Cambridge, MA – November 25, 2024 – Flare Therapeutics Inc., a clinical-stage biotechnology company targeting transcription factors to discover precision medicines for oncology and other therapeutic areas, today announced that the company will participate in two upcoming investor conferences in December:
About Flare Therapeutics Inc.
Flare Therapeutics is a biotechnology company exclusively focused on drugging transcription factors to fully unlock the therapeutic potential of this previously elusive target class. Flare Therapeutics’ integrated discovery engine converges rich genetic, biochemical, and chemical insights to reveal druggable pockets and identify small molecule ligands capable of modulating transcription factors of high therapeutic potential. Flare Therapeutics’ proteomic and mass spectrometry platform is powered by a proprietary library of electrophilic compounds unique to Flare Therapeutics. Since its inception, Flare Therapeutics has rapidly established an emerging pipeline of programs, highlighted by FX-909, a first-in-class investigational orally bioavailable small molecule inhibitor of PPARG, a master regulator of the luminal lineage in advanced urothelial cancer that is currently in a Phase I study. Additionally, Flare Therapeutics has advanced a second program with a differentiated mechanism for prostate cancer entering the Investigational New Drug (IND)-enabling stage, along with an earlier-stage portfolio targeting transcription factors involved in oncology and other therapeutic areas. For more information, please visit www.flaretx.com and follow us on LinkedIn.
Contacts:
Investors:
investorrelations@flaretx.com
Media:
media@flaretx.com
Collaboration will leverage Flare Therapeutics’ proteomic and mass spectrometry platform and expertise, powered by its proprietary library of electrophilic compounds, to discover novel small molecules aimed at transcription factor targets in oncology
Flare Therapeutics to receive US $70 million upfront, and potential milestone payments exceeding US$1.8 billion, as well as royalties
Cambridge, MA – November 12, 2024 – Flare Therapeutics Inc., a clinical-stage biotechnology company targeting transcription factors to discover precision medicines for oncology and other therapeutic areas, today announced it has entered into a strategic discovery collaboration with Roche (SIX: RO, ROG; OTCQX: RHHBY). This partnership will leverage Flare Therapeutics’ proteomic and mass spectrometry platform and expertise, powered by its proprietary library of electrophilic compounds, to discover novel small molecule drugs aimed at previously undrugged transcription factor targets in oncology.
“Roche is an ideal partner for Flare Therapeutics because we share a commitment to tackling the most challenging disease areas with novel approaches and overcoming the difficulties of drugging transcription factors. Our platform and expertise have rapidly generated a clinical-stage pipeline, demonstrating the strong potential of our approach. This collaboration will accelerate the expansion of our capabilities, enabling us to develop treatments for transcription factors implicated in indications with high unmet needs. Together with Roche’s expertise, our objective is to successfully pursue challenging transcription factor targets, with the ultimate goal of providing novel interventions for patients who are not currently served by standard-of-care therapies,” said Rob Sims, Ph.D., Chief Scientific Officer and Co-founder of Flare Therapeutics.
“We are excited to join forces with Flare Therapeutics, combining our leading expertise and global reach in oncology with Flare Therapeutics’ deep knowledge in drug discovery for difficult-to-drug transcription factor targets. Transcription factors play a crucial role in various oncological diseases and have the potential to address high unmet medical needs. We are looking forward to developing therapeutic options never possible before,” said Boris L. Zaïtra, Head of Roche Corporate Business Development.
As part of the collaboration, Flare Therapeutics will receive a US$70 million upfront cash payment and is eligible to receive discovery, development, and commercialization milestone payments potentially exceeding US$1.8 billion and royalties. Flare Therapeutics will lead discovery and preclinical activities targeting multiple transcription factor targets in oncology, while Roche will pursue the further preclinical and clinical development and commercialization of potential products from the collaboration, leveraging its industry-leading capabilities in oncology.
