Latest news with #CERo
Business Wire
08-07-2025
- Business
- Business Wire
Invivoscribe Expands Flow Cytometry Services to Accelerate CAR-T Immunotherapy Development and Regulatory Readiness with the Initiation of CERo Therapeutics Phase 1 Clinical Trial
SAN DIEGO--(BUSINESS WIRE)--Invivoscribe Inc., a global leader in precision diagnostics and measurable residual disease (MRD) testing, is proud to support CERo Therapeutics Holdings, Inc., an innovative immunotherapy company seeking to advance the next generation of engineered T cell therapeutics that employ phagocytic mechanisms. Through this collaboration, LabPMM (Invivoscribe's global reference laboratories) have customized their multiparametric flow cytometry (MFC) services and implemented their sensitive MFC AML MRD assay to support CERo's clinical trial of its lead compound, CER-1236. The trial targets Acute Myeloid Leukemia (AML) in patients who are relapsed/refractory, in remission with MRD, or newly diagnosed with TP53-mutated MDS/AML. AML is an aggressive blood cancer characterized by the rapid accumulation of abnormal myeloid cells in the bone marrow and blood, disrupting normal hematopoiesis. 1 Treating AML is especially complex due to its genetic heterogeneity and the high risk of relapse. CAR-T (chimeric antigen receptor T-cells) and Chimeric Engulfment Receptor T-cells ('CER-T') therapies, which involve engineering a patient's own T-cells to recognize and attack cancer cells, have shown promise in other hematologic malignancies and are now being explored for AML. However, because these therapies are manufactured from patient-derived cells, it's critical to confirm that leukemic blasts are not inadvertently included in the final therapeutic product – underscoring the need for sensitive, validated assays like those offered by Invivoscribe and its global accredited regional laboratories, LabPMM. LabPMM's CAP/CLIA-Validated AML MRD MFC assay, which was designed to quantify residual leukemic cells in patients undergoing treatment, was customized to meet two critical needs in CERo's drug development program: (1) assessing the purity of the manufactured T-cell product by detecting residual AML blasts prior to infusion, and (2) evaluating therapeutic response to CER-1236 during the trial. Kristen Pierce, Ph.D., CERo Chief Development Officer, commented, 'Invivoscribe has played an integral role in the execution of this clinical trial. Its technology and expertise have facilitated our advancement into the clinic by helping to ensure the purity of our investigational product, and now we are reaping the benefits of our collaboration as the trial is underway and we seek to assess therapeutic response.' This collaborative effort was instrumental in advancing CER-1236, which recently received FDA Orphan Drug Designation for the treatment of AML 2. The designation highlights the growing urgency of integrated diagnostic support in the advancement of personalized immunotherapies and reflects Invivoscribe's commitment to driving innovation and standardization across the oncology treatment landscape – now helping bring immunotherapies to patients faster. For more information about LabPMM's flow cytometry and molecular testing services, please visit or contact us at inquiry@ and follow us on LinkedIn. About Invivoscribe Inc. Invivoscribe ® is a global, vertically integrated biotechnology company dedicated to Improving Lives with Precision Diagnostics ®. For thirty years, Invivoscribe has improved the quality of healthcare worldwide by providing high quality standardized reagents, tests, and bioinformatics tools to advance the field of precision medicine. Invivoscribe has a successful track record of partnerships with pharmaceutical companies interested in clinical trial testing via our global lab network located in the U.S., Germany, Japan and China, and in developing and commercializing companion diagnostics, with our rigorous expertise in both regulatory and laboratory services. Providing distributable kits, as well as clinical trial services through its globally located clinical lab subsidiaries (LabPMM ®), Invivoscribe is an ideal partner from diagnostic development, through clinical trials, regulatory submissions, and commercialization. About CERo Therapeutics Holdings, Inc. CERo is an innovative immunotherapy company advancing the development of next generation engineered T cell therapeutics for the treatment of cancer. Its proprietary approach to T cell engineering, which enables it to integrate certain desirable characteristics of both innate and adaptive immunity into a single therapeutic construct, is designed to engage the body's full immune repertoire to achieve optimized cancer therapy. This novel cellular immunotherapy platform is expected to redirect patient-derived T cells to eliminate tumors by building in engulfment pathways that employ phagocytic mechanisms to destroy cancer cells, creating what CERo refers to as Chimeric Engulfment Receptor T cells ('CER-T'). CERo believes the differentiated activity of CER-T cells will afford them greater therapeutic application than currently approved chimeric antigen receptor ('CAR-T') cell therapy, as the use of CER-T may potentially span both hematological malignancies and solid tumors. CERo has commenced clinical trials for its lead product candidate CER-1236 for hematological malignancies.
