A Phase II Open Label, Randomized Study Testing the Efficacy of Retifanlimab in Combination with Bevacizumab and Hypofractionated Radiotherapy in Patients with Recurrent GBM

This phase II trial tests how well retifanlimab with bevacizumab and hypofractionated radiotherapy, compared to bevacizumab and hypofractionated radiotherapy alone, works in treating patients with glioblastoma that has come back after a period of improvement (recurrent). A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as retifanlimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Giving retifanlimab with bevacizumab and hypofractionated radiotherapy may work better in treating patients with recurrent glioblastoma than bevacizumab and hypofractionated radiotherapy alone.

开始日期2024-10-02

申办/合作机构

National Cancer Institute

NCT06290622 / Withdrawn临床1期IIT

PD-1, LAG-3 and TIM-3 Checkpoint Blockade in DLBCL Post Chimeric Antigen Receptor T-cEll Therapy fAilUre (PLATEAU Study)

This study is investigating the optimal dose and the advantage in combining investigational immunotherapy drugs known as Retifanlimab, INCAGN02385 and INCAGN02390 to improve the responses to CAR T-cell therapy. Additionally, the study will investigate that triple checkpoint blockade of PD-1, TIM-3 and LAG-3 molecules will overcome CAR T-cell therapy resistance in patients with suboptimal responses.

开始日期2024-08-30

申办/合作机构

The University of Alabama at Birmingham

NCT06389799 / Recruiting临床2期IIT

A Phase 2, Open Label Study of PEmigatinib and REtifanlimab in Advanced Dedifferentiated LIposarcoma

Dedifferentiated liposarcomas (DDLPS) are aggressive soft tissue sarcomas with no effective medical treatment options.
Immunotherapy with checkpoint inhibitors, so-called PD-1 inhibitors, have shown some effect in DDLPS in previous studies. Effect of immunotherapy can be improved by combining it with other types of tumor drugs. Medicines that inhibit signaling via the FGF receptor, so-called FGFR inhibitors, have shown a tumor-slowing effect in DDLPS in early studies. FGFR inhibitors can also induce changes that make the tumor more available to treatment with immunotherapy.
The study aims to investigate whether the combination of an FGFR inhibitor, pemigatinib, with a PD-1 inhibitor, retifanlimab can provide a tumor-slowing effect in patients with advanced DDLPS who have progressed on first-line treatment.

开始日期2024-06-20

申办/合作机构

Lund University Hospital

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2025-01-01·BIOCHEMICAL AND BIOPHYSICAL RESEARCH COMMUNICATIONS

High-resolution crystal structure of PD-1 in complex with retifanlimab, the FDA-approved immune checkpoint blocking antibody for treating Merkel cell carcinoma

Article

作者: Choi, Seung-Beom ; Park, Jeong-Min ; Heo, Yong-Seok ; Lee, Eun Ho ; Cho, Seong-Ha ; Jang, Yu-Jeong ; Song, Ye Han

Retifanlimab is a humanized monoclonal antibody that specifically targets programmed cell death protein 1 (PD-1), an essential immune checkpoint that modulates T-cell immune responses. Several anti-PD-1 antibodies have been market-approved, marking a significant advancement in the treatment of diverse tumor types by restoring the T-cell immune response. Recently, the US FDA approved retifanlimab for treating metastatic or recurrent locally advanced Merkel cell carcinoma. We present the crystal structure of PD-1 in complex with the retifanlimab Fab at a resolution of 1.54 Å to elucidate the structural basis for the mechanism of action of this antibody. This work clarifies the detailed interactions and conformational alterations that occur upon antibody binding. The epitope of retifanlimab partially overlaps with the ligand binding site, and its binding induced unique conformations of the flexible loops within PD-1, including BC, C'D, and FG loops, thereby optimizing interactions with the antibody. A thorough analysis of its interaction with PD-1 and other FDA-approved anti-PD-1 antibodies may provide valuable insights into the rational design of enhanced therapies to regulate immune responses in cancer treatment.

2024-12-31·mAbs

Antibodies to watch in 2024

Article

作者: Crescioli, Silvia ; Kaplon, Hélène ; Reichert, Janice M. ; Wang, Lin ; Visweswaraiah, Jyothsna ; Chenoweth, Alicia

