally advanced nasopharyngeal carcinoma, with a pretreatment plasma EBV DNA concentration of at least 1500 copies per mL and an Eastern Cooperative Oncology Group performance score of 0-1, were eligible. Patients were randomly assigned (2:1) using an interactive web response system (block size of six), stratified by TNM stage (III vs IVa), to neoadjuvant toripalimab (240 mg intravenously) or placebo once every 2 weeks for two cycles, followed by concurrent cisplatin (100 mg/m² intravenously) on days 1, 22, and 43 during intensity-modulated radiotherapy and adjuvant toripalimab (240 mg intravenously) or placebo once every 3 weeks for up to eight cycles. The primary endpoint was 2-year progression-free survival in the intention-to-treat population. This study was registered with ClinicalTrials.gov, NCT03925090, and is closed to enrolment; follow-up is ongoing.

FINDINGS:

Between Dec 6, 2019, and Dec 9, 2021, 150 patients were enrolled and randomly assigned to the toripalimab group (n=100) or placebo group (n=50). 115 (77%) patients were male and 35 (23%) were female. As of data cutoff (May 31, 2024), median follow-up for progression-free survival was 37·8 months (IQR 34·2-46·5) for the intention-to-treat population analyses. 2-year progression-free survival was higher in the toripalimab group (92·0% [95% CI 86·7-97·3]) than in the placebo group (74·0% [61·8-86·2]; stratified hazard ratio 0·40 [95% CI 0·18-0·89]; log-rank p=0·019). The most common grade 3 or worse acute adverse events (occurring within 1 year of randomisation) were leukopenia (40 [40%] of 99 patients in the toripalimab group vs 22 [44%] of 50 patients in the placebo group), mucositis (28 [28%] vs ten [20%]), neutropenia (17 [17%] vs nine [18%]), anaemia (16 [16%] vs five [10%]), and weight loss (12 [12%] vs six [12%]). The most common grade 3 or worse late adverse events (occurring >1 year after randomisation) was auditory or hearing loss (eight [8%] vs four [8%]). Immune-mediated adverse events of grade 3 or worse occurred in ten (10%) patients only in the toripalimab group. One (2%) of 50 patients in the placebo group died due to septic shock caused by bacteraemia considered not treatment related. There were no treatment-related deaths in the toripalimab group.

INTERPRETATION:

Our findings suggested that a so-called sandwich approach involving toripalimab (in the neoadjuvant and adjuvant phases) combined with concurrent chemoradiotherapy could be a highly promising therapy for the treatment of locoregionally advanced nasopharyngeal carcinoma. Phase 3 non-inferiority trials are warranted comparing neoadjuvant and adjuvant toripalimab versus cisplatin plus gemcitabine neoadjuvant chemotherapy combined with concurrent chemoradiotherapy.

FUNDING:

National Key Research and Development Program of China, National Natural Science Foundation of China, Guangdong Basic and Applied Basic Research Foundation, Science and Technology Program of Guangzhou, Sun Yat-sen University Clinical Research 5010 Program, Innovative Research Team of High-level Local Universities in Shanghai, Postdoctoral Innovative Talent Support Program, Planned Science and Technology Project of Guangdong Province, Key Youth Teacher Cultivating Program of Sun Yat-sen University, and Fundamental Research Funds for the Central Universities.

TRANSLATION:

For the Chinese translation of the abstract see Supplementary Materials section.

01 Dec 2024·ANNALS OF ONCOLOGY

Disitamab vedotin plus toripalimab in patients with locally advanced or metastatic urothelial carcinoma (RC48-C014): a phase 1b/2 dose-escalation and dose-expansion study

Article

Author: Li, S M ; Cui, C L ; Guo, J ; Zhou, L ; Yan, X Q ; Si, L ; Yang, K W ; Li, J ; He, Z S ; Tang, B X ; Zhang, S ; Chi, Z H ; Liu, Y Q ; Guo, H Q ; Sheng, X N ; Xu, H Y

BACKGROUND:

HER2-targeted antibody-drug conjugates (ADCs) such as disitamab vedotin (DV) and trastuzumab deruxtecan (T-Dxd) have emerged as effective treatment options and received regulatory approvals for HER2 expressing locally advanced or metastatic urothelial carcinoma (la/mUC). In addition, ADCs in combination with immunotherapy have demonstrated anti-tumor activity. The current study aimed to evaluate the combination of DV and toripalimab in patients with la/mUC.