Yahoo
17-06-2025
- Business
- Yahoo
CERo Therapeutics Holdings, Inc. Announces FDA Orphan Drug Designation Granted to CER-1236 for the Treatment of Acute Myeloid Leukemia (AML)
SOUTH SAN FRANSCISCO, Calif., June 17, 2025 (GLOBE NEWSWIRE) -- CERo Therapeutics Holdings, Inc., (Nasdaq: CERO) ('CERo' or the 'Company') an innovative immunotherapy company seeking to advance the next generation of engineered T cell therapeutics that deploy phagocytic mechanisms, announces that the U.S. Food and Drug Administration (FDA) has granted CERo's Orphan Drug Designation (ODD) for the company's lead drug candidate CER-1236, for the treatment of acute myeloid leukemia (AML). CER-1236 is an innovative therapy that engineers a cancer patient's own T cell therapeutics that deploy phagocytic (i.e., target-cell eating) mechanisms alongside the array of built-in target cell destroying mechanisms used by T cells. CER-1236 is currently in Phase 1 clinical trials for AML. The first-in-human, multi-center, open label, Phase 1/1b study is designed to evaluate the safety and preliminary efficacy of CER-1236 in patients with acute myeloid leukemia that is either relapsed/refractory, or in remission with measurable residual disease, or newly diagnosed patients with TP53 mutated MDS/AML or AML. The two-part study has begun with dose escalation to determine highest tolerated dose and recommended dose for Phase 2, followed by an expansion phase to evaluate safety and efficacy. Primary outcome measures include incidence of adverse events (AEs) and serious adverse events (SAEs), incidence of dose limited toxicities and estimation of overall response rate (ORR), complete response (CR), composite complete response (cCR), and measurable residual disease (MRD). Secondary outcome measures include pharmacokinetics (PK). Chris Ehrlich, CERo CEO, commented, 'Orphan Drug Designation underscores the importance of developing new treatments for AML, and the potential for CER-1236 to provide a new and differentiated approach toward treatment. We believe that we are at the forefront of innovation in immuno-oncology and are grateful for the recognition from FDA. We look forward to providing updates on our trial in the near term.' The FDA's Orphan Drug program is designed to advance the development of drugs that treat a condition affecting 200,000 or fewer US patients annually. ODD status is given to medicinal products that represent a significant benefit over existing treatments and are intended for the treatment of a disease that is life-threatening or chronically debilitating. The ODD designation qualifies CERo and CER-1236 for certain incentives, which include FDA assistance in designing clinical trials, access to the FDA Orphan Drug Grants Program, exemption from the drug approval application fee and eligibility for seven years of marketing exclusivity. About CERo Therapeutics Holdings, Inc. CERo is an innovative immunotherapy company advancing the development of next generation engineered T cell therapeutics for the treatment of cancer. Its proprietary approach to T cell engineering, which enables it to integrate certain desirable characteristics of both innate and adaptive immunity into a single therapeutic construct, is designed to engage the body's full immune repertoire to achieve optimized cancer therapy. This novel cellular immunotherapy platform is expected to redirect patient-derived T cells to eliminate tumors by building in engulfment pathways that employ phagocytic mechanisms to destroy cancer cells, creating what CERo refers to as Chimeric Engulfment Receptor T cells ('CER-T'). CERo believes the differentiated activity of CER-T cells will afford them greater therapeutic application than currently approved chimeric antigen receptor ('CAR-T') cell therapy, as the use of CER-T may potentially span both hematological malignancies and solid tumors. CERo has commenced clinical trials for its lead product candidate CER-1236 for hematological malignancies. Forward-Looking Statements This communication contains statements that are forward-looking and as such are not historical facts. This includes, without limitation, statements regarding the financial position, business strategy and the plans and objectives of management for future operations of CERo, as well as statements regarding the Company's plans to regain compliance with Nasdaq listing requirements and the ability for the Company's securities to remain listed on Nasdaq. These statements constitute projections, forecasts and forward-looking statements, and are not guarantees of performance. Such statements can be identified by the fact that they do not relate strictly to historical or current facts. When used in this communication, words such as 'anticipate,' 'believe,' 'continue,' 'could,' 'estimate,' 'expect,' 'intend,' 'may,' 'might,' 'plan,' 'possible,' 'potential,' 'predict,' 'project,' 'should,' 'strive,' 