预约演示
更新于：2025-06-21
Firicabtagene autoleucel
更新于：2025-06-21
概要
基本信息
非在研机构- |
权益机构- |
最高研发阶段临床1期 |
首次获批日期- |
最高研发阶段(中国)- |
特殊审评突破性疗法 (美国) |
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结构/序列
Sequence Code 1277313905
来源: *****
关联
2
项与 Firicabtagene autoleucel 相关的临床试验NCT05972720
An Open-label, Multicenter Phase 2 Study Evaluating the Efficacy and Safety of Firi-cel, a CD22-directed Autologous Chimeric Antigen Receptor (CAR) T-cell Therapy in Patients With Relapsed/Refractory Large B-Cell Lymphoma After CD19-directed CAR T-cell Therapy
This is a prospective, open-label, multi-center clinical study designed to evaluate the safety, tolerability, efficacy, pharmacokinetics, pharmacodynamics, and immunogenicity of firicabtagene autoleucel (firi-cel), a CD22-directed autologous Chimeric Antigen Receptor (CAR) T-cell therapy for the treatment of relapsed or refractory large B-cell lymphoma (LBCL).
开始日期2023-08-01 |
申办/合作机构 |
NCT04088890
Phase I/Ib Clinical Trial of Autologous CD22 Chimeric Antigen Receptor (CAR) T Cells in Adults With Recurrent or Refractory B Cell Malignancies
The primary purpose of this study is to test whether CD22-CAR T cells can be successfully made from immune cells collected from adults with relapsed/refractory B-cell malignancies (leukemia and lymphoma).
开始日期2019-09-12 |
申办/合作机构  Stanford University [+3] |
100 项与 Firicabtagene autoleucel 相关的临床结果
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100 项与 Firicabtagene autoleucel 相关的转化医学
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100 项与 Firicabtagene autoleucel 相关的专利（医药）
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1
项与 Firicabtagene autoleucel 相关的文献（医药）2024-07-01·LANCET
CD22-directed CAR T-cell therapy for large B-cell lymphomas progressing after CD19-directed CAR T-cell therapy: a dose-finding phase 1 study
Article
作者: Mackall, Crystal L ; Patel, Shabnum ; Egeler, Emily ; Muffly, Lori ; Sahaf, Bita ; Kramer, Anne Marijn ; Oak, Jean S ; Chinnasamy, Harshini ; Baird, John H ; Brown, Annie Kathleen ; Younes, Sheren F ; Feldman, Steven A ; Natkunam, Yasodha ; Su, Yi-Jiun ; Hamilton, Mark P ; Miklos, David B ; Agarwal, Neha ; Srinagesh, Hrishikesh K ; Mavroukakis, Sharon ; Frank, Matthew J
BACKGROUND:
Outcomes are poor for patients with large B-cell lymphoma who relapse after CD19-directed chimeric antigen receptor (CAR) T-cell therapy (CAR19). CD22 is a nearly universally expressed B-cell surface antigen and the efficacy of a CD22-directed CAR T-cell therapy (CAR22) in large B-cell lymphoma is unknown, which was what we aimed to examine in this study.
METHODS:
In this single centre, open-label, dose-escalation phase 1 trial, we intravenously administered CAR22 at two dose levels (1 million and 3 million CAR22-positive T cells per kg of bodyweight) to adult patients (aged ≥18 years) who relapsed after CAR19 or had CD19-negative large B-cell lymphoma. The primary endpoints were manufacturing feasibility, safety measured by the incidence and severity of adverse events and dose-limiting toxicities, and identification of the maximum tolerated dose (ie, the recommended phase 2 dose). This study is registered with ClinicalTrials.gov (NCT04088890) and is active, but closed for enrolment.
FINDINGS:
From Oct 17, 2019, to Oct 19, 2022, a total of 41 patients were assessed for eligibility; however, one patient withdrew. 40 patients underwent leukapheresis and 38 (95%) had CAR T-cell products manufactured successfully. The median age was 65 years (range 25-84), 17 (45%) were women, 32 (84%) had elevated pretreatment lactate dehydrogenase, 11 (29%) had refractory disease to all previous therapies, and patients had received a median of four lines of previous therapy (range 3-8). Of the 38 patients treated, 37 (97%) had relapsed after previous CAR19. The identified maximum tolerated dose was 1 million CAR T cells per kg. Of 29 patients who received the maximum tolerated dose, no patients developed a dose-limiting toxicity or grade 3 or higher cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, or immune effector cell-associated haemophagocytic lymphohistiocytosis-like syndrome.
