Oncology.

TTX335Dx and TTX335o

ProductTarget & MOAIndicationPreclinicalPh.1Ph.2aPh.2bPh.3Reg FilingReg ApprovalMilestones
Oncology
TTX335oLMTK3Ovarian Cancer
IND Enabling Studies 2025-2027
ProductBiomarkerIndicationProof of Concept & FeasibilityDesign & VerificationPivotalReg Filing & ApprovalLaunchMilestones
Companion Diagnostic Biomarker-FDA & EMA CE-IVD
TTX335DxUndisclosed
Biomarker
Ovarian Cancer
Screen & Therapy Response
Expanding screening of novel biomarker to more patient samples N=470 H1-2026 to H2-2027

Ovarian cancer remains one of the most aggressive and least understood diseases in women’s health. Despite decades of research, survival rates have seen little improvement. At Temple Therapeutics, we are addressing the fundamental reasons why progress has been so slow. Using validated biobanks, we have uncovered novel targets, early detection biomarkers and key receptors, holding promise for precision and targeted therapeutics and diagnostics.

1. Late and Difficult Detection.

Ovarian cancer develops quietly. Early symptoms are vague and easily mistaken for benign conditions. There are currently no reliable screening tools capable of detecting the disease at its earliest, most treatable stage. As a result, nearly 70% of women are diagnosed when the cancer has already spread, dramatically reducing survival outcomes.

2. High Recurrence and Resistance.

While many patients initially respond to platinum-based chemotherapy, most experience relapse within two years. Each recurrence brings diminishing returns as the cancer becomes increasingly resistant to treatment. Over time, this transforms ovarian cancer into a chronic, treatment-resistant condition with limited options.

3. Biological Complexity, Uniform Treatment.

Ovarian cancer is not a single disease—it comprises multiple subtypes, each driven by distinct molecular mechanisms. Yet, most patients receive similar chemotherapy regimens. This “one-size-fits-all” approach fails to address the biological diversity that drives poor outcomes and limits therapeutic innovation.

Our mission is to change this. Temple Therapeutics is advancing biology-driven therapies designed to overcome resistance, target the root causes of disease progression, and improve outcomes for women worldwide.

We believe the future of ovarian cancer care lies in precision, not probability—and we’re building it now.

Objective:

Bring novel molecule TTX335o and novel companion biomarker TTX335Dx targeting LMTK3 to phase 2 trials, either as a single agent or combination therapy, in subset of ovarian cancer patients who do not respond to current therapies, have recurrence or platinum sensitive.

Development Milestones

  • 2019 awarded prestigious Eureka Eurostars $3M grant for novel treatment for ovarian cancer
  • Target validated on well over 700+ ovarian patient samples via a validated biobank of ovarian cancers (all stages and subtype, including prognostic data, and full pathology completed)
  • Key biomarker identified which is tied to proposed mechanism
  • Molecule engineered, target binding confirmed with molecule, efficacy confirmed in various in-vitro and in-vivo (comparison to cisplatin) and replicated by three independent labs
  • Dose optimization ongoing (no toxicity observed at current high doses in-vivo).
  • Plans are to optimize molecule and enter IND enabling studies over next 18 months.
  • Six peer reviewed publications since 2023

“Research done by Saed et al showed compelling evidence positioning Lemur Tail Kinase 3 (LMTK3) as both a prognostic biomarker and a prospective novel therapeutic target in OC. The present study is the first to assess LMTK3’s prognostic value in patients with early-stage OC and its therapeutic potential in OC” — Molecular Therapy Oncology 

“From a therapeutic standpoint, the development of TTX335o that specifically target cancer cells without damaging normal tissues is particular promising, as it address a critical challenge in OC cancer treatment, maximizing efficacy while minimizing toxicity. Molecular Therapy Oncology” — Molecular Therapy Oncology

Overall, the study’s findings provide a solid foundation for the development of LMTK3-targeted therapies that could be used in combination with existing treatments to improve OC patient outcomes, especially in the context of chemoresistant disease.

