[Translation] A multicenter, single-arm Phase II clinical study to evaluate the efficacy and safety of JK1201I in the treatment of triple-negative breast cancer patients with brain metastases

主要目的：评价JK1201I治疗合并有脑转移的三阴性乳腺癌患者的有效性。次要目的：评价JK1201I治疗合并有脑转移的三阴性乳腺癌患者的安全性；评价JK1201I治疗合并有脑转移的三阴性乳腺癌患者中给予JK1201I的群体药代动力学特征。

[Translation]

Primary purpose: To evaluate the effectiveness of JK1201I in the treatment of patients with triple-negative breast cancer with brain metastases. Secondary purpose: To evaluate the safety of JK1201I in the treatment of patients with triple-negative breast cancer with brain metastases; To evaluate the population pharmacokinetic characteristics of JK1201I in the treatment of patients with triple-negative breast cancer with brain metastases.

Start Date01 Nov 2024

Sponsor / Collaborator

JenKem Technology Co., Ltd.

CTR20243174

/ RecruitingPhase 3

JK1201I对比注射用盐酸托泊替康治疗复发或进展的广泛期小细胞肺癌患者的多中心、随机、阳性对照、开放的III期临床研究

[Translation] A multicenter, randomized, positive-controlled, open-label phase III clinical study of JK1201I versus topotecan hydrochloride for injection in the treatment of patients with relapsed or progressive extensive-stage small cell lung cancer

主要目的：在既往接受过针对广泛期小细胞肺癌的一线含铂方案全身治疗，并在一线治疗过程中或一线治疗结束后≤6个月复发或进展的广泛期小细胞肺癌患者中，评价JK1201I对比注射用盐酸托泊替康治疗方案的有效性。次要目的： 1)评价JK1201I对比注射用盐酸托泊替康，在既往接受过针对广泛期小细胞肺癌的一线含铂方案全身治疗，并在一线治疗过程中或一线治疗结束后≤6个月复发或进展的广泛期小细胞肺癌患者中的安全性； 2）评价JK1201I在既往接受过针对广泛期小细胞肺癌的一线含铂方案全身治疗，并在一线治疗过程中或一线治疗结束后≤6个月复发或进展的广泛期小细胞肺癌患者中的群体药代动力学特性。

[Translation]

Primary objective: To evaluate the efficacy of JK1201I compared with topotecan hydrochloride injection in patients with extensive-stage small cell lung cancer who have previously received first-line platinum-based systemic treatment for extensive-stage small cell lung cancer and have relapsed or progressed ≤6 months during or after first-line treatment. Secondary objectives: 1) To evaluate the safety of JK1201I compared with topotecan hydrochloride injection in patients with extensive-stage small cell lung cancer who have previously received first-line platinum-based systemic treatment for extensive-stage small cell lung cancer and have relapsed or progressed ≤6 months during or after first-line treatment; 2) To evaluate the population pharmacokinetic properties of JK1201I in patients with extensive-stage small cell lung cancer who have previously received first-line platinum-based systemic treatment for extensive-stage small cell lung cancer and have relapsed or progressed ≤6 months during or after first-line treatment.

Start Date29 Sep 2024

Sponsor / Collaborator

JenKem Technology Co., Ltd.

NCT06581380

/ Not yet recruitingPhase 3

A Multicenter, Randomized, Positive-Controlled, Open-label, Phase 3 Study of JK-1201I Compared with Topotecan in Patients with Relapsed Extensive Stage Small Cell Lung Cancer After Platinum-based First-line Chemotherapy

This study was designed to compare the efficacy and safety of JK-1201I with Topotecan in patients with relapsed extensive stage small cell lung cancer (ES SCLC).

Start Date16 Sep 2024

Sponsor / Collaborator

Jenkem Technology Co., Ltd.

