SELLAS Life Sciences Adds Once-a-Week Dose Cohort in Ongoing Phase 1 Clinical Trial with its Highly Selective CDK9 Inhibitor GFH009

Rhea-AI Summary

SELLAS Life Sciences Group announced an expansion in its ongoing global Phase 1 clinical trial for the CDK9 inhibitor GFH009, focusing on patients with advanced relapsed or refractory lymphoma and acute myeloid leukemia (AML). A new once-a-week dose cohort has been added, starting at 30 mg. Previous cohorts showed no significant toxicities at the 22.5 mg dose. With safety assessments underway for the twice-a-week regimen, the company aims to determine the optimal dosing for the upcoming Phase 2 study, potentially enhancing efficacy in these patient populations.

Positive

• Introduction of a new once-a-week dosing cohort for GFH009 at 30 mg.
• No dose-limiting toxicities reported in previously tested cohorts.
• Safety assessments for ongoing cohorts are proceeding as planned.

Negative

• None.

The Company Continues to Evaluate Optimal Dosing for Patients with Acute Myeloid Leukemia and Lymphoma in Preparation for Phase 2

NEW YORK, July 07, 2022 (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 Company has added a second, once-a-week dose cohort in its ongoing global Phase 1 clinical trial in both the United States and China with the highly selective CDK9 inhibitor GFH009 for patients suffering from advanced relapsed or refractory lymphoma and acute myeloid leukemia (AML).

SELLAS previously reported that AML patients treated twice-a-week at the 22.5mg dose level experienced no dose-limiting toxicities, including no Grade 3/4 neutropenia (an abnormally low count of neutrophils, a type of white blood cell). The patients in the AML arm of the clinical trial have entered the last twice-a-week 30mg planned dose level. Additionally, enrollment for lymphoma patients at the twice-a-week 15mg dose level cohort has been completed and safety assessments are underway. The twice-a-week dose regimens for both groups will proceed as planned and are on target for completion this year.

Given that both AML and lymphoma patients tolerated all dose levels studied to date with the twice-a-week administration as well as the efficacy signals seen with both AML and lymphoma patients, SELLAS has amended its protocol to introduce an additional single-dose cohort to study GFH009 once-a-week administration starting at the higher dose level of 30 mg.

The new, weekly single-dose cohort regimen is as follows:

• Dose levels are 30mg, 45mg and 60mg once per week.
• The amended protocol allows SELLAS to further escalate the doses if each level is determined safe for patients.
• The new cohort is expected to take approximately one month to enroll patients and another 21 days to complete the safety assessment for each dose level.

“As we continue to evaluate GFH009 with its unique mechanism of action, increasing the dose administered and extending the administration of the dose will allow us to expand our knowledge of the drug’s safety and efficacy profile, including potentially seeing whether there are further increases in efficacy beyond the already observed efficacy for these patients,” said Dragan Cicic, MD, Senior Vice President, Clinical Development, SELLAS. “With this additional valuable data on the new dose levels and regimen, SELLAS will be one step closer to discovering the optimal dosage for patients in preparation for the Phase 2 study.”

About SELLAS Life Sciences Group, Inc.
SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) 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 or in 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 statements include, without limitation, statements related to the clinical data for GFH009, plans for further development of GFH009, and the potential for GFH009 as a drug development candidate. 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
Allison Soss
KCSA Strategic Communications
Email: SELLAS@kcsa.com
Phone: 212.896.1267

Media Contacts
Raquel Cona / Michaela Fawcett
KCSA Strategic Communications
Email: SELLAS@kcsa.com
Phone: 212.896.1276

FAQ

What is the purpose of SELLAS's Phase 1 trial for GFH009?

The purpose is to evaluate the safety and efficacy of the CDK9 inhibitor GFH009 in patients with advanced relapsed or refractory lymphoma and acute myeloid leukemia.

What dose levels are being tested in the new once-a-week cohort for GFH009?

The new cohort is testing dose levels of 30 mg, 45 mg, and 60 mg once per week.

What were the results of previous cohorts in the GFH009 trial?

Previous cohorts reported no significant dose-limiting toxicities at the 22.5 mg dose level.

What are the next steps for SELLAS after this Phase 1 trial?

The next steps include determining the optimal dosing for GFH009 based on the trial results in preparation for a Phase 2 study.

When is enrollment expected to be completed for the new dose cohort of GFH009?

Enrollment for the new cohort is expected to take approximately one month.