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

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

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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

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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.

Contact

Investors:
ir@treadwelltx.com

General inquiries:
info@treadwelltx.com

Treadwell Therapeutics Announces a Presentation at the 2021 SITC Annual Meeting Featuring a Clinical Trial Update on CFI-402411, a First-in-Class HPK1 inhibitor

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November 12, 2021

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Treadwell Therapeutics Announces Acquisition of TCRyption Inc., a Novel TCR-Based T Cell Therapy Company and TIO Bioventures Portfolio Company

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October 15, 2021

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Treadwell Expands Operations with New Local Footprint at Toronto’s University Health Network

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Leading new oncology start-up establishes its research and development base at the Princess Margaret Cancer Research Tower

Toronto, February 10, 2021 — Following a very successful 2020, UHN spin-out Treadwell Therapeutics continues its global growth with the recent opening of its 9000 square-foot research and development facility in February 2021 at Toronto’s University Health Network, Canada’s leading research hospital. Treadwell’s footprint in Toronto is an important addition to Ontario’s emerging biotechnology cluster with the hire of 17 employees and a focus on current programs involving small molecules, biologics, TCR-based cell therapy and novel platforms for target discovery and validation.

“Treadwell is a company with global aspirations and deep roots in Toronto,” said Dr. Michael W. Tusche, co-CEO. “We see a tremendous talent pool and favourable environment that allows us to grow our team locally and to continue to contribute to the life science innovation ecosystem in Canada.”

“We are pleased to see Treadwell begin operations right here in Toronto,” says Mark Taylor, Director, Technology Development & Commercialization, UHN. “We consider it vitally important to support our companies, and we have shown that proximity creates new opportunities for collaboration that keeps companies in Canada.”

About Treadwell Therapeutics

Treadwell Therapeutics is a clinical-stage oncology company exploiting cancer cells’ vulnerabilities to develop first-in-class and best-in-class therapeutics to address unmet needs in patients with cancer.

The Company’s robust, internally developed clinical pipeline includes a first-in-class PLK4 kinase inhibitor, CFI-400945 and a potentially best in class TTK inhibitor, CFI-402257 ready for Phase 2, and CFI-402411, an oral immunomodulatory kinase inhibitor with activity toward HPK1 in Phase 1/2 studies. For more information, please visit www.treadwelltx.com

Contact

Investors:
ir@treadwelltx.com

General inquiries:
info@treadwelltx.com