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Zymeworks Inc. (NASDAQ:ZYME) has made nice progress in advancing its pipeline. That is as a result of it has been in a position to report optimistic outcomes from a section 1b/2 research utilizing zanidatamab + chemotherapy + tislelizumab for the therapy of 1st-line sufferers with superior HER2-positive gastroesophageal adenocarcinoma (GEA) on the European Society of Medical Oncology (ESMO) Annual Congress. Such information was introduced by its companion for this program BeiGene (BGNE).
Why I consider Zymeworks Inc. is a vital biotech to think about for funding is as a result of there’s a main catalyst that’s going to be launched within the coming yr. That is going to be the discharge of outcomes from the section 3 HERIZON-GEA-01 research in 2024, which is utilizing the zanidatamab mixture routine for the therapy of 1st-line sufferers with superior HER2-positive GEA. Zymeworks has additionally established a partnership with Jazz Prescription drugs as effectively to advance zanidatamab for the therapy of sufferers with HER2 expressing cancers.
Lastly, this firm is incorporating the “5 by 5” technique, which is the development of a number of merchandise into the clinic. It not too long ago nominated its fourth medical candidate referred to as ZW251 for the therapy of GPC3-expressing liver most cancers. An IND submitting for this candidate is anticipated within the 1st half of 2025, together with ZW220, which is an NaPi2b focused topoisomerase 1 inhibitor for the therapy of sufferers with ovarian and lung most cancers. Different candidates being deployed as a part of this technique are ZW191 for folate receptor alpha (FRa) expressing tumors and ZW171 for pancreatic and ovarian most cancers. IND filings for these candidates are anticipated in 2024.
Zanidatamab Mixture For Therapy of HER2 Expressing Cancers
Zymeworks has made vital progress in advancing its pipeline, as a result of it featured up to date outcomes from a section 1b/2 research of zanidatamab plus chemotherapy together with tislelizumab for the first-line therapy of human epidermal progress issue receptor (HER2)-positive gastric/gastroesophageal junction adenocarcinoma (G/GEJC). One factor to notice is that this information was introduced from a research by the biotech’s companion BeiGene. It was proven that this therapy mixture produced an objective response rate (ORR) of 75.8% and a median length of response (mDOR) of twenty-two.8 months.
As well as, it was additionally famous that it was in a position to obtain a median progression-free survival (PFS) charge of 16.7 months. This optimistic information was sufficient for the biotech to maneuver this program ahead towards section 3 medical testing. This can be a section 3 research evaluating the usage of zanidatamab + chemotherapy + tislelizumab for the therapy of first-line HER2-positive G/GEJC.
This research is anticipated to recruit as much as 714 sufferers who’re to be randomized to one in all three therapy teams, that are as follows:
- Comparator arm A – Trastuzumab (Herceptin) plus doctor’s selection of capecitabine plus oxaliplatin (CAPOX) or 5-fluorouracil (5-FU) plus cisplatin (FP)
- Experimental arm B – Zanidatamab plus doctor’s selection of CAPOX or FP
- Experimental arm C – Zanidatamab and tislelizumab plus doctor’s selection of CAPOX or FP.
The first endpoints of the trial are going to be progression-free survival (PFS) by blinded unbiased central overview (BICR) and overall-survival (OS).
There may be going to be a serious catalyst alternative for buyers to sit up for, which is the discharge of top-line information from this trial. It’s anticipated that top-line information from this phase 3 HERIZON-GEA-01 study, utilizing zanidatamab + chemotherapy + tislelizumab for the therapy of 1st-line G/GEJC, are anticipated in 2024.
Financials
In line with the 10-Q SEC Filing, Zymeworks Inc. had money, money equivalents, and marketable securities of $390.2 million as of September thirtieth, 2023. The rationale for the money available is as a result of, again in November ninth, of 2022, it entered right into a Gross sales Settlement with Cantor Fitzgerald & Co. to promote shares of its widespread inventory with an mixture providing worth of as much as $150 million. This settlement was made by which the corporate may promote sometimes shares of its widespread inventory to lift money. On June sixteenth, 2023 it offered an mixture of three,350,000 shares of its widespread inventory at a worth of $8.12 per share.
