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）

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. ; Wiseman, Charles L. ; Kharazi, Alexander

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 ; Brähler, Elmar ; Kerper, Léonie F. ; Krampe, Henning ; Salz, Anna-Lena ; Tafelski, Sascha ; Neumann, Tim ; Spies, Claudia D. ; Weiß-Gerlach, Edith ; Wernecke, Klaus-Dieter ; Glaesmer, Heide ; Romanczuk-Seiferth, Nina ; Lau, Alexandra

Abstract:

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.

2004-09-01·Journal of nuclear medicine : official publication, Society of Nuclear Medicine

Molecular transport mechanisms of radiolabeled amino acids for PET and SPECT.

Article

作者: Bröer, Stefan ; Langen, Karl-Josef

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

2024-06-03

·GlobeNewswire-Health Care

BriaCell Presents Clinical Efficacy Data at ASCO 2024

BriaCell doubles Progression-Free-Survival (PFS) and Clinical Benefit Rate vs historical results in the literatureBria-IMT™ PFS compares favorably to PFS of most recent treatment in 48% of Antibody-Drug Conjugate (ADC) resistant patientsTherapy well-tolerated with no Bria-IMT™ related discontinuationsClinical data highlight significant potential of Bria-IMT™ in advanced metastatic breast cancerSuperiority of selected Phase 3 regimen and formulation confirmedOral presentation by Mayo Clinic Professor and Principal Investigator, Saranya Chumsri, MD, on Monday June 3; 11:30 AM-1:00 PM CDT PHILADELPHIA and VANCOUVER, British Columbia, June 03, 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, announces positive clinical efficacy data updates of its ongoing randomized Phase 2 study evaluating lead clinical candidate Bria-IMT™ in patients with advanced metastatic breast cancer. Two poster sessions, one abstract, and one oral presentation session (by Principal Investigator and Professor of Oncology, Mayo Clinic, Saranya Chumsri, MD), will be presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting taking place today June 3, 2024 at McCormick Place, Chicago, IL. “We are very impressed with both clinical efficacy and safety data in these heavily pretreated patients. Given the limited effective treatment options in this group of patients, and the fact that most treatments are associated with significant toxicities, physicians and patients often opt to decline further ineffective and toxic drugs in lieu of palliative care,” Saranya Chumsri, MD, Principal Investigator and Professor of Oncology, Mayo Clinic. “Antibody-drug conjugates (ADCs) and immune checkpoint Inhibitors (CPIs) have emerged as the latest therapies to treat these patients. However, a large percentage of late-stage patients do not respond, and all patients inevitably develop resistance to them, making a safe and effective treatment an urgent medical need. BriaCell’s novel immunotherapy offers a well-tolerated treatment option for these patients beyond the currently approved drugs.” “While immunotherapy has emerged as an active treatment option for multiple cancer types, its use in breast cancer is rather restricted to a minority of patients. Discovering new strategies, in order to enhance the responsiveness of various subtypes of breast cancer to immunotherapy, presents as a therapeutic opportunity. Through its unique mechanism of action, Bria-IMT™ regimen selectively activates adaptive cancer-fighting CD4+ and CD8+ T cells and innate responses (dendritic and NK cells) to activate patients’ immune systems without producing serious side effects,” stated Carmen Calfa, M.D., Clinical Research Lead for the breast site disease group at the University of Miami Miller School of Medicine, Co-Director of the Cancer Survivorship Program at Sylvester Comprehensive Cancer Center, and Principal Clinical Investigator of the Phase 2 Bria-IMT™ study. “Our ASCO presentations highlight how Bria-IMT™’s activities – through diverse mechanisms including adaptive and innate responses - synergize with multiple mechanisms of action of checkpoint inhibitors,” stated Dr. Williams, BriaCell’s President and CEO. “We believe Bria-IMT™ has the potential to become a breakthrough novel treatment option for patients in advanced metastatic breast cancer.” The details of the presentations are summarized below. Oral Presentation Summary Abstract