A Phase 2, Open-Label Study to Evaluate the Safety and Antitumor Activity of Praluzatamab Ravtansine (CX-2009) in Advanced HR-Positive/HER2-Negative Breast Cancer and of Praluzatamab Ravtansine as Monotherapy and in Combination With Pacmilimab (CX-072) in Advanced Triple-Negative Breast Cancer (CTMX-2009-002)

A Phase 2, clinical study in advanced, metastatic breast cancer that will evaluate CX-2009 monotherapy in both Hormone Receptor(HR) positive/HER2 negative breast cancer and in TNBC, and evaluate CX-2009+CX-072 in TNBC

Start Date29 Dec 2020

Sponsor / Collaborator

CytomX Therapeutics, Inc.

NCT03149549

/ TerminatedPhase 1/2

A Phase 1-2, Open-Label, Dose-Finding, Proof of Concept, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CX-2009 in Adults With Metastatic or Locally Advanced Unresectable Solid Tumors (PROCLAIM-CX-2009)

The purpose of this first-in-human study of CX-2009 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of CX-2009 in adult subjects with metastatic or locally advanced unresectable solid tumors. PROCLAIM: PRObody CLinical Assessment In Man CX-2009 clinical trial 001
PROBODY is a trademark of CytomX Therapeutics, Inc

Start Date01 Jun 2017

Sponsor / Collaborator

CytomX Therapeutics, Inc.

100 Clinical Results associated with Praluzatamab ravtansine

100 Translational Medicine associated with Praluzatamab ravtansine

100 Patents (Medical) associated with Praluzatamab ravtansine

Literatures (Medical) associated with Praluzatamab ravtansine

13 May 2022·Clinical cancer research : an official journal of the American Association for Cancer Research

Praluzatamab Ravtansine, a CD166-Targeting Antibody–Drug Conjugate, in Patients with Advanced Solid Tumors: An Open-Label Phase I/II Trial

Article

Author: Wang, Song ; Zein, Ivan A. ; LoRusso, Patricia ; Garcia-Corbacho, Javier ; Vugts, Danielle J. ; Arkenau, Hendrik-Tobias ; Sanborn, Rachel E. ; Liu, Joyce F. ; Meric-Bernstam, Funda ; Jalal, Shadia ; Menke van der Houven van Oordt, C. Willemien ; Miedema, Iris H.C. ; Harding, James J. ; Lyman, Susan K. ; Kim, Stella K. ; Huisman, Marc C. ; Boni, Valentina ; Uboha, Nataliya ; Zwezerijnen, Gerben J.C. ; Hannah, Alison ; van Dongen, Guus A.M.S. ; Spira, Alexander ; Fidler, Mary J. ; Paton, Virginia ; Dang, Tam ; Vasiljeva, Olga ; Nagasaka, Misako ; Sweis, Randy F.

Abstract:

Purpose::

Praluzatamab ravtansine (CX-2009) is a conditionally activated Probody drug conjugate (PDC) comprising an anti-CD166 mAb conjugated to DM4, with a protease-cleavable linker and a peptide mask that limits target engagement in normal tissue and circulation. The tumor microenvironment is enriched for proteases capable of cleaving the linker, thereby releasing the mask, allowing for localized binding of CX-2009 to CD166. CX-2009 was evaluated in a phase I/II clinical trial for patients with advanced solid tumors.

Patients and Methods::

Eligible patients had metastatic cancer receiving ≥2 prior treatments. CX-2009 was administered at escalating doses every 3 weeks (0.25–10 mg/kg) or every 2 weeks (4–6 mg/kg). Primary objective was to determine the safety profile and recommended phase II dose (RP2D).

Results::

Of 99 patients enrolled, the most prevalent subtype was breast cancer (n = 45). Median number of prior therapies was 5 (range, 1–19). Dose-limiting toxicities were observed at 8 mg/kg every 3 weeks and 6 mg/kg every 2 weeks. On the basis of tolerability, the RP2D was 7 mg/kg every 3 weeks. Tumor regressions were observed at doses ≥4 mg/kg. In the hormone receptor–positive/HER2-nonamplified breast cancer subset (n = 22), 2 patients (9%) had confirmed partial responses, and 10 patients (45%) had stable disease. Imaging with zirconium-labeled CX-2009 confirmed uptake in tumor lesions and shielding of major organs. Activated, unmasked CX-2009 was measurable in 18 of 22 posttreatment biopsies.

