RE:Oncological Joint Ventures hit record heights in 2021 650MM$ in upfront payment plus an additional 1.45B$ milestones for a jointly developed Phase 1 molecule for which there is little data so far and that will try to widen the less than 30% market penetration of patients targetted by immunotherapies. So assuming this technology allows to enlarge the market of immuno-therapies above their current 30%, that's like if TLT's technology could be entitled to a 2B$ upfront payment, as we don't discriminate among patients genetic profiles and that we would have Ph. 2 data demonstrating high efficacy in destroying solid tumors. Just imagine us, when Ph. 2b data that shows high CR and DR% where we don't discriminate among patients!!!!
GSK and iTeos Therapeutics will jointly develop iTeos’ anti-TIGIT monoclonal antibody EOS-448, currently in phase 1 for advanced solid tumors. So what's behind this deal?
April 2021 -
GSK and iTeos Therapeutics announce development and commercialisation collaboration for EOS-448, an anti-TIGIT monoclonal antibody, enabling novel next-generation immuno-oncology combinations | GSK - EOS-448 is currently in phase I for advanced solid tumours with a randomised PD-1 combination study planned for 2022
- iTeos to receive a $625 million upfront payment in addition to potential milestones, and royalty payments on ex-US sales
- GSK and iTeos will co-commercialise and share profits in the US
- GSK now has the leading portfolio of antibodies targeting the CD226 axis - a key target for next-generation immuno-oncology therapies
- Under the terms of the collaboration agreement, iTeos will receive an upfront payment of $625 million. iTeos will be eligible to receive up to an additional $1.45 billion in milestone payments, should the EOS-448 programme achieve certain development and commercial milestones.
- Within the collaboration, GSK and iTeos will share responsibility and costs for the global development of EOS-448 and will jointly commercialise and equally split profits in the US. Outside of the US, GSK will receive an exclusive license for commercialisation and iTeos will receive tiered royalty payments.
Dr Hal Barron, Chief Scientific Officer and President R&D, GSK, said: “Immuno-oncology has transformed cancer care but unfortunately less than 30% of patients respond to treatment with the current leading immune checkpoint inhibitors. Based on the underlying science, we believe that combinations of a PD-1, TIGIT, CD96 and PVRIG inhibitor could become transformative medicines for many patients with cancer.
Michel Detheux, President and CEO, iTeos, said: “Through this transformative collaboration, iTeos now has access to GSK’s best-in-class resources which will provide us with a significant advantage in a highly competitive, global market. We have chosen GSK because of their commercial capabilities, experience in immuno-oncology and their commitment to invest in the rapid advancement of our TIGIT programme and create a clear path forward for EOS-448. April 2021 -
iTeos Therapeutics Announces New Preliminary Data Indicating Clinical Activity with its Anti-TIGIT Antibody, EOS-448, at the AACR Annual Meeting 2021 - Initial data from the Phase 1 dose escalation part of the Phase 1/2a trial in adult patients with advanced solid tumors indicated EOS-448 was generally well tolerated with no dose-limiting toxicities observed
- EOS-448 showed preliminary signs of clinical activity as a monotherapy, including a partial response in one pembrolizumab-resistant melanoma patient, and stable disease in multiple patients
- EOS-448 reduced TIGIT+ suppressive T regulatory cells and CD8 T cells considered to be exhausted at all tested doses, indicating engagement of FcγR, an essential component in many immune system effector functions
- Company to advance EOS-448 into combination trials with pembrolizumab and other novel agents in both checkpoint-nave and resistant patients
- Company to host conference call on Monday, April 12th at 8:00 a.m. EDT to discuss results
CAMBRIDGE, Mass. and GOSSELIES, Belgium, April 10, 2021 (GLOBE NEWSWIRE) -- iTeos Therapeutics, Inc. (Nasdaq: ITOS), clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of highly differentiated immuno-oncology therapeutics for patients, today announced a presentation featuring preliminary clinical data from 22 adult patients in the ongoing Phase 1/2a trial of its anti-TIGIT antibody, EOS-448, at the American Association of Cancer Research (AACR) Annual Meeting 2021, taking place virtually April 10-15. The presentation highlights initial findings from the completed dose escalation monotherapy portion of the trial, indicating a favorable tolerability profile and early signs of clinical activity in advanced cancers.