PATIENTS AND METHODS:

This open-label phase 1b/2 study enrolled patients with untreated or chemo-refractory la/mUC. During the dose escalation phase, DV was administered at escalating doses of 1.5 and 2.0 mg/kg in combination with toripalimab 3.0 mg/kg once every two weeks. Primary endpoints were safety and the recommended phase 2 dose (RP2D). Secondary endpoints included objective response rate (ORR), progression-free survival (PFS), and overall survival (OS).

RESULTS:

From August 2020 to December 2021, a total of forty-one patients were enrolled, including six in the dose-escalation phase, and thirty-five in the dose-expansion phase. Sixty-one percent of patients were treatment naïve. No dose-limiting toxicity was observed. The RP2D was determined as DV (2.0 mg/kg) plus toripalimab (3.0 mg/kg). By the data cutoff date of March 1, 2024, the confirmed ORR was 73.2%. The median PFS was 9.3 months, and the median OS was 33.1 months. The most common treatment-related adverse events (TRAEs) were aspartate aminotransferase increased (65.9%), alanine aminotransferase increased (63.4%), and peripheral sensory neuropathy (63.4%). Grade 3 or higher TRAEs occurred in 51.2% of patients, with the most common being gamma-glutamyltransferase increased (12.2%), asthenia (9.8%), and alanine aminotransferase increased (7.3%). One treatment-related death (due to pneumonitis) was reported.

CONCLUSIONS:

The combination of DV and toripalimab demonstrated promising response rate and overall survival results with a manageable safety profile in HER2 unselected la/mUC patients. This combination represents a promising first-line option for la/mUC. Randomized phase III study is currently ongoing.

858

News (Medical) associated with Toripalimab

18 Dec 2024

·www.globenewswire.com

Coherus to Present Final Phase 2 Casdozokitug Combination Data in Patients with Metastatic Hepatocellular Carcinoma at ASCO-GI 2025

