SELLAS Life Sciences Strengthens Leadership Team with Appointment of Vice President Head of Regulatory Affairs

Rhea-AI Summary

SELLAS Life Sciences Group announces the appointment of Andrew Elnatan as Vice President, Head of Regulatory Affairs, Chemistry, Manufacturing, and Controls (CMC) and Quality. With nearly 30 years of experience in regulatory affairs, particularly in oncology, Elnatan aims to strengthen SELLAS' leadership during critical development phases for its clinical programs galinpepimut-S (GPS) and GFH009. His prior success with drug approvals across various global bodies, including the FDA, positions him well to advance SELLAS' regulatory strategies and milestones.

Positive

• Andrew Elnatan's extensive regulatory experience may expedite clinical program timelines.
• His successful history with FDA approvals can strengthen SELLAS' potential for future drug approvals.

Negative

• Changes in leadership may disrupt continuity during crucial development phases.
• Potential gaps in experience could pose challenges in navigating regulatory landscapes.

Andrew Elnatan Brings Nearly Three Decades of Global Regulatory Experience with Successful Breakthrough Therapy Designation and Global Drug Approvals

NEW YORK, Jan. 05, 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 the appointment of Andrew Elnatan as Vice President, Head of Regulatory Affairs, Chemistry, Manufacturing, and Controls (CMC) and Quality. He joins the Company’s executive leadership team and is responsible for developing and executing regulatory strategies.

Elnatan has extensive regulatory and CMC pharmaceutical industry experience in the areas of oncology, immunology, and hematological diseases. His career spans over 25 years at companies such as Amgen, SQZ Biotechnologies Company, International AIDS Vaccine Initiative, and Celldex Therapeutics. He has successfully coordinated regulatory submissions, negotiations and approvals of drugs and biologics with several global regulatory bodies, including the US Food and Drug Administration (FDA), China’s National Medical Products Administration Center for Drug Evaluation, Taiwan Food and Drug Administration, Australian Therapeutic Goods Administration, and the European Medicines Agency and other EU national agencies. This includes achievement of US FDA Breakthrough Therapy Designation granted for an oncology asset.

“Andrew Elnatan is a welcomed addition who strengthens SELLAS’ leadership team at a strategic point in development of our galinpepimut-S (GPS) and GFH009 clinical programs,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. “Andrew’s extensive background as a regulatory affairs leader in the area of oncologic malignancies, along with his successful track record of strategies that expedite development timelines, brings enormous value to SELLAS at a point where the Company is poised to execute several regulatory milestones over the coming year.”

"It’s an honor to join the SELLAS team at a transformative time for this innovative oncology company and I am excited to be part of their mission to provide much-needed treatment options to those battling cancer,” said Andrew Elnatan, Vice President, Head of Regulatory Affairs, CMC and Quality at SELLAS. “I look forward to leveraging my experience to implement regulatory strategies that build on the momentum of advancing our GPS and GFH009 clinical programs."

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, 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 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 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 associated with the COVID-19 pandemic and its impact on the Company’s clinical plans and business strategy, risks and uncertainties associated 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 31, 2022 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

Who is Andrew Elnatan and what is his role at SELLAS?

Andrew Elnatan is the newly appointed Vice President, Head of Regulatory Affairs at SELLAS, responsible for executing regulatory strategies.

What experience does Andrew Elnatan bring to SELLAS?

Elnatan has nearly 30 years of experience in regulatory affairs, specifically in oncology, with a track record of successful drug approvals.

What are the key clinical programs mentioned in the press release?

The key clinical programs are galinpepimut-S (GPS) and GFH009.

How might Andrew Elnatan's appointment impact SELLAS' regulatory strategy?

His extensive background could potentially expedite regulatory processes and approvals for SELLAS' therapies.

What challenges could arise from the leadership change at SELLAS?

Leadership changes might lead to continuity issues and possible gaps in regulatory experience.