alpha-gal glycolipids (AGI-134) / BioLineRx, Kode Biotech, UMass Chan Medical School - LARVOL DELTA

Self-Tumor Antigens in Solid Tumors Turned into Vaccines by α-gal Micelle Immunotherapy. (PubMed, Pharmaceutics) - "It is suggested that, in addition to converting treated metastases into an autologous TA vaccine, this treatment should be considered as a neoadjuvant therapy, administering α-gal micelles into primary tumors immediately following their detection. Such an immunotherapy will convert tumors into a personalized anti-TA vaccine for the period prior to their resection."

Journal • Review • Melanoma • Oncology • Solid Tumor • CD4 • CD8

Study to Evaluate Safety & Tolerability of AGI-134 in Solid Tumour (clinicaltrials.gov) - P1/2 | N=40 | Completed | Sponsor: Agalimmune Ltd. | Active, not recruiting ➔ Completed

Trial completion • Oncology • Solid Tumor

BioLineRx Reports Second Quarter 2023 Financial Results and Recent Corporate and Portfolio Updates (PRNewswire) - "Evaluating next development pathways for AGI-134 program in consultation with scientific advisory board. Results from Phase 1/2a first-in-human, single-agent study announced in Q4 2022....Research and development expenses for the three months ended June 30, 2023 were $3.0 million, a decrease of $2.4 million, or 44.3%, compared to $5.4 million for the three months ended June 30, 2022. The decrease resulted primarily from lower expenses related to NDA supporting activities related to motixafortide as well as lower expenses associated with the completed AGI-134 clinical trial."

Commercial • P1/2 data • Hematological Malignancies • Multiple Myeloma • Oncology • Solid Tumor

BioLineRx Reports First Quarter 2023 Financial Results and Recent Corporate and Portfolio Updates (PRNewswire) - "Research and development expenses for the three months ended March 31, 2023 were $3.7 million, a decrease of $0.7 million, or 16.9%, compared to $4.4 million for the three months ended March 31, 2022. The decrease resulted primarily from lower expenses related to NDA supporting activities for motixafortide, as well as lower expenses associated with the completed AGI-134 clinical trial."

Commercial • Oncology • Solid Tumor

BioLineRx Announces Results from Phase 1/2a Study of Investigational Anti-Tumor Vaccine AGI-134 in Metastatic Solid Tumors (PRNewswire) - P1/2 | N=40 | NCT03593226 | Sponsor: Agalimmune Ltd. | "BioLineRx Ltd....announced results from the Phase 1/2a study of intratumoral cancer vaccine candidate, AGI-134, designed to evaluate the safety and biological activity of AGI-134 in patients with unresectable metastatic solid tumors. The study met its primary endpoint of AGI-134's safety and tolerability....'We plan to seek publication of our data at a medical congress in 2023, and in consultation with our scientific advisory board, we will determine the next steps for the program in the first half of next year'....IMMUNE RESPONSE BIOMARKERS: 59 percent (10/17) of evaluable patients showed an increase in conventional dendritic cells (CD11c+ HLADR+) within or outside of the tumor. 29 percent (5/17) of evaluable patients showed an increase in T helper cells (CD3+CD4+) in injected lesions and 47 percent (8/17) in un-injected lesions."

P1/2 data • Oncology • Solid Tumor

"BiolineRx has AGI134 in phase 1/2" (@HealthGemini)

P1/2 data

Study to Evaluate Safety & Tolerability of AGI-134 in Solid Tumour (clinicaltrials.gov) - P1/2 | N=40 | Active, not recruiting | Sponsor: Agalimmune Ltd. | Recruiting ➔ Active, not recruiting | Trial completion date: Mar 2022 ➔ Sep 2022 | Trial primary completion date: Mar 2022 ➔ Sep 2022

Enrollment closed • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

BioLineRx Reports First Quarter 2022 Financial Results and Provides Corporate Update (PRNewswire) - "BioLineRx Ltd...today reports its financial results for the first quarter ended March 31, 2022 and provides a corporate update....Upcoming Expected Milestones: Submission of NDA to FDA for Motixafortide as novel mobilization agent for multiple myeloma patients undergoing autologous stem cell transplantation in mid-2022; Initial results from Part 2 of Phase 1/2a trial of AGI-134 in solid tumors in H2 2022; Initiate Phase 2 study of AGI-134 in 2023..."

NDA • New P2 trial • P1/2 data • Colorectal Cancer • Hematological Malignancies • Multiple Myeloma • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

BioLineRx Reports Year-End 2021 Financial Results and Provides Corporate Update (PRNewswire) - "Upcoming Expected Milestones: (i) Announce initial results for Part 2 of Phase 1/2a trial of AGI-134 in solid tumors in H2 2022; (ii) Initiate Phase 2 study of AGI-134 in 2023."

