{"id":25785,"date":"2025-10-09T16:44:06","date_gmt":"2025-10-09T14:44:06","guid":{"rendered":"https:\/\/www.izb-online.de\/catalym-dosiert-ersten-patienten-in-phase-2b-studie-zur-bewertung-von-visugromab-in-kombination-mit-chemoimmuntherapie-bei-nicht-plattenepithelialem-nsclc-innovations-und-gruenderzentrum-bi\/"},"modified":"2025-10-09T17:10:01","modified_gmt":"2025-10-09T15:10:01","slug":"catalym-doses-first-patient-in-phase-2b-trial-evaluating-visugromab-in-combination-with-chemoimmunotherapy-in-non-squamous-nsclc-innovations-und-gruenderzentrum-biotechnologie-izb","status":"publish","type":"post","link":"https:\/\/www.izb-online.de\/en\/izb-biotech-news\/catalym-doses-first-patient-in-phase-2b-trial-evaluating-visugromab-in-combination-with-chemoimmunotherapy-in-non-squamous-nsclc-innovations-und-gruenderzentrum-biotechnologie-izb\/","title":{"rendered":"CatalYm doses first patient in Phase 2b trial evaluating visugromab in combination with chemoimmunotherapy in non-squamous NSCLC"},"content":{"rendered":"

[vc_row el_class=”gco-magazine-container”][vc_column el_class=”bildspalte”][vc_row_inner][vc_column_inner offset=”vc_col-lg-12 vc_col-md-12″][vc_column_text css=”” el_class=”gco-magazine–title”]<\/p>\n

CatalYm doses first patient in Phase 2b trial evaluating visugromab in combination with chemoimmunotherapy in non-squamous NSCLC<\/h1>\n

[\/vc_column_text][vc_column_text css=”” el_class=”gco-magazine-lead”]The trial evaluates the efficacy and safety of the company\u2019s lead antibody visugromab, in combination with standard-of-care chemoimmunotherapy, as a first-line treatment[\/vc_column_text][vc_column_text css=”” el_class=”gco-magazine–post-date”]October, 2025[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_row_inner el_class=”two-columns” el_id=”corona-ausblenden”][vc_column_inner el_class=”bild-zwei-spalten-links”][vc_single_image image=”6283″ img_size=”full”][vc_column_text el_class=”gco-magazine-copyright”]\u00a9 Pieris[\/vc_column_text][vc_column_text el_class=”gco-magazine-picture-discription”]The Lungs[\/vc_column_text][vc_single_image image=”6285″ img_size=”full”][vc_column_text el_class=”gco-magazine-copyright”]\u00a9 Pieris[\/vc_column_text][vc_column_text el_class=”gco-magazine-picture-discription”]Stephen S. Yoder<\/strong>, CEO, Pieris Pharmaceuticals Inc.[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner][vc_single_image image=”25783″ img_size=”full” css=””][vc_column_text css=”” el_class=”gco-magazine-copyright”]\u00a9 iStock \/ MTStock Studio[\/vc_column_text][vc_column_text css=”” el_class=”gco-magazine-picture-discription”]The randomized, blinded, placebo-controlled Phase 2b trial will enroll patients across multiple sites in the US, EU and Switzerland.[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_row_inner el_class=”gco-magazine–quote” css=”.vc_custom_1611310713611{margin-top: 33px !important;}”][vc_column_inner][vc_column_text css=””]<\/p>\n

\u201cOur clinical trials have clearly shown visugromab\u2019s impact for solid tumor patients in multiple settings. Given the strong anti-tumor effect with long durability, we believe that visugromab is uniquely positioned to demonstrate compelling efficacy as part of a first-line treatment regimen.\u201d<\/h6>\n

Scott Clarke, Chief Executive Officer at CatalYm<\/p>\n

[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_row_inner el_class=”gco-magazine-container–copy” css=”.vc_custom_1591795890737{margin-top: 21px !important;}”][vc_column_inner][vc_column_text css=””]IZB-based CatalYm announced that the first patient has been dosed in the randomized Phase 2b GDFATHER-NSCLC-01 trial (NCT07098988<\/a>) at the end of September. The trial investigates the efficacy and safety of the company\u2019s anti-GDF-15 antibody visugromab, in combination with standard-of-care chemoimmunotherapy, compared to placebo plus chemoimmunotherapy, as a first-line treatment for patients with newly diagnosed metastatic non-squamous non-small cell lung cancer (NSQ mNSCLC).<\/p>\n

Visugromab is a humanized, monoclonal antibody designed to neutralize Growth Differentiation Factor-15 (GDF-15), a tumor-derived cytokine that plays a central role in immune suppression and anti-PD-(L)-1 resistance. CatalYm demonstrated visugromab\u2019s therapeutic potential in the exploratory Phase 1\/2a GDFATHER trial (NCT04725474<\/a>), where the combination of visugromab and an anti-PD-1 inhibitor led to deep and durable responses across multiple solid tumor types while maintaining a favorable safety profile. Visugromab also showed potential to mitigate cancer cachexia, enhancing patients\u2019 quality of life and treatment tolerability, which could extend therapy duration. Results from an additional blinded, exploratory phase 2 trial of nivolumab and visugromab or placebo as neoadjuvant treatment in patients with muscle-invasive bladder cancer will be announced at ESMO 2025.<\/p>\n