Conclusions::

CD166 is a novel, ubiquitously expressed target. CX-2009 is the first conditionally activated antibody–drug conjugate to CD166 to demonstrate both translational and clinical activity in a variety of tumor types.

01 Jan 2020·TheranosticsQ1 · MEDICINE

The tumor targeting performance of anti-CD166 Probody drug conjugate CX-2009 and its parental derivatives as monitored by ⁸⁹Zr-immuno-PET in xenograft bearing mice

Q1 · MEDICINE

ArticleOA

Author: Chomet, Marion ; Schreurs, Maxime ; van Dongen, Guus A M S ; Howng, Bruce ; Villanueva, Ruth ; Vasiljeva, Olga ; Nguyen, Margaret ; Krimm, Michael ; Vugts, Danielle J

Probody^® therapeutics are recombinant masked monoclonal antibody (mAb) prodrugs that become activated by proteases present in the tumor microenvironment. This makes them attractive for use as Probody drug conjugates (PDCs). CX-2009 is a novel PDC with the toxic drug DM4 coupled to an anti-CD166 Probody therapeutic. CD166 is overexpressed in multiple tumor types and to a lesser extent by healthy tissue. Methods: The tumor targeting potential of CX-2009 was assessed by performing ⁸⁹Zr-immuno-PET/biodistribution/therapy studies in a CD166-positive H292 lung cancer mouse model. Head-to-head comparisons of CX-2009 with the Probody therapeutic without DM4 (CX-191), the unmasked antibody drug conjugate (ADC) CX-1031, and the parental mAb CX-090 were performed. All constructs were ⁸⁹Zr labeled in a GMP compliant way, administered at 10, 110, or 510 µg, and ex vivo biodistribution was assessed at 24, 72, and 168 hours post-injection. Results: Comparable biodistribution was observed for all constructs, confirmed with PET/CT. Tumors showed the highest uptake: 21.8 ± 2.3 ([⁸⁹Zr]Zr-CX-2009), 21.8 ± 5.0 ([⁸⁹Zr]Zr‑CX-191), 18.7 ± 2.5 ([⁸⁹Zr]Zr-CX-1031) and 20.8 ± 0.9 %ID/g ([⁸⁹Zr]Zr-CX-090) at 110 µg injected. Increasing the dose to 510 µg resulted in lower tumor uptake and higher blood levels for all constructs, suggesting receptor saturation. In addition, CX-2009 and CX-1031 showed similar therapeutic potential. Conclusions: CX-2009 is optimally capable of targeting CD166-expressing tumors when compared with its derivatives, implying that enzymatic activation inside the tumor, required to allow CD166 binding, does not limit tumor targeting. Because CX-2009 does not bind to mouse CD166, however, reduced targeting of healthy organs should be confirmed in ongoing clinical ⁸⁹Zr-immuno-PET studies.

10 Oct 2019·ACS medicinal chemistry letters

Peptide-Cleavable Self-immolative Maytansinoid Antibody–Drug Conjugates Designed To Provide Improved Bystander Killing

Article

Author: Ponte, Jose F. ; Salomon, Paulin ; Veale, Karen H. ; Wu, Rui ; Ab, Olga ; Dong, Ling ; Maloney, Erin K. ; Setiady, Yulius ; Bartle, Laura M. ; Widdison, Wayne C. ; Lanieri, Leanne ; Costoplus, Juliet A. ; Qiu, Qifeng ; Kovtun, Yelena V. ; Skaletskaya, Anna ; Lai, Kate ; Chari, Ravi V. J.

A new type of antibody-drug conjugate (ADC) has been prepared that contains a sulfur-bearing maytansinoid attached to an antibody via a highly stable tripeptide linker. Once internalized by cells, proteases in catabolic vesicles cleave the peptide of the ADC's linker causing self-immolation that releases a thiol-bearing metabolite, which is then S-methylated. Conjugates were prepared with peptide linkers containing only alanyl residues, which were all l isomers or had a single d residue in one of the three positions. A d-alanyl residue in the linker did not significantly impair a conjugate's cytotoxicity or bystander killing unless it was directly attached to the immolative moiety. Increasing the number of methylene units in the maytansinoid side chain of a conjugate did not typically affect an ADC's cytotoxicity to targeted cells but did increase bystander killing activity. ADCs with the highest in vitro bystander killing were then evaluated in vivo in mice, where they displayed improved efficacy compared to previously described types of maytansinoid conjugates.

