This is a multicenter randomized, open label study to evaluate overall survival with the Bria-IMT regimen in combination with Checkpoint Inhibitor [Retifanlimab], versus Treatment of Patients'/Physicians' Choice (TPC) in advanced metastatic or locally recurrent breast cancer (aMBC) patients with no approved alternative therapies available.

开始日期2023-12-05

申办/合作机构

BriaCell Therapeutics Corp.

NCT03328026

/ Enrolling by invitation临床1/2期

A Phase I/II Study of the SV-BR-1-GM Regimen in Metastatic or Locally Recurrent Breast Cancer Patients in Combination With Retifanlimab

This is an open-label, phase I/II double arm study of the SV-BR-1-GM regimen in combination with retifanlimab in patients with metastatic or locally recurrent breast cancer who have failed standard therapy.
Patients will receive the SV-BR-1-GM regimen with combination immunotherapy. There will be an initial evaluation of the combination of the SV-BR-1-GM regimen with retifanlimab every 3 weeks. If this is found to be safe and well tolerated in a cohort of at least 12 patients (dose-limiting toxicities (DLTs) in less than 30% of the patients evaluated), then an expansion cohort of up to 24 patients will be treated with that combination. These will be randomized to two regimens differing in the timing of checkpoint inhibitor administration.

开始日期2018-03-16

申办/合作机构

BriaCell Therapeutics Corp.

[+1]

NCT03066947

/ Completed临床1/2期

A Phase I/IIa Study of SV-BR-1-GM in Metastatic or Locally Recurrent Breast Cancer Patients

This is a single arm, open label study of SV-BR-1-GM, a targeted immunotherapy for breast cancer. Eligible patients will have histological confirmation of breast cancer with recurrent and/or metastatic lesions. The treatment regimen includes a pre-treatment with low-dose cyclophosphamide 2-3 days before the inoculation; inoculation in 4 sites on the thighs and upper back; and post-treatment inoculation of Interferon-alpha-2b into the sites of inoculation
2 and
4 days after the inoculation. These is repeated every 2 weeks for one month (3 treatments), then monthly for up to one year. Standard tumor assessments are performed at baseline and then every 2-3 months.

开始日期2017-05-05

申办/合作机构

BriaCell Therapeutics Corp.

[+1]

100 项与 SV BR 1 GM cancer vaccine ( BriaCell Therapeutics) 相关的临床结果

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100 项与 SV BR 1 GM cancer vaccine ( BriaCell Therapeutics) 相关的转化医学

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100 项与 SV BR 1 GM cancer vaccine ( BriaCell Therapeutics) 相关的专利（医药）

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项与 SV BR 1 GM cancer vaccine ( BriaCell Therapeutics) 相关的文献（医药）

2024-12-31·Human Vaccines & Immunotherapeutics

Results of a phase I/IIa trial of SV-BR-1-GM inoculation with low-dose cyclophosphamide and interferon alpha (Bria-IMT) in metastatic breast cancer

Article

作者: Lopez-Lago, Miguel ; Adams, Daniel L. ; Williams, William V. ; Holmes, Jarrod P. ; Calfa, Carmen ; Bhattacharya, Saveri ; Lacher, Markus D. ; Chang, Mingjin ; Del Priore, Giuseppe ; Kharazi, Alex ; Dakhil, Shaker R. ; Wiseman, Charles L. ; Peoples, George E.

This Phase I/IIa open-label, single-arm clinical trial addressing advanced, refractory, metastatic breast cancer was conducted at six medical centers in the United States. We repeated inoculations with irradiated SV-BR-1-GM, a breast cancer cell line with antigen-presenting activity engineered to release granulocyte-macrophage colony-stimulating factor (GM-CSF), with pre-dose low-dose cyclophosphamide and post-dose local interferon alpha. Twenty-six patients were enrolled; 23 (88.5%) were inoculated, receiving a total of 79 inoculations. There were six Grade 4 and one Grade 5 adverse events noted (judged unrelated to SV-BR-1-GM). Disease control (stable disease [SD]) occurred in 8 of 16 evaluable patients; 4 showed objective regression of metastases, including 1 patient with near-complete regressions in 20 of 20 pulmonary lesions. All patients with regressions had human leukocyte antigen (HLA) matches with SV-BR-1-GM; non-responders were equally divided between matching and nonmatching (p = .01, Chi-squared), and having ≥2 HLA matches with SV-BR-1-GM (n = 6) correlated with clinical benefit. Delayed-type hypersensitivity (DTH) testing to candida antigen and SV-BR-1-GM generated positive responses (≥5 mm) in 11 (42.3%) and 13 (50%) patients, respectively. Quantifying peripheral circulating tumor cells (CTCs) and cancer-associated macrophage-like cells (CAMLs) showed that a drop in CAMLs was significantly correlated with an improvement in progression-free survival (PFS; 4.1 months vs. 1.8 months, p = .0058). Eight of 10 patients significantly upregulated programmed cell death ligand 1 (PD-L1) on CTCs/CAMLs with treatment (p = .0012). These observations support the safety of the Bria-IMT regimen, demonstrate clinical regressions, imply a role for HLA matching, and identify a possible value for monitoring CAMLs in peripheral blood.