“We are pleased to share these data showing promising preliminary signs of clinical activity and a favorable tolerability profile with our anti-TIGIT antibody, EOS-448, in patients with advanced cancers,” said Joanne Jenkins Lager, M.D., chief medical officer of iTeos Therapeutics. “The results support our excitement around TIGIT as a therapeutic target capable of harnessing the immune system to treat patients with advanced, difficult to treat cancers. We believe the depletion of TIGIT+ suppressive and exhausted cells shown at even the lowest tested dose provides evidence of engagement of the FcγR, and therefore the potential of EOS-448 to activate multiple immune mechanisms. Based on these encouraging results, we are enrolling a total of 40 patients in this study to evaluate the effects of EOS-448 within the tumor. We are advancing EOS-448 into the next stage of clinical development as both a monotherapy and in combination for the treatment of multiple indications, with the goal of improving outcomes for people with advanced cancers.”
Summary of the Data Presented
The objective of the dose escalation portion of the ongoing EOS-448 trial, presented at AACR, is to evaluate primary objectives of safety and tolerability, and secondary objectives of pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activity of EOS-448 as a monotherapy in patients with advanced solid tumor cancers. As of the data cut-off (December 31, 2020), the trial had enrolled 22 advanced cancer patients with solid tumors for whom no standard treatment was available. The patients received EOS-448 intravenously (IV) once every two weeks (Q2W) or once every four weeks (Q4W) according to their dose and schedule allocation. Doses of 20, 70, 200, 700 mg Q2W and 1400 mg Q4W were evaluated. Since the data cut-off for the AACR poster, as of March 9, 2021, an additional 11 patients have received single agent EOS-448. In addition to the five dose levels which were described at AACR, patients have also received doses of 400mg Q4w and 700mg Q4w.
EOS-448 was generally well-tolerated at all tested doses in patients with advanced cancer. Preliminary evidence of clinical activity as a monotherapy, including a confirmed partial response in one pembrolizumab-refractory melanoma patient and disease stabilization in nine patients, was also observed. The most common treatment related adverse events were itching, infusion-related reactions, fatigue, rash and fever, and one treatment related serious adverse event, a grade 2 systemic inflammatory response, was observed. As of March 9, 2020, two additional treatment-related serious events have been reported: Grade 2 Systemic Inflammatory Response and Grade 3 infusion-related reaction.
PK assessments indicated a linear and dose-proportional response and PD assessments showed complete target engagement. Biomarker analyses showed evidence of FcγR engagement, as demonstrated by a reduction in suppressive immune cells and immune cells considered to be exhausted in the blood, including TIGIT+ regulatory T cells (Tregs) and TIGIT+ CD8 T cells, with only a slight reduction in the total CD8+ T cell count. A shift towards a more functional immune response was observed, with a two-fold increase in the ratio of CD8+ T cells to Treg and a four-fold increase in the ratio of CD8+ TIGIT- T cells to CD8+ TIGIT+ T cells.
“I am highly encouraged by these initial results from the EOS-448 trial, particularly the clinically meaningful response to treatment in the pembrolizumab-refractory melanoma patient,” said Mario Sznol, M.D., professor of medicine and leader, Melanoma/RCC Disease-Associated Research Team, at Yale University. “The treatment of patients who develop resistance to checkpoint inhibitors is challenging in a number of tumor types, and these data give us hope that EOS-448 could provide benefit in adult solid tumor patients who don’t respond to or who progress on current checkpoint inhibitors.”
April 8, 2022 -
iTeos Presents New Data for Anti-TIGIT Antibody, EOS-448/GSK4428859A, at the AACR Annual Meeting 2022