On May 11, 2023 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS’’ or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported a business update and provided its financial results for the quarter ended March 31, 2023 (Press release, Sellas Life Sciences, MAY 11, 2023, View Source [SID1234631534]).
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"We are pleased with the continued advancement of both our galinpepimut-S (GPS) and GFH009 clinical programs during the first quarter of 2023, which positions us for near-term execution of several key value-driving milestones," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "Positive topline data for the patient group with acute myeloid leukemia (AML) from the GFH009 Phase 1 dose-escalation trial in relapsed/refractory myeloid malignancies suggests strong evidence of anti-tumor activity and survival benefit in this group with no significant safety issues. This supports advancement to a Phase 2a trial in patients with AML in combination with azacitidine and venetoclax, which we are initiating this quarter, with topline data expected in Q4 2023. Last month, the Independent Data Monitoring Committee (IDMC) also recommended that our GPS Phase 3 REGAL study continue without any modifications and is expected to meet again in Q3 to provide further guidance."
Dr. Stergiou continued "The key objectives for us this quarter and next, among others, will include:
the initiation of the GFH009 Phase 2a study in AML patients in combination with azacitadine and venetoclax;
completion of, and report of, data from the lymphoma patient group from the GFH009 Phase 1 study;
report of topline data from the GPS investigator-sponsored trial (IST) in malignant pleural mesothelioma (MPM);
abstract acceptance of our GPS ovarian cancer data from a major medical gynecological conference;
3D Medicines participation in the REGAL study; and
meeting of, and feedback from, the IDMC for the REGAL study."
"It was a great pleasure meeting our SELLAS colleagues last month at our Shanghai headquarters where we had a chance to discuss and further strengthen our strategic partnership," said John Gong, M.D., Ph.D., Chairman and Chief Executive Officer of 3D Medicines. "The blinded pooled analysis of GPS in AML conducted at the end of last year is indeed very exciting and may have the potential to improve AML patients’ quality of life and extend survival. We eagerly anticipate joining the REGAL trial very soon and to enroll about 20 patients in China to satisfy Chinese regulatory requirements towards a potential market approval. In addition, we will work together to explore solid tumor indications for GPS by combination with our subcutaneous anti-PD-L1, envafolimab, and other products."
Pipeline Update:
Galinpepimut-S (GPS): Wilms Tumor-1 (WT1) targeting immunotherapeutic
Phase 3 REGAL study in AML: Enrollment continued in the global Phase 3 REGAL registrational clinical trial in patients with AML who have achieved complete remission following second-line salvage therapy (CR2 patients), with interim analysis continuing to be expected to occur in late 2023 or early 2024. The participation of 3D Medicines in the REGAL study through the enrollment of patients from the Greater China territory will trigger milestone payments totaling $13.0 million to SELLAS, which the Company expects to receive by the end of the third quarter of 2023. The IDMC performed a routine, prespecified risk-benefit assessment of unblinded data from the REGAL study in April 2023 and recommended that the trial continue without modifications. The IDMC endorsed all clinical trial initiatives undertaken in REGAL to advance GPS, including the addition of clinical sites in China. The next routine IDMC meeting is scheduled for the third quarter of 2023.
3D Medicines Phase 1 clinical trial in China: 3D Medicines continued enrollment in China for their open-label, single-arm, multi-center Phase 1 clinical trial in patients with AML, multiple myeloma, non-Hodgkin’s lymphoma, or higher-risk myelodysplastic syndrome.
Phase 1/2 Study in combination with pembrolizumab (Keytruda) in ovarian cancer: Top-line data released in November 2022 showed clinical benefit of GPS in combination with pembrolizumab anti-PD-1 therapy in WT1 positive relapsed or refractory platinum resistant advanced metastatic ovarian cancer patients. The study was conducted under a Clinical Trial Collaboration and Supply Agreement with Merck & Co., Inc., Rahway, N.J., USA (known as MSD outside the United States and Canada), and SELLAS plans to present final data at a medical conference during the fourth quarter of 2023.
Phase 1 Study in combination with nivolumab (Opdivo) for MPM: Patient enrollment was completed at the end of 2022 for an investigator sponsored open-label Phase 1 trial for GPS combination therapy with checkpoint inhibitor nivolumab (Opdivo) for treatment of MPM in patients who were either refractory to or relapsed after at least one line of the standard of care therapy. SELLAS expects to report topline data during the first half of 2023.
Phase 1 Study in combination with nivolumab (Opdivo) in ovarian cancer: Final analysis was published in the peer-reviewed journal Cancers on previously reported data from the Phase 1 clinical trial showing clinical benefit of GPS combination with anti-PD-1 antibody nivolumab (Opdivo) in patients with relapsed WT1-expressing ovarian cancers (NCT02737787).
GFH009: highly selective CDK9 inhibitor
Phase 1 clinical trial in hematological malignancies: In the Phase 1 trial of GFH009, dose escalation was successfully completed in the group of patients with AML, while dose escalation continues in the lymphoma group at the highest dose level for that group (75 mg). Positive topline data for the group of patients with AML showed evidence of anti-tumor activity increasing with higher doses and no significant safety issues even at the highest dose levels. The recommended Phase 2 dose (RP2D) has been established for AML. SELLAS plans to commence a Phase 2a trial with GFH009 in combination with venetoclax and azacitidine (aza/ven) in patients with AML during the second quarter of 2023 with topline data expected in the fourth quarter of 2023.
Corporate Updates:
Underwritten Public Offering: On February 28, 2023, the Company closed an underwritten public offering providing gross proceeds of $20.0 million, before deducting underwriting discounts and commissions and offering expenses.
Appointment of Vice President, Head of Regulatory Affairs: Andrew Elnatan joined the leadership team in January 2023 as Vice President, Regulatory Affairs, CMC and Quality. He brings nearly three decades of global regulatory experience with successful breakthrough therapy designation and global drug approvals.
Financial Results for the First Quarter 2023:
Licensing Revenue: There was no licensing revenue for the first quarter of 2023, as compared to $1.0 million for the same period in 2022.
Cost of Revenue: There was no cost of revenue for the first quarter of 2023, as compared to $0.1 million for the same period in 2022.
R&D Expenses: Research and development expenses for the first quarter of 2023 were $7.2 million, compared to $4.6 million for the same period in 2022. The increase was primarily due to the ongoing Phase 3 REGAL clinical trial of GPS in AML patients and the Phase 1 clinical trial of GFH009 in hematological malignancies.
G&A Expenses: General and administrative expenses for the first quarter of 2023 were $4.1 million, as compared to $3.0 million for the same period in 2022. The increase was primarily due to personnel-related expenses due to increased headcount.
Acquired In-Process Research and Development: There was no acquired in-process research and development for the first quarter of 2023, compared to $10.0 million for the same period in 2022 from the in-licensing of GFH009.
Net Loss: Net loss was $11.1 million for the first quarter of 2023, or a basic and diluted loss per share of $0.47, compared to a net loss of $16.7 million for the same period in 2022, or a basic and diluted loss per share of $1.05.
Cash Position: As of March 31, 2023, cash and cash equivalents totaled approximately $23.9 million.
Keytruda is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA and is not a trademark of SELLAS. Opdivo is a registered trademark of Bristol-Myers Squibb Company, New York, NY, USA and is not a trademark of SELLAS. The manufacturers of these brands are not affiliated with and do not endorse SELLAS or its products.