TwoStep Therapeutics, a biotechnology company specializing in targeted therapeutics for solid tumors, has officially launched following a successful $6.5 million seed round led by NFX, with additional investments from 2048 Ventures, Alexandria Venture Investments, Cooley’s affiliated fund GC&H Investments, and the family office of the founder of Arcadia Investment Partners. The funds will be used to advance TwoStep’s therapeutic pipeline, focusing on targeted cytotoxic drug delivery and immunotherapy for solid tumors.

Solid tumors represent about 90% of all cancers and have been difficult to treat due to the lack of suitable extracellular targets for effective treatment delivery. While targeted therapies have made significant progress in treating hematological malignancies, their success in solid tumors has been limited to small patient subsets with specific tumor markers. TwoStep Therapeutics aims to address this critical unmet need by developing a tumor-targeted approach that can treat a broader range of solid tumors.

“For the majority of solid tumors lacking well-defined targets, there are few precise treatment options and limited development of new modalities, which is a painful reality for many people with cancer,” said Caitlyn Miller, PhD, CEO and co-founder of TwoStep Therapeutics. “Our initial focus at TwoStep is to couple our tumor-targeting technology with clinically-validated payloads, which has the potential to extend the benefits of paradigm-shifting therapies to a greater number of patients.”

“NFX Bio backs scientist-founders creating ‘defensible magic’ for massive markets. Imagine one system that can target most solid tumors and deliver the exact treatment needed. It could mean many lives saved with one core technology platform,” said Omri Amirav-Drory, PhD, General Partner at NFX. “Caitlyn is a perfect example for a ‘scientist-founder’ and is surrounded with amazing scientific founders from Stanford including Jennifer Cochran, Ronald Levy, and Carolyn Bertozzi.”

TwoStep’s proprietary PIP agent enables targeted delivery to nearly any solid tumor by binding to multiple tumor-associated integrins. By binding with strong affinity to integrin conformations highly expressed on solid tumor tissue, the exposure to healthy tissue is minimized. The modular design of this tumor-targeting agent allows for modality-agnostic technology with tunable pharmacokinetics, compatible with various therapeutic payloads.

“In its compact form, PIP is a synthetic, ultra-stable peptide that has been engineered to localize and penetrate tumors – ideal properties for broad targeted therapy applications,” said Jennifer Cochran, PhD, co-founder of TwoStep Therapeutics and Professor of Bioengineering at Stanford University, whose laboratory first developed the PIP molecule. 

The development of TwoStep’s platform was driven by the combined expertise of its founding team in chemical biology, antibody-drug conjugates (ADCs), and immuno-oncology. The founders established in vivo proof of concept for its multi-targeted agent using various therapeutic payloads and fusion proteins in their academic labs and within the Stanford Innovative Medicines Accelerator (IMA). TwoStep is the first company to emerge from the IMA entrepreneur-in-residence program.

Caitlyn Miller, PhD, founded TwoStep Therapeutics in collaboration with world-renowned academic entrepreneurs affiliated with Stanford University, including Carolyn Bertozzi, PhD, Professor of Chemistry, Investigator at Howard Hughes Medical Institute and Nobel Laureate; Jennifer Cochran, PhD, Senior Associate Vice Provost for Research and Professor of Bioengineering; and Ronald Levy, MD, Professor of Medicine, Oncology. Dr. Miller is joined by Chief Business Officer Michael Ostrach and drug development and scientific advisor Robert Coffman, PhD, both veterans of Dynavax.

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