The 'Antibodies to Watch' article series provides an annual summary of commercially sponsored monoclonal antibody therapeutics currently in late-stage clinical development, regulatory review, and those recently granted a first approval in any country. In this installment, we discuss key details for 16 antibody therapeutics granted a first approval in 2023, as of November 17 (lecanemab (Leqembi), rozanolixizumab (RYSTIGGO), pozelimab (VEOPOZ), mirikizumab (Omvoh), talquetamab (Talvey), elranatamab (Elrexfio), epcoritamab (EPKINLY), glofitamab (COLUMVI), retifanlimab (Zynyz), concizumab (Alhemo), lebrikizumab (EBGLYSS), tafolecimab (SINTBILO), narlumosbart (Jinlitai), zuberitamab (Enrexib), adebrelimab (Arelili), and divozilimab (Ivlizi)). We briefly review 26 product candidates for which marketing applications are under consideration in at least one country or region, and 23 investigational antibody therapeutics that are forecast to enter regulatory review by the end of 2024 based on company disclosures. These nearly 50 product candidates include numerous innovative bispecific antibodies, such as odronextamab, ivonescimab, linvoseltamab, zenocutuzumab, and erfonrilimab, and antibody-drug conjugates, such as trastuzumab botidotin, patritumab deruxtecan, datopotamab deruxtecan, and MRG002, as well as a mixture of two immunocytokines (bifikafusp alfa and onfekafusp alfa). We also discuss clinical phase transition and overall approval success rates for antibody therapeutics, which are crucial to the biopharmaceutical industry because these rates inform decisions about resource allocation. Our analyses indicate that these molecules have approval success rates in the range of 14-32%, with higher rates associated with antibodies developed for non-cancer indications. Overall, our data suggest that antibody therapeutic development efforts by the biopharmaceutical industry are robust and increasingly successful.

2024-07-01·ESMO Open

Open-label, dose-escalation FIGHT-101 study of pemigatinib combined with targeted therapy, chemotherapy, or immunotherapy in patients with advanced malignancies

Article

作者: Tian, C ; Subbiah, V ; Papadopoulos, K P ; Saleh, M ; Mettu, N B ; Morgensztern, D ; Veronese, M L ; Silverman, I M ; Barve, M ; Gutierrez, M ; Spanggaard, I ; Roychowdhury, S

BACKGROUND:

Pemigatinib is an oral, potent, selective fibroblast growth factor receptor (FGFR) 1-3 inhibitor. FIGHT-101, a three-part, open-label, first-in-human, phase I/II study (NCT02393248), evaluated pemigatinib in patients with advanced solid tumors. In parts 1 and 2, pemigatinib monotherapy had a manageable safety profile and antitumor activity in FGFR-altered tumors. Part 3 (pemigatinib combination therapies) results are presented here.

PATIENTS AND METHODS:

Patients received 9, 13.5, or 20 mg oral once-daily pemigatinib on continuous or intermittent schedules with gemcitabine and cisplatin (pemi/gem/cis), docetaxel (pemi/doc), trastuzumab (pemi/tras), pembrolizumab (pemi/pembro), or retifanlimab (pemi/reti) irrespective of whether the tumor was confirmed as FGFR altered. Primary endpoints were safety and pharmacodynamics. Secondary endpoints were investigator-assessed tumor objective response rates (ORRs) and pharmacokinetics (PK).

RESULTS:

Of 65 enrolled patients (pemi/gem/cis, n = 8; pemi/doc, n = 7; pemi/tras, n = 6; pemi/pembro, n = 26; pemi/reti, n = 18), all discontinued. Treatment-emergent adverse events (TEAEs) were generally consistent with individual drug AEs. Serious and grade ≥3 TEAEs occurred in 0%-85.7% and 33.3%-100.0% of patients across treatment groups, respectively. All pemigatinib combinations demonstrated steady-state PK comparable to monotherapy. Pharmacodynamic effects in all pemigatinib combinations, except pemi/gem/cis, were consistent with monotherapy. Less inhibition of FGFR2α phosphorylation was observed with this combination. ORRs (95% confidence interval) were 37.5% [8.5% to 75.5% (pemi/gem/cis)], 14.3% [0.4% to 57.9% (pemi/doc)], 0% (pemi/tras), 26.9% [11.6% to 47.8% (pemi/pembro)], and 11.1% [1.4% to 34.7% (pemi/reti)]. All groups had instances of tumor shrinkage. ORRs in assessable patients with FGFR rearrangements and mutations were 50% and 33%, respectively.

CONCLUSIONS:

Pemigatinib combination therapy showed no unexpected toxicities. PK and pharmacodynamics were mostly consistent with pemigatinib monotherapy. Pemi/gem/cis (37.5%) and pemi/pembro (26.9%) had the highest ORR; most responders had FGFR alterations.

