INNOVATIVE THERAPIES

REPROGRAMMING CANCER CELL DEATH

cell xray

INNOVATIVE THERAPIES

REPROGRAMMING CANCER CELL DEATH

Dialectic Therapeutics’ mission is to create innovative new technologies to treat cancer. Our goal is to relieve the suffering of patients with cancer, to give them hope and prolong their productive lives through targeted therapies with limited toxicities and complications.

 

Dialectic Therapeutics is a biotechnology company dedicated to the development of unique, impactful anti-cancer drugs that effectively treat patients with few to no other options. Dialectic® was founded by three respected cancer scientists and two successful biotech investors and operators. Dialectic® is located in Dallas, Texas and has research partners and facilities at UT Health at San Antonio and the University of Florida Health Cancer Center.

DIALECTIC’S LEAD CANDIDATE, DT2216, is a novel Antiapoptotic Protein Targeted Degradation (APTaD™) compound that selectively induces cancer cells to degrade B-cell lymphoma extra large, or BCL-XL, stimulating the cells to commit suicide or become more susceptible to chemotherapy. DT2216 is currently in the clinical phase as a single agent and combination therapy in liquid and solid cancer tumors.

 

Preclinical studies show that DT2216 is highly effective in various liquid and solid tumors as a single agent and in combination with chemotherapy.  Further, these studies show cancer cells are less likely to develop resistance to DT2216 than to other chemotherapy drugs. DT2216 accomplishes this with very little toxicity, particularly to platelets.

 

As with BCL-XL, there are many other significant proteins associated with cancer that cannot be targeted with current therapies. Our APTaD™ platform is a novel approach that can be applied to the broader BCL family and other protein targets. Dialectic® efforts are focused on developing drug candidates to address this high unmet need.  If successful, we will be able to provide cancer patients who have little hope with increased disease-free survival.

 

DT2216 and Dialectics Therapeutics’ other compounds are protected under one or more of US patent nos. 10,807,977, 11,319,316, and 11,365,415, corresponding foreign patents and other pending US and foreign patent applications.

OUR TEAM

The Dialectic® team is focused on creating innovative new technologies to address late-stage difficult cancer diagnoses. We are comprised of protein degradation experts and leadership with a strong track record of clinical development and commercial success.

RESOURCES

 

Patients and Caregivers

Dialectic is dedicated to developing novel therapies for patients that overexpress the antiapoptotic BCL-2 family of proteins.

Patients with serious illnesses that have exhausted all available treatment options often inquire how they can receive access to investigational drugs that have not been approved by government regulatory agencies like the FDA and Health Canada. The following information provides information on some of the options available to patients meeting these criteria.

Clinical Trials
For a new drug to be approved for use, companies like Dialectic are required to evaluate the safety and efficacy of their investigational drug in clinical trials and submit trial results to regulatory agencies. To participate in a trial, you must meet certain criteria. For those patients that meet the criteria of a clinical trial, participation comes with certain risks and these risks need to be discussed with your doctor. Our lead product DT2216 is currently being investigated in a Phase 1 clinical trial. To learn more, visit www.clinicaltrials.gov.

Expanded Access
In cases where a clinical trial is not an option and the patient has exhausted all available treatment options, regulatory agencies may grant permission for a company to provide a doctor with an investigation drug prior to its approval. This use of an investigational drug pre-approval is often referred to as expanded access but may be referred to by other names depending upon the regulatory agency. Dialectic is currently in an early Phase 1 trial and is not eligible to provide access to investigational drug through expanded access at this time.

It is important to remember that the investigational drugs have not received regulatory approval. Because these drugs have yet to be approved the full potential of their risks and benefits are not known. Doctors and patients should consider all possible benefits and risks involving an investigational drug.

For questions, please email us at info@dtsciences.com or use the form below.

 

News


04.05.2022
PRNewswire
Dialectic Therapeutics Announces DT2216 Has Received Fast Track Designation from the FDA for Adult Patients with Relapsed or Refractory Peripheral and Cutaneous T-Cell Lymphoma
DALLAS, April 5, 2022 /PRNewswire/ — Dialectic Therapeutics, Inc. (Dialectic®), a Texas-based clinical stage biotechnology company focused on creating innovative new technologies to treat cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted fast track designation to DT2216 for adult patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL). DT2216 is Dialectic’s first generation compound built using its proprietary and novel Antiapoptotic Protein Targeted Degradation (APTaD™) technology platform.
 


