Treadwell Announces Ocifisertib, a First-in-Class PLK4 Inhibitor, has Received Orphan Designation from U.S. FDA for the Treatment of Acute Myeloid Leukemia

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TORONTO & SAN FRANCISCO–(BUSINESS WIRE)–Treadwell Therapeutics, a privately held clinical-stage biotechnology company pioneering and advancing novel first-in-class medicines for unmet needs in cancer, today announced the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to ocifisertib (CFI-400945), a first-in-class, investigational PLK4 inhibitor for the treatment of acute myeloid leukemia (AML). Ocifisertib is currently being evaluated in a Phase 1b/2 study in adults with relapsed/refractory AML following standard of care therapy.

Orphan drug designation is granted by the FDA to drugs intended for treatment, prevention or diagnosis of a rare disease or condition that affects fewer than 200,000 people in the U.S. at the time of designation. Under the FDA’s Orphan Drug Act, orphan drug status provides incentives, grants, tax credits and waiver of certain administrative fees as well as seven years of market exclusivity following marketing authorization.

Treadwell also announced today the appointment of Brenda Marczi, as SVP and Head of Regulatory Affairs. Brenda comes to Treadwell with over 30 years of regulatory experience in the pharmaceutical and biotechnology industries. She most recently served as Senior Vice President, Regulatory Affairs at Tracon Pharmaceuticals, Inc., where she oversaw their regulatory function and led all of their strategies and filing activities in the US and UK. Brenda holds a Master of Science in Pharmaceutical Sciences from Rutgers University, a PharmD from the University of Maryland, and an MBA from Wharton, University of Pennsylvania.

“The FDA’s decision to grant orphan drug designation, along with the previous FDA Fast Track designation for ocifisertib underscores Treadwell’s dedication to addressing this patient population with few treatment options. Patients with relapsed and/or refractory AML, in particular TP53 mutated disease suffer poor overall survival and represents a high unmet clinical need,” said Roger Sidhu, M.D., Acting CEO of Treadwell. “We look forward to advancing ocifisertib in partnership with investigators, regulators, patients and their families for those with limited treatment options in tough to treat AML. In addition, we are thrilled to have Brenda join us to lead Regulatory Affairs at Treadwell. She is a seasoned strategic leader with a broad experience in leading regulatory strategy from early development through approval. Her leadership will be invaluable to Treadwell as we advance ocifisertib into potentially pivotal studies in 2025.”

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 the Formation and Members of Scientific Advisory Board

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TORONTO & SAN FRANCISCO–(BUSINESS WIRE)–Treadwell Therapeutics, a privately held clinical-stage biotechnology company pioneering and advancing novel first-in-class medicines for unmet needs in cancer, today announced the formation of a Scientific Advisory Board comprised of prominent oncology leaders and drug developers. The SAB will work closely with Treadwell to advance the company’s pipeline of small molecules, biologics and cell therapies.

“We are delighted and honored to be working with this prestigious group of innovators and thought leaders as our Scientific Advisory Board. We are very much looking forward to collaborating with this group to inform and shape our research and development efforts in advancing our pipeline,” said Roger Sidhu, M.D., Acting CEO of Treadwell. “This SAB brings tremendous experience in advancing novel therapeutics in oncology from early to late stage development including drug approvals. We are confident that this group will be invaluable in supporting the development of our pipeline with a focus on our lead program CFI-400945, a PLK4 inhibitor currently being advanced in AML.”

The founding members of the Treadwell Scientific Advisory Board are:

Antoni Ribas, M.D., Ph.D., is currently Professor of Medicine, Surgery, and Molecular and Medical Pharmacology at the University of California Los Angeles (UCLA), directory of the Tumor Immunology Program at the Jonsson Comprehensive Cancer Center and director of the Parker Institute for Cancer Immunotherapy at UCLA. Dr. Ribas has played a pivotal role in the development and approval pembrolizumab in advanced melanoma and multiple additional drugs in this disease. Dr. Ribas was formerly President of the American Association for Cancer Research and has been elected to the National Academy of Medicine.

Carl June, M.D., is the Richard W. Vague Professor in Immunotherapy in the Department of Pathology and Laboratory Medicine in the Perelman School of Medicine at the University of Pennsylvania and director of Center for Cellular Immunotherapies at the University of Pennsylvania. Dr. June is internationally recognized for his role in pioneering CAR-T cell therapy which led to the first FDA-approved cellular therapy for children and young adults with acute lymphoblastic leukemia. Dr. June has published more than 500 manuscripts and is the recipient of multiple prestigious scientific achievement awards and is a member of the National Academy of Medicine and the National Academy of Sciences.