Number for Publication: 1022Title: Outcomes of advanced/metastatic breast cancer (aMBC) treated with Bria-IMT™, an allogeneic whole cell immunotherapy.Session Type and Title: Rapid Oral Abstract – Breast Cancer—MetastaticSession Date and Time: 6/3/2024; 11:30 AM-1:00 PM CDT This presentation details the results of BriaCell’s randomized Phase 2 study of Bria-IMT™ in combination with retifanlimab, an immune checkpoint inhibitor (CPI). The goal of randomization was to compare whether administration of the CPI early, in the first cycle of therapy, or later, late in the second cycle of therapy, offered any advantage. Two different formulations of Bria-IMT™ were also evaluated; one treated with interferon gamma and one untreated. The patients entering the study were very heavily pretreated and had failed multiple prior therapies as shown in the Table 1 below. Table 1. Prior Therapies in the Bria-IMT™ Phase 2 Study Previous TherapiesNumber of Patients (%)Antibody-Drug Conjugates (ADC)23 (44%)Immune Checkpoint Inhibitor (CPI)11 (20%)Cyclin-Dependent Kinase (CDK) 4/6 Inhibitors34 (63%) A total of 54 patients were included in the Phase 1/2 study. Nearly half of these had been treated previously with an antibody drug conjugate and had progressed in their disease following this treatment. Another 20% had failed a prior immune checkpoint inhibitor. Nearly 2/3 of the patients had failed therapy with a CDK 4/6 inhibitor. On average they had failed six prior therapy attempts. In the Phase 2 portion of the study, there were 32 patients with 16 treated with CPI early and 16 treated with CPI late. There was no statistically significant difference in progression-free survival (PFS) two groups. However, a slight advantage in the CPI early group has led this to be the selected regimen for the Phase 3 study. In the entire Phase 1/2 experience, with 54 patients, the formulation not incubated with interferon gamma showed a statistically significant improvement in PFS. Therefore, this formulation was selected for the Phase 3 study. The data are shown in Figure 1. Figure 1. Effect of treatment sequence and formulation on PFS Clinical benefit was seen in 55% of evaluable patients across all subtypes of breast cancer as shown in Figure 2 below. Figure 2: Objective Response Rate (ORR) and Clinical Benefit Rate (CBR) in the Bria-IMT™ Phase 1/2 Study The progression free survival rate and the clinical benefit rate as well as the objective response rate were markedly higher than those of similar patients treated with the treatment of their physician’s choice in other studies. Notably, “Treatment of Physician’s Choice” (TPC) will be the comparator in the Phase 3 study of Bria-IMT™. This is noted in Table 2 below. Table 2. Comparative PFS, ORR and CBR in Similar Patients StudyPrior Lines ofTherapy(median, range)PFS(months)ORR(%)CBR(%)BriaCell's Phase 2 study patients who received pivotal Phase 3 study formulation 6 (2-13)3.99.5*55*BriaCell's ADC Resistant Phase 2 patients who received pivotal Phase 3 study formulation 6 (3-13)4.112**53**Bardia, A. et. al. 14 (2-14)1.748Tripathy D. et. al. 2≥4 in 91%1.9310 O'Shaughnessy J. et. al. non-TNBC 35 (2-14)2.347 O'Shaughnessy J. et. al. TNBC 34 (2-10)1.6510 *Data is for evaluable patients, n=42 with 12 not evaluable. ** Data is for evaluable patients, n = 17 with 6 not evaluable.References: Data is shown for the intent to treat population for the control group treated with treatment of physician’s choice, which is the comparator in the BriaCell Phase 3 study1. Bardia A, et al. J Clin Oncol. 2024 May 20;42(15):1738-1744. 2. Tripathy D, et al. JAMA Oncol. 2022 Nov 1;8(11):1700-1701. jamaoncol.2022.4346. PMID: 36136348. This paper describes patients with brain metastases.3. O'Shaughnessy J, et al. Breast Cancer Res Treat. 