2020 Could be a Defining Year for SQZ Biotech

If 2019 was a breakthrough year for Watertown, Mass.-based SQZ Biotech, 2020 could be a defining year as the company tests is first antigen-presenting cell asset in the clinic to treat solid tumors that are HPV positive.

Armon Sharei, chief executive officer of SQZ Biotech, said 2020 is going to be an exciting year for the company as it anticipates having clinical data available from its first trial by the end of this year. SQZ received approval from the U.S. Food and Drug Administration last year to launch its Phase I trial for SQZ-PBMC-HPV, a novel cellular immunotherapy of antigen presenting cells (APCs). SQZ-PBMC-HPV is the first product stemming from the 2018 collaboration expansion between Roche and SQZ to develop SQZ-APCs for oncology. The SQZ APC platform is designed to present tumor antigens to the body’s endogenous CD8 T cells. The companies aim to use SQZ technology to introduce proteins into a patients’ immune cells in hopes of activating T-cells to fight off cancer – all without toxic side effects that can be seen in other treatments.

“This is the first baby of the program that Roche bought into in 2015 and doubled down on in 2018,” Sharei told BioSpace in an exclusive interview.

SQZ received clearance for its Investigational New Drug Application in the fall of 2019 and Sharai said the company anticipates news on enrollment and dosing within the next several weeks and potential data should be available closer to the end of the year.

Sharei described the antigen-presenting cells as the generals of the body’s immune system. The SQZ technology engineers these APCs from the extracted white blood cells of a patient and are then administered into the body. The APCs then take command of the immune system and direct it to fight against the tumor. Sharai said the company is exploiting a physiological mechanism and anticipate seeing a “powerful response” without side effects. Preclinical data has shown significant tumor reduction driven by high CD8 T cell infiltration into the tumor microenvironment.

 This mechanism has been something that other cellular-focused companies have sought to develop but have not been as successful, he added. But, where others have fallen short, Sharei believes SQZ has succeeded. That belief will be determined through the clinical study, he said.

But it’s not just the APC program that Sharei is looking forward to seeing play out in the clinic. SQZ Biotech is also developing an activating antigen carrier (AAC) immunotherapy program for oncology indications. The AAC program, which SQZ is developing on its own, used red blood cells, which are then “squeezed with antigen and adjuvant” to create AACs. When the cells are reintroduced to the body, “they are rapidly taken up by phagocytic cells in the liver and spleen which subsequently present the antigen to both CD8+ and CD4+ T cells, priming a potentially potent anti-tumor T cell response,” the company announced in November when it presented preclinical data demonstrating an in vivo response.

“This is really a very exciting approach to waking up the immune system against tumors,” Sharei said. He added that the company believes there is significant potential in this approach and hopes to see this enter the clinic by the end of the year.

As SQZ moves into becoming a clinical company, Sharei said the company will continue to explore its technology as a potential therapy in other indications, including immune tolerance to AAV (adeno-associated virus) gene therapies. In November, SQZ and Asklepios Biopharmaceutical (ASKBio) forged a collaboration to create tolerizing antigen carriers (TACs) containing AAV components to overcome a barrier to treatment that many patients face. Neutralizing antibodies can prevent large populations of patients from benefitting from AAV gene therapies. The collaboration, Sharei said, will bring together the power of cell and gene therapy platforms to benefit patients and allow them to receive novel therapies.

“We’re all in this to try and make a difference for the patients,” he said. Sharai added that with everything on SQZ’s proverbial plate in 2020, he “thinks there’s a lot to look forward to.”