Additionally, Flare Therapeutics retains a right to co-fund development for one target under the collaboration in exchange for increased royalties in the United States for this target. Flare Therapeutics will retain ownership of its existing pipeline, including its lead clinical-stage program, FX-909, in advanced urothelial cancer, its prostate cancer program entering IND-enabling studies, and other programs in discovery and early development in oncology and other therapeutic areas.
About Flare Therapeutics Inc.
Flare Therapeutics is a biotechnology company exclusively focused on drugging transcription factors to fully unlock the therapeutic potential of this previously elusive target class. Flare Therapeutics’ integrated discovery engine converges rich genetic, biochemical, and chemical insights to reveal druggable pockets and identify small molecule ligands capable of modulating transcription factors of high therapeutic potential. Flare Therapeutics’ proteomic and mass spectrometry platform is powered by a proprietary library of electrophilic compounds unique to Flare Therapeutics. Since its inception, Flare Therapeutics has rapidly established an emerging pipeline of programs, highlighted by FX-909, a first-in-class investigational orally bioavailable small molecule inhibitor of PPARG, a master regulator of the luminal lineage in advanced urothelial cancer that is currently in a Phase I study. Additionally, Flare Therapeutics has advanced a second program with a differentiated mechanism for prostate cancer entering the Investigational New Drug (IND)-enabling stage, along with an earlier-stage portfolio targeting transcription factors involved in oncology and other therapeutic areas. For more information, please visit www.flaretx.com and follow us on LinkedIn.
Investors:
investorrelations@flaretx.com
Media:
Peg Rusconi
peg.rusconi@deerfieldgroup.com
Deerfield Group
Cambridge, MA – November 6, 2024 – Flare Therapeutics Inc., a clinical-stage biotechnology company targeting transcription factors to discover precision medicines for oncology and other therapeutic areas, today announced that the company will participate in two upcoming investor conferences in November:
About Flare Therapeutics Inc.
Flare Therapeutics is a biotechnology company exclusively focused on drugging transcription factors to fully unlock the therapeutic potential of this previously elusive target class. Flare Therapeutics’ integrated discovery engine converges rich genetic, biochemical, and chemical insights to reveal druggable pockets and identify small molecule ligands capable of modulating transcription factors of high therapeutic potential. Flare Therapeutics’ proteomic and mass spectrometry platform is powered by a proprietary library of electrophilic compounds unique to Flare Therapeutics. Since its inception, Flare Therapeutics has rapidly established an emerging pipeline of programs, highlighted by FX-909, a first-in-class investigational orally bioavailable small molecule inhibitor of PPARG, a master regulator of the luminal lineage in advanced urothelial cancer that is currently in a Phase I study. Additionally, Flare Therapeutics has advanced a second program with a differentiated mechanism for prostate cancer entering the Investigational New Drug (IND)-enabling stage, along with an earlier-stage portfolio targeting transcription factors involved in oncology and other therapeutic areas. For more information, please visit www.flaretx.com and follow us on LinkedIn.
Contacts:
Investors:
investorrelations@flaretx.com
Media:
media@flaretx.com
Cambridge, MA – June 3, 2024 – Flare Therapeutics Inc., a clinical-stage biotechnology company targeting transcription factors to discover precision medicines for cancer and other diseases, today announced that Daphne Karydas, President and Chief Financial Officer, will present a company overview at the upcoming Goldman Sachs 45th Annual Global Healthcare Conference on Monday, June 10, 2024 at 3:20 p.m. ET in Miami, FL.
About Flare Therapeutics Inc.