117

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2024-12-11

·GlobeNewswire-Health Care

BriaCell Presents Unprecedented Overall Survival Data in Metastatic Breast Cancer in Spotlight Poster at 2024 SABCS®

Median overall survival (OS) to date of 13.4 months for Phase 2 patients treated with the Phase 3 formulation (15.6 months for those treated since 2022), double that of comparable patients in the literatureFinal Phase 2 OS calculation is pending as many patients remain alive well over 1 year after starting the studyMedian OS of 13.7 months in breast cancer patients with central nervous system (CNS) metastasis treated with the Bria-IMT™ regimen alone or in combination with an immune check point inhibitor (CPI)Five BriaCell posters (four today and one on Dec 13th) showcase robust survival and clinical benefit data, plus key biomarker data from Phase 2 trial of Bria-IMT™ in metastatic breast cancer (MBC)Biomarkers identify patients who benefit from treatments with the Bria-IMT™ regimenNo toxicity related discontinuations PHILADELPHIA and VANCOUVER, British Columbia, Dec. 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 showcase its impressive survival and clinical benefit data in MBC patients, including those with CNS metastases, treated with the Bria-IMT™ plus CPI regimen. The data is featured in BriaCell’s “Spotlight” poster presentation session, at the 2024 San Antonio Breast Cancer Symposium® (SABCS®) held at Henry B. Gonzalez Convention Center, San Antonio, TX. “Metastatic breast cancer remains an essentially incurable disease, with a significant unmet medical need in patients who are relapsed/refractory to recently approved therapies such as CPIs and antibody-drug conjugates (ADCs),” stated Dr. William V. Williams, BriaCell’s President & CEO. “We are very pleased with the Bria-IMT™ combination regimen’s tolerability profile, and most importantly its outstanding clinical activity in heavily pre-treated patients who failed other therapeutic options.” “In addition to our striking survival data in MBC patients, we are excited by potential biomarkers for early identification of patients who would benefit from treatment with the Bria-IMT™ combination regimen,” noted Giuseppe Del Priore, MD, MPH, BriaCell’s Chief Medical Officer. “We expect to replicate Phase 2’s impressive survival and clinical benefit data in our ongoing pivotal Phase 3 study.” “While CNS metastatic disease has historically had a very poor prognosis, our clinical data to date, shows solid survival and clinical benefit in patients with CNS metastasis,” stated Sailaja Kamaraju, MD, Assistant Professor of Medicine at the Medical College of Wisconsin, Division of Hematology and Oncology. “We are optimistic that the Bria-IMT™ combination regimen, with its unique targeted mechanism of action, may be able to produce meaningful clinical and survival benefits in other cancer patients with CNS metastases who have lost hope with little to no other therapeutic options.” The data presented is from the fully enrolled BriaCell Phase 2 combination study of Bria-IMT™ plus CPI. An aggregate of 54 MBC patients were enrolled in the study – all treated with the Bria-IMT™ combination regimen {11 patients received KEYTRUDA® (pembrolizumab), and 43 patients received Incyte’s retifanlimab with one patient cross over from the KEYTRUDA® study to retifanlimab}. Data is available on all 54 of these heavily pre-treated metastatic breast cancer patients (average number of prior treatments = 6). Of these 54 patients, 37 were treated with the formulation currently under investigation in BriaCell’s ongoing pivotal Phase 3 study in metastatic breast cancer (listed on ClinicalTrials.gov as NCT06072612). Final median overall survival calculation for the patients in the Phase 2 portion of the study is pending, as most of these patients remain alive over 1 year following their start on the study. No Bria-IMT™ related discontinuations have been reported to date. The details about the Spotlight presentation and other poster sessions are as follows: Abstract Number: SESS-1071 (Spotlight Poster)Title: Overall survival results of Bria-IMT™ allogenic whole cell-based cancer vaccineTime: Wednesday, December 11, 2024 7:00 AM – 8:30 AM CSTPresentation ID: PS3-06 Bria-IMT™ regimen’s impressive OS and tolerability in MBC patients Median overall survival (OS) to date of 13.4 months for Phase 2 patients treated with the Phase 3 formulation (15.6 months for those treated since 2022 with the Phase 3 formulation) double that of comparable patients in the literature (Cortes J, et al. Annals of Oncology 2018; Kazmi S, et al. Breast Cancer Res Treat. 2020; O’Shaughnessy J et al. Breast Cancer Res Treat. 2022; Tripathy D, et al. JAMA Oncol. 2022; Bardia A, et al. J Clin Oncol. 2024)Final Phase 2 OS calculation is pending as many patients remain alive well over 1 year after starting the studyMedian overall survival (OS) for patients who received the Phase 3 formulation in the Phase 2 portion of the study who also developed an immune response to the vaccine as measured by delayed-type hypersensitivity (DTH) not yet reached with >1 year follow-up13.7 months median OS in MBC patients with central nervous system (CNS)/intracranial tumors treated with the Bria-IMT™ regimen with or without a CPIObjective response rates (ORR) and clinical benefit rates (CBR) were observed across all MBC patient subsets, but positive clinical outcomes were more prominent in HER2+ and HR+/HER2- patient subsetsBria-IMT™ regimen was well-tolerated and produced clinical benefit in heavily pretreated MBC patientsPatients who developed a DTH response had lower neutrophil to lymphocyte ratio (NLR), suggesting improved clinical benefit in these patientsDelayed-type hypersensitivity (DTH) response, and circulating tumor cells (CTC) levels were significantly different between