News (Medical) associated with Praluzatamab ravtansine

22 Mar 2023

·www.businesswire.com

HR Positive/ Her2 Negative Breast Cancer - Pipeline Insight, 2023 - ResearchAndMarkets.com

DUBLIN--( BUSINESS WIRE )--The "HR Positive/ Her2 Negative Breast Cancer - Pipeline Insight, 2023" clinical trials has been added to ResearchAndMarkets.com's offering. This "HR Positive/ HER2 Negative Breast Cancer - Pipeline Insight, 2023" report provides comprehensive insights about 50+ companies and 53+ pipeline drugs in HR Positive/ HER2 Negative Breast Cancer pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. Geography Covered Global coverage HR Positive/ HER2 Negative Breast Cancer: Overview Three common tests employed to test for HER2 levels are chromogenic in situ hybridization (CISH), immunohistochemistry (IHC) and fluorescent in situ hybridization (FISH). Depending on the levels of HER2 or ERBB2 in the laboratory test breast cancer is classified as HER2 or ERBB2 positive or HER2 negative breast cancer. In HER2 or ERBB2 receptors in a normal breast maintains growth, division and repairing while in HER2 or ERBB2 positive breast cancer over-expression of HER2 or ERBB2 is seen. In case of HER2 negative breast cancer the levels of HER2 protein is in normal. The present goal of therapy for early HR+/HER2- breast cancer (BC) is to optimize disease-free survival (DFS) and overall survival (OS) rates with the currently available therapies while avoiding any relevant long-term sequalae. Local therapies have evolved toward less aggressive techniques (i.e. breast-preserving surgery, sentinel lymph node biopsy and intraoperative radiotherapy), which significantly reduce the long-term sequalae observed with more radical treatments. Endocrine therapy (ET) is still the cornerstone of adjuvant treatment because it significantly reduces BC relapse and mortality. Adjuvant chemotherapy is today recommended only for a particular subset of patients with a high risk of recurrence with ET alone, identified through genomic assays, age and/or disease stage. Bisphosphonates reduce the risk of bone metastasis and produce a slight although statistically significant improvement in survival in postmenopausal women. The CDK 4/6 inhibitor abemaciclib has been recently approved by the US FDA for patients at high risk of relapse. The report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the HR Positive/ HER2 Negative Breast Cancer pipeline landscape is provided which includes the disease overview and HR Positive/ HER2 Negative Breast Cancer treatment guidelines. The assessment part of the report embraces, in depth HR Positive/ HER2 Negative Breast Cancer commercial assessment and clinical assessment of the pipeline products under development. Report Highlights The companies and academics are working to assess challenges and seek opportunities that could influence HR Positive/ HER2 Negative Breast Cancer R&D. The therapies under development are focused on novel approaches to treat/improve HR Positive/ HER2 Negative Breast Cancer. HR Positive/ HER2 Negative Breast Cancer Emerging Drugs Chapters This segment of the HR Positive/ HER2 Negative Breast Cancer report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases. HR Positive/ HER2 Negative Breast Cancer Emerging Drugs Camizestrant: AstraZeneca Camizestrant is a potent, next-generation oral SERD and pure ER? antagonist, that has demonstrated anti-cancer activity across a range of preclinical models, including those with ER-activating mutations. The asset has been shown to promising anti-tumour profile when administered alone or in combination with palbociclib and thus, the company is running a Phase III trial for the same. Dato-DXd: Daiichi Sankyo, Inc. Datopotamab deruxtecan (Dato-DXd) is an investigational currently in Phase III for HR-positive, HER2- negative breast cancer. It is a TROP2 directed antibody drug conjugate (ADC) designed using Daiichi Sankyo's proprietary DXd ADC technology, datopotamab deruxtecan is one of the three lead ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programs in AstraZeneca's ADC scientific platform. Datopotamab deruxtecan is comprised of a humanized anti-TROP2 IgG1 monoclonal antibody, developed in collaboration with Sapporo Medical University, attached to a number of topoisomerase I inhibitor payloads, an exatecan derivative, via tetrapeptide-based cleavable linkers. CX-2009: CytomX Therapeutics CX-2009 is a Probody drug