Flare Therapeutics is a biotechnology company exclusively focused on drugging transcription factors (TFs) to fully unlock the therapeutic potential of this previously elusive target class. Flare Therapeutics’ integrated discovery engine converges rich genetic, biochemical, and chemical insights to reveal druggable pockets and identify small molecule ligands capable of modulating TFs of high therapeutic potential. Flare Therapeutics’ proteomic and mass spectrometry platform is powered by a proprietary library of electrophilic compounds unique to Flare Therapeutics. The team has rapidly established an emerging pipeline of programs, highlighted by FX-909, a first-in-class investigational orally bioavailable small molecule inhibitor of PPARG, a master regulator of the luminal lineage in advanced urothelial cancer that is currently in a Phase I study. For more information, please visit www.flaretx.com and follow us on LinkedIn.
Investors:
investorrelations@flaretx.com
Media:
Peg Rusconi
Verge Scientific Communications
peg.rusconi@vergescientific.com
Cambridge, MA – April 23, 2024 – Flare Therapeutics Inc., a clinical-stage biotechnology company targeting transcription factors to discover precision medicines for cancer and other diseases, today announced the appointment of Douglas Manion, M.D., FRCP (C), as Chief Executive Officer, effective immediately. Dr. Manion brings over two decades of experience in pharmaceutical research and development, having held leadership roles across several biotechnology and pharmaceutical companies. He succeeds interim CEO Abbie Celniker, Ph.D., a partner at Third Rock Ventures, who will continue to serve as Chair of the Company’s Board of Directors.
“I am delighted to welcome Doug to FlareTx and want to express my deepest confidence in his ability to lead the company during this next stage of growth. Over the course of his career, he has gained substantial company building and drug development expertise, which will be invaluable as FlareTx continues to grow as an organization and advances its clinical-stage pipeline and capabilities in drugging transcription factors,” said Dr. Celniker. “I look forward to working with him and the leadership team as they drive the company’s strong momentum.”
“There has been rapid growth at FlareTx since the company was launched and I am excited for this opportunity to lead such an exceptional and cross-functional team as we advance FX-909 toward clinical proof of concept data in the second half of this year and fully recognize the potential of our discovery engine as we seek to change the paradigm in drugging transcription factors,” said Dr. Manion. “I share in the team’s vision to rapidly transform this novel science into approved medicines for people with cancer and other diseases.”
Dr. Manion joins Flare Therapeutics from Aclaris Therapeutics, Inc. (NASDAQ: ACRS), where he was President and Chief Executive Officer. Before that, he was Executive Vice President of Research and Development at Arena Pharmaceuticals, Inc., where he oversaw all research and development activities until its acquisition by Pfizer Inc. Dr. Manion joined Arena after serving as Chief Executive Officer of Kleo Pharmaceuticals, a private immuno-oncology company, from 2017 until its acquisition by Biohaven Holdings in January 2021. Previously Dr. Manion was Senior Vice President, Head of Specialty Development and Head of R&D Japan and China at Bristol-Myers Squibb. During his 11-year tenure at BMS, he held leadership roles overseeing global clinical research, clinical development, pharmacovigilance and biostatistics, across various therapeutic areas, including virology, immunology, neurology, cardiology, metabolic diseases, genetically-defined diseases and fibrosis. Dr. Manion’s previous biopharmaceutical experience includes progressive leadership roles at GlaxoSmithKline, DuPont Pharmaceuticals, and DuPont Merck Pharmaceuticals. He is Board Certified in Internal Medicine and completed an Infectious Diseases Fellowship at the University of Ottawa in Ontario, Canada followed by post-doctoral training at Massachusetts General Hospital and Harvard Medical School.
About Flare Therapeutics Inc.
Flare Therapeutics is a biotechnology company exclusively focused on drugging transcription factors (TFs) to fully unlock the therapeutic potential of this previously elusive target class. Flare Therapeutics’ integrated discovery engine converges rich genetic, biochemical, and chemical insights to reveal druggable pockets and identify small molecule ligands capable of modulating TFs of high therapeutic potential. Flare Therapeutics’ proteomic and mass spectrometry platform is powered by a proprietary library of electrophilic compounds unique to Flare Therapeutics. The team has rapidly established an emerging pipeline of programs, highlighted by FX-909, a first-in-class investigational orally bioavailable small molecule inhibitor of PPARG, a master regulator of the luminal lineage in advanced urothelial cancer that is currently in a Phase I study. For more information, please visit www.flaretx.com and follow us on LinkedIn.
