An Open-Label, Single-Arm Study of Autologous Anti-HER2 Chimeric Antigen Receptor Monocytes (CT-0525), in Participants With HER2 Over Expressing Solid Tumors

This is a first-in-human open-label study to evaluate the safety and tolerability, and manufacturing feasibility of anti-HER2 CAR-monocytes (CT-0525) in participants with locally advanced (unresectable) or metastatic solid tumors overexpressing HER2 whose disease has progressed on standard approved therapies.

Start Date08 Jan 2024

Sponsor / Collaborator

CTx Operations, Inc.

CTR20210648 / TerminatedPhase 3

VB4-845注射液治疗非肌层浸润性膀胱癌患者的有效性和安全性多中心、单臂、开放临床研究

[Translation] A multicenter, single-arm, open clinical study on the efficacy and safety of VB4-845 injection in the treatment of patients with non-muscle invasive bladder cancer

评估VB4-845用于BCG膀胱灌注治疗非肌层浸润性膀胱癌（包括CIS伴或不伴乳头状癌；高级别Ta期或任何级别的T1期乳头状癌）后失败的患者的疗效和安全性。

[Translation]

To evaluate the efficacy and safety of VB4-845 in patients with non-muscle invasive bladder cancer (including CIS with or without papillary carcinoma; high-grade Ta stage or any grade T1 papillary carcinoma) who have failed intravesical BCG therapy.

Start Date16 Jun 2021

Sponsor / Collaborator

Sesen Bio, Inc.

[+2]

NCT04660929 / Active, not recruitingPhase 1

A Phase 1, First in Human Study of Adenovirally Transduced Autologous Macrophages Engineered to Contain an Anti-HER2 Chimeric Antigen Receptor in Subjects With HER2 Overexpressing Solid Tumors

Phase 1, first-in-human, open label study of CAR macrophages in HER2 overexpressing solid tumors.

Start Date02 Feb 2021

Sponsor / Collaborator

CTx Operations, Inc.

100 Clinical Results associated with Carisma Therapeutics, Inc.

0 Patents (Medical) associated with Carisma Therapeutics, Inc.

Literatures (Medical) associated with Carisma Therapeutics, Inc.

01 Jul 2018·Cancer Research

Abstract 2788: VB6-845d tumor cell killing elicits biologic features of immunogenic cell death

Author: Adams, Gregory P. ; Chooniedass, Shilpa ; Cizeau, Jeannick ; Premsukh, Arjune ; Dillon, Rachelle L. ; MacDonald, Glen C.

AbstractVB6-845d is a Targeted Protein Therapeutic, TPT, that comprises a Fab fragment specific for the Epithelial Cell Adhesion Molecule (EpCAM) genetically fused to deBouganin via a furin protease sensitive linker. DeBouganin (deB) is a de-immunized variant of bouganin, a ribosome inactivating protein (RIP), that when internalized blocks protein synthesis thereby leading to cell death. While all cytotoxic molecules induce tumor cell killing, only some are capable of inducing biological manifestations indicative of immunogenic cell death (ICD). ICD is characterized by the collective appearance of distinct cellular changes termed damage associated molecular patterns, or DAMPs, which play a role in immune cell activation by triggering pro-inflammatory processes. Key DAMPs necessary for defining ICD are cell surface translocation of calreticulin, an endoplasmic reticulum chaperone protein, ATP secretion and release of HMGB1 (high mobility group box 1). To evaluate whether VB6-845d cell killing elicits the hallmark features of ICD, VB6-845d treated tumor cell lines were assessed for the presence of these distinct signaling molecules. In vitro studies showed that VB6-845d cytotoxicity induces the translocation of calreticulin to the cell surface as well as the release of ATP and HMGB1. The expression of other potential immune regulators following VB6-845d treatment was also examined. In summary, the data presented suggests that VB6-845d mediates tumor cell killing by an ICD pathway. The potential cross-priming effect initiated by VB6-845d-induced ICD suggests the use of VB6-845d in combination with immune checkpoint inhibitors may enhance their effectiveness in EpCAM-positive epithelial cancers.Citation Format: Rachelle L. Dillon, Shilpa Chooniedass, Arjune Premsukh, Glen C. MacDonald, Jeannick Cizeau, Gregory P. Adams. VB6-845d tumor cell killing elicits biologic features of immunogenic cell death [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2018; 2018 Apr 14-18; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2018;78(13 Suppl):Abstract nr 2788.