patients who responded vs those who did not respond to the Bria-IMT™ combination regimen In conclusion, clinical findings to date support the potential safety and efficacy of Bria-IMT™, along with its potential use in CNS metastases, as well as the possible use of biomarkers to predict clinical outcomes in BriaCell’s ongoing pivotal Phase 3 study in MBC. Abstract Number: SESS-1431Title: Identification of antigenic determinants in SV-BR-1 derived cellular breast cancer vaccinesTime: Wednesday, December 11, 2024 5:30 – 7:00 PM CSTPresentation ID: P2-06-02 Summary: BriaCell successfully identified immunogenic (i.e. immune system activating) peptides in patients treated with Bria-IMT™, a cell-based cancer vaccine, and showed Bria-IMT™’s ability to produce a targeted immune response against tumor antigens. Key immunogenic peptides detected included those with post-translational modifications (PTMs), such as citrullination and cysteinylation, an important type of neoantigen that may be shared across many patients with cancerHighlighted the advantage of cell-based cancer vaccines over RNA and peptide-based vaccines including their ability to present a broad and diverse repertoire of antigens (i.e. both conventional and unconventional types)Cell-based cancer vaccines also display unknown, patient-specific neoantigens that are hard to reproduce with RNA or peptide vaccinesDiverse antigen presentation produces a robust, polyclonal immune response, engaging both CD8+ and CD4+ T cells against multiple tumor target In conclusion, scientific data presented suggests that the unique mechanism of cell-based cancer vaccines may reduce cancer cells’ immune escape and may potentially lead to strong and long-lasting clinical outcomes in cancer patients. Abstract Number: SESS-2217Title: PD-L1 upregulation in circulating tumor associated cells predicts for clinical outcomes in a phase I/II clinical trial using SV-BR-1-GM vaccine with the checkpoint inhibitor retifanlimab in metastatic breast cancer patients, an interim analysisTime: Wednesday, December 11, 2024 12:00 – 2:00 PM CSTPresentation ID: P1-01-17 Summary:Interim analysis after at least one year of Bria-IMT™ plus CPI regimen shows the following: Significantly lowered levels of circulating tumor cells (CTCs) and cancer associated macrophage-like cells (CAMLs) in 40% of heavily pre-treated MBC patientsLower CTCs/CAMLs levels were significantly correlated with better survival outcomes (i.e. better PFS and trended for better OS)Bria-IMT™ appeared to increase PD-L1 levels in 15 patients which correlated with better clinical responses to combination treatment with the anti-PD-1 check point inhibitor retifanlimab In conclusion, clinical data support the combination regimen in our ongoing pivotal Phase 3 study and suggests CTCs and CAMLs and PD-L1 levels may be relevant indicators of clinical outcome in MBC patients treated with Bria-IMT™ plus CPI. Abstract Number: SESS-1068Abstract Title: ASTRO-VAC CNS: Bria-IMT™ in the management of tumor agnostic metastatic CNS lesionsTime: Wednesday, December 11, 2024 5:30 – 7:00 PM CSTPresentation ID: P2-10-24 Results: The poster provides the details of a planned Phase 2 study design expanding the use of Bria-IMT™ + CPI to tumor agnostic cancer patients (i.e. kidney cancer, brain cancer, etc.) with central nervous system (CNS) metastasis. To view the posters, please visit https://briacell.com/scientific-publications/. About BriaCell Therapeutics Corp. BriaCell is a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care. More information is available at https://briacell.com/. Safe Harbor This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements, including those about the potential safety and efficacy of Bria-IMT™, along with its potential use in CNS metastases; biomarkers assisting with early identification of patients who would benefit from treatment with the Bria-IMT™ combination regimen; BriaCell expecting to replicate Phase 2’s survival and clinical benefit data in its ongoing pivotal Phase 3 study and the Company’s plans to share the data in the coming months; the Bria-IMT™ combination regimen’s ability to produce meaningful clinical and survival benefits in other cancer patients with CNS metastasis; the Company’s ongoing evaluation of biomarkers to predict clinical outcomes in its ongoing pivotal Phase 3 study in MBC; cell-based cancer vaccines potentially reducing cancer cells’ immune escape and leading to strong and long-lasting clinical outcomes in cancer patients; and CTCs, CAMLs and PD-L1 levels having the potential to be relevant indicators of clinical outcomes in MBC patients treated with Bria-IMT™ plus CPI 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, such as those are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully under the heading “Risks and Uncertainties” in the Company’s most recent Management’s Discussion and Analysis, under the heading “Risk Factors” in the Company’s most recent Annual Information Form, and under “Risks and Uncertainties” in the Company’s other filings with the Canadian securities regulatory authorities and the U.S. Securities and Exchange Commission, all of which are available under the Company's profiles on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov. Forward-looking statements contained in this announcement are made as of this date, and BriaCell Therapeutics Corp. undertakes no duty to update such information except as required under applicable law. Neither the Toronto Stock Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Toronto Stock Exchange) accepts responsibility for the adequacy or accuracy of this release. Contact Information Company Contact:William V. Williams, MDPresident & CEO1-888-485-6340info@briacell.com Media Relations:Jules AbrahamCORE IRjulesa@coreir.com Investor Relations Contact:CORE IRinvestors@briacell.com