100 Clinical Results associated with PEG-Irinotecan

100 Translational Medicine associated with PEG-Irinotecan

100 Patents (Medical) associated with PEG-Irinotecan

250

Literatures (Medical) associated with PEG-Irinotecan

01 Jan 2025·Therapeutic Advances in Medical Oncology

Real-world effectiveness and safety of second- or third-line pegylated liposomal irinotecan plus 5-fluorouracil and folinic acid in pancreatic ductal adenocarcinoma in Spain

Article

Author: Angeles, Maria Cristina ; Ghanem, Ismael ; Pazo-Cid, Roberto ; Granja, Monica ; Hernández, Irene ; Martin Valadés, Jose Ignacio ; Martinez, Joaquina ; Álvarez-Gallego, Rafael ; Diaz, Roberto ; Martinez, Eva ; López de San Vicente, Borja ; Ribera, Paula ; Macarulla, Teresa ; Garicano, Fernando ; Cubillo, Antonio

Treatment with pegylated nanoliposomal irinotecan (nal-IRI) plus 5-fluorouracil/leucovorin (folinic acid; 5-FU/LV) has demonstrated remarkable efficacy for metastatic pancreatic ductal adenocarcinoma (PDAC) in clinical trials. However, real-world data on the effectiveness of nal-IRI+5-FU/LV is heterogeneous and is lacking in Spain. To assess the effectiveness and safety of nal-IRI+5-FU/LV in real-life PDAC patients in Spain. A multicenter retrospective study was conducted. Patients aged ⩾18 years who had received at least one cycle of nal-IRI+5-FU/LV as second- or third-line therapy for PDAC were included. The primary endpoint was overall survival (OS) from nal-IRI+5-FU/LV treatment initiation and OS from the diagnosis of metastatic disease (metOS). Overall, 200 evaluable patients were included (⩾3 metastatic sites: 22%; liver/lung metastases: 71.5%/36.9%; and Eastern Cooperative Oncology Group 0–1: 87% at nal-IRI+5FU/LV treatment initiation). Patients received a median of four cycles of nal-IRI+5FU/LV for 2.8 months (range 1.4–7.2), and the treatment was received in the second line by 80% of the patients. The median OS was 7.2 months (6- and 12-month OS rates: 58.1% and 28.9%, respectively), with 27.2% of the patients achieving OS ⩾12 months. The median metOS was 17.5 months, with 30.2% of the patients experiencing metOS ⩾ 24 months. The median progression-free survival (PFS) was 3.7 months (6- and 12-month PFS rate: 37.6% and 15.3%, respectively). The disease control rate was 35.5%. The median CA 19-9 levels decreased by at least 50% in 28.2% of the cases during treatment. Overall, 36% of the patients experienced at least one grade 3–4 adverse event during treatment, the most common being diarrhea (42.6%) and asthenia (30.9%). This real-world study shows that treatment with nal-IRI+5-FU/LV for advanced or metastatic PDAC affords benefit in terms of survival, radiological and CA 19-9 response, and PFS comparable to that reported in the clinical trial setting with a manageable safety profile.

01 Sep 2024·Perfusion

Administration of a new nano delivery system coated with Tirofiban to prevent early thrombosis of vein graft

Article

Author: Wang, Yapei ; Wang, Bolin ; Yu, Yang ; Dong, Shuo ; Gao, Mingxin ; Ding, Xiaohang ; Lian, Xiaodong ; Yu, Wenyuan

Objective:

To verify the administration of a new nano delivery system coated with Tirofiban on preventing early thrombosis in vein graft.

Methods:

Forty New Zealand white rabbits were randomly divided into five groups with eight rabbits in each group. The rabbits of all groups underwent jugular vein transplantation, except group I with only neck opening and closing operation. Vein grafts of group II were preprocessed by intravenous injection of normal saline; group III were preprocessed by tirofiban alone; group IV were preprocessed by unloaded nanoparticles of PLGA-PEG; group V were preprocessed by PLGA-PEG coated with tirofiban. Coagulation and platelet function of peripheral and vein graft blood were detected at 1, 2, 4, 12 h and 1, 3, 7, 10, 14 days after operation. Patency rate of vein graft and blood flow index were measured by vascular ultrasound at third, seventh, 10th, and 14th days after operation; two rabbits in each group were randomly sacrificed at the corresponding time of detection. Pathological differences of vein grafts were observed by HE stainin.

