Squeezing cells at high speeds could lead to novel therapies
SQZ Soars
SQZ Biotechnologies (NYSE:SQZ), a cell therapy company developing novel treatments for multiple therapeutic areas, will participate in multiple investor conferences in April 2021. Armon Sharei, PhD, chief executive officer, will present a corporate overview at the 20th Annual Needham Virtual Healthcare Conference April 12 to 15 and participate in a cell therapy focused panel at the Canaccord Horizons in Oncology Virtual Conference on April 15. The company will also be hosting one on one meetings at both conferences. What makes this company special?
A clinical-stage biotechnology company developing transformative cell therapies for patients with cancer, infectious diseases, and other serious conditions, SQZ uses its proprietary technology that offers the unique ability to deliver multiple materials into many patient cell types to engineer a wide range of potential therapeutics for a variety of diseases. SQZ has the potential to create well-tolerated cell therapies that can provide therapeutic benefit for patients and to improve the patient experience over existing cell therapy approaches.
With accelerated production timelines under 24 hours and the opportunity to eliminate preconditioning and lengthy hospital stays, the company said that its goal is to use the SQZ approach to establish a new paradigm for cell therapies. Its first therapeutic applications aim to leverage the potential to generate target-specific immune responses, both in activation for the treatment of solid tumors and immune tolerance for the treatment of unwanted immune reactions and autoimmune diseases. Its first clinical trial, SQZ-PBMC-HPV-001, is currently enrolling patients with HPV16+ advanced or metastatic tumors.
At the heart of SQZ is the Cell Squeeze® technology, in which cells are physically squeezed at high speeds through a microfluidic chip, temporarily opening the cell membrane and enabling biologic material of interest, or cargo, to diffuse into the cell before the membrane reseals. This technology has enabled SQZ to create a broad pipeline of product candidates for different diseases.
SQZ founder and CEO, Dr. Armon Sharei, invented the Cell Squeeze® technology during his PhD in the laboratories of Dr. Klavs Jensen and Dr. Robert Langer at MIT. This innovation overcame major barriers to cell therapy development and implementation. Thus, SQZ Biotech was founded with the goal of creating a new generation of cell therapies – cell therapies that could enable transformative patient outcomes across disease areas while remaining safe and practical to administer.
According to Dr. Sharei, “In 2020, we experienced the most important moment in SQZ’s journey so far: dosing our first patient. This accomplishment was coupled with exciting progress across our pipeline and the transition to being a public company. Despite the many challenges of COVID-19, our team continued to maintain focus on our mission to create transformative cell therapies for patients, for which I am proud and thankful. We have many exciting milestones ahead and are committed to delivering on SQZ’s potential for patients across diseases.”
Recent pipeline developments are encouraging. In the area of oncology, SQZ announced initial safety data from the first 12 patients in SQZ-PBMC-HPV-101, the first clinical trial of the SQZ APC platform, demonstrated no dose limiting toxicities or grade 3 or higher treatment-related adverse events through year end 2020. SQZ will be presenting biomarker data from SQZ-PBMC-HPV-101 monotherapy cohorts in mid-2021.
In terms of infectious diseases, SQZ generated preclinical data across multiple infectious disease antigens showing specific and robust CD8 T cell responses and selected HBV as initial disease target. SQZ’s Next-Gen SQZ™ Enhanced Antigen Presenting Cell (“eAPC”) Platform is an advanced eAPC platform leveraging multiplexed delivery of mRNA cargos to incorporate additional functionality and potentially broaden the addressable patient population.
When presenting preclinical data at AACR 2021, SQZ officials said that they anticipate filing an investigational new drug application (“IND”) in 2021. The company also announced that that the SQZ AAC IND in HPV+ tumors was cleared by the FDA in January 2021 for a Phase 1 study to evaluate SQZ-AAC-HPV as a monotherapy and in combination with immune-oncology agents.
SQZ is also continuing preclinical work for SQZ-AAC-KRAS for potential applications across KRAS tumors. In terms of the SQZ™ Tolerizing Antigen Carriers (“TAC”) Platform in Immune Tolerance, the company presented preclinical data at ASIT showing how SQZ TACs drive multiple antigen specific tolerance mechanisms, including deletion, anergy and Treg expansion.
In 2020 SQZ grew in the areas of manufacturing and patient experience. The company produced doses for each patient in the SQZ-PBMC-HPV-101 trial in under 24 hours. It is developing a point-of-care manufacturing prototype that could potentially enable further efficiencies in its process and improve patient accessibility to novel cell therapies.
Additionally, SQZ raised more than $200 million in gross proceeds from equity financings, including a private round that closed in the first half of 2020, an initial public offering in October 2020 and a follow-on public offering in February 2021. The company believes that the cash, cash equivalents and marketable securities as of December 31, 2020, along with the subsequent follow-on offering in February 2021 will be sufficient to fund operating expenses and capital expenditure requirements through the first half of
2023.
SQZ added key board members and advisors, including Sapna Srivastava, PhD, Paul Bolno, MD, and Marc Schegerin, MD to the Board of Directors and Kai Wucherpfenning, MD, PhD to its Scientific Advisory Board. The company also added key members of senior management, including Micah Zajic as chief business officer and David First as chief people officer.
The company ended 2020 with $170.4 million in cash, cash equivalents and marketable securities, as compared to $98.3 million as of December 31, 2019. Revenue was $21.0 million for the year ended December 31, 2020, as compared to $20.1 million for the year ended December 31, 2019.
Howard Bernstein, MD, PhD, SQZ chief scientific officer, concluded, “The flexibility of the Cell Squeeze® technology enables us to rapidly pursue new tumor types, such as those with KRAS mutations, as well as to add diverse functionalities to our APCs. Next generation eAPCs are building on the strength of our SQZ APC’s efficient and specific CD8 T cell activation. Further enhancing cytokine and costimulatory signaling could be an innovative way for us to provide the benefits of numerous immune-oncology mechanism combinations into a single cell therapy. ”