2022 Sep;195(2):127-139. For additional detailed information of the clinical data on the oral presentation, please visit BriaCell Doubles Progression-Free-Survival (PFS) and Reports Clinical Benefit Data at ASCO 2024. Poster Presentation Summary The first poster described BriaCell’s ongoing pivotal Phase 3 registrational study in advanced metastatic breast cancer. BriaCell is excited to collaborate on this important program with authors and BriaCell medical advisory board members Sara A. Hurvitz, MD, Professor of Medicine, Fred Hutchinson Cancer Center, Adam M. Brufsky, MD, PhD, Professor of Medicine, University of Pittsburgh School of Medicine, and Massimo Cristofanilli, MD, Professor of Medicine, Weill Cornell Medical College, Cornell University. The second poster described clinical data of Bria-IMT™ in metastatic breast cancer patients who failed antibody drug conjugates (ADCs) and is spearheaded by Chaitali Nangia, MD, Partner, Hoag Medical Group, and Carmen Calfa, MD, Professor of Medicine, University of Miami.Abstract Number for Publication: TPS1137Title: Study of the Bria-IMT™ regimen and CPI vs physicians' choice in advanced metastatic breast cancer (BRIA-ABC).Based on Phase 2 clinical data showing numerous survival and clinical benefit outcomes in advanced breast cancer patients treated with the Bria-IMT™ regimen, the pivotal Phase 3 study has been designed as a multicenter randomized, open label comparison of the Bria-IMT™ regimen plus CPI in one arm versus Treatment of Physicians' Choice (TPC) in metastatic breast cancer patients with no approved alternative therapies available. Patients’ eligibility includes treatment with 2 or more prior regimens. There will be another arm of the Bria-IMT™ regimen alone (monotherapy). For additional information on the pivotal Phase 3 study, please visit ClinicalTrials.gov as NCT06072612. Abstract Number for Publication: 1087Title: SV-BR-1-GM after progression on ADC in patients with metastatic breast cancer. Remarkable progression-free survival and clinical benefit of Bria-IMT™ in ADC resistant advanced metastatic breast cancer Phase 2 clinical data of the Bria-IMT™ regimen in 23 advanced metastatic breast cancer patients who failed multiple prior treatments including ADCs and CPIs (median of 6 prior treatments) are presented. Clinical efficacy In evaluable patients, the ORR was 12% and CBR was 53% which is remarkable versus similar data suggesting clinical benefit.Median PFS of 4.1 months with the Phase 3 formulation was ~twice that seen of patients in similar studies - 1.71 and 2.23 months - who received TPC. The PFS results suggest superior clinical efficacy given the larger number of prior treatments (median of 6) in Bria-IMT™ patients vs those of the other studies (median of 4).Subset specific clinical benefits: Study data to date suggests clinical benefit for multiple breast cancer subtypes including HR+/HER2- (the most common breast cancer subtype, testing positive for estrogen and/or progesterone receptors and negative for human epidermal growth factor receptor 2 or HER2) with a CBR following treatment, of 63% (5 of 8 patients); HER2+ subtype (a positive test for HER2) with a 100% CBR (2 of 2 patients) and HR-/HER2 low subtype (a negative test for estrogen and/or progesterone receptor and a negative test for HER2) showing a CBR of 66% (2 of 3 patients). See Table 3. Table 3: Treatment Efficacy by Metastatic Breast Cancer Subtype in ADC-resistant patients HistologyAll Patients (N)Evaluable (N) PatientsBest ORRBest CBRAll ADC Resistant231712% (2 / 17)53% (9 / 17)ER/PR + / HER2 low or -8813% (1 / 8)63% (5 / 8)HER2+3250% (1 / 2)100% (2 / 2)TNBC127029% (2 / 7) Bria-IMT™ showed potential survival advantage over penultimate treatment in 48% of patients, likely by reversing immune exhaustion in patients irrespective of specific prior ADC. Safety profile Absence of both interstitial lung disease (ILD), a common serious adverse event with ADCs, and Bria-IMT™-related treatment discontinuations underscore Bria-IMT™'s excellent tolerability and favorable safety profile. In summary, the data to date shows that Bria-IMT™ offers extended progression-free survival and clinical benefit in heavily pre-treated, ADC resistant breast cancer patients versus those in other similar studies. BriaCell is closely monitoring ADC resistant patients in its ongoing pivotal Phase 3 study of Bria-IMT™ and CPI in advanced metastatic breast cancer. Title: Differential efficacy of SV-BR-1-GM in inducing intracranial metastasis regression. Superior clinical benefit of Bria-IMT™ regimen - alone or combined with an immune check point inhibitor (CPI) in advanced breast cancer patients with CNS metastatic disease Central nervous system (CNS) metastases, including brain metastases and other intracranial metastases, is a dire clinical