New P2 trial • P1/2 data • Oncology • Solid Tumor

BioLineRx Announces Completion of Enrollment of Phase 1/2a Study of Innovative Intratumoral Cancer Vaccine, AGI-134, in Unresectable Metastatic Solid Tumors (PRNewswire) - "BioLineRx Ltd...announced that the Company has completed enrollment of the Phase 1/2a study of its innovative intratumoral cancer vaccine candidate, AGI-134, designed to evaluate the safety and biological activity of AGI-134 in patients with unresectable metastatic solid tumors. Results of AGI-134's safety and proof of mechanism are anticipated in the first half of 2022."

Enrollment closed • P1/2 data • Oncology • Solid Tumor

BioLineRx Reports Third Quarter 2021 Financial Results and Provides Corporate Update (PRNewswire) - "Upcoming Expected Milestones:...Complete pre-NDA meeting with the FDA for SCM, scheduled for mid-December 2021; Complete recruitment of part 2 of ongoing Phase 1/2a trial of AGI-134 in solid tumors by end of 2021; Announce initial results for Part 2 of Phase 1/2a trial of AGI-134 in solid tumors in first half of 2022; Submit NDA for Motixafortide in SCM in first half of 2022."

Enrollment status • FDA event • P1/2 data • Hematological Malignancies • Leukemia • Multiple Myeloma • Oncology • Solid Tumor

BioLineRx Reports Third Quarter 2021 Financial Results and Provides Corporate Update (PRNewswire) - "Complete recruitment of part 2 of ongoing Phase 1/2a trial of AGI-134 in solid tumors by end of 2021; Announce initial results for Part 2 of Phase 1/2a trial of AGI-134 in solid tumors in first half of 2022."

Enrollment status • P1/2 data • Oncology • Solid Tumor

BioLineRx Reports Second Quarter 2021 Financial Results and Provides Corporate Update (PRNewswire) - “Results from pharmacoeconomic cost effectiveness study of Motixafortide in SCM in the second half of 2021; Pre-NDA meeting with the FDA for SCM in the second half of 2021…Research and development expenses for the three months ended June 30, 2021 were $5.1 million, an increase of $0.5 million, or 10.8%, compared to $4.6 million for the three months ended June 30, 2020. The increase resulted primarily from higher expenses related to NDA supporting activities for Motixafortide, an increase in payroll and related-expenses due to a company-wide salary reduction in connection with the COVID-19 pandemic in the 2020 comparable period, and an increase in expenses associated with the AGI-134 study; offset by a decrease in expenses related to the GENESIS and COMBAT clinical trials for Motixafortide, and a timing difference related to a tax credit received in respect of AGI-134.”

Commercial • FDA event • HEOR • Hematological Malignancies • Multiple Myeloma • Oncology

Study to Evaluate Safety & Tolerability of AGI-134 in Solid Tumour (clinicaltrials.gov) - P1/2; N=40; Recruiting; Sponsor: Agalimmune Ltd.; Trial completion date: Aug 2021 ➔ Mar 2022; Trial primary completion date: Mar 2021 ➔ Mar 2022

Clinical • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

BioLineRx Reports First Quarter 2021 Financial Results and Provides Corporate Update (PRNewswire) - “Initial results from Part 2 of the Phase 1/2a trial of AGI-134 in solid tumors in the second half of 2021..."

P1/2 data • Oncology • Solid Tumor

BioLineRx Reports Year-End 2020 Financial Results and Provides Corporate Update (PRNewswire) - “Initial results from Part 2 of the Phase 1/2a trial of AGI-134 in solid tumors in the second half of 2021.”

P1/2 data • Oncology • Solid Tumor

BioLineRx Reports Third Quarter 2020 Financial Results and Provides Corporate Update (PRNewswire) - “Overall final results, including PFS and OS data, from the COMBAT/KEYNOTE-202 Phase 2a triple combination study in second-line PDAC by the end of 2020; Final results from the Phase 3 GENESIS trial in SCM in the first half of 2021...Initial results from Part 2 of the Phase 1/2a trial of AGI-134 in solid tumors in the second half of 2021; Data from the Columbia University-initiated study of motixafortide in combination with LIBTAYO® and chemotherapy in first-line PDAC in mid-2022.”

P1/2 data • P2 data • P3 data • Gastrointestinal Cancer • Multiple Myeloma • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

BioLineRx Reports Second Quarter 2020 Financial Results and Provides Corporate Update (PRNewswire) - "Upcoming Expected 2020 and 2021 Milestones: Overall results, including progression free survival (PFS) and overall survival (OS) data, from the COMBAT/KEYNOTE-202 Phase 2a triple combination study in the second half of this year; Interim analysis from the BLAST Phase 2b AML consolidation study during the second half of 2020, unchanged from prior guidance; Initial results from Part 2 of Phase 1/2a trial of AGI-134 in the second half of 2021."