- Randomized Phase 2 study initiated evaluating the combination of casdozokitug, toripalimab and bevacizumab in patients with liver cancer - REDWOOD CITY, Calif., Dec. 18, 2024 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (“Coherus,” NASDAQ: CHRS) today announced that an abstract highlighting final clinical and biomarker data from its Phase 2 clinical trial evaluating casdozokitug (casdozo), a selective and potent IL-27-antagonistic antibody, in combination with atezolizumab (atezo) and bevacizumab (bev) in treatment naïve patients with unresectable locally advanced or metastatic hepatocellular carcinoma (HCC), has been selected for a poster presentation at the upcoming 2025 ASCO GI Annual Meeting, being held January 23-25, 2025, in San Fransisco, CA. “Casdozo is a first-in-class antibody, and in oncology, is the first IL-27 cytokine antagonist to demonstrate monotherapy responses and immune activation with a safety profile that lends itself to combination,” said Rosh Dias, M.D., Coherus’ Chief Medical Officer. “We look forward to sharing the final data from this Phase 2 combination study of casdozo with standard of care with the medical community at the upcoming 2025 ASCO-GI annual meeting. We now have data across several tumor types for casdozo demonstrating clinical activity. We are particularly excited about HCC given the strong preclinical package for targeting IL-27 in liver cancer and now translation to the clinic.” Coherus has initiated a new randomized Phase 2 study (NCT06679985) evaluating casdozo, in combination with bevacizumab and toripalimab, Coherus’ next-generation anti-PD-1 monoclonal antibody, in participants with first-line HCC. This randomized, parallel, open-label Phase 2 study is designed to evaluate the safety, efficacy, and Project Optimus1 dosing of the triplet combination. The study is expected to enroll up to 72 patients, who will be randomized to receive one of two biologically active doses of casdozo with toripalimab plus bevacizumab or toripalimab plus bevacizumab without casdozo. “Advancing casdozo development in first-line HCC with a randomized Phase 2 combination study marks a significant milestone in our strategic path to progress our clinical pipeline, which is focused on overcoming immune suppression in the tumor microenvironment to extend survival and improve outcomes for patients and pursuing new indications for toripalimab in the U.S.,” continued Dr. Dias. “Casdozo has shown encouraging responses in the first line setting when added to the existing standard of care, atezolizumab and bevacizumab, and we’re excited to build upon these data with this new Phase 2 study evaluating casdozo in combination with toripalimab and bevacizumab.” In the Phase 3 HEPATORCH study, conducted by Junshi Biosciences, patients with advanced HCC treated with toripalimab combined with bevacizumab as a first-line therapy showed significantly better clinical efficacy than sorafenib monotherapy.2 HEPATORCH patients showed an objective response rate of 25.3% versus 6.1% in the sorafenib group, a median progression-free survival of 5.8 months, and a median overall survival of 20 months, compared to 4 and 14.5 months, respectively, for the sorafenib group.3 Toripalimab in combination with bevacizumab was well tolerated, with a toxicity profile consistent with the known toxicity profile of each monotherapy, with no new safety signals identified.3 The results of the HEPATORCH study support the clinical study of toripalimab in combination with bevacizumab as a new first-line treatment option for advanced HCC which, along with the results from the Phase 2 casdozo study reported to date, support pursuing a triple combination of casdozo with toripalimab plus bevacizumab in patients with advanced or metastatic HCC. ASCO-GI 2025 Presentation Details Title: Results from a phase 2 study of triplet blockade of the IL-27, PD-(L)1, and VEGF pathways with casdozokitug (casdozo, CHS-388) in combination with atezolizumab and bevacizumab in patients with unresectable, locally advanced or metastatic hepatocellular carcinoma (uHCC) Lead Author: Daneng Li, City of Hope National Comprehensive Cancer CenterAbstract #: 605Poster Session B: Cancers of the Pancreas, Small Bowel, and Hepatobiliary TractDate and Time: Friday, January 24, 2025; 11:30 a.m. – 1:00 p.m. PT Hepatobiliary cancers include a spectrum of invasive carcinomas arising in the liver (hepatocellular carcinoma; HCC), gall bladder, and bile ducts (collectively called biliary tract cancers). The most common type of primary liver cancer in adults is HCC (accounting for ~90%), which is the third leading cause of cancer-related deaths worldwide. According to the NCI Surveillance, Epidemiology and End Results Program (SEER), there will be an estimated 41,630 new cases and 29,840 deaths from liver and intrahepatic bile duct cancer in the US in 2024.4 The U.S. 5-year relative survival rate for liver and intrahepatic bile duct cancer is 21.7%.4 The liver cancer treatment pattern has changed in recent years with the emergence of immunotherapy combinations and will continue to evolve as more treatment options become available for these highly lethal cancers. About Coherus BioSciences Coherus is a commercial-stage biopharmaceutical company focused on the research, development and commercialization of innovative immunotherapies to treat cancer. Coherus is developing an innovative immuno-oncology pipeline that is expected to be synergistic with toripalimab and its proven commercial capabilities in oncology. Coherus’ immuno-oncology pipeline includes multiple antibody immunotherapy candidates