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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

June 13, 2022/in 2022, news/by Vladimir Vinogradov

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

April 26, 2022/in 2022, news/by Vladimir Vinogradov

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

April 19, 2022/in 2022, news/by Vladimir Vinogradov

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.

Contact

Investors:
ir@treadwelltx.com

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

April 10, 2022/in 2022, news/by Vladimir Vinogradov

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

Treadwell Therapeutics Announces A Presentation at the 2021 SABCS Annual Meeting Featuring a Clinical Trial Update on CFI-402257, a Best-in-Class TTK inhibitor

December 8, 2021/in 2021, news/by Emily Hennes

New York and Hong Kong – December 8th, 2021 – Treadwell Therapeutics, today announced a presentation for the Company’s CFI-402257 program, an oral, best-in-class TTK inhibitor, at the 2021 San Antonio Breast Cancer Symposium (SABCS) being held from December 7-10, 2021. This presentation will describe dose escalation and expansion data from CFI-402257-CL-001, an investigator-initiated study of CFI-402257 in advanced solid tumors.

“The anti-tumor activity observed with CFI-402257 alone or in combination with Fulvestrant in patients with ER+/Her2- breast cancer, including patients previously treated with CDK4/6 inhibitors, is encouraging and warrants further investigation” said Dr. Phillipe Bedard, Study investigator, Associate Professor of Medicine at the University of Toronto and Staff Medical Oncologist at the Princess Margaret Cancer Centre, Toronto, Canada. “We look forward to additional data from this study, as well as the initiation of our company sponsored TWT-203 trial in ER+/Her2- breast cancer,” added Dr. Michael Tusche, Treadwell co-CEO.

2021 SABCS Poster Presentations and Details:
CFI-402257-CL-001: An Open-Label, Dose Escalation, Safety, and Pharmacokinetic Study of CFI-402257
Administered Orally to Patients with Advanced Solid Tumors
Poster Number: P1-18-17
Date: December 8th, 7:00 am – 8:30 pm

In this presentation, CFI-402257 demonstrated a tolerable safety profile at doses up to 168 mg QD and linear pharmacokinetics, with 168 mg as the RP2D. In this heavily pre-treated, all-comer patient population (N=67), 25 patients (53.2%) showed disease control (SD+PR+CR) and 5 patients showed confirmed PRs (10.6%), 4 patients with ER+/Her2- breast cancer and 1 with hepatocellular carcinoma. Two of the breast cancer patients were treated with monotherapy and two were treated in combination with fulvestrant. The median duration of response for the breast cancer patients was 256 days with PRs coming after only 2 cycles. The most common drug related toxicities of any grade, which occurred in greater than 10% of patients, were nausea (29.9%), fatigue (22.4%), decreased appetite (20.9%), diarrhea (16.4%), vomiting (13.4%), neutrophil count decrease (11.9%), alopecia (10.4%), neutropenia (10.4%), and white blood cell count decrease (10.4%).

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

Treadwell Announces Two Presentations at the 2020 ASH Annual Meeting Featuring Clinical Trial Updates on Lead Product Candidate, CFI-400945

December 7, 2021/in 2020, news/by Emily Hennes

December 7, 2020

Treadwell Therapeutics Announces US FDA Clearance of IND Application for Phase 2 Study of TTK inhibitor, CFI-402257

November 30, 2021/in 2021, news/by Emily Hennes

New York and Hong Kong – November 30th, 2021 – Treadwell Therapeutics, a clinical stage biotechnology company developing novel therapeutics for highly aggressive cancers, today announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application to evaluate CFI-402257, an oral, first-in-class inhibitor of Threonine Tyrosine Kinase (TTK, also as MPS1) in advanced solid tumors and breast cancer.

“TTK is a critical component of the Spindle Assembly Checkpoint and potentially represents a tumor specific vulnerability. Pharmacologic inhibition of TTK using CFI-402257 causes tumor cells to prematurely exit mitosis, leading to increased genomic instability and cell death,” said Dr. Mark Bray, Treadwell Chief Scientific Officer and Co-Founder. “CFI-402257 was developed from concept to clinic by our world class team. Preclinical studies and emerging clinical evidence support the use of CFI-402257 in the context of CDK4/6 inhibitor failure in ER+/Her2- breast cancer, a segment where there is a strong unmet need. We are excited by the promise of the molecule in advanced breast cancer and beyond” added Dr. Michael Tusche, Treadwell co-Chief Executive Officer.

Under this IND, Treadwell intends to initiate a Phase 2 clinical trial of CFI-402257 in the first quarter of 2022. This clinical trial is designed to confirm previously efficacious doses and to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of CFI-402257 as a single agent in advanced solid tumors, and in combination with fulvestrant in patients with ER+/HER2- advanced breast cancer after disease progression on prior CDK4/6 inhibitor and endocrine therapy. Start-up activities are currently underway.

CFI-402257 is a highly bioavailable, potent and selective inhibitor of TTK. Preclinical studies showed robust inhibition of tumor growth in a wide variety of xenograft models. CFI-402257 also demonstrated durable activity and a manageable safety profile as a single agent and in combination with fulvestrant in advanced ER+ breast cancer in studies conducted at select Canadian sites.

About Treadwell Therapeutics

Treadwell Therapeutics is a science driven, clinical-stage, multi-modality biotechnology company spun out of the University Health Network (UHN) in Toronto. The company is developing first-in-class and best-in-class medicines to address unmet needs in patients with cancer. Founded by a cadre of pre-eminent scientific luminaries, including Dr. Tak W. Mak, the Company’s robust, internally developed clinical pipeline includes CFI-400945 (PLK4 inhibitor), 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 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 Closing of a $91 Million Series B Financing

November 18, 2021/in 2021, news/by Emily Hennes

Proceeds will fund the continued clinical development of CFI-400945, CFI-402257 and CFI-402411, the preclinical development of the Biologics and Cell Therapy platform, as well as general corporate purposes

Financing led by Sino Biopharmaceutical Limited and 3W Fund and includes other healthcare focused funds

New York and Hong Kong – November 18th, 2021 – Treadwell Therapeutics, a clinical-stage biotechnology company developing novel, cross-modality medicines for unmet needs in cancer, today announced the closing of an oversubscribed Series B financing, which raised more than $91 million. The financing was led by Sino Biopharmaceutical Limited and 3W Fund Management Limited (“3W Fund”), and included new investors including renowned culture entrepreneur and investor Mr. Adrian Cheng, Prosperous Alliance, Alpha Win Capital, Fortune Ocean Growth Fund L.P. and, along with existing investors TIO Bioventures, and other undisclosed institutional and individual investors.

“Our team is very excited to announce the closing of this transformative Series B financing, and are very grateful to our investors, both old and new, for their belief, commitment and support of our goal to build a globally impactful Biotechnology organization,” said Shane Burgess, Chairman and co-CEO of Treadwell Therapeutics. “Since our company was founded in July 2019, we have made significant strides in building and validating our clinical stage small molecule portfolio, as well as broadening our pre-clinical pipeline of novel biologic and cell therapy assets. The funding will allow us to further the development of our product candidates, as well as to continue building out our organization in all functions with the talent necessary to support our mission, which is to translate novel scientific insights into hope for patients in need,” added Dr. Michael Tusche, co-CEO of Treadwell Therapeutics.

“Treadwell Therapeutics is a company steeped in world class science and has an exciting pipeline of first in class drugs with compelling signs of clinical activity,” said Dr. Mao Li, Chief Medical Officer at Sino Biopharmaceutical Limited. “We are excited to be part of Treadwell in the next phase of its growth.”

“We are excited to support Treadwell to further develop its strong pipeline of first in class drugs to help patients worldwide.” said Cathy Chen of 3W Fund. “We look forward to significant growth of Treadwell in the near future.”

The proceeds from this financing will allow Treadwell to continue the clinical and pre-clinical development of its broad, multi-modality pipeline. This includes the company sponsored TWT-101 study of CFI-402411 in advanced solid tumors as a monotherapy and in combination with pembrolizumab; the company sponsored TWT-202 study of CFI-400945 in leukemia as a monotherapy and in combination with decitabine or azacitidine, an IND filing in late 2021 and subsequent company sponsored study of CFI-402257 in metastatic ER+ Breast cancer, as well as other opportunistic trials. The Series B financing will also support Treadwell’s continued development and validation of its preclinical pipeline of novel biologic and cell therapy approaches, the latter of which is expected to enter the clinic around early 2023. Lastly, the funding will allow Treadwell to continue to grow and operationalize the organization with world class talent and infrastructure.

About Treadwell Therapeutics

Treadwell Therapeutics is a science driven, clinical-stage, multi-modality oncology company, spun out of the University Health Network (UHN), in Toronto, Canada. The company is developing first-in-class and best-in-class medicines to address unmet needs in patients with cancer. Founded by a cadre of pre-eminent scientific luminaries, including Dr. Tak W. Mak, the Company’s robust, internally developed clinical stage 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 robust pre-clinical pipeline with multiple biologic and next generation TCR based autologous cell therapy programs. For more information, please visit www.treadwelltx.com.