01 Jul 2017·Cancer Research

Abstract 614: VB4-845 tumor cell killing in a combination study with the anti-PD-1, Nivolumab

Author: Adams, Gregory A. ; Chooniedass, Shilpa ; Cizeau, Jeannick ; MacDonald, Glen ; Premsukh, Arjune ; Dillon, Rachelle Lee

AbstractVB4-845 is a Targeted Protein Therapeutic (TPT) comprised of a scFv fragment specific for the Epithelial Cell Adhesion Molecule (EpCAM) genetically fused to a truncated form of Pseudomonas exotoxin A (ETA), via a flexible linker. Due to the inherent immunogenicity of the ETA moiety, VB4-845 is only used for the treatment of loco-regionally accessible tumors and is currently in a Phase III clinical trial for the treatment of high grade, non-muscle invasive bladder cancer. In a Phase I study in late stage squamous cell carcinoma of the head and neck, direct injection of VB4-845 led to shrinkage of the principal injected tumor, as well as non-targeted tumors in some patients, suggesting the activation of a T cell-mediated anti-tumor response through cross-priming. Only cells undergoing immunogenic cell death, or ICD, are capable of stimulating cross-priming. ICD is characterized by distinct “eat-me” signals such as the release of ATP and HMGB1, and cell surface translocation of calreticulin, an endoplasmic reticulum chaperone protein. To evaluate whether VB4-845-mediated cell killing results in ICD events, treated tumor cell lines were assessed for these distinct signaling molecules. In vitro studies using flow cytometry and ELISA showed both translocation of calreticulin and release of ATP and HMGB1 by VB4-845-treated tumor cells. Immune T cell activation via an ICD pathway suggests a complimentary outcome when combined with checkpoint inhibitors. A study was performed in PDX tumor-bearing NOG mice reconstituted with a human immune system to assess the combination of intratumoral injection of VB4-845 with an anti-PD1 antibody, Nivolumab, given i.p. VB4-845 showed growth suppression of the injected tumor whereas the growth delay of the contralateral, non-injected tumor was more pronounced with the addition of Nivolumab. In summary, the data presented suggests that VB4-845 mediates tumor cell killing by an ICD pathway and that the resulting cross-priming effect can enhance the anti-tumoral activity of immune checkpoint inhibitors.Citation Format: Rachelle Lee Dillon, Shilpa Chooniedass, Arjune Premsukh, Glen MacDonald, Jeannick Cizeau, Gregory A. Adams. VB4-845 tumor cell killing in a combination study with the anti-PD-1, Nivolumab [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2017; 2017 Apr 1-5; Washington, DC. Philadelphia (PA): AACR; Cancer Res 2017;77(13 Suppl):Abstract nr 614. doi:10.1158/1538-7445.AM2017-614

01 Jul 2017·Cancer Research

Abstract 79: Trastuzumab and C6.5 diabody armed with deBouganin overcome drug resistance to ADCs comprised of anti-microtubule agents

Author: Chooniedass, Shilpa ; MacDonald, Glen C. ; Dillon, Rachelle L. ; Premsukh, Arjune ; Cizeau, Jeannick ; Adams, Gregory P.