Results:

The patency rate of vein grafts in group V was significantly higher than that in group II to IV. The platelet and platelet aggregation rate in group V were inhibited in vein graft blood significantly. The post-operative PT and APTT in vein graft blood in group V were increased obviously while the FBG, D-dimer and FDP were significantly inhibited. Except group I, the lumen loss rate of vein grafts in group V was significantly lower than that in other groups, and vein graft blood in group V had a significant lower expression of platelet P-selectin and GP IIb/IIIa receptor than that in other groups.

Conclusion:

This study proves that PEG-PLGA coated with tirofiban can effectively prevent early vein graft stenosis from thrombosis by inhibition of platelet function, coagulation function.

01 Sep 2024·Cancer Medicine

Phase Ib/II study on the safety, tolerability, and preliminary efficacy of pegylated irinotecan (JK1201I) as second‐line monotherapy for patients with small‐cell lung cancer

Article

Author: Shi, Jinsheng ; Zhao, Xuan ; Zhao, Yanqiu ; Li, Xuefei ; Fang, Jian ; Nie, Ligong ; Yu, Guohua ; Zang, Aimin ; Long, Jieran ; Wu, Lin

Abstract:

Purpose:

To evaluate the safety, tolerability, and preliminary efficacy of multiple doses of pegylated irinotecan (JK1201I) as a second‐line monotherapy for treating small‐cell lung cancer (SCLC) patients.

Methods:

According to the “3 + 3” dose‐escalation principle, patients received intravenous JK1201I at 180 or 220 mg/m2 once every 3 weeks for four cycles. Progression‐free survival (PFS), overall survival (OS), median progression‐free survival (mPFS), and median overall survival (mOS) were evaluated. The Kaplan–Meier method was used to analyze PFS and overall OS. Brookmeyer and Crowley's method was used for mPFS and mOS.

Results:

This study included 29 patients with stage III–IV SCLC (stage IIIa, n = 1; stage IIIb, n = 1; and stage IV, n = 27). Of these, 26 patients were enrolled in the 180 mg/m2 dose group, and 3 patients were enrolled in the 220 mg/m2 dose group. No dose‐limiting toxicity (DLT) was noted during the first 28 days of treatment. Grade 3 or higher adverse events were recorded in the 180 mg/m2 group, including diarrhea (11.5%, 3/26), neutropenia (7.7%, 2/26), and leukopenia (7.7%, 2/26). In the 220 mg/m2 group, one patient (33.3%, 1/3) experienced neutropenia or leukopenia. In the 180 mg/m2 group, 38.5% (10/26) of patients achieved an objective response rate (ORR), with a disease control rate (DCR) of 73.1% (19/26). The mPFS and mOS were 3.4 and 12.1 months, respectively. In the 220 mg/m2 group, one patient had stable disease, and one had progressive disease (PD). The ORR, DCR, mPFS, and mOS were 0% (0/3) and 33.3% (1/3), 2.7 months and 2.7 months, respectively.

Conclusion:

JK1201I exhibits promising efficacy and relatively low toxicities as a second‐line monotherapy for SCLC, warranting further large‐scale clinical studies to evaluate its efficacy in greater detail.

News (Medical) associated with PEG-Irinotecan

02 Dec 2024

·www.accesswire.com

Alligator Sharpens Focus on Mitazalimab and Announces Cost Reduction Program to Maximize Long-Term Value Creation

