TYME-18 / Syros - LARVOL DELTA

TYME Provides Business Update and Announces Preliminary First Quarter Fiscal 2021 Financial and Operating Results (Businesswire) - "Anticipated Upcoming Key Events: TYME currently expects the following key events in calendar year 2020: Continue to advance enrollment in TYME-88-Panc pivotal study; Continue to advance enrollment in PanCAN’s Precision PromiseSM adaptive randomized Phase II/III registration-intent trial in patients with pancreatic cancer using oral SM-88 in second-line monotherapy."

Enrollment status • Oncology • Pancreatic Cancer

[VIRTUAL] In vivo mouse model data demonstrating reduction in tumor cell proliferation following intratumoral administration of TYME 18 (AACR-II 2020) - "TYME-18 demonstrated a significant difference between treated and untreated animals (see Tables 1, 2, 3). A minor reduction in tumor cell mass was observed in response to the surfactant, with the greatest response (ANOVA p=.001) observed in the TYME-18 (surfactant + TUDCA) (table 2). The local administration of an ambiphilic steroid acid along with surfactants, impeded the ability of tumors to increase in size. Both the surfactants and the ambiphilc steroid acid contributed to this effect with an apparent synergistic effect.Aside from the physical chemical acid effect on tissue, ambiphilic steroid acids are now recognized as important regulators of energy metabolism."

Preclinical • Oncology • IR

TYME-18 Demonstrates Anti-Cancer Effect in New Preclinical Data Presented at AACR 2020 (Businesswire) - "Preclinical animal studies demonstrated TYME-18’s potential to dramatically shrink and/or resolve tumors. TYME-18 treatment resulted in a 91.6% (11/12) complete resolution of established tumors within two weeks. Novel mechanism of action contributes to a strong anti-cancer effect while minimizing systemic and local toxicity…'TYME-18’s preclinical development is ongoing with the goal of identifying an IND pathway during 2020'…None of the mice in the control or surfactant alone group achieved tumor-free status, although 25% (3/12) of the surfactant alone group had tumor shrinkage from baseline. Results from this study replicate and confirm observations in preliminary TYME-18 studies. While not a primary focus of the preclinical studies, TYME-18 did not show local or systemic toxicities in treated mice."

IND • Preclinical • Oncology

TYME announces abstracts selected for presentation at the American Association for Cancer Research, AACR 2020 (Businesswire) - "Tyme Technologies...announced that two posters will be presented at the American Association for Cancer Research (AACR) 2020 Virtual Meeting to be held from June 22 to June 24, 2020. TYME’s presentations include findings from preclinical data on two CMBTs: SM-88 and TYME-18....The first abstract describing SM-88 showed that mice receiving SM-88 monotherapy demonstrated significantly reduced tumor size as compared to control mice. The preclinical data suggest SM-88 monotherapy increases oxidative stress from reactive oxygen species (ROS) and interferes with autophagy, an important survival mechanism utilized by cancer cells....Separately, new data will be presented for TYME’s CMBT compound, TYME-18. TYME-18 is designed for intra-tumoral administration of difficult to treat tumors and leverages the acidic tumor microenvironment and signaling pathways to kill cancer cells."

Preclinical • Breast Cancer • Lung Cancer • Lymphoma • Oncology • Pancreatic Cancer • Prostate Cancer • Sarcoma

Tyme announces fourth quarter and fiscal year 2020 financial and operating results (Businesswire) - "Anticipated Upcoming Key Events: TYME currently expects the following key events in calendar year 2020: Present preclinical data for SM-88 and TYME-18 at AACR 2020, Advance enrollment in TYME-88-Panc pivotal study, Advance enrollment in the HopES Sarcoma Phase II Trial, Advance enrollment in PanCAN’s Precision PromiseSM adaptive randomized Phase II/III registration-intent trial in patients with pancreatic cancer using oral SM-88 in second-line monotherapy, Publish final data for SM-88 Phase II prostate study, Initiate plans for SM-88 clinical programs into other tumor types potentially including metastatic breast, recurrent prostate and/or hematological cancers, Present and/or publish final data from Part 1 of TYME-88-Panc study, Continue proof-of-concept and IND-enabling activities for TYME-18."

Enrollment status • IND • New trial • P2 data • Preclinical • Breast Cancer • Genito-urinary Cancer • Hematological Malignancies • Oncology • Prostate Cancer • Solid Tumor

TYME announces third quarter fiscal 2020 financial and operating results (GlobeNewswire) - "Second half of calendar 2020: Publish SM-88 Phase II prostate study; Advance SM-88 clinical programs into other tumor types potentially including metastatic breast, recurrent prostate and/or hematological cancers; Advance PanCAN’s Precision Promise^SM adaptive Phase II/III trial evaluating SM-88 in patients with first-line pancreatic cancer in combination with gemcitabine and Abraxane; Present and/or publish final data from Part 1 of TYME-88-Panc study; Complete enrollment in TYME-88-Panc pivotal study; Advance plans for TYME-18 IND program"

Enrollment status • IND • P2 data • P2/3 data • Trial status

TYME announces third quarter fiscal 2020 financial and operating results (GlobeNewswire) - "First half of calendar 2020:...Present preclinical data for SM-88; Advance enrollment in TYME-88-Panc pivotal study and the HopES Phase II Trial; Initiate enrollment in PanCAN’s Precision Promise^SM adaptive randomized Phase II/III registration-intent trial in patients with pancreatic cancer using oral SM-88 in second-line monotherapy; Present preclinical data for TYME-18"

Enrollment status • Preclinical