AbstractDeBouganin (deB) is a de-immunized form of bouganin, a Ribosome Inactivating Protein (RIP) that when internalized blocks protein synthesis thereby leading to cell death. When conjugated to trastuzumab (T-deB) or genetically attached to the C6.5 diabody, deBouganin was more potent than DM1 and unaffected by mechanisms of resistance to which DM1 is susceptible. To further highlight the differentiating mechanism of action of deBouganin, HCC1419 and BT-474 tumor cells that survived T-DM1 or trastuzumab-MMAE (T-MMAE) treatment in vitro were re-exposed to T-DM1, T-MMAE, or treated with T-deB or an anti-HER2 C6.5 diabody-deBouganin fusion protein. C6.5 diabody-deBouganin and T-deB were potent against HCC1419 and BT-474 cells surviving T-DM1 or T-MMAE treatment. However, the surviving cell populations were resistant to T-DM1, T-MMAE, DM1, MMAE and taxol treatment. In addition, cross-resistance was seen against trastuzumab-duocarmycin which contains a payload with a cell cycle independent mechanism of action. The contribution of multi-drug resistance, Bcl-2 family members and other survival pathways accounting for the resistant phenotype will be discussed. Overall, the data suggest that treatment with chemotherapeutics or ADCs comprised of small molecule compounds such as anti-microtubule agents, can lead to the outgrowth of tumor cells resistant to similar agents. In contrast, antibodies and antibody fragments armed with deBouganin can overcome these mechanisms of resistance and may therefore represent a more effective treatment option.Citation Format: Shilpa Chooniedass, Rachelle L. Dillon, Arjune Premsukh, Gregory P. Adams, Glen C. MacDonald, Jeannick Cizeau. Trastuzumab and C6.5 diabody armed with deBouganin overcome drug resistance to ADCs comprised of anti-microtubule agents [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2017; 2017 Apr 1-5; Washington, DC. Philadelphia (PA): AACR; Cancer Res 2017;77(13 Suppl):Abstract nr 79. doi:10.1158/1538-7445.AM2017-79

142

News (Medical) associated with Carisma Therapeutics, Inc.

30 Oct 2024

·www.prnewswire.com

Carisma Therapeutics Announces Changes to its Board of Directors

Appointment of Sohanya Cheng Resignation of Michael Torok PHILADELPHIA, Oct. 30, 2024 /PRNewswire/ -- Carisma Therapeutics Inc. (Nasdaq: CARM) ("Carisma" or the "Company"), a clinical-stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, today announced the appointment of Sohanya Cheng, MBA to the Company's Board of Directors, effective October 31, 2024. Additionally, Michael Torok has informed the Board of his intention to step down as a member, effective October 31, 2024, due to other professional commitments. "It's a pleasure to welcome Sohanya to our Board," said Sanford Zweifach, Chair of the Carisma Board. "Her broad experience in oncology, alongside her skills in leadership, strategic planning, and commercialization, will be instrumental as we continue to advance our portfolio and strengthen our foundation. We are also thankful to Michael for his valuable service and wish him all the best in his next chapter." "I am excited to join Carisma's Board and collaborate with the management team as the Company advances its mission to deliver innovative immunotherapies to patients facing serious diseases," said Ms. Cheng. "I look forward to sharing my insights and supporting the Company's strategic goals as it solidifies its position as a leader in engineered macrophages within oncology and beyond." About Sohanya Cheng, MBA Ms. Cheng brings over 20 years of experience in biopharmaceutical commercialization and research, with a strong focus on oncology. She currently serves as the EVP, Chief Commercial Officer, and Head of Business Development at Karyopharm Therapeutics. Prior to this, she was Vice President, Head of Marketing and Corporate Affairs at Arrowhead Pharmaceuticals. Ms. Cheng also spent over a decade at Amgen in various leadership roles, including Executive Director, Head of Marketing & Sales for multiple myeloma and Head of Oncology National Sales, contributing to the commercialization of key oncology brands. She holds an MBA from the MIT Sloan School of Management and both a BSc and MA from the University of Cambridge, UK. About Carisma Carisma Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on utilizing our proprietary macrophage and monocyte cell engineering platform to develop transformative immunotherapies to treat cancer and other serious diseases. We have created a comprehensive, differentiated proprietary cell therapy platform focused on engineered macrophages and monocytes, cells that play a crucial role in both the innate and adaptive immune response. Carisma is headquartered in Philadelphia, PA. For more information, please visit . Investors: Shveta Dighe Head of Investor Relations [email protected] Media Contact: Julia Stern (763) 350-5223 [email protected] SOURCE Carisma Therapeutics Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Executive ChangeImmunotherapyCell Therapy

