Treadwell Therapeutics Announces a Presentation at the 2023 ASH Annual Meeting and Advisory Board Meeting

/in /by

TORONTO and SAN MATEO, Calif., Dec. 15, 2023 (GLOBE NEWSWIRE) — Treadwell Therapeutics, a clinical-stage biotechnology company developing novel first-in-class medicines for unmet needs in cancer, today announced a presentation for the Company’s lead program, CFI-400945, a first-in-class inhibitor of Polo-like Kinase 4 (PLK4) being advanced in relapsed/refractory AML, at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition being held from December 9-12, 2023. Treadwell also conducted a clinical advisory board meeting on December 10th at ASH with experienced experts in the treatment of AML and in clinical trials of novel agents, which included current investigators and thought leaders new to the program.

“CFI-400945 is demonstrating complete remissions as a single agent and in combination with azacitadine in relapsed, adverse risk AML, including those with TP53 mutant disease. As we optimize dose and schedule, we are encouraged by the data with this oral dosing regimen,” said Principal Investigator and Advisory Board Co-Chair Dr. Gautam Borthakur, MD, Professor, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center. “The advisory board confirmed the enthusiasm about the data to date in the relapsed AML setting, in particular with TP53 mutant disease and look forward to working with Treadwell to advance and shape this program.”

“CFI-400945, our lead program and first-in-class PLK4 inhibitor, represents an opportunity to address a substantial unmet in relapsed/refractory AML, including TP53 mutant AML,” said Roger Sidhu, MD, Acting CEO at Treadwell Therapeutics. “We look forward to advancing the program into key dose expansion studies in monotherapy and in combination in 2024 with a view to initiating pivotal studies in 2025.”

2023 ASH Poster Presentations and Details:

Title: Preliminary Results from a Phase 1b/2 Open-Label, Multicenter, Dose Optimization Clinical Study of the Safety, Tolerability, and Pharmacokinetic (PK) and Pharmacodynamic (PD) Profiles of CFI-400945 As a Single Agent or in Combination with Azacitidine in Patients (Pts) with Acute Myeloid Leukemia, Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia (TWT-202)
Session Name: 616. Acute Myeloid Leukemias: Investigational Therapies, Excluding Transplantation and Cellular Immunotherapies: Poster III
Publication Number: 4294
Session Date: Monday, December 11, 2023
Presentation Time: 6:00 PM – 8:00 PM
Location: San Diego Convention Center, Halls G-H

CFI-400945 has been generally well tolerated in this difficult to treat patient population, including patients whose disease has progressed on or following venetoclax based therapies​.

Three of 6 evaluable patients with AML achieved a response (MLFS=2, CRi=1 with MRD+) at the 96mg dose​. After this data cut, one additional MLFS response (end of cycle 1) and two additional CRs (end of cycle 2) were seen in two patients treated with 80 mg + azacitidine combination cohort and became transplant eligible (PI communication)​. PK characteristics support daily dosing of CFI-400945 and PD studies are ongoing​. Dose expansions are planned and enrollment continues​.

About Treadwell Therapeutics

Treadwell Therapeutics is a clinical-stage oncology company developing novel medicines to address unmet needs in patients with cancer. The Company’s robust, internally developed clinical pipeline includes CFI-400945 (PLK4 inhibitor), CFI-402257 (TTK/Mps1 inhibitor) and CFI-402411 (HPK1 inhibitor). Treadwell also has a broad pre-clinical pipeline with multiple biologic and next generation TCR based autologous cell therapy programs. For more information, please visit www.treadwelltx.com.

Contact

ir@treadwelltx.com

Treadwell Announces Strategic Pipeline Prioritization and Leadership Transitions

/in /by

TORONTO AND SAN FRANCISCO, Dec 5, 2023 — Treadwell Therapeutics, a clinical-stage biotechnology company developing novel first-in-class medicines for unmet needs in cancer, today announced that it is realigning its pipeline, workforce and management structure to support its highest value program and extend its cash runway to prioritize the execution of key near term value drivers and clinical milestones.

Treadwell has elected to focus on its first-in-class PLK4 inhibitor, CFI-400945, in relapsed/refractory AML by expanding the ongoing company sponsored TWT-202 study, building on exciting signals of efficacy seen at earlier phases, and advancing towards a potential pivotal study in 2025. The company will seek to capitalize on very promising proof-of-concept from sponsored clinical studies of CFI-402257 (TTK/Mps1 inhibitor) and CFI-402411 (HPK1 inhibitor) through further, innovative collaborative studies and work with potential partners to accelerate timelines.

