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| Statement |
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| This strategic approach capitalizes on the established efficacy associated with the chosen toxin class, ensuring a solid foundation for potential therapeutic success |
| Furthermore, the utilization of a known linker enhances the predictability and reliability of our ADC’s performance, providing confidence in its potential clinical utility |
| Our ADC design holds strong promise for clinical efficacy, leveraging a payload derived from a validated class of toxins, specifically camptothecin, incorporating a known linker, the MC-GGFG-based linker |
| Our preclinical data is encouraging, with strong anti-tumor activity demonstrated across a range of patient-derived non-small-cell lung cancer and ovarian xenograft models |
| These three candidates, along with our 2+1 mesothelin-targeting bispecific T-cell engager, ZW171, featuring a novel anti-GPC3 specificity, provide us with multiple data catalysts in the next 24 months to showcase our innovative and differentiated approach |
| By combining these elements in ZW191, ZW220 and ZW251, we believe we are poised to deliver a robust therapeutic solution to address unmet medical needs across various tumor types |
| I think we’re making really good progress in 2024 and we expect a really exciting rest of 2024 year |
| When conjugated to different tumor-targeting antibodies via clinically validated MC-GGFG-based linker, ZD06519 demonstrated impressive efficacy in multiple xenograft models and noteworthy tolerability in healthy mice, rats and non-human primates |
| The NaPi2b targeting monospecific antibody incorporated in ZW220 was generated in-house and selected based on favorable binding profile and enhanced internalization properties to enable targeting of both high and low-expressing NaPi2b -expressing tumors |
| Throughout 2023, we successfully positioned Zymeworks as a thought leader in the development of antibody drug conduits, or ADCs, and multispecific antibody therapeutics |
| Our strategy of refocusing the business and building a diverse clinical-stage product pipeline of ADCs and multispecific antibody therapeutics continues to provide a solid foundation, helping to achieve our long-term goal of identifying additional product candidates and seeking valuable partnership options with a strong financial position of $456.3 million as of the end of December 31, 2023 |
| Despite the accelerated development of our pipeline, we have maintained our strong financial position and remain financially disciplined with projected cash resources to support operations into the second half of 2027 |
| The overall differentiated design of ZW220, featuring our TOPO1-based payload with moderate potency and mid-range DAR, we believe will overcome issues associated with prior ADCs targeting NaPi2b |
| We’re very pleased to see positive results for these patient populations and look forward to further advancements of zanidatamab’s development in multiple indications, led by our partners, Jazz Pharmaceuticals and BeiGene |
| ZD06519 was selected based on its favorable properties as a free molecule and as an antibody conjugate, which include moderate payload -- free payload potency of approximately 1 nanomolar, low hydrophobicity, strong bystander activity, robust plasma stability and high monomeric ADC content |
| So that shows that we feel reasonably confident in the design of the study right there |
| And I think we’ve constructed a very good global early-stage development group, which allows us to focus on doing that in a very nimble way with all five of those programs with a high percentage of the patients being recruited outside the U.S., which we think makes it quicker and it is less expensive in the capital plan to do that |
| As you can see from this slide, there are many opportunities beyond these indications in other HER2-expressing tumors, which makes zanidatamab a potentially very rewarding financial investment, both for our partners and for shareholders of Zymeworks, while also supporting our goal to improve the standard of care for difficult-to-treat diseases for patients with high unmet needs |
| As many on this call will know, in recent years, the field of ADCs has seen a resurgence, largely driven by the clinical benefit observed in patients treated with ADCs incorporating camptothecin-based TOPO1 inhibitor payloads |
| We are very fortunate at Zymeworks to have a wealth of experience in proprietary technology, which provide the foundation for continuous innovation for our next-generation of candidates for ADCs, multispecific antibody therapeutics and beyond |
| These developments, coupled with our work on demystifying the ADC dogma by reviewing 40 years of clinical data and taking these learnings to redefine our own approach to develop the next generation of ADCs, are key differentiators for Zymeworks, as we aim to develop practice-changing therapeutics and indications with higher medical needs |
| And I think, what we’ll show is that, preclinically we do see the benefit of adding the costimulation and we can enhance efficacy while balancing what was very important for us in the design of this molecule, was balancing the potential for any sort of T-cell activation independent of engagement with the tumor antigen |
| So, I think when we have, you know, internal data, or in this case, external events happen, I think, it’s a good discipline for us to pause, to get clarity, and just to make sure that we can both execute the clinical development plan that we had outlined for this specific program and also to make sure that the commercial opportunity at the end of that clinical development program is still intact |
| We’re also very excited about the potential for zanidatamab to provide a chemo-free regimen, which we know would be of great value to patients and we look forward to data from the I-SPY program and Jazz’s collaboration with MD Anderson |
| TOPO1 inhibitor-based technologies show meaningful clinical benefit in a wide range of solid tumors, including hard-to-treat solid tumors, and have been validated across many targets |
| I’m very cognizant of the fact that I think with respect to zani, if you go back in history, I think that the company could have accelerated some of the zani development, broadened out the clinical applications and been more competitive if they had partnered sooner than we did with Jazz, and obviously, we’re quite happy with the Jazz partnership |
| Today, we have a broad and differentiated pipeline with novel candidates focused on validated targets in areas of significant interest, which continue to provide multiple opportunities for business development collaboration -- and collaborations |
| We’re excited for what comes next, both with zanidatamab as topline data becomes available and as it moves through the process of potential regulatory approvals initiated by our partners, Jazz and BeiGene, and for our early-stage assets that we had -- as we head into the clinic |
| And this is clearly an area where, in this patient population, second-line biliary tract cancers, there is no HER2-targeted therapy and we expect the data set, while small, was very compelling |
| Based on empirical findings and our own preclinical data, we believe our novel payloads could provide us with improved efficacy and tolerability, and have utilized ZD06519 in three of our ADC product candidates |
| Statement |
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| And then also we’ve seen significant safety concerns for other CD28 assets |
| Striking the right balance between ADC efficacy and tolerability remains an ongoing challenge, making a critical factor in designing a new ADC platform, ultimately enhancing the likelihood of clinical success |
| First of all, it’s important to recognize there are significant challenges with repurposing older toxins not originally developed for ADCs |
| However, it’s important to consider that more potent and more permeable payloads may also lead to increased toxicities, potentially requiring a reduction in the antibody dose, a challenge we have seen for many prior assets in the clinic |
| In these assays, what we are looking for is a decrease in the viability of tumor target antigen negative cells when co-cultured with target antigen positive cells, shown in brown, but limited impact on the viability of tumor antigen negative cells when cultured alone, shown in red |
| In 2023, we incurred a net loss compared to a net income in 2022, primarily due to the income from the Jazz partnership in 2022 |
| It’s a good part of the terms were, I think, in excess of expectations |
| Zymeworks’ net loss for the year ended December 31, 2023, was $118.7 million or $1.72 loss per diluted share, compared to a net income of $124.3 million for the year ended December 31, 2022 |
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