NLM-001 / Nelum - LARVOL DELTA

NUMANTIA-2: A Clinical Study Evaluating a New Treatment Strategy for Patients With Advanced Pancreatic Cancer Who Have Not Received Prior Treatment for Advanced Disease. (clinicaltrials.gov) - P2 | N=40 | Not yet recruiting | Sponsor: Nelum Corp

New P2 trial • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

NUMANTIA: Study to Evaluate the Safety and Efficacy of Treatment With NLM-001 and Standard Chemotherapy Plus Zalifrelimab in Patients With Advanced Pancreatic Cancer (clinicaltrials.gov) - P1/2 | N=28 | Active, not recruiting | Sponsor: Nelum Corp | Trial completion date: Oct 2024 ➔ Apr 2025 | Trial primary completion date: Oct 2024 ➔ Apr 2025

Trial completion date • Trial primary completion date • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Phase Ib/IIa study to evaluate safety and efficacy of priming treatment with the hedgehog inhibitor NLM-001 prior to gemcitabine and nab-paclitaxel plus zalifrelimab as first-line treatment in patients with advanced pancreatic cancer: NUMANTIA study (ESMO-GI 2024) - P1/2 | "Background: FOLFIRINOX and gemcitabine (G) in combination with nab-paclitaxel (nP) are the standard first-line treatment for patients (Pt) with advanced pancreatic cancer (aPC) but the impact on outcomes is limited... Safety profile of study treatment is as expected for G+nP standard regimen. No new safety signals were observed for the NLM-001 + G+nP+Z treatment. Preliminary efficacy results are promising."

Clinical • Metastases • P1/2 data • Gastrointestinal Cancer • Hematological Disorders • Hepatology • Neutropenia • Oncology • Pancreatic Cancer • Solid Tumor • CA 19-9

NUMANTIA: Study to Evaluate the Safety and Efficacy of Treatment With NLM-001 and Standard Chemotherapy Plus Zalifrelimab in Patients With Advanced Pancreatic Cancer (clinicaltrials.gov) - P1/2 | N=28 | Active, not recruiting | Sponsor: Nelum Corp | Recruiting ➔ Active, not recruiting

Enrollment closed • Metastases • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

NUMANTIA: Study to Evaluate the Safety and Efficacy of Treatment With NLM-001 and Standard Chemotherapy Plus Zalifrelimab in Patients With Advanced Pancreatic Cancer (clinicaltrials.gov) - P1/2 | N=28 | Recruiting | Sponsor: Nelum Corp | Trial completion date: Jun 2023 ➔ Sep 2024 | Trial primary completion date: Jun 2023 ➔ Sep 2024

Metastases • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

Agenus Advances Portfolio with 6 Clinical Collaborations (GlobeNewswire) - "Targovax to conduct a clinical trial combining botensilimab and balstilimab with ONCOS-102...in patients with PD-1 relapsed/refractory melanoma; Oxford BioTherapeutics to conduct a clinical trial combining balstilimab with OBT076...in patients with solid tumors, including lung, gastric, and ovarian cancer; Immunogenesis to conduct a clinical trial combining balstilimab and zalifrelimab with evofosfamide...in patients with advanced solid tumors, including prostate, pancreatic, HPV-negative head and neck cancer; Targovax to conduct a clinical trial combining QS-21 STIMULON with TG01...in up to 3 cancer indications, including multiple myeloma; Rottapharm Biotech is conducting a clinical trial combining balstilimab with CR6086 (EP4 antagonist) in patients with pMMR-MSS colorectal cancer; Nelum is conducting a clinical trial combining zalifrelimab with NLM-001...and chemotherapy in patients with advanced pancreatic cancer."

Licensing / partnership • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Head and Neck Cancer • Hematological Malignancies • Lung Cancer • Melanoma • Multiple Myeloma • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Solid Tumor

NUMANTIA: Study to Evaluate the Safety and Efficacy of Treatment With NLM-001 and Standard Chemotherapy Plus Zalifrelimab in Patients With Advanced Pancreatic Cancer (clinicaltrials.gov) - P1/2 | N=24 | Recruiting | Sponsor: Nelum Corp | Trial completion date: Nov 2022 ➔ Jun 2023 | Trial primary completion date: Nov 2022 ➔ Jun 2023

Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

NUMANTIA: Study to Evaluate the Safety and Efficacy of Treatment With NLM-001 and Standard Chemotherapy Plus Zalifrelimab in Patients With Advanced Pancreatic Cancer (clinicaltrials.gov) - P1/2; N=24; Recruiting; Sponsor: Nelum Corp; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

NUMANTIA: Study to Evaluate the Safety and Efficacy of Treatment With NLM-001 Before Standard Chemotherapy Plus Zalifrelimab in Patients With Advanced Pancreatic Cancer (clinicaltrials.gov) - P1/2; N=24; Not yet recruiting; Sponsor: Nelum Corp

New P1/2 trial • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

Agenus Enters into Clinical Collaboration with Nelum for Zalifrelimab Combination (GlobeNewswire) - "Agenus Inc...announced that it has entered into a clinical collaboration with Nelum Corp. to evaluate the safety and efficacy of zalifrelimab, Agenus’ anti-CTLA-4 antibody, in combination with NLM-001, Nelum’s small molecule hedgehog inhibitor, and chemotherapy for first-line advanced pancreatic cancer....Under the terms of the agreement, Agenus will supply zalifrelimab to Nelum for the combination study. Nelum will sponsor and be responsible for the conduct of the trial, which is set to begin enrolling in 1H21."

Licensing / partnership • New trial • Gastrointestinal Cancer • Oncology • Pancreatic Cancer