2023-05-01·Recent patents on anti-cancer drug discovery

Regression of Breast Cancer Metastases Following Treatment with Irradiated SV-BR-1-GM, a GM-CSF Overexpressing Breast Cancer Cell Line: Intellectual Property and Immune Markers of Response

作者: Sunkari, Vivekananda G. ; Williams, William V. ; Lacher, Markus D. ; Macúchová, Eva ; Hashwah, Hind ; Dozio, Vito ; Galeas, Jacqueline L. ; Kharazi, Alexander ; Wiseman, Charles L.

Background::

SV-BR-1-GM, derived from a patient with grade 2 (moderately differentiated) breast cancer, is a GM-CSF-secreting breast cancer cell line with properties of antigen-presenting cells. SV-BR-1-GM and next-generation versions are covered by several pending and granted patents.

Methods::

We report findings from an open-label phase I, single-arm pilot study with irradiated SV-BR-1-GM cells in 3 breast and 1 ovarian cancer subjects. Inoculations were preceded by low-dose intravenous cyclophosphamide and followed by interferon-alpha2b injections into the SV-BR-1-GM inoculation sites. We assessed both cellular and humoral immune responses, and measured expression levels of SV-BR-1-GM HLA alleles.

Results::

Treatment was generally safe and well tolerated. Immune responses were elicited universally. Overall survival was more than 33 months for three of the four patients. As previously reported, one patient had prompt regression of metastases in lung, breast, and soft tissue. Following cessation of treatment, the patient relapsed widely, including in the brain. Upon retreatment, rapid tumor response was again seen, including complete regression of brain metastases. Consistent with a role of Class II HLA in contributing to SV-BR-1-GM’s mechanism of action, this patient allele-matched SV-BR-1-GM at the HLA-DRB1 and HLA-DRB3 loci. We are in the process of developing next-generation SV-BR-1-GM, expressing patient-specific HLAs. Patent applications were filed in various jurisdictions. Thus far, one is granted, in Japan.

Conclusion::

A whole-cell immunotherapy regimen with SV-BR-1-GM cells induced regression of met-astatic breast cancer. We develop intellectual property based on SV-BR-1-GM’s predicted mechanism of action to develop additional whole-cell immunotherapies for cancer patients.

Clinical Trail Registration::

This clinical trial was registered under ClinicalTrials.gov Identifier NCT00095862.

2015-07-01·Anesthesiology1区 · 医学

Effects of an Innovative Psychotherapy Program for Surgical Patients

1区 · 医学

Article

作者: Neuner, Bruno ; Balzer, Felix ; Kerper, Léonie F ; Brähler, Elmar ; Spies, Claudia D ; Krampe, Henning ; Salz, Anna-Lena ; Tafelski, Sascha ; Neumann, Tim ; Wei-Gerlach, Edith ; Glaesmer, Heide ; Wernecke, Klaus-Dieter ; Romanczuk-Seiferth, Nina ; Lau, Alexandra

AbstractAbstract:

In 220 surgical patients with comorbid mental disorders (primarily mood, anxiety and adjustment disorders, or alcohol or tobacco abuse), those randomized to psychotherapy sessions perioperatively and up to 3 months postoperatively were more likely to participate in psychosocial mental health care 6 months after surgery than those randomized to brief written advice only.

Background::

The stepped care program Bridging Intervention in Anesthesiology (BRIA) aims at motivating and supporting surgical patients with comorbid mental disorders to engage in psychosocial mental healthcare options. This study examined the efficacy of BRIA.

Methods::

This randomized, parallel-group, open-label, controlled trial was conducted in the preoperative anesthesiological assessment clinics and surgical wards of a large university hospital in Germany. A total of 220 surgical patients with comorbid mental disorders were randomized by using the computer-generated lists to one of two intervention groups: BRIA psychotherapy sessions up to 3 months postoperatively (BRIA) versus no psychotherapy/computerized brief written advice (BWA) only. Primary outcome was participation in psychosocial mental healthcare options at month 6. Secondary outcome was change of self-reported general psychological distress (Global Severity Index of the Brief Symptom Inventory) between baseline and month 6.

Results::

At 6-month follow-up, the rate of patients who engaged in psychosocial mental healthcare options was 30% (33 of 110) in BRIA compared with 11.8% (13 of 110) in BWA (P = 0.001). Number needed to treat and relative risk reduction were 6 (95% CI, 4 to 13) and 0.21 (0.09 to 0.31), respectively. In BRIA, Global Severity Index decreased between baseline and month 6 (P < 0.001), whereas it did not change significantly in BWA (P = 0.197).

Conclusions::

Among surgical patients with comorbid mental disorders, BRIA results in an increased engagement in subsequent therapy options and a decrease of general psychological distress. These data suggest that it is reasonable to integrate innovative psychotherapy programs into the context of interdisciplinary surgical care.