临床2期免疫疗法临床3期临床结果疫苗

2024-12-09

·Endpoints

Enanta's mid-stage win in pediatric RSV; Carisma to lay off 34% of staff

Plus, news about Innovent Biologics, Relmada Therapeutics, Zevra Therapeutics, Incyte and Bionical Emas: Enanta’s Ph2 win in RSV: The company’s oral N-protein inhibitor achieved a 1.4 log decline in viral load at day five versus placebo in the mid-stage trial in pediatric respiratory syncytial virus. A prespecified analysis of patients randomized within three days of symptom onset showed a decline of 1.2 log compared with placebo. Adverse events with Enanta’s zelicapavir and placebo were similar, and there were no treatment discontinuations or study withdrawals owing to side effects. — Elizabeth Cairns Carisma Therapeutics to lay off 34% of its workforce: The Philadelphia biotech will let go of 23 employees and stop developing its lead asset, a CAR-monocyte program called CT-0525. The biotech had expected to have initial data from its Phase 1 trial of the asset in the first quarter of 2025. It will now focus on an in vivo macrophage engineering platform for potential applications in fibrosis, cancer and autoimmune diseases. — Kyle LaHucik Innovent Biologics details early-stage data for its ADC: It said IBI343, Innovent’s anti-CLDN18.2 antibody-drug conjugate, produced an overall objective response rate of 32.6% in 43 patients with CLDN18.2-positive advanced pancreatic ductal adenocarcinoma who had been previously treated. The data, presented at the ESMO Asia Congress, also demonstrated a confirmed ORR of 23.3% and confirmed disease control rate of 81.4%. Among 26 patients, median progression-free survival was 5.3 months; overall survival data are not yet mature. — Elizabeth Cairns Relmada Therapeutics looks for alternatives: The Florida biotech is ending its Phase 3 trials in major depression disorder after saying last week that the rapid-acting NMDA drug was likely to fail . It will also seek strategic alternatives, which could include a sale of assets, reverse merger or other deals. Relmada said it will keep running its Phase 1 in metabolic disease. — Kyle LaHucik Zevra Therapeutics says goodbye to two execs: The biotech parted ways with its chief development officer Christal M.M. Mickle and chief scientific officer Sven Guenther as part of a reprioritization. It also let go an undisclosed number of people in CMC and clinical development. It had 65 full-time workers at the end of 2023. — Kyle LaHucik Incyte’s PD-1 antibody-chemo combo wins in non-small cell lung cancer: The Phase 3 trial met the primary endpoint of overall survival and all secondary endpoints in patients with previously untreated metastatic NSCLC. Patients taking the Zynyz-chemotherapy combination achieved a median overall survival of 18.1 months compared to 13.4 months in the placebo arm. Secondary endpoints included overall response rate and duration of response. Incyte plans to submit a supplemental BLA to the FDA next year. — Katherine Lewin Bionical Emas divests CRO to UK private equity firm: Kester Capital is buying Bionical’s clinical research organization, dubbed EMAS Pharma, which will now operate as an independent business. The sale will allow Bionical to focus on its “core” businesses, including its early access programs and clinical trial supply units. No financial details were disclosed. — Anna Brown Janux Therapeutics raised $402.5 million in its public offering, up from the $300 million it initially planned to raise. — Jaimy Lee

临床结果临床3期临床1期并购抗体药物偶联物

2024-11-26

·GlobeNewswire-Health Care

BriaCell 2024 SABCS® Spotlight Poster to Showcase Positive Overall Survival Data Across All Patient Subtypes in Metastatic Breast Cancer