INTERPRETATION:
This trial identifies CD22 as an immunotherapeutic target in large B-cell lymphoma and demonstrates the durable clinical activity of CAR22 in patients with disease progression after CAR19 therapy. Although these findings are promising, it is essential to recognise that this is a phase 1 dose-finding study. Further investigations are warranted to establish the long-term efficacy and to delineate the patient subgroups that will derive the most benefit from this therapeutic approach.
FUNDING:
National Cancer Institute, National Institutes of Health, Stanford Cancer Institute, Leukemia & Lymphoma Society, Parker Institute for Cancer Immunotherapy, Lymph & Co, and the European Hematology Association.
47
项与 Firicabtagene autoleucel 相关的新闻（医药）2025-01-10
- 71 patients dosed in the potentially pivotal Phase 2 clinical study of firicabtagene autoleucel (firi-cel); Interim analysis results expected to be reported in 1H’25 -
- IND application for CRG-023, CARGO’s tri-specific CAR T, cleared by the FDA; Phase 1 study enrollment expected to initiate mid-year 2025 -
- CARGO announces novel allogeneic platform based on a universal allogeneic-enabling vector intended to be paired with any new or existing CAR vector to create an allogeneic CAR T-cell therapy while leveraging existing autologous drug product processes -
SAN CARLOS, Calif., Jan. 10, 2025 (GLOBE NEWSWIRE) -- CARGO Therapeutics, Inc. (NASDAQ: CRGX), a clinical-stage biotechnology company positioned to advance next-generation, potentially curative cell therapies for cancer patients, today provided a corporate update and anticipated milestones for 2025.
“2024 highlighted our excellence in execution and innovation. We now have three programs – two clinical-stage with another advancing quickly – all driven by our strong capabilities designing, developing, and delivering next-generation, and potentially curative cell therapies,” said Gina Chapman, President and Chief Executive Officer of CARGO. “We are on track to report our interim analysis results for FIRCE-1 in first half 2025. I am also delighted to announce the clearance of our IND for CRG-023, a potentially best-in-class CAR T-cell therapy with Phase 1 enrollment to initiate mid-year. Rapid progression of CRG-023 from lead construct to IND submission in less than 12 months was enabled by our robust CMC and pre-clinical development capabilities. Finally, I’m very excited to announce our novel allogeneic platform, which I believe can meaningfully improve the availability of potentially curative cell therapies for patients by realizing the promise of an allogeneic solution in a universally applicable way. I’d like to thank the entire CARGO organization for their tenacity and innovative spirit, positioning us for our important milestones this year.”
“The challenges that limit a broader impact for autologous cell therapy include the quality of T cells derived from sick patients and availability of product. For allogeneic cell therapy, durable efficacy has been difficult to achieve,” said Michael Ports, Chief Scientific Officer of CARGO. “Over the past three years, we set out to solve these limitations through sophisticated cell therapy design and engineering, starting with CRG-023 and now with our novel allogenic platform that is intended to address immune-based rejection of allogeneic CAR T. The allogeneic CAR T platform is comprised of a universal vector with multiple transgene “cargo” to limit T and NK rejection and downregulate TCR. Importantly, the vector can be paired with pre-existing CAR vectors across targets and indications and can leverage existing autologous drug product processes. We are encouraged by our preclinical results which suggest the potential of a universal approach to creating off-the-shelf allogeneic CAR T products to provide more life-saving therapies for patients.”
Corporate Update and Anticipated Milestones for 2025:
Firi-cel:
As of December 31, 2024, 71 patients have been dosed in the potentially pivotal Phase 2 study of firi-cel, FIRCE-1. CARGO continues to achieve strong manufacturing success of firi-cel. The Company is partnering with National Resilience, Inc. and ElevateBio to manufacture drug product for the FIRCE-1 study. CARGO expects to share topline data from an interim analysis for a meaningful patient sample size with at least 3 months of follow-up in 1H’25.
CRG-023:
In January, the FDA cleared the Investigational New Drug (IND) application for CRG-023, CARGO’s novel tri-specific CAR T that is designed to address several known causes of relapse, resulting in a potential best-in-class CAR T-cell therapy across a broad range of B-cell malignancies with the goal of providing more patients with a durable complete response. CRG-023 is a first-of-its-kind CAR T to express three independent CARs (CD19, CD20, CD22) from a single vector, with each CAR having a distinct co-stimulatory domain. CRG-023 lentiviral vector is produced using suspension culture process which provides a line of sight to commercially suitable expression level. CRG-023 drug product is produced leveraging CARGO’s internally developed process and analytical methods. Given the encouraging pre-clinical data of CRG-023, CARGO intends to demonstrate the product candidate’s best-in-class potential through a Phase 1 dose escalation study in 3L+ LBCL including CAR T-naïve patients. The Company plans to leverage proof-of-concept data to support moving quickly into earlier lines of therapy and additional indications in B-cell malignancies for CRG-023. The Phase 1, open-label, multi-center, dose escalation and dose expansion study is expected to evaluate the safety, tolerability, pharmacokinetics, and efficacy of CRG-023 and to establish the recommended Phase 2 dose of CRG-023. Dose escalation will begin at a dose level of 25 million cells, which was informed by preclinical data that demonstrated in vivo tumor clearance at low dose levels. Enrollment for the Phase 1 study, including CAR T-naïve patients, is expected to initiate mid-year 2025. CARGO plans to leverage its established manufacturing and supply chain infrastructure to accelerate readiness for its Phase 1 study.
Novel Allogeneic Platform:
CARGO’s novel allogeneic platform is a universal vector solution designed to limit immune-based rejection and enable durable response of CAR T-cell therapy. Through sophisticated engineering, the differentiated platform aims to transform potentially curative autologous CAR T-cell therapies into allogeneic products for broader patient benefit. The universal, allogeneic-enabling vector is intended to pair with new or clinically established CAR vectors, which can be accomplished while leveraging existing autologous drug product processes. The result is intended to be an off-the-shelf allogeneic CAR T product designed to limit rejection, promote safety, improve the starting quality of T cells, and maintain comparable CAR-mediated activity. To date, CARGO has advanced several lead allogeneic constructs and demonstrated proof of concept in limiting immune rejection, preventing graft vs. host disease (GvHD), and preserving comparable CAR activity when co-transduced with CAR vector utilized for autologous CAR T-cell therapy. CARGO expects to select the lead vector candidate in 1H’25.
Financial Outlook:
As of December 31, 2024, the Company’s preliminary cash, cash equivalents and marketable securities were $368.1 million(1), which we believe will be sufficient to fund our expected operations through 2026.
Gina Chapman, President and Chief Executive Officer, is scheduled to present at the 43rd Annual J.P. Morgan Healthcare Conference on Monday, January 13, at 10:30 a.m. PT. Interested parties can access the live webcast for the presentation in the Investors section of CARGO’s website under News & Events. A replay of the webcast will be available after the conclusion of the live presentation for approximately 30 days.
About CARGO Therapeutics CARGO Therapeutics, Inc. is a clinical-stage biotechnology company positioned to advance next-generation, best-in-class, and potentially curative cell therapies for cancer patients. CARGO’s programs, platform technologies, and manufacturing strategy are designed to directly address the limitations of approved cell therapies, including limited durability of effect, safety concerns and availability. CARGO has a growing and focused pipeline that includes firicabtagene autoleucel (firi-cel), an autologous CD22 chimeric antigen receptor (CAR) T-cell therapy candidate currently in a potentially pivotal Phase 2 clinical study in patients with large B-cell lymphoma (LBCL) whose disease relapsed or was refractory (R/R) to CD19 CAR T-cell therapy. CARGO is also preparing to initiate a Phase 1 study for its CRG-023 product candidate, a CD19/CD20/CD22 tri-specific CAR T developed using a tri-cistronic construct and designed to address several known causes of relapse, resulting in a potential best-in-class CAR T-cell therapy across a broad range of B-cell malignancies with the goal of providing more patients with a durable complete response. CARGO’s latest program advancement, a novel allogeneic platform, is a universal vector solution designed to limit immune-based rejection and enable durable response of CAR T-cell therapy. The universal allogeneic-enabling vector is intended to be paired with any CAR vector to create an allogeneic CAR T-cell therapy, with the potential to maintain the efficacy, durability, and safety of autologous cell therapy while broadening availability to more people with cancer. CARGO’s leadership and team have significant experience in designing, developing and delivering oncology and cell therapy products. For more information, please visit the CARGO Therapeutics website at https://cargo-tx.com/. Follow us on LinkedIn: CARGO Therapeutics Follow us on X (Twitter): @CARGOTx
(1) The Company’s actual consolidated cash, cash equivalents, marketable securities as of December 31, 2024 may differ from this preliminary estimate due to the completion of the Company’s year-end closing and auditing procedures.
Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. All statements other than statements of historical facts contained in this press release are forward-looking statements. These forward-looking statements include, but are not limited to, statements about: the initiation, timing, progress, advancement, and results of CARGO’s clinical and preclinical programs; the potential benefits of CARGO’s product candidates; the timing of data reports, including the release of interim data from CARGO’s ongoing Phase 2 clinical trial of firi-cel; CARGO’s strategic plans for its business and product candidates; CARGO’s estimated cash, cash equivalents and marketable securities as of December 31, 2024 and CARGO’s expectations that its current cash, cash equivalents and marketable securities will be sufficient to fund its expected operations through 2026. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to: the company’s ability to obtain necessary capital to fund its clinical programs; the early stages of clinical development of the company’s product candidates and the product candidates involving novel technologies; clinical and preclinical development being a lengthy and expensive process with uncertain outcomes; data from the company’s clinical trials and preclinical studies, including the performance and characteristics of the company’s product candidates, including any undesirable side effects or other properties discovered or detected in the company’s clinical trials and preclinical studies; any favorable data from trials conducted by third-parties, including Stanford University or the NCI, may not be replicated in the company’s clinical trials or predictive of future results; the company’s ability to obtain regulatory approval of and successfully commercialize its product candidates; the company’s reliance on third-party suppliers and manufacturers, including CROs; the outcomes of any future collaboration agreements; and the company’s ability to adequately maintain intellectual property rights for its product candidates. For a detailed discussion of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to CARGO’s business in general, please refer to the risk factors identified in the Company’s filings with the Securities and Exchange Commission (SEC), including but not limited to its Quarterly Report on Form 10-Q for the quarter ended September 30, 2024 filed on November 12, 2024. Any forward-looking statements that the company makes in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and speak only as of the date of this press release. Except as required by law, the company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.
Contacts Media Contact: Denise Powell denise@redhousecomms.com
Investor Contact: Jessica Serra jserra@cargo-tx.com Laurence Watts laurence@newstreetir.com
细胞疗法临床2期临床1期免疫疗法临床申请
2024-12-23
Issued on behalf of Oncolytics Biotech Inc.
VANCOUVER, BC, Dec. 23, 2024 /PRNewswire/ -- USA News Group News Commentary – Recent advancements in cancer treatment continue to underscore the transformative potential of innovative therapies to improve patient outcomes. A stage 4 breast cancer patient in the United States reportedly achieved complete remission within six weeks through a novel immunotherapy approach, as highlighted by the New York Post. Meanwhile, in Europe, a Scottish woman became the first recipient of a personalized mRNA cancer vaccine, training her immune system to target cancer cells and marking a significant step toward more precise, less toxic treatments. These breakthroughs emphasize the dynamic nature of oncology research and the commitment to delivering groundbreaking therapies to patients worldwide. Key players driving these advancements include
Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC),
Cargo Therapeutics, Inc. (NASDAQ: CRGX),
Immuneering Corporation (NASDAQ: IMRX),
RenovoRx, Inc. (NASDAQ: RNXT), and
Repare Therapeutics Inc. (NASDAQ: RPTX).
The article continued: Additionally, the oncology sector has attracted significant investment, with companies like
Ottimo Pharma raising $140 million to develop more effective cancer treatments with fewer side effects—highlighting the industry's commitment to addressing the global cancer burden.
Oncolytics Biotech® Highlights 2024 Achievements and Prepares for an Influential 2025 with Promising Breast and GI Cancer Data
Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today released a recap of major accomplishments from 2024 and a preview of anticipated milestones for the next 12 months. Following the promising BRACELET-1 readout,
Oncolytics expects additional data readouts across its clinical development program in 2025, forming what it believes is a clear pathway to future commercialization opportunities.