focused on enhancing the innate and adaptive immune responses to enable a robust antitumor immunologic response and enhance outcomes for patients with cancer, particularly patients underserved by current immunotherapy treatments. Casdozokitug is a novel IL-27 antagonistic antibody being evaluated in two ongoing clinical studies: a Phase 1/2 study in advanced solid tumors and a Phase 2 study in hepatocellular carcinoma. CHS-114 is a highly selective, competitively positioned, cytolytic anti-CCR8 antibody currently in a Phase 1 study in patients with advanced solid tumors, including HNSCC. CHS-1000 is a novel humanized Fc-modified IgG1 monoclonal antibody specifically targeting ILT4 (LILRB2). An IND for CHS-1000 was allowed to proceed by the FDA in the second quarter of 2024 and proceeding to the first-in-human clinical study is subject to further evaluation in our portfolio prioritization process. Coherus markets LOQTORZI® (toripalimab-tpzi), a novel next-generation PD-1 inhibitor, and UDENYCA® (pegfilgrastim-cbqv), a biosimilar of Neulasta. In December 2024, Coherus announced that it entered into an agreement for the divestiture of the UDENYCA franchise. The proposed transaction is expected to close by the end of the first quarter of 2025. Neulasta® is a registered trademark of Amgen, Inc. Forward-Looking Statements Except for the historical information contained herein, the matters set forth in this press release are 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 Coherus’ expectations about identifying synergies between its I-O pipeline and its commercial operations and its I-O pipeline and toripalimab; future enrollment estimates for Coherus’ clinical studies; Coherus’ expectations that it will be able to demonstrate that its clinical pipeline candidates can extend patient survival; and the ability to satisfy the closing conditions to consummate the proposed transaction for the divestiture of the UDENYCA franchise at all or in the estimated time. Such forward-looking statements involve substantial risks and uncertainties that could cause Coherus’ actual results, performance or achievements to differ significantly from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the risks and uncertainties inherent in the clinical drug development process; risks related to Coherus’ existing and potential collaboration partners; risks of Coherus’ reliance on third-parties; the risks and uncertainties related to manufacturing and supply of Coherus’ products, the risks and uncertainties of the regulatory approval process, including the speed of regulatory review and the timing of Coherus’ regulatory filings; uncertainties as to the timing for completion of the proposed transaction; uncertainties as to the Company’s ability to obtain the approval of its shareholders required to consummate the proposed transaction for the divestiture of UDENYCA; the possibility that competing offers will be made by third parties; the occurrence of any event, change or other circumstance that may give rise to a right of one or both parties to terminate the agreement to divest UDENYCA; the possibility that the proposed transaction for the divestiture of UDENYCA may not be completed in the time frame expected by the Company or at all, including due to the possibility that a governmental entity may prohibit, delay, or refuse to grant approval, if required, for the consummation of the proposed transaction to divest UDENYCA (or only grant approval subject to adverse conditions or limitations). All forward-looking statements contained in this press release speak only as of the date of this press release. Unless required by law, the Company 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. For a further description of the significant risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Coherus’ business in general, see Coherus’ Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2024 filed with the Securities and Exchange Commission on November 6, 2024, including the section therein captioned “Risk Factors” and in other documents Coherus files with the Securities and Exchange Commission including, when available, the proxy statement of the Company relating to the proposed transaction for the divestiture of UDENYCA. UDENYCA® and LOQTORZI®, whether or not appearing in large print or with the trademark symbol, are trademarks of Coherus, its affiliates, related companies or its licensors or joint venture partners unless otherwise noted. Trademarks and trade names of other companies appearing in this press release are, to the knowledge of Coherus, the property of their respective owners. Coherus Contact Information:For Investors:Jodi SieversVP, Investor Relations & Corporate CommunicationsIR@coherus.com For Media:Argot Partners(212) 600-1902coherus@argotpartners.com 1Project Optimus: Reforming the dose optimization and dose selection paradigm in oncology 2Shanghai Junshi Biosciences Co., Ltd (2024, June 11) Junshi Biosciences Announces Phase 3 Study of Toripalimab Combined with Bevacizumab for the First-line Treatment of Advanced Hepatocellular Carcinoma Meets Primary Endpoint 3FAN, J. (2024) HEPATORCH: A randomized, open-label, multicenter, phase III clinical study of the safety and efficacy of toripalimab combined with bevacizumab versus sorafenib as first-line treatment for advanced hepatocellular carcinoma presented at the 2024 Annual Meeting of Chinese Society of Clinical Oncology 4National Cancer Institute Cancer Stat Facts: Liver and Intrahepatic Bile Duct Cancer; retrieved December 17, 2024, from https://seer.cancer.gov/statfacts/html/livibd.html

