AsherBio

Flare Therapeutics Presents Comprehensive Real-World Data in Advanced and Metastatic Urothelial Cancer in Support of Therapeutic Targeting of PPARG at 2022 EORTC-NCI-AACR Symposium

Cambridge, Mass. – October 28, 2022 – Flare Therapeutics, a biotechnology company targeting transcription factors to discover precision medicines for cancer and other diseases, today presented translational insights from a retrospective advanced urothelial cancer (UC) cohort in a poster titled, “Peroxisome Proliferator-Activated Receptor Gamma (PPARG) status defines the luminal lineage in molecular profiles of advanced urothelial cancers (UC)” at the 34th EORTC-NCI-AACR Symposium, being held in Barcelona, Spain. Molecular RWD, comprising of more than 3,000 genomic and transcriptomic profiles from advanced UC tissue, were utilized to evaluate the transcription factor PPARG, and its role as a master regulator of the luminal lineage associated with its expression and mutational status.

“To the best of our knowledge, this represents the largest RWD from patients with advanced and metastatic urothelial cancer, providing unique insights into the persistence of PPARG signaling through disease progression, independent of the treatment paradigm,” said Michaela Bowden, Ph.D., Senior Vice President of Biology and Translation at Flare Therapeutics. “Stratification of patients based upon their PPARG status serves as the foundation for our precision approach in identifying individuals most likely to respond to PPARG inhibition.”

Flare presented its novel PPARG program demonstrating robust preclinical activity in a poster presentation titled, “Novel inhibitors of the luminal lineage transcription factor peroxisome proliferator-activated receptor gamma (PPARG) durably eradicate tumors in urothelial cancer animal models” on Wednesday, October 26th at same symposium.

Data highlights:

  • 65% of advanced urothelial cancers evaluated were classified as luminal, of which one in three were enriched for genetic alterations in PPARG, RXRA or FGFR3
  • PPARG amplification, including a gain of only one copy number, is associated with higher PPARG expression
  • PPARG expression levels were sustained in metastatic lesions compared locally advanced tissues and did not significantly vary by metastatic tissue site

Flare is advancing a novel PPARG inhibitor through Investigational New Drug (IND)-enabling studies and expects to initiate its Phase 1 clinical trial in 2023 in individuals with locally advanced or metastatic UC.

About Advanced Urothelial Cancer
Muscle-invasive UC is a common type of bladder cancer, with about 20,000 individuals diagnosed each year in the United States alone, and significantly higher incidence rates in other regions of the world. This disease has high rates of recurrence and the five-year survival rate is approximately 5% in metastatic cases. The transcription factor peroxisome proliferator-activated receptor gamma (PPARG) is associated with the luminal lineage subtype reflecting  approximately 65% of all advanced UC patients. Recurrent genetic alterations in PPARG, including focal amplification, missense mutations, and fusions, as well as hotspot mutations in its binding partner, retinoid X receptor alpha (RXRA) are characteristic of this molecular subtype.

About Flare Therapeutics
Flare Therapeutics is a biotechnology company pioneering a new therapeutic space with a novel approach to decipher the biology of transcription factors to develop small molecule medicines. Based on insights from the seminal work of its scientific founders, Flare’s team has uncovered ‘switch sites,’ druggable regions that are key targets for transcription factor regulation, to address mutations that cause disease. Flare’s drug discovery efforts to target switch sites has rapidly advanced, resulting in an emerging pipeline of research programs that address well-validated genetically-defined transcription factors, initially focused on precision oncology with future potential in neurology, rare genetic disorders, immunology and inflammation. Flare Therapeutics was launched in 2021 and is backed by founding investor Third Rock Ventures, as well as Boxer Capital, Nextech Invest, Casdin Capital, Invus Financial Advisors and Eventide Asset Management. For more information, please visit www.flaretx.com.

Contacts

Investors:
Sarah McCabe
Stern Investor Relations, Inc.
Sarah.mccabe@sternir.com 

Media:
Michelle Thaler
Michelle Thaler PR, LLC
516-225-4313
Michelle@ThalerComms.com

AsherBio

Flare Therapeutics Presents Preclinical Data that Show Potential of Novel PPARG Inhibitors to Treat Urothelial Cancer at 2022 EORTC-NCI-AACR Symposium

– First data showing durable in vivo tumor regression in urothelial cancer (UC) animal models
– Data highlight the potential for novel small molecule inhibitors of key transcription factors to target and effectively treat advanced UC

Cambridge, Mass. – October 26, 2022 – Flare Therapeutics, a biotechnology company targeting transcription factors to discover precision medicines for cancer and other diseases, today presented new preclinical data in a poster presentation titled, “Novel inhibitors of the luminal lineage transcription factor peroxisome proliferator-activated receptor gamma (PPARG) durably eradicate tumors in urothelial cancer (UC) animal models” at the 34th EORTC-NCI-AACR Symposium in Barcelona, Spain. The data presented by Robert Sims, Ph.D., Chief Scientific Officer and Co-founder of Flare, show that FTX-6746, a potent, selective, small molecule PPARG inhibitor (inverse agonist), drives robust PPARG target gene silencing in UC cell lines and drives tumor regression in PPARG-amplified and RXRA-mutant UC xenograft models.