With respect to this sale of shares, it raised roughly $27.2 million in gross proceeds and $26.2 million in internet money proceeds after bills. This biotech is in wonderful form in relation to money. Why do I say that? It’s as a result of it believes that it has sufficient money available to fund its operations by way of at the least the top of 2026 and possibly even past.
Dangers To Enterprise
There are a number of dangers that buyers ought to pay attention to earlier than investing in Zymeworks. The first threat to think about can be with respect to the continuing section 3 HERIZON-GEA-01 research, which is utilizing zanidatamab + chemotherapy + tislelizumab for the therapy of 1st-line sufferers with superior HER2-positive gastroesophageal adenocarcinoma (GEA). That is as a result of regardless of optimistic outcomes being launched from this research like an enchancment in goal response charge (ORR), median length of response (mDOR), and progression-free survival (PFS), there isn’t any assurance that the section 3 research will obtain the first endpoints with statistical significance.
A second threat to think about can be with respect to the zanidatamab program as an entire, which is that despite the fact that this firm has been profitable in utilizing this drug for the therapy of G/GEJC, there isn’t any assurance {that a} related optimistic consequence will likely be achieved when it’s examined towards different HER2-expressing cancers.
A third threat to think about can be with respect to the partnerships that this firm has established with BeiGene and Jazz Prescription drugs. That is as a result of despite the fact that these corporations have seen promise in such a collaboration so far, there isn’t any assurance that they are going to keep on as companions as zanidatamab progresses by way of the clinic.
The fourth and ultimate threat to think about can be with respect to the IND filings anticipated from all different antibody drug conjugates (ADCs) being superior within the pipeline. These can be the opposite ADC candidates I listed above, reminiscent of the next:
- ZW251 : GPC3-expressing liver cancers being focused
- ZW220 : NaPi2b focused topoisomerase 1 inhibitor for therapy of ovarian and lung cancers
- ZW191 : Folate receptor alpha (FRa) cancers being focused
- ZW171 : Pancreatic and ovarian cancers being focused
A few of these candidates are going to have IND filings in 2024 after which some others in 2025. The purpose is that even upon such IND filings being submitted, there isn’t any assure that the FDA will settle for them, nor that Zymeworks will have the ability to provoke section 1 research for them. Even when early-stage research are initiated for these different ADCs, there isn’t any assurance that optimistic outcomes will finally be launched from them.
Conclusion
Zymeworks Inc. has made nice progress in with the ability to advance its pipeline, particularly when you think about how far alongside it has include respect to producing medical information. It had its companions BeiGene and Jazz Prescription drugs each submit poster displays for zanidatamab information on the European Society of Medical Oncology (ESMO) Congress 2023, which passed off on October twentieth to twenty fourth of 2023. Up to now, the information appears to be superb. As an example, with respect to the section 1b/2 research utilizing the zanidatamab mixture in 1st-line HER2-positive gastric/gastroesophageal junction adenocarcinoma (G/GEJC), the target response charge (ORR) achieved was 75.8%.
Zymeworks Inc. has an in depth pipeline, and that is very true with it going to have two IND submitting in 2024 after which one other two IND filings in 2025 thereafter. Nonetheless, there’s one other program I’ve not but mentioned. This could be with respect to the usage of one other candidate in its pipeline referred to as zanidatamab zovodotin, which is an HER2-targeted bispecific antibody drug conjugate (ADC). What’s distinctive about this candidate is that it incorporates each of Zymeworks proprietary Azymetric and ZymeLink Auristatin platform applied sciences, together with the addition of a proprietary cytotoxin.
Editor’s Word: This text discusses a number of securities that don’t commerce on a serious U.S. alternate. Please pay attention to the dangers related to these shares.
