ABX196 / Abivax - LARVOL DELTA

Abivax reports 2023 financial results and operational update (Abivax Press Release) - "Abivax SA...today announced its 2023 annual financial results, as of December 31, 2023, and provided an update on the progress of its development programs....General and administrative (G&A) expenses increased to EUR -22.4M compared to EUR -7.5M for 2022 (excluding the one-time goodwill impairment charge taken in 2022 of EUR -13.6M to ABX196 for the treatment of hepatocellular cancer)."

Commercial • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

Abivax Reports 2022 Financial Results and Operations Update (Issuer Direct) - "The results of the dose escalation phase support the further clinical development of ABX196 in the HCC setting. However, in the absence of progress on partnership discussions in the second half of 2022, the Company has decided to put the ABX196 program on hold."

Pipeline update • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

A phase 1 study of ABX196 in combination with nivolumab in patients with previously treated hepatocellular carcinoma (HCC). (ASCO-GI 2022) - P1/2 | "ABX196 plus N was very well tolerated without any DLTs or treatment emergent SAEs. In this small but heavily pre-treated HCC population, ABX196 plus N demonstrated promising signals of clinical benefit, including in patients with previous ICI therapy. These results support further clinical development of ABX196 in the front-line HCC setting."

Clinical • Combination therapy • P1 data • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

Demonstration of the antitumor activity of the INKT agonist ABX196, a novel enhancer of cancer immunotherapy, in melanoma and hepatocarcinoma mouse models. (PubMed, Mol Cancer Ther) - "In the melanoma model, immune response evaluation included immunofluorescence staining and detection by flow cytometry to identify anti-CD45, anti-CD8, anti-CD4, anti-CD3, anti-CD19, anti-FoxP3, CD1d tetramer, and anti-PD-1 markers. A synergistic combination effect was apparent when interferon-γ was measured in peripheral blood, indicating sustained activation of iNKT cells. In both models, the anti-tumor effects were associated with a generation of a more advantageous T-effector to Treg cell ratio within the tumor, which could lead to in the proliferation and accumulation of cells that would otherwise be anergized."

IO biomarker • Journal • Preclinical • Hepatocellular Cancer • Hepatology • Immune Modulation • Inflammation • Melanoma • Oncology • Solid Tumor • CD8 • FOXP3 • IFNG • PD-L1

Abivax’s Phase 1/2 Clinical Study Results of ABX196 in Liver Cancer to be Presented on Jan. 21, at ASCO GI Cancers Symposium 2022 (BioSpace) - "Darren Sigal, M.D...principal investigator of the study said: 'I am looking forward to presenting the encouraging results on the safety profile and clinical benefit of ABX196 as part of this phase 1/2 study at the ASCO GI Cancers Symposium 2022....It is remarkable that four of these patients were previously exposed to a checkpoint inhibitor and benefited when rechallenged with a checkpoint inhibitor in combination with ABX196.'"

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Abivax's phase 1/2 clinical study results of ABX196 in liver cancer to be presented on Jan. 21, at ASCO GI Cancers Symposium 2022 (Yahoo Finance UK) - P1/2, N=48; NCT03897543; Sponsor: Abivax S.A.; "Abivax SA...announces today the detailed results of the dose escalation phase of its clinical phase 1/2 study conducted with ABX196 for the treatment of hepatocellular carcinoma (HCC), to be presented at the ASCO GI Cancers Symposium on January 20-22, 2022....A clinical benefit was observed in 5 patients, including 1 patient with a partial response and 4 patients with stable disease. Median progression-free survival for all patients was 113.5 days (49-450 days) and at 276 days (172-450 days) for those showing a clinical benefit. ABX196 in combination with nivolumab was well tolerated without any dose limiting toxicities or treatment related serious adverse events."

P1/2 data • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

Abivax’s phase 1/2 clinical study results of ABX196 in liver cancer show good tolerability and promising signals of clinical benefit and were selected for presentation at the ASCO GI Cancers Symposium 2022 (Abivax Press Release) - P1/2, N=48; NCT03897543; Sponsor: Abivax S.A; "ABX196 was well tolerated and demonstrated promising signals of clinical benefit in heavily pre-treated hepatocellular cancer patients. ABX196 phase 1/2 study results were selected for a presentation at the 2022 ASCO Gastrointestinal Cancers Symposium...reports the good tolerability and promising signals of clinical benefit resulting from its clinical phase 1/2 study conducted with ABX196. In this study, heavily pre-treated hepatocellular cancer (HCC) patients were administered ABX196 in combination with checkpoint inhibitor nivolumab, including patients who were previously exposed to checkpoint inhibitor treatments."

P1/2 data • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology

Abivax capital increase and convertible bonds issue to qualified investors for an aggregate amount of approximately EUR 80m (PharmiWeb) - "Abivax...has been in discussions with investors regarding a private placement comprising of an issue of new ordinary shares and convertible bonds which is being facilitated by J.P. Morgan AG and Bryan, Garnier & Co., for a total gross amount of approximately EUR 80 million....The Company intends to use the net proceeds of the Transaction for...Advancement of the phase 1/2 proof-of-concept clinical trial of ABX196 for the treatment of hepatocellular carcinoma, for around 2% of the proceeds."

