Solu Therapeutics Secures $41M Series A and Doses First Patient in STX-0712 Phase 1 Trial for Hematologic Cancers

Solu Therapeutics, a biotech innovator based in Boston, has announced the completion of a significant $41 million Series A funding round. This financial boost involves new investments from prominent entities such as Eli Lilly and Company, Biovision Ventures, Pappas Capital, Hengdian Group Capital, and The Leukemia & Lymphoma Society Therapy Acceleration Program®. The funding round also saw continued backing from existing investors including Longwood Fund, DCVC Bio, Santé Ventures, Astellas Venture Management, and Alexandria Venture Investments. The capital raised is set to advance the company’s pioneering efforts in targeting disease-driving cells, particularly in cancer and immunology.

A major milestone accompanying this announcement is the initiation of Solu Therapeutics' first-in-human clinical trial for STX-0712. This trial is designed to evaluate the safety and preliminary antitumor activity of this novel therapy in patients suffering from chronic myelomonocytic leukemia (CMML) and other resistant or refractory hematologic conditions. The trial's commencement marks a pivotal step in advancing treatments for these challenging diseases.

According to Philip J. Vickers, President and CEO of Solu Therapeutics, the rapid transition from seed funding to clinical-stage operations underscores the company’s commitment to addressing significant unmet medical needs. Vickers noted the enthusiasm and support from both new and existing investors, reflecting confidence in Solu’s innovative CyTAC (Cytotoxicity Targeting Chimera) and TicTAC (Therapeutic Index Control Targeting Chimera) platforms. These platforms allow for precise targeting and elimination of disease-driving cells, potentially offering more effective treatment options where traditional methods fall short.

The Series A funding will primarily support the dose escalation and expansion of STX-0712, focusing initially on CMML treatment. The funds will also enable the development of additional therapeutic candidates, including a novel mast cell depletor aimed at treating immunological diseases. Solu plans to further expand its pipeline and explore new applications for its proprietary platforms, aiming to uncover high-value targets and develop therapies that exceed the capabilities of conventional antibodies.

STX-0712 is crafted to target CCR2-positive malignant monocytes, which play a crucial role in driving advanced hematologic malignancies. The Phase 1 trial is structured as an open-label, multicenter study divided into two parts. Part A will concentrate on identifying the optimal dosing levels by enrolling patients with resistant/refractory CMML. Part B will delve deeper into assessing safety, tolerability, and the recommended Phase 2 dose, alongside evaluating initial antitumor activity.

Sergio Santillana, MD, Chief Medical Officer at Solu Therapeutics, expressed enthusiasm about launching the clinical trial for STX-0712, emphasizing its potential to provide a targeted therapy for patients with limited treatment options. This endeavor represents a significant achievement for the company in its pursuit of developing novel and potent therapies for CMML and similar conditions.

Preclinical data presented at the American Society of Hematology Annual Meeting demonstrated that STX-0712 exhibits strong activity against CCR2-positive monocytes, a characteristic feature of CMML. This disease is marked by abnormal monocyte levels and bone marrow dysplasia, offering limited therapeutic avenues.

Solu Therapeutics, co-founded by Longwood Fund, is dedicated to creating a new class of therapeutic agents. These agents uniquely combine the targeting capabilities of small molecules with the therapeutic benefits of monoclonal antibodies. Leveraging its proprietary platforms, Solu is at the forefront of developing treatments that offer enhanced precision and efficacy for tackling disease-driving cells, aiming to redefine therapeutic strategies in cancer and beyond.