"This past year produced highly encouraging clinical developments that we believe set the stage for significant progress, headlined by the robust efficacy results from the BRACELET-1 breast cancer study," said Wayne Pisano, Interim CEO and Chair of
Oncolytics Biotech's Board of Directors. "In addition, our gastrointestinal cancer program continues to impress, resulting in meaningful collaborations with well-respected experts in the field. Key opinion leaders in both breast and GI cancers continue to be excited by pelareorep's potential as we move into 2025. Based on these insights from leading oncologists, we believe pelareorep has the potential to become a transformational immunotherapy—and that pelareorep-based combination therapies could accelerate our path toward regulatory approval. We are very optimistic about our plans for the next year, and we look forward to showcasing our latest clinical progress early in the new year at the
ASCO GI Symposium—an event that could provide key catalysts for our ongoing gastrointestinal cancer programs. Unlike many immunotherapies that struggle to convert 'cold' tumors to 'hot,' pelareorep's unique mechanism of action following intravenous delivery has shown the potential to significantly boost patients' immune responses—making previously unresponsive tumors more susceptible to treatment. I would like to say thank you to our shareholders, clinical collaborators, study sites and their staff, the patients who participate in our trials, and the employees of
Oncolytics Biotech who have stepped up in a significant way in the temporary absence of our CEO, Matt Coffey."
Oncolytics Biotech continues to advance pelareorep, its innovative immunotherapy for multiple cancer indications. Final efficacy results from the BRACELET-1 study in HR+/HER2- metastatic breast cancer demonstrated a median overall survival benefit exceeding one year and a two-year survival rate nearly double that of paclitaxel monotherapy. These findings, supported by earlier IND-213 data, highlight pelareorep's promise as a groundbreaking treatment option. With
FDA alignment on a planned registration-enabling study,
Oncolytics Biotech aims to offer improved treatment options for approximately 55,000 U.S. patients annually.
Significant progress has also been made in pancreatic cancer. Collaborations with the
Global Coalition for Adaptive Research (GCAR) and
Roche have set the stage for a registration-enabling study. This builds on the GOBLET study's outcomes, which more than doubled response rates in first-line metastatic pancreatic ductal adenocarcinoma (PDAC) patients. Additionally, the
PanCAN-funded GOBLET cohort, evaluating pelareorep plus mFOLFIRINOX with or without atezolizumab, recently completed safety run-in enrollment and received positive feedback from the
Data Safety Monitoring Board.
Looking ahead,
Oncolytics Biotech will present at the Biotech Showcase on January 13, 2025, and host investor meetings during the
J.P. Morgan Healthcare Conference that same week. These events will provide a platform to highlight its clinical advancements and reinforce its commitment to addressing critical unmet needs in oncology.
CONTINUED… Read this and more news for Oncolytics Biotech at:
In other recent industry developments and happenings in the market include:
Cargo Therapeutics, Inc. (NASDAQ: CRGX), a clinical-stage biotechnology company positioned to advance next-generation, potentially curative cell therapies for cancer patients, recently reported financial results and key program updates. In the Phase 2 FIRCE-1 study, 57 LBCL patients relapsed or refractory to CD19 CAR T-cell therapy have been dosed, with the IDMC recommending the study continue without modification. Interim results are expected in the first half of 2025. For CRG-023, the company plans to submit an IND application for Non-Hodgkin's lymphoma in Q1 2025 and dose the first patient later that year. Preclinical data demonstrating CRG-023's durable anti-tumor activity across multiple antigens will be presented at the 66th ASH Annual Meeting.
"We are pleased to report another quarter of strong execution underscored by continued progress in our FIRCE-1, Phase 2 study of firi-cel in addition to meaningful pipeline advancements," said Gina Chapman, President and CEO of
CARGO. "With 57 patients dosed and continued, strong manufacturing success, we remain on track to report our interim analysis in the first half of 2025. We also anticipate a clear path forward to advancing CRG-023, our innovative tri-specific CAR T product candidate, into the clinic following our successful pre-IND meeting with the
FDA and we are excited to share more at the upcoming ASH meeting."