Phase 2Clinical ResultImmunotherapyPhase 3ASCO

16 Dec 2024

·www.accesswire.com

Xenetic Biosciences, Inc. Extends Research Agreement with the University of Virginia for the Advancement of its DNase-Based Oncology Platform

Company continuing to advance DNase-based oncology program towards clinical proof-of-concept studies in multiple indications FRAMINGHAM, MA / ACCESSWIRE / December 16, 2024 / Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing innovative immuno-oncology technologies addressing hard to treat cancers, today announced it has extended its previously announced Research Funding Agreement (the "Agreement") with the University of Virginia ("UVA") to advance the development of its systemic DNase program through 2025. Xenetic's DNase-based oncology platform is designed to target neutrophil extracellular traps (NETs), which are weblike structures composed of extracellular chromatin coated with histones and other proteins. In cancer, NETs are expelled by activated neutrophils into the tumor microenvironment (TME) and blood, thereby promoting cancer spread, local and systemic immunosuppression, as well as cancer-associated thrombosis. Reduction of NETs burden via application of Xenetic's proprietary recombinant human DNase I has been shown to improve efficacy of immunotherapy, adoptive cell therapy and chemotherapy in preclinical animal models."Allan Tsung, MD, and the team at UVA continue to be valued partners and we are pleased with the progress under the Agreement in evaluating the potential addition of DNase to available treatment options in areas of significant unmet need. The preclinical and translational data that UVA has accumulated under the initial Scope of Work to the Agreement further strengthens the scientific rationale for investigating combinations of DNase I with immunotherapies and chemotherapies. In the next phase of this partnership, UVA will continue to investigate combinations of DNase I with immunotherapies in models of primary and metastatic colorectal cancer. As a surgical oncologist and scientist, Dr. Tsung is internationally recognized for leading substantial research on the role of NETs in tumor growth, metastasis, and resistance to existing cancer therapies and we look forward to leveraging that expertise as we advance our technology toward the clinic," commented Reid P. Bissonnette, Ph.D., Executive Consultant for Translational Research and Development of Xenetic.Under the terms of the Agreement, in addition to advancing Xenetic's existing intellectual property, Xenetic has an option to acquire an exclusive license to any new intellectual property arising from the DNase research program. Allan Tsung, MD, a member of the Company's Scientific Advisory Board and Chair of the Department of Surgery at the UVA School of Medicine, will continue to oversee the research conducted under the Agreement. Xenetic is working toward its planned first-in-human study to evaluate DNase combined with immune checkpoint inhibitors or chemotherapy.About Xenetic BiosciencesXenetic Biosciences, Inc. is a biopharmaceutical company focused on advancing innovative immune-oncology technologies addressing hard to treat cancers. The Company's DNase I platform is designed to improve outcomes of existing treatments, including immunotherapies, by targeting neutrophil extracellular traps (NETs), which are involved in cancer progression. Xenetic is currently focused on advancing its systemic DNase program into the clinic as an adjunctive therapy for pancreatic carcinoma, colorectal cancer and locally advanced or metastatic solid tumors.For more information, please visit the Company's website at www.xeneticbio.com and connect on X, LinkedIn, and Facebook.Forward-Looking StatementsThis press release contains forward-looking statements that we intend to be subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release other than statements of historical facts may constitute forward-looking statements within the meaning of the federal securities laws. These statements can be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," "remain," "focus", "confidence in", "potential", "making", and other words of similar meaning, including, but not limited to: all statements regarding the collaboration agreement with UVA, including regarding the next phase of the partnership with UVA where UVA will continue to investigate combinations of DNase I with immunotherapies in models of primary and metastatic colorectal cancer and our plans to continue to leverage the knowledge and expertise of the team at UVA to potentially expand and broaden the utility of our proprietary platform technology; and expectations regarding our DNase-based oncology platform, including statements regarding: advancing DNase-based oncology program towards clinical proof-of-concept studies in multiple indications; focusing on advancing innovative immuno-oncology technologies addressing hard to treat oncology indications; advancing the development of the Company's program on the combination of systemic DNase and CAR T-cell therapies; the DNase platform improving outcomes of existing treatments, including immunotherapies, by targeting neutrophil extracellular traps (NETs), which are involved in cancer progression; and our focus on advancing our systemic DNase program into the clinic as an adjunctive therapy for pancreatic carcinoma, colorectal cancer and locally advanced or metastatic solid tumors. All forward-looking statements contained herein are based on current expectations and are subject to a number of risks and uncertainties. Many factors could cause our actual activities, performance, achievements, or results to differ materially from the activities and results anticipated in forward-looking statements. Important factors that could cause actual activities, performance, achievements, or results to differ materially from such plans, estimates or expectations include, among others, (1) failure to achieve the expected outcomes and realize the anticipated benefits from our collaboration agreements, including the agreement with UVA; (2) unexpected costs, charges or expenses resulting from our manufacturing and collaboration agreements, including the agreement with UVA; (3) unexpected costs, charges or expenses resulting from the licensing of the DNase platform; (4) uncertainty of the expected financial performance of the Company following the licensing of the DNase platform; (5) failure to realize the anticipated potential of the DNase or PolyXen technologies; (6) the ability of the Company to obtain funding and implement its business strategy; and (7) other risk factors as detailed from time to time in the Company's reports filed with the SEC, including its annual report on Form 10-K, periodic quarterly reports on Form 10-Q, current reports on Form 8-K and other documents filed with the SEC. The foregoing list of important factors is not exclusive. In addition, forward-looking statements may also be adversely affected by general market factors, general economic and business conditions, including potential adverse effects of public health issues, such as the COVID-19 outbreak, and geopolitical events, such as the conflicts in Ukraine and in the Middle East, on economic activity, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new product candidates and indications, manufacturing issues that may arise, patent positions, litigation and shareholder activism, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and the Company does not undertake any obligation to update forward-looking statements, except as required by law.Contact:JTC Team, LLCJenene Thomas(908) 824-0775[email protected]SOURCE: Xenetic Biosciences, Inc.

ImmunotherapyLicense out/inCell Therapy

16 Dec 2024

·www.biopharmadive.com

Could the gut microbiome hold the key to fighting cancer?