Sharpening focus on preparing mitazalimab for Phase 3 and continuing partnering discussionsPlanned reduction of workforce, mainly within Discovery and Non-Clinical unitExpected annual cash savings of at least SEK 65 millionWill continue to conduct limited research activities, primarily related to mitazalimabLUND, SE / ACCESSWIRE / December 02, 2024 / Alligator Bioscience AB ("Alligator" or the "Company") announced today that it is sharpening its primary focus on its lead asset mitazalimab, and, given current capital restraints, plans to adjust the size of its organization and scope of operations to reflect that. All other assets under development are under strategic evaluation.Given the unprecedented survival benefits observed in first line metastatic pancreatic cancer, including a near doubling of the overall survival rate at 18 months compared to FOLFORINOX alone, Alligator believes that mitazalimab should advance into Phase 3 for metastatic pancreatic cancer as soon as possible.The planned restructuring remains subject to negotiation with the relevant trade unions and may result in a reduction of approximately 70% of the current workforce, mainly affecting the discovery and non-clinical operations. Once implemented, the restructuring is expected to reduce operational costs by at least SEK 65 million annually. Going forward Alligator will focus on late-stage development with an adequate workforce of approximately 15 FTEs. Furthermore, Alligator will continue to be able to conduct limited research activities, primarily related to mitazalimab, through internal and external resources.Alligator has separately announced the plans for a Rights issue to be completed in Q1 2025. If the Rights issue is fully subscribed, Alligator will have secured financing up until the end of 2025.Alligator is continuing to prepare mitazalimab for Phase 3 development, in parallel with ongoing partnership discussions. It expects to report 24 months follow-up data from the mitazalimab OPTIMIZE-1 Phase 2 trial in Q1 2025. The 24-month timepoint is longer than many other treatments in metastatic pancreatic cancer have shown, as most trials have been stopped earlier as the clinical efficacy was no longer evident and patients had relapsed or died."Being able to report the OPTIMIZE-1 24-month timepoint sets mitazalimab apart and is a clear testimony to its clinical benefit. Because Alligator at that timepoint expects to continue to deliver additional outstanding Phase 2 clinical data for mitazalimab in 1st line pancreatic cancer, we remain laser focused on mitazalimab development and it is our objective to deliver outstanding returns to our shareholders. The cost savings announced today will strengthen our ability to continue developing mitazalimab and enhance the chances to unlock its value by making it more attractive for partnership," said Søren Bregenholt, CEO of Alligator Bioscience. "In order to focus our current resources on mitazalimab, our most important asset,we have no other option than to reduce our earlier stage research and development activities and workforce. We thank our colleagues, who have strived professionally and with great dedication to innovate and deliver on Alligator'smission to develop drugs for patients with hard-to-treat cancers since the Company's inception. We will make the utmost efforts to support the highly talented people affected by this initiative. I am confident they will prove to be important contributors to other innovative organizations."Alligator will notify the Swedish Public Employment Service (Sw. Arbetsförmedlingen) and seek consultations with trade unions regarding the reorganization. Decisions regarding specific employee reductions will take place after the change consultations have been concluded according to local regulations.For further information, please contact:Søren Bregenholt, CEOE-mail: [email protected] Phone: +46 (0) 46 540 82 00Johan Giléus, CFOE-mail: [email protected] Phone: +46 (0) 46 540 82 00This information is information that Alligator Bioscience is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2024-12-02 08:35 CET.About Alligator BioscienceAlligator is a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs focused on the CD40 receptor. This validated approach promotes priming of tumor-specific T cells and reversing the immunosuppressive nature of the tumor microenvironment, with significant potential benefits for cancer patients across multiple types of cancer. Its portfolio includes lead drug candidate mitazalimab, for which the company reported unprecedented survival data at 18-months follow up in first-line metastatic pancreatic cancer patients in Phase 2 testing and is in preparation for Phase 3 development. The follow-on bispecific antibody ATOR-4066 is in preclinical testing. Alligator has a proprietary technology platform, comprised of two antibody libraries, ALLIGATOR-GOLD® and ALLIGATOR-FAB™, the powerful protein optimization strategy FIND® and the bispecific antibody format RUBY™, which drives rapid design and development of innovative drugs.Alligator is listed on Nasdaq Stockholm (ATORX) and headquartered in Lund, Sweden.For more information, please visit alligatorbioscience.com .AttachmentsAlligator sharpens focus on mitazalimab and announces cost reduction program to maximize long-term value creationSOURCE: Alligator Bioscience

