PeptiCRAd-1 / Valo Tx - LARVOL DELTA

START: Safety and Anti-Tumor Activity of PeptiCRAd-1 in Treatment of Cancer (clinicaltrials.gov) - P1 | N=15 | Active, not recruiting | Sponsor: Valo Therapeutics Oy | Recruiting ➔ Active, not recruiting | Trial completion date: Sep 2025 ➔ Dec 2026 | Trial primary completion date: Jun 2025 ➔ Oct 2026

Enrollment closed • Trial completion date • Trial primary completion date • Breast Cancer • Colorectal Cancer • Liposarcoma • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Osteosarcoma • Sarcoma • Solid Tumor • Synovial Sarcoma • Triple Negative Breast Cancer • PD-L1

Lisata Therapeutics and Valo Therapeutics Announce Preclinical Research Collaboration (GlobeNewswire) - "Lisata Therapeutics...and Valo Therapeutics Oy...are pleased to announce a preclinical research collaboration to investigate the benefits of combining Lisata's novel product candidate, certepetide, with ValoTx's innovative platform technology, PeptiCRAd, and a checkpoint inhibitor in a melanoma mouse model. Under the agreement, ValoTx will be conducting the research, while Lisata will supply certepetide product."

Preclinical • Melanoma

Improving safety and productivity of rAdV manufacturing process by versatile adaptation to scale‐X manufacturing technology (ESGCT 2023) - "Combination of suspension adapted A549 cells, cultivated in SFM conditions, and identified key process parameters applied to scale-X fixed-bed bioreactor technology is an innovative approach for rAdV manufacturing. This approach will help to bring down the cost of goods of the future therapy, while increasing safety and robustness."

Clinical • Infectious Disease

START: Safety and Anti-Tumor Activity of PeptiCRAd-1 in Treatment of Cancer (clinicaltrials.gov) - P1 | N=15 | Recruiting | Sponsor: Valo Therapeutics Oy | Trial completion date: Jan 2024 ➔ Sep 2025 | Trial primary completion date: Oct 2023 ➔ Jun 2025

Combination therapy • Trial completion date • Trial primary completion date • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Liposarcoma • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Sarcoma • Solid Tumor • Synovial Sarcoma • Triple Negative Breast Cancer • PD-L1

Valo Therapeutics Announces Regulatory Approval to Expand Phase I Immuno-oncology Trial into Sarcoma (GlobeNewswire) - "Valo Therapeutics Oy...announces it has received approval from Germany’s PEI (Paul Ehrlich Institute) to extend the tumor types to be treated in the company’s current Phase I trial into two subtypes of sarcoma. The subtypes, synovial and myxoid round cell sarcoma, have high levels of expression of the well-known, tumor specific antigen targets MAGE-A3 and NY-ESO-1, and hence are an ideal target for ValoTx’s lead cancer immunotherapy program, PeptiCRAd-1 (Peptide-coated Conditionally Replicating Adenovirus 1)....ValoTx’s Phase I, first-in-human trial of PeptiCRAd-1 is currently in three tumor types: melanoma, triple negative breast cancer and non-small cell lung cancer. Up to 15 patients will be treated with PeptiCRAd-1 in combination with the checkpoint inhibitor, pembrolizumab."

Clinical protocol • Trial status • Melanoma • Non Small Cell Lung Cancer • Synovial Sarcoma • Triple Negative Breast Cancer

Hygrovest welcomes dosing of first patient by investment ValoTx in Phase I trial (Proactiveinvestors) - "Hygrovest Ltd...welcomes the dosing by its Finland-based investment Valo Therapeutics Oy (ValoTx) of the first patient in a Phase I trial of PeptiCRAd-1 (Peptide-coated Conditionally Replicating Adenovirus) in three tumour types. The German-based trial will involve 15 patients with melanoma, triple-negative breast cancer or non-small cell lung cancer....The first patient has been administered with PeptiCRAd-1 successfully, without any initial safety concerns and the Safety Data Committee has concluded that the study can continue enrolment. Following this green light, further patients are now being recruited at the Krankenhaus Nordwest in Frankfurt, and at the National Center for Tumor Diseases (NCT) in Heidelberg."

Trial status • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Valo Therapeutics and Texcell Announce Research Collaboration to Evaluate Immune Responses to PeptiCRAd-1 in Phase I Clinical Study (GlobeNewswire) - "Valo Therapeutics Oy...announces a collaboration with global contract research organization, Texcell, to investigate immune responses to PeptiCRAd-1 in its Phase 1 clinical study. ValoTx’s PeptiCRAd-1 combines the power of a tumor-specific adenovirus (expressing immune-stimulatory molecules CD40L and OX40L) with immunogenic tumor peptides derived from NY-ESO-1 and MAGE-A3 proteins thereby generating tumor-specific, cytotoxic T-cells that will attack and kill cancer cells."