'would' and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. When CERo discusses its strategies or plans, it is making projections, forecasts or forward-looking statements. Such statements are based on the beliefs of, as well as assumptions made by and information currently available to, CERo's management. Actual results could differ from those implied by the forward-looking statements in this communication. Certain risks that could cause actual results to differ are set forth in CERo's filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q, and the documents incorporated by reference therein. The risks described in CERo's filings with the Securities and Exchange Commission are not exhaustive. New risk factors emerge from time to time, and it is not possible to predict all such risk factors, nor can CERo assess the impact of all such risk factors on its business, or the extent to which any factor or combination of factors may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements are not guarantees of performance. You should not put undue reliance on these statements, which speak only as of the date hereof. All forward-looking statements made by CERo or persons acting on its behalf are expressly qualified in their entirety by the foregoing cautionary statements. CERo undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Contact: Chris EhrlichChief Executive Officerchris@ Investors: CORE IRinvestors@
Business Insider
13-06-2025
- Business
- Business Insider
CERo Therapeutics, Inc. Announces Option Exercise for Additional Series D Financing
SOUTH SAN FRANCISCO, Calif., June 06, 2025 (GLOBE NEWSWIRE) -- CERo Therapeutics Holdings, Inc. (Nasdaq: CERO) ('CERo'), an innovative immunotherapy company seeking to advance the next generation of engineered T cell therapeutics that employ phagocytic mechanisms, announces that the Company has issued additional shares of its Series D Preferred Stock to certain institutional investors (the 'Investors') pursuant to the securities purchase agreement previously entered into by and between the Company and such Investors on April 22, 2025 with respect to the issuance of shares of Series D Preferred Stock for an aggregate purchase price of up to $8 million, including $5 million previously issued in April 2025 and up to $3 million issuable at the option of the Investors. The shares of Series D Preferred Stock are convertible into shares of the Company's common stock. 'We welcome this vote of confidence and the continued support of our investors as we continue to show progress along our clinical timeline. The completion of our first-in-human dosing represents a significant clinical development milestone in AML for CER-1236, a novel autologous CAR-T therapeutic candidate targeting TIM 4L, and we will continue to communicate results as the data matures,' said Chris Ehrlich, Chief Executive Officer. The gross proceeds to CERo from today's closing are expected to be approximately $750,000, with up to $2.25 million of cash that may be funded at one or more additional closings, at the election of the Investors. CERo intends to use the net proceeds from the offering to take advantage of the two recent FDA IND allowances in liquid and solid tumors and complete the previously announced site activation at MDACC, as well as bring other sites online quickly. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction. CERo is an innovative immunotherapy company advancing the development of next generation engineered T cell therapeutics for the treatment of cancer. Its proprietary approach to T cell engineering, which enables it to integrate certain desirable characteristics of both innate and adaptive immunity into a single therapeutic construct, is designed to engage the body's full immune repertoire to achieve optimized cancer therapy. This novel cellular immunotherapy platform is expected to redirect patient-derived T cells to eliminate tumors by building in engulfment pathways that employ phagocytic mechanisms to destroy cancer cells, creating what CERo refers to as Chimeric Engulfment Receptor T cells ('CER-T'). CERo believes the differentiated activity of CER-T cells will afford them greater therapeutic application than currently approved chimeric antigen receptor ('CAR-T') cell therapy, as the use of CER-T may potentially span both hematological malignancies and solid tumors. In April 2025, CERo initiated clinical trials for its lead product candidate, CER-1236,for hematological malignancies. Forward-Looking Statements This communication contains statements that are forward-looking and as such are not historical facts. This includes, without limitation, statements regarding the financial position, business strategy and the plans and objectives of management for future operations of CERo. These statements constitute projections, forecasts and forward-looking statements, and are not