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Details:
L1-79 (DL-alpha-Methyltyrosine) is a tyrosine hydroxylase inhibitor which is under phase 2 clinical development . It is designed to improve the core socialization and communication symptoms of autism spectrum disorder (ASD).
Lead Product(s): Methyltyrosine
Therapeutic Area: Neurology Product Name: L1-79
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 20, 2023
Details:
SM-88 (racemetyrosine) is an orally administered cancer metabolism-based therapy that is chemically altered to be non-functional for fundamental tumor cell processes, including protein synthesis.
Lead Product(s): Methyltyrosine,Methoxsalen,Phenytoin
Therapeutic Area: Oncology Product Name: SM-88
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Syros Pharmaceuticals
Deal Size: $130.0 million Upfront Cash: Undisclosed
Deal Type: Private Placement September 16, 2022
Details:
In the merger, Syros expects to issue approximately 74.3 million shares of its common stock to TYME stockholders to acquire TYME’s pipeline including SM-88 (D/L-alpha-metyrosine).
Lead Product(s): Methyltyrosine,Methoxsalen,Phenytoin
Therapeutic Area: Oncology Product Name: SM-88
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Syros Pharmaceuticals
Deal Size: $60.0 million Upfront Cash: Undisclosed
Deal Type: Merger July 05, 2022
Details:
The results that SM-88 alone showed antiproliferative effects in each of the sensitive and resistant cells lines, and that the combination of SM-88 and MPS had an additive effect in these models.
Lead Product(s): Methyltyrosine,Methoxsalen,Phenytoin
Therapeutic Area: Oncology Product Name: SM-88
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 09, 2022
Details:
SM-88 (D/L-alpha-metyrosine), with MPS arm of Phase 2/3 platform trial in metastatic pancreatic cancer discontinued for futility on primary endpoint of overall survival.
Lead Product(s): Methyltyrosine,Methoxsalen,Phenytoin
Therapeutic Area: Oncology Product Name: SM-88
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 26, 2022
Details:
As part of investment in Yamo to support a Phase 2 study of L1-79 in adolescents and adults with ASD. L1-79, the company’s lead candidate, is a tyrosine hydroxylase inhibitor designed to modulate the catecholaminergic pathways implicated in ASD.
Lead Product(s): Methyltyrosine
Therapeutic Area: Neurology Product Name: L1-79
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: The Autism Impact Fund
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Financing November 10, 2021
Details:
SM-88 is an oral investigational modified proprietary tyrosine derivative that interrupt the metabolic processes of cancer cells by breaking down the cells’ key defenses and leading to cell death through oxidative stress and exposure to the body’s natural immune system.
Lead Product(s): Methyltyrosine,Methoxsalen,Phenytoin
Therapeutic Area: Oncology Product Name: SM-88
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 26, 2021
Details:
The study demonstrated that SM-88 had promising efficacy and safety outcomes for prostate cancer patients while sparing testosterone. The study also demonstrated a reduction of CTCs that may prove to be a better surrogate for patient outcomes than PSA, particularly for SM-88.
Lead Product(s): Methyltyrosine,Methoxsalen,Phenytoin
Therapeutic Area: Oncology Product Name: SM-88
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 15, 2020
Details:
The interim futility review of company's HopES Sarcoma Phase II clinical trial for SM-88 was completed in late July and, based on the analysis of the data and recommendations of Dr. Sant Chawla, the study will proceed with the current trial design as planned.
Lead Product(s): Methyltyrosine,Methoxsalen,Phenytoin
Therapeutic Area: Oncology Product Name: SM-88
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 11, 2020
Details:
SM-88 has demonstrated encouraging tumor responses in 15 different cancers across four separate studies with minimal serious grade 3 or higher adverse events .
Lead Product(s): Methyltyrosine,Methoxsalen,Phenytoin
Therapeutic Area: Oncology Product Name: SM-88
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 03, 2020
Details:
TYME-88-Panc pivotal trial enrolling patients using oral SM-88 as a potential treatment for third-line pancreatic cancer.
Lead Product(s): Methyltyrosine,Methoxsalen,Phenytoin
Therapeutic Area: Oncology Product Name: SM-88
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 13, 2020
Details:
Oral SM-88 is designed to selectively disrupt cancer’s metabolic process and cause cancer cell death; SM-88 is currently in a pivotal trial for 3rd-line pancreatic cancer. Preclinical data shows statistically significant tumor reduction in SM-88 treated arms versus controls.
Lead Product(s): Methyltyrosine,Methoxsalen,Phenytoin
Therapeutic Area: Oncology Product Name: SM-88
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 22, 2020
Details:
Lead pipeline investigational compound, SM-88, represents a new approach designed to selectively disrupt cancers metabolic process leading to cancer cell death SM-88 has demonstrated clinical responses in 15 different cancer types across four separate studies.
Lead Product(s): Methyltyrosine
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 28, 2020
Details:
Preclinical data suggests multiple mechanisms of action for SM-88, including an increase in reactive oxygen species, alterations in autophagy and immunomodulation.
Lead Product(s): Methyltyrosine
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 15, 2020
Details:
The collaboration leverages combined capabilities of Tyme Technologies and Eagle Pharmaceuticals to maximize potential of oral SM-88 by advancing pivotal trials and commercialization.
Lead Product(s): Methyltyrosine
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Eagle Pharmaceuticals
Deal Size: $40.0 million Upfront Cash: $20.0 million
Deal Type: Collaboration January 07, 2020