{"id":3040,"date":"2026-09-09T07:00:00","date_gmt":"2026-09-09T11:00:00","guid":{"rendered":"https:\/\/www.insilens.com\/?p=3040"},"modified":"2026-09-10T19:57:36","modified_gmt":"2026-09-10T23:57:36","slug":"twostep-raises-62-5-million-as-ts-104-clears-ind","status":"publish","type":"post","link":"https:\/\/www.insilens.com\/?p=3040","title":{"rendered":"TwoStep Raises $62.5 Million as TS-104 Clears IND"},"content":{"rendered":"

Evidence<\/strong> Company disclosure · Discovery<\/strong> September 10, 2026 · Importance<\/strong> 4\/5 · Direction<\/strong> Positive<\/p>\n

\"TwoStep<\/p>\n

Summary<\/h4>\n

TwoStep Therapeutics closed an oversubscribed $62.5 million Series A and received FDA clearance to begin first-in-human testing of TS-104, a peptide-drug conjugate designed to bind five tumor-associated integrins. The financing funds Phase I development, a radioligand program and additional conjugates. The combined capital and IND clearance move the company into clinical translation, but neither event establishes tumor-selective delivery or therapeutic margin in patients.<\/p>\n

What Happened<\/h4>\n

Insight Partners and Medical Excellence Capital led the round; M Ventures and Pfizer Ventures co-led, with participation from existing investors NFX and 2048 Ventures and from Stanford University. TwoStep reported total capital raised of $71.2 million. TS-104 links a polyspecific integrin-binding knottin peptide to monomethyl auristatin E through a cleavable linker. The company expects to enroll the first Phase I participants with solid tumors later in 2026. Proceeds are also intended to advance a radioligand program and next-generation peptide conjugates; valuation, financing terms, runway and the development budget allocated to each program were not disclosed.<\/p>\n

Deep Analysis<\/h4>\n

Polyspecificity may broaden tumor coverage:<\/strong> Mechanism novelty lies in using one compact ligand to recognize αvβ1, αvβ3, αvβ5, αvβ6 and α5β1, potentially reducing escape caused by heterogeneous expression of any single integrin. Preclinical activity across cell- and patient-derived models and IND clearance support clinical testing. Against it, integrins are also present in normal and remodeling tissues; human active-conformation selectivity, biodistribution, payload release and dose margin have not been demonstrated.<\/p>\n

Financing buys time to test the targeting premise:<\/strong> The quality and breadth of the investor syndicate support resource availability, but participation is not independent validation of efficacy. A small peptide may offer rapid tumor penetration and clearance relative to antibodies, but those properties can also shorten tumor exposure and increase kidney or normal-tissue burden. The first clinical pharmacokinetic, imaging and toxicity data will be more informative than the round size.<\/p>\n

Signal Extraction<\/h4>\n

Verified facts: $62.5 million Series A; named lead and co-lead investors; FDA IND clearance; planned Phase I start in 2026; total capital raised of $71.2 million. Missing facts: valuation, runway, TS-104 dose range, quantitative human dosimetry plan and radioligand candidate identity. Upgrade evidence would be tumor-selective human exposure with on-target pharmacodynamics, manageable MMAE toxicities and responses across integrin-heterogeneous tumors.<\/p>\n

Company and Product Background<\/h4>\n

TwoStep Therapeutics is a Stanford-origin biotechnology company developing peptide-based targeted therapeutics. TS-104 is its first peptide-drug conjugate and uses a knottin scaffold linked to the microtubule toxin MMAE.<\/p>\n

The company’s broader platform is intended to support cytotoxic and radiopharmaceutical payloads for solid tumors with heterogeneous integrin expression. Translational risk centers on whether a compact, polyspecific ligand can achieve tumor-selective exposure without unacceptable normal-tissue uptake.<\/p>\n

InSilens Take<\/h4>\n

The combined financing and IND clearance make this a meaningful platform-transition signal. Direction is positive for execution capacity, while the therapeutic interpretation remains provisional. TS-104 must show that broader binding improves clinically useful delivery rather than merely expanding normal-tissue interactions.<\/p>\n

Signal Assessment<\/h4>\n\n\n\n\n\n
Signal Importance<\/strong><\/td>\n4 \/ 5 — a well-syndicated Series A paired with IND clearance for a novel polyspecific integrin-targeted conjugate<\/td>\n<\/tr>\n
Signal Direction<\/strong><\/td>\nPositive — materially improves execution capacity and advances a defined Phase I plan<\/td>\n<\/tr>\n
Confidence in Facts<\/strong><\/td>\nHigh — round size, investors and IND clearance disclosed by the company<\/td>\n<\/tr>\n
Confidence in Interpretation<\/strong><\/td>\nModerate-low — human selectivity, biodistribution and dose margin remain untested<\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

TwoStep Therapeutics closed an oversubscribed $62.5 million Series A and received FDA clearance to begin first-in-human testing of TS-104, a peptide-drug conjugate designed to bind five tumor-associated integrins. The financing funds Phase I development,…<\/p>\n","protected":false},"author":1,"featured_media":3044,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[2],"tags":[698,697,696,695],"class_list":["post-3040","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-deals-and-financing","tag-integrin","tag-peptide-drug-conjugate","tag-ts-104","tag-twostep-therapeutics"],"blocksy_meta":[],"_links":{"self":[{"href":"https:\/\/www.insilens.com\/index.php?rest_route=\/wp\/v2\/posts\/3040","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.insilens.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.insilens.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.insilens.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.insilens.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=3040"}],"version-history":[{"count":1,"href":"https:\/\/www.insilens.com\/index.php?rest_route=\/wp\/v2\/posts\/3040\/revisions"}],"predecessor-version":[{"id":3060,"href":"https:\/\/www.insilens.com\/index.php?rest_route=\/wp\/v2\/posts\/3040\/revisions\/3060"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.insilens.com\/index.php?rest_route=\/wp\/v2\/media\/3044"}],"wp:attachment":[{"href":"https:\/\/www.insilens.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=3040"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.insilens.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=3040"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.insilens.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=3040"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}