SORT1

Theratechnologies Announces Dosing of First Patient in Updated Clinical Trial of Sudocetaxel Zendusortide in Advanced Ovarian Cancer

Retrieved on: 
Thursday, October 12, 2023
Senior, TSX, Food, SORT1, American Society of Clinical Oncology, Society, Safety, FDA, Ovarian cancer, Food and Drug Administration, FACOG, Patient, Gynecologic Oncology (journal), Phase 1, PDC, Pharmaceutical industry

Sudocetaxel zendusortide is an investigational, first-in-class peptide-drug conjugate (PDC) that targets the sortilin (SORT1) receptor and expedites the internalization and delivery of a cytotoxic payload directly into cancer cells.

Key Points: 
  • Sudocetaxel zendusortide is an investigational, first-in-class peptide-drug conjugate (PDC) that targets the sortilin (SORT1) receptor and expedites the internalization and delivery of a cytotoxic payload directly into cancer cells.
  • “We are excited to dose the first of six patients in Part 3 of the Phase 1 trial of sudocetaxel zendusortide with its modified design and dosing regimen,” said Christian Marsolais, Ph.D., Senior Vice President and Chief Medical Officer at Theratechnologies.
  • The revised protocol is designed to improve the therapeutic window of sudocetaxel zendusortide and extend its duration of therapy.
  • It includes weekly administration and also narrows the patient population to focus on individuals with high-grade serous ovarian cancer, including high-grade peritoneal or fallopian tube cancer, or high-grade endometrioid cancer - a population in which sudocetaxel zendusortide has demonstrated preliminary efficacy.

Theratechnologies Reports Second Quarter 2023 Financial Results and Business Updates

Retrieved on: 
Wednesday, July 12, 2023
ACT, Part 1, Triple-negative breast cancer, TNBC, Index, Probability, HIV, VL, Pharmacy, Part, Diabetic neuropathy, DLT, Weakness, BOR, ART, Research, Observation, ASCO, Synthetic control method, EBITDA, Endometrial cancer, Patient, Treatment, Marathon Asset Management, Part Two, Viral load, MTD, SMR, Growth, Diagnosis, Toxic leukoencephalopathy, R, CD4, Ovarian cancer, American Conference, Hand, Conference, SD, Disease, PR, Safety, Prostate cancer, SORT1, Fine chemical, Pharmaceutical industry, Vaccine

For the second quarter of fiscal 2023, net sales of EGRIFTA SV® were $10,853,000 compared to $11,416,000 in the second quarter of fiscal 2022, representing a decrease of 4.9% year-over-year.

Key Points: 
  • For the second quarter of fiscal 2023, net sales of EGRIFTA SV® were $10,853,000 compared to $11,416,000 in the second quarter of fiscal 2022, representing a decrease of 4.9% year-over-year.
  • Trogarzo® net sales in the second quarter of fiscal 2023 amounted to $6,696,000 compared to $7,852,000 for the same quarter of 2022, representing a decrease of 14.7% year-over-year.
  • We ended the second quarter of fiscal 2023 with $25,369,000 in cash, bonds and money market funds.
  • In the second quarter of fiscal 2023, changes in operating assets and liabilities had a positive impact on cash flow of $4,643,000 (2022-positive impact of $10,701,000).

Theratechnologies June 13 Oncology Investigator Call to Update Investors & Analysts on Phase 1 Sudocetaxel Zendusortide Trial

Retrieved on: 
Monday, June 12, 2023
American Society of Clinical Oncology, ASCO, PDC, TSX, FDA, Society, Food, SORT1, Pharmaceutical industry

During the call, Theratechnologies will provide insights on preliminary Phase 1 safety and efficacy data that were presented at the 2023 annual meeting of the American Society of Clinical Oncology (ASCO), as well as the U.S. Food and Drug Administration’s (FDA) recent agreement to the Company’s amended Phase 1 trial protocol.