situation with very poor survival. Very few therapies have shown any effect on CNS or intracranial metastases in breast cancer and it is a serious unmet medical need. Clinical efficacy: 83% (5/6) intracranial objective response rate (iORR) was reported in evaluable patients with central nervous system (CNS) metastases treated with the Bria-IMT™ regimen, either alone or in combination with an immune checkpoint inhibitor (i.e. PD-1 inhibitor pembrolizumab or retifanlimab). These patients failed multiple prior treatments including 2 antibody-drug conjugates in one case. This is illustrated in Figure 3. Figure 3. Intracranial Tumor Responses in Patients with Intracranial Metastases Treated with Bria-IMT™ Tumor reductions (≥30% reduction in the sum of diameters) were observed in heavily pretreated patients highlighting potential clinical benefit of Bria-IMT™ in managing CNS metastasesThis is a pre-planned subgroup analysis in the pivotal Phase 3 study of Bria-IMT™ providing another opportunity for approval Safety profile: No treatment related discontinuation was reported. In summary, Bria-IMT™’s tumor reductions observed in patients with intracranial disease underlines its potential clinical effectiveness in managing CNS metastatic disease in advanced breast cancer. BriaCell will continue to monitor the data in this subgroup of patients in its ongoing pivotal Phase 3 study in advanced metastatic breast cancer. Treatment of patients with CNS metastatic disease represents a potential additional indication for market approval of Bria-IMT™. Copies of the poster presentations and abstracts are posted on https://briacell.com/scientific-publications/. References Bardia A, et al. Final Results From the Randomized Phase III ASCENT Clinical Trial in Metastatic Triple-Negative Breast Cancer and Association of Outcomes by Human Epidermal Growth Factor Receptor 2 and Trophoblast Cell Surface Antigen 2 Expression. J Clin Oncol. 2024 May 20;42(15):1738-1744. doi: 10.1200/JCO.23.01409. Epub 2024 Feb 29. PMID: 38422473.Tripathy D, et al. Treatment with etirinotecan pegol for patients with metastatic breast cancer and brain metastases: final results from the Phase 3 ATTAIN randomized clinical trial. JAMA Oncol. 2022;8(7):1047-1052. doi:10.1001/jamaoncol.2022.0514.O'Shaughnessy J et al. Analysis of patients without and with an initial triple-negative breast cancer diagnosis in the Phase 3 randomized ASCENT study of sacituzumab govitecan in metastatic triple-negative breast cancer. Breast Cancer Res Treat. 2022 Sep;195(2):127-139. doi: 10.1007/s10549-022-06602-7. Epub 2022 May 11. PMID: 35545724; PMCID: PMC9374646. 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 the presentation at the 2024 ASCO of two poster sessions, one abstract, and the delivery of an oral presentation by Dr. Saranya Chumsri, and the contents of all such materials and presentations; BriaCell's novel immunotherapy offering a well-tolerated treatment option for patients beyond the currently approved drugs; Bria-IMT™ having the potential to become a breakthrough novel treatment option for patients in advanced metastatic breast cancer; “Treatment of Physician’s Choice” (TPC) being the comparator in the Phase 3 study of Bria-IMT™; monotherapy becoming another arm of the Bria-IMT™ regimen; the potential clinical benefit of Bria-IMT™ in managing CNS metastases disease in advanced breast cancer; BriaCell continuing to monitor the data in the intracranial disease subgroup of patients in its ongoing pivotal Phase 3 study in advanced metastatic breast cancer; and the treatment of patients with CNS metastatic disease representing a potential additional indication for market approval of Bria-IMT™, are based on BriaCell’s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. 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, MDPresident & CEO1-888-485-6340info@briacell.com Media Relations:Jules AbrahamCORE IRjulesa@coreir.com Investor Relations Contact:CORE IRinvestors@briacell.com Photos accompanying this announcement are available at https://www.globenewswire.com/NewsRoom/AttachmentNg/6fff10ca-4660-4c6f-bb46-719f0f21887dhttps://www.globenewswire.com/NewsRoom/AttachmentNg/2b7cbddb-da76-486d-b6c3-22894a42933ahttps://www.globenewswire.com/NewsRoom/AttachmentNg/66f03119-a4b3-4d2d-a998-ab355aefdeac

免疫疗法临床结果ASCO会议临床3期临床2期

2024-06-01

·医药观澜

治疗实体瘤，这6款细胞疗法入选ASCO口头报告，来自西比曼/阿斯利康、科济药业等公司！

▎药明康德内容团队报道2024年美国临床肿瘤学会（ASCO）年会已于今日（当地时间5月31日）在美国芝加哥正式开幕。根据ASCO官网摘要信息，今年共有5800+项研究入选本届大会，其中有426项研究入选了“口头报告环节（Oral Abstract Session）”和“快速口头报告（Rapid Oral Abstract Session）环节”。梳理这些口头报告研究，我们发现有近20项细胞疗法相关研究入选，包括了CAR-T细胞疗法、TCR-T细胞疗法、TIL疗法、基于细胞的现货型免疫疗法等等。在这其中，多家中国公司的细胞疗法也入选了ASCO大会口头报告，如科济药业Claudin18.2靶向CAR-T、艺妙神州靶向GUCY2C的CAR-T、博生吉CD7靶向CAR-T产品等。我们注意到，入选本次ASCO大会口头报告的细胞疗法中，有至少6项研究针对的适应症为实体瘤，涵盖胃肠道肿瘤、滑膜肉瘤、肝癌、乳腺癌、黑色素瘤等。在细胞治疗领域，实体瘤曾经是一座难以逾越的高峰，而近年来越来越多的新疗法、新技术正在解决这一挑战，并取得临床突破。本文中我们将一起看看针对实体瘤适应症的细胞疗法，看看它们的临床表现如何？注：本表由《医药观澜》根据ASCO官网摘要整理，如有遗漏，欢迎补充。西比曼生物/阿斯利康：C-CAR031作用机制：自体抗GPC3 CAR-T疗法适应症：肝细胞癌C-CAR031是一种针对肝细胞癌的自体抗GPC3的CAR-T疗法。本次入选口头报告的是该产品治疗晚期肝细胞癌（HCC）患者的1期研究结果。GPC3是HCC中过表达的表面抗原，在健康组织中几乎不存在。截至2024年1月5日，共有24例患者接受了4个剂量水平（DLs）的C-CAR031输注。所有患者均可进行安全性评估。未观察到剂量限制性毒性和免疫效应细胞相关神经毒性综合征（ICANS）。22个患者可评估疗效。90.9%的患者肿瘤缩小，肝内病变和肝外病变患者的中位肿瘤缩小率为44.0%（范围为3.4%~94.4%）。所有患者疾病控制率（DCR）为90.9%，客观缓解率（ORR）为50.0%，DL4的ORR为57.1%。该研究显示C-CAR031在接受过重度治疗的晚期HCC患者中具有可控的安全性和增强的抗肿瘤活性。艺妙神州：IM96作用机制：靶向GUCY2C的CAR-T疗法适应症：结直肠癌IM96是一款靶向鸟苷酸环化酶2C（GUCY2C）的CAR-T疗法，本次入选口头报告的是该产品治疗转移性结直肠癌患者的1期研究结果。GUCY2C在结直肠癌的所有阶段均异位表达。截至2023年12月，20名患者入组并注射了IM96，所有患者随访时间为7~19个月。安全性数据显示，只有5%的患者表现出神经毒性和3级细胞因子释放综合征（CRS），研究没有达到剂量限制毒性和最大耐受剂量。19例可评估患者中，DCR为73.7%，ORR为26.3%。DL3组（12×108）患者的ORR为40.0%，与肝转移与否无关。DL3组中位无进展生存期为7个月，中位缓解持续时间为10个月。在所有患者中，肿瘤应答与癌胚抗原水平的显著降低相关。本研究表明，IM96在错配修复完整（pMMR）mCRC患者中具有持久的疗效和可接受的安全性，特别是在肝转移患者中显示出较高的治疗潜力。科济药业：CT041作用机制：靶向Claudin18.2自体CAR-T细胞候选产品适应症：胃肠道肿瘤CT041是一种靶向Claudin18.2蛋白的自体CAR-T细胞候选产品，正在针对晚期胃癌/食管胃结合部腺癌的确证性2期临床试验。本次入选口头报告的是一项治疗胃肠道肿瘤患者的1期临床研究数据。疗效数据显示，所有患者的ORR和DCR分别达到37.8%和75.5%。所有患者的中位无进展生存期（PFS）和中位总生存期（OS）分别为4.4个月和8.4个月。在接受CT041单药治疗的可评估疗效的胃癌患者中，有可测量疾病（n=47）的ORR和DCR分别达到57.4%和83.0%，所有可评估疗效的胃癌患者（n=55）的中位PFS和中位OS分别为5.8个月和9.7个月。研究人员认为，CT041在大量预处理的Claudin18.2阳性晚期GI癌症患者中显示出有希望的安全性和高度令人鼓舞的疗效。