GPC3

SAN DIEGO and AUSTIN, Texas and HAMILTON, ON, Feb. 5, 2024 /PRNewswire/ -- Triumvira Immunologics, a clinical-stage company developing novel, targeted autologous and allogeneic T cell therapeutics that co-opt the natural biology of T cells to treat patients with solid tumors, today announced that the first patient has been dosed in its TACTIC-3 trial, a Phase I/II study, (NCT05862324) investigating the safety and efficacy of autologous TAC-T cell asset, TAC101-CLDN18.2, targeting Claudin 18.2+ solid tumors. TAC101-CLDN18.2 is a novel cell therapy based on genetically engineered autologous T cells expressing a T-cell Antigen Coupler (TAC) that harnesses the inherent signaling pathways of the native T cell receptor complex and targets Claudin 18.2, an epithelial transmembrane protein overexpressed in gastric cancer and several other solid tumor types. "Claudin 18.2 is a promising target for cell therapy," said Andreas Bader, Ph.D., Chief Scientific Officer of Triumvira Immunologics. "Among normal tissues, it is restricted to the stomach and hidden between neighboring cells. In gastric cancer and a few other solid tumors, however, it is accessible and abundantly expressed on tumor cell surfaces and, therefore, it represents a significant tumor selective opportunity to address these types of cancers." "We are delighted to initiate this study at such a pivotal moment for Triumvira as we advance an exciting clinical program aimed at addressing a substantial therapeutic gap for solid tumors," said Deyaa Adib, M.D., Chief Medical Officer of Triumvira Immunologics. "TAC101-CLDN18.2 represents a unique new therapy in our pipeline that has the potential to provide a new therapeutic solution for CLDN18.2 positive solid tumors including gastric, lung, ovarian and pancreatic cancers. There are currently no other approved treatment options against CLDN18.2, and novel therapeutics in development, such as TAC101-CLDN18.2, offer hope to a patient segment that constitutes ~40% of the gastric cancer population in the U.S. alone. Through our TAC technology, which harnesses the inherent signaling pathways of native TCRs, we aspire to bring forward innovative, chemotherapy-sparing therapeutic strategies for solid tumors." TACTIC-3 is a first-in-human study investigating TAC101-CLDN18.2 to evaluate the safety, recommended Phase II dose (RP2D), pharmacokinetic profile, and efficacy in subjects with CLDN18.2+ solid tumors who have been treated with at least 2 lines of prior therapy in Phase I and between 2-4 lines of prior therapy in Phase II. In each phase, subjects with pancreatic ductal adenocarcinoma may have been treated with 1 line of prior antineoplastic therapy. In addition, subjects who are being treated with the current lines of therapy with no demonstrated benefit may also be eligible on the condition that no measurable disease was reported at baseline as a starting reference point. About Triumvira Immunologics Triumvira Immunologics, Inc. ("Triumvira") is a leading clinical-stage solid tumor cell therapy company developing unique, non-gene edited, first-in-class targeted autologous and allogeneic T cell therapeutics that co-opt the natural biology of T cells to treat patients with solid tumors. The company's proprietary T cell Antigen Coupler (TAC) technology platform activates natural T cell functions differently from other cell therapies such as CAR-T and engineered T cell receptor (TCR) therapies, resulting in clinically safe, effective, and re-dosable cell therapies. Triumvira is developing a pipeline targeting promising tumor-associated antigens such as Claudin 18.2, HER2, GUCY2C and GPC3. Triumvira has operations in San Diego, CA, Austin, Texas, and Hamilton, Ontario. For more information, visit us at or follow us on LinkedIn and X. Media Contact David Schull or Ignacio Guerrero-Ros, Ph.D. Russo Partners 858-717-2310 646-942-5604 [email protected] [email protected] SOURCE Triumvira Immunologics

Takeda’s pipeline cull affected assets outside of oncology. Takeda’s vision of becoming a leader in oncology ran into more trouble Thursday when the drugmaker axed (PDF) a midphase immunocytokine and three early-stage CAR-T cell therapy prospects from its R&D pipeline. Under CEO Christophe Weber, Takeda has worked to establish itself as a leader in oncology. But, as the executive said on a quarterly results call with investors, the company has “had some wins ... [and] some setbacks.” The results brought news of more setbacks, with Takeda using the update to reveal it has dropped a clutch of cancer candidates led by modakafusp alfa. Formerly known as TAK-573, modakafusp alfa consists of two interferon alpha-2b molecules fused to an anti-CD38 monoclonal antibody. The idea was to activate innate and adaptive immune cells—while also directly stopping the proliferation of multiple myeloma cells—through targeted interferon signaling. Takeda began a phase 1/2a Darzalex combination trial one year ago, adding to the slate of studies run in support of the immunocytokine, but has now pulled the plug on the program. Andrew Plump, M.D., Ph.D., president of R&D at Takeda, explained the decision on the conference call with investors.  “This is a strategic decision based on a number of factors, including the existing data set, the rapidly evolving multiple myeloma treatment landscape and the long development timelines,” the R&D chief said.  Takeda pushed modakafusp alfa out of the door as part of a pipeline clear-out that also hit three phase 1 autologous CAR-T candidates. Two of the prospects, GPC3-targeted TAK-102 and mesothelin-directed TAK-103, were in development in solid tumors. The third asset, TAK-940, was a CD19-directed, Memorial Sloan Kettering Cancer Center-partnered program that used the 1XX domain to try to enhance efficacy.