conjugate that consists of a humanized anti-CD166 monoclonal antibody conjugated to DM4, a potent microtubule inhibitor known to be active against multiple cancer types. It is currently being tested in Phase II trial in Advanced HR-Positive/HER2-Negative Breast Cancer and of Praluzatamab Ravtansine as Monotherapy and in Combination with Pacmilimab (CX-072) in Advanced Triple-Negative Breast Cancer. RGT-419B: Regor Therapeutics RGT-419B is a new generation of CDK inhibitor with an optimized kinase activity spectrum. The clinical development program of RGT-419B is designed to address the unmet medical needs of patients who are refractory or have relapsed after previous treatment, providing new opportunities to improve survival and quality of life for patients with advanced/metastatic breast cancer. It is currently being tested in Phase I trial in in subjects with Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative Advanced/Metastatic Breast Cancer. HR Positive/ HER2 Negative Breast Cancer: Therapeutic Assessment This segment of the report provides insights about the different HR Positive/ HER2 Negative Breast Cancer drugs segregated based on following parameters that define the scope of the report, such as: Major Players in HR Positive/ HER2 Negative Breast Cancer There are approx. 50+ key companies which are developing the therapies for HR Positive/ HER2 Negative Breast Cancer. The companies which have their HR Positive/ HER2 Negative Breast Cancer drug candidates in the most advanced stage, i.e. phase III include, AstraZeneca. Phases The report covers around 53+ products under different phases of clinical development like Late stage products (Phase III) Mid-stage products (Phase II) Early-stage product (Phase I) Pre-clinical and Discovery stage candidates Discontinued & Inactive candidates Route of Administration HR Positive/ HER2 Negative Breast Cancer pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as Intra-articular Intraocular Intrathecal Intravenous Ophthalmic Oral Parenteral Subcutaneous Topical Transdermal Molecule Type Products have been categorized under various Molecule types such as Oligonucleotide Peptide Small molecule Product Type Drugs have been categorized under various product types like Mono, Combination and Mono/Combination. HR Positive/ HER2 Negative Breast Cancer: Pipeline Development Activities The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses HR Positive/ HER2 Negative Breast Cancer therapeutic drugs key players involved in developing key drugs. Pipeline Development Activities The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging HR Positive/ HER2 Negative Breast Cancer drugs. HR Positive/ HER2 Negative Breast Cancer Report Insights HR Positive/ HER2 Negative Breast Cancer Pipeline Analysis Therapeutic Assessment Unmet Needs Impact of Drugs HR Positive/ HER2 Negative Breast Cancer Report Assessment Pipeline Product Profiles Therapeutic Assessment Pipeline Assessment Inactive drugs assessment Unmet Needs Key Questions Answered Current Treatment Scenario and Emerging Therapies: How many companies are developing HR Positive/ HER2 Negative Breast Cancer drugs? How many HR Positive/ HER2 Negative Breast Cancer drugs are developed by each company? How many emerging drugs are in mid-stage, and late-stage of development for the treatment of HR Positive/ HER2 Negative Breast Cancer? What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the HR Positive/ HER2 Negative Breast Cancer therapeutics? What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies? What are the clinical studies going on for HR Positive/ HER2 Negative Breast Cancer and their status? What are the key designations that have been granted to the emerging drugs? Key Players Regor Therapeuics Seagen Inc. CytomX Therapeutics Taizhou EOC Pharma Chia Tai Tianqing Pharmaceutical Group AstraZeneca Daiichi Sankyo, Inc. Tyme, Inc. Seagen Inc. Context Therapeutics Eisai Inc. Shanghai Hengrui Pharmaceutical Co., Ltd. Jiangsu Simcere Pharmaceutical Co., Kind Pharmaceuticals Merus N.V. Atossa Therapeutics Roche Ellipses Pharma Key Products RGT-419B SGN-B7H4V CX-2009 EOC202 TQB3616 Camizestrant Dato-DXd SM-88 SGN-B7H4V Onapristone Giredestrant H3B-6545 Z-endoxifen MCLA-128 EP0062 HRS8807 SCR-6852 AND019 For more information about this clinical trials report visit https://www.researchandmarkets.com/r/g7co1l About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Phase 1Phase 2Phase 3