04 Oct 2024

·www.prnewswire.com

Carisma Therapeutics Announces Upcoming Presentations at SITC 2024

PHILADELPHIA, Oct. 4, 2024 /PRNewswire/ -- Carisma Therapeutics Inc. (Nasdaq: CARM) ("Carisma" or the "Company"), a clinical-stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, today announced its upcoming poster presentations at the Society for Immunotherapy of Cancer (SITC), taking place in Houston, Texas, November 6 -10, 2024. Details on the poster presentations at SITC 2024 are below: Title: Pre-clinical efficacy of a novel anti-GPC3 in vivo CAR-M for hepatocellular carcinoma Publication Number: 329 Session Date & Time: Friday, Nov. 8, 2024 Location: Exhibit Halls A B George R. Brown Convention Center Title: A Phase 1, First-in-Human study of autologous monocytes engineered to express an anti-HER2 chimeric antigen receptor (CAR) in participants with HER2 overexpressing solid tumors Publication Number: 659 Session Date & Time: Friday, Nov. 8, 2024 Location: Exhibit Halls A B George R. Brown Convention Center The posters presented at SITC 2024 will be available online in the "Publications" section of Carisma's website at following the start of the poster session. About Carisma Therapeutics Carisma Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on utilizing our proprietary macrophage and monocyte cell engineering platform to develop transformative immunotherapies to treat cancer and other serious diseases. We have created a comprehensive, differentiated proprietary cell therapy platform focused on engineered macrophages and monocytes, cells that play a crucial role in both the innate and adaptive immune response. Carisma is headquartered in Philadelphia, PA. For more information, please visit . Cautionary Note on Forward-Looking Statements Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to Carisma's business, strategy, future operations, cash runway, the advancement of Carisma's product candidates and product pipeline, and clinical development of Carisma's product candidates, including expectations regarding timing of initiation and results of clinical trials. The words "anticipate," "believe," "contemplate," "continue," "could," "estimate," "expect," "goals," "intend," "may," "might," "outlook," "plan," "project," "potential," "predict," "target," "possible," "will," "would," "could," "should," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. These risks and uncertainties include, but are not limited to, (i) Carisma's ability to realize the anticipated benefits of its pipeline reprioritization and corporate restructuring, (ii) Carisma's ability to obtain, maintain and protect its intellectual property rights related to its product candidates; (iii) Carisma's ability to advance the development of its product candidates under the timelines it anticipates in planned and future clinical trials and with its current financial and human resources; (iv) Carisma's ability to replicate in later clinical trials positive results found in preclinical studies and early-stage clinical trials of its product candidates; (v) Carisma's ability to realize the anticipated benefits of its research and development programs, strategic partnerships, research and licensing programs and academic and other collaborations; (vi) regulatory requirements or developments and Carisma's ability to obtain and maintain necessary approvals from the U.S. Food and Drug Administration and other regulatory authorities related to its product candidates; (vii) changes to clinical trial designs and regulatory pathways; (viii) risks associated with Carisma's ability to manage expenses; (ix) changes in capital resource requirements; (x) risks related to the inability of Carisma to obtain sufficient additional capital to continue to advance its product candidates and its preclinical programs; and (xi) legislative, regulatory, political and economic developments. For a discussion of these risks and uncertainties, and other important factors, any of which could cause Carisma's actual results to differ from those contained in the forward-looking statements, see the "Risk Factors" set forth in the Company's Annual Report on Form 10-K for the year ended December 31, 2023, its Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, as well as discussions of potential risks, uncertainties, and other important factors in Carisma's other recent filings with the Securities and Exchange Commission. Any forward-looking statements that are made in this press release speak as of the date of this press release. Carisma undertakes no obligation to revise the forward-looking statements or to update them to reflect events or circumstances occurring after the date of this press release, whether as a result of new information, future developments or otherwise, except as required by the federal securities laws. Investors: Shveta Dighe Head of Investor Relations [email protected] Media Contact: Julia Stern (763) 350-5223 [email protected] SOURCE Carisma Therapeutics Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ImmunotherapyCell TherapyPhase 1

