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Allschwil, Switzerland, December 13, 2022

Spexis announces promising pre-clinical data with balixafortide in combination with various therapies on the market for treating B-cell lymphomas

• Balixafortide shown to have synergistic or additive effect with conventional or targeted therapies across all tested B-cell lymphomas

Spexis AG (SIX: SPEX), a clinical-stage biopharmaceutical company focused on rare diseases and oncology, today announced results from an in vitro study evaluating the effects of combining Spexis’ potent CXCR4 inhibitor balixafortide (BLX) with several conventional or targeted therapies on the market in B-cell lymphoma models. The research was conducted under the leadership of Prof. Francesco Bertoni at the renowned Institute of Oncology Research in Bellinzona, Switzerland. 

The study results demonstrated that the addition of either BLX or another CXCR4 inhibitor from the Spexis macrocycles platform, SPX5551, to conventional or targeted therapies, including the BCR-ABL tyrosine kinase inhibitor imatinib, the P13K inhibitor copanlisib and the BTK inhibitor ibrutinib, showed an increase in anti-proliferative activity, either additive or synergistic, across all tested B-cell lymphomas. These data suggest that the addition of balixafortide or SPX5551 has the potential to improve the effect of BCR inhibitors and may overcome resistance to BTK and PI3K inhibitors in the treatment of patients with certain types of B-cell lymphoma.

The study was designed to assess whether the pharmacological inhibition of CXCR4 could increase the anti-tumor activity of various anti-lymphoma agents across different B-cell lymphoma cell lines, including some with secondary resistance to BTK and PI3K inhibitors. Anti-proliferative activity was measured by the MTT assay in cell lines derived from mantle cell lymphoma, chronic lymphocytic leukemia, and marginal zone lymphoma. The MTT assay is used to measure cellular metabolic activity as an indicator of cell viability, proliferation and cytotoxicity.

“While we have seen important advancements in the treatment of B-cell lymphomas in recent years, many patients still do not respond to or relapse following treatment with currently available therapies. We are pleased with the anti-proliferative effects we saw in our in vitro work combining the CXCR4 inhibitors balixafortide or SPX5551 with various therapies and look forward to these combinations being studied further in the clinic,” said Prof. Francesco Bertoni, Head of the Lymphoma Genomics group at Institute of Oncology Research in Bellinzona, Switzerland, the Institute Deputy Director and Adjunct Professor at the Università della Svizzera Italiana (USI).

Juergen Froehlich, MD, Chief Medical Officer of Spexis, added: “These data support our ongoing evaluation to harness the clinical potential of balixafortide, building on existing clinical data and other research. Spexis is currently considering additional clinical trials with balixafortide to further investigate these findings in patients with various B-cell malignancies.”

Detailed findings from the study are being submitted for presentation at an upcoming medical conference.

About Balixafortide (“BLX”)

Discovered from Spexis’ macrocycle platform, BLX is a potent, specific and highly selective macrocycle inhibitor of CXCR4 that plays a role in a number of tumor types as well as non-oncology indications. BLX has been studied in 8 clinical trials to date involving over 500 subjects and in multiple therapeutic indications such as solid tumors, hematologic malignancy and stem cell mobilization. Spexis has partnered China rights of BLX to Fosun Pharma, a leading Chinese pharmaceutical company. In addition, Spexis is analyzing existing BLX clinical and preclinical data to determine the appropriate development path forward, including potential new indications. In line with this ongoing review, Spexis recently published data demonstrating synergistic efficacy in combination with docetaxel in metastatic prostate cancer.  These data, combined with the renal impairment clinical trial data announced today and other ongoing studies and analyses, will inform decisions on potential future development of BLX and related macrocycles within the Spexis portfolio.

About Spexis’ Macrocycle Platform:

Macrocycles are a proven chemical class of pharmaceutical therapeutics occupying the chemical space between small molecules and biologics.  With a unique conformational balance of flexibility and rigidity, macrocycles can act on both extracellular and intracellular targets that are not easily accessible by other chemical classes.  Indeed, since 2014, some 19 distinct macrocycle compounds have been approved by various drug regulatory authorities worldwide, involving a wide range of diseases and indications.  More recently, with the emergence of the field of molecular glues and protein-protein interactions/degraders, macrocycles are increasingly recognized as possessing significant potential to target unique molecular targets and be combined with a variety of complementary technologies.  Spexis possesses two distinct, highly diverse and well-characterized macrocycle libraries, together with deep data on same: PEMfinder^®, comprised of peptidomimetic macrocycles, and MacroFinder^®, comprised of small molecule macrocycles.  Each library has distinct applications depending on the targets in question.  In addition, Spexis has several pre-clinical leads for various indications which have already been considerably characterized.  Spexis is looking to partner either these pre-clinical leads or the entire platform itself, potentially in combination with complementary technologies.

About Spexis

Spexis (SIX: SPEX) is a clinical-stage biopharmaceutical company based in Allschwil, Switzerland, focused on rare diseases and oncology. For further information please visit: www.spexisbio.com.

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Disclaimer

This press release contains forward-looking statements which are based on current assumptions and forecasts of Spexis management. Known and unknown risks, uncertainties, and other factors could lead to material differences between the forward-looking statements made here and the actual development, in particular Spexis’ results, financial situation, and performance. Readers are cautioned not to put undue reliance on forward-looking statements, which speak only of the date of this communication. Spexis disclaims any intention or obligation to update and revise any forward-looking statements, whether as a result of new information, future events or otherwise.