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| Through the progression of our clinical programs and robust R&D initiatives, we've made significant contributions to an expanding repository of clinical and preclinical data showcasing the distinct advantages of iNKTs in immune therapy for immune-related diseases |
| So as you know, or for those of you who don't know, bot/bal has generated really remarkable activity in cold tumors and more than 900 patients studied nine different tumor types that are that have been previously unresponsive to immune therapies are actually responding to bot/bal and it opens up an enormous opportunity for patients with these diseases that have previously gone - unable to be treated effectively |
| We've seen our off-the-shelf invariants iNKT cells strongly enhance tumor killing and immune activation when combined with cell engages in our model systems and we believe that co-administration of invariants iNKT cells and T-cell engagers has to potential to extremely increase clinical efficacy especially in solid tumors where cell engagers have not yet shown great results |
| So, we are quite excited about what the future holds and we'll continue to be very prudent in the selection of our clinical programs to high impact trials and high impact results as we continue to pursue ways of improving our financial health, as well in parallel |
| Now beyond oncology, this is a growing area of therapeutic opportunity for cell therapies and we are particularly well-positioned in this space given our scalability and our efficiency and being able to generate an allogenic, donor-derived iNKTs at scale that can be cryopreserved and retained their functional characteristics |
| So we're excited about our ability to do that |
| Our focus on 797 serves as the cornerstone of our vision driving us forward to redefine treatment standards, positively impacting patients’ lives with the accessible, living medicines designed to deliver benefit without the disabling side-effects of standard chemotherapeutic approaches and this is particularly evident in patients with gastric cancer |
| Furthermore, our T cell engager platform bodes unique development capabilities and also holds the promise that’s really quite unique to MiNK of delivering engager T cells in combination with native iNKTs |
| In summary, our approach to rapidly advanced iNKT cells in patients with respiratory distress underscores our commitment to addressing unmet medical needs and improving patient outcomes in oncology and beyond |
| Now these clinical trials have demonstrated promising results regarding the activity of iNKT cells in patients facing severe respiratory distress |
| We’ve remained really diligent leveraging our in-house manufacturing process, which is incredibly efficient to significantly reduce their external dependencies, as well as costs |
| We launched the trial in February and have already accrued our initial cohort of patients and have had the pleasure of seeing some very initial preliminary positive signals which we’re quite excited about |
| The trial is supported by Stand Up to Cancer and this phase 2 study holds promise in really changing the treatment landscape for patients with this cancer |
| These are unique to MiNK in this space and these capabilities really underscore our efficiency and the progress we’ve been able to make to-date |
| These achievements underscore our pivotal role in advancing state-of-the-art cell therapies on what we believe to be an optimal cell platforms positioning iNKT Therapeutics as a key contributor to the progress of living medicines |
| And the leadership of this platform are world experts and very high profile individuals |
| Excellent |
| Excellent |
| Excellent |
| It's really quite exciting and it does give us an opportunity to present to the agency what we believe to be the most impactful would be and the speediest to develop would be dropping the therapies on top of standard of care ram/tax |
| They have very limited activity and as you know, probably just a little over 20%, 25%, which gives us a big opportunity to really make a significant difference in the treatment landscape here |
| And so we're continuing to expand that trial and we have the opportunity to do so in an incredibly efficient way through a phase 2 trial large national platform program that would allow us to interrogate the cells compared to standard of care, corticosteroids, which we believe is going to - we have a lot of confidence and what the cells can do, compared to standard of care based on what our observations have been to-date |
| Now, another development that we're actually very enthusiastic about is combining our off-the-shelf invariant iNKT cells with cell engagers both with existing third-party T cell engagers as well as with our own invariant iNKT cell engagers |
| Our CMC team has achieved a major milestone in developing and implementing an FDA cleared end-to-end automatic, closed and industrialized iNKT manufacturing process, which is fully in-house demonstrating MiNK’s internal manufacturing capacity in compliance with rigorous regulatory standards and its readiness for clinical production to support our trials |
| It also speaks to her convincing argument about the unmet need and the urgency of delivering therapies for these patients |
| We would do so provided they are positive signals |
| Throughout 2023 and into the beginning of this year already, we've achieved some significant milestones that I'm going to go through today |
| And it ensures our control end-to-end control over an efficient and reliable play of our products |
| A published data highlights the important role that iNKTs could play in immunity more broadly and these include infections, inflammatory diseases, as well as autoimmunity and you're going to hear some data in an upcoming conference in the first half of this year about some important signals that in the treatment paradigm with patients who have both autoimmunity and infections, which I think will make you as excited as it has made me |
| Our comprehensive dataset nearly 100 patients treated to-date showcases the efficacy and activity of iNKTs in addressing solid tumor cancers and in other immune-related diseases such as acute respiratory distress syndrome with promising outcomes observed |
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| This is associated with very poor response to current pharmacological treatments including immune checkpoint blockade |
| And I think importantly at the ATS conference, we also showed that patients on the most severe forms of life supports with ARDS, these patients are treated with ECMO, VV ECMO and those patients treated with VV ECMO actually had a survival rate of over 80%, which is also really quite unexpected in this patient population |
| Could you provide some color on the cadence of enrollment? Are there any staggers early in the study with these multiple arms between the different patients? Jennifer Buell So, I should I should share with you, Jack, that's a great question and it is something that we - in the industry has typically been plagued with waiting 28 days per patient |
| Our net loss for the year ended December 31, 2023 was $22.5 million or $0.65 per share, which compares to net loss for the same period in 2022 of $28 million or E0.83 per share |
| These statements are subject to risks and uncertainties, and we refer you to our SEC filings available on our website for more details on these risks |
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