Immuneering Corporation (NASDAQ: IMRX), a clinical-stage oncology company developing universal-RAS/RAF medicines for broad cancer patient populations, recently announced plans to host a virtual Investor Event in early January 2025 to discuss data from its Phase 2a trial of IMM-1-104. The event will feature additional data on IMM-1-104 combined with mGnP in first-line pancreatic cancer, initial data on IMM-1-104 combined with mFFX in first-line pancreatic cancer, and monotherapy results in second-line pancreatic cancer. Initial PK, PD, and safety data from the Phase 1 portion of the Phase 1/2a trial of IMM-6-415 will also be presented. Access details for the event will be shared closer to the date.
"We are excited to soon share additional data from our Phase 2a study of IMM-1-104 in patients with pancreatic cancer," said Ben Zeskind, Ph.D., Co-Founder and CEO of
Immuneering. "Pancreatic cancer patients urgently need new options that enable them to live longer and feel better. The
FDA has recently granted IMM-1-104 Orphan Drug designation in pancreatic cancer, along with Fast Track designations in first and second-line pancreatic cancer, and advanced melanoma. We look forward to building on our September update with additional data from the Phase 2a study of IMM-1-104."
RenovoRx, Inc. (NASDAQ: RNXT), a life sciences company developing novel targeted oncology therapies and commercializing RenovoCath®, a novel,
FDA-cleared local drug-delivery platform, recently announced that
SCRI Oncology Partners in Nashville, TN, has begun enrolling patients with locally advanced pancreatic cancer (LAPC) in the pivotal Phase III TIGeR-PaC clinical trial. This study leverages
RenovoRx's TAMPTM (Trans-Arterial Micro-Perfusion) therapy platform, which delivers gemcitabine directly to tumors via the RenovoCath system using pressure-mediated delivery. The trial is comparing this innovative drug-device combination to the current standard-of-care systemic intravenous chemotherapy, with the goal of improving outcomes for LAPC patients.
"On an annual basis,
SCRI and its affiliated sites reach one in five patients with cancer and is responsible for enrolling thousands of patients on clinical trials," said Leesa Gentry, Chief Clinical Officer of
RenovoRx. "We believe this collaboration will assist the Company in both accelerating patient enrollment in our pivotal Phase III TIGeR-PaC clinical trial and driving the study towards its expected enrollment completion in the first half of 2025."
Repare Therapeutics Inc. (NASDAQ: RPTX), a leading clinical-stage precision oncology company, recently reported positive data from its MYTHIC Phase 1 gynecologic expansion clinical trial evaluating the combination of lunresertib (a first-in-class precision oncology small molecule PKMYT1 inhibitor) and camonsertib (Lunre+Camo) (a potential best-in-class oral small molecule inhibitor of ATR) at the recommended Phase 2 dose (RP2D) in patients with endometrial cancer and platinum-resistant ovarian cancer (PROC) harboring lunre-sensitizing biomarkers.
"We are encouraged by the strong response and the clear benefit we observed in patients with endometrial and platinum-resistant ovarian cancers in the MYTHIC clinical trial," said Lloyd M. Segal, President and CEO of
Repare. "These patients need new treatment options and our results support the potential for Lunre+Camo to make a real, positive difference if approved, particularly as a chemotherapy alternative. We have positive feedback from regulatory agencies in both the US and Europe and we look forward to getting started on a registrational Phase 3 trial of Lunre+Camo in endometrial cancer in the second half of 2025."
Source:
CONTACT:
USA NEWS GROUP
[email protected]
(604) 265-2873
DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles.
While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment.
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临床2期免疫疗法临床结果临床1期
2024-12-23
Issued on behalf of Oncolytics Biotech Inc.
VANCOUVER, BC, Dec. 23, 2024 /PRNewswire/ -- USA News Group News Commentary – Recent advancements in cancer treatment continue to underscore the transformative potential of innovative therapies to improve patient outcomes. A stage 4 breast cancer patient in the United States reportedly achieved complete remission within six weeks through a novel immunotherapy approach, as highlighted by the New York Post. Meanwhile, in Europe, a Scottish woman became the first recipient of a personalized mRNA cancer vaccine, training her immune system to target cancer cells and marking a significant step toward more precise, less toxic treatments. These breakthroughs emphasize the dynamic nature of oncology research and the commitment to delivering groundbreaking therapies to patients worldwide. Key players driving these advancements include
Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC),
Cargo Therapeutics, Inc. (NASDAQ: CRGX),
Immuneering Corporation (NASDAQ: IMRX),
RenovoRx, Inc. (NASDAQ: RNXT), and
Repare Therapeutics Inc. (NASDAQ: RPTX).