Phase 2Phase 3

11 Sep 2024

·www.globenewswire.com

BriaCell Reports Positive Overall Survival (OS) in Metastatic Breast Cancer

Median overall survival of 15.6 months in Phase 2 Bria-IMT™ study patients treated in combination with immune checkpoint inhibitorOS of 15.6 months compares favorably with 6.7-9.3 months reported for similar patients in the literatureOngoing Phase 3 study investigating Bria-IMT™ in similar metastatic breast cancer populationNo drug related discontinuations to date PHILADELPHIA and VANCOUVER, British Columbia, Sept. 11, 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, is pleased to announce positive overall survival data of its Phase 2 clinical study of Bria-IMT™ in combination with an immune check point inhibitor (CPI) in late stage metastatic breast cancer. Median overall survival of 15.6 months is reported in BriaCell’s most recent patients (treated since 2022) vs. 6.7-9.3 months for similar patients reported in the literature (see table below). These patients are being treated with the same Bria-IMT™ formulation currently being used in BriaCell’s ongoing Phase 3 pivotal study in metastatic breast cancer (listed on ClinicalTrials.gov as NCT06072612) and represent patients enrolled post-COVID when full study activities resumed. This represents a substantial improvement over BriaCell’s 13.4 months median overall survival previously reported in December 2023. “Overall survival in patients with heavily pre-treated metastatic breast cancer is very poor,” stated Sara A. Hurvitz, MD, Professor of Medicine, Fred Hutch Cancer Center and University of Washington and BriaCell medical advisory board member. “The BriaCell early data is quite encouraging from both efficacy and tolerability standpoints.” “We wanted to look at the Phase 2 data of those patients who most closely resemble the patients being treated in our ongoing phase 3 study and compare them to similar patients in the literature,” stated Dr. William V. Williams, BriaCell’s President and CEO. “The nearly two-fold overall survival benefit we are seeing with the Bria-IMT™ regimen, together with the similar previously reported approximate doubling of progression free survival, compared with literature controls, strongly support our belief that Bria-IMT™ could have a meaningful impact in the lives of heavily pre-treated metastatic breast cancer patients. We look forward to further clinical development of Bria-IMT™ with the goal of establishing it as a new standard of care for patients with metastatic breast cancer.” “The Bria-IMT™ regimen is the only investigational drug we have seen to show these impressive survival numbers in heavily pre-treated metastatic breast cancer patients who have failed numerous prior treatments including immune check point inhibitors and antibody drug conjugates,” stated Giuseppe Del Priore, MD, MPH, BriaCell’s Chief Medical Officer. “These survival and clinical benefit data support BriaCell’s hypothesis of additive and/or synergistic effects of immune check point inhibitors with Bria-IMT™ and drive the ongoing pivotal study of our combination regimen in the treatment of metastatic breast cancer.” The Phase 2 study enrolled 54 heavily pre-treated metastatic breast cancer patients (average number of prior treatments = 6) who were treated with the Bria-IMT™ regimen and an immune checkpoint inhibitor. Of these 54 patients, 37 were treated with the Phase 3 formulation and 25 of these were treated post-COVID when full study activities resumed. This data represents an additional six months of follow-up of the survival data presented at the San Antonio Breast Cancer Symposium in December 2023. Table 1. Comparative Median Overall Survival (OS) and Progression-Free Survival (PFS) in Similar Patients (Interim Analysis Using Kaplan-Meier Estimate) StudyPrior Lines of Therapy (median, range)Number of PatientsOS (months)PFS (months) BriaCell’s Phase 2 study patients who received pivotal Phase 3 study formulation (since 2022)5.5 (2-13)2515.64.1 BriaCell’s Phase 2 study patients who received pivotal Phase 3 study formulation (total)6 (2-13)3713.43.9 Bardia, A. et. al. 1 (TNBC)4 (2-14)2626.91.7 Tripathy D. et. al. 2 (Brain metastases)≥4 in 91%1787.5-7.81.9-2.8 O’Shaughnessy J. et. al. 3non-TNBC at initial diagnosis5 (2-14)766.72.3 O’Shaughnessy J. et. al. 3TNBC at initial diagnosis4 (2-10)1576.91.6 Cortes et. al. 44 (0-13)5949.1-9.31.9-2.5 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.Cortes J, Perez-Garcia J, Levy C, Gómez Pardo P, Bourgeois H, Spazzapan S, Martínez-Jañez N, Chao TC, Espié M, Nabholtz JM, Gonzàlez Farré X, Beliakouski V, Román García J, Holgado E, Campone M. Open-label randomised phase III trial of vinflunine versus an alkylating agent in patients with heavily pretreated metastatic breast cancer. Ann Oncol. 2018 Apr 1;29(4):881-887. doi: 10.1093/annonc/mdy051. PMID: 29481630. 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 statements about: the impact of Bria-IMT™ on patients with metastatic breast cancer; BriaCell’s further clinical development of Bria-IMT™; and the efficacy of immune check point inhibitors, 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