guarantees of performance. Such statements can be identified by the fact that they do not relate strictly to historical or current facts. When used in this communication, words such as 'anticipate,' 'believe,' 'continue,' 'could,' 'estimate,' 'expect,' 'intend,' 'may,' 'might,' 'plan,' 'possible,' 'potential,' 'predict,' 'project,' 'should,' 'strive,' 'would' and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. When CERo discusses its strategies or plans, it is making projections, forecasts or forward-looking statements. Such statements are based on the beliefs of, as well as assumptions made by and information currently available to, CERo's management. Actual results could differ from those implied by the forward-looking statements in this communication. Certain risks that could cause actual results to differ are set forth in CERo's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K, filed on April 15, 2025, and the documents incorporated by reference therein. The risks described in CERo's filings with the Securities and Exchange Commission are not exhaustive. New risk factors emerge from time to time, and it is not possible to predict all such risk factors, nor can CERo assess the impact of all such risk factors on its business, or the extent to which any factor or combination of factors may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements are not guarantees of performance. You should not put undue reliance on these statements, which speak only as of the date hereof. All forward-looking statements made by CERo or persons acting on its behalf are expressly qualified in their entirety by the foregoing cautionary statements. CERo undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
Business Insider
13-06-2025
- Business
- Business Insider
CERo Therapeutics Holdings, Inc. Announces Continued Enhancement of Intellectual Property Portfolio with Two Granted U.S. Patents and European Patent Application Allowance Regarding Company's...
Results in 18 Issued Patents and Allowed Patent Applications Internationally with Nine Total Patent Families SOUTH SAN FRANSCISCO, Calif., June 02, 2025 (GLOBE NEWSWIRE) -- CERo Therapeutics Holdings, Inc., (Nasdaq: CERO) ('CERo' or the 'Company') an innovative immunotherapy company seeking to advance the next generation of engineered T cell therapeutics that deploy phagocytic (i.e., target-cell eating) mechanisms alongside the array of built-in target cell destroying mechanisms used by T cells, announces two previously announced U.S. patent applications have been granted by the U.S. Patent and Trademark Office (USPTO), and one European patent application has been allowed by the European Patent Office, all of which significantly expand the Company's intellectual property portfolio. The USPTO granted U.S. Patent No. 12,291,557, titled, 'CHIMERIC TIM4 RECEPTORS AND USES THEREOF' on May 6, 2025. The granted claims cover certain design aspects of CER-1236, the Company's lead compound. This patent provides composition of matter protection for a chimeric TIM4 receptor comprising a TIM4 binding domain and canonical T cell signaling domains. Additionally, the European Patent Office has allowed European Patent Application No. 1882166.7 titled, 'CHIMERIC ENGULFMENT RECEPTOR MOLECULES AND METHODS OF USE' on May 16, 2025. The allowed claims encompass a chimeric engulfment receptor comprising a TIM4 binding domain and TLR2 signaling domain. The allowance of this European patent application expands protection of additional design aspects of CER-1236, which have already been granted in the U.S., Japan, and China. Finally, the USPTO granted U.S. Patent No. 12,303,551, titled, 'CELLULAR IMMUNOTHERAPY COMPOSITIONS AND USES THEREOF,' on May 20, 2025. This patent provides coverage for combination cellular immunotherapy compositions and methods of use for CER-1236. The patent covers combination of a chimeric engulfment receptor CD4 + T cell (CD4 + CER-T cell) with a chimeric antigen receptor CD8 + T cell (CD8 + CAR-T cell) or T cell receptor CD8 + T cell (CD8 + TCR-T cell), and their use to treat cancer. This type of combination therapy could be an exciting avenue to complement the CER-T cell technology with other powerful anti-cancer therapies. CERo's intellectual property portfolio now includes 9 total patent families with protection out to 2042 in the United States. With these additional granted patents and allowed application, CER-1236 and its platform technology is supported by 18 total issued patents and allowed patent application internationally. Chris Ehrlich, CERo Therapeutics CEO, commented, 'We continue to aggressively expand our intellectual property portfolio, as it ensures CERo's success in the market. These patents protect the core innovations of the CER-T technology that differentiate it from other cell therapies and demonstrate the true novelty of our design . We continue to seek a