Pasi A. Jänne, M.D., Ph.D., is a world renowned translational medical oncologist and the Senior Vice President of Translational Medicine at Dana-Farber Cancer Institute and Professor of Medicine at Harvard Medical School. He is the Director of the Belfer Center for Applied Cancer Science. He was a co-discoverer of epidermal growth factor receptor (EGFR) mutations that has led to the development of multiple therapeutic strategies for patients with EGFR mutant lung cancer. Dr. Jänne has received the 2024 Medal of Honor from the American Cancer Society and multiple awards from ASCO, AACR and ESMO.

S. Gail Eckhardt is Associate Dean of Experimental Therapeutics at Baylor College of Medicine and Associate Director of Translational Research at the Dan L Duncan Comprehensive Cancer Center. Dr. Eckhardt has served on numerous committees and study sections, including the ASCO Molecular Oncology Task Force, the ASCO Board of Directors, the FDA Oncology Drugs Advisory Committee, and the National Cancer Institute (NCI) Cancer Centers Study Section. She serves on 10 external advisory boards of NCI-designated cancer centers, is a past member of the Board of Directors of the Association of American Cancer Institutes (AACI) and previous Chair of the Cancer Prevention and Research Institute of Texas’ (CPRIT) Clinical Trials Advisory Committee. She is a current member of the National Academies of Science, Engineering, and Medicine’s Cancer Policy Forum. Dr. Eckhardt serves on the Board of Directors of Syros Pharmaceuticals and Exelixis and the Scientific Advisory Board of Amgen.

Lillian L Siu, M.D., FRCPC, is an internationally recognized expert in the development of novel cancer therapeutics. Dr. Siu is a senior medical oncologist at the Princess Margaret Cancer Centre and a Professor of Medicine at the University of Toronto. She is the Director of the Phase I Program and Co-Director of the Bras and Family Drug Development Program at the Princess Margaret Cancer Centre, and holds the BMO Chair in Precision Genomics. Dr. Siu served on the Board of Directors for the American Society of Clinical Oncology (ASCO) and the American Association for Cancer Research (AACR). Internationally, Dr. Siu was the recipient of the US NCI Michaele C. Christian Award in Oncology Drug Development in 2010. She was awarded the TAT 2020 Honorary Award for contributions in the development of anticancer drugs. In 2023, Dr. Siu is currently the co-Editor-in-Chief for AACR’s newest journal Cancer Research Communications and is on the editorial board for Cell and Cancer Cell.

Patricia LoRusso, has been a practicing academic medical oncologist performing clinical/translational research in early phase clinical trials for over 30 years, and is currently the Associate Director of Experimental Therapeutics at the Yale Cancer Center and director of their Early Phase Clinical Trials Program. She has had continuous NIH/NCI peer review funding for over 28 years, as well as numerous other team science grants, including SPORE funding and other funding mechanisms such as Stand Up to Cancer (Co-Leader: Melanoma Dream Team), the Department of Defense (DOD) and the Komen Foundation (Co-leader, KG111063:Targeting Stem Cells in Triple-Negative Breast Cancer (TNBC) in Different Racial Populations). In addition to serving in NCI extramural positions, Dr. LoRusso is currently serving a 3-year term as the chair of their New Agents Committee (NAC), committees for the Cancer Research United Kingdom (CRUK). Dr. LoRusso has also served in leadership positions of several other organizations, including the Board of Directors and current President-elect of the AACR, and education and scientific committees of the ASCO. Internationally, she has taught several clinical trials educational workshops, educating many physicians and scientists across the globe. Working closely over the past 3 decades with patients suffering from advanced malignancies, Dr. LoRusso has become an advocate, not only for cancer researchers and clinicians, but more importantly for the patients and their caregivers.

Tak Wah Mak, Ph.D., co-founder of Treadwell Therapeutics, is one of the world’s most cited and accomplished scientists. Dr. Mak is currently a Senior Scientist at Princess Margaret Cancer Centre, Director of the Campbell Family Institute for Breast Cancer Research and Professor, Department of Medical Biophysics at the University of Toronto. Dr. Mak is credited with the discovery of the T-cell receptor and pioneering work in the genetics of immunology, including publishing a landmark paper on the discovery and function of the immune checkpoint protein CTLA-4. Dr. Mak is also the founder of Agios Pharmaceuticals, whose lead compound, IDHIFA®, was approved by the FDA for acute myelogenous leukemia in 2017. Dr. Mak has served as author on over 1000 peer-reviewed articles. Dr. Mak is a Fellow of the AACR Academy, has received honorary degrees from many universities around the world and has received various international awards such as the Paul Ehrlich Prize, the Ludwig Darmstaeder Prize and most recently the 2023 International Award for Extraordinary Achievement in Cancer Research from the Pezcoller Foundation and the American Association for Cancer Research (AACR).

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 a Presentation at the 2023 ASH Annual Meeting and Advisory Board Meeting

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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

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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

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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

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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

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.

Contact

Investors:
ir@treadwelltx.com

General inquiries:
info@treadwelltx.com

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.

Contact

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.

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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.

Contact

Investors:
ir@treadwelltx.com

General inquiries:
info@treadwelltx.com