About Amphivena Therapeutics

Amphivena Therapeutics, Inc. is a clinical-stage, immuno-oncology company with a novel platform of T cell engagers (Amphivena ReSTORE™) that directly targets myeloid derived suppressor cells (MDSC), thus relieving cancer-induced immune suppression while controlling cytokine release syndrome (CRS).

Science

Our science and platform address major limitations in cancer immunotherapy

Cancer-associated immune suppression and CRS are major limiting factors in current immunotherapy. MDSC actively inhibit T cell responses in cancer patients and promote immune suppression in solid tumors. They are also significant producers of pathologic CRS-promoting myeloid cytokines, such as IL6.

Our molecules deplete MDSC resulting in the activation and expansion of anti-tumor T cells, without causing CRS, in both immune sensitive and insensitive cancers.

AMV564, Amphivena’s lead molecule, is a clinical stage T cell engager that is highly potent and selectively binds to MDSC while sparing other myeloid cells such as monocytes and neutrophils, activating and expanding anti-tumor T cells in cancer patients. Other platform molecules are trispecific and target tumor antigens in addition to MDSC, providing direct tumor cell killing while combatting immune suppression and restoring anti-tumor immunity.

ReSTORE molecules have prolonged pharmacodynamic activity and are delivered subcutaneously (SC) at home via pre-filled syringe. The dosing route and regimen of these molecules is patient-friendly and highly compatible with other therapies (e.g. checkpoint blockade, CAR-T, vaccines).

SC administration serves as a mechanism for effective delivery of our molecules to the lymphatics, the brain center of the immune system, where T cell education and metastatic spread occur. MDSC accumulate in the lymphatic system where they suppress the generation of anti-tumor T cells. By removing MDSC with ReSTORE molecules, the anti-tumor T cells are relieved from their immune suppressed status, allowing them to migrate to tumors and kill tumor cells.

Press Release
June 4, 2021

Amphivena Presents New Monotherapy and First Combination Therapy Clinical Data in Solid Tumor Patients

South San Francisco, CA – June 4, 2021 — Amphivena Therapeutics, a clinical-stage oncology company focused on developing immune-therapeutics that restore anti-cancer immunity to patients, today reported a favorable safety profile for AMV564 and clinical responses including a CR in patients with advanced relapsed or refractory solid tumors. The poster presentation at the 2021 virtual American Society of Clinical Oncology (ASCO) Annual Meeting disclosed the first comprehensive set of clinical results from Amphivena’s Phase 1 dose escalation study of AMV564 dosed subcutaneously (sc) as monotherapy or in combination with pembrolizumab, including in post checkpoint treatment failures…..

Press Release
April 12, 2021

Amphivena Presents Translational Data Highlighting the Cytokine Profile for its Lead Clinical Candidate, AMV564 at the AACR 2021 Virtual Annual Meeting

South San Francisco, CA – April 12, 2021 –Amphivena Therapeutics today presents translational data for the Company’s lead clinical candidate from a Phase 1 study in patients with advanced solid tumors. The poster, entitled “MDSC Suppress the T Cell Repertoire and Contribute to a Pathologic Cytokine Milieu in Cancer Patients,” (Abstract 528) is presented today at the American Association for Cancer Research (AACR) 2021 Virtual Annual Meeting…..

Press Release
December 16, 2020

Amphivena Therapeutics Announces First Patient Dosed in the Phase 1 Dose Expansion of AMV564

South San Francisco, CA – Dec 16, 2020 — Amphivena Therapeutics, a clinical-stage oncology company focused on developing a platform of bivalent T-cell engagers that restore anti-cancer immunity in patients, today announced the first patient has been dosed in the Phase 1 dose expansion study evaluating AMV564, an investigational, first-in-class agent that depletes myeloid derived suppressor cells (MDSC) and activates T cells, in adult patients with selected solid tumor indications….

Presentations & Publications