03.14.2022
PRNewswire
Dialectic Therapeutics Announces DT2216 Has Received Orphan Drug Designation from the FDA for the Treatment of T-Cell Lymphoma
DALLAS, March 14, 2022 /PRNewswire/ — Dialectic Therapeutics, Inc. (Dialectic®), a Texas-based clinical stage biotechnology company focused on creating innovative new technologies to treat cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to DT2216 for the treatment of T-cell lymphoma. DT2216 is Dialectic’s first generation compound built using its proprietary and novel Antiapoptotic Protein Targeted Degradation (APTaD™) technology platform.
 


10.06.2021
PRNewswire
Dialectic Therapeutics Announces First-in-Human Dose in Phase 1 Clinical Trial Evaluating DT2216, its First Generation Antiapoptotic Protein Targeted Degradation (APTaD™) Compound, in Patients with Relapsed or Refractory Malignancies
DALLAS, Oct. 6, 2021 /PRNewswire/ — Dialectic Therapeutics, Inc. (Dialectic®), a Texas-based clinical stage biotechnology company focused on creating innovative new technologies to treat cancer, today announced the dosing of the first patient in a first-in-human, dose escalation Phase 1 trial evaluating DT2216, the first generation compound built using its proprietary and novel Antiapoptotic Protein Targeted Degradation (APTaD™) technology, in patients with relapsed or refractory solid tumor and hematologic malignancies.

 


08.20.2021
PRNewswire
Dialectic Therapeutics Receives $14.4 Million Texas Company Product Development Research Award from the Cancer Prevention & Research Institute of Texas
DALLAS, Aug. 20, 2021 /PRNewswire/ — Dialectic Therapeutics, Inc. (Dialectic®), a Texas-based clinical stage biotechnology company focused on creating innovative new technologies to treat cancer, today announced it has received a $14.4 million Texas Company (TXCO) Product Development Research Award from the Cancer Prevention & Research Institute of Texas (CPRIT). Dialectic will use the funding from this grant award to further advance the clinical development of its lead product candidate, DT2216, a unique compound built using its proprietary and novel Antiapoptotic Protein Targeted Degradation (APTaD™) technology platform.

 


03.03.2021
PRNewswire
Dialectic Therapeutics Receives FDA Clearance of IND Application for Lead Antiapoptotic Protein Targeted Degradation (APTaD) Candidate DT2216
DALLAS, March 3, 2021 /PRNewswire/ — Dialectic Therapeutics, Inc. (Dialectic®), a Texas-based biotechnology company focused on creating innovative new technologies to treat cancer, today announced that the U.S. Food and Drug Administration (FDA) has concluded that Dialectic may proceed with its clinical investigation for its lead product candidate, DT2216, a unique compound built using its proprietary and novel Antiapoptotic Protein Targeted Degradation (APTaD™) technology. In pre-clinical studies supported through a Seed Award from the Cancer Prevention & Research Institute of Texas (CPRIT), DT2216 selectively induces cancer cells to degrade B-cell lymphoma extra-large, or BCL-XL, stimulating the cells to commit suicide or become more susceptible to chemotherapy.

 


02.24.2021
UF Health Cancer Center
Dialectic Therapeutics’ Co-founders Daohong Zhou and Guangrong Zheng Contribute to Newly Published Nature Communications Study
Gainesville, FL – February 24, 2021 – University of Florida Health Cancer Center researchers have found a potential new way of targeting this population of immune-suppressive T cells that could possibly benefit a large population of cancer patients, including those who will not respond to other immunotherapies.

The researchers discovered that B-cell lymphoma extra-large, or BCL-XL, is a potential molecular target of TI-Tregs, which play an important role within tumors to promote an immunosuppressive microenvironment and inhibit anti-cancer immunity. BCL-XL is an important survival factor for tumor cells and TI-Tregs.

“We purposely developed therapeutics that target the BCL-XL protein to kill both tumor cells and TI-Tregs and improve anti-tumor immunity, as well as to enhance anti-tumor response to chemotherapy,” said Daohong Zhou, M.D., associate director for translation and drug development at the UF Health Cancer Center and a co-corresponding author on the study, which was published online today in Nature Communications.

