murlentamab (GM102) / Exelixis - LARVOL DELTA

Anti-Müllerian hormone - clinical use and future possibilities. (PubMed, Ceska Gynekol) - "In oncology, it is used as a tumor marker for monitoring patients with granulosa tumors. In the future, however, it is also promising to use the knowledge of AMH function for the treatment of gynecological as well as other solid malignancies expressing a tissue-specific receptor for AMH."

Journal • Endometrial Cancer • Oncology • Ovarian Cancer • Pediatrics • Solid Tumor

Study for Evaluation of Murlentamab (GM102) Anti-tumoral Activity in Colorectal Cancers (clinicaltrials.gov) - P2a | N=65 | Completed | Sponsor: GamaMabs Pharma | Active, not recruiting ➔ Completed | N=39 ➔ 65

Combination therapy • Enrollment change • Trial completion • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

First In Human Safety, Pharmacokinetics and Anti-tumoral Activity of GM102 in Gynecological Cancers (clinicaltrials.gov) - P1 | N=78 | Completed | Sponsor: GamaMabs Pharma | Active, not recruiting ➔ Completed

Trial completion • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

Murlentamab, a Low Fucosylated Anti-Müllerian Hormone Type II Receptor (AMHRII) Antibody, Exhibits Anti-Tumor Activity through Tumor-Associated Macrophage Reprogrammation and T Cell Activation. (PubMed, Cancers (Basel)) - "Those mechanisms might contribute to the sustained clinical benefit observed in advanced cancer patients treated with murlentamab. Finally, the enhanced murlentamab activity in combination with pembrolizumab opens new therapeutic perspectives."

Journal • Gynecologic Cancers • Immune Modulation • Inflammation • Oncology • Ovarian Cancer • Solid Tumor • CD4 • CD8

Exelixis Expands its Biotherapeutics Portfolio with Acquisition of GamaMabs Pharma’s First-in-Class Humanized Antibody Program Against a Novel Oncology Target (Businesswire) - "Exelixis, Inc...and GamaMabs Pharma SA...announced that they have entered into an agreement under which Exelixis will, upon the future closing of the asset purchase and subject to certain conditions to closing, acquire all rights, title and interest in GamaMabs’ AMHR2 antibody technology. Exelixis will pay GamaMabs $5 million upon signing of the agreement, make additional payments upon completion of closing conditions, and make additional milestone payments after closing, contingent upon various events. Once the transfer is completed, Exelixis will control 100% of GamaMabs’ AMHR2 franchise technology including all assets pertaining to GamaMabs’ monoclonal antibody drug product murlentamab (GM-102)."

Licensing / partnership • Oncology

The Expression of Anti-Müllerian Hormone Type II Receptor (AMHRII) in Non-Gynecological Solid Tumors Offers Potential for Broad Therapeutic Intervention in Cancer. (PubMed, Biology (Basel)) - "Overall, our results suggest that this embryonic receptor could be a suitable target for treating AMHRII-expressing tumors with an anti-AMHRII selective agent such as murlentamab, also named 3C23K or GM102. This potential therapeutic intervention was confirmed in vivo by showing antitumor activity of murlentamab against AMHRII-expressing colorectal cancer and hepatocarcinoma Patient-Derived tumor Xenografts (PDX) models."

Journal • Colorectal Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Hematological Malignancies • Hepatology • Kidney Cancer • Lung Cancer • Lymphoma • Neuroendocrine Tumor • Non-Hodgkin’s Lymphoma • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor • TGFB1

Circulating CD14 CD16 intermediate blood monocytes as a biomarker of ascites immune status and ovarian cancer progression. (PubMed, J Immunother Cancer) - P1 | "This study, which links IBM level with immunosuppression and tumor burden in peritoneum, identifies IBMs as apotential predictive signature of ascites immune status and as a biomarker ofovarian cancer development and treatment response."

Biomarker • IO Biomarker • Journal • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor • CD 163 • CD14

Phase 2 study results of murlentamab, a monoclonal antibody targeting the Anti-Mullerian-Hormone-Receptor II (AMHRII), acting through Tumor-Associated Macrophage engagement in advanced/metastatic colorectal cancers. (PubMed, Ann Oncol) - No abstract available

Journal • P2 data

Based on WCGC 2019, murletamab + Lonsurf combination therapy for patients with locally advanced / metastatic colorectal cancer, showing good progression-free survival [Google translation] - P2, N=39; "The results of Phase 2 trials that verified safety and safety were published by Eric Van Cutsem...From the results of the above Phase II study, Eric Van Cutsem...concluded the following. 'Murlentamab (GM102) + Lonsurf (TAS-102), an anti-Muellerian hormone type II receptor monoclonal antibody for patients with locally advanced / metastatic colorectal cancer with high expression of AMHR-II, has progression-free survival (PFS) Was good.'"

Media quote • P2 data

First In Human Safety, Pharmacokinetics and Anti-tumoral Activity of GM102 in Gynecological Cancers (clinicaltrials.gov) - P1; N=78; Active, not recruiting; Sponsor: GamaMabs Pharma; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

Study for Evaluation of GM102 Anti-tumoral Activity in Colorectal Cancers (clinicaltrials.gov) - P2a; N=39; Active, not recruiting; Sponsor: GamaMabs Pharma; Recruiting ➔ Active, not recruiting; N=30 ➔ 39; Trial primary completion date: Jun 2019 ➔ Dec 2019

Clinical • Combination therapy • Enrollment change • Enrollment closed • Trial primary completion date

GamaMabs Pharma announces presentation of murlentamab phase 2 study results in colorectal cancer at ESMO World Congress on Gastrointestinal Cancer (PharmiWeb) - P2, N=29; "In combination with trifluridine/tipiracil (FTD/TPI - Lonsurf®), progression-free survival (PFS) was longer than expected (40% and 31% at 4 and 6 months respectively). This was especially pronounced in patients with more than 20% AMHRII-positive tumor cells, with respectively 83% and 75% patients free of progression at 4 and 6 months. 1.7-fold and 3.6-fold tumor growth rate decrease was observed with murlentamab single agent and murlentamab combined with trifluridine/tipiracil, respectively."

P2 data