项与 SV BR 1 GM cancer vaccine ( BriaCell Therapeutics) 相关的新闻（医药）

2025-02-03

·briacell.com

BriaCell Announces Resolution of Lung Metastasis in First Patient treated with Bria-OTS(TM)

Lung metastasis (from metastatic breast cancer) resolved – after only 2 months (4 doses) of treatment with Bria-OTS™ monotherapy No toxicity related to the treatment; Patient remains on study Unprecedented result in first patient dosed supports Bria-OTS™ personalized immunotherapy approach Ongoing Phase 1/2a dose escalation study to evaluate Bria-OTS™, BriaCell’s personalized off-the-shelf immunotherapy in metastatic breast cancer PHILADELPHIA and VANCOUVER, British Columbia, Feb. 03, 2025 (GLOBE NEWSWIRE) — BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, is pleased to announce an unprecedented clinical response including resolution of a lung metastasis (breast cancer tumor that spread to the lung) with stable disease elsewhere. This patient is the first metastatic breast cancer (MBC) patient treated with Bria-OTS™. Bria-OTS™ is a personalized off-the-shelf immunotherapy, currently under investigation in a Phase 1/2a dose escalation study (ClinicalTrials.gov identifier: NCT06471673 ) in metastatic recurrent breast cancer. Bria-OTS™ represents a personalized, next generation, advancement of BriaCell’s lead candidate Bria-IMT™ which is currently in a pivotal Phase 3 study for metastatic breast cancer. Figure 1: Treatment with Bria-OTS™ monotherapy resulted in 100% resolution of tumor in the lung of the MBC patient following 4 injection cycles[1] As shown in Figure 1, the lesion in the patient’s right lung (left side of the image) is no longer detectable on the images taken 2 months after treatment with Bria-OTS™ monotherapy. This 78-year-old woman with metastatic breast cancer (hormone receptor positive, HER2 negative) had failed several prior lines of therapy and received the lowest dose level in the Phase 1/2a Bria-OTS™ study. At enrollment on Nov 21, 2024, she had extensive metastases including multiple bone, lymph node and lung metastases. Following 4 injections with Bria-OTS™ every 2 weeks, the lung metastasis completely resolved, and she had stable disease elsewhere. “Despite recent advancements in cancer treatment with antibody-drug-conjugates (ADCs) and immune check point inhibitors (CPIs), metastatic breast cancer remains an unmet medical need as many patients do not respond to these treatments,” stated Dr. Neal Chawla, Associate Director of Clinical Research at the Sarcoma Oncology Center, and Principal Investigator for the Bria-OTS™ study. “We are very impressed by the clinical response observed showing rapid and robust clinical activity in addition to excellent tolerability in the first patient treated with Bria-OTS™ and look forward to reproducing these results in other cancer patients in the study.” “This data supports our hypothesis of personalized immunotherapy with Bria-OTS™, potentially leading to new and effective treatment of metastatic breast cancer,” stated Dr. William V. Williams, BriaCell’s President and CEO. “We hope to transform the way we treat cancer patients with our novel personalized off-the-shelf immunotherapy approach.” “Resolution of metastatic lung disease in this breast cancer patient highlights the clinical effectiveness of Bria-OTS™, and its therapeutic potential in MBC,” commented Dr. Giuseppe Del Priore, BriaCell’s Chief Medical Officer. “This result represents a major step towards advancing our innovative technology platform and our goal of offering safe and effective treatment to MBC patients and our plans to extend into prostate cancer, melanoma, and lung cancer.” The Phase 1/2a clinical trial is initially evaluating the safety and efficacy of Bria-OTS™ as monotherapy and, later, in combination with an immune checkpoint inhibitor in metastatic breast cancer. Key inclusion criteria include recurrent metastatic breast cancer and at least two failed prior attempts of systemic therapy (e.g., chemotherapy). The study design includes a dose escalation monotherapy phase followed by an expansion phase that will include combination therapy with an immune check point inhibitor. About BriaCell Therapeutics Corp. BriaCell is a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care. More information is available at https://briacell.com/ . Safe Harbor This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release include statements regarding: BriaCell reproducing similar results in other cancer patients in BriaCell’s Phase 1/2a Bria-OTS™ study; Bria-OTS™ potentially leading to new and effective treatment of metastatic breast cancer; BriaCell transforming the way we treat cancer patients with its novel personalized off-the-shelf immunotherapy approach; the clinical effectiveness of Bria-OTS™ and its therapeutic potential in MBC; BriaCell’s technology offering a safe and effective treatment to MBC patients; BriaCell’s plans to extend into prostate cancer, melanoma, and lung cancer; and BriaCell’s Phase 1/2a clinical trial initially evaluating the safety and efficacy of Bria-OTS™ as monotherapy and later in combination with an immune checkpoint inhibitor in metastatic breast cancer. Forward-looking statements may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully under the heading “Risks and Uncertainties” in the Company’s most recent Management’s Discussion and Analysis, under the heading “Risk Factors” in the Company’s most recent Annual Information Form, and under “Risks and Uncertainties” in the Company’s other filings with the Canadian securities regulatory authorities and the U.S. Securities and Exchange Commission, all of which are available under the Company’s profiles on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov . Forward-looking statements contained in this announcement are made as of this date, and BriaCell Therapeutics Corp. undertakes no duty to update such information except as required under applicable law. Neither the Toronto Stock Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Toronto Stock Exchange) accepts responsibility for the adequacy or accuracy of this release. Contact Information Company Contact: William V. Williams, MD President & CEO 1-888-485-6340 info@briacell.com Media Relations: Jules Abraham CORE IR julesa@coreir.com Investor Relations Contact: CORE IR investors@briacell.com A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/90d9b907-91ef-40c5-ac9f-87ff883327f6 [1]Note that the other white dots in the lungs are blood vessels.