SABCS® “Spotlight” poster to be presented on Wednesday, December 11, 2024 7:00 AM – 8:30 AM CST highlights positive BriaCell survival and clinical benefit data across all metastatic breast cancer patient subtypes Median overall survival of 13.4 months exceeds historical controls. Phase 2 final median overall survival calculation is pending, as many patients remain alivePotential identification of biomarkers to predict responseFive poster presentations to feature increased presence of cancer fighting CD8+ “killer” T cell in metastatic breast cancer tumors, response in central nervous system (CNS) metastases and additional Bria-IMT™ clinical data from the Phase 2 trial of Bria-IMT™ + immune check point inhibitor in metastatic breast cancer Collaboration with the Medical College of Wisconsin will investigate use of Bria-IMT™ + CPI in any cancer patient with central nervous system (CNS) metastases PHILADELPHIA and VANCOUVER, British Columbia, Nov. 26, 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, will be highlighting its positive overall survival and clinical benefit data in metastatic breast cancer (MBC) patients including those with CNS metastasis (not shown on the abstracts) who were treated with the Bria-IMT™ plus immune checkpoint inhibitor (CPI) combination in its “Spotlight” poster presentation session, at the 2024 San Antonio Breast Cancer Symposium® (SABCS®) held at Henry B. Gonzalez Convention Center, San Antonio, TX. “In the Phase 2 study, the Bria-IMT™ combination regimen significantly increased overall survival versus comparable published benchmarks. Additionally, objective response rate and clinical benefit rate data, support the potential benefit of Bria-IMT™ plus CPI in patients with this difficult-to-treat cancer,” stated Saranya Chumsri, MD, Principal Investigator, and Professor of Oncology, Mayo Clinic. “We plan to confirm the impressive clinical data in the BriaCell pivotal Phase 3 study as we continue to explore the use of Bria-IMT™ regimen across all breast cancer subtypes.” “At BriaCell, we are committed to finding therapeutic options for difficult-to-treat metastatic breast cancer patients,” stated Dr. William V. Williams, BriaCell’s President & CEO. “BriaCell’s clinical data demonstrating impressive overall survival in all patient subsets including very difficult to treat patient populations, such as those who have failed prior checkpoint inhibitor and/or antibody-drug conjugate therapy, reinforces our confidence in the potential use of the combination regimen in MBC patients. Additionally, clinical benefit was seen across metastatic breast cancer subtypes including HER2+, HR+/HER2-, and even in triple-negative breast cancer (TNBC) patients. Bria-IMT™ may provide a significant contribution to the lives of patients and their families fighting this incurable disease.” The details about the submitted abstracts are as follows: Abstract Number: SESS-1071 (Selected as Spotlight Poster)Title: Overall survival results of Bria-IMT allogenic whole cell-based cancer vaccineTime: Wednesday, December 11, 2024 7:00 AM – 8:30 AM CSTPresentation ID: PS3-06 Abstract Summary: 54 patients were enrolled with 22 patients in phase 1 and 32 patients in phase 2.11 patients were treated with pembrolizumab and 44 patients with retifanlimab (1 patient received pembrolizumab and later retifanlimab).The Bria-IMT™ combination regimen was well tolerated.The Bria-IMT™ regimen demonstrated promising results across all subtypes of breast cancer with favorable safety profiles.Patients receiving the pivotal Phase 3 Bria-IMT™ combination regimen (n=37) showed significantly higher median overall survival (OS) (13.4), an objective response rate (ORR) of 9.5% and a clinical benefit rate (CBR) of 55%.Final median overall survival calculation for the Phase 2 study is pending, as many patients remain alive.Among 36 patients with post-dose cancer-associated circulating tumor cell (CTC) data, patients with post-dose CTC count < 5 had a significantly better OS compared with a CTC count > 5 (13.4 vs. 5.5 months, P 0.01).Patients with positive delayed type hypersensitivity (DTH), an inflammatory marker to measure the response to Bria-IMT™ immunization, had significantly better OS. “Our clinical findings support the use of the current Phase 3 formulation,” noted Giuseppe Del Priore, MD, MPH, BriaCell’s Chief Medical Officer. “We plan to confirm the potential use of key biomarkers to predict patient clinical outcomes in the Bria-IMT™ plus CPI ongoing pivotal Phase 3 study (NCT06072612) in metastatic breast cancer.” Abstract Number: SESS-1431Title: Identification of antigenic determinants in SV-BR-1 derived cellular breast cancer vaccinesTime: Wednesday, December 11, 2024 5:30 – 7:00 PM CSTPresentation ID: P2-06-02 Abstract Number: SESS-2217Title: PD-L1 upregulation in circulating tumor associated cells predicts for clinical outcomes in a phase I/II clinical trial using SV-BR-1-GM vaccine with the checkpoint inhibitor retifanlimab in metastatic breast cancer patients, an interim analysisTime: Wednesday, December 11, 2024 12:00 – 2:00 PM CSTPresentation ID: P1-01-17 Abstract Number: SESS-1068Abstract Title: ASTRO-VAC CNS: Bria-IMT in the management of tumor agnostic metastatic CNS lesionsTime: Wednesday, December 11, 2024 5:30 – 7:00 PM CSTPresentation ID: P2-10-24 Abstract Number: SESS-1069Title: Bria-IMT CD8+ tumor infiltrating lymphocytes turn “Cold” tumor “Hot” in metastatic breast cancerTime: Friday, December 13, 2024 12:00 PM – 2:00 PM CSTPresentation ID: P5-10-12 Following presentations, the posters can be viewed at the following: https://briacell.com/scientific-publications/. About BriaCell Therapeutics Corp. BriaCell is a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care. More information is available at https://briacell.com/. Safe Harbor This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements, including those about BriaCell’s potential use of key biomarkers to predict patient clinical outcomes in the Bria-IMT™ plus CPI ongoing pivotal Phase 3 study; BriaCell’s potential use of the combination regimen in MBC patients; BriaCell conducting a poster presentation at the 2024 San Antonio Breast Cancer Symposium®, and the contents of such presentation; the potential benefit of Bria-IMT™ plus CPI in cancer patients; BriaCell’s plans to confirm the clinical data in their pivotal Phase 3 study; BriaCell’s Phase 3 study exploring the use of the Bria-IMT™ regimen across all breast cancer subtypes; and the Bria-IMT™ regimen having the potential to provide a significant contribution to the lives of 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, such as those are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully under the heading “Risks and Uncertainties” in the Company’s most recent Management’s Discussion and Analysis, under the heading “Risk Factors” in the Company’s most recent Annual Information Form, and under “Risks and Uncertainties” in the Company’s other filings with the Canadian securities regulatory authorities and the U.S. Securities and Exchange Commission, all of which are available under the Company's profiles on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov. Forward-looking statements contained in this announcement are made as of this date, and BriaCell Therapeutics Corp. undertakes no duty to update such information except as required under applicable law. Neither the Toronto Stock Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Toronto Stock Exchange) accepts responsibility for the adequacy or accuracy of this release. Contact Information Company Contact:William V. Williams, MDPresident & CEO1-888-485-6340info@briacell.com Media Relations:Jules AbrahamCORE IRjulesa@coreir.com Investor Relations Contact:CORE IRinvestors@briacell.com