Phase 3ImmunotherapyPhase 2Clinical Result

18 Jul 2024

·www.globenewswire.com

BriaCell Quadruples Progression Free Survival (PFS) in Patient with “Eye-Bulging” Metastatic Breast Cancer

Progression free survival (PFS) extended to 9.1 months in ADC resistant patient - quadruple the PFS of patients in similar studies 1, 2, 3Significant reduction of “Eye-Bulging” metastatic breast cancer tumor was previously reportedHeavily pre-treated patient had failed 8 prior regimens including antibody-drug conjugate (ADC) therapy and continues to receive BriaCell treatment PHILADELPHIA and VANCOUVER, British Columbia, July 18, 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, is pleased to report significantly higher PFS for its top responder patient in the Phase 2 study of BriaCell’s Bria-IMT™ regimen in combination with an immune checkpoint inhibitor in metastatic breast cancer. The patient remains alive and she continues to receive BriaCell’s treatment regimen. “We are extremely pleased with the unprecedented survival benefit in this very-difficult-to-treat patient,” stated Dr. William V. Williams, BriaCell’s President and CEO. “This data represents a step forward in our efforts to build on our knowledge and successes to transform cancer care for patients. We expect to replicate this positive data in our ongoing Phase 3 study and bring relief to cancer patients whose medical needs remain unmet.” “Despite recent advances in cancer therapy, metastatic breast cancer remains an unmet medical need, as current treatments are limited by poor survival and harsh side effects,” commented Dr. Giuseppe Del Priore, BriaCell’s Chief Medical Officer. “The Bria-IMT™ regimen produced a much longer than expected survival benefit in addition to its favorable safety and tolerability in this patient suggesting its potential as a therapeutic option for these cancer patients.” The patient had a large right orbital lesion (behind the right eye) and a right temporal lobe lesion (in the right side of the brain). The temporal lobe lesion is no longer detectable, while the orbital lesion has continued to shrink markedly (see figure showing resolution of proptosis post treatment (small arrows) with reduction in tumor indicated by the large arrows). In addition, her tumor markers (blood tests that correlate with the amount of tumor in the body) have markedly decreased from her pre-treatment levels. Figure 1: Responder Images - Bria-IMT™ Regimen Table 1: Bria-IMT™ and historical clinical data in MBC patients who failed multiple prior treatments StudyPFS (months)Top Responder Patient9.1+Bardia, A. et. al. 11.7Tripathy D. et. al. 21.9O’Shaughnessy J. et. al. non-TNBC 32.3O’Shaughnessy J. et. al. TNBC 31.6 1,2,3 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’s ongoing pivotal Phase 3 study.2 This paper describes patients with brain metastases, which were also present in the patient described.+ Indicates the patient is ongoing in the study. 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 BriaCell replicating positive data in its ongoing Phase 3 study; BriaCell’s Bria-IMT™ regimen bringing relief to cancer patients whose medical needs remain unmet; and the Bria-IMT™ regimen becoming a therapeutic option for metastatic breast cancer patients, 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 A photo accompanying this announcement is available at:https://www.globenewswire.com/NewsRoom/AttachmentNg/cef51e5b-ff25-4c3e-929d-22ad6df22927