免疫疗法临床3期临床结果

2025-01-01

·梅斯医学

超10款，有望“治愈”肿瘤的疫苗已在路上！或开创癌症治疗新时代

近年来，全球肿瘤疫苗的研发领域迎来了前所未有的发展浪潮。随着科技的飞速进步，特别是随着人工智能、mRNA疫苗技术的崛起，肿瘤疫苗作为癌症预防与治疗的新兴手段，正逐步从实验室走向临床应用，为全球癌症患者带来了新的希望。下面小编就结合全球肿瘤疫苗的研发管线，盘点一下研发进度相对靠前的部分肿瘤疫苗。值得注意的是，树突状细胞DC疫苗DCVax-L三期已经成功，mRNA疫苗mRNA-4157已经启动三期临床，有望在2025年上市。 DCVax-L：树突状细胞（DC）疫苗该候选疗法是一种个性化的免疫疗法，由患者自身肿瘤样本中的树突细胞和抗原(生物标记物)制成。适应症：胶质母细胞瘤临床进展：三期结果达到积极顶线结果三期结果显示：新诊断的GBM患者(n=232)随机化后的中位总生存期(mOS)为19.3个月(手术后22.4个月)，而对照组随机化后的mOS为16.5个月(HR=0.80, p=0.002)；48个月生存率为15.7% vs. 9.9%， 60个月生存率为13% vs. 5.7%。新诊断胶质母细胞瘤患者的总生存率复发性GBM (n=64)的mOS为复发后13.2个月vs. 7.8个月(HR = 0.58, p<0.001)；复发后24个月和30个月生存率分别为20.7% vs.9.6%，11.1% vs.5.1%。复发胶质母细胞瘤患者的总生存率在新诊断的伴有MGMT甲基化的GBM患者中，使用DCVax-L治疗的mOS为30.2个月(手术后33个月)，而对照组为21.3个月(n=199) (HR=0.74, p=0.027)。目前国内DC疫苗领域也取得了重大的突破，恒瑞源正研发的MASCT-I已经进入临床Ⅱ期，启辰生生物、康德赛医疗、立康生命、中生康元及恒赛生物等公司的DC候选药物也已经步入了一期临床，其中多款候选药物并展现出了良好的早期疗效。PDS0101：HPV阳性癌症疫苗简介：PDS0101是一种针对人乳头瘤病毒（HPV）的新型研究性免疫疗法，专为HPV阳性癌症设计。通过强烈刺激T细胞攻击，该疫苗展现出显著的抗癌潜力。可与其他免疫疗法和癌症治疗联合使用，以增强治疗效果。临床进展：2期临床在2024年欧洲肿瘤内科学会（ESMO）大会上发布的研究显示，癌症疫苗PDS0101联合PD-1免疫药物K药，显著提高了HPV16阳性的复发或转移性头颈鳞状细胞癌（HNSCC）患者的治疗效果。在53名PD-L1阳性（指标预示免疫治疗可能有效）的患者中，接受新型HPV疫苗PDS0101联合K药治疗的患者，平均生存时间为30个月。Bria-IMT：乳腺癌联合免疫治疗方案简介：Bria-IMT 方案是使用同种异体全肿瘤细胞疫苗联合检查点抑制剂 (checkpoint inhibitors, CPIs) 的联合免疫治疗。皮内给予经辐照的 SV-BR-1-GM 乳腺癌细胞能够分泌GM-CSF，并通过HLA-I和HLA-II分子提呈肿瘤相关抗原（TAAs），从而直接激活抗肿瘤免疫反应。作用机制：间接和直接刺激人体自身的抗癌细胞，包括激活CD4+和CD8+ T细胞，增强抗肿瘤免疫反应。临床进展：3期 1/2期临床试验显示，BRIA-IMT 治疗显示出较好的安全性，同时使得多药治疗无效的进展/转移性乳腺癌患者获益。研究者在接受3期制剂患者中观察到更好的疗效和生存率。该制剂已应用于正在进行中的3期临床试验， BNT116：非小细胞肺癌mRNA免疫疗法简介：BNT116是由BioNTech公司开发的基于mRNA技术的癌症疫苗，专用于治疗非小细胞肺癌（NSCLC）。工作原理：通过编码NSCLC细胞经常表达的抗原，触发免疫反应，激活免疫系统识别和攻击癌细胞。临床进展：1/2期试验正在进行中 2023 年公布的一项针对该疫苗用于 NSCLC 治疗的 I 期试验结果发现，89% 既往接受过 3 种以上的治疗 18 例 NSCLC 患者接受 BNT116 治疗后，6 例患者达到疾病稳定（SD），中位疾病控制时间为 1.53 个月。ELI-002 7P：KRAS突变型癌症肽疫苗简介：ELI-002 7P是由Elicio Therapeutics开发的治疗性癌症疫苗，旨在刺激针对七种最常见的KRAS突变的免疫应答。给药方式：利用专有AMP平台，有效传递到淋巴结。临床进展：2期试验 1期试验显示，该疫苗具有良好的耐受性，显著降低了肿瘤生物标志物，引发了强烈的T细胞反应，减少了患者的复发和死亡风险，。BNT111：现货型、表达黑色素瘤相关抗原的mRNA癌症疫苗临床进展：一项随机2期临床试验正在进行中，以评估其与cemiplimab联合治疗对PD1/PD-L1抑制剂耐药/复发、不可切除的III或IV期黑色素瘤患者的效果。BNT122：个性化mRNA疫苗简介：BNT122是由BioNTech和基因泰克联合开发的个性化mRNA癌症疫苗给药方式：通过mRNA表达患者肿瘤中的新抗原，使用脂质纳米颗粒（LNP）静脉注射给药。临床进展：临床试验显示，该疫苗能够激活并持续刺激患者体内的T细胞，降低癌症复发风险。目前正在进行多项2期临床试验，包括评估其在高风险肌层浸润性尿路上皮癌、切除后的胰腺导管腺癌、结直肠癌和一线晚期黑色素瘤中的疗效。 