Adaptimmune：letetresgene autoleucel（lete-cel）作用机制：靶向NY-ESO-1抗原的TCR-T疗法适应症：滑膜肉瘤或粘液样/圆形细胞脂肪肉瘤Lete-cel为一种靶向NY-ESO-1实体瘤抗原的工程化T细胞受体（TCR）-T细胞疗法。NY-ESO-1通过在HLA-A*02于滑膜肉瘤和黏液样/圆细胞脂肪肉瘤（MRCLS）中高度表达。本次入选口头报告的是一项2期临床研究结果。研究纳入98名滑膜肉瘤和MRCLS患者，45名患者可评估疗效。结果显示，总体ORR为40%（包括2例CR，16例PR），其中滑膜肉瘤和MRCLS患者的ORR分别为39%和41%。中位反应持续时间为10.6个月。在该研究中，不良事件与先前观察到的一致。研究人员认为，该研究进一步支持了Lete-cel作为晚期滑膜肉瘤和MRCLS疗法的潜力。Obsidian Therapeutics：OBX-115作用机制：靶向IL-15的TIL疗法适应症：黑色素瘤OBX-115是一款保留白细胞介素2（IL2）的工程化肿瘤浸润淋巴细胞（TIL）疗法，该产品使用经FDA批准的小分子药物乙酰唑胺（ACZ）调节膜结合IL15的表达，为TIL的扩增和存续提供细胞因子支持，因此患者在接受该疗法治疗时不需要同时接受高剂量IL2。该产品目前正处于1/2期多中心研究阶段。入选口头报告的是一项1期研究结果，评估了OBX-115方案在ICI耐药、不可切除/转移性黑色素瘤患者中的疗效和安全性。截至2024年1月2日，9名黑色素瘤患者接受了OBX-115输注，他们既往治疗的中位线为3。在至少12周随访的患者中（n=6），按RECIST v1.1计算的ORR为50%（2例CR，1例PR，3例SD）；所有反应都发生在第6~18周之间，最长反应持续时间>12个月。研究人员认为，OBX-115治疗耐受性良好，产生持续加深和持久的反应，表明其可能介导无大剂量IL2的ICI耐药转移性黑色素瘤的完全缓解和持久的临床益处。BriaCell公司：Bria-IMT（SV-BR-1-GM）作用机制：基于细胞的靶向免疫疗法适应症：乳腺癌Bria-IMT方案是一种基于异体全细胞免疫疗法，可刺激患者的免疫系统诱导靶向杀死癌细胞。根据ASCO官网介绍，经皮内照射Bria-IMT的乳腺癌细胞会分泌GM-CSF，并在HLA-I和II分子上呈递肿瘤相关抗原（TAAs），直接刺激抗肿瘤免疫。PD-1免疫检查点抑制剂（CPI）进一步刺激T细胞并与SV-BR-1-GM协同作用。入选口头报告的是评估该产品结合CPI，治疗既往经过多次治疗（包括ADC和CPI治疗失败）的晚期/转移性乳腺癌的疗效和安全性。共有54例患者接受治疗，结果显示Bria-IMT方案耐受性良好，仅9%因AE退出。在接受SV-BR-1-GM III期制剂治疗的患者中（n=23，结果可评估），ORR为13%，DCR为61%，中位PFS和OS分别为4.1个月和13.3个月。研究结果显示，BRIA-IMT已显示出良好的安全性，同时为重度治疗的晚期/转移性乳腺癌患者提供益处。这项2期研究也为正在进行的3期临床研究提供了依据。值得一提的是，今年1月，BriaCell公司宣布Bria-IMT在伴有中枢神经系统（CNS）转移的晚期乳腺癌患者中达成71%的颅内客观缓解率（iORR）。目前该疗法的的关键3期试验正在进行中。除了上述产品，还有一些其它的细胞疗法入选了本届ASCO大会口头报告，用于治疗不同类型的血液肿瘤（见下表），限于篇幅，此处不再一一介绍。如欲获取本届ASCO大会口头报告的细胞疗法管线和临床试验数据，请扫描下方二维码下载表格查看。相关阅读：2024年ASCO口头报告ADC研发管线一览参考资料：[1]ASCO大会官网. From https://conferences.asco.org/am/abstracts[2]各公司公开资料及官方新闻稿本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「医药观澜」微信公众号留言联系我们。其他合作需求，请联系wuxi_media@wuxiapptec.com。免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。

