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| Statement |
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| We remain confident in the potential of targeting the B7-H3 pathway viewing our Topo 1 inhibitor strategy as an additional valuable tool in our therapeutic repertoire |
| So from all these vantage points and from all the things that I described earlier, looking at the ability to treat with vobra duo, looking at potential combinations with 026 down the line, looking at treatment of different tumors, I think this provides us with a great opportunity |
| And so given that we've had wonderful experience with the variable domain of vobra duo in its activity and what we believe to potentially be a superior topo1 inhibitor payload based on the Synaffix profile |
| Now with regard to 026, as I pointed out, this is a great opportunity for us to really take an important - answer important questions and a great opportunity for treating a wide range of cancers |
| And we believe that with the improved potential safety profile of the new dosing regimen, these patients with these other cancers will be able to stay on drug longer to have potentially good outcomes |
| We believe Synaffix's approach potentially provides advantages vis-a-vis other topoisomerase 1 inhibitor-based ADCs |
| We also had seen in the expansion studies, very good activity in other indications |
| As I was commenting on earlier, the surge of enrollment once we had the go ahead from the amended protocol in Europe, there was tremendous enthusiasm to join the study |
| We continue to believe our proprietary pipeline of product candidates has great promise, and we'll walk you through each of our key programs, including newly disclosed molecules momentarily, as well as tell you about our plans for upcoming clinical programs |
| In preclinical studies, MGC026 exhibited a favorable profile with potent in vivo activity to our B7-H3 expressing tumor xenografts representing a range of cancer indications |
| Next, I'm very excited to tell you about our growing ADC portfolio, which now includes an additional product candidate in the clinic |
| And as I pointed out from various vantage points, including increased activity, potency, a less susceptibility to efflux multidrug resistance, better cell permeability by standard effect |
| So that was clearly a population that we had a strong interest in |
| Additionally, site-specific conjugation of SYNtecan to the normally glycosylated amino acid in the FC domain abolishes FC gamma receptor and manhouse receptor binding, which contribute to nontargeted uptake of ADCs in our alveolar macrophages and reported to be associated with lung toxicity and therefore, may provide a safety benefit for patients |
| We are also considering others, which would be very good opportunities for looking at the value of vobra duo |
| But obviously, looking at the landscape, what is necessary to get a high confidence for a regulatory approval, I think we are in a fortunate position now that with the 177 patients dosed, and what I have commented on earlier that we had a sizable number of patients that were both chemotherapy experienced, as well as chemotherapy naive in this study |
| So things like non-small cell lung cancer became a great opportunity to us, activity in head and neck cancer as well |
| MGC028 was well tolerated in a repeat dose nonhuman primate toxicology study up to 55 milligrams per kg, the highest dose level tested |
| Obviously, given the experience in small cell, for instance, where both Daiichi and Hanso [ph] have seen very nice activity in small cell cancer |
| ADAM9 or disintegrin and metalloprotease domain 9 is a member of the ADAM family of multifunctional Type 1 transmembrane proteins that play a role in tumor genesis and cancer progression and is overexpressed in multiple cancers, making it an attractive target for cancer treatment |
| And again, if we can reduce that both in terms of incidents and grade, I think that will be better |
| And so we felt that we should do this because the patients made a -- and the investigators made great efforts to find patients in the study |
| And so with the approval of the amendments in the European sites later in the year, this created an opportunity for initiating enrollment in a large number of sites |
| To conclude, we believe we have the technical development and clinical expertise as well as financial resources to support our vision of developing and delivering life-changing medicines to cancer patients |
| As you know, we believe that this has the attributes of an ideal cancer target |
| Now with regard to the specific tumor types, we have selected four study in these expansions, again, taking advantage of our own experiences of treatment of patients with a subset of these tumors as well as the histology and expression of B7-H3 on these tumor types, we think these are very promising tumors to pursue |
| But I think by midyear, we'll know quite well if we're on track for moving forward to a Phase III point |
| More specifically, we believe that having distinct mechanisms of action, vober duo and MGC 026 may address different cancers, tumor stages or be used in combination with alternate agents or potentially with one another to enhance their clinical utility |
| We are working both from a regulatory advantage and operationalizing this so that we can get going by midyear |
| MGC0026 was tolerated in cinemalogous monkeys, a relevant toxicology model at exposure levels exceeding those required for antitumor activity |
| Statement |
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| I think that if that trial is successful, it's a great problem to have if the vobra duo pans out also in that same line of therapy |
| The issue was that patients would either with Grade 2 where they have experiencing pain would be electing to come off treatment despite the fact that they were having antitumor effects |
| Obviously, we want to avoid that at all though the incidence of that was quite low |
| Our concern was not Grade 3 hand foot |
| Could you just comment on some of the factors that resulted in the heavy over-enrollment and as well as the speed to which it was overenrolled |
| Our net loss was $9.1 million for the year ended December 31, 2023, compared to a net loss of $119.8 million for the year ended December 31, 2022 |
| That will not slow that down at all |
| And as we've discussed before, the rapidity of enrollment was far beyond what we expected |
| With regard to the neutropenia, clearly, that is something most likely due to free toxin getting to the bone marrow |
| Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the Risk Factors section of our annual, quarterly and current reports filed with the SEC |
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