BNT123：编码HPV16抗原mRNA疫苗临床进展：目前正在全球范围内进行一项随机2期临床试验，以评估其与PD1抑制剂pembrolizumab联合治疗PD-L1+、HPV16+头颈部鳞状细胞癌的疗效。 mRNA-4157（V940）：高危黑色素瘤的个性化mRNA疫苗简介：mRNA-4157（V940）是由Moderna和默沙东联合开发的个性化mRNA癌症疫苗，专为高危黑色素瘤患者设计。疫苗设计：包含编码多达34种新抗原的单一合成mRNA分子，根据每位患者肿瘤独特的DNA序列突变特征设计而成。联合疗法：与PD-1抑制剂帕博利珠单抗联合使用，进一步提高患者免疫系统的能力。临床进展：三期临床（全球进展最快的mRNA疫苗之一） 1/2期临床结果显示，在中位随访期34.9个月中，与Keytruda单药相比，mRNA-4157与Keytruda联合治疗可使患者的复发或死亡风险降低49%，远处转移或死亡风险降低62%。获得美国FDA突破性疗法认定，有望成为首款上市的mRNA肿瘤疫苗，最早或将于2025年问世！SCIB1：黑色素瘤质粒DNA疫苗简介：SCIB1是由Scancell ImmunoBody公司开发的基于质粒DNA的癌症疫苗，专用于治疗黑色素瘤。疫苗设计：编码来自黑色素瘤抗原酪氨酸酶相关蛋白-2（TRP-2）和糖蛋白100（GP100）的CD8和CD4表位。独特之处：靶向树突状细胞，引起更广泛的免疫作用来抗击肿瘤。临床进展：1/2期。最新公布的数据显示，SCIB1联合双免疫疗法Opdivo+Yervoy的一线治疗在晚期不可切除黑色素瘤患者(n=13)中的总反应率(ORR)达到85%。VBI-1901：复发性胶质母细胞瘤的病毒样颗粒疫苗简介：VBI-1901是由VBI Vaccines Inc.开发的创新癌症疫苗免疫疗法，专门针对复发性胶质母细胞瘤（GBM）。疫苗设计：利用包膜病毒样颗粒（eVLP）技术，靶向两种高度免疫原性的巨细胞病毒（CMV）抗原。临床进展：2b期数据显示，该疫苗将GBM患者中位总生存期延长了5个月（疫苗组12.9：对照组8个月），疾病控制率更是从0跃升至40%。这一突破性成果使FDA授予其快速通道指定和孤儿药资格。 DOC1021：胶质母细胞瘤的树突细胞疫苗简介：DOC1021是由Diakonos Oncology开发的树突细胞疫苗，用于治疗胶质母细胞瘤（GBM）。疫苗设计：通过模仿病毒感染患者的癌症标志物，利用人体发现和杀死受感染细胞的能力。独特之处：采用“双重加载”技术，刺激新型病毒识别和反应途径。临床进展：临床试验正在进行中，评估其疗效和安全性。GNOS-PV02：晚期肝细胞癌的DNA新抗原疫苗简介：GNOS-PV02是由Genexine公司开发的个性化DNA新抗原疫苗，用于治疗晚期肝细胞癌（HCC）。疫苗设计：包含一个DNA质粒，编码多达40个从患者肿瘤样本中确定的新抗原。给药方式：与编码细胞因子白介素-12（IL-12）的DNA质粒共配方，通过皮内注射和体内电穿孔给药。临床进展：1/2期临床试验结果显示，该试验达到了安全性和免疫原性的主要终点，以及基于缓解率的疗效次要终点。在36名晚期肝癌患者中，有11名（30.6%）对该疫苗与KY药联合疗法产生缓解，这大约是过去对照药物缓解率的两倍。其中3例患者达到了CR，8例患者达到了部分缓解（PR）。数据截止时，患者的mOS为19.9个月。 ▲GNOS-PV02治疗晚期肝癌患者的临床结果Galinpepimut-S：WT1靶向的癌症疫苗简介：Galinpepimut-S（GPS）是由SELLAS Life Sciences Group开发的靶向WT1（Wilms肿瘤蛋白）的癌症疫苗。疫苗设计：由4条多肽链构成，抗原表位多达25个，能够激发自身免疫系统对WT1抗原产生强烈的免疫反应。临床进展：1期临床新数据显示，该试验达到了安全性和疗效的主要终点，Galinpepimut-S（GPS）联用纳武利尤单抗治疗恶性胸膜间皮瘤，患者的中位总生存期（OS）约为接受标准治疗的患者的2.5倍。接受联合疗法的患者的中位OS为70.3周，而接受标准治疗的复发/难治性患者的中位OS约为28周。对GPS没有免疫反应的患者的中位OS为9.0个月，对GPS有免疫反应的患者的中位OS为27.8个月。结语展望未来，全球肿瘤疫苗的研发之路虽然充满挑战，但随着各国科研人员的共同努力、新技术的不断涌现以及国际合作的不断深化，我们有理由相信，肿瘤疫苗将在癌症治疗中发挥越来越重要的作用，为全球癌症患者带来更加精准、高效的治疗方案。这一领域的持续进步，不仅将推动医学科学的发展，更将为人类健康事业作出重要贡献。声明：本文旨在促进医药学术的沟通和交流，仅供医疗卫生专业人士参阅，梅斯医学不对任何药品和/或适应症作推荐。文中涉及的药品信息仅供参考，不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议。若您想了解具体疾病诊疗信息，请遵从医院医生的意见或指导。往期 · 推荐啊！这三种常见早餐每多吃一次，都是在加速肿瘤生长间歇化疗、节拍化疗、剂量密集化疗分别是什么？有何区别怎么处理癌痛？一文讲清癌痛诊疗、评估要点和治疗措施！一天一包烟反而不患肺癌？nature新研究：重度吸烟者能复原积累的突变，保护自己免受肺癌侵害星标🌟“梅斯肿瘤新前沿” 🌟及时接收每篇新鲜出炉的推文！