07 Dec 2022

·www.biospace.com

CytomX Therapeutics to Present Phase 2 Data for Praluzatamab Ravtansine (CX-2009) in Patients with Advanced Breast Cancer at the San Antonio Breast Cancer Symposium

SOUTH SAN FRANCISCO, Calif., Dec. 07, 2022 (GLOBE NEWSWIRE) -- CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally activated oncology therapeutics, today announced that Phase 2 data for CX-2009, a conditionally activated antibody drug conjugate (ADC) targeting CD166, will be presented at the San Antonio Breast Cancer Symposium on December 8th. The poster details the results from patients treated with monotherapy praluzatamab ravtansine for the treatment of advanced HR+/HER2- breast cancer and triple negative breast cancer (TNBC). “We thank our investigators and the patients and families who contributed to our comprehensive evaluation of praluzatamab ravtansine in breast cancer. Although we elected previously in 2022 not to advance this program further without a partner, this research has benefited many patients, provided important insights into our conditionally activated ADC strategy and informed our next generation of Probody® therapeutic candidates,” said Sean McCarthy, D.Phil, CEO and Chairman of CytomX. Details for the poster presentation are as follows: Presentation Title: Results from a phase 2 study of praluzatamab ravtansine (CX-2009) in patients with advanced breast cancer (ABC) Poster: P4-01-15 Session and Location: Poster Session 4 – Hall 1 Session Date and Time: December 8, 2022, 7:00 am - 8:15 am CT Presenting Author: Dr. Kathy Miller, Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis, IN, USA About CytomX Therapeutics, Inc. CytomX is a clinical-stage, oncology-focused biopharmaceutical company dedicated to destroying cancer differently. By pioneering a novel class of conditionally activated biologics, powered by its Probody® technology platform, CytomX’s goal is to transcend the limits of current cancer treatments. CytomX’s robust and differentiated pipeline comprises seven therapeutic candidates across multiple treatment modalities including antibody-drug conjugates (“ADCs”), T-cell engaging bispecific antibodies (“TCBs”), and immune modulators such as cytokines and checkpoint inhibitors (“CPIs”). CX-2029 is an investigational conditionally activated antibody-drug conjugate (ADC) directed toward CD71, which has demonstrated encouraging antitumor activity in patients with squamous non-small cell lung cancer and is being developed in collaboration with AbbVie. CytomX’s clinical pipeline also includes cancer immunotherapeutic candidates against validated targets such as the CTLA-4-targeting Probody therapeutics, BMS-986249 and BMS-986288, partnered with Bristol Myers Squibb, as well as CX-904, a conditionally activated T-cell-engaging bispecific antibody targeting the epidermal growth factor receptor (EGFR) on tumor cells and the CD3 receptor on T cells, which is partnered with Amgen. In addition, CytomX has a diverse preclinical portfolio of wholly owned assets including CX-801, an interferon alpha-2b Probody cytokine that has broad potential applicability in traditionally immuno-oncology sensitive as well as insensitive (cold) tumors and CX-2051, a conditionally activated ADC directed toward EpCAM, with potential applicability across multiple EpCAM-expressing epithelial cancers. Praluzatamab ravtansine (CX-2009) is an investigational conditionally activated ADC directed toward CD166 that has demonstrated single agent clinical activity in a Phase 2 study for patients with advanced HR+/HER2-non-amplified breast cancer. Following the Phase 2 results, CytomX decided not to further progress praluzatamab ravtansine alone and is seeking a partner to further develop the molecule. CytomX has also established strategic collaborations with multiple leaders in oncology, including AbbVie, Amgen, Astellas, Bristol Myers Squibb