Investors:
Media:
Peg Rusconi
Verge Scientific Communications
peg.rusconi@vergescientific.com
— Data support the potential to explore lead Phase 1 monotherapy asset FX-909 in combination with an anti-PD1 agent —
Cambridge, MA – April 9, 2024 – Flare Therapeutics Inc., a clinical-stage biotechnology company targeting transcription factors to discover precision medicines for cancer and other diseases, today shared data identifying immunosuppressive cell phenotypes associated with high PPARG expression in urothelial cancer (UC) patients treated with anti-PD1 therapy in a poster presentation at the American Association for Cancer Research (AACR) Annual Meeting 2024 taking place April 5-10 in San Diego, California.
“Translational insights from our single cell analysis shed further light on the role that PPARG expression plays in the immune cell phenotypes of advanced UC patients following anti-PD1 therapy,” said Michaela Bowden, Ph.D., Chief Development Officer at Flare Therapeutics. “The ongoing study of our lead asset FX-909 – which is currently being evaluated as a monotherapy in a Phase 1 clinical study – includes an exploratory biomarker approach to assess the effect of PPARG inhibition on the innate and adaptive immune response of the patients enrolled, and may inform the ability to expand this novel treatment into a potential combination treatment strategy in the future.”
The poster, titled, “PPARG-high circulating monocytes exhibit an immunosuppressive phenotype in urothelial cancer patients treated with anti-PD1,” offers a comprehensive analysis of PPARG expression in peripheral blood mononuclear cells (PBMCs) of advanced UC patients. PPARG has been previously associated with immune-mediated resistance and is upregulated in a variety of immune cells such as monocytes, macrophages, and lymphocytes, where it plays a role in their maturation and function.
Flare Therapeutics scientists showed that circulating classical monocytes harboring high levels of PPARG expression exhibited an immunosuppressive phenotype in UC patients who received anti-PD1 therapy. Findings corroborate molecular real-world data presented at the SITC 2023 Annual Meeting that demonstrated high PPARG expression in patients with muscle-invasive UC is associated with an immunosuppressive tumor microenvironment and shorter real-world progression-free survival to anti-PD1 treatment.
Additional key takeaways from the poster are as follows:
About Flare Therapeutics Inc.
Flare Therapeutics is a biotechnology company exclusively focused on drugging transcription factors (TFs) to fully unlock the therapeutic potential of this previously elusive target class. Flare Therapeutics’ integrated discovery engine converges rich genetic, biochemical, and chemical insights to reveal druggable pockets and identify small molecule ligands capable of modulating TFs of high therapeutic potential. Flare Therapeutics’ proteomic and mass spectrometry platform is powered by a proprietary library of electrophilic compounds unique to Flare Therapeutics. The team has rapidly established an emerging pipeline of programs, highlighted by FX-909, a first-in-class investigational orally bioavailable small molecule inhibitor of PPARG, a master regulator of the luminal lineage in advanced urothelial cancer that is currently in a Phase I study. For more information, please visit www.flaretx.com and follow us on LinkedIn.
Investors:
Media:
Peg Rusconi
Verge Scientific Communications
peg.rusconi@vergescientific.com
Cambridge, MA – March 5, 2024 – Flare Therapeutics Inc., a clinical-stage biotechnology company targeting transcription factors to discover precision medicines for cancer and other diseases, today announced a poster presentation identifying immunosuppressive cell phenotypes associated with high PPARG expression in urothelial cancer (UC) patients treated with anti-PD1 therapy at the upcoming American Association for Cancer Research (AACR) Annual Meeting 2024 taking place April 5-10 in San Diego, California.