Key Points: 
  • During the call, Theratechnologies will provide insights on preliminary Phase 1 safety and efficacy data that were presented at the 2023 annual meeting of the American Society of Clinical Oncology (ASCO), as well as the U.S. Food and Drug Administration’s (FDA) recent agreement to the Company’s amended Phase 1 trial protocol.
  • Both events are significant milestones in the development of sudocetaxel zendusortide, a PDC that targets the sortilin (SORT1) receptor, and a product of Theratechnologies’ SORT1+ Technology™ platform.
  • Paul Lévesque, President and Chief Executive Officer of Theratechnologies, will host the call, which will feature presentations from the Company’s Senior Vice President and Chief Medical Officer, Christian Marsolais, Ph.D., as well as from investigators from the Phase 1 trial.
  • Oncology Investigator Call for Investors & Analysts: Phase 1 Trial Update

Theratechnologies Receives FDA Agreement to Amended Trial Protocol for its Lead PDC Candidate Sudocetaxel Zendusortide

Retrieved on: 
Friday, June 2, 2023
Senior, American Society of Clinical Oncology, DLT, Toxicity, Part, EDT, ASCO, PDC, Patient, Lifting, TSX, FDA, Ovarian cancer, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, News, Society, Food, Safety, Body surface area, SORT1, Pharmaceutical industry

Today’s announcement also marks the lifting of the FDA’s partial clinical hold on the Phase 1 trial, following the Company’s voluntary pause of patient recruitment in December 2022.

Key Points: 
  • Today’s announcement also marks the lifting of the FDA’s partial clinical hold on the Phase 1 trial, following the Company’s voluntary pause of patient recruitment in December 2022.
  • In May 2023, Theratechnologies filed the amended trial protocol, which is designed to improve the therapeutic window of sudocetaxel zendusortide and extend its duration of therapy.
  • If deemed safe (0 or 1 DLT), the trial will enroll an additional six patients at the 2.5 mg/kg dose.
  • Those preliminary safety and efficacy data, which can be found here , informed the FDA-approved amended protocol.

Theratechnologies to Present Preliminary Safety and Efficacy Data from Phase 1 Trial of Sudocetaxel Zendusortide in Heavily Pretreated Cancer Patients at ASCO 2023

Retrieved on: 
Thursday, May 25, 2023
Part 1, Triple-negative breast cancer, TNBC, Index, Senior, SORT1, Part, American Society of Clinical Oncology, Diabetic neuropathy, Conjugation, BOR, MD Anderson Cancer Center, ASCO, Endometrial cancer, PDC, Patient, University, Part Two, TSX, MTD, Diagnosis, Toxic leukoencephalopathy, CDT, FDA, Therapy, Ovarian cancer, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Society, SD, Food, PR, Safety, Prostate cancer, Pharmaceutical industry, Dietary supplement

Based on the results presented at ASCO, Theratechnologies is engaged with the U.S. Food and Drug Administration (FDA) to amend the protocol of the Phase 1 clinical trial of sudocetaxel zendusortide.

Key Points: 
  • Based on the results presented at ASCO, Theratechnologies is engaged with the U.S. Food and Drug Administration (FDA) to amend the protocol of the Phase 1 clinical trial of sudocetaxel zendusortide.
  • The amendments are designed to improve the therapeutic window and allow for more prolonged therapy with sudocetaxel zendusortide, reflecting changes in patient selection and evaluation of alternative dosing regimens.
  • “The early efficacy data for our lead peptide-drug conjugate, sudocetaxel zendusortide, confirm that it rapidly internalizes and hyper-targets delivery of cytotoxic payload directly into cancer cells,” said Christian Marsolais, Ph.D., Senior Vice President and Chief Medical Officer at Theratechnologies.
  • The starting dose of 30 mg/m2 every 3 weeks (Q3W) was selected based on sudocetaxel zendusortide preclinical data.