ImmunotherapyPhase 2Phase 3Clinical ResultADC

100 Deals associated with PEG-Irinotecan

External Link

KEGG	Wiki	ATC	Drug Bank
D10367	PEG-Irinotecan	L01XX56	DB14951

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Indication	Highest Phase	Country/Location	Organization	Date
Extensive stage Small Cell Lung Cancer	Phase 3	CN	JenKem Technology Co., Ltd.	29 Sep 2024
Recurrent Lung Small Cell Carcinoma	Phase 3	-	Jenkem Technology Co., Ltd.	16 Sep 2024
Brain metastases	Phase 3	US	Nektar Therapeutics	01 Nov 2016
Brain metastases	Phase 3	AU	Nektar Therapeutics	01 Nov 2016
Brain metastases	Phase 3	BE	Nektar Therapeutics	01 Nov 2016
Brain metastases	Phase 3	CA	Nektar Therapeutics	01 Nov 2016
Brain metastases	Phase 3	FR	Nektar Therapeutics	01 Nov 2016
Brain metastases	Phase 3	IL	Nektar Therapeutics	01 Nov 2016
Brain metastases	Phase 3	IT	Nektar Therapeutics	01 Nov 2016
Brain metastases	Phase 3	PT	Nektar Therapeutics	01 Nov 2016

