On June 25, 2024 TwoStep Therapeutics, a biotechnology company developing new targeted therapeutics for solid tumors, reported its official launch following a successful $6.5 million seed round led by NFX, with participation from other investors including 2048 Ventures, Alexandria Venture Investments, Cooley’s affiliated fund GC&H Investments, and the family office of the founder of Arcadia Investment Partners (Press release, TwoStep Therapeutics, JUN 25, 2024, View Source [SID1234644544]). Proceeds from the financing will be used to advance TwoStep’s therapeutic pipeline of solid tumor-targeting therapies, with an initial focus on targeted cytotoxic drug delivery and immunotherapy.
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Solid tumors, which account for approximately 90% of all cancers, have been historically challenging to treat due to a scarcity of extracellular targets that meet the criteria for effective treatment delivery. While tumor-targeted therapies have begun to transform the treatment paradigm for hematological malignancies, their viability in solid tumors has been limited to small subsets of patients with high levels of specific tumor markers. This presents a critical unmet need – and vast therapeutic opportunity – to develop a tumor-targeted approach that can viably treat the majority 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 focusat 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 unique PIP agent enables targeted delivery to virtually any solid tumor by binding multiple tumor-associated integrins. Additionally, by binding with strong affinity to integrin conformations that are highly expressed on solid tumor tissue, exposure to healthy tissue is minimized. The modular design of this tumor-targeting agent makes for a modality-agnostic technology with tunable pharmacokinetics, compatible with a diversity of 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.
Development of TwoStep’s solid tumor-focused 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 of its multi-targeted agent using various therapeutic payloads and fusion proteins in the academic labs of its co-founders, and later within the Stanford Innovative Medicines Accelerator (IMA). It 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. As CEO Dr. Miller is joined by Chief Business Officer Michael Ostrach and drug development and scientific advisor Robert Coffman, PhD, both veterans of Dynavax.