and Regeneron. For more information about CytomX and how it is working to make conditionally activated treatments the new standard-of-care in the fight against cancer, visit and follow us on LinkedIn and Twitter. Forward-Looking Statements This press release includes forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors that are difficult to predict, may be beyond our control, and may cause the actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied in such statements, including those related to the future potential of partnerships or collaboration agreements. Accordingly, you should not rely on any of these forward-looking statements, including those relating to the potential benefits, safety and efficacy or progress of CytomX’s or any of its collaborative partners’ product candidates, including CX-2029, BMS-986249, BMS-986288, pacmilimab, CX-904, CX-801,CX-2051, and praluzatamab ravtansine, the potential benefits or applications of CytomX’s Probody platform technology, CytomX’s ability to develop and advance product candidates into and successfully complete clinical trials, including the ongoing and planned clinical trials of CX-2029, BMS-986249, BMS-986288, pacmilimab, CX-904, and praluzatamab ravtansine, and the timing of the commencement of clinical trials, initial and ongoing data availability, investigational new drug applications and other development milestones. Risks and uncertainties that contribute to the uncertain nature of the forward-looking statements include: the unproven nature of CytomX’s novel Probody Platform technology; CytomX’s clinical trial product candidates are in the initial stages of clinical development and its other product candidates are currently in preclinical development, and the process by which preclinical and clinical development could potentially lead to an approved product is long and subject to significant risks and uncertainties, including the risk that the COVID-19 worldwide pandemic may continue to negatively impact the business, research and clinical operations of CytomX or its partners, including the development of preclinical drug candidates due to delays in and disruption of research activities and the development of clinical drug candidates due to delays in or disruption of clinical trials, including impacts on the enrollment of patients in clinical trials or other clinical trial disruptions; the possibility that the results of preclinical research and early clinical trials may not be predictive of future results; the possibility that CytomX’s clinical trials will not be successful; the possibility that current preclinical research may not result in additional product candidates; CytomX’s dependence on the success of CX-2029, BMS-986249, BMS-986288, pacmilimab, CX-904, CX-801, and CX-2051; CytomX’s reliance on third parties for the manufacture of the Company’s product candidates; and possible regulatory developments in the United States and foreign countries. Additional applicable risks and uncertainties include those relating to our preclinical research and development, clinical development, and other risks identified under the heading "Risk Factors" included in CytomX’s Quarterly Report on Form 10-Q filed with the SEC on November 8, 2022. The forward-looking statements contained in this press release are based on information currently available to CytomX and speak only as of the date on which they are made. CytomX does not undertake and specifically disclaims any obligation to update any forward-looking statements, whether as a result of any new information, future events, changed circumstances or otherwise. Probody is a U.S. registered trademark of CytomX Therapeutics, Inc. CytomX Contact: Chris Ogden SVP, Finance and Accounting cogden@cytomx.com 317-767-4764 Investor and Media Contact: Stern Investor Relations Stephanie Ascher stephanie.ascher@sternir.com 212-362-1200