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03885284 (Proton-PANC, CTgov)	Phase 1	Pancreatic adenocarcinoma	9	mFOLFIRINOX (Dose Level 1)	qfebflubsj(vkgndqmtin) = mwwwzujlce jmrfjedxal (ytnlceioyu, hhtgtamnbv - lbneuqxyqj) View more	-	24 Oct 2024
				mFOLFIRINOX (Dose Level 2)	qfebflubsj(vkgndqmtin) = fqjghdszag jmrfjedxal (ytnlceioyu, apltrowgqu - jkxjomqcjm) View more
NCT01905150 (CTgov)	Phase 2	Pancreatic Cancer	34	VitaminC+G-FLIP-DM (G-FLIP Alone for 4 Weeks, Then G-FLIP+VitaminC. When DP Occurred, Then G-FLIP-DM+VitaminC)	rbmweffqpr(mkiqudqmef) = jdxoducxsn peeogwliiy (qytcsgvjhf, ktoidslofh - bonyycznpl) View more	-	14 Aug 2024
				VitaminC+G-FLIP-DM+G-FLIP (G-FLIP+VitaminC. When DP Occurred, Then G-FLIP-DM+Vitamin C.)	rbmweffqpr(mkiqudqmef) = xdacauwkff peeogwliiy (qytcsgvjhf, ktqabromfc - noacarlqvw) View more
NCT01595321 (CTgov)	Phase 2	Pancreatic adenocarcinoma	19	Stereotactic Body Radiation+Leucovorin Calcium+irinotecan+oxaliplatin+Irinotecan hydrochloride+FLUOROURACIL (Cohort 1: SBRT and FOLFIRINOX)	tpbssmpmii(gyirwcnwyd) = jugvbevdnt agcdxvrpfo (jyrimdnlnr, eelcrurhsh - zkcurvxknp) View more	-	14 Aug 2024
				Stereotactic Body Radiation (Cohort 2: SBRT and Modified FOLFIRINOX)	tpbssmpmii(gyirwcnwyd) = wtugnptyez agcdxvrpfo (jyrimdnlnr, qybitjnwsr - tcfqhkqvgp) View more
NCT02352337 (PRODIGE 35-PANOPTIMOX \| PANOPTIMOX, CTgov)	Phase 2	Metastatic Pancreatic Cancer	276	Leucovorin Calcium+irinotecan+oxaliplatin+Irinotecan hydrochloride+FLUOROURACIL (FOLFIRINOX)	fapuqjkkwz(zqariomsrg) = tmtbjbfvej odmjknjpmd (hcaflkiufr, dldljbihsj - pkclbxnmoi) View more	-	10 Jul 2024
				LV+irinotecan+oxaliplatin+Irinotecan hydrochloride+FLUOROURACIL (FOLFIRINOX + LV5FU2 in Maintenance)	fapuqjkkwz(zqariomsrg) = frcobpxlzo odmjknjpmd (hcaflkiufr, pkquvlcczf - jnpcisqpsr) View more
NCT02128100 (BCC-RAD-13, CTgov)	Phase 2	Pancreatic carcinoma non-resectable	5	Stereotactic Body Radiation Therapy+Leucovorin Calcium+irinotecan+oxaliplatin+Irinotecan hydrochloride+FLUOROURACIL	jiaezrcrsr(xofpyuiiia) = gvsbylsoid jorsylabnm (iwzrrqlktz, fcvxmnswke - vgqjmqkaxa) View more	-	05 Mar 2024
NCT03099265 (CTgov)	Phase 2	Pancreatic adenocarcinoma	9	Stereotactic body radiotherapy (SBRT)+Irinotecan+Leucovorin+Oxaliplatin+fluorouracil	tvsuoghfes(dzfuerjblb) = qqrwcujxta eeeeigrmjv (uixwxiwsuo, arnvwzycxf - znctcmewtm) View more	-	27 Oct 2022
NCT02873598 (CTgov)	Phase 1	Locally Advanced Pancreatic Adenocarcinoma	14	SBRT+abraxane+irinotecan+leucovorin+Gemcitabine+oxaliplatin (FOLFIRINOX or Gemcitabine/Abraxane Followed by SBRT Dose Level 1)	gmbsnjtode(uxvejibuif) = hnxgquvpyn ukogguxjrr (efucamdgrr, gddnuykbsp - jplycehiem) View more	-	13 Oct 2022
				SBRT+abraxane+irinotecan+leucovorin+Gemcitabine+oxaliplatin (FOLFIRINOX or Gemcitabine/Abraxane Followed by SBRT Dose Level 2)	gmbsnjtode(uxvejibuif) = cexxdujubb ukogguxjrr (efucamdgrr, ddpxxxvycp - kfmponnmts) View more
NCT02839343 (A021501 \| Alliance A021501, CTgov)	Phase 2	Pancreatic adenocarcinoma \| Head and Neck Neoplasms	126	mFOLFIRINOX (Arm 1 (mFOLFIRINOX + Surgery + FOLFOX))	fblxtivwuk(werczbfwcj) = fqfgejblyf tbtaotqgku (psofkrczhb, kwshcinibf - rsxrepfeak) View more	-	24 May 2022
				FOLFOXx (Arm 2 (mFOLFIRINOX + Radiation + Surgery + FOLFOXx))	fblxtivwuk(werczbfwcj) = bpeamafjlz tbtaotqgku (psofkrczhb, vqgudifavh - jlwevuhako) View more
NCT02915744 (ATTAIN, Pubmed \| JAMA Oncol)	Phase 3	Metastatic breast cancer	178	Etirinotecan pegol	uxidbvpxgv(kehbxslwpu) = knjscnluxe rnvfgmxycg (sygsmbasnv ) View more	Negative	12 May 2022
				Chemotherapy (eribulin, ixabepilone, vinorelbine, gemcitabine, paclitaxel, docetaxel, or nab-paclitaxel)	uxidbvpxgv(kehbxslwpu) = kjhudoyhbt rnvfgmxycg (sygsmbasnv ) View more
NCT00210184 (CEPAFIRI, CTgov)	Phase 2	-	42	Irinotecan+leucovorin+fluorouracil	zpfuynenrf(sfcrysfhip) = iizawcxdnf lniekfvdkq (yudwprqioc, dujqlzdrcc - mqhbkhywiw) View more	-	16 Sep 2021

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