03 Oct 2024

·www.pharmaceutical-technology.com

Resolution scores $83m to develop macrophage cell therapies

Resolution had previously raised £22m in Series A funding in 2020. Image credit: Watchara Ritjan / Shutterstock. Resolution Therapeutics has raised £63.5m ($83.3m) in a Series B financing round to develop its macrophage cell therapies. The UK-based company plans to use the money to finance the Phase I/II EMERALD trial for its lead candidate, RTX001, as a treatment for end-stage liver disease. Resolution also intends to direct the funds to expand its pipeline in other inflammatory and fibrotic indications, including graft-vs-host disease (GvHD) and lung fibrosis. RTX001 is an engineered autologous macrophage cell therapy. Macrophages act as effector cells of the innate immune system and play an important role in mediating inflammation and eliminating foreign organisms. RTX001 is designed to decrease fibrosis and inflammation in patients with end-stage liver disease. The open-label Phase I/II EMERALD trial will evaluate the therapy in the indication, with recruitment expected to start across the UK and Spain by the end of the year. The trial’s primary endpoint will measure clinical events including all-cause mortality. Resolution previously raised £22m in Series A funding in 2020. Both financing rounds were led by Syncona , a UK-based investment fund. Sycona has a portfolio of pharmaceutical startups , including iOncura, which raised $86m in Series B in June. See Also: BMS receives FDA approval for Opdivo to treat NSCLC Advancing Pharmaceutical Security: The Role of SECURtracers in On-Dose Authentication Another company developing macrophage therapies is Carisma Therapeutics . The company’s portfolio consists of chimeric antigen receptor macrophage and monocyte (CAR-M) therapies. In September, Carisma signed a discovery and licensing agreement with Moderna for two CAR-M therapies for treating autoimmune diseases. The cell and gene therapy market is forecasted to be worth over $81bn by 2029, as per GlobalData’s sales and forecast database. Multiple companies have invested in bolstering their cell and gene therapy pipeline. GlobalData is the parent company of Pharmaceutical Technology . In December 2023, AstraZeneca signed a $1.2bn deal to acquire China-based Gracell Biotechnologies. Gracell’s lead asset is a dual B cell maturation antigen (BCMA) and CD19-targeting CAR-T cell therapy, GC01F. The therapy is being investigated in multiple indications including multiple myeloma and systemic lupus erythematosus (SLE). Earlier this year, Genentech signed a $644m collaboration agreement with biotech GenEdit to use the latter’s non-viral delivery platform for gene editing therapies against autoimmune diseases. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva . Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content. Free Whitepaper Cell and gene therapies: Pipe dream to pipeline The cell and gene industry is gaining momentum, with a new wave of therapies promising to transform the way doctors treat, and even cure, disease. In this report, Cytiva and GlobalData have collaborated to explore the rise of the cell and gene therapy industries, the current state of the market, present and future opportunities for advancement, and the challenges that lie ahead. Thank you. You will receive an email shortly. Please check your inbox to download the Whitepaper. By Cytiva Thematic By downloading this Whitepaper, you acknowledge that GlobalData may share your information with Cytiva Thematic and that your personal data will be used as described in their Privacy Policy

Cell TherapyLicense out/inGene TherapyAcquisitionImmunotherapy

100 Deals associated with Carisma Therapeutics, Inc.

100 Translational Medicine associated with Carisma Therapeutics, Inc.

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Pipeline Snapshot as of 25 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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Drug(Targets)	Indications	Global Highest Phase

CT-0508 ( HER2 )	Gastroesophageal junction adenocarcinoma More	Phase 1
CT-0525 ( HER2 )	HER2 Positive Solid Tumors More	Phase 1
EBI-031 ( IL-6 )	Uveitis More	Phase 1
EBI-029 ( IL-6 )	Diabetic macular oedema More	Preclinical
Pulmonary Fibrosis (Carisma Therapeutics) ( TGFBR2 )	Pulmonary Fibrosis More	Preclinical

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