INNOVATIVE THERAPIES
REPROGRAMMING CANCER CELL DEATH
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.
John Harkey Jr., JD, MBA – Executive Chairman & Co-founder
Mr. Harkey is the Founder of JDH Investment Management, LLC, which is focused on leading innovative and impactful opportunities in the biotechnology industry. Notably, he was the Co-founder and Executive Chairman of AveXis, which was acquired by Novartis for $8.7bn in 2018. He currently serves as Co-founder, Board Member and Co-CEO of Cessation Therapeutics. He also served on the board of CerSci Therapeutics until acquisition by Acadia Pharmaceuticals and on the board of directors of Emisphere Technologies until its acquisition by Novo Nordisk. Mr. Harkey received a B.B.A. in Business Honors and a J.D. from the University of Texas at Austin, and an M.B.A. from Stanford University School of Business.
Joshua Sills – Executive Vice President of Operations
Mr. Sills has over two decades of experience in project/program management and operations and had led teams on location and remotely in over seventy countries. Since making the leap from tech to biotech, he has been listed as primary investigator on two grants from the Cancer Prevention and Research Institute of Texas (CPRIT) totaling $17.4m. Mr. Sills received a B.S. in Management Information Systems from Florida State University.
Stephen Friedberg - Chief Financial Officer
Mr. Friedberg has over a decade of experience in principal investing, growth strategy, and operations on behalf of private equity, venture capital, and growth stage businesses. Notably, he served as part of Google's business operations and strategy team, where he advised senior leadership on pricing, monetization, and operations strategy across the broader Alphabet portfolio. He also served as part of the investment team for The Sterling Group, driving commercial diligence for new platform acquisitions and strategy with management teams post-close. Mr. Friedberg received a B.B.A. in Finance from the University of Texas at Austin.
Larry Tremaine, PhD – Chief Scientific Officer
Dr. Tremaine has over three decades of experience in the pharmaceutical industry, mainly at Pfizer. There he led a variety of laboratory groups with the Drug Metabolism and preclinical PK (DMPK) discipline, providing experimental data for all small molecule programs. He contributed to the development of successfully approved drugs, including Zoloft, Geodon, Chantix, Eliquis, and Xeljanz. Dr. Tremaine received a Ph.D. in Pharmacology from the University of Minnesota Medical School.
James Strauss, MD – Chief Medical Officer
Dr. Strauss specializes in clinical trial development, trial recruitment and clinical oncology and currently serves as a principal investigator for clinical trials at the Mary Crowley Cancer Center in Dallas. Dr. Strauss received a B.A. from Harvard University, an M.D. from New York University School of Medicine and trained at Baylor University Medical Center in Dallas.
Guangrong Zheng, PhD – Director of Medicinal Chemistry & Scientific Co-founder
Dr. Zheng is an Associate Professor in the Department of Medicinal Chemistry at the University of Florida College of Pharmacy. He received his B.S. in Medicinal Chemistry from Fudan University and his Ph.D. in Synthetic Organic Chemistry from Shanghai Institute of Materia Medica. He then completed his postdoctoral training in drug design and discovery at the University of Kentucky College of Pharmacy. Dr. Zheng’s expertise is in the design, synthesis and structure-activity relationship study of both synthetically derived and natural product-based compounds.
David Hitt, JD, MTax – Intellectual Property Strategist
Mr. Hitt practiced transactional intellectual property law for 30 years, including over two decades at Hitt Gaines, gaining extensive experience in patent procurement and counseling in a wide array of physical, electrical, mechanical, mathematical, and computer technologies. He now dedicates his time to protection strategy and teaming with other entrepreneurs to launch and lead early-stage companies. Mr. Hitt received a B.S. in Physics and a B.S. in Business and Public Administration from the University of Texas at Dallas, J.D. from Southern Methodist University, and M.S. in Taxation from Baylor University.
Jeff Harder, JD – General Counsel
Mr. Harder has been at the center of venture capital and angel investor transactions in a wide variety of industries. He spent 10 years in-house at companies such as Exxon Corp., Amoco, MEDC and ForeFront and over 30 years in private practice which has provided him with a unique blend of experience and a more practical, business-like approach to his practice. His passion and expertise led to Mr. Harder's engagement as VP for Corporate Development and General Counsel at a Nasdaq listed public company, The ForeFront Group, Inc., that he had taken public in 1995. His leadership contributed to the sale of ForeFront two years later to CBT Group PLLC for nearly $160 million.
Eric Rasmussen – Controller
Mr. Rasmussen has 25 years of experience in business accounting, mergers and acquisitions, legal administration and corporate record keeping. He was a member of original founding team of AveXis and has been an integral part of portfolio investments in over 50 public and private companies. Mr. Rasmussen received a B.A. in Business Administration and Management from Dallas Baptist University.
Robert Hromas, MD – Board Member & Scientific Co-founder
Dr. Hromas is currently the Dean of the Long School of Medicine at the University of Texas Health Science Center at San Antonio. Previously he was Chair of Medicine at the University of Florida, Deputy Director of Indiana University Cancer Center, and Deputy Director and Chief of Hematology-Oncology at the University of New Mexico Cancer Center. Dr. Hromas has been continuously funded by the NIH in cancer research for almost three decades. He currently serves as Chairman of the SAB of Abfero Pharmaceuticals.
Daohong Zhou, MD – Board Member & Scientific Co-founder
Dr. Daohong Zhou is a professor in the Department of Biochemistry & Structural Biology and a Joe R. and Terry Lozano Long Distinguished Chair of Developmental Therapeutics at the Long School of Medicine, University of Texas Health San Antonio (UTHSA). Dr. Zhou also serves as the Co-Director of the CPRIT-supported Center of Innovative Drug Discovery (CIDD) and as the Associate Director for Drug Development at the Mays Cancer Center (MCC). Dr. Daohong Zhou has published more than 160 peer reviewed scientific articles and book chapters. Dr. Zhou’s efforts in the development of promising senolytics and cancer therapeutics has led to the Dialectic's lead candidate, DT2216.
J.D. McCulloch, MBA, CFA – Advisor
Mr. McCulloch has over 20 years of private and public investment experience including biotech venture with successful exits in the precision oncology, non-opioid pain, and gene therapy areas. Most recently, he managed investments for a private investment firm with an emphasis on biotech venture investing. He previously advised on approximately $10 billion of M&A and capital markets transactions for mid and large cap companies while at JPMorgan’s Investment Banking Groups in New York and Dallas. Until its acquisition by Acadia Pharmaceuticals, he served as a Board observer at CerSci Therapeutics. Mr. McCulloch received an M.B.A. and B.S. in Mechanical Engineering from the University of Texas at Austin and is a CFA Charterholder.
In Memoriam: David Genecov, MD – President & CEO, Co-founder, Board Member
Dr. Genecov is a successful health care entrepreneur and trained as a craniofacial surgeon. He co-founded and served on the Board of AveXis with Mr. Harkey, which was acquired by Novartis for $8.7bn in 2018. AveXis created the first successful therapy for spinal muscular atrophy, now FDA-approved. Along with Mr. Harkey, he co-founded and serves on the board of Cessation Therapeutics and served on the board of CerSci Therapeutics until acquisition by Acadia Pharmaceuticals. Dr. Genecov received a M.D. from the Long School of Medicine at the University of Texas Health Science Center at San Antonio.
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
Contact Us