Trillions of bacteria, fungi and viruses live within our bodies, making up our microbiome. Scientists have been studying the role these microorganisms play in our health, and in recent years, the focus has shifted to oncology. Specifically, could mitigate complications of cancer treatments and potentially improve the bodys response to certain cancer treatments leading to improved survival?MaaT Pharma is at the forefront of innovation in this field, striving to achieve the first-ever approval of a microbiome-driven immunomodulator in oncology.In 2022, the biotech company launched a Phase 3 clinical trial, in Europe, in patients with acute graft versus host disease (aGvHD), and topline results are anticipated as early as January 2025. If approved, the drug candidateMaaT013could offer a new treatment option to patients with steroid refractory and ruxolitinib refractory or intolerant aGvHD.Herv AffagardPermission granted by MaaT PharmaWe have decided to focus on oncology patients because that's where we believe the most unmet medical need and potential for microbiome-based therapies exists, says Herv Affagard, CEO and co-founder of MaaT Pharma. What were doing is modulating the immunity of the patient in oncology to improve survival.We sat down with Affagard to talk about the potential of microbiome therapeutics for oncology patients, and his vision for the future.The microbiome is increasingly recognized as crucial for health and disease. Can you explain how it's relevant for oncology, and why MaaT Pharma is focused on this area?Affagard: We know that 25% of the worlds population shows an alteration of its microbiome, and there can be different reasons for that. In oncology, cancer patients are receiving harsh treatments, such as chemotherapy, antibiotics and stem cell transplantation, that can alter the microbiome to the point that sometimes the microbiome becomes unstable or ineffective, resulting in dysbiosis. When that happens, the immune system loses its counterpart which can trigger hyperinflammation in the body. These changes are often more significant in cancer than we see in other diseases, so the potential in oncology is very clear.At MaaT Pharma, we want to restore the balance between the microbiome and the immune system. We are on the verge of demonstrating, potentially for the first time, that a microbiome-based therapy could improve overall survival in patients with acute Graft-versus-Host Disease. Everything that has been done before, especially in infectious disease, is only dealing with symptoms and complications, but here we are dealing with a hard end point: survival.That's fascinating. So, how does MaaT Pharma leverage the gut microbiome to potentially treat cancer?Affagard: We approach the potential to treat cancer in two ways. One, we accompany anti-cancer treatments as a partner to optimize the treatment. In that situation, were aiming to create a drug which is a phenotype that will make the patient respond to the treatment, such as immune checkpoint inhibitors. Also, were aiming to directly treat certain diseases, such as aGvHD, by replacing the microbiome with a very specific microbiome that may be able to reduce inflammation.What makes your approach different from others who are exploring these kinds of therapies?Affagard: There are different modalities to trick the microbiome. For example, you could have something simple, like a probiotic or a prebiotic to promote certain bacteria, which can be effective when dysbiosis is mild. But with aGvHD patients were dealing with an emergencyhalf of them die after just 28 days, to give you an idea. So, we want to repair everything as fast as possible. Thats why were dealing with a full reset of the microbiome, and what sets MaaT Pharma apart from others in this space is the fact that we are restoring the entire ecosystem. Weve developed a high-density drug using pooling technology, which allows us to pool donor-derived microbiota donations to create a standardized product with highly rich and diverse microbial content that will be impactful for the maximum number of patients. We are the only company in the world with an investigational new drug authorized to use this pooling technology in clinical trials in the U.S.Your lead candidate, MaaT013, has shown promise in clinical trials. What can you tell us about its progress?Affagard: Through the Early Access Program for MaaT013, weve treated more than 200 patients with aGvHD, including different subsets of these patients. One subset, for example, resembles the patients that we are treating in our Phase 3 clinical trial, and we see a significant overall survival benefit in this subset. Historical data showed that one-year survival rates for aGvHD patients receiving third-line treatments have been dismal, with only 15% surviving at 12 months. In contrast, our latest results presented at ASH 2024 highlight an impressive 49% overall survival at one year for similar patients population treated with MaaT013tripling the historical survival rate (from literature). Its very promising and were encouraged by what were seeing, which underscores MaaT013s potential to address a significant unmet need for patients with aGvHD.Weve also initiated the first treatment at City of Hope in the U.S. of a patient with aGvHD under the US Food and Drug Administration (FDA) Single Patient Expanded Access. How do these therapies have the potential to impact patients lives, especially those who are undergoing cancer treatments?Affagard: The feedback were receiving from physicians evaluating MaaT013 in patients through clinical trials is that its safe. You see, HSCT is a treatment often used in leukemia and other blood cancers. However, it comes with its own challenges, such as GvHDa complication where the donor cells attack the recipient's body. When this happens, immunosuppressants are usually the drug used. And immunosuppressants, at a certain point in time, create complications as the patient risks developing infections because the immune system is down. But you don't see that with our microbiome-based therapy, which has a direct impact on quality of life for the patients. In addition, our treatment is not a chronic treatment. You receive three doses, and when it works, it works very well. And if it doesn't work, it doesn't work, but you do not have to be under treatment for six months, which would be the case for immunosuppressants.Looking ahead, what are your predictions for the microbiome therapy space over the next five years?Affagard: I believe there will be more and more applications leveraging the microbiome in oncology, especially coming from small companies. Academic research has been very important since 2010, and now were at a point where there's a lot of innovation. I believe that the field of inflammatory bowel disease, neurodegenerative disease and oncology will be the next big things in microbiome therapies.What are the next goals for MaaT Pharma?Affagard: Our primary focus is to deliver the topline results for the Phase 3 trial in January 2025, because it will be the cornerstone of everything else in our pipeline. We believe a success in aGvHD will open the doors to many other therapeutic areas. Looking ahead, we have other programs in blood cancers but also in solid tumors and neurodegenerative disease where we are generating proof of concept data. But first, we need to demonstrate that by modulating the microbiome you can modulate the immune system and potentially cure diseases. That will be absolutely fantastic. '