疫苗免疫疗法临床2期信使RNA临床3期

2024-12-13

·GlobeNewswire-Health Care

BriaCell 2024 SABCS® Poster Highlights Ability of Bria-IMT™ Regimen to Increase Cancer-Fighting Immune Cells in Metastatic Breast Cancer

BriaCell reports influx of cancer fighting CD8+ “killer” T cell into metastatic breast cancer tumors and lymph organs turning “Cold” tumors and lymph nodes “Hot” on ImmunoPET imaging in cancer patients treated with Bria-IMT™ plus an immune checkpoint inhibitor (CPI)Imaging confirms clinical responses seen in metastatic breast cancer correlate with increase in CD8+ “killer” T Cells in lesions and lymph nodes PHILADELPHIA and VANCOUVER, British Columbia, Dec. 13, 2024 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, highlights the infiltration of cancer fighting immune cells into tumors, using leading CD8 ImmunoPET imaging technology, in its poster presentation at the 2024 San Antonio Breast Cancer Symposium ® at Henry B. Gonzalez Convention Center, San Antonio, TX. Today’s poster shows influx of cancer fighting immune cells into tumors and lymphatic tissue leading to cancer cell destruction following treatment with the Bria-IMT™ plus CPI regimen. BriaCell employed this advanced imaging technology as a precision diagnostic tool to monitor patients’ immune system responses in its phase 2 study, establishing the ability of the Bria-IMT™ regimen to induce tumor infiltration with CD8+ “killer” T cells. These results suggest a potential value of CD8 ImmunoPET in identifying pseudo progression in patients with clinical benefit vs tumor progression. CD8+ T cell infiltration also correlated with a marked reduction in tumor markers, indicating clinical benefit, in some patients. “We are excited to successfully utilize innovative technology such as CD8 ImmunoPET imaging to gain insight into the mechanism of action and potential strength of the BriaCell immunotherapy program,” stated Russ Kuker, MD, Associate Professor of Clinical Radiology at the University of Miami Miller School of Medicine and author of the P5-10-12 poster. “By employing more accurate precision imaging techniques, we have been able to document the mechanism of action of the Bria-IMT™ regimen as we progress this therapy to revolutionize the way we treat cancer patients and improve patient outcomes,” noted Giuseppe Del Priore, MD, MPH, BriaCell’s Chief Medical Officer. The details about the poster presentation are as follows:Abstract Number: SESS-1069Title: Bria-IMT CD8+ tumor infiltrating lymphocytes turn “Cold” tumor “Hot” in metastatic breast cancerTime: Friday, December 13, 2024 12:00 PM – 2:00 PM CSTPresentation ID: P5-10-12CD8 ImmunoPET imaging, an imaging analysis technology, is used to mark CD8+ T-cells (also known as cytotoxic “killer” T cells) that are important components of the immune system and key to cancer cell detection and destruction. Bria-IMT™ plus CPI produced cancer-fighting CD8+ T cells infiltration into metastatic tumors and lymphoid tissue, leading to cancer destruction - turning “Cold” tumors and lymph nodes “Hot” on ImmunoPET imaging Using metastatic site-specific CD8+ PET imaging technology, BriaCell reports the following in 6 patients treated {median # of prior treatments = 7; prior lines of treatment included antibody-drug conjugates (ADCs) and CPIs} with Bria-IMT™ plus CPI after 9 cycles (27weeks) of treatment: Treatment generally well toleratedReduction in tumor markers in 2 patients who had cold tumors turn hot3 out of the 6 patients (50%) showed a decrease in neutrophil/lymphocyte ratio (NLR) at cycle 2 when compared to baseline values suggesting immune system activation of the patientsEvidence of “cold” tumors and lymph nodes becoming “hot” suggesting immune system activation in the patientsImmune system activation results in increased migration of cancer-fighting CD8+ T-cells into MBC tumors and lymphatic tissue, leading to destruction of cancer cellsImmune response following peripheral non-lesional Bria-IMT™ therapy suggests systemic activation of the immune systemClinical and CD8+ T cell response support the clinical benefit of the Bria-IMT™ plus CPI regimen in cancer patients In summary, advanced ImmunoPET imaging technology correlates with clinical benefit with the Bria-IMT™ combination regimen in metastatic breast cancer and suggests possible use in identifying immunotherapy responsive tumors. These findings support the continued use of the Bria-IMT™ combination regimen in BriaCell’s ongoing pivotal Phase 3 study (listed on ClinicalTrials.gov as NCT06072612) in MBC. To view the posters, please visit https://briacell.com/scientific-publications/. About BriaCell Therapeutics Corp. BriaCell is a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care. More information is available at https://briacell.com/. Safe Harbor This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements, including those about BriaCell’s phase 2 study results suggesting a potential value of CD8 ImmunoPET in identifying pseudo progression in patients with clinical benefit vs tumor progression; the Bria-IMT™ regimen having the ability to revolutionize the treatment of cancer patients and improve patient outcomes; and the potential use of the Bria-IMT™ combination regimen in identifying immunotherapy responsive tumors are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements, such as those are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully under the heading “Risks and Uncertainties” in the Company’s most recent Management’s Discussion and Analysis, under the heading “Risk Factors” in the Company’s most recent Annual Information Form, and under “Risks and Uncertainties” in the Company’s other filings with the Canadian securities regulatory authorities and the U.S. Securities and Exchange Commission, all of which are available under the Company's profiles on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov. Forward-looking statements contained in this announcement are made as of this date, and BriaCell Therapeutics Corp. undertakes no duty to update such information except as required under applicable law. Neither the Toronto Stock Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Toronto Stock Exchange) accepts responsibility for the adequacy or accuracy of this release. Contact Information Company Contact:William V. Williams, MDPresident & CEO1-888-485-6340info@briacell.com Media Relations:Jules AbrahamCORE IRjulesa@coreir.com Investor Relations Contact:CORE IRinvestors@briacell.com