 

References

  1. Ittner E, Swenson H, Werner L, Rönnerman EW, Mateoiu C, Kovács A, Dahm-Kähler P, Saed G, Karlsson P, Parris TZ, Helou K. Diagnostic and prognostic biomarkers associated with histotype in advanced epithelial ovarian cancer. Sci Rep. 2025 Oct 23;15(1):37171. doi: 10.1038/s41598-025-24938-0. PMID: 41131133; PMCID: PMC12550092.
  2. Swenson H, Ittner E, Werner L, Rönnerman EW, Mateoiu C, Kovács A, Dahm-Kähler P, Saed GM, Nemes S, Karlsson P, Parris TZ, Helou K. Integrative analysis of epigenetic and transcriptional interrelations identifies histotype-specific biomarkers in early-stage ovarian carcinoma. J Ovarian Res. 2025 May 19;18(1):103. doi: 10.1186/s13048-025-01676-5. PMID: 40390000; PMCID: PMC12087105.
  3. Saed GM, Fletcher NM, Sharma H, Tullberg AS, Ittner E, Parris TZ, Pettersson D, Kovács A, Rönnerman EW, Dahm-Kähler P, Portela A, Garzone PD, Morris R, Helou K. Lemur tail kinase 3 serves as a predictor of patient outcomes and a target for the treatment of ovarian cancer. Mol Ther Oncol. 2024 Aug 26;32(3):200864. doi: 10.1016/j.omton.2024.200864. PMID: 39290318; PMCID: PMC11406030.
  4. Saed GM, Nawaz A, Alvero AA, Harper AK, Morris RT. Monomeric myeloperoxidase is a specific biomarker for early-stage ovarian cancer. Biomarkers. 2023 Dec;28(7):663-671. doi: 10.1080/1354750X.2023.2284106. Epub 2023 Dec 11. PMID: 37982229.
  5. Harper AK, Kirsch-Mangu TK, Lutfi H, Morris RT, Saed GM. Binding of Intracellular Myeloperoxidase to αV/β1 Integrin Serves as a Mechanism of Survival in Epithelial Ovarian Cancer. Reprod Sci. 2023 Jan;30(1):291-300. doi: 10.1007/s43032-022-01025-7. Epub 2022 Jul 7. PMID: 35799017.
 

“Tissue fibrosis causes adhesions which are a big problem, and we would use this drug in every procedure.”

Dr. Rudy Leon De Wilde

References

  1. Ittner E, Swenson H, Werner L, Rönnerman EW, Mateoiu C, Kovács A, Dahm-Kähler P, Saed G, Karlsson P, Parris TZ, Helou K. Diagnostic and prognostic biomarkers associated with histotype in advanced epithelial ovarian cancer. Sci Rep. 2025 Oct 23;15(1):37171. doi: 10.1038/s41598-025-24938-0. PMID: 41131133; PMCID: PMC12550092.
  2. Swenson H, Ittner E, Werner L, Rönnerman EW, Mateoiu C, Kovács A, Dahm-Kähler P, Saed GM, Nemes S, Karlsson P, Parris TZ, Helou K. Integrative analysis of epigenetic and transcriptional interrelations identifies histotype-specific biomarkers in early-stage ovarian carcinoma. J Ovarian Res. 2025 May 19;18(1):103. doi: 10.1186/s13048-025-01676-5. PMID: 40390000; PMCID: PMC12087105.
  3. Saed GM, Fletcher NM, Sharma H, Tullberg AS, Ittner E, Parris TZ, Pettersson D, Kovács A, Rönnerman EW, Dahm-Kähler P, Portela A, Garzone PD, Morris R, Helou K. Lemur tail kinase 3 serves as a predictor of patient outcomes and a target for the treatment of ovarian cancer. Mol Ther Oncol. 2024 Aug 26;32(3):200864. doi: 10.1016/j.omton.2024.200864. PMID: 39290318; PMCID: PMC11406030.
  4. Saed GM, Nawaz A, Alvero AA, Harper AK, Morris RT. Monomeric myeloperoxidase is a specific biomarker for early-stage ovarian cancer. Biomarkers. 2023 Dec;28(7):663-671. doi: 10.1080/1354750X.2023.2284106. Epub 2023 Dec 11. PMID: 37982229.
  5. Harper AK, Kirsch-Mangu TK, Lutfi H, Morris RT, Saed GM. Binding of Intracellular Myeloperoxidase to αV/β1 Integrin Serves as a Mechanism of Survival in Epithelial Ovarian Cancer. Reprod Sci. 2023 Jan;30(1):291-300. doi: 10.1007/s43032-022-01025-7. Epub 2022 Jul 7. PMID: 35799017.