Presentation details are as follows:
Abstract Title: PPARG-high circulating monocytes exhibit an immunosuppressive phenotype in urothelial cancer patients treated with anti-PD1
Abstract Number: 5627
Presenter: Ani Phuong Nguyen, Director, Computational Biology, Flare Therapeutics
Date, Time: Tuesday, April 9, 2024, 1:30pm – 5:00pm PDT (4:30pm – 8:00pm EDT)
Location: Poster Section 15, Poster Board #6, San Diego Convention Center
About Flare Therapeutics Inc.
Flare Therapeutics is a biotechnology company exclusively focused on drugging transcription factors (TFs) to fully unlock the therapeutic potential of this previously elusive target class. Flare Therapeutics’ integrated discovery engine converges rich genetic, biochemical, and chemical insights to reveal druggable pockets and identify small molecule ligands capable of modulating TFs of high therapeutic potential. Flare Therapeutics’ proteomic and mass spectrometry platform is powered by a proprietary library of electrophilic compounds unique to Flare Therapeutics. The team has rapidly established an emerging pipeline of programs, highlighted by FX-909, a first-in-class investigational orally bioavailable small molecule inhibitor of PPARG, a master regulator of the luminal lineage in advanced urothelial cancer that is currently in Phase I study. For more information, please visit www.flaretx.com and follow us on LinkedIn.
Investors:
investorrelations@flaretx.com
Media:
Peg Rusconi
Verge Scientific Communications
peg.rusconi@vergescientific.com
Cambridge, Massachusetts – January 26, 2024 – Flare Therapeutics Inc., a biotechnology company targeting transcription factors (TF) to discover precision medicines for cancer and other diseases, today announced a poster presentation outlining the Phase 1 clinical trial design of FX-909, a highly potent and selective inhibitor of PPARG, at the 2024 ASCO Genitourinary Cancers Symposium taking place from January 25-27, 2024 in San Francisco, CA.
“FlareTx has built a robust body of preclinical evidence that supports investigation of FX-909 in clinical trials in patients,” said Michael L. Meyers, M.D., Ph.D., Chief Medical Officer of Flare Therapeutics. “Results shown to date reveal that FX-909 eradicates tumors in urothelial cancer (UC) animal models at low oral doses. Our scientists have also leveraged high PPARG expression as a defining feature of luminal muscle-invasive UC (MIUC) to identify genetically defined populations and select the patients that may be more likely to benefit from a treatment like FX-909. In addition, we recently shared novel translational data correlating increased PPARG expression with an immunosuppressive tumor microenvironment (TME) and shorter real-world progression-free survival to anti-PD1 treatment.”
PPARG drives luminal cell identity and accounts for two-thirds of all advanced cases of UC. Targeting PPARG offers a novel approach to treating advanced UC that could pave the way to improved clinical outcomes in patients with a luminal subtype. Treatment of genetically defined UC xenografts with FX-909 has shown an 84% tumor growth inhibition at a dose expected to be equivalent to a 50 mg dose in humans – the starting dose in the Phase 1 clinical study.
FX-909-CLINPRO-1 (NCT05929235) is a first-in-human, multicenter, open-label Phase 1 study designed to assess the safety and tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of FX-909 given orally to patients with advanced solid malignancies. Exploratory objectives include the evaluation of patient selection biomarkers from tissue and blood samples and association with clinical outcomes. In the US, approximately 10 sites are planned for Phase 1A and 12-15 sites for Phase 1B.
“While advanced bladder cancer and MIUC remain lethal diseases, we are starting to see a real renaissance in providing new treatment options, thanks to increasing knowledge of the underlying molecular pathways involved,” said Gopa Iyer, Genitourinary Oncologist & Early Drug Development Specialist, Memorial Sloane Kettering Cancer Center. “FlareTx’s novel mechanism of action offers the possibility of a much needed second line option for patients who demonstrate disease progression following standard-of-care platinum chemotherapy, immune checkpoint inhibition, and/or ADC-based therapies.”