Shane Burgess, co-CEO has transitioned to the role of Executive Chair, while Michael Tusche, Ph.D., co-CEO has left the company to pursue other endeavours. Roger Sidhu, M.D., Chief Medical Officer, has been appointed Acting CEO.

Dr. Sidhu brings to Treadwell an extensive track record of success over the last nearly 20 years in hematologic and solid tumor oncology research and development. He is a seasoned leader with deep translational, clinical and regulatory experience across multiple therapeutic modalities and platforms including small molecules, biologics and cell and gene therapies. Most recently, Dr. Sidhu was the Chief Medical Officer at Eterna Therapeutics, a gene editing and cell therapy company where he advanced multiple novel programs. Previously, Dr. Sidhu served as Executive Vice President and Chief Medical officer at Roivant Sciences. Roger was also the Chief Medical Officer at Cell Design Labs, up until its acquisition by the Gilead subsidiary Kite, where he subsequently served as VP, Clinical Development. Dr. Sidhu also held various roles of increasing responsibility at Amgen over a nearly decade that included managing FDA and EU approval of panitumumab in metastatic colorectal cancer. Dr. Sidhu is a Fellow of the Royal College of Physicians and Surgeons of Canada in both internal medicine and medical oncology. He earned his medical degree from Queen’s University in Kingston, Ontario Canada.

“Roger brings a unique and broad set of skills and strategic thinking to Treadwell over a long and successful career. We are confident that under his leadership, Treadwell will aggressively advance into an exciting new chapter in our mission to address unmet needs in difficult to treat cancers with first-in-class medicines,” said Shane Burgess, Executive Chair of Treadwell Therapeutics. “In order to increase operational efficiency and to focus on key, value driving priorities, we have made the difficult business decision to reduce our workforce by approximately 30% and to redirect clinical efforts for several Treadwell-sponsored trials to other avenues. We would like to extend our deep gratitude to the

Treadwell team, investigators and patients involved in our clinical programs. These actions allow us to focus on investing in key near term milestones for CFI-400945.”

“Treadwell has developed a broad clinical and research-stage pipeline of first-in-class small molecules, biologics and TCR-based cell therapies. We have reached an inflection point which allows us to focus on the most near-term path to value with CFI-400945 in relapsed/refractory AML with a view to advancing to pivotal stage studies,” said Roger Sidhu, M.D., Acting CEO of Treadwell Therapeutics. “Given the very promising clinical data we have generated, we also look forward to advancing CFI-402257 (TTK inhibitor) and CFI-402411 (HPK1 inhibitor) with external collaborators and investigators moving forward in breast cancer and immunotherapy-based treatment of cancer, respectively, in addition to actively seeking partners for our pre-clinical programs.”

About Treadwell Therapeutics

Treadwell Therapeutics is a clinical-stage oncology company developing novel medicines to address unmet needs in patients with cancer. The Company’s robust, internally developed clinical pipeline includes CFI-400945 (PLK4 inhibitor), CFI-402257 (TTK/Mps1 inhibitor) and CFI-402411 (HPK1 inhibitor). Treadwell also has a broad pre-clinical pipeline with multiple biologic and next generation TCR based autologous cell therapy programs. For more information, please visit www.treadwelltx.com.

Contact

ir@treadwelltx.com

Treadwell Therapeutics Announces the Appointment of Roger Sidhu, M.D., as Chief Medical Officer

/in /by

NEW YORK, Feb. 3, 2023 /CNW/ — Treadwell Therapeutics, a clinical-stage, global biotechnology company developing novel, first in class therapeutics for highly aggressive cancers, today announced that it has appointed Roger Sidhu, M.D., as Chief Medical Officer. Dr. Sidhu is a seasoned leader and brings to Treadwell an extensive track record of success over the last 15 years in hematologic and solid tumor oncology research and development with deep translational, clinical and regulatory experience across multiple therapeutic modalities and platforms including small molecules, biologics and cell and gene therapies.

“We are excited to welcome Dr. Sidhu to our team as we further the development of our small molecule, biologic and cell therapy pipeline,” said Dr. Michael Tusche, Treadwell co-CEO. “Roger has an extensive track record of success in all aspects of drug development from early to late stage through regulatory approval, as well as being a proven leader and builder. His expertise will be invaluable to our mission of translating novel scientific ideas into first in class medicines for patients in need.”

“Treadwell’s innovative, first in class pipeline against novel targets in hematologic and solid tumors is driven by world class science and positions the company at the forefront of the next generation of personalized medicines,” said Dr. Sidhu. “I am excited to join the world class team at Treadwell and advance the mission of delivering new medicines for patients with high unmet need in cancer globally.”

