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SELLAS Receives European Medicines Agency Orphan Drug Designation for SLS009 for the Treatment of Acute Myeloid Leukemia

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SELLAS Life Sciences Group announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) for SLS009, a selective CDK9 inhibitor, for treating acute myeloid leukemia (AML).

This designation follows positive preliminary Phase 2 data and aligns with the previous FDA ODD. The designation provides financial and regulatory incentives, including a 10-year marketing exclusivity in the EU post-approval.

SLS009 is currently in a Phase 2a clinical trial evaluating its safety and efficacy. The trial targets a 20% response rate and a median survival over three months, focusing on patients with specific myelodysplasia-related mutations.

Positive
  • EMA granted Orphan Drug Designation for SLS009.
  • SLS009 received financial and regulatory incentives, including 10-year marketing exclusivity in the EU post-approval.
  • Strong preliminary Phase 2 data for SLS009.
  • Continued progress towards regulatory approval in both EU and US.
Negative
  • Target response rate of 20% and median survival over three months may be perceived as modest.

The European Medicines Agency's Orphan Drug Designation (ODD) for SLS009 is an important milestone for SELLAS and its potential treatment for acute myeloid leukemia (AML). As an Oncology Doctor, it is critical to understand that orphan drug designations are given to therapies targeting rare diseases, underlining the unmet medical need in this area.

AML is a rapid and aggressive blood cancer characterized by the overproduction of abnormal white blood cells, which can spread to other parts of the body. Achieving ODD signifies that SLS009 has shown preliminary efficacy and potential benefits in treating AML, especially for patients who have relapsed or are refractory to existing treatments. This can expedite the drug's development and approval process, providing a potentially life-saving option for patients.

The target response rate of 20% and target median survival of over 3 months in the ongoing Phase 2a trial will be closely watched. These metrics, while modest, represent significant progress in the treatment landscape of AML. However, the small patient cohort and early-stage data mean that further validation will be necessary before substantial clinical conclusions can be drawn.

The ODD granted by the EMA has financial implications for SELLAS. The designation allows for marketing exclusivity for ten years upon approval in the EU. This exclusivity can potentially translate into substantial revenue streams, assuming successful commercialization. Additionally, the reduced fees for protocol assistance from the EMA can lower development costs, improving the financial metrics of the drug's development.

Investors should consider that the successful completion of clinical trials and subsequent approval could significantly boost SELLAS' stock price. However, the company's current financial health and ability to fund ongoing trials are critical factors to monitor. The recent Phase 2 data, coupled with this designation, suggests strong progress, but the market will need to see continued positive results and potential partnership or funding announcements to maintain long-term confidence.

The broader biopharmaceutical market often sees volatility around clinical trial results and regulatory announcements. Thus, while the current news is positive, investors should remain cautious and watch for further developments in clinical efficacy and regulatory pathways.

The ODD for SLS009 highlights SELLAS' strategic positioning in the oncology market, particularly in the niche segment of AML treatment. From a market research perspective, this designation not only validates the therapeutic potential of SLS009 but also enhances the company's credibility among stakeholders and potential partners.

AML affects a relatively small population, which means that any effective treatment can command a premium price point. The combination of financial incentives like reduced fees for EMA assistance and exclusive marketing rights can make SLS009 a lucrative asset. However, competitive analysis indicates that new entrants and advancements in existing therapies will keep the market dynamic. Continuous innovation and adaptive strategies will be key for SELLAS to maintain a competitive edge.

Furthermore, the partnership between the EMA and FDA on protocol assistance and approval processes can streamline the drug's entry into both the European and US markets, broadening the potential patient base and revenue sources.

NEW YORK, July 08, 2024 (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 European Commission, based on a positive opinion issued by the European Medicines Agency (EMA), has granted Orphan Drug Designation (ODD) for SLS009, a novel, and highly selective CDK9 inhibitor, for the treatment of acute myeloid leukemia (AML).

“We are thrilled to receive ODD from the EMA for the treatment of AML. This designation along with the recently announced strong preliminary Phase 2 data and previous FDA ODD designation reinforces our continued progress and commitment to developing SLS009 as a potential treatment for AML,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. “We look forward to working closely with the EMA and the FDA to advance SLS009 clinical development and ultimately deliver it to the patients who need it most. To that end, we remain on track to share further data around SLS009 in the third quarter of this year.”

Orphan drug designation in the European Union (EU) is granted by the European Commission based on a positive opinion issued by the European Medical Association (EMA) Committee for Orphan Medicinal Products. The EMA’s orphan designation is available to companies developing treatments for life-threatening or chronically debilitating conditions that affect fewer than five in 10,000 persons in the EU. Medicines that meet the EMA’s orphan designation criteria qualify for financial and regulatory incentives that include a 10-year period of marketing exclusivity in the EU after product approval, protocol assistance from the EMA at reduced fees during the product development phase, and access to centralized marketing authorization. The treatment must also provide significant benefit to those affected by the condition.

“We are excited to receive this designation from the EMA to complement the earlier FDA’s ODD. The ongoing clinical trial data continues to support significant benefit in patients with AML relapsed after or refractory to venetoclax regimens and the EMA recognizes the significant benefit of SLS009 for patients impacted by AML. Together with EMA’s Protocol Assistance will define a path to an eventual regulatory approval in the European Union and working with the FDA towards a potential approval in the US,” said Andrew Elnatan, Vice President of Regulatory Affairs at SELLAS.

The Phase 2a clinical trial of SLS009 is an open-label, single-arm, multi-center study designed to evaluate the safety, tolerability, and efficacy of SLS009 in combination with aza/ven at two dose levels, 45 and 60 mg. In the 60 mg dose cohort patients were randomized into either a 60 mg dose once per week or a 30 mg dose two times per week. The target response rate at the optimal dose level is 20% with a target median survival over 3 months. ASXL1 mutation has been identified as the most promising target mutation based on biology of the mutation and the SLS009 mechanism of action that has been confirmed by the clinical results to date. The trial continues enrollment in two cohorts, both enrolling patients with myelodysplasia-related mutations, one with ASXL1 mutations and the other with myelodysplasia-related mutations other than ASXL1. For more information on the study, visit clinicaltrial.gov identifier NCT04588922.

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’ other lead product candidate, 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 the 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) - potentially the first and best-in-class differentiated small molecule CDK9 inhibitor with reduced toxicity and increased potency compared to other CDK9 inhibitors. Data suggests that SLS009 demonstrated a high response rate in AML patients with unfavorable prognostic factors including ASXL1 mutation, commonly associated with poor prognosis in various myeloid diseases. 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 28, 2024 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

____________________
References:
1. European Medicines Agency (2023). "Orphan Designation." https://www.ema.europa.eu/en/human-regulatory-overview/orphan-designation-overview


FAQ

What is the significance of the EMA granting Orphan Drug Designation for SLS009?

The EMA's Orphan Drug Designation for SLS009 provides financial and regulatory incentives, including a 10-year marketing exclusivity in the EU post-approval.

What is SLS009 being developed to treat?

SLS009 is being developed to treat acute myeloid leukemia (AML).

What are the key benefits of EMA's Orphan Drug Designation for SLS009?

The key benefits include financial incentives, regulatory support, and a 10-year marketing exclusivity in the EU post-approval.

What is the target response rate for SLS009 in the Phase 2a clinical trial?

The target response rate for SLS009 in the Phase 2a clinical trial is 20%.

When will further data on SLS009 be shared?

Further data on SLS009 is expected to be shared in the third quarter of this year.

SELLAS Life Sciences Group, Inc.

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