Phase 2ImmunotherapyADCClinical Result

13 Sep 2022

·www.globenewswire.com

CytomX Therapeutics Announces Phase 1 Data Update for anti-CTLA-4 Probody® Therapeutic BMS-986249

SOUTH SAN FRANCISCO, Calif., Sept. 12, 2022 (GLOBE NEWSWIRE) -- CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally activated oncology therapeutics, today announced that its collaborator, Bristol Myers Squibb, presented updated Phase 1 results with BMS-986249, a Probody® therapeutic version of ipilimumab, the anti-CTLA-4 antibody, at the ESMO Congress 2022 in Paris, France. “BMS-986249 is a conditionally activated CTLA-4-targeting antibody that has shown clinical activity in multiple tumor types, and the safety profile and disease control rate observed in the updated Phase 1 data for BMS-986249 with and without nivolumab is promising. BMS-986249 appears to be tolerated at higher doses than traditional ipilimumab dosing, and we are encouraged by the report of a complete response in melanoma and a case study of a partial response in microsatellite-stable colorectal cancer. This Phase 1 study set the stage for the ongoing randomized Phase 2 trial of BMS-986249 in melanoma evaluating the potential differentiation of the Probody from ipilimumab, and we look forward to results from this study in due course,” said Sean McCarthy, D.Phil., chief executive officer and chairman of CytomX Therapeutics. About CytomX Therapeutics, Inc. CytomX is a clinical-stage, oncology-focused biopharmaceutical company dedicated to destroying cancer differently. By pioneering a novel class of conditionally activated biologics, powered by its Probody® technology platform, CytomX’s goal is to transcend the limits of current cancer treatments. CytomX’s robust and differentiated pipeline comprises seven therapeutic candidates across multiple treatment modalities. Three of these candidates are in Phase 2 studies across multiple cancer types, including CX-2029 and praluzatamab ravtansine. CX-2029 is an investigational conditionally activated antibody-drug conjugate (ADC) directed toward CD71, which has demonstrated encouraging antitumor activity in patients with squamous non-small cell lung cancer and is being developed in collaboration with AbbVie. Praluzatamab ravtansine is an investigational conditionally activated ADC directed toward CD166 and is being studied in patients with advanced breast cancer. CytomX’s clinical pipeline also includes cancer immunotherapeutic candidates against validated targets such as the CTLA-4-targeting Probody therapeutics, BMS-986249 and BMS-986288, partnered with Bristol Myers Squibb, as well as CX-904, a conditionally activated T-cell-engaging bispecific antibody targeting the epidermal growth factor receptor on tumor cells and the CD3 receptor on T cells, which is partnered with Amgen. In addition, CytomX has a diverse preclinical portfolio of wholly-owned assets such as CX-801, an interferon alpha-2b Probody cytokine that has broad potential applicability in traditionally immuno-oncology sensitive as well as insensitive (cold) tumors, and CX-2051, a conditionally activated ADC directed toward EpCAM, with potential applicability across multiple EpCAM-expressing epithelial cancers. CytomX has established strategic collaborations with multiple leaders in oncology, including AbbVie, Amgen, Astellas, and Bristol Myers Squibb. For more information about CytomX and how it is working to make conditionally activated treatments the new standard-of-care in the fight against cancer, visit www.cytomx.com and follow us on LinkedIn and Twitter.

CollaborateAntibodyADCPhase 1Clinical Result

100 Deals associated with Praluzatamab ravtansine

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced breast cancer	Phase 2	United States	CytomX Therapeutics, Inc.	29 Dec 2020
Advanced breast cancer	Phase 2	South Korea	CytomX Therapeutics, Inc.	29 Dec 2020
Advanced breast cancer	Phase 2	Spain	CytomX Therapeutics, Inc.	29 Dec 2020
Advanced Triple-Negative Breast Carcinoma	Phase 2	United States	CytomX Therapeutics, Inc.	29 Dec 2020
Advanced Triple-Negative Breast Carcinoma	Phase 2	South Korea	CytomX Therapeutics, Inc.	29 Dec 2020
Advanced Triple-Negative Breast Carcinoma	Phase 2	Spain	CytomX Therapeutics, Inc.	29 Dec 2020
Hormone receptor positive HER2 negative breast cancer	Phase 2	United States	CytomX Therapeutics, Inc.	29 Dec 2020
Hormone receptor positive HER2 negative breast cancer	Phase 2	South Korea	CytomX Therapeutics, Inc.	29 Dec 2020
Hormone receptor positive HER2 negative breast cancer	Phase 2	Spain	CytomX Therapeutics, Inc.	29 Dec 2020
HR Positive/HER2 Negative/Node positive breast cancer	Phase 2	United States	CytomX Therapeutics, Inc.	29 Dec 2020

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03149549 (PROCLAIM-CX-2009, ASCO2020)	Phase 1/2	Ovarian Cancer \| Solid tumor \| Breast Cancer ... View more	92	CX-2009 7 mpk Q3W	yhxnoptywe(bqwouwtulf) = ecemclweuf pynfdifewb (etvldwoyem ) View more	-	25 May 2020
NCT03149549 (PROCLAIM-CX-2009, AACR2019)	Phase 1/2	HR-positive/HER2-low Solid Tumors	37	CX-2009	wexluynnav(witngjbmqc) = Grade 3-4 TRAEs were seen in 22% of pts (most frequently keratitis: 4 pts; 8, 9, and 10 mg/kg groups) and were managed and reversed with topical steroids. fgorwygpll (wnbgccerhi ) View more	Positive	01 Jul 2019

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