\u201cOur clinical trials have clearly shown visugromab\u2019s impact for solid tumor patients in multiple settings,\u201d said\u00a0Scott Clarke, Chief Executive Officer at CatalYm<\/strong>. \u201cGiven the strong anti-tumor effect with long durability, we believe that visugromab is uniquely positioned to demonstrate compelling efficacy as part of a first-line treatment regimen. We will explore the full potential of GDF-15 neutralization through our targeted Phase 2b development program across different tumor types, treatment settings and associated conditions like cancer cachexia.\u201d<\/p>\n

The randomized, blinded, placebo-controlled Phase 2b GDFATHER-NSCLC-01 (GDF<\/strong>-15\u00a0A<\/strong>ntibody-mediaT<\/strong>ed\u00a0H<\/strong>uman\u00a0E<\/strong>ffector Cell\u00a0R<\/strong>elocation) trial will enroll approximately 107 patients across multiple sites in the US, EU and Switzerland. The trial consists of an initial non-randomized safety run-in, followed by a randomized part. The primary endpoint of the trial is objective response rate (ORR). Key secondary endpoints include duration of response (DOR), complete and partial response rates (CR and PR), progression-free survival (PFS), overall survival (OS), body weight trends as well as safety and tolerability parameters.<\/p>\n

\u201cJoining CatalYm at this pivotal stage, I am encouraged by the clear scientific rationale supporting visugromab\u2019s mechanism of action. GDF-15 plays a critical role in shielding tumors from immune attack, limiting the effectiveness of current immunotherapies. This mechanism is particularly relevant in first-line metastatic NCSLC, where many patients fail to respond or relapse early on immunotherapy. This trial marks an important step in evaluating visugromab\u2019s potential to overcome this resistance and improve outcomes in a setting with limited options,\u201d said\u00a0Sujata Rao, MD, Chief Medical Officer at CatalYm<\/strong>.<\/p>\n

About NSCLC
\n<\/strong>Lung cancers remain the leading cause of cancer-related mortality globally and non-small cell lung cancers (NSCLCs) account for approximately 87% of the 210,000 annual lung cancer diagnoses in the US1<\/sup>. Five-year survival rates in the US for non-squamous NSCLC are low: 12.8% for adenocarcinoma and 5.1% for large-cell carcinoma2<\/sup>. 70-85% of NSCLC patients either exhibit primary resistance to PD-1 blockade or develop acquired resistance to immunotherapy3<\/sup>, emphasizing the need for innovative approaches to overcome immunotherapy resistance.<\/p>\n

About Visugromab
\n<\/strong>Visugromab is a monoclonal antibody that neutralizes Growth Differentiation Factor-15 (GDF-15), a locally acting immunosuppressant produced by tumors which fosters immunotherapy resistance and drives cachexia in people with cancer. Neutralizing GDF-15 with visugromab reverses key cancer resistance mechanisms to reinstate an efficient anti-tumor response by re-enabling immune cell activation, proliferation and induction of interferon-\u03b3. In addition, visugromab also mitigates cancer cachexia, a severe condition affecting a significant number of advanced cancer patients by inhibiting the activation of the GFRAL pathway in the brainstem, a key driver of weight loss and appetite suppression in cancer patients.<\/p>\n

About CatalYm
\n<\/strong>CatalYm is developing visugromab, a first-in-class anti-GDF-15 antibody, in solid tumors and cachexia. In its first-in-human Phase 1\/2a study, visugromab demonstrated durable anti-tumor efficacy with long-lasting objective responses in relapsed and refractory metastatic solid tumor patients in combination with anti-PD-1 treatment. In addition, data from the same study demonstrated that visugromab can significantly counteract the effects of cachexia in these patients. This data was published in Nature and presented at the International Conference on Sarcopenia, Cachexia & Wasting Disorders. CatalYm is now advancing visugromab into multiple Phase 2b studies including first-line metastatic NSCLC (NCT07098988<\/a>) and cachexia (NCT07112196<\/a>).<\/p>\n

Founded in 2016 and based in Munich, Germany and San Francisco, USA, CatalYm is backed by leading international investors including Canaan Partners, Bioqube Ventures, Forbion, Omega Funds, Gilde Healthcare, Jeito Capital, Novartis Venture Fund, Vesalius, Brandon Capital, Bayern Kapital, BioGeneration Ventures, and Coparion.<\/p>\n

[1] American Cancer Society, Key Statistics for Lung Cancer, 2025:\u00a0https:\/\/www.cancer.org\/cancer\/types\/lung-cancer\/about\/key-statistics.html<\/a>, retrieved on Aug. 06, 2025<\/p>\n

[2] https:\/\/seer.cancer.gov\/<\/a><\/p>\n

[3]\u00a0Mariniello A, Borgeaud M, Weiner M, Frisone D, Kim F, Addeo A. Primary and Acquired Resistance to Immunotherapy with Checkpoint Inhibitors in NSCLC: From Bedside to Bench and Back. BioDrugs. 2025 Mar;39(2):215-235. doi:\u00a010.1007\/s40259-024-00700-2<\/a>. Epub 2025 Feb 15. PMID: 39954220; PMCID: PMC11906525.[\/vc_column_text][vc_column_text css=”.vc_custom_1583761043671{background-color: #1e73be !important;}” el_class=”redaktionell”][\/vc_column_text][\/vc_column_inner][\/vc_row_inner]\n\n

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