As the United States enters nearly its fifth month in the global fight against COVID-19, many investors have set their eyes on companies racing to discover a cure and restore things back to a sense of normalcy. But despite this new threat to public health, cancer never paused for a pandemic. That’s why savvy investors and healthcare professionals alike continue to focus on the promising companies who are advancing late-stage cancer trials, including SELLAS Life Sciences Group, Inc. (NASDAQ: SLS).
SELLAS Life Sciences is a late-stage biopharmaceutical company focused on the development of a wide range of cancer immunotherapeutic solutions that address critical unmet medical needs. Founded in 2012, the company has made significant progress in the second half of 2019 and early 2020 in progressing its key clinical trials in its fight against a broad range of cancers.
SELLAS Life Sciences is well-positioned for near and long-term clinical success. The company is focusing on progressing its innovative immunotherapeutic, galinpepimut-S (GPS). Despite the pandemic-related slowdown in many industries, SELLAS has reported itself to be not materially affected by the COVID-19 lockdown as its clinical programs for GPS generally continue to advance. The challenges brought on by the pandemic are being navigated by an experienced management team prepared to bring treatments to patients who need it most as efficiently as possible given the complexities of drug development.
As part of the new era in treating cancers, SELLAS has focused its development on GPS, a cancer immunotherapeutic targeting the Wilms Tumor (WT1) protein, ranked by the National Cancer Institute as the #1 cancer antigen and overexpressed in around 20 tumor types.
SELLAS President and CEO, Angelos M. Stergiou, MD, ScD h.c. noted in a shareholder letter that the company’s progress over the past two years has fortunately positioned the company to keep its clinical programs pretty much on course as the pandemic has struck over the last few months. The company’s work is attracting the attention of investors and since April 1, 2020, SELLAS shares have risen by roughly 120%. (as of closing price on 6/3/20)
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Immunotherapy Targeting WT1 Protein
SELLAS’s novel GPS immunotherapy could be a potential treatment for a broad range of blood cancers and solid tumors. GPS is a mixture of innovative, highly engineered and artificially mutated peptides and utilizes the heteroclitic technology as a leading immunotherapeutic that is designed to activate tumor-killing cells and generate an immune response against WT1 expressing tumors.
This immune response has been shown in clinical trials and patients receiving GPS have demonstrated longer overall survival and/or progression-free survival as compared to patients not receiving GPS in these clinical trials.
SELLAS is currently conducting a pivotal, registration-enabling Phase III clinical trial (the REGAL study) of GPS in patients with acute myeloid leukemia (AML) who have a second complete remission. SELLAS is also conducting a Phase I/II basket study for GPS in combination with Merck’s (NYSE: MRK) anti-PD-1 therapy KEYTRUDA in patients with selected WT1-positive cancers which is being conducted at numerous centers nationwide with initial focus on ovarian cancer and colorectal cancer and to be followed by other indications.
Clinical and immune data in such a combination setting with Bristol Myers Squibb’s (NYSE: BMY) anti-PD-1 drug, Opdivo, reported in November 2019, indicated that the progression-free survival rate for patients with ovarian cancer who received greater than two doses of GPS and Opdivo was approximately 30%, which is clinically meaningful and highly promising relative to the historical 3% to 10% rates seen in patients receiving only salvage chemotherapy. Furthermore, under an IST study being conducted at Memorial Sloan Kettering Cancer Center, and in collaboration with Bristol Myers Squibb, GPS is also currently being studied in combination with Opdivo in malignant pleural mesothelioma (MPM).
REGAL Phase 3 Trial Targeting AML
In November 2019, SELLAS hosted its first R&D investor event, “Galinpepiut-S (GPS) and the Next Generation of Cancer Immunotherapy” which was focused on the promise of GPS and its upcoming phase III REGAL study. More than 350 investors listened to top key opinion leaders (KOLs) in immunotherapeutics and AML.
The phase III REGAL study is an exciting period of transition for the company. The trial is a 1:1, randomized, open-label study comparing GPS monotherapy vs. Best Available Treatment. This maintenance-based study places GPS against the trial investigators’ “best choice available treatment” in AML patients who have achieved hematologic complete remission. That remission can be with or without thrombocytopenia (CR2/CR2p), after second-line antileukemic therapy and who are deemed ineligible for or unable to undergo allogeneic stem-cell transplantation. With nearly 116 patients to be enrolled across 50 clinical sites in the US and Europe, the primary goal of the study is to measure the overall survival rate from the time of study entry, with secondary endpoints including leukemia-free survival and antigen-specific T-cells immune response dynamics, and more.
SELLAS’s REGAL clinical trial is the only phase III study currently focused on remission prolongation through maintenance post-CR2 therapy, a significant unmet medical need. The Phase 2 study previously conducted in this setting showed a 21-month median overall survival vs. 5.4 months in favor of GPS with a p-value of 0.02 and GPS has received fast-track and orphan drug designations by the FDA and orphan drug designation by the EMA.
SELLAS recently announced the formation of an Independent Data Monitoring Committee (DMC) to evaluate patient safety and efficacy data. The DMC will help to maintain the highest levels of integrity for this pivotal study, and is comprised of highly regarded and experienced physicians and bio-statisticians who will confer with the physicians on the trial’s Steering Committee.
In February of 2020, SELLAS began an investigator-sponsored phase I/II clinical trial of GPS used in combination with Bristol-Myers Squibb’s anti-PD-1 therapy, Opdivo, in patients with malignant pleural mesothelioma (MPM). The study is enrolling patients with MPM who have relapsed or suffered secondary effects after receiving standard of care multimodality therapy.
Additionally, treatment with GPS throughout all of its complete studies to date was well-tolerated and did not cause unexpected or pronounced adverse side effects in patients. Thus, SELLAS is checking off the right boxes for its development programs for GPS: it has been shown to be well-tolerated, and may potentially improve survival upon current treatments for certain blood cancers and solid tumors.
Looking Forward Into 2H 2020
SELLAS is primarily focusing its resources to advance its GPS therapy. Key objectives for the remainder of 2020 and the first half 2021 include the progression of the GPS REGAL study as well as releasing updated results of ongoing clinical trials involving GPS with Keytruda and Opdivo.
If these studies produce positive results, SELLAS will be exceptionally well-positioned to potentially bring to market a drug that targets critical unmet medical needs. The data, to date, is supportive of such a potential scenario.. Like all developing biotechs, SELLAS Life Sciences Group has navigated challenges since its inception in 2012. However, SELLAS is continuing on a journey that can potentially benefit patients and their families, change options for physicians, and help usher in a new era of hope to treat devastating cancers that take the lives of millions of people each year.
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