Sentiment Analysis of the earnings transcript to help figure out if there are any bullish or bearish sentiments that could be gathered from it. We're doing ML and AI based analysis on the earnings call to get some more insights.
Please consider a small donation if you think this website provides you with relevant information
| Statement |
|---|
| So as described today, happily Gritstone is in a period of significant momentum, robust enrollment within our PCV program, GRANITE has enabled steady expansion, and the generation of additional clinical and scientific data to inform the future development of GRANITE and further validate our approach to solid tumors |
| In summary, we are pleased to have maintained a strong cash position and extended our runway during the first quarter of this year and are confident in our ability to execute on our strategic objectives |
| We're very excited by the GRANITE Phase 2 trial, the momentum it's gained, and its potential to serve as a major advance in cancer immunotherapy as we seek to extend the emerging benefits of PCV to cold tumors |
| And so even the very last patient we put on the study has a good chance of having achieved a progression event by mid-24 |
| Secondly, momentum behind study enrollment has been very strong as of May the 10th, 2023, we've randomized 71 of the initially planned 80 patients, and that number is already gone up |
| Now over the years, you've heard me speak of our strong belief that OUR PCV approach could be uniquely capable of unlocking the power of immunotherapy for patients with immunologically cold tumors |
| Our Phase 1/2 data from GRANITE in advanced cancer patients that included immunologically cold tumors, published in Nature Medicine last summer, provided strong clinical data in support of the therapeutic hypothesis |
| The basic idea is that delivering many neoantigens to solid tumor patients in a potent vaccine that drives strong CDA T cell responses will drive clinical benefit |
| And with infectious disease, we're making great strides in realizing the untapped potential of self-amplifying mRNA |
| This is a really exciting time for Gritstone, significant momentum has been established for our personalized cancer vaccine or PCV program called GRANITE , which is driving towards randomized clinical trial data |
| And the induction of broad, long term and potentially variant proof immune responses that we're seeing in our Phase 1 studies is highly promising for the field |
| And we are extremely well powered to detect at least a 20% difference between the two arms of the study |
| And actually, obviously, historically, very good with vaccines |
| And so I think there's a really interesting opportunity to combine those small molecule drugs with both PD-1 antibody and vaccine because the preclinical data suggests that there's likely to be meaningful synergy |
| And approximately half of these were randomized in 2023, all sites of screening and consenting enthusiastically and we expect this strong enrollment trend to continue for the foreseeable future |
| We maintained a strong cash position in the first quarter of 2023 and have been able to extend our runway for multiple sources, adding this recent quarter with $153.2 million in cash, cash equivalents, marketable securities, and restricted cash |
| Our team has done a beautiful job of obviously driving momentum and enthusiasm for the trial |
| But even within that data set, as you are well aware, if you look at the PDL-1 negative population, the treatment effect with the Moderna PCV was actually stronger than the treatment effect in the overall population |
| So I think the study design is good |
| However, showing the GRANITE delivers efficacy in a randomized controlled trial is our highest near term priority |
| It is clear that there is still need for next generation solutions against COVID-19 and the recent actions by the White House and BARDA are encouraging signals that the pursuit of enhanced breadth and durability of protection is not going to the wayside |
| And our preclinical projects against Human Papilloma virus, influenza, and a new combination vaccine against multiple respiratory viruses continued to progress well |
| And it's all about driving large numbers of neoantigen specific T cells, you can do that you seem to see benefit |
| Leveraging our neural network epitope identification platform, EDGE, to accurately predict which subset of tumor DNA mutations forms true neoantigens that will stimulate an effective anti-tumor immune response and our published clinical data show that patients mount strong T cell responses to most of the administered neoantigen with T cells trafficking into their tumors and killing tumor cells, as evidenced by the approximately 50% molecular response rate that we've observed |
| And so it is possible and we've certainly seen evidence of this in our earliest stage studies but OS actually is a really good endpoint for a study with a vaccine such as ours |
| And we are in the fortunate position that just a short period of extended open enrollment will put in a meaningful number of incremental patients |
| We obviously have shown very nice data, single arm trial Phase 1, two in advanced disease, obviously, we're now doing the randomized study |
| And the biology I think, actually holds together remarkably well |
| When they repeated similar experiments in immunologically competent mice, using a syngeneic tumor system, there was a much better outcome for those mice that tumor seems to respond much better more durably to the small molecule KRAS-G12C inhibitor |
| Now we drive a good T cell response in just about everybody we vaccinate |
| Statement |
|---|
| So it's been somewhat challenging for some of those companies to successfully and safely combine their small molecule drugs with PD-1 antibodies |
| That's obviously a problem |
| But this is big issue |
| Turning now to our first quarter 2023 operating results, we reported a net loss of $34 million, compared with $28.9 million for the same period last year |
| So I think it's not a huge blow for the program |
| So yes, we'll lose a bit of time on the front end |
| So clearly, we'd be remiss not to be paying attention |
| Because the virus can mutate around a single drug, it has a problem mutating around three different drugs or being used in concert |
| ctDNA dynamics are costing light on the key issue of what's actually going on in those complex lesions |
| anything but stable |
| And as I've already noted, we anticipate using a traditional efficacy endpoint such as PFS, or OS in the pivotal trial, but there is a possibility that molecular response will have accrued enough support by 2024 to be used as a surrogate endpoint for accelerated approval |
Please consider a small donation if you think this website provides you with relevant information