SELLAS Life Sciences (NASDAQ: SLS) shares are in focus after the company published its business update and Q2 2020 financial results on
Two other studies are also advancing through clinical evaluations. Those include a Phase I/II basket study of GPS in combination with
Path Of GPS To
Its flagship product, galinpepimut-S (GPS), is a peptide-based immunotherapeutic with highly sophisticated and broadly differentiating features. It targets the Wilms Tumor-1 (WT1) protein, a well-validated cancer antigen, which was independently prioritized by the
WT1 is found to be present in around 20 cancers, both in solid tumors and hematologic malignanciesand it is densely expressed and subsequently processed within cancer cells, with its various peptide fragments then 'presented' on the surface of the cancer cells. Thus, if a patient's immune system becomes specifically activated against select WT1 peptides, through GPS vaccination, the peptide fragments on the cancer cells can then be recognized by the immune system, and eventually killed by the patient's T-lymphocytes. Attacking WT1-positive cancers through the above immunologic mechanism could be potentially quite effective, as WT1 does not down-regulate or become mutated frequently, and is also expressed on cancer stem cells (in addition to the replicating cells, which represent the majority of malignant cells within a given tumor).
GPS was discovered at Memorial
At MSK, GPS underwent extensive preclinical testing, including validation assays for antigenicity and immunogenicity. Additionally, it validated the ability to induce T-lymphocytes that could lyse (kill) WT1-expressing cancer cells ex vivo (i.e., antigen-specific cytotoxicity).
Importantly, GPS is stable, off-the shelf, does not involve cells (like cell-based vaccines, with their associated complex and expensive manufacturing and distribution attributes), and is open to practically all HLA types. And by design, GPS exhibits a unique ability to both mitigate against immune tolerance, plus induce and activate both CD8+ cytotoxic T-lymphocytes (which are responsible for tumor cell kill) and CD4+ T-cells (a fraction of T-cells that is responsible for establishing long-term immunologic memory.
These benefits are crucial to keep tumor growth in check. It's also significant that GPS is WT1-specific and is not marred by severe or serious toxicities such as development of cytokine-release syndrome (like CAR-T, TIL and some TCR-T and NK cell approaches) or induction of autoimmunity (seen often with checkpoint inhibitors).
Ongoing Trials Set Up For Potential Milestones
The company's pivotal, registration-enabling Phase III trial sets up 2020 to deliver some potential catalysts. Investors need to keep in mind that
The company has also seen positive responses using GPS in a very advanced patient population, who initially were diagnosed with AML, received appropriate frontline therapy, but relapsed. When used in the setting of maintenance after achievement of patients' first complete remission (CR1) following successful front-line antileukemic therapy, GPS demonstrated a median overall survival (OS; since initial AML diagnosis) of 67.6 months across all ages (historical controls: ~24-26 months) and 35.3 months in patients >60 years of age (historical controls: ~12-14.5 months).
In the setting of maintenance after achievement of patients' second complete remission (CR2) following successful second-line (salvage) antileukemic therapy, i.e., in a much more advanced and older population of AML patients vs. the CR1 setting, a pilot comparative study of GPS demonstrated a median OS (since time of achievement of CR2 status) of 21 months vs. 5.4 months in a contemporaneously treated unvaccinated patient cohort.
The 'control' patients had a much shorter median overall survival of just 5.4 months, which is typical of the natural history of AML at that advanced stage. That difference in favor of GPS is highly statistically significant and clinically meaningful. In those studies,
These positive findings pushed the company to design the currently ongoing randomized pivotal, potentially registration-enabling Phase III trial of GPS in AML CR2 patients, named the REGAL study. The clinical program is the most advanced AML peptide vaccine program in AML globally to-date, and the company estimates that they are at least around four years ahead of even the 'closest' competitor in the 'space'.
The combined opportunities have created an exciting period of transition as a company. Momentum can be carried by the Phase III design and treatment regimen being truly optimized, to maximize the probability of eventual clinical success.
As
Finally, it's important to note that
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