robust range of patents across multiple geographies that cover this technology in general, and CER-1236 in particular. The appreciation of the novelty of the CER-T technology by the patent offices validates the innovation and therapeutic potential of this approach, and we believe that we will continue to grow the portfolio. In the near term, we anticipate updates on our clinical trial progress in AML, and the announcement of initiating human trials to treat ovarian and non-small cell lung cancers.' About CERo Therapeutics Holdings, Inc. CERo is an innovative immunotherapy company advancing the development of next generation engineered T cell therapeutics for the treatment of cancer. Its proprietary approach to T cell engineering, which enables it to integrate certain desirable characteristics of both innate and adaptive immunity into a single therapeutic construct, is designed to engage the body's full immune repertoire to achieve optimized cancer therapy. This novel cellular immunotherapy platform is expected to redirect patient-derived T cells to eliminate tumors by building in engulfment pathways that employ phagocytic mechanisms to destroy cancer cells, creating what CERo refers to as Chimeric Engulfment Receptor T cells ('CER-T'). CERo believes the differentiated activity of CER-T cells will afford them greater therapeutic application than currently approved chimeric antigen receptor ('CAR-T') cell therapy, as the use of CER-T may potentially span both hematological malignancies and solid tumors. CERo has commenced clinical trials for its lead product candidate CER-1236 for hematological malignancies. This communication contains statements that are forward-looking and as such are not historical facts. This includes, without limitation, statements regarding the financial position, business strategy and the plans and objectives of management for future operations of CERo. These statements constitute projections, forecasts and forward-looking statements, and are not guarantees of performance. Such statements can be identified by the fact that they do not relate strictly to historical or current facts. When used in this communication, words such as 'anticipate,' 'believe,' 'continue,' 'could,' 'estimate,' 'expect,' 'intend,' 'may,' 'might,' 'plan,' 'possible,' 'potential,' 'predict,' 'project,' 'should,' 'strive,' 'would' and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. When CERo discusses its strategies or plans, it is making projections, forecasts or forward-looking statements. Such statements are based on the beliefs of, as well as assumptions made by and information currently available to, CERo's management. Actual results could differ from those implied by the forward-looking statements in this communication. Certain risks that could cause actual results to differ are set forth in CERo's filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q, and the documents incorporated by reference therein. The risks described in CERo's filings with the Securities and Exchange Commission are not exhaustive. New risk factors emerge from time to time, and it is not possible to predict all such risk factors, nor can CERo assess the impact of all such risk factors on its business, or the extent to which any factor or combination of factors may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements are not guarantees of performance. You should not put undue reliance on these statements, which speak only as of the date hereof. All forward-looking statements made by CERo or persons acting on its behalf are expressly qualified in their entirety by the foregoing cautionary statements. CERo undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
Business Insider
13-06-2025
- Business
- Business Insider
Cero Therapeutics announces option exercise for additional Series D financing
CERo Therapeutics (CERO) announces that the company has issued additional shares of its Series D Preferred Stock to certain institutional investors pursuant to the securities purchase agreement previously entered into by and between the Company and such Investors on April 22 with respect to the issuance of shares of Series D Preferred Stock for an aggregate purchase price of up to $8M, including $5M previously issued in April and up to $3M issuable at the option of the Investors. The shares of Series D Preferred Stock are convertible into shares of the Company's common stock. The gross proceeds to CERo from today's closing are expected to be approximately $750,000, with up to $2.25M of cash that may be funded at one or more additional closings, at the election of the Investors. CERo intends to use the net proceeds from the offering to take advantage of the two recent FDA IND allowances in liquid and solid tumors and complete the previously announced site activation at MDACC, as well as bring other sites online quickly. Confident Investing Starts Here:
