Treadwell Therapeutics Announces A Presentation at the 2022 ASH Annual Meeting Featuring a Clinical Trial Update on CFI-400945, an oral PLK4 inhibitor

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NEW YORK, Dec. 13, 2022 /PRNewswire/ — Treadwell Therapeutics, a clinical-stage biotechnology company developing novel, small molecule therapeutics for highly aggressive cancers, today announced a presentation for the Company’s CFI-400945 program, a first in class inhibitor of Polo-like Kinase 4 (PLK4) a critical regulator of centriole duplication, at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition being held from December 10-13, 2022. The poster presentation described the preliminary results from the monotherapy dose optimization portion of the TWT-202 in advanced leukemias.

“CFI-400945 had previously shown single agent complete remissions in refractory high risk AML. As we optimize dose for the agent in unselected leukemia patients in study TWT-202, we are encouraged by the continued signs of safety and tolerability with this oral dosing regimen,” said Principal Investigator, Dr. Gautam Borthukar, MD, Professor, Department of Leukemia, Division of Cancer Medicine, MD Anderson Cancer Center.

“We look forward to dose selection for CFI-400945, and expansion into populations of interest, including patients with TP53 mutations, where there is substantial unmet need,” said Dr. Michael Tusche, Co-CEO at Treadwell Therapeutics.

2022 ASH Poster Presentations and Details:

Preliminary Results from a Phase 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 or Decitabine in Patients with Acute Myeloid Leukemia, Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia (TWT-202)

Publication Number: 4087
Session: 616; Poster III
Date and Time: December 12th, 2022, 6:00 PM-8:00 PM

Data presented on CFI-400945, an oral, first-in-class PLK4 inhibitor, showed a tolerable safety profile at the 32, 48 and 64 mg cohorts (N=12), with exposures being approximately dose linear. No dose limiting toxicities have been observed to date, suggesting further dose optimization is required. Five cases of stable disease have been observed – 3 per ELN with 1 at 48 mg, and 2 at 64 mg, as well as 2 at 48 mg per IWG. Adverse events (AEs) for CFI-400945 in this study were in line with those observed in previous studies in similar patient populations. Main AEs (any grade) were hematologic, gastrointestinal and metabolism/nutritional disorders. Most predominant severe AE was febrile neutropenia. No treatment emergent adverse events led to study drug discontinuation.

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.

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Treadwell Therapeutics Announces A Presentation at the 2022 SABCS Annual Meeting Featuring a Clinical Trial Update on CFI-402257, a Best-in-Class TTK inhibitor

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NEW YORK, Dec. 9, 2022 /PRNewswire/ — Treadwell Therapeutics, a clinical-stage biotechnology company developing novel medicines for highly aggressive cancers, today announced that data presented on the ongoing CFI-402257-CL-001 clinical study of the Company’s CFI-402257 program in advanced solid tumors, continued to show a tolerable safety profile and demonstrated clinical benefit both as a monotherapy as well in combination with fulvestrant. Data were presented at the 2022 San Antonio Breast Cancer Symposium (SABCS) being held from December 6-10, 2022 at the Henry B. Gonzalez Convention Center in San Antonio, Texas.

“CFI-402257 is well-tolerated and showed signs of anti-tumor activity either as a monotherapy or in combination with Fulvestrant, including some patients who were with durable disease control after progression on prior CDK4/6 inhibitor therapy” said Dr. Philippe Bedard, Study investigator and Associate Professor of Medicine at the University of Toronto and Staff Medical Oncologist at the Princess Margaret Cancer Centre, Toronto, Canada.

“CFI-402257 continues to demonstrate an encouraging clinical profile, and we look forward to further developing the molecule for the treatment of ER+ breast cancer,” added Dr. Michael Tusche, Treadwell co-CEO.

2022 SABCS Poster Presentations and Details:

An Update to a Phase I Trial of CFI-402257, an oral TTK Inhibitor, in Patients with Advanced Solid Tumors with HER2-Negative Breast Cancer Expansion Cohorts

Poster Number: P6-10-13

Date: December 9th, 7:00 am CT

Data presented on CFI-402257, an oral, best-in-class TTK inhibitor, continue to show a tolerable safety profile at the recommended Phase 2 dose of 168 mg once daily with manageable, dose-dependent neutropenia being the primary toxicity. In this heavily pre-treated population (N=86), the overall response rate was 6% for monotherapy patients (4/66) and 10% for ER+/HER2- breast cancer patients treated in combination with fulvestrant (2/20). The clinical benefit rate (CR+PR+SD>6 months) for monotherapy and combination were 12% and 25%, respectively. Patients achieving stable disease or better stayed on treatment for a median of 242 days (range: 112 to 673). Significantly, several ER+ breast cancer patients who previously failed CDK4/6 inhibitors in the combination cohort remained on therapy for a year or more. The most common drug related toxicities of any grade, which occurred in greater than 10% of all patients, included fatigue (48%), nausea (48%), decreased appetite (34%), diarrhea (34%), vomiting (24%), constipation (21%) and headache (21%).

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.

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Investors:
ir@treadwelltx.com

General inquiries:
info@treadwelltx.com

Treadwell Therapeutics Announces Presentations at the 2022 San Antonio Breast Cancer Symposium Featuring a Clinical Trial Update on the CFI-402257 and CFI-400945 programs

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NEW YORK, Nov. 21, 2022 /PRNewswire/ — Treadwell Therapeutics, a clinical-stage biotechnology company developing novel medicines for highly aggressive cancers, today announced that four abstracts highlighting CFI-402257 and CFI-400945, the Company’s potent and selective inhibitors of TTK and PLK4, respectively, have been accepted for presentation at the 2022 San Antonio Breast Cancer Symposium (SABCS) being held from December 6-10, 2022 at the Henry B. Gonzalez Convention Center in San Antonio, Texas.

“We are grateful that several abstracts highlighting our TTK and PLK4 inhibitor programs have been selected for presentation,” said Dr. Michael Tusche, Treadwell co-CEO. “We look forward to additional data from these studies, as we further characterize the utility of our agents in various breast cancer settings.”

Information on the four abstracts:

Abstract Title: An Update to a Phase I Trial of CFI-402257, an oral TTK Inhibitor, in Patients with Advanced Solid Tumors with HER2-Negative Breast Cancer Expansion Cohorts
Poster ID: P6-10-13
Session: Treatment: Therapeutic Strategies – Novel Targets and Targeted Agents
Date: Friday, December 9, 2022
Time: 7:00 am CT

Abstract Title: CCTG IND.236: A Phase 1b Trial of Combined CFI-402257 and Weekly Paclitaxel in Patients with HER2 Negative (HER2-) Advanced Breast Cancer (aBC)
Poster ID: P3-07-10
Session: Treatment: Therapeutic Strategies – New Drugs and Treatment Strategies
Date: Wednesday, December 7, 2022
Time: 5:00 pm CT

Abstract Title: CCTG IND.237: A phase II study of CFI-400945 in patients with advanced/metastatic HER2-negative breast cancer
Poster ID: P3-07-14
Date: Wednesday, December 7, 2022
Time: 5:00 pm CT

Abstract Title: CCTG IND.239: A Phase 2 Study of Combined CFI-400945 and Durvalumab in Patients with Advanced Triple Negative Breast Cancer (aTNBC)
Poster ID: P3-07-18
Date: Wednesday, December 7, 2022
Time: 5:00 pm CT

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

Treadwell Therapeutics Announces A Presentation at the 2022 SITC Annual Meeting Featuring a Clinical Trial Update on CFI-402411, a First-in-Class HPK1 inhibitor

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NEW YORK, Nov. 11, 2022 /PRNewswire/ — Treadwell Therapeutics, a clinical-stage biotechnology company developing novel medicines cancer, today announced a presentation for CFI-402411, an oral, first-in-class inhibitor of Hematopoietic Progenitor Kinase 1 (HPK1), a negative regulator of immune cell activation, at the 37th Society for Immunotherapy of Cancer (SITC) Annual Meeting being held virtually and in-person from November 8-12, 2022 at the Boston Convention and Exhibition Center in Boston, MA. This presentation will provide an interim update from the ongoing TWT-101, a Treadwell-sponsored, first in human study of CFI-402411 in advanced solid tumors.

“Inhibition of HPK1 with CFI-402411 could represent a safe and effective means to stimulate anti-tumor immunity. We continue to observe good tolerability and emerging signs of clinical activity, including in patients that have failed anti-PD1 therapy” said Dr. Omid Hamid, Chief of Research/ Immuno-Oncology at The Angeles Clinic & Research Institute, a Cedars-Sinai affiliate, Los Angeles, California.

“We are encouraged by the emerging clinical profile of CFI-402411,” said Dr. Michael Tusche, co-Chief Executive Officer at Treadwell Therapeutics. “We hope to define the Recommended Phase 2 dose for the molecule in the near term and are excited about the next stage of development for CFI-402411 both as a monotherapy and in combination with checkpoint blockade.”

2022 SITC Poster Presentations and Details

TWT-101: A First-In-Clinic, Phase 1/2 Study Of CFI-402411, a Hematopoietic Progenitor Kinase-1 (HPK1) Inhibitor, as a Single Agent and in Combination with Pembrolizumab in Subjects with Advanced Solid Malignancies
Publication Number: 750
Poster Hall
Date and Time: November 11, 2022, 7:00 am – 8:30 pm

In the presentation titled, “TWT-101: A First In-human, Phase 1/2 Study of CFI-402411, Hematopoietic Progenitor Kinase-1 (HPK1) Inhibitor, as a single agent and in combination with pembrolizumab in subjects with advanced solid malignancies,” CFI-402411 demonstrated a clinically manageable safety profile at doses up to 560 mg QD with exposures increasing proportionately with dose. In the efficacy evaluable population (N=31), 2 patients achieved partial response as best response. Both of responses were in Head and Neck Squamous Cell Carcinoma (HNSCC) patients previously treated with pembrolizumab. One patient was treated as a monotherapy (400 mg) and the other treated in combination (60 mg + pembrolizumab) with 36% and 81% reduction in target lesions, respectively. Nine patients had best response as stable disease and stayed on study for at least 4 cycles. The most common treatment emergent toxicities of any grade, which occurred in greater than 10% of patients, were diarrhea (61%), fatigue (39%), nausea (33%), decreased appetite (30%), vomiting (26%), dehydration (17%), ALT increase (15%). dyspepsia (15%) and back pain (11%).

About CFI-402411

CFI-402411 is a highly potent inhibitor of HPK1, which in preclinical studies has been shown to have an immune-activating effects including the alleviation of inhibition of T cell receptors (TCR), disruption of abnormal cytokine expression, alteration of the tumor immunosuppressive environment through effector cells (i.e. Regulatory T cells or Treg), and potent anti-leukemic effects in several mouse models.

About TWT-101

TWT-101 is a Phase 1/2 clinical trial of CFI-402411 in advanced solid malignancies. The study is designed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of CFI-402411, as well as to determine optimal dosing as a monotherapy and in combination with the anti-PD1 antibody, pembrolizumab. The trial could enroll up to 170 patients at up to 15 sites in North America and Asia. It will involve 5 arms including monotherapy and combination dose escalation and expansion in a variety of tumor types, as well as biomarker backfills.

About Treadwell Therapeutics

Treadwell Therapeutics is a science driven, clinical-stage multi-modality oncology company. The company is developing first-in-class and best-in-class medicines to address unmet needs in patients with cancer. The Company’s robust, internally developed pipeline includes a first-in-class PLK4 kinase inhibitor, CFI-400945 and a best-in-class TTK inhibitor, CFI-402257, and CFI-402411. Treadwell also has a rapidly advancing pre-clinical pipeline with multiple biologic and next generation TCR based autologous cell therapy programs. For more information, please visit www.treadwelltx.com.

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Investors:
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Treadwell Announces Initiation of Patient Dosing in TWT-203, a Phase 1b/2 study of TTK Inhibitor, CFI-402257, in Patients with ER+/Her2- Breast cancer

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NEW YORK and HONG KONG, June 13, 2022 /PRNewswire/ — Treadwell Therapeutics, a clinical-stage biotechnology company developing novel medicines for unmet needs in cancer, today announced the initiation of patient dosing in TWT-203, its Phase 1b/2 study to evaluate CFI-402257, an oral, best-in-class inhibitor of Threonine Tyrosine Kinase (TTK, also known as MPS1) in patients with advanced solid tumors and ER+/Her2- breast cancer. Dosing of the first patient in the trial commenced June 8th at START Mountain Region in Salt Lake City, Utah.

“Inhibition of TTK, a key mitotic checkpoint, with CFI-402257 represents a novel treatment approach for ER+/Her2-breast cancer, particularly in the context of CDK4/6 inhibitor failure” said Principal Investigator, Dr. Justin A. Call, MD, Director of Clinical Research at START Mountain Region in Salt Lake City, Utah.

“We are excited about the initiation of TWT-203 with our potent and selective TTK inhibitor,” said Dr. Michael Tusche, Treadwell co-CEO. “Previous clinical studies have demonstrated that CFI-402257 has a tolerable safety profile and confirmed responses in ER+/Her2- breast cancer after progression on CDK4/6 inhibitors. We look forward to the continued development of this molecule in breast cancer.”

The Phase 1b/2 clinical trial of CFI-402257 is an open-label, multi-center, dose optimization study designed to assess the safety, tolerability, pharmacokinetic and pharmacodynamic profiles of CFI-402257 as a single agent in advanced solid tumors or in combination with fulvestrant in ER+/Her2- Breast Cancer patients after disease progression on prior CDK4/6 inhibitor and endocrine therapy. The trial will enroll approximately 40 patients at up to 10 sites in the United States. It will include a dose confirming portion in advanced solid tumors and expansions at the Recommended Phase 2 dose as a monotherapy in solid tumors and in combination with fulvestrant in breast cancer patients.

About Treadwell Therapeutics

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

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Investors:
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General inquiries:
info@treadwelltx.com

Treadwell Therapeutics Announces Fast Track Designation Granted by the FDA to CFI-400945 for the Treatment of Acute Myeloid Leukemia

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NEW YORK and HONG KONG, April 26, 2022 /PRNewswire/ — Treadwell Therapeutics, a clinical-stage biotechnology company developing novel medicines for unmet needs in cancer, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to CFI-400945, a first in class inhibitor of Polo-like kinase 4 (PLK4), for the treatment of adult patients with relapsed or refractory Acute Myeloid Leukemia (AML).

“Although several exciting new classes of medicines have emerged in the past decade for patients with AML, there still remains an unmet need for certain patient segments, where survival rates remain low,” said Dr. Michael Tusche, Treadwell co-CEO. “CFI-400945, has shown encouraging signs of monotherapy activity in AML patients with adverse cytogenetics. We are grateful for the Fast Track Designation for this exciting program, and look forward to frequent interactions with the FDA to chart our regulatory path forward, as we continue the development of ‘945 in leukemia.”

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 AML

AML is a disease characterized by uncontrolled proliferation of malignant clonal hematopoietic stem cells which can lead to anemia, neutropenia, and thrombocytopenia. If left untreated, AML can lead to death within weeks. In the US, an estimated 19,940 new cases of AML were expected to be diagnosed and approximately 11,180 deaths attributed to AML, nearly all in adults. AML is generally a disease of the elderly with an average age of 68 years at the time of diagnosis and is more common in men than women. For adults <65 years of age, the 5-year survival is approximately 33%, but drops dramatically to 4% in adults >65 years of age.

About Treadwell Therapeutics

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

Contact

Investors:
ir@treadwelltx.com

General inquiries:
info@treadwelltx.com

Treadwell Therapeutics Announces the Appointment of J.D. Mowery, as Chief Operating Officer

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NEW YORK and HONG KONG, April 19, 2022 /PRNewswire/ — Treadwell Therapeutics (“Treadwell“), a clinical-stage biotechnology company developing novel, cross-modality medicines for unmet needs in cancer, announced today the appointment of J.D. Mowery as Chief Operating Officer (COO). Reporting into the office of the CEO, J.D. will play an integral role in the continued evolution of Treadwell Therapeutics, leveraging his 20 years of industry experience and technical acumen.

“J.D. is a key addition to Treadwell’s culture of purpose,” said Shane Burgess, co-CEO of Treadwell. “We are delighted to welcome J.D. into our organization. We are confident his operational experience in multiple modalities will bring significant value to Treadwell,” added Michael Tusche, Ph.D., co-CEO of Treadwell.

J.D. has worked across multiple disciplines within the small molecule, mammalian, microbial, cell therapy and viral vector sectors, all while leading both drug product and drug substance organizations. He has also spent time on both the innovator and contract manufacturing side of the industry, gaining experience in contract negotiation, business development, and securing critical investments. During his time at Genentech, Lonza, Juno/Celgene, and most recently AGC Biologics, he has been continually recognized as an inspiring leader and mentor for his teams.

“My career has taken me in many different directions but I have always made those choices with a deep focus on learning and growing,” said J.D. Mowery, COO of Treadwell. “The opportunity to join an organization that brings together all of my past experiences alongside such amazing vision, leadership, and devotion to the patient is a dream come true.”

J.D. earned a Bachelor of Science from George Fox University and a Master of Business Administration at Marylhurst University, both in Oregon. He is widely considered an industry expert and thought leader on topics such as aseptic processing, cell & gene therapies, facility design, and contract manufacturing.

About Treadwell Therapeutics

Treadwell Therapeutics is a science driven, clinical-stage multi-modality oncology company developing first-in-class and best-in-class medicines to address unmet needs in patients with cancer. Treadwell’s robust, internally developed pipeline includes a first-in-class PLK4 kinase inhibitor, CFI-400945 and a best-in-class TTK inhibitor, CFI-402257, and CFI-402411, an oral immunomodulatory kinase inhibitor with activity toward HPK1. Treadwell also has a strong pre-clinical pipeline with multiple biologic and next generation TCR based autologous cell therapy programs. For more information, please visit www.treadwelltx.com.

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Investors:
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Treadwell Therapeutics and University Health Network Sign Licensing Agreement for pre-clinical biologic and small molecule assets

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NEW YORK and HONG KONG and TORONTO , April 6, 2022 /PRNewswire/ — Treadwell Therapeutics today announced that it has entered into a license agreement with the University Health Network (UHN) in Toronto, Canada for four novel oncology target programs, including a deep estate of pre-clinical therapeutic candidates including both antibodies and small molecules. These programs were initiated and validated by the therapeutics team at UHN’s Campbell Family Institute at the Princess Margaret Cancer Centre, which previously drove the development of Treadwell’s small molecule pipeline from concept to clinic. The terms of the agreement, as well as the identity of the targets, were not disclosed.

“It is extremely gratifying to have the opportunity to build on the legacy of innovation represented in these programs within Treadwell. This expansion of our preclinical pipeline aligns with Treadwell’s commitment to continue to deliver effective, first-in-class therapeutic options for cancer patients. We look forward to further validating these assets and selecting a development candidate for the most advanced program in 2022.” said Dr. Mark Bray, Treadwell CSO and co-founder. “Our goal at Treadwell is to leverage novel scientific insight into a multi-modality pipeline. With small molecule, cell therapy and now biologic candidates, we are well on our way to achieving that goal.” added Dr. Michael Tusche, Treadwell co-CEO.

“We are pleased to expand our commercialization partnership further with Treadwell, a UHN spinout company, with these newest license deals. Treadwell’s deeply experienced team is a sound choice to be taking UHN’s world-class medical technologies forward,” says Mark Taylor, Director, Commercialization at UHN.

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 (PLK4 inhibitor), CFI-402257 (TTK inhibitor), and CFI-402411 (HPK1 inhibitor). For more information, please visit www.treadwelltx.com.

Contact

Investors:
ir@treadwelltx.com