“Targeting cell lineage-defined transcription factors with small molecules is a proven and effective therapeutic strategy, as demonstrated by estrogen and androgen receptor therapies for breast and prostate cancers. Our goal is to add PPARG to that list, to potentially enable treatment of urothelial cancers. Leveraging our deep expertise in transcription factor biochemistry, we engineered compounds capable of driving a powerful repressive conformation of PPARG with high specificity, thereby inducing significant pharmacological effects,” said Dr. Sims. “In preclinical models, FTX-6746 demonstrated a favorable therapeutic profile, suppressing PPARG target genes with durable tumor regression at well-tolerated doses. We are currently advancing a novel PPARG inhibitor through IND-enabling studies and plan to advance that therapeutic candidate into the clinic in 2023 in locally advanced or metastatic UC.”

Data highlights:

• FTX-6746 drives an enhanced repressive conformation to overcome UC mutations
• FTX-6746 counteracts the activating effects of recurrent PPARG and RXRA missense mutations in preclinical models of UC
• FTX-6746 treatment results in robust PPARG target gene silencing in cells (average 50% maximal inhibitor concentration (IC50) ~5 nM); in vitro growth inhibition is preferentially observed in cell lines with activated PPARG signaling
• Tumor growth inhibition or regression was observed in PPARG-amplified and RXRA-mutant UC xenograft models, with no tumor regrowth upon cessation of treatment

“Today’s data presentation demonstrates the strength and depth of Flare’s research platform and our teams’ ability to rapidly advance a first-in-class molecule in precision oncology,” said Amit Rakhit, M.D., Chief Executive Officer of Flare Therapeutics. “Flare is poised to transition to a clinical-stage company early next year with our lead molecule in the PPARG program. Given the high unmet medical need with poor survival in advanced stages of disease, novel approaches that provide alternative therapeutic options are needed for people living with bladder cancer.”

About Urothelial Cancer
Muscle-invasive UC is a common type of bladder cancer, with about 20,000 individuals diagnosed each year in the United States alone, and significantly higher incidence rates in other regions of the world. This disease has high rates of recurrence and the five-year survival rate is approximately 5% in metastatic cases. The transcription factor peroxisome proliferator-activated receptor gamma (PPARG) is associated with the luminal lineage subtype reflecting approximately 65% of all advanced UC patients. Recurrent genetic alterations in PPARG, including focal amplification, missense mutations, and fusions, as well as hotspot mutations in its binding partner, retinoid X receptor alpha (RXRA) are characteristic of this molecular subtype.

About Flare Therapeutics
Flare Therapeutics is a biotechnology company pioneering a new therapeutic space with a novel approach to decipher the biology of transcription factors to develop small molecule medicines. Based on insights from the seminal work of its scientific founders, Flare’s team has uncovered ‘switch sites,’ druggable regions that are key targets for transcription factor regulation, to address mutations that cause disease. Flare’s drug discovery efforts to target switch sites has rapidly advanced, resulting in an emerging pipeline of research programs that address well-validated genetically-defined transcription factors, initially focused on precision oncology with future potential in neurology, rare genetic disorders, immunology and inflammation. Flare Therapeutics was launched in 2021 and is backed by founding investor Third Rock Ventures, as well as Boxer Capital, Nextech Invest, Casdin Capital, Invus Financial Advisors and Eventide Asset Management. For more information, please visit www.flaretx.com.

Contacts

Investors:
Sarah McCabe
Stern Investor Relations, Inc.
Sarah.mccabe@sternir.com

Media:
Michelle Thaler
Michelle Thaler PR, LLC
516-225-4313
Michelle@ThalerComms.com

AsherBio

Flare Therapeutics Appoints Amit Rakhit, M.D. as President and Chief Executive Officer

Biopharma industry veteran to lead advancement of company’s transcription factor-focused pipeline into clinical stage and expand discovery efforts

Cambridge, Mass. – July 25, 2022 – Flare Therapeutics, a biotechnology company targeting transcription factors to discover precision medicines for cancer and other diseases, today announced the appointment of Amit Rakhit, M.D., MBA, as President and Chief Executive Officer. Dr. Rakhit has over 20 years of life sciences leadership experience and joins at a pivotal time as Flare transitions into a clinical-stage company. 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.

