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BriaCell Presents Clinical Efficacy Data at ASCO 2024

BriaCell Presents Clinical Efficacy Data at ASCO 2024

BriaCell在ASCO 2024展示臨牀效果數據。
GlobeNewswire ·  06/03 20:00
  • BriaCell doubles Progression-Free-Survival (PFS) and Clinical Benefit Rate vs historical results in the literature
  • Bria-IMT PFS compares favorably to PFS of most recent treatment in 48% of Antibody-Drug Conjugate (ADC) resistant patients
  • Therapy well-tolerated with no Bria-IMT related discontinuations
  • Clinical data highlight significant potential of Bria-IMT in advanced metastatic breast cancer
  • Superiority of selected Phase 3 regimen and formulation confirmed
  • Oral presentation by Mayo Clinic Professor and Principal Investigator, Saranya Chumsri, MD, on Monday June 3; 11:30 AM-1:00 PM CDT
  • BriaCell將Progression-Free-Survival（PFS）和臨床受益率與文獻中的歷史結果相比翻倍。Bria-IMT PFS與48%的抗體藥物聯合物（ADC）耐藥患者中最近治療的PFS相比有利。
  • 該療法耐受良好，無Bria-IMT相關的停止治療情況。
  • 臨床數據突顯Bria-IMT在晚期轉移性乳腺癌中的重要潛力。
  • 選擇的第3期方案和配方的卓越性得到確認。
  • 梅奧診所教授和主要研究員Saranya Chumsri，MD於6月3日星期一上午11:30至下午1:00在口頭彙報中分享。
  • PHILADELPHIA和溫哥華，2024年6月3日（全球新聞）- BriaCell Therapeutics Corp。（Nasdaq：BCTX，BCTXW）（TSX：BCT）（“BriaCell”或“公司”），一家臨床階段的生物技術公司，開發新型免疫療法改變癌症治療，宣佈對其正在進行的隨機第2階段研究評估先導臨床候選藥Bria-IMT在晚期轉移性乳腺癌患者中的陽性臨床功效數據進行更新。兩個海報展示、一個摘要和一個口頭展示（由梅奧診所腫瘤學教授和主要研究員Saranya Chumsri，MD主持）將在2024年美國臨床腫瘤學會年會上展示。該會議於2024年6月3日（星期五）在芝加哥McCormick Place舉行。

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.

“我們對這些經過重度治療的患者的臨床效果和安全數據都非常滿意。由於這組患者治療選擇有限，而大多數治療方法都伴隨着嚴重的毒性反應，醫生和患者經常選擇拒絕進一步的無效和有毒藥物而選擇姑息治療，"梅奧診所腫瘤學教授和主要研究員Saranya Chumsri，MD說。"抗體藥物聯合物（ADC）和免疫檢查點抑制劑（CPIs）已成爲最新的治療這些患者的方法。然而，大量晚期患者無法產生反應，所有患者最終都會產生耐藥性，因此需要一種安全而有效的治療。BriaCell的新型免疫療法爲這些患者提供了一種耐受性良好的治療選擇，超越現有批准的藥物。"

"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."

“雖然免疫療法已經成爲多種癌症類型的有效治療選擇，但在乳腺癌中的應用相當有限。發掘新的策略，以增強各亞型乳腺癌對免疫療法的響應能力，可以作爲一種治療機會。通過其獨特的作用機制，Bria-IMT方案可選擇性地激活適應性抗癌CD4+和CD8+ T細胞以及先天免疫反應（樹突狀和NK細胞），以激活患者的免疫系統而不產生嚴重的副作用，"邁阿密大學米勒醫學院乳腺病組的臨床研究負責人、Sylvester Comprehensive Cancer Center癌症康復計劃的聯合主任和Bria-IMT第2期研究的主要臨床調查員Carmen Calfa，M.D.說。

"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.

"我們的ASCO講演重點介紹了Bria-IMT通過多種機制，包括適應性和先天免疫反應，與多種檢查點抑制劑的多種作用機制相互協同的活動，"BriaCell總裁兼首席執行官Williams博士說。"我們認爲，Bria-IMT有可能成爲晚期轉移性乳腺癌患者的突破性新治療選擇。"

"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."

演示的詳細信息總結如下。

The details of the presentations are summarized below.

口頭彙報摘要

Oral Presentation Summary

出版物的摘要編號：1022

Abstract Number for Publication: 1022
Title: 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—Metastatic
Session Date and Time: 6/3/2024; 11:30 AM-1:00 PM CDT

標題：aMBC 患者採用全病理細胞免疫治療 Bria-IMT 的療效
會話類型和標題：自適應口頭摘要-乳腺癌-轉移
會議日期和時間：2024年6月3日下午11:30至下午1:00 CDT
該展示詳細介紹了BriaCell正在進行的使用免疫檢查點抑制劑(retifanlimab)的隨機第2階段研究評估Bria-IMT的結果。隨機化的目的是比較第一輪療法早期或在第二輪療法後期後給予CPI對患者是否有任何優勢。還評估了兩種不同的Bria-IMT配方；一種用干擾素γ處理，一種未經處理。進入研究的患者都經過了重度治療，並在下表中列出了多個先前的治療方案。

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.

表1.Bria-IMT 第2期研究中的先前治療方案

The patients entering the study were very heavily pretreated and had failed multiple prior therapies as shown in the Table 1 below.

進入研究的患者經過大量治療，且以前存在多種治療失敗的情況，詳見表1。

Table 1. Prior Therapies in the Bria-IMT Phase 2 Study
Previous Therapies Number of Patients (%)
Antibody-Drug Conjugates (ADC) 23 (44%)
Immune Checkpoint Inhibitor (CPI) 11 (20%)
Cyclin-Dependent Kinase (CDK) 4/6 Inhibitors 34 (63%)
表1. Bria-IMT第2階段研究中的先前治療
以往療法 患者數量（%）
抗體藥物結合物（ADC） 23（44%）
免疫檢查點抑制劑（CPI） 11（20%）
週期蛋白依賴性激酶（CDK）4/6抑制劑 34（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.


共有54名患者參加了第1/2階段的研究，其中近一半的患者之前接受過抗體-藥物結合物治療，並在此次治療後疾病進展。還有20%的患者未能成功進行先前的免疫檢查點抑制劑治療，將近2/3的患者治療CDK 4/6抑制劑時療效不佳，平均而言，他們之前進行了6次治療嘗試。在第2階段研究中，32名患者中，有16名早期用CPI治療，另外16名晚期用CPI治療，在這兩組間，進展無病生存期(PFS)無統計學差異。但是，CPI早期組略優的表現使其被選爲第3階段的治療方案，整個第1/2階段經驗中，54名患者未與干擾素γ孵育的製劑表現出統計學顯著的PFS改善，因此該製劑被選爲第3階段的治療方案。具體數據見圖1。

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.

在第2階段研究中，32例患者中的16例早期接受了CPI治療，另16例晚期接受同類治療。這兩組之間沒有統計學顯著差異，但由於CPI早期組有輕微優勢，使其成爲第3階段研究的所選療法。在整個第1/2階段的經驗中，共54例患者，未與干擾素γ孵育的製劑顯示出統計學顯著的PFS改善，因此該製劑被選爲第3階段研究的治療方案。具體數據見圖1。

Figure 1. Effect of treatment sequence and formulation on PFS

圖1。不同治療順序和配方對PFS的影響

Clinical benefit was seen in 55% of evaluable patients across all subtypes of breast cancer as shown in Figure 2 below.

在所有乳腺癌亞型中評估患者中，有55%的患者獲得了臨床上的益處，具體見圖2。

Figure 2: Objective Response Rate (ORR) and Clinical Benefit Rate (CBR) in the Bria-IMT Phase 1/2 Study

圖2：Bria-IMT 1/2期研究中的客觀緩解率(ORR)和臨床益處率(CBR)

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.

進展無病生存率、臨床受益率和客觀緩解率均顯著高於其他治療方案的同類患者。值得注意的是，醫師選擇的治療方案(TPC)將成爲Bria-IMT第3階段研究的比較組，詳見表2。

Table 2. Comparative PFS, ORR and CBR in Similar Patients
Study Prior Lines of
Therapy
(median, range) 		PFS
(months)		 ORR
(%)		 CBR
(%)
BriaCell's Phase 2 study patients who received pivotal Phase 3 study formulation 6 (2-13) 3.9 9.5* 55*
BriaCell's ADC Resistant Phase 2 patients who received pivotal Phase 3 study formulation 6 (3-13) 4.1 12** 53**
Bardia, A. et. al. 1 4 (2-14) 1.7 4 8
Tripathy D. et. al. 2 ≥4 in 91% 1.9 3 10
O'Shaughnessy J. et. al. non-TNBC 3 5 (2-14) 2.3 4 7
O'Shaughnessy J. et. al. TNBC 3 4 (2-10) 1.6 5 10
表2. 同類患者的PFS，ORR和CBR比較
學習 之前的店鋪
療法
(中位數，區間)		 PFS
(月份)		 ORR
(%)		 CBR
(%)
BriaCell階段2研究接受關鍵階段3研究製劑的患者 6（2-13） 3.9 9.5* 55*
BriaCell的ADC耐藥階段2研究接受關鍵階段3研究製劑的患者 6（3-13） 4.1 12** 53**
Bardia，A. et. al.1 4（2-14） 1.7 4 8
Tripathy D. et. al. 2 ≥4佔91％ 1.9 3 10
O’ Shaughnessy J.等人的非TNBC3 5(2-14) 2.3 4 7
O’ Shaughnessy J.等人的TNBC3 4(2-10) 1.6 5 10

*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 study
1. 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.

*數據適用於可評估的患者，n=42人，其中12人不可評估。
**數據適用於可評估的患者，n=17人，其中6人不可評估。
參考資料：數據適用於意向治療人群，對照組受到醫生選擇的治療，這是BriaCell第3期研究中的比較組
1. Bardia A等人。J Clin Oncol.2024年5月20日; 42(15): 1738-1744。
2. Tripathy D等人。JAMA Oncol.2022年11月1日; 8(11): 1700-1701. jamaoncol.2022.4346。PMID: 36136348。本文描述了具有腦轉移的患者。
3. O’Shaughnessy J等人。Breast Cancer Res Treat.2022年9月; 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.

如需有關口頭報告的臨床數據的詳細信息，請訪問BriaCell在ASCO 2024年實現雙倍無進展生存並報告臨床獲益數據的網站。

Poster Presentation Summary

海報展示總結

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: TPS1137
Title: 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.

第一張海報介紹了BriaCell進行的先進轉移性乳腺癌的關鍵性第3期註冊研究。 BriaCell很高興與作者和BriaCell醫學顧問委員會成員Sara A. Hurvitz博士，醫學教授，弗雷德·哈欽森癌症研究中心，Adam M. Brufsky博士，醫學博士，匹茲堡大學醫學院教授，以及Massimo Cristofanilli博士，醫學教授，威爾康奈爾醫學院，康奈爾大學合作進行這個重要項目。第二張海報描述了接替抗體藥物複合物（ADC）治療失敗的轉移性乳腺癌患者中Bria-IMT的臨床數據，並由Chaitali Nangia博士領導，首席合夥人，Hoag醫療組，和Carmen Calfa博士，醫學教授，邁阿密大學。
TPS1137的摘要號碼
標題：BRIA-ABC中比較了Bria-IMT方案和CPI與醫生選擇治療在先進的轉移性乳腺癌治療的研究。
基於Bria-IMT方案在治療先進乳腺癌患者中顯示出多種生存和臨床獲益結果的2期臨床數據，關鍵性第3期研究已設計爲多中心隨機、開放標籤比較Bria-IMT方案和與無可用替代治療的轉移性乳腺癌患者的醫生選擇治療（TPC）。患者的資格包括治療2種或更多種前期方案。還將有一個單獨的Bria-IMT方案治療組（單藥治療組）。有關關鍵性第3期研究的更多信息，請訪問ClinicalTrials.gov作爲NCT06072612。

Abstract Number for Publication: 1087
Title: SV-BR-1-GM after progression on ADC in patients with metastatic breast cancer.

1087的摘要號碼
標題：在可移植性乳腺癌患者中，ADC進展後的SV-BR-1-GM。

Remarkable progression-free survival and clinical benefit of Bria-IMT in ADC resistant advanced metastatic breast cancer

Bria-IMT在對抗ADC耐藥的晚期轉移性乳腺癌中表現出卓越的無進展生存期和臨床益處。

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.

在23位ADC耐藥的晚期轉移性乳腺癌患者中，Bria-IMT方案的2期臨床數據顯示這些患者經歷了多種先前的治療方法，包括抗體藥物聯合化療和細胞免疫治療(CPI)，及中位數達到6次。

Clinical efficacy

臨床療效

  • 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.
  • 在可評估的患者中，ORR爲12%，CBR爲53%，這些數據相當顯著，表明其在獲得臨床益處方面的療效。
  • 在3期製劑中，中位PFS爲4.1個月，是類似研究中患者(中位數爲1.7個月和2.2個月，他們接受了TPC)的2倍，這一PFS結果表明，Bria-IMT患者前期治療次數較多(中位數爲6)，因此在臨床療效方面表現出了優勢。1和其他研究中患者(中位數爲4)相比。3亞組特定的臨床益處：研究數據表明，針對多種乳腺癌亞型，包括HR+/HER2- (最常見的乳腺癌亞型，測試爲雌激素和/或黃體酮受體陽性，且人類表皮生長因子受體2或HER2陰性) 的治療後CBR可達到63%(8名患者中的5名)；HER2+亞型(HER2陽性)的CBR可達100%(2名患者)；HR-/HER2低亞型(雌激素和/或黃體酮受體陰性，HER2陰性)的治療CBR爲66%(3名患者中的2名)。詳見表3。
  • 亞集具體的臨床效益：截止目前的研究數據顯示出多個乳腺癌亞型中的臨床效益，其中HR+/HER2-（最常見的乳腺癌亞型，其試驗呈陽性，表明對雌激素和/或黃體酮受體呈陽性，而人表皮生長因子受體2或HER2檢驗呈陰性）在治療後表現出63%（8名患者中5名）CBR；HER2+亞型(HER2陽性檢測)在治療後表現出100%的臨床益處(2名患者中的2名)；HR-/HER2偏低亞型(雌激素和/或黃酮激素受體陰性檢測和HER2陰性檢測)在治療後顯示出66%的臨床益處（3名患者中2名）。詳見表3。
Table 3: Treatment Efficacy by Metastatic Breast Cancer Subtype in ADC-resistant patients
Histology All Patients (N) Evaluable (N) Patients Best ORR Best CBR
All ADC Resistant 23 17 12% (2 / 17) 53% (9 / 17)
ER/PR + / HER2 low or - 8 8 13% (1 / 8) 63% (5 / 8)
HER2+ 3 2 50% (1 / 2) 100% (2 / 2)
TNBC 12 7 0 29% (2 / 7)
表3：針對ADC耐藥性乳腺癌亞型的治療效果
組織 所有患者(N) 可評估患者(N) 最佳ORR 最佳CBR
所有ADC耐藥患者 23 17 12%(17人中的2人) 53%(17人中的9人)
ER/PR + / HER2低或-型 8 8 13%(8人中的1人) 63%(8人中的5人)
HER2陽性 3 2 50％（1 / 2） 100％（2 / 2）
TNBC 12 7 0 29％（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.
  • Bria-IMT顯示，在48％的患者中顯示出比次級處理潛在的生存優勢，可能通過逆轉患者的免疫耗竭來實現，而不考慮特定的前期ADC。

Safety profile

安全資料

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.