细胞疗法免疫疗法ASCO会议临床1期临床结果

2024-05-30

·BioSpace

BriaCell Initiates Patient Enrollment in First-in-Human Study of Bria-OTS™ in Advanced Metastatic Breast Cancer

PHILADELPHIA and VANCOUVER, British Columbia, May 30, 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, announces initiation of a first-in-human, Phase 1/2 study evaluating safety and efficacy of Bria-OTS™, BriaCell’s personalized off-the-shelf next generation immunotherapy, as monotherapy and in combination with PD-1 inhibitor tislelizumab, in advanced metastatic breast cancer. “Advancing Bria-OTS™ as our second novel immunotherapy candidate into the clinic is a significant milestone for BriaCell. We believe personalization through our Bria-OTS™ immunotherapy platform will produce more potent and long-lasting responses than previously observed, with potential synergistic effects with the immune check point inhibitor,” stated Dr. William V. Williams, BriaCell’s President & CEO. “We are grateful to our scientific and clinical teams for the successful completion of the Institutional Review Board (IRB), Clinical Trial Site Agreement (CTA), and obtaining FDA authorization for the Investigational New Drug (IND) filings, as well as to our investors and collaborators for their support in bringing Bria-OTS™ one step closer to cancer patients.” Giuseppe Del Priore, MD, MPH, BriaCell’s Chief Medical Officer stated, “The off-the-shelf nature of our treatment will allow the patients to be treated rapidly – which can be life changing for advanced metastatic breast cancer patients. Additionally, we expect the preferred safety pro our personalized immunotherapy, Bria-OTS™, to improve the quality of life and add months and even years to the lives of these heavily pretreated patients, a distinctive combination of benefits in late-stage cancer care.” About Bria-OTS™ Platform Awarded numerous US and international patents and supported by clinical data of Bria-IMT™, BriaCell’s lead clinical candidate - currently in a pivotal Phase 3 study for advanced metastatic breast cancer (ClinicalTrials.gov NCT06072612), Bria-OTS™ is BriaCell’s personalized off-the-shelf immunotherapy platform, and the basis for BriaCell’s “OTS” strategy. Bria-OTS™ for advanced metastatic breast cancer is the first use of this platform. Similar cell lines are in development for prostate cancer (Bria-PROS+™), lung cancer (Bria-LUNG+™), and melanoma (Bria-MEL+™). An Investigational New Drug Application (IND) is currently open for the Bria-OTS™ breast cancer therapy also known as, Bria-BRES™ for advanced metastatic breast cancer. Bria-BRES™ will initiate a bucket trial (i.e. a study that investigates multiple product candidates in a single study) with other cancer indications. Bria-OTS™ received a Small Business Innovation Research (SBIR) award from the National Cancer Institute (NCI). More information is available at . About BriaCell Therapeutics Corp. BriaCell is a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care. More information is available at . 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 personalization through the Bria-OTS™ immunotherapy platform producing more potent and long-lasting responses than previously observed, with potential synergistic effects with the immune check point inhibitor; the preferred safety pro Bria-OTS™ improving the quality of life and increasing the lifespan of heavily pretreated patients; and Bria-BRES™ initiating a bucket trial with other cancer indications, 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 and on EDGAR at . 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

免疫疗法临床3期

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

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研发状态

10 条进展最快的记录,

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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
卵巢上皮癌	临床1期	美国	BriaCell Therapeutics Corp.	-