Details for the presentation are as follows:
Poster Title: A Phase 1, First-in-Human, Dose-Escalation and Expansion Study of FX-909 in Patients with Advanced Solid Malignancies, Including Advanced Urothelial Carcinoma
Abstract Number: TPS709
Presenter: Gopa Iyer MD, Memorial Sloane Kettering Cancer Center
Date, Time: Session B: Urothelial Carcinoma – Friday, January 26, 2024, 11:30 AM-1:00 PM PT; 5:45 PM-6:45 PM PT
Location: Moscone West Conference Center, San Francisco, California Posters, Exhibits, and Food Room
About FX-909
Flare Therapeutics’ lead investigational compound, FX-909, is a first-in-class, highly potent and selective small molecule that inhibits the transcription factor peroxisome proliferator-activated receptor gamma (PPARG) to treat patients with the luminal subtype of advanced urothelial carcinoma (UC) and potentially other solid tumors. Preclinical data for FX-909 has demonstrated robust anti-tumor activity, excellent PK/PD correlation, durable efficacy, and a favorable safety profile in mouse models of UC (PPARG-amp and RXRA-mut) at very low oral doses.
About the FX-909 Phase 1 Study
The ongoing Phase 1 study is a first-in-human, dose-escalation and -expansion study of FX-909 in patients with advanced solid malignancies, including advanced urothelial carcinoma. The study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and clinical activity of FX-909. FX-909 will be given initially in a dose-escalation phase (Part A) to determine the recommended Phase 2 dose. FX-909 will be given initially orally once daily in 28-day cycles. Part B will be a monotherapy expansion phase to further evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of FX-909 in patients with locally advanced (unresectable) or metastatic urothelial carcinoma. Additional information on this clinical trial can be found on www.clinicaltrials.gov (NCT05929235).
About Advanced Urothelial Carcinoma (UC)
There are an estimated 725,549 people living with bladder cancer in the United States alone, making it the sixth most common cancer overall, and fourth most common among men (SEER – 2020). Each year, there are more than 83,000 new cases diagnosed among men and women, and about 25% of those cases are classified as muscle-invasive UC (DRG 2020). Treatment outcomes have remained poor with typical five-year survival rates of 8% in advanced metastatic disease (SEER – 2020). The transcription factor peroxisome proliferator-activated receptor gamma (PPARG) is associated with the luminal lineage subtype which represents approximately 65% of all advanced UC cases (Robertson, Cell 2017). Recurrent genetic alterations in PPARG are characteristic of this molecular subtype.
About Flare Therapeutics Inc.
Flare Therapeutics is a biotechnology company exclusively focused on drugging transcription factors (TFs) to fully unlock the therapeutic potential of this previously elusive target class. Flare Therapeutics’ integrated discovery engine converges rich genetic, biochemical, and chemical insights to reveal druggable pockets and identify small molecule ligands capable of modulating TFs of high therapeutic potential. Our proteomic and mass spectrometry platform is powered by a proprietary library of electrophilic compounds unique to Flare Therapeutics. The team has rapidly established an emerging pipeline of programs, highlighted by FX-909, a first-in-class investigational orally bioavailable small molecule inhibitor of PPARG, a master regulator of the luminal lineage in advanced urothelial cancer that has entered the clinic. For more information, please visit www.flaretx.com and follow us on LinkedIn.
Investors:
Anne Marie Fields
Stern Investor Relations
annemarie.fields@sternir.com
Media:
Marites Coulter
Verge Scientific Communications
marites.coulter@vergescientific.com
Cambridge, MA – November 3, 2023 – Flare Therapeutics Inc., a clinical-stage biotechnology company targeting transcription factors to discover precision medicines for cancer and other diseases, today revealed molecular real-world data (RWD) demonstrating that high PPARG expression in patients with MIUC is associated with an immunosuppressive tumor microenvironment (TME) and shorter real-world progression-free survival to anti-PD1 treatment. The translational data were shared at the Society for Immunotherapy of Cancer’s 38th Annual Meeting (SITC) 2023 taking place November 1-5, 2023 in San Diego, California.