Phase 3Microbial therapyPhase 2

100 Deals associated with Toripalimab

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KEGG	Wiki	ATC	Drug Bank
-	-	L01XC	DB15043

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Metastatic Esophageal Squamous Cell Carcinoma	EU	Tmc Pharma (Eu Ltd.	19 Sep 2024
Metastatic Esophageal Squamous Cell Carcinoma	IS	Tmc Pharma (Eu Ltd.	19 Sep 2024
Metastatic Esophageal Squamous Cell Carcinoma	LI	Tmc Pharma (Eu Ltd.	19 Sep 2024
Metastatic Esophageal Squamous Cell Carcinoma	NO	Tmc Pharma (Eu Ltd.	19 Sep 2024
Nasopharyngeal Neoplasms	EU	Tmc Pharma (Eu Ltd.	19 Sep 2024
Nasopharyngeal Neoplasms	IS	Tmc Pharma (Eu Ltd.	19 Sep 2024
Nasopharyngeal Neoplasms	LI	Tmc Pharma (Eu Ltd.	19 Sep 2024
Nasopharyngeal Neoplasms	NO	Tmc Pharma (Eu Ltd.	19 Sep 2024
Oesophageal squamous cell carcinoma recurrent	EU	Tmc Pharma (Eu Ltd.	19 Sep 2024
Oesophageal squamous cell carcinoma recurrent	IS	Tmc Pharma (Eu Ltd.	19 Sep 2024
Oesophageal squamous cell carcinoma recurrent	LI	Tmc Pharma (Eu Ltd.	19 Sep 2024
Oesophageal squamous cell carcinoma recurrent	NO	Tmc Pharma (Eu Ltd.	19 Sep 2024
Unresectable Esophageal Squamous Cell Carcinoma	EU	Tmc Pharma (Eu Ltd.	19 Sep 2024
Unresectable Esophageal Squamous Cell Carcinoma	IS	Tmc Pharma (Eu Ltd.	19 Sep 2024
Unresectable Esophageal Squamous Cell Carcinoma	LI	Tmc Pharma (Eu Ltd.	19 Sep 2024
Unresectable Esophageal Squamous Cell Carcinoma	NO	Tmc Pharma (Eu Ltd.	19 Sep 2024
Triple Negative Breast Cancer	CN	Shanghai Junshi Biosciences Co., Ltd.	18 Jun 2024
Extensive stage Small Cell Lung Cancer	CN	Shanghai Junshi Biosciences Co., Ltd.	04 Jun 2024
Metastatic Renal Cell Carcinoma	CN	Shanghai Junshi Biosciences Co., Ltd.	07 Apr 2024
Unresectable Renal Cell Carcinoma	CN	Shanghai Junshi Biosciences Co., Ltd.	07 Apr 2024

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic melanoma	NDA/BLA	CN	Shanghai Junshi Biosciences Co., Ltd.	12 Aug 2024
Unresectable Melanoma	NDA/BLA	CN	Shanghai Junshi Biosciences Co., Ltd.	12 Aug 2024
Advanced Hepatocellular Carcinoma	NDA/BLA	CN	Shanghai Junshi Biosciences Co., Ltd.	18 Jul 2024
Nasopharyngeal Cancer, Recurrent	NDA/BLA	EU	Tmc Pharma (Eu Ltd.	14 Nov 2022
Recurrent Lung Non-Squamous Non-Small Cell Carcinoma	Phase 3	CN	Shanghai Junshi Biosciences Co., Ltd.	11 Jul 2024
Small cell lung cancer limited stage	Phase 3	US	Shanghai Junshi Biosciences Co., Ltd.	15 Nov 2023
Small cell lung cancer limited stage	Phase 3	CN	Shanghai Junshi Biosciences Co., Ltd.	15 Nov 2023
Small cell lung cancer limited stage	Phase 3	BE	Shanghai Junshi Biosciences Co., Ltd.	15 Nov 2023
Small cell lung cancer limited stage	Phase 3	FR	Shanghai Junshi Biosciences Co., Ltd.	15 Nov 2023
Small cell lung cancer limited stage	Phase 3	GE	Shanghai Junshi Biosciences Co., Ltd.	15 Nov 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


