Thank you, Tim and good morning everyone. And thank you for joining us on our fourth quarter earnings conference call today. Earlier this morning, we issued our Q4 results press release, a copy of which is available in the investor relations section of our Web site. It was also filed as a 6K.
As is our custom, I will begin with some brief prepared remarks and then Mali Zeevi, our Chief Financial Officer, will provide a short discussion of our financial results.
We will then open up the call to your questions. Also joining the call for Q&A are, Avi Vainstein, our Chief Medical Officer; and Ella Sorani, our Chief Development Officer. The fourth quarter 2020 was our most significant yet as we produced positive data sets from two key programs, stem cell mobilization and metastatic pancreatic cancer, or PDAC. I would like to begin with a brief discussion of stem cell mobilization. In October, we announced positive results from pre-planned interim analysis of our GENESIS Phase 3 study, evaluating our lead clinical candidate motixafortide in stem cell mobilization for patients undergoing autologous hematopoetic stem cell transplantation. Stem cell mobilization is an area of significant unmet need as 50% to 70% of patients are poor mobilizers, necessitating multiple aphoresis sessions.
In addition, a portion of these patients require one to four daily injections of mozibil on top of G-CSF, the current standard of care in order to reach the required level of stem cell mobilization and collection. The primary objective of the GENESIS study was to demonstrate that only one dose of motixafortide on top of G-CSF is superior to G-CSF alone in the ability to mobilize greater than 6 million CD-34 positive cells and up to two aphoresis sessions. We were pleased to announce that the results of the interim analysis were overwhelmingly positive, as the interim analysis found highly statistically significant evidence for the primary endpoint favoring treatment with motixafortide. Upon the recommendation of the independent data monitoring committee, study recruitment was terminated early at a 122 out of a planned 177 patients.
We are planning to announce top line data in early Q2 of this year, including full primary and secondary efficacy end points. These data are exciting for two very important reasons; first, we hope that the data will show that the combination of motixafortide and G-CSF is well positioned to become the new standard of care in autologous stem cell transplantation; and second, stem cell mobilization is our most expedient path to registration. It goes without saying that if motixafortide is ultimately approved for this indication, it would be a transformational event for our company. To that end, we are already proceeding with all activities in support of an NDA submission in this indication, which we are targeting for the first half of 2022, including a pre NDA meeting with the FDA in the second half of this year.
Now turning to our PDAC program. In December, we announced final results from the Phase 2a COMBAT/KEYNOTE-202 study of motixafortide in combination with Merck's PD-1 inhibitor, KEYTRUDA and chemotherapy, as a second line therapy in stage four metastatic PDAC. A total of 43 patients initially diagnosed with unresectable stage four metastatic PDAC who had progressed following first line gemcitabine based therapy were enrolled in a triple combination arm. Patients received motixafortide monotherapy prime treatment for five days, followed by combination cycles of motixafortide, KEYTRUDA and chemotherapy Onivyde, 5-fluorouracil, leucovorin in combination until progression.
As is well known, PDAC is among the most difficult cancers to treat in patients with this diagnosis have historically had very poor prognosis, with five year survival rates of just 9% overall and just 3% of the greater than 50% of patients initially diagnosed at stage four. Many patients are first diagnosed with advanced stage four disease due mainly to the fact that this cancer is a symptomatic while it is metastasizing. And as mentioned, the patients in our COMBAT/KEYNOTE study were initially diagnosed at stage four, so this was a patient population with an extremely poor prognosis and perhaps worse than the patient populations evaluated in previous PDAC studies to date. It is against this backdrop that the date that we announced in December are all the more encouraging. The data demonstrated substantial improvement across all study end points as compared to historical data, including overall survival, median progression free survival, confirmed overall response rate, overall response rate and disease control rate. This is a big differentiation factor from other studies in this indication, which showed improvement in only one specific endpoint.
Let's recap the results. Median overall survival in months with 6.5 months in our COMBAT/ KEYNOTE study versus 4.7 months of historical data. Median progression free survival was 4.0 months in our COMBAT/KEYNOTE study versus 2.7 to 3.1 months of historical data.
Our confirmed overall response rate in the COMBAT/KEYNOTE study was 13.2% versus 7.7% in the historical data.
Our overall response rate was 21.2% versus 16% relating to historical data. And finally, our disease control rate in the study was 63.2% versus between 30% and 50% relating to historical data.
As you can see, again, the data demonstrated is substantial improvement across all study end points. We refer you to our press release dated December 16th for more detail, as well as important references to accompany the historical data.
We are currently planning the next development [phases] for this program, including discussions with potential collaboration partners and development of a protocol for a randomized controlled study. At this point, I'd like to very briefly recap two investigator initiated trials that are also evaluating motixafortide. Also in PDAC, Columbia University is leading a Phase 2 study evaluating motixafortide in combination with the anti PD-1 cemiplimab, known by its brand name Libtayo and standard of care chemotherapy gemcitabine and nab-paclitaxel. Notably, this is an entirely new study that is evaluating this combination as a first line treatment as compared to the COMBAT study, which is second line. This investigator initiated Phase 2 study will initially enroll 10 to 12 PDAC patients and will be expanded to a total of 40 patients following an evaluation of the initial 10 to 12 patients based on predefined criteria. Data from this study is anticipated in mid 2022.
Although, since this trial is not a company sponsored trial, the timelines are ultimately driven by the independent investigators, and therefore, could be subject to change. A second investigator initiated trial of motixafortide is ongoing in patients with COVID induced acute respiratory distress syndrome, or ARDS. The open label single arm Phase 1b study is being conducted at Wolfson Medical Center in Holon, Israel, and will enroll up to 25 hospitalized COVID patients. An interim analysis is planned after 10 patients have completed the initial treatment period, after which a decision to continue or not will be conducted. These preliminary results could be announced as early as the second half of this year.
Although, as with the Columbia University study, the timelines are driven by the independent investigators and could be subject to change.
Regarding our second clinical candidate AGI-134. Recall that we are evaluating safety and tolerability at the recommended dose in multiple solid tumor types in a Phase 1/2a study. The study is designed to evaluate a wide array of biomarkers and to validate AGI-134’s mechanism of action.
We will also assess clinical and pharmacodynamic parameters. In September 2019, we announced positive safety data and later that same month, we moved quickly to initiate part two, which is a dose expansion phase. We previously talked about enrollment delays caused by COVID-19, particularly as the pandemic impacted the UK and Israel particularly hard. And while this has caused delays, enrollment has now resumed and new sites and countries have been added and we remain on track to report data in the back half of this year. This is unchanged from the guidance that we provided last quarter. I would now like to turn the call over to Mali Zeevi, CFO, who will give a brief overview of our key fourth quarter financial statement items. Mali, please go ahead.