临床结果临床2期免疫疗法临床3期疫苗

100 项与瑞弗利单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11827	-	-	DB15766

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
转移性Merkel细胞癌	美国	Incyte Corp.	2023-03-22

未上市

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
子宫内膜癌	临床3期	中国	再鼎医药（上海）有限公司	2021-09-20
肛管鳞状细胞癌	临床3期	美国	Incyte Corp.	2021-01-12
肛管鳞状细胞癌	临床3期	日本	Incyte Corp.	2021-01-12
肛管鳞状细胞癌	临床3期	澳大利亚	Incyte Corp.	2021-01-12
肛管鳞状细胞癌	临床3期	比利时	Incyte Corp.	2021-01-12
肛管鳞状细胞癌	临床3期	丹麦	Incyte Corp.	2021-01-12
肛管鳞状细胞癌	临床3期	法国	Incyte Corp.	2021-01-12
肛管鳞状细胞癌	临床3期	德国	Incyte Corp.	2021-01-12
肛管鳞状细胞癌	临床3期	意大利	Incyte Corp.	2021-01-12
肛管鳞状细胞癌	临床3期	挪威	Incyte Corp.	2021-01-12

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03328026 (SABCS2024 \| GlobeNewswire) 人工标引	临床1/2期	转移性乳腺癌	54	Bria-IMT regimen with pembrolizumab/retifanlimab	醖構選夢鏇顧齋窪壓齋(艱鬱鬱獵夢網簾獵廠醖) = 構築遞蓋顧夢膚蓋夢膚淵範廠壓鏇齋餘願構淵 (鏇襯襯觸廠艱選繭範願 )	积极	2024-12-11
				Bria-IMT regimen with pembrolizumab/retifanlimab (without IFN incubation; phase 3 formulation)	醖構選夢鏇顧齋窪壓齋(艱鬱鬱獵夢網簾獵廠醖) = 壓齋範淵齋獵齋憲淵糧淵範廠壓鏇齋餘願構淵 (鏇襯襯觸廠艱選繭範願 ) 更多
NCT04438824 (ESMO2024) 人工标引	临床2期	去分化脂肪肉瘤	28	Palbociclibretifanlimab	艱窪襯顧網淵遞夢鹹願(選顧選窪窪夢鬱鬱壓醖) = 壓築築鬱製鏇廠網壓築遞襯選鹹簾鑰願觸築醖 (鑰夢窪淵壓廠鬱築積餘, 4.7 ~ 33.6) 更多	积极	2024-09-13
NCT03328026 (ASCO2024) 人工标引	临床1/2期	转移性乳腺癌 \| 晚期乳腺癌 CAMLs \| CTCs	54	SV-BR-1-GMegimen with oriretifanlimabce	獵顧範窪鑰鹹網鑰願觸(窪餘醖蓋襯選夢網餘窪) = 醖鏇獵遞廠壓顧製窪齋範廠餘襯簾鏇簾觸窪積 (齋淵廠醖願構餘網蓋觸 ) 更多	积极	2024-05-24
NCT04634825 (CTgov)	临床2期	转移性头颈部鳞状细胞癌	62	Enoblituzumab+Retifanlimab (Retifanlimab Cohort)	鏇壓選構選繭築淵築醖(壓蓋夢獵簾鑰網齋鹹範) = 觸顧壓壓願齋衊襯醖鹽積鹹選廠夢艱積衊艱網 (鏇觸網窪鑰積膚鏇醖壓, 淵憲獵齋鏇顧獵蓋壓壓 ~ 築鑰製憲憲簾鑰製蓋範) 更多	-	2023-12-20
				Enoblituzumab+Tebotelimab (Tebotelimab Cohort)	積積夢鏇夢簾顧夢積顧(糧糧鏇簾廠鏇鑰築構鹽) = 襯鹽簾獵糧醖選夢糧襯簾憲膚構繭鏇積廠遞鹹 (築簾鹽鬱醖鑰獵壓鑰鹽, 衊積繭鏇繭觸衊遞範壓 ~ 鹹繭襯顧鏇積鹽選積繭) 更多