 


10.13.2020
Dialectic Therapeutics
Dialectic Therapeutics Recently Presents at Several Conferences Highlighting Protein Degradation Research
Dallas, TX – October 13, 2020 – Dialectic Therapeutics, Inc., a Texas-based biotechnology company focused on creating innovative new technologies to end cancer, announced that Dr. Daohong Zhou, Scientific Co-Founder of Dialectic and Professor of Pharmacodynamics & Associate Director for Translation & Drug Development University of Florida, and Dr. Guangrong Zheng, Scientific Co-Founder of Dialectic and Associate Professor of Medicinal Chemistry University of Florida, recently presented at several scientific conferences highlighting progress in the protein degradation research field and published work on Dialectic’s lead candidate, DT2216 a unique compound built using its proprietary and novel Antiapoptotic Protein Targeted Degradation (APTaD™) technology. In pre-clinical studies, DT2216 selectively induces cancer cells to degrade B-cell lymphoma extra large, or BCL-XL, stimulating the cells to commit suicide or become more susceptible to chemotherapy. DT2216 is currently in the IND-enabling phase for use as a single agent or as part of a combination therapy in hematologic cancers.

 


02.26.2020
PRNewswire
Dialectic Therapeutics Receives $3 Million Seed Award for Product Development Research from the Cancer Prevention & Research Institute of Texas
DALLAS, Feb. 26, 2020 /PRNewswire/ — Dialectic Therapeutics, Inc., a Texas-based biotechnology company focused on creating innovative new technologies to end cancer, today announced it has received a $3 million Seed Award for Product Development Research from the Cancer Prevention & Research Institute of Texas (CPRIT).

 

Publications

01.02.2023
Cell Death Discovery
Co-targeting BCL-XL and MCL-1 with DT2216 and AZD8055 synergistically inhibit
small-cell lung cancer growth without causing on-target toxicities in mice
Sajid Khan et al., 2023

 

11.08.2022
Cancer Chemotherapy and Pharmacology
Resistance to the BCL‑XL degrader DT2216 in T‑cell acute lymphoblastic leukemia
is rare and correlates with decreased BCL‑XL proteolysis
Arunima Jaiswal et al., 2022

 

09.08.2022
JCI Insight
Targeting BCL-XL in fibrolamellar hepatocellular carcinoma
Bassem Shebl et al., 2022

 

03.09.2022
Journal of Hematology & Oncology
BCL-XL PROTAC degrader DT2216 synergizes with sotorasib in preclinical models of KRASG12C-mutated cancers
Sajid Khan et al., 2022

 

12.07.2021
Nature Communications
Development of a BCL-xL and BCL-2 dual degrader with improved anti-leukemic activity
Dongwen Lv et al., 2021

 

10.19.2021
Molecular Cancer Therapeutics
Overcoming Gemcitabine Resistance in Pancreatic Cancer Using the BCL-XL–Specific Degrader DT2216
Dinesh Thummuri et al., 2021

 

09.17.2021
Journal of Medicinal Chemistry
Discovery of a Novel BCL-XL PROTAC Degrader with Enhanced BCL-2 Inhibition
Pratik Pal et al., 2021

 

02.24.2021
Nature Communications
Proteolysis-targeting chimera against BCL-XL destroys tumor-infiltrating regulatory T cells
Ryan Kolb et al., 2021

 

08.01.2020
European Journal of Medicinal Chemistry
Discovery of IAP-recruiting BCL- XL PROTACs as potent degraders across multiple cancer cell lines
Xuan Zhang et al., 2020

 

07.27.2020
Journal of Hematology & Oncology
Proteolysis targeting chimeras (PROTACs) are emerging therapeutics for hematologic malignancies
Yonghan He et al., 2020

 

07.16.2020
Journal of Hematology & Oncology
DT2216—a Bcl-xL-specific degrader is highly active against Bcl-xL-dependent T cell lymphomas
Yonghan He et al., 2020

 

05.20.2020
Oncogene
PROteolysis TArgeting Chimeras (PROTACs) as emerging anticancer therapeutics
Sajid Khan et al., 2020

 

05.20.2020
Future Medicinal Chemistry
Assays and technologies for developing proteolysis targeting chimera degraders
Xingui Liu et al., 2020

 

04.24.2020
Nature Communications
Using proteolysis-targeting chimera technology to reduce navitoclax platelet toxicity
and improve its senolytic activity
Yonghan He et al., 2020

 

04.15.2020
European Journal of Medicinal Chemistry
Discovery of PROTAC BCL- XL degraders as potent anticancer agents with low on-target platelet toxicity
Xuan Zhang et al., 2020

 

02.21.2020
Future Medicinal Chemistry
Targeting anti-apoptotic BCL-2 family proteins for cancer treatment
Xuan Zhang et al., 2020

 

12.02.2019
Nature Medicine
A selective BCL-XL PROTAC degrader achieves safe and potent antitumor activity
Khan, S. et al., 2019

 

11.19.2019
Chemical Communications
Utilizing PROTAC technology to address the on-target platelet toxicity associated with inhibition of BCL- XL
Xuan Zhang et al., 2019

 

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