SIRPant Immunotherapeutics Announces First Patient Dosed in Phase 1 Clinical Trial Evaluating SIRPant-M in Patients with Relapsed/Refractory Non-Hodgkin Lymphoma

HUMMELSTOWN, Pa., March 12, 2024 (GLOBE NEWSWIRE) — SIRPant Immunotherapeutics, Inc., a clinical-stage immuno-oncology company focusing on developing next-generation macrophage-based immunotherapies for the treatment of hematological malignancies and solid tumors, today announced the first patient has been dosed in the Company’s Phase 1, first-in-human, multi-center study evaluating SIRPant-M™ alone or in combination with focal external-beam radiotherapy (XRT) in patients with relapsed/refractory Non-Hodgkin lymphoma (R/R-NHL).

“The culmination of years of development work, initially in Academia, and later taken forward by SIRPant, we are pleased to announce the dosing of the first patient in this Phase 1 study evaluating SIRPant-M™, last week at the City of Hope Cancer Center.”, said Jelle Kijlstra, M.D., Chief Medical Officer of SIRPant. “With its unique polyclonal mechanism of action, relying on tumor-specific neo-antigens, SIRPant-M™ is well positioned to reveal the therapeutic potential of activated macrophage cell-therapy, and we look forward to providing updates as early outcomes emerge in in 2024.”

“I am excited to have our first patient with advanced and refractory cutaneous T cell lymphoma treated with the autologous cell therapy SIRPant-M™. The interaction of immune cells in the tumor microenvironment influences progression of cutaneous T cell lymphoma,” said Christiane Querfeld, M.D., Ph.D., Director of the Multidisciplinary Cutaneous Lymphoma Program, and one of the principal investigators of the study. “The initial therapy response we have now seen in this patient is very encouraging and I look forward to treating patients with advanced stage T cell lymphoma, which are generally relapse or become refractory to standard regimens that target tumor cells alone.”

SIRPant Immunotherapeutics’ Phase 1 clinical trial (NCT05967416) is a first-in-human, open-label, multi-center study of SIRPant-M™ in serial cohorts either alone (monotherapy) or combined with low-dose focal XRT in patients with R/R-NHL. Both B-cell and certain T-cell NHL (select PTCL; CTCL) are eligible. The primary objective of the study is to assess the safety and tolerability of autologous SIRPant-M™.

In December 2023, the company presented the trial design at the 65^th American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego, CA a poster (abstract number: 4856) outlining the Company’s Phase 1 clinical trial of SIRPant-M™ for the treatment of R/R-NHL.

About SIRPant Immunotherapeutics, Inc.

SIRPant Immunotherapeutics Inc is a clinical-stage immuno-oncology company specializing in the development of next-generation macrophage-based immunotherapies for the treatment of hematological malignancies and solid tumors. The cell therapy technology SIRPant employs is based on the reduction of SIRPα expression combined with activation of the patient’s own macrophages. This population of SIRPαlow activated macrophages are designed to attack the tumor following injection by activating the patient’s immune system to produce broad spectrum anti-tumor activity that utilizes patient T-cells and antibodies targeting cancer neoantigens. Because SIRPant does not genetically engineer its cell therapies, the company believes its product candidates will be easier and less expensive to manufacture, with reduced toxicities, compared to current engineered cell therapies in the clinic, and may provide patients with meaningful clinical benefit. As a result, SIRPant-M™ has a compelling product profile when compared to current gene-modified cell therapies. For more information, please visit www.sirpantimmunotx.com.

Forward-looking statements

This press release contains certain “forward-looking statements” concerning the development of SIRPant Immunotherapeutics products, the potential benefits and attributes of those products, and the company’s expectations regarding its prospects. Forward-looking statements are subject to risks, assumptions and uncertainties that could cause actual future events or results to differ materially from such statements. These statements are made as of the date of this press release. Actual results may vary. SIRPant Immunotherapeutics undertakes no obligation to update any forward-looking statements for any reason.

Investor Contact:

Matthew Guido

Stern Investor Relations, Inc.

matthew.guido@sternir.com

Media Contact:

Robert Towarnicki

President & CEO

(610) 321-3111 Ext 700

rtowarnicki@sirpantimmunotx.com