Bria-IMT與ADCs的常見嚴重不良事件之一的間質性肺疾病（ILD）和治療中止相關的缺失強調了Bria-IMT的良好耐受性和優良的安全性資料。

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.

總之，迄今的數據顯示，Bria-IMT相對於其他類似研究中的患者，可爲經過大量預處理、ADC耐藥的乳腺癌患者提供延長的無進展生存期和臨床益處。BriaCell正在密切監測ADC耐藥患者，在其進行的Bria-IMT和CPI在愛文思控股的晚期轉移性乳腺癌中的關鍵第3期研究中。

Title: Differential efficacy of SV-BR-1-GM in inducing intracranial metastasis regression.

標題：SV-BR-1-GM在誘導顱內轉移消退中的差異療效。

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

Bria-IMT方案具有優異的臨床益處-獨立或者聯合免疫檢查點抑制劑（CPI）在患有中樞神經系統轉移疾病的晚期乳腺癌患者中使用。

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.

包括腦轉移和其他顱內轉移瘤的中樞神經系統（CNS）轉移瘤是一種嚴重的臨床情況，患者生存率非常低。極少有療法對乳腺癌CNS或顱內轉移瘤有任何影響，這是一個嚴重的未滿足的醫學需求。

Clinical efficacy:

臨床療效：

  • 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.
  • 使用Bria-IMT方案單獨或與免疫檢查點抑制劑（例如PD-1抑制劑pembrolizumab或retifanlimab）聯合治療有中樞神經系統（CNS）轉移瘤的可評估患者報告了83％（5/6）的顱內客觀縮小率（iORR），這些患者在多種前期治療失敗後，包括在一種情況下使用了2種抗體藥物結合物。這在圖3中有所說明。

Figure 3. Intracranial Tumor Responses in Patients with Intracranial Metastases Treated with Bria-IMT

圖3.使用Bria-IMT治療顱內轉移瘤的顱內腫瘤反應

  • 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 metastases
  • This is a pre-planned subgroup analysis in the pivotal Phase 3 study of Bria-IMT providing another opportunity for approval
  • 觀察到重度預處理患者的腫瘤縮小（直徑和的≥30％減小），強調了Bria-IMT在治療CNS轉移瘤中的潛在臨床益處
  • 這是Bria-IMT關鍵第3期研究中預先計劃的亞組分析，爲獲得另一次批准提供了機會

Safety profile:

安全資料：

No treatment related discontinuation was reported.

未指出任何與治療相關的中止。

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.

總之，Bria-IMT在患有顱內疾病的患者中觀察到的腫瘤縮小，突顯了其在治療晚期乳腺癌中CNS轉移疾病方面的潛在臨床有效性。BriaCell將繼續監測其在關鍵第3期研究中患有CNS轉移疾病的患者的數據。治療患有CNS轉移疾病的患者也是Bria-IMT獲得市場批准的潛在額外適應症。

Copies of the poster presentations and abstracts are posted on

海報和摘要的副本已張貼在

References

參考文獻

  1. 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.
  2. 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.
  3. 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.
  1. Bardia A等人。Ⅲ期ASCENT臨床試驗轉移性三陰性乳腺癌的最終結果及與人類表皮生長因子受體2和滋養層細胞表面抗原2表達情況的相關性。J Clin Oncol。2024年5月20日;42（15）：1738-1744。doi：10.1200/JCO.23.01409。Epub 2024年2月29日。PMID：38422473。
  2. Tripathy D等人。用於轉移性乳腺癌和腦轉移患者的依替腺苷酸聚乙二醇處理的最終結果：來自ATTAIN隨機臨床試驗的第3階段。JAMA Oncol。2022年;8（7）：1047-1052。doi：10.1001/jamaoncol.2022.0514。
  3. O'Shaughnessy J等人。在Ⅲ期ASCENT研究中，分析沒有和有最初三陰性乳腺癌診斷的患者，在轉移性三陰性乳腺癌中應用sacituzumab govitecan的有效性和安全性。Breast Cancer Res Treat。2022年9月; 195（2）：127-139。doi：10.1007/s10549-022-06602-7。Epub 2022年5月11日。PMID：35545724；PMCID：PMC9374646。

About BriaCell Therapeutics Corp.

關於BriaCell Therapeutics Corp。

BriaCell is a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care. More information is available at

BriaCell是一家臨床階段的生物技術公司，開發新型免疫療法來改變癌症治療。更多信息可在

Safe Harbor

免責聲明

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 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.

本新聞稿包含“前瞻性聲明”，受到重大風險和不確定性的影響。除了歷史事實陳述外，本新聞稿中包含的所有其他陳述均屬於前瞻性聲明。前瞻性聲明包括在本新聞稿中，如關於2024年ASCO會議上兩個海報和一個口頭陳述的演示，以及Saranya Chumsri博士的演示內容; BriaCell的新型免疫療法爲超出目前批准藥物的患者提供了一個耐受性良好的治療選擇; Bria-IMT有可能成爲晚期轉移性乳腺癌患者的突破性新型治療選擇; “醫生的選擇治療”（TPC）是Bria-IMT的第三期研究中的對照組; 單藥治療成爲Bria-IMT方案的另一個治療方案; Bria-IMT在治療晚期乳腺癌中管理中樞神經系統轉移疾病的潛在臨床益處; BriaCell將繼續監測進行中的面向晚期轉移性乳腺癌的關鍵第三期研究中的顱內疾病亞組數據; 用於治療中樞神經系統轉移性疾病的患者的治療代表Bria-IMT的潛在附加適應症，並且是市場批准的另一個適應症，都基於BriaCell目前的預期並且存在困難預測的固有不確定性和風險和假設。此外，某些前瞻性聲明基於未來事件的假設，這些假設可能證明不準確。更進一步的風險和不確定性的描述，請參閱公司最新的管理層討論與分析報告中的“風險和不確定性”一章，最新的年度信息表中的“風險因素”一章，以及公司在加拿大證券監管機構和美國證券交易委員會上的其他申報文書中的“風險和不確定性”。所有這些申報文書都可以在公司的SEDAR個人配置文件和EDGAR個人配置文件下找到 和 www.sec.gov中。本公告中包含的前瞻性聲明均截至本日，並且BriaCell Therapeutics Corp.除適用法律規定外，無需更新此類信息。

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.

多倫多證券交易所及其監管服務提供商（根據多倫多證券交易所政策中此項術語的定義）不對本公告的充足性或準確性承擔任何責任。

Contact Information

聯繫信息

Company Contact:
William V. Williams, MD
President & CEO
1-888-485-6340
info@briacell.com

公司聯繫人：
William V. Williams，MD
總裁兼首席執行官
1-888-485-6340
info@briacell.com

Media Relations:
Jules Abraham
CORE IR
julesa@coreir.com

媒體關係：
Jules Abraham
CORE IR
julesa@coreir.com

Investor Relations Contact:
CORE IR
investors@briacell.com

投資者關係聯繫人：
CORE IR
investors@briacell.com

Photos accompanying this announcement are available at

附帶的照片可在以下網址獲取


譯文內容由第三人軟體翻譯。


以上內容僅用作資訊或教育之目的，不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。
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