The article continued: Additionally, the oncology sector has attracted significant investment, with companies like
Ottimo Pharma raising $140 million to develop more effective cancer treatments with fewer side effects—highlighting the industry's commitment to addressing the global cancer burden.
Oncolytics Biotech® Highlights 2024 Achievements and Prepares for an Influential 2025 with Promising Breast and GI Cancer Data
Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today released a recap of major accomplishments from 2024 and a preview of anticipated milestones for the next 12 months. Following the promising BRACELET-1 readout,
Oncolytics expects additional data readouts across its clinical development program in 2025, forming what it believes is a clear pathway to future commercialization opportunities.
"This past year produced highly encouraging clinical developments that we believe set the stage for significant progress, headlined by the robust efficacy results from the BRACELET-1 breast cancer study," said Wayne Pisano, Interim CEO and Chair of
Oncolytics Biotech's Board of Directors. "In addition, our gastrointestinal cancer program continues to impress, resulting in meaningful collaborations with well-respected experts in the field. Key opinion leaders in both breast and GI cancers continue to be excited by pelareorep's potential as we move into 2025. Based on these insights from leading oncologists, we believe pelareorep has the potential to become a transformational immunotherapy—and that pelareorep-based combination therapies could accelerate our path toward regulatory approval. We are very optimistic about our plans for the next year, and we look forward to showcasing our latest clinical progress early in the new year at the
ASCO GI Symposium—an event that could provide key catalysts for our ongoing gastrointestinal cancer programs. Unlike many immunotherapies that struggle to convert 'cold' tumors to 'hot,' pelareorep's unique mechanism of action following intravenous delivery has shown the potential to significantly boost patients' immune responses—making previously unresponsive tumors more susceptible to treatment. I would like to say thank you to our shareholders, clinical collaborators, study sites and their staff, the patients who participate in our trials, and the employees of
Oncolytics Biotech who have stepped up in a significant way in the temporary absence of our CEO, Matt Coffey."
Oncolytics Biotech continues to advance pelareorep, its innovative immunotherapy for multiple cancer indications. Final efficacy results from the BRACELET-1 study in HR+/HER2- metastatic breast cancer demonstrated a median overall survival benefit exceeding one year and a two-year survival rate nearly double that of paclitaxel monotherapy. These findings, supported by earlier IND-213 data, highlight pelareorep's promise as a groundbreaking treatment option. With
FDA alignment on a planned registration-enabling study,
Oncolytics Biotech aims to offer improved treatment options for approximately 55,000 U.S. patients annually.
Significant progress has also been made in pancreatic cancer. Collaborations with the
Global Coalition for Adaptive Research (GCAR) and
Roche have set the stage for a registration-enabling study. This builds on the GOBLET study's outcomes, which more than doubled response rates in first-line metastatic pancreatic ductal adenocarcinoma (PDAC) patients. Additionally, the
PanCAN-funded GOBLET cohort, evaluating pelareorep plus mFOLFIRINOX with or without atezolizumab, recently completed safety run-in enrollment and received positive feedback from the
Data Safety Monitoring Board.
Looking ahead,
Oncolytics Biotech will present at the Biotech Showcase on January 13, 2025, and host investor meetings during the
J.P. Morgan Healthcare Conference that same week. These events will provide a platform to highlight its clinical advancements and reinforce its commitment to addressing critical unmet needs in oncology.
CONTINUED… Read this and more news for Oncolytics Biotech at:
In other recent industry developments and happenings in the market include:
Cargo Therapeutics, Inc. (NASDAQ: CRGX), a clinical-stage biotechnology company positioned to advance next-generation, potentially curative cell therapies for cancer patients, recently reported financial results and key program updates. In the Phase 2 FIRCE-1 study, 57 LBCL patients relapsed or refractory to CD19 CAR T-cell therapy have been dosed, with the IDMC recommending the study continue without modification. Interim results are expected in the first half of 2025. For CRG-023, the company plans to submit an IND application for Non-Hodgkin's lymphoma in Q1 2025 and dose the first patient later that year. Preclinical data demonstrating CRG-023's durable anti-tumor activity across multiple antigens will be presented at the 66th ASH Annual Meeting.