免疫疗法临床2期临床结果临床3期

100 项与 SV BR 1 GM cancer vaccine ( BriaCell Therapeutics) 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
乳腺癌	临床3期	美国	BriaCell Therapeutics Corp.	2023-12-05
转移性乳腺癌	临床2期	美国	BriaCell Therapeutics Corp.	2017-05-05
转移性乳腺癌	临床2期	美国	LumaBridge LLC初创企业	2017-05-05
卵巢上皮癌	临床1期	美国	BriaCell Therapeutics Corp.	-

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03328026 (SABCS2024 \| GlobeNewswire) 人工标引	临床1/2期	转移性乳腺癌	54	Bria-IMT regimen with pembrolizumab/retifanlimab	顧窪積構鏇襯遞醖願鹽(簾糧窪憲遞廠網願繭廠) = 構鬱憲淵簾鬱鑰壓簾淵艱鹽遞範鏇顧獵糧艱積 (襯鏇憲積繭糧衊製簾願 )	积极	2024-12-11
NCT03328026 (SABCS2024 \| GlobeNewswire) 人工标引	临床1/2期	转移性乳腺癌	54	Bria-IMT regimen with pembrolizumab/retifanlimab (without IFN incubation; phase 3 formulation)	顧窪積構鏇襯遞醖願鹽(簾糧窪憲遞廠網願繭廠) = 壓遞觸網構願構夢網簾艱鹽遞範鏇顧獵糧艱積 (襯鏇憲積繭糧衊製簾願 ) 更多	积极	2024-12-11
NCT06072612 (GlobeNewswire) 人工标引	临床2期	转移性乳腺癌	54	Bria-IMT™ regimen + immune checkpoint inhibitor (since 2022)	艱鹽獵鑰網觸蓋選膚鏇(構糧鏇鬱膚衊襯簾繭齋) = 遞窪鹹糧憲糧醖顧鑰憲選餘艱鬱衊淵範遞淵鏇 (構遞淵簾積遞餘積糧壓 ) 更多	积极	2024-09-11
NCT06072612 (GlobeNewswire) 人工标引	临床2期	转移性乳腺癌	54	Bria-IMT™ regimen + immune checkpoint inhibitor (total)	艱鹽獵鑰網觸蓋選膚鏇(構糧鏇鬱膚衊襯簾繭齋) = 鏇淵選獵膚鏇遞觸鹹繭選餘艱鬱衊淵範遞淵鏇 (構遞淵簾積遞餘積糧壓 ) 更多	积极	2024-09-11
NCT03328026 (ASCO2024) 人工标引	临床1/2期	转移性乳腺癌 \| 晚期乳腺癌 CAMLs \| CTCs	54	SV-BR-1-GMegimen with oriretifanlimabce	艱築繭醖範遞顧膚夢鏇(構選齋構繭憲構鹽鹽鹹) = 範選遞網窪膚淵範鹹鏇鬱壓積蓋齋繭廠糧繭衊 (淵糧蓋夢鬱夢憲獵鏇艱 ) 更多	积极	2024-05-24
NCT03328026 (SV-BR-1-GM, ASCO2024)	临床2期	转移性乳腺癌	54	Bria-IMT + CPI	憲築鑰製願獵網築艱夢(願夢鏇遞顧壓網遞窪網) = 43% (10/23) reported grade 3 or 4 AEs, independent of study drug causality. AEs included injection site reaction (39%), fatigue (26%), and nausea/vomiting (43%), mostly mild to moderate. One case of elevated lipase was the most clinically significant grade 4 AE. No interstitial lung disease (ILD) was reported. 繭膚壓糧選選憲廠築鬱 (觸壓艱夢築糧網餘齋構 ) 更多	积极	2024-05-24