Financing • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology

ABX196 in Combination With Nivolumab in Patients With Hepatocellular Carcinoma (clinicaltrials.gov) - P1/2; N=48; Recruiting; Sponsor: Abivax S.A.; Trial completion date: Jun 2021 ➔ Jun 2023; Trial primary completion date: Jan 2021 ➔ Jun 2021

Clinical • Combination therapy • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Oncology • Solid Tumor • AFP

ABX196 in Combination With Nivolumab in Patients With Hepatocellular Carcinoma (clinicaltrials.gov) - P1/2; N=48; Recruiting; Sponsor: Abivax S.A.; Not yet recruiting ➔ Recruiting

Clinical • Combination therapy • Enrollment open • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Oncology • Solid Tumor • AFP

ABX196 in Combination With Nivolumab in Patients With Hepatocellular Carcinoma (clinicaltrials.gov) - P1/2; N=48; Not yet recruiting; Sponsor: Abivax S.A.

Clinical • Combination therapy • New P1/2 trial • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Oncology • Solid Tumor • AFP

Abivax reports 2020 financial results and operations update (news with additional features) (PharmiWeb) - “ABX196 in hepatocellular carcinoma (HCC): The patient recruitment within the dose escalation phase will be completed shortly, with top-line data in Q2 2021. The most efficient and well-tolerated dose of ABX196 will be defined and applied to the follow-on expansion phase, to be started in Q3 2021.”

P1/2 data • Trial status • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology

Abivax’s Phase I/II ABX196 in second-line HCC draws odds if front-line shake-up negatively impacts its success trajectory (Clinical Trials Arena) - P1/2, N=48; NCT03897543; Sponsor: Abivax S.A.; "...SOC change in 1L HCC could defer the use of 2L therapies, said Dr Riad Salem....ABX196’s mechanism is designed to circumvent Opdivo monotherapy's limitations in the new 2L setting, Kaseb said. Because Opdivo is now unlikely to work in the new 2L space, this might lower the efficacy bar for ABX196/Opdivo, said Dr Lorenza Rimassa...ABX196/Opdivo may only have to improve upon Opdivo monotherapy, Rimassa added. If the Phase I/II trial reports of positive results, it would be an upside for Opdivo as it would keep its relevance in 2L HCC, Kaseb noted."

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Abivax includes first patient in U.S. phase 1/2 clinical trial of ABX196 to treat hepatocellular carcinoma (PharmiWeb) - p1/2, N=NA; "Abivax SA...today announced dosing of the first patient in a U.S. Phase 1/2 clinical trial of ABX196 to treat patients with hepatocellular carcinoma (HCC), the most common form of liver cancer. In this trial, ABX196...is administered together with the checkpoint inhibitor nivolumab (Opdivo(R), Bristol Myers Squibb) to evaluate the potential beneficial effects of a combination therapy, with ABX196 boosting the activity of nivolumab in HCC patients. Darren Sigal, M.D...said: 'Despite the recent advances in treating hepatocellular carcinoma, most patients will still not respond to checkpoint inhibitor therapy and ultimately die of their disease. ABX196 is the first non-checkpoint inhibitor immune therapy to be evaluated in HCC; it activates the iNKT cell, a key anti-cancer immune cell. We are excited to investigate the potential clinical benefits of combining ABX196 with nivolumab in this Phase 1/2 trial.'"

Enrollment open • P1/2 data • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology

Union-Tribune Covers Unique Clinical Trial for Liver Cancer (Scripps News) - "There is a pressing need for new treatments for liver cancer, as the number of new diagnoses is growing in the U.S. and survival rates remain relatively low. The new clinical trial is being led by Darren Sigal, MD..."

Study includes a unique drug that is derived from ocean algae (Scripps News) - "Led by Darren Sigal, MD...the study includes the use of a new type of immune therapy derived from ocean algae. The new drug, currently called 'ABX196,' is being used in combination with an existing cancer immunotherapy, Opdivo." "

Abivax presents first-half 2020 financial results and operations update (news with additional features) (PharmiWeb) - “ABX196 in hepatocellular carcinoma (HCC): In the Phase 1/2 clinical trial ongoing at the Scripps MD Anderson Cancer Center in San Diego and the MD Anderson Cancer Center in Houston, HCC patients are treated with ABX196 in combination with the checkpoint inhibitor nivolumab (Opdivo(R), Bristol Myers Squibb). Up to 46 patients will be included into this clinical study that consists of two phases, a dose escalation phase and an expansion phase. Top-line data from the dose escalation phase are expected at the end of this year.”

P1/2 data • Trial status • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology

Abivax and Scripps Research announce FDA approval to initiate a phase 1/2 clinical trial with ABX196 in patients with hepatocellular carcinoma (Businesswire) - “Abivax…announced today, with their collaborator, Scripps Research, that the U.S. Food and Drug Administration (FDA) has accepted an investigational new drug (IND) application for ABX196, which showed potent efficacy in HCC animal models. The open IND allows Abivax to test ABX196 in combination with nivolumab (Opdivo®, Bristol Myers Squibb), a checkpoint inhibitor, in a first Phase 1/2 clinical trial to treat patients with HCC. The initial dose-escalation phase of the study will be conducted at the Scripps MD Anderson Cancer Center in San Diego, CA, USA...The first patient is expected to be enrolled this summer.”

Enrollment status • IND • New P1/2 trial