“While immunotherapy approvals have changed the treatment landscape for MIUC, approximately 70% of patients will still succumb to refractory or acquired resistance,” said Michaela Bowden, Ph.D., Chief Development Officer at Flare Therapeutics. “These results offer a unique opportunity to further investigate an immune-mediated mechanism of action for FX-909 with the potential to combine with an anti-PD1 agent.”In the poster presentation titled, “PPARG amplification is associated with lack of response to anti-PD1 in Muscle-Invasive Urothelial Cancer,”
Molecular RWD, comprising 1,393 genomic and/or transcriptomic profiles from MIUC patients were utilized to evaluate baseline PPARG expression and amplification associated with anti-PD1 response in MIUC patients. Additional key takeaways are as follows:
FX-909, a first-in-class covalent PPARG inhibitor, entered the clinic this year and is currently being evaluated in a Phase 1 study. The data presented today suggest that FX-909 in combination with ICI agents could potentially provide a new therapeutic strategy that helps MIUC patients with high PPARG expression overcome resistance to immunotherapy.
About FX-909
Flare Therapeutics’ lead investigational compound, FX-909, is a first-in-class novel, highly potent and selective small molecule that inhibits the transcription factor peroxisome proliferator-activated receptor gamma (PPARG) to treat patients with the luminal subtype of advanced urothelial carcinoma (UC) and potentially other solid tumors. Preclinical data for FX-909 has demonstrated robust anti-tumor activity, excellent PK/PD correlation, durable efficacy, and a favorable safety profile in mouse models of UC (PPARG-amp and RXRA-mut) at very low oral doses.
About the FX-909 Phase 1 Study
The ongoing phase 1 study is a first-in-human, dose-escalation and -expansion study of FX-909 in patients with advanced solid malignancies, including advanced urothelial carcinoma. The study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and clinical activity of FX-909. FX-909 will be given initially in a dose-escalation phase (Part A) to determine the recommended phase 2 dose. FX-909 will be given initially orally once daily in 28-day cycles. Part B will be a monotherapy expansion phase to further evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of FX-909 in patients with locally advanced (unresectable) or metastatic urothelial carcinoma. Additional information on this clinical trial can be found on www.clinicaltrials.gov (NCT05929235).
About Advanced Urothelial Carcinoma (UC)
In 2020, there were an estimated 725,549 people living with bladder cancer in the United States alone, making it the sixth most common cancer overall, and fourth most common among men (SEER – 2020). Each year, there are more than 83,000 new cases diagnosed among men and women, and about 25% of those cases are classified as muscle-invasive UC (DRG 2020). Advanced UC has high rates of recurrence, where treatment outcomes have remained poor with typical five-year survival rates of 8% in advanced metastatic disease (SEER – 2020). The transcription factor peroxisome proliferator-activated receptor gamma (PPARG) is associated with the luminal lineage subtype reflecting approximately 65% of all advanced UC cases (Robertson, Cell 2017). Recurrent genetic alterations in PPARG are characteristic of this molecular subtype.
About Flare Therapeutics Inc.
Flare Therapeutics is a biotechnology company exclusively focused on drugging transcription factors (TFs) to fully unlock the therapeutic potential of this previously elusive target class. Flare Therapeutics’ integrated discovery engine converges rich genetic, biochemical, and chemical insights to reveal druggable pockets and identify small molecule ligands capable of modulating TFs of high therapeutic potential. Our proteomic and mass spectrometry platform is powered by a proprietary library of electrophilic compounds unique to Flare Therapeutics. The team has rapidly established an emerging pipeline of programs, highlighted by FX-909, a first-in-class investigational orally bioavailable small molecule inhibitor of PPARG, a master regulator of the luminal lineage in advanced Urothelial Cancer that has entered the clinic. For more information, please visit www.flaretx.com and follow us on LinkedIn.
Investors:
Julie Seidel
Stern Investor Relations
julie.seidel@sternir.com
Media:
Peg Rusconi
Verge Scientific Communications
prusconi@vergescientific.com
Cambridge, MA – October 31, 2023 – Flare Therapeutics Inc., a clinical-stage biotechnology company targeting transcription factors to discover precision medicines for cancer and other diseases, today announced a poster presentation at the upcoming Society for Immunotherapy of Cancer’s 38th Annual Meeting (SITC) 2023, taking place November 1-5, 2023 in San Diego, California.
Details for the presentation are as follows:
Abstract Title: PPARG amplification is associated with lack of response to anti-PD1 in Muscle-Invasive Urothelial Cancer
Abstract Number: 537
Presenter: Evisa Gjini, Senior Director, Translational Medicine, Flare Therapeutics
Date, Time: Friday, November 3, 2023, 9:00am – 7:00pm PDT (12:00pm – 10:00pm EDT)
Location: Exhibit Halls A and B1, San Diego Convention Center, San Diego
About Flare Therapeutics Inc.
Flare Therapeutics is a biotechnology company exclusively focused on drugging transcription factors (TFs) to fully unlock the therapeutic potential of this previously elusive target class. Flare Therapeutics’ integrated discovery engine converges rich genetic, biochemical, and chemical insights to reveal druggable pockets and identify small molecule ligands capable of modulating TFs of high therapeutic potential. Our proteomic and mass spectrometry platform is powered by a proprietary library of electrophilic compounds unique to Flare Therapeutics. The team has rapidly established an emerging pipeline of programs, highlighted by FX-909, a first-in-class investigational orally bioavailable small molecule inhibitor of PPARG, a master regulator of the luminal lineage in advanced Urothelial Cancer that has entered the clinic. For more information, please visit www.flaretx.com and follow us on LinkedIn.
About FX-909
Flare Therapeutics’ lead investigational compound, FX-909, is a first-in-class novel, highly potent and selective small molecule that inhibits the transcription factor peroxisome proliferator-activated receptor gamma (PPARG) to treat patients with the luminal subtype of advanced urothelial carcinoma (UC) and potentially other solid tumors. FX-909 is currently undergoing investigation in a Phase 1 clinical study, a first-in-human, dose-escalation and expansion study evaluating safety, tolerability, pharmacokinetics, pharmacodynamics and clinical activity. Preclinical data for FX-909 has demonstrated robust anti-tumor activity, excellent PK/PD correlation, durable efficacy, and a favorable safety profile in mouse models of UC (PPARG-amp and RXRA-mut) at very low oral doses.
About Advanced Urothelial Carcinoma (UC)
In 2020, there were an estimated 725,549 people living with bladder cancer in the United States alone, making it the sixth most common cancer overall, and fourth most common among men (SEER – 2020). Each year, there are more than 83,000 new cases diagnosed among men and women, and about 25% of those cases are classified as muscle-invasive UC (DRG 2020). Advanced UC has high rates of recurrence, where treatment outcomes have remained poor with typical five-year survival rates of 8% in advanced metastatic disease (SEER – 2020). The transcription factor peroxisome proliferator-activated receptor gamma (PPARG) is associated with the luminal lineage subtype reflecting approximately 65% of all advanced UC cases (Robertson, Cell 2017). Recurrent genetic alterations in PPARG are characteristic of this molecular subtype.
Investors:
Julie Seidel
Stern Investor Relations
julie.seidel@sternir.com
Media:
Peg Rusconi
Verge Scientific Communications
prusconi@vergescientific.com
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