Theratechnologies Data Presentations at AACR 2023 Showcase Potential of Sudocetaxel Zendusortide as a Single Agent and in Combination with other Anticancer Therapies

Retrieved on: 
Tuesday, April 18, 2023
Docetaxel, TNBC, Tumor-associated macrophage, AACR, Senior, Neoplasm, Trastuzumab, Survival, American Association for Cancer Research, Research, Cell, Immunotherapy, IHC, Next, PDC, Patient, Melanoma, TSX, MTD, Immunohistochemistry, Mouse, PD-L1, Tumor microenvironment, Breast cancer, SORT1, Pharmaceutical industry, Medical imaging

The new data were presented in poster sessions at the 2023 annual meeting of the American Association for Cancer Research (AACR) in Orlando, Fla.

Key Points: 
  • The new data were presented in poster sessions at the 2023 annual meeting of the American Association for Cancer Research (AACR) in Orlando, Fla.
  • Furthermore, sudocetaxel zendusortide generated superior activity in comparison to a combination of Herceptin and docetaxel in the HER2+ Herceptin-resistant tumor model.
  • “Collectively our three AACR poster presentations reinforce the potential of sudocetaxel zendusortide, on its own and in combination, to enable targeted delivery of anticancer therapy.
  • Next, the researchers halved the doses of sudocetaxel zendusortide and docetaxel and combined each agent with an anti-PD-L1 checkpoint inhibitor.

Theratechnologies to Present Preclinical Data at AACR Demonstrating Synergy Between TH1902 and Anti-PD-L1 Immunotherapy in Cold Tumor Model

Retrieved on: 
Tuesday, March 14, 2023
Poster, PDC, TSX, AACR, Triple-negative breast cancer, American Association for Cancer Research, SORT1, Senior, Patient, PD-L1, Melanoma, Breast, TNBC, Eastern Time Zone, Medical imaging

The new data, to be presented in three poster sessions at the 2023 annual meeting of the American Association for Cancer Research (AACR) being held April 14-19 in Orlando, Fla., highlight a synergistic effect of sudocetaxel zendusortide in combination with programmed death-ligand 1 (PD-L1), checkpoint inhibitor therapy in a melanoma mouse model; high expression of the sortilin (SORT1) receptor in multiple tumor types compared to healthy tissues; and the rationale for using sudocetaxel zendusortide as a potential therapeutic approach in SORT1-positive triple-negative breast cancer (TNBC) and HER2-positive breast cancers.

Key Points: 
  • The new data, to be presented in three poster sessions at the 2023 annual meeting of the American Association for Cancer Research (AACR) being held April 14-19 in Orlando, Fla., highlight a synergistic effect of sudocetaxel zendusortide in combination with programmed death-ligand 1 (PD-L1), checkpoint inhibitor therapy in a melanoma mouse model; high expression of the sortilin (SORT1) receptor in multiple tumor types compared to healthy tissues; and the rationale for using sudocetaxel zendusortide as a potential therapeutic approach in SORT1-positive triple-negative breast cancer (TNBC) and HER2-positive breast cancers.
  • “We are particularly encouraged by the potential synergistic activity of sudocetaxel zendusortide when combined with an anti-PD-L1 checkpoint inhibitor in a melanoma model,” said Christian Marsolais, Ph.D., Senior Vice President and Chief Medical Officer of Theratechnologies.
  • “Our new data continue to support the clinical development of sudocetaxel zendusortide as a single agent and in combination with other anticancer therapies.
  • Together, the AACR poster presentations provide fresh insights to guide our oncology program, and our efforts to bring advanced personalized therapies to patients with cancer.”
    Theratechnologies will present the following data on Tuesday April 18, 2023, from 9:00am-12:30pm Eastern Time (ET) at AACR 2023:

Theratechnologies Announces Update from Ongoing TH1902 Study

Retrieved on: 
Thursday, December 1, 2022
Survival, Peripheral neuropathy, Docetaxel, Cancer, Research, SEDAR, Clinical trial, TSX, FDA, Senior, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Observation, Patient, SORT1, EDGAR, PDC, Food, Pharmaceutical industry, Medical imaging

Theratechnologies voluntarily made the decision to pause enrollment and revisit the study design after consulting with its investigators.