“Flare’s pioneering approach to drugging transcription factors stands to profoundly impact medical practice globally for people living with cancer and other difficult to treat diseases. I am excited to join such a dynamic and experienced leadership team at this important inflection point for the company,” said Dr. Rakhit. “The team’s swift progress in identifying dozens of novel druggable pockets, or ‘switch sites’, within therapeutic transcription factor targets of interest and rapid advancement of the lead precision oncology program both inspired my belief in Flare and compelled me to join to help catapult the company into its next stage of growth.”

“Dr. Rakhit’s experience includes a rare mix of business acumen, clinical development expertise and passion for leading innovation in new treatment modalities that can benefit patients,” said Dr. Celniker. “His leadership and experience will be extremely valuable in driving the strategy forward as we transition our first precision oncology program into the clinic and grow our pipeline of discovery targets in multiple new therapeutic indications.”

For more than two decades, Dr. Rakhit has served in key leadership, clinical and operational roles in biotechnology and pharmaceutical companies spanning diverse therapeutic areas including rare disease, neurology, oncology and cardiology. Most recently, he has focused on launching and growing start-up biotechnology companies, overseeing clinical development and commercialization strategy in roles as CEO of Sporos BioVentures and President and Chief Medical Officer of Ovid Therapeutics. Earlier in his career, he was Senior Vice President and Head of Worldwide Medical Affairs at Biogen, Inc. where he led global external collaborations with key stakeholders and executed post-marketing development strategies for the launch and commercialization of key products in rare disease, including Spinraza®, and in neurology. Prior to Biogen, he held multiple roles of increasing seniority in global clinical development and medical affairs at Bristol-Myers Squibb, including spearheading global initiatives for Plavix®. Dr. Rakhit holds an M.D. from Tufts University School of Medicine and dual MBAs from Columbia University and London Business School. He completed his fellowship in pediatric cardiology at Harvard Medical School and was previously on staff at Boston Children’s Hospital.

About Flare Therapeutics
Flare Therapeutics is a biotechnology company pioneering a new therapeutic space with a novel approach to decipher the biology of transcription factors to develop small molecule medicines. Based on insights from the seminal work of its scientific founders, Flare’s team has uncovered ‘switch sites,’ druggable regions that are key targets for transcription factor regulation, to address mutations that cause disease. Flare’s drug discovery efforts to target switch sites has rapidly advanced, resulting in an emerging pipeline of drug programs that address well-validated transcription factors, initially focused on precision oncology with future potential in neurology, rare genetic disorders, immunology and inflammation. Flare Therapeutics was launched in 2021 and is backed by founding investor Third Rock Ventures, as well as Boxer Capital, Nextech Invest, Casdin Capital, Invus Financial Advisors and Eventide Asset Management. For more information, please visit www.flaretx.com.

We invite you to follow us on LinkedIn and @Flaretx.

Contacts

Investors:
Sarah McCabe
Stern Investor Relations, Inc.
Sarah.mccabe@sternir.com

 

Media:
Michelle Thaler
Michelle Thaler PR, LLC
516-225-4313
Michelle@ThalerComms.com

AsherBio

Flare Therapeutics Appoints Adrian Jubb as Chief Medical Officer

Dr. Jubb’s research and clinical development experience strongly positions company for clinical excellence in advancing precision oncology pipeline

Cambridge, Mass. – April 26, 2022 – Flare Therapeutics, a biotechnology company targeting transcription factors to discover precision medicines for cancer and other diseases, today announced the appointment of Adrian Jubb, MB ChB, PhD, FRCPath, as Chief Medical Officer. Dr. Jubb joins the Flare leadership team at a key inflection point as the company progresses from early drug discovery into clinical development.

“We are extremely fortunate to be growing Flare’s executive team with the addition of Adrian, who is vastly accomplished and brings a wealth of oncology clinical development experience,” said Abbie Celniker, PhD, interim Chief Executive Officer of Flare and partner at Third Rock Ventures. “Adrian’s leadership and deep drug development expertise will be invaluable as we enter our next phase of growth, advancing precision oncology programs from our drug discovery engine into the clinic.”

Dr. Adrian Jubb is a board-certified physician scientist with more than 20 years of research and clinical development experience spanning oncology, infectious disease and neuroscience. Dr. Jubb has devoted much of his career to the translational and clinical development of cancer medicines, including Avastin®, Tarceva®, Zelboraf®, and Cