SELLAS Receives FDA Orphan Drug Designation for SLS009 for Treatment of Peripheral T-cell Lymphomas
- SLS009 demonstrated a higher clinical response rate compared to the standard of care for r/r PTCL patients.
- The FDA granting Orphan Drug Designation signifies the drug's potential for treating rare diseases, providing benefits to drug developers.
- The ongoing Phase 1b/2 study in PTCL, fully funded by GenFleet Therapeutics, Inc., indicates potential for SLS009 to serve as a registrational study.
- None.
Insights
The recent FDA Orphan Drug Designation (ODD) for SLS009, a CDK9 inhibitor developed by SELLAS Life Sciences Group, indicates a positive regulatory milestone that could potentially expedite the drug's development and review process. The clinical response rate of 36.4% in relapsed/refractory (r/r) Peripheral T-cell Lymphomas (PTCL) patients is notable, especially when compared to the 25.8% response rate from the current standard of care, belinostat. This suggests a potentially significant advancement in treatment options for PTCL, a rare and aggressive form of cancer.
From a medical research perspective, the complete responses observed in the Phase 1 study, along with the favorable safety profile, provide a strong foundation for the ongoing Phase 1b/2 trial. The fact that patients who responded to SLS009 had prior treatments with regimens containing an HDAC inhibitor, like belinostat, further underscores the drug's potential efficacy. The ODD status not only underscores the unmet medical need in this therapeutic area but also provides SELLAS with development incentives, including tax credits and marketing exclusivity, which could positively impact the company's financial outlook.
The ODD for SLS009 as a treatment for PTCL is a critical step in the clinical development process, especially for a late-stage clinical biopharmaceutical company like SELLAS. The designation is a testament to the drug's potential to address a significant unmet need in the treatment of PTCL. In clinical trials, the primary endpoint often includes objective response rates (ORR) and the reported 36.4% ORR for SLS009 is promising. This data, particularly the instances of complete metabolic response and complete response by CT, is significant for patient outcomes and could lead to expedited approval if the ongoing trials continue to yield positive results.
For stakeholders, the implications are twofold: there is the potential for SELLAS to capture a niche market in PTCL treatment and for patients, a new treatment option may soon become available. However, it is important to note that these results are preliminary and the full data set from the Phase 1b/2 trial will be critical in determining the drug's future. The top-line data expected in the first half of 2024 will be a key indicator of SLS009's potential market impact and financial viability for SELLAS.
SELLAS Life Sciences Group's announcement regarding SLS009's ODD for PTCL treatment has significant implications for the company's market positioning and investor interest. The ODD, coupled with the previously granted Fast Track Designation, not only reflects the therapeutic potential of SLS009 but also positions SELLAS favorably within the competitive landscape of oncology drugs. The reported clinical response rate surpassing the standard of care highlights the drug's market potential and could lead to an increased valuation of the company.
Investors should monitor the progression of the ongoing Phase 1b/2 trial, as positive results could lead to a registrational study and eventual drug approval. The financial incentives associated with ODD, such as tax credits and fee exemptions, will likely reduce development costs and enhance profitability. Nevertheless, the biopharmaceutical sector is subject to high levels of risk and further data will be necessary to validate SLS009's commercial prospects fully. The partnership with GenFleet Therapeutics for funding the PTCL study in China also indicates a strategic move to mitigate financial risk and tap into international markets.
- SLS009 Demonstrated Promising Efficacy in Phase 1 Study with
- One Patient with Complete Metabolic Response Continuing Treatment for over 62 weeks and another patient with Complete Response by CT Continuing Treatment for over 24 weeks -
- Phase 1b/2 Study in PTCL Ongoing with top line data expected in 1H 2024 -
NEW YORK, Dec. 21, 2023 (GLOBE NEWSWIRE) -- 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, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for SLS009, the Company’s novel and highly selective CDK9 inhibitor, for the treatment of relapsed/refractory (r/r) Peripheral T-cell Lymphomas (PTCL).
“We are delighted to announce the FDA’s granting of ODD for SLS009, marking another significant milestone following the recent Fast Track Designation by the FDA for PTCL,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. “In the recently completed dose-escalation portion of the Phase 1 trial in r/r hematological malignancies, SLS009 achieved clinical responses in PTCL including two patients reaching complete response. We are excited to see a favorable safety profile, strong initial efficacy signals, and evidence of anti-tumor activity across the Phase 1 study as well as the ongoing Phase 2 studies. With both designations in hand, we look forward to advancing the development of SLS009 and continuing to work closely with regulators with the goal of delivering this treatment to those who may benefit from it.”
As it relates to PTCL, SLS009 is currently being evaluated in a Phase 1b/2 trial in patients with r/r PTCL. The open-label, single-arm study will enroll up to 95 patients to evaluate safety and efficacy and, based on the results, may serve as a registrational study. This initial PTCL study is fully funded by GenFleet Therapeutics, Inc. and is being conducted in China.
In the recently completed dose-escalation portion of the Phase 1 trial in r/r hematological malignancies, SLS009 demonstrated a favorable safety profile and promising clinical efficacy. Complete or partial responses were observed in patients with acute myeloid leukemia as well as lymphoma, including four PTCL patients (
The FDA’s Office of Orphan Products Development grants ODD status to drugs and biologics intended for the safe and effective treatment, diagnosis or prevention of rare diseases or conditions affecting fewer than 200,000 people in the United States. ODD provides benefits to drug developers designed to support the development of drugs and biologics for small patient populations with unmet medical needs. These benefits include assistance in the drug development process, tax credits for qualified clinical costs, exemptions from certain FDA fees and seven years of marketing exclusivity.
About SELLAS Life Sciences Group, Inc.
SELLAS is a late-stage clinical biopharmaceutical company focused on the development of novel therapeutics for a broad range of cancer indications. SELLAS’ lead product candidate, galinpepimut-S (GPS), is licensed from Memorial Sloan Kettering Cancer Center and targets the WT1 protein, which is present in an array of tumor types. GPS has potential as a monotherapy and combination with other therapies to address a broad spectrum of hematologic malignancies and solid tumor indications. The Company is also developing SLS009 (formerly GFH009), a small molecule, highly selective CDK9 inhibitor, which is licensed from GenFleet Therapeutics (Shanghai), Inc., for all therapeutic and diagnostic uses in the world outside of Greater China. For more information on SELLAS, please visit www.sellaslifesciences.com.
Forward-Looking Statements
This press release contains forward-looking statements. All statements other than statements of historical facts are “forward-looking statements,” including those relating to future events. In some cases, forward-looking statements can be identified by terminology such as “plan,” “expect,” “anticipate,” “may,” “might,” “will,” “should,” “project,” “believe,” “estimate,” “predict,” “potential,” “intend,” or “continue” and other words or terms of similar meaning. These statements include, without limitation, statements related to the SLS009 clinical development program, including data therefrom, and regulatory strategy. These forward-looking statements are based on current plans, objectives, estimates, expectations and intentions, and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties with oncology product development and clinical success thereof, the uncertainty of regulatory approval, and other risks and uncertainties affecting SELLAS and its development programs as set forth under the caption “Risk Factors” in SELLAS’ Annual Report on Form 10-K filed on March 16, 2023 and in its other SEC filings. Other risks and uncertainties of which SELLAS is not currently aware may also affect SELLAS’ forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. The forward-looking statements herein are made only as of the date hereof. SELLAS undertakes no obligation to update or supplement any forward-looking statements to reflect actual results, new information, future events, changes in its expectations or other circumstances that exist after the date as of which the forward-looking statements were made.
Investor Contact
Bruce Mackle
Managing Director
LifeSci Advisors, LLC
SELLAS@lifesciadvisors.com
FAQ
What is the significance of the FDA granting Orphan Drug Designation for SLS009?
What is the clinical response rate of SLS009 in r/r PTCL patients?
What is the status of the ongoing Phase 1b/2 study of SLS009 in PTCL?