Key Points: 
  • Theratechnologies voluntarily made the decision to pause enrollment and revisit the study design after consulting with its investigators.
  • The current intent for the protocol amendment is to modify the dosage regimen to optimize the delivery of TH1902, with lower doses at more frequent intervals.
  • Theratechnologies is currently developing a platform of proprietary peptides called SORT1+ TechnologyTM for cancer drug development targeting SORT1 receptors.
  • TH1902 is currently Theratechnologies lead investigational PDC candidate for the treatment of cancer derived from its SORT1+ Technology.

Theratechnologies Reports Data Showing High Expression of Sortilin (SORT1) in Multiple Solid Tumors from Tissue Microarrays

Retrieved on: 
Wednesday, October 26, 2022
Lung, Skin, Nephron, Survival, Human, Company, Clinical trial, Sertoli cell, NASDAQ, Cancer, SORT1, Risk, Docetaxel, Cell, Spleen, SEDAR, Biopsy, Particle-size distribution, EDGAR, Ovary, TSX, Prostate, Esophagus, Stomach, Mission statement, Forward-looking statement, Thyroid, Bone marrow, FDA, PDC, Astrocyte, Liver, Medical imaging

Theratechnologies is currently developing a platform of proprietary peptides called SORT1+ TechnologyTM for cancer drug development targeting SORT1 receptors.

Key Points: 
  • Theratechnologies is currently developing a platform of proprietary peptides called SORT1+ TechnologyTM for cancer drug development targeting SORT1 receptors.
  • It is highly expressed in cancer cells compared to healthy tissue, which makes SORT1 an attractive target for cancer drug development.
  • TH1902 is currently Theratechnologies lead investigational PDC candidate for the treatment of cancer derived from its SORT1+ Technology.
  • Further information about Theratechnologies is available on the Company's website at www.theratech.com, on SEDAR at www.sedar.com and on EDGAR at www.sec.gov.

Theratechnologies Presents Data Demonstrating High Expression of Sortilin (SORT1) in Multiple Tumor Types at 34th EORTC-NCI-AACR Symposium

Retrieved on: 
Wednesday, October 12, 2022
American Association for Cancer Research, Observation, TSX, Forward-looking statement, SORT1, NASDAQ, Patient, Mission statement, European Organisation for Research and Treatment of Cancer, Treatment, Company, AACR, National Cancer Institute, American Association, Research, EORTC, Toxicity, National, GLOBE, Clinical trial, EDGAR, Human, NCI, SEDAR, Pharmaceutical industry, Cancer

We look forward to presenting data from tissue microarrays at the EORTC-NCI-AACR symposium, as the findings reinforce SORT1 as a promising target for the delivery and internalization of anticancer agents, commented Dr. Christian Marsolais, Chief Medical Officer, Theratechnologies.

Key Points: 
  • We look forward to presenting data from tissue microarrays at the EORTC-NCI-AACR symposium, as the findings reinforce SORT1 as a promising target for the delivery and internalization of anticancer agents, commented Dr. Christian Marsolais, Chief Medical Officer, Theratechnologies.
  • We are investigating our SORT1-targeted peptide-drug conjugate (TH1902) across eight solid tumor types in our ongoing first-in-human study of TH1902 and eagerly await the data readout from this trial.
  • Further information about Theratechnologies is available on the Company's website at www.theratech.com, on SEDAR at www.sedar.com and on EDGAR at www.sec.gov.
  • The reader is cautioned to consider these and other risks and uncertainties carefully and not to put undue reliance on Forward-Looking Statements.