"We are pleased to report another quarter of strong execution underscored by continued progress in our FIRCE-1, Phase 2 study of firi-cel in addition to meaningful pipeline advancements," said Gina Chapman, President and CEO of
CARGO. "With 57 patients dosed and continued, strong manufacturing success, we remain on track to report our interim analysis in the first half of 2025. We also anticipate a clear path forward to advancing CRG-023, our innovative tri-specific CAR T product candidate, into the clinic following our successful pre-IND meeting with the
FDA and we are excited to share more at the upcoming ASH meeting."
Immuneering Corporation (NASDAQ: IMRX), a clinical-stage oncology company developing universal-RAS/RAF medicines for broad cancer patient populations, recently announced plans to host a virtual Investor Event in early January 2025 to discuss data from its Phase 2a trial of IMM-1-104. The event will feature additional data on IMM-1-104 combined with mGnP in first-line pancreatic cancer, initial data on IMM-1-104 combined with mFFX in first-line pancreatic cancer, and monotherapy results in second-line pancreatic cancer. Initial PK, PD, and safety data from the Phase 1 portion of the Phase 1/2a trial of IMM-6-415 will also be presented. Access details for the event will be shared closer to the date.
"We are excited to soon share additional data from our Phase 2a study of IMM-1-104 in patients with pancreatic cancer," said Ben Zeskind, Ph.D., Co-Founder and CEO of
Immuneering. "Pancreatic cancer patients urgently need new options that enable them to live longer and feel better. The
FDA has recently granted IMM-1-104 Orphan Drug designation in pancreatic cancer, along with Fast Track designations in first and second-line pancreatic cancer, and advanced melanoma. We look forward to building on our September update with additional data from the Phase 2a study of IMM-1-104."
RenovoRx, Inc. (NASDAQ: RNXT), a life sciences company developing novel targeted oncology therapies and commercializing RenovoCath®, a novel,
FDA-cleared local drug-delivery platform, recently announced that
SCRI Oncology Partners in Nashville, TN, has begun enrolling patients with locally advanced pancreatic cancer (LAPC) in the pivotal Phase III TIGeR-PaC clinical trial. This study leverages
RenovoRx's TAMPTM (Trans-Arterial Micro-Perfusion) therapy platform, which delivers gemcitabine directly to tumors via the RenovoCath system using pressure-mediated delivery. The trial is comparing this innovative drug-device combination to the current standard-of-care systemic intravenous chemotherapy, with the goal of improving outcomes for LAPC patients.
"On an annual basis,
SCRI and its affiliated sites reach one in five patients with cancer and is responsible for enrolling thousands of patients on clinical trials," said Leesa Gentry, Chief Clinical Officer of
RenovoRx. "We believe this collaboration will assist the Company in both accelerating patient enrollment in our pivotal Phase III TIGeR-PaC clinical trial and driving the study towards its expected enrollment completion in the first half of 2025."
Repare Therapeutics Inc. (NASDAQ: RPTX), a leading clinical-stage precision oncology company, recently reported positive data from its MYTHIC Phase 1 gynecologic expansion clinical trial evaluating the combination of lunresertib (a first-in-class precision oncology small molecule PKMYT1 inhibitor) and camonsertib (Lunre+Camo) (a potential best-in-class oral small molecule inhibitor of ATR) at the recommended Phase 2 dose (RP2D) in patients with endometrial cancer and platinum-resistant ovarian cancer (PROC) harboring lunre-sensitizing biomarkers.
"We are encouraged by the strong response and the clear benefit we observed in patients with endometrial and platinum-resistant ovarian cancers in the MYTHIC clinical trial," said Lloyd M. Segal, President and CEO of
Repare. "These patients need new treatment options and our results support the potential for Lunre+Camo to make a real, positive difference if approved, particularly as a chemotherapy alternative. We have positive feedback from regulatory agencies in both the US and Europe and we look forward to getting started on a registrational Phase 3 trial of Lunre+Camo in endometrial cancer in the second half of 2025."
Source:
CONTACT:
USA NEWS GROUP
[email protected]
(604) 265-2873
DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles.
While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment.
SOURCE USA News Group
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