Dr. Sidhu was most recently the Chief Medical Officer at Brooklyn (now Eterna) ImmunoTherapeutics, a gene editing and cell therapy company where he advanced multiple novel programs. Previously, Dr. Sidhu served as Executive Vice President and Chief Medical officer at Roivant Sciences. Roger was also the Chief Medical Officer at Cell Design Labs, up until its acquisition by the Gilead subsidiary Kite, where he subsequently served as VP, Clinical Development. Dr. Sidhu also held various roles of increasing responsibility at Amgen where he was an Executive Medical Director in the Hematology/Oncology Therapeutic area with responsibilities that included advancing preclinical and clinical candidates through registration globally. Dr. Sidhu is a Fellow of the Royal College of Physicians and Surgeons of Canada in both internal medicine and medical oncology. He earned his medical degree from Queen’s University in Kingston, Ontario Canada and his Bachelor’s degree in biochemistry from the University of Alberta in Edmonton, Alberta. Dr. Sidhu trained in internal medicine at Queen’s University and medical oncology at the British Columbia Cancer Agency in Vancouver, British Columbia and the Cross Cancer Institute in Edmonton, Alberta.

About Treadwell Therapeutics

Treadwell Therapeutics is a science driven, clinical-stage, multi-modality biotechnology company developing first-in-class and best-in-class medicines to address unmet needs in patients with cancer. The Company’s internally developed small molecule clinical pipeline includes CFI-400945 (PLK4 inhibitor), CFI-402257 (TTK inhibitor) and CFI-402411 (HPK1 inhibitor). The company is also advancing a pre-clinical pipeline of first-in-class antibody and TCR-based cell therapy assets. For more information, please visit www.treadwelltx.com.

Contact

Investors:
ir@treadwelltx.com

Treadwell Therapeutics Announces Fast Track Designation Granted by the FDA to CFI-402257 for the Treatment of ER+/HER2- Breast Cancer

/in /by

NEW YORK, Jan. 10, 2023 /PRNewswire/ — Treadwell Therapeutics, a clinical-stage biotechnology company, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to CFI-402257, a best in class inhibitor of Threonine Tyrosine Kinase (TTK, also known as Mps1), for the treatment of adult patients with ER+/HER2- advanced breast cancer after disease progression on prior CDK4/6 inhibitors and endocrine therapy, both as a monotherapy and in combination with fulvestrant.

“There is an urgent need for new, safe and efficacious therapies to treat ER+/HER2- breast cancer, particularly when standard of care regimens fail,” said Dr. Mark Bray, Treadwell CSO and Co-founder. “CFI-402257 has shown early signs of durable activity with a manageable safety profile, as a monotherapy and in combination with fulvestrant in ER+/HER2- breast cancer patients that have failed CDK4/6 inhibitors. We are thankful for the Fast Track Designation granted by the FDA and look forward to the continued development of CFI-402257 in ER+/HER2- breast cancer.”

Fast Track designation seeks to streamline the development and accelerate the review of new agents with potential to treat serious or life-threatening diseases and that potentially address an unmet medical need. Drugs that are granted this designation can have more frequent interactions with the FDA, as well as potential pathways for expedited approval.

About ER+/Her2- Breast Cancer

Globally, breast cancer is the world’s most prevalent cancer and the 2nd leading cause of cancer death in women in many countries. The ER+/HER2- subtype is the most common subtype of breast cancer, accounting for 68% of all breast cancer types, with nearly 1.2 million women living with the disease in the US alone. Standard of care for ER+ patients is CDK4/6 inhibitors in combination with endocrine therapies, which have been very successful in prolonging survival for this patient population. However, resistance to this treatment occurs within a median of 2 years. As a result, the ER+ population resistant to this standard of care is growing and is an unmet medical need requiring new treatment options.

About Treadwell Therapeutics

Treadwell Therapeutics is a science driven, clinical-stage, multi-modality biotechnology company developing first-in-class and best-in-class medicines to address unmet needs in patients with cancer. The Company’s internally developed clinical pipeline includes CFI-400945, CFI-402257 (TTK inhibitor) and CFI-402411 (HPK1 inhibitor). The company is also advancing a pre-clinical pipeline of first-in-class antibody and TCR-based cell therapy assets. For more information, please visit www.treadwelltx.com.

Contact

Investors:
ir@treadwelltx.com

General inquiries:
info@treadwelltx.com