NCT03059823 (POD1UM-101, ESMO 12023 \| ESMO 22023) 人工标引	临床1期	错配修复缺陷子宫内膜癌 \| MSI-H 子宫内膜癌 MSI-High \| Deficient DNA Mismatch Repair (dMMR)	76	Retifanlimab 500 mg	繭鏇觸夢顧襯窪網積築(衊壓廠鑰糧構膚夢夢餘) = 鏇糧鹹餘網壓餘餘願獵網鬱獵蓋鑰蓋襯淵餘蓋 (衊範憲顧醖製鏇積糧齋, 32 ~ 55)	积极	2023-10-22
NCT04370704 (ASCO 12023 \| ASCO 22023) 人工标引	临床1/2期	HR阳性/HER2低表达实体瘤	21	INCAGN02385 350 mg+INCAGN02390 400 mg	蓋鹽選築醖範鹹鹽蓋壓(網醖鏇壓鑰襯築選遞醖) = occurred in 1 pt in part 1 (grade [G] 3 vasculitis) and 1 pt in part 2 (G3 myocarditis and pericardial effusion) 艱醖憲醖範選鏇積簾願 (衊鹹夢築製製憲構憲遞 ) 更多	积极	2023-05-26
				retifanlimab 500 mg+INCAGN02385 350 mg+INCAGN02390 400 mg
NCT04577014 (ASCO 12023 \| ASCO 22023) 人工标引	临床2期	局部晚期软组织肉瘤一线	43	Retifanlimab+gemcitabine+docetaxel	製衊構襯憲壓夢願築淵(積遞構願觸憲襯餘選簾) = 網願艱範鏇淵獵糧構鹹製獵淵顧範積鑰衊遞獵 (窪鏇簾鏇衊遞鹽鏇獵壓 ) 更多	积极	2023-05-26
NCT04225039 (ASCO2023) 人工标引	临床2期	复发性胶质母细胞瘤	32	INCAGN01876+Retifanlimab+FSRT (single-arm, primary efficacy cohort)	鹹遞製鹹夢觸夢憲餘顧(齋襯糧餘糧觸艱觸鏇壓) = 窪獵鬱製淵願蓋簾齋艱廠廠積衊鹽構壓醖範淵 (艱構壓築窪網獵遞簾遞, 2.1 ~ 6.2) 更多	不佳	2023-05-26
				INCAGN01876+Retifanlimab+FSRT (two-arm neoadjuvant window-of-opportunity cohort)	鹹遞製鹹夢觸夢憲餘顧(齋襯糧餘糧觸艱觸鏇壓) = 獵艱醖蓋醖鏇鑰餘膚衊廠廠積衊鹽構壓醖範淵 (艱構壓築窪網獵遞簾遞 ) 更多
NCT04231981 (ORPHEUS, ASCO 12023 \| ASCO 22023) 人工标引	临床2期	阴茎鳞状细胞癌	18	Retifanlimab	夢齋積構窪醖憲繭壓膚(簾鏇範選齋構觸鑰構鑰) = 築繭遞觸壓積顧廠願築觸夢憲簾鏇鏇鏇積網網 (製顧膚窪醖衊範網襯夢, 5.8 ~ 39.2) 更多	积极	2023-05-26
NCT03599713 (POD1UM-201, CTgov)	临床2期	转移性Merkel细胞癌	107	retifanlimab (Chemotherapy: Naïve)	鑰鑰繭鹽構觸積顧鏇壓(蓋願構艱網願齋憲廠築) = 鬱襯壓襯壓鬱壓夢鏇衊鑰憲鑰顧襯範鹹窪遞積 (醖壓鬱憲築築鬱夢鹹網, 網網廠鹽襯鑰製選襯齋 ~ 襯構鹽鏇淵艱鹽鑰範憲) 更多	-	2023-05-03
				retifanlimab (Chemotherapy: Refractory)	襯鏇顧築襯鏇範壓憲膚(壓鬱窪鬱壓糧獵衊艱齋) = 齋齋獵築築繭鏇製鬱醖鹽衊積簾鹽鹽範壓艱製 (窪網膚簾觸遞願鬱衊網, 觸願餘觸蓋艱積窪積壓 ~ 鏇夢膚製遞艱鏇獵築襯) 更多