Licensing / partnership • Breast Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Skin Cancer • Solid Tumor • Thoracic Cancer • Triple Negative Breast Cancer

Valo Therapeutics Announces First Patient Dosed with PeptiCRAd-1 - Innovative Immuno-oncology (GlobeNewswire) - "Valo Therapeutics Oy...announces that the first patient has been treated in its Phase I trial of PeptiCRAd-1 (Peptide-coated Conditionally Replicating Adenovirus) in three tumor types....The first patient has been administered with PeptiCRAd-1 successfully, without any initial safety concerns and the Safety Data Committee has concluded that the study can continue enrolment."

Trial status • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Skin Cancer • Solid Tumor

Valo Therapeutics Announces Two European Patents Granted for its Lead Asset PeptiCRAd-1 in Immuno-Oncology (GlobeNewswire) - "Valo Therapeutics Oy...announces it has been granted European patents EP3768305 and EP3768830, issued by the European Patent Office (EPO) on 7 February 2023. The patents cover the pharmaceutical composition and method of use for the treatment of cancer for ValoTx’s lead product PeptiCRAd-1 (Peptide-coated Conditionally Replicating Adenovirus-1). These two patents cover its lead virus VALO-D102 and the peptides coating the virus, MAGE-A3 and NY-ESO-1. PeptiCRAd-1 is a first-in-class cancer immunotherapy drug candidate that is designed to stimulate systemic tumor-directed cytotoxic T-cell responses in cancer patients."

Patent • Oncology

START: Safety and Anti-Tumor Activity of PeptiCRAd-1 in Treatment of Cancer (clinicaltrials.gov) - P1 | N=15 | Recruiting | Sponsor: Valo Therapeutics Oy | Not yet recruiting ➔ Recruiting | Initiation date: Aug 2022 ➔ Feb 2023

Combination therapy • Enrollment open • Trial initiation date • Breast Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CTAG1B • MAGEA3 • PD-L1

Valo Therapeutics selects Exothera to develop large-scale oncolytic Adenovirus manufacturing (GlobeNewswire) - "Valo Therapeutics Oy...announced it has selected Exothera S.A., a full-service Contract Development and Manufacturing Organization (CDMO) specialized in gene therapy, vaccines, and oncolytic viruses, to develop a large-scale manufacturing process for clinical development of its oncolytic adenovirus, VALO-D102....Exothera will perform tech transfer, analytical development, and scale-up to initiate manufacturing of clinical material for EU Phase II clinical trials in its GMP facility in Jumet, Belgium - one of the biggest dedicated viral vector manufacturing facilities in Europe."

Clinical • Oncology

START: Safety and Anti-Tumor Activity of PeptiCRAd-1 in Treatment of Cancer (clinicaltrials.gov) - P1 | N=15 | Not yet recruiting | Sponsor: Valo Therapeutics Oy

Combination therapy • New P1 trial • Breast Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CTAG1B • MAGEA3 • PD-L1

Valo Therapeutics Announces €11m Fundraise to Advance PeptiCRAd Immunotherapy Platform into the Clinic (PRNewswire) - “Valo Therapeutics Oy…announced it has successfully raised Euro 11 million (around USD 12.75 million) in an oversubscribed Pre-IPO funding round. Corporate advisory firm Ironside Capital acted as lead manager for Valo Tx. The Pre-IPO fund included participation from existing investors, Freeman Road, and new investors, including ASX-listed MMJ Group Holdings. The total raised to date is now over Euro 22 million (around USD 25.5 million). The majority of the proceeds will be used to finalise preparations and initiate a Phase 1 clinical study of the company's lead tumour antigen-coated oncolytic virus candidate, PeptiCRAd-1, in addition to the continued development of the anti-infectives platforms including PeptiBAC and PeptiVAX. The proceeds will also be used to support the preparation of Valo's IPO in 2022.”

Grant • Oncology

Valo Therapeutics Announces Clinical Trial Application Submission for German Phase I Oncology Clinical Trial of PeptiCRAd-1 with Pembrolizumab (PRNewswire) - "Valo Therapeutics...announced it has submitted a clinical trial application (CTA) to the German Regulatory Agency, The Paul Ehrlich Institute (PEI) for a Phase I, first-in-human trial of PeptiCRAd-1 (Peptide-coated Conditionally Replicating Adenovirus 1) in three tumor types....The trial, to take place in Germany, will be an open-label, non-randomized, multi-centre study to evaluate the safety and immune activity of PeptiCRAd-1...in 15 patients with melanoma, triple negative breast cancer or non-small cell lung cancer. The company plans to start the trial in Q4 2021, with completion of 12 patients due by end of 2022. Trial endpoints include safety of PeptiCRAd-1 alone and in combination with pembrolizumab, and will explore local and systemic immune activation, and immune responses against the immunogenic peptides derived from NY-ESO-1 and MAGE-A3, as well as clinical responses to PeptiCRAd-1 + CPI."

New P1 trial • Breast Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Triple Negative Breast Cancer