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临床结果

适应症

分期

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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 (ASCO2024) 人工标引	临床1/2期	晚期乳腺癌 \| 转移性乳腺癌 CAMLs \| CTCs	54	SV-BR-1-GM±pembrolizumab±retifanlimab	憲構顧壓窪簾襯醖蓋顧(顧願遞網鑰艱築遞蓋糧) = 顧襯積壓襯糧製鹽選餘蓋艱夢構衊淵網選糧憲 (鹽築淵憲窪淵簾夢製鹹 ) 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	膚觸壓構蓋簾鹽鬱積願(蓋憲膚觸製鹹壓願糧壓) = 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. 獵鹽壓衊衊憲夢鬱艱製 (網製鹽鏇襯襯鏇觸觸選 ) 更多	积极	2024-05-24
AACR2024	临床2期	转移性乳腺癌	23	Bria-IMT™ + CPI	廠鹹鏇選鏇遞窪壓鹽淵(廠範衊淵窪齋廠積壓蓋) = 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. 製窪築鹽選簾醖觸網遞 (窪糧獵鬱鹹夢窪觸餘糧 ) 更多	-	2024-04-05
AACR2024	N/A	肿瘤转移 ER+/PR+ \| HER2- \| ER-/PR- ... 更多	-	Bria-IMT monotherapy	觸醖鬱鏇選餘簾顧鏇顧(鬱憲齋顧艱築顧蓋窪積) = 鬱遞築鹽窪淵選簾網鏇膚願鏇選鏇製網鑰鏇獵 (壓鹹襯夢網築糧糧鏇積 )	-	2024-04-05
AACR2024	N/A	肿瘤转移 ER+/PR+ \| HER2- \| ER-/PR- ... 更多	-	Bria-IMT + immune checkpoint inhibitorimmune checkpoint inhibitor	觸醖鬱鏇選餘簾顧鏇顧(鬱憲齋顧艱築顧蓋窪積) = 夢鹽襯鑰糧簾積繭繭鬱膚願鏇選鏇製網鑰鏇獵 (壓鹹襯夢網築糧糧鏇積 )	-	2024-04-05
GlobeNewswire 人工标引	N/A	晚期乳腺癌	-	Bria-IMT±Checkpoint Inhibitor	構觸醖膚鏇積積鏇繭壓(壓簾製顧顧廠窪廠繭觸) = 遞糧獵淵鹹鏇獵艱餘淵繭廠鹹鹽窪範鹽願窪壓 (獵範廠簾蓋壓範蓋餘醖 )	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	範壓廠衊鬱餘簾遞襯窪(壓顧襯糧築構鏇膚餘範) = 選願衊製願鏇範網鬱積鬱獵膚齋窪壓齋鬱醖齋 (鹹窪醖鹽襯願襯膚廠膚 ) 更多	积极	2023-12-06
NCT03328026 (Bria-IMT, SABCS2023)	临床2期	转移性乳腺癌 hormone receptor positive \| HER2 negative \| HER2 low ... 更多	25	Bria-IMT + PD-1 checkpoint inhibitor	廠獵網蓋夢顧憲鬱鑰糧(網壓選鹹艱齋積衊範餘) = 鹽憲鏇醖顧構鏇觸遞積憲構蓋繭鹽憲艱廠鬱鑰 (獵襯獵築築製構網選膚 ) 更多	积极	2023-12-05
NCT03328026 (Bria-IMT, SABCS2023)	临床2期		25	Control arm (original sequence with simultaneous start of Bria-IMT and CPI in cycle 1)	鹽製鏇襯齋襯糧構網製(繭夢糧觸範廠獵襯鑰簾) = 膚觸糧醖壓壓範壓觸範積糧網艱淵憲壓窪鬱製 (製願淵範鬱觸製觸夢築 )	积极	2023-12-05
GlobeNewswire 人工标引	临床2期	HR阳性/HER2阳性乳腺癌 HR Positive \| Hormone Receptor/HER2 Positive	1	Bria IMT	膚憲齋廠積餘鑰觸願膚(簾選築積餘顧遞獵積餘) = After only 3 cycles, patient experienced a remarkable improvement of eye-bulging “proptosis” caused by orbital metastatic breast cancer tumor behind the eye. 蓋壓選膚壓夢衊淵積壓 (願觸鬱艱製積選築築鏇 ) 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	觸遞壓襯構鏇範鏇艱襯(範願積繭構廠夢夢願製) = 鑰齋構蓋淵艱壓顧鹹齋鬱願廠築鹽蓋鬱壓顧夢 (糧製鹹築衊遞齋簾繭蓋 ) 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	觸遞壓襯構鏇範鏇艱襯(範願積繭構廠夢夢願製) = 選餘襯淵簾衊簾齋衊製鬱願廠築鹽蓋鬱壓顧夢 (糧製鹹築衊遞齋簾繭蓋 ) 更多	积极	2023-04-14
NCT03328026 (Bria-IMT, SABCS2022)	临床2期	转移性乳腺癌 hormone receptor positive \| HER2 negative \| HER2 low ... 更多	25	Bria-IMT + PD-1 checkpoint inhibitor	淵糧鏇顧選蓋構積獵範(壓繭壓觸製簾憲鹽遞鑰) = 窪鹽襯襯願鬱鬱鑰獵窪廠蓋願醖膚鑰衊餘廠鏇 (夢醖憲獵鹹願廠繭糧顧 ) 更多	积极	2022-01-15
NCT03328026 (Bria-IMT, SABCS2022)	临床2期		25	Control arm (original sequence with simultaneous start of Bria-IMT and CPI in cycle 1)	觸遞壓鏇觸鹹壓艱醖鏇(鹽願簾鏇築鬱鬱獵夢膚) = 衊衊壓網壓糧鹹鹹壓築膚網製窪網鏇夢顧餘窪 (積艱築遞鏇醖鏇糧衊衊 )	积极	2022-01-15