P2 data • Acute Myelogenous Leukemia • Gastrointestinal Cancer • Hematological Malignancies • Oncology • Pancreatic Cancer

BioLineRx reports first quarter 2020 financial results and provides corporate update (PRNewswire) - "Upcoming 2020 and 2021 Milestones: Progression-free survival and overall survival data from the triple combination arm of the COMBAT/KEYNOTE-202 Phase 2a study in mid-2020; Interim results from the BLAST Phase 2b AML consolidation study in the second half of 2020; Results from the GENESIS Phase 3 registrational study in stem cell mobilization in the second half of 2020; Initial results from Part 2 of Phase 1/2a trial of AGI-134, which were initially expected by year-end 2020, are now anticipated in the second half of 2021 due to a temporary suspension of recruitment caused by the COVID-19 pandemic."

P1/2 data • P2a data • P2b data • P3 data • Gastrointestinal Cancer • Hematological Malignancies • Multiple Myeloma • Oncology • Pancreatic Cancer • Solid Tumor

BioLineRx reports year-end 2019 financial results and provides corporate update (BioLineRx Press Release) - “Upcoming 2020 Milestones: Progression-free survival and overall survival data from the triple combination arm of the COMBAT/KEYNOTE-202 Phase 2a study in mid-2020; Interim results from the Phase 2b AML consolidation study in the second half of 2020; Top-line results from Phase 3 GENESIS registrational study in stem cell mobilization in the second half of 2020; Initial results from Part 2 of Phase 1/2a trial of AGI-134 by year-end 2020.”

P1/2 data • P2 data • P3 data: top line

AGI-134: a fully synthetic α-Gal glycolipid that converts tumors into in situ autologous vaccines, induces anti-tumor immunity and is synergistic with an anti-PD-1 antibody in mouse melanoma models. (PubMed, Cancer Cell Int) - "Combinations of AGI-134 and anti-PD-1 antibody shows a synergistic benefit in protection from secondary tumor growth. We have identified AGI-134 as an immunotherapeutic drug candidate, which could be an excellent combination partner for anti-PD-1 therapy, by facilitating tumor antigen processing and increasing the repertoire of tumor-specific T cells prior to anti-PD-1 treatment."

Journal • Preclinical • CD8

Study to Evaluate Safety & Tolerability of AGI-134 in Solid Tumour (clinicaltrials.gov) - P1/2; N=40; Recruiting; Sponsor: Agalimmune Ltd.; N=70 ➔ 40

Clinical • Enrollment change

BioLineRx reports third quarter 2019 financial results and provides corporate update (PRNewswire) - Upcoming Milestones [2019]: Response results from the Phase 2a triple combination COMBAT/KEYNOTE-202 pancreatic cancer trial of BL-8040…Oral presentation with additional data from the Phase 2a triple combination COMBAT/KEYNOTE-202 pancreatic cancer trial at the European Society of Medical Oncology Immuno-Oncology Congress in December; Upcoming Milestones [2020]: Progression-free survival and overall survival data from the COMBAT/KEYNOTE-202 Phase 2a triple combination study in mid-2020; Interim results from the Phase 2b AML consolidation study during the first half of 2020; Top-line results from Phase 3 GENESIS registrational study in stem cell mobilization in the second half of 2020; Initial results from Part 2 of Phase 1/2a trial of AGI-134 by year-end 2020.”

P1/2 data • P3 data: top line

BioLineRx announces dosing of first patient in part 2 of phase 1/2a clinical study for AGI-134, a novel immunotherapy for treatment of solid tumors (PRNewswire) - “BioLineRx Ltd….announced today dosing of the first patient in part 2 of the Phase 1/2a clinical study for AGI-134, a novel compound that evokes a direct anti-tumor response, as well as a vaccine effect, via a unique, multi-arm mechanism that targets patient-specific tumor neoantigens….We are looking forward to initial results from part 2 of the study expected by year-end 2020.”’

Enrollment open • P1/2 data

BioLineRx successfully completes dose-escalation part of phase 1/2a clinical study for AGI-134, a novel immunotherapy for treatment of solid tumors (PRNewswire) - “BioLineRx Ltd….announced today that it has successfully completed the dose-escalation part of the Phase 1/2a clinical study for AGI-134, a novel compound that evokes a direct anti-tumor response…AGI-134 was found to be safe and well tolerated, with no serious drug-related adverse events or dose-limiting toxicities reported. The maximal tolerated dose was not reached and the recommended dose for part 2 of the study was determined….we plan to add sites in the US to the study...by the first half of 2020. We are looking forward to initiating part 2 of the study shortly, with initial results expected by year-end 2020’.’In addition, we are also waiting with great anticipation for the upcoming top-line data for BL-8040's COMBAT/KEYNOTE-202 trial in pancreatic cancer…expected to read out by the end of the year,’ added Mr. Serlin.”

P1/2 data • P2 data • Trial status