HEPATORCH (PRNewswire) Manual	Phase 3	Hepatocellular Carcinoma	326	特瑞普利单抗+贝伐珠单抗	jpdydscqtl(bvqekoatol) = zxllunxyuo uguwtwsdji (uhluvujjxx ) View more	Positive	29 Sep 2024
				索拉非尼	jpdydscqtl(bvqekoatol) = jtjgbkynrm uguwtwsdji (uhluvujjxx ) View more
NCT03430297 (MELATORCH, PRNewswire) Manual	Phase 3	Melanoma First line	255	特瑞普利单抗	pqgoktnjqz(fomvsilqhf) = vkicrxegzf cjtulypkkx (hwmagwrykq ) View more	Positive	29 Sep 2024
				达卡巴嗪	pqgoktnjqz(fomvsilqhf) = mhjmgxxowa cjtulypkkx (hwmagwrykq ) View more
NCT03926338 (PICC, ESMO2024) Manual	Phase 2	Microsatellite instability-high colorectal cancer Neoadjuvant MSI-High \| Deficient DNA Mismatch Repair (dMMR)	43	Toripalimab 3 mg/kg + Celecoxib 200 mg	iygqmqhycr(kjzrqitkpt) = hbabwcoctb oczvqnjzdo (rgcoiqtdvf, 70 - 96) Met View more	Positive	16 Sep 2024
				Toripalimab 3 mg/kg	iygqmqhycr(kjzrqitkpt) = wpfbvwngvg oczvqnjzdo (rgcoiqtdvf, 57 - 88) Met View more
NCT04005170 (EC-CRT-001, ESMO2024) Manual	Phase 2	Esophageal Squamous Cell Carcinoma	42	Toripalimab plus definitive chemoraditoripalimab	uiasdxkehz(ziigusqrjw) = fqsruleajc vtxxjlqjry (bpoavqignj, 31.9 - 62.8) View more	Positive	16 Sep 2024
				Chemotherapy (paclitaxel and cisplatitoripalimab	-
ChiCTR2000030405 (NEOTAX, ESMO2024) Manual	Phase 2	Renal Cell Carcinoma Neoadjuvant	25	Toripalimabaxitinib	gzhkbmyikc(uufxvqgbwz) = kagxpjxfab ynipsitxdi (qaalqvbuua, 62.7 - 97.2) View more	Positive	15 Sep 2024
ChiCTR2000039175 (ESMO2024) Manual	Phase 2	Recurrent Glioblastoma	54	Toripalimab in combination with Anlotinib	teisokylfo(rlfkvtecym) = hvyqmsjmgz tfcuogojjk (ngiignuocb ) View more	Positive	15 Sep 2024
ChiCTR2000035573 (ESMO2024) Manual	Phase 2	Non-Small Cell Lung Cancer First line	40	Toripalimab + CIK + Chemotherapy	tyjuwwgyed(fbwjnrpgxy) = ucrnkqdewu wrptbilnkl (xmbeykygtq ) View more	Positive	14 Sep 2024
				Toripalimab + CIK	tyjuwwgyed(fbwjnrpgxy) = nolldzuvlj wrptbilnkl (xmbeykygtq ) View more
NCT04856631 (ESMO2024) Manual	Phase 1/2	Squamous Cell Carcinoma of Head and Neck First line PD-L1 Positive	43	Toripalimab cetuximab	dqhxggcvfj(mrcfldfedo) = nttuhmvpio fmmzbwqpdx (oxonoshydw, 27.0 - 57.9) View more	Positive	14 Sep 2024
NCT06117566 (ESMO2024) Manual	Phase 1/2	Squamous Cell Carcinoma of Head and Neck	65	WX390aToripalimab	dglmhhawsm(qlaeozbcvg) = yrezhmghid fpglzchkcj (ridkcpjqco ) View more	Positive	14 Sep 2024
				WX390Toripalimab	dlddgxblvo(hzlvinmzjs) = ptmvdoigmi sftzlzpxkg (dhnhkrdozp ) View more
NCT05000684 (WCLC2024) Manual	Phase 1/2	Extensive stage Small Cell Lung Cancer PD-L1 \| HVEM positive	43	Tifcemalimab 200mg + Toripalimab 240mg	pjvgpbxgoz(mciyqedubo) = zsrjkskdsu bnqswqgcln (gcjlwmdvye ) View more	Positive	10 Sep 2024

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