AACR2024	N/A	肿瘤转移 ER+/PR+ \| HER2- \| ER-/PR- ... 更多	-	Bria-IMT monotherapy	鏇網鹽網蓋壓齋糧積選(鏇簾顧簾夢淵築壓鬱襯) = 鹽鬱簾衊醖網顧窪鏇製鏇齋衊築顧繭構製願衊 (選醖選範壓鏇憲餘餘艱 )	-	2024-04-05
AACR2024	N/A	肿瘤转移 ER+/PR+ \| HER2- \| ER-/PR- ... 更多	-	Bria-IMT + immune checkpoint inhibitor	鏇網鹽網蓋壓齋糧積選(鏇簾顧簾夢淵築壓鬱襯) = 積膚憲衊構鹹範築艱積鏇齋衊築顧繭構製願衊 (選醖選範壓鏇憲餘餘艱 )	-	2024-04-05
AACR2024	临床2期	转移性乳腺癌	23	Bria-IMT™ + CPI	選選網蓋鏇網願憲獵鑰(醖鏇鹹襯窪夢簾構憲壓) = 43% (10/23) reported grade 3 or 4 AEs, independent of study drug causality. No interstitial lung disease (ILD) reported. AEs included injection site reaction (39%), fatigue (26%), and nausea/vomiting (43%), mostly mild to moderate. One case of elevated lipase was the most clinically significant grade 4 AE. 簾構繭顧觸遞蓋遞鹽壓 (膚觸艱顧觸築獵蓋鏇夢 ) 更多	-	2024-04-05
GlobeNewswire 人工标引	N/A	晚期乳腺癌	-	Bria-IMT±Checkpoint Inhibitor	鏇構餘艱繭製獵築糧蓋(構構淵窪蓋簾獵選構鹹) = 觸製遞衊鑰衊艱廠網繭製願糧窪願繭餘襯鹹衊 (遞夢簾餘網製簾鹹鏇網 )	积极	2023-12-28
NCT03328026 (Biospace) 人工标引	临床2期	转移性乳腺癌	54	Bria-IMT+CPI	蓋築鹽蓋淵艱網顧壓願(簾顧構餘製築窪夢艱積) = 遞獵遞艱窪網築簾遞廠衊餘獵鹹繭衊獵範構齋 (鑰糧餘鏇餘淵醖齋製構 ) 更多	积极	2023-12-06
GlobeNewswire 人工标引	临床2期	HR阳性/HER2阳性乳腺癌 Hormone Receptor/HER2 Positive \| Hormone Receptor Positive	1	Bria IMT	顧壓獵網範鏇選窪襯鏇(選繭襯廠構願鏇簾鬱網) = After only 3 cycles, patient experienced a remarkable improvement of eye-bulging “proptosis” caused by orbital metastatic breast cancer tumor behind the eye. 糧顧觸築蓋鏇衊鹽鏇廠 (壓製鏇淵廠衊繭壓鏇憲 ) 更多	积极	2023-11-30
NCT03066947 \| NCT03328026 (AACR2023) 人工标引	临床1/2期	转移性乳腺癌	51	SV-BR-1-GM	齋獵壓顧窪觸膚構繭範(願遞築夢窪糧夢窪壓簾) = 膚襯繭衊憲鑰範積糧醖窪顧廠餘餘壓顧構艱製 (製繭鑰鹹餘衊齋鹽鬱觸 ) 更多	积极	2023-04-14
NCT03066947 \| NCT03328026 (AACR2023) 人工标引	临床1/2期	转移性乳腺癌	51	SV-BR-1-GM+Pembrolizumab or Retifanlimab	齋獵壓顧窪觸膚構繭範(願遞築夢窪糧夢窪壓簾) = 蓋膚衊夢選築網鹽夢製窪顧廠餘餘壓顧構艱製 (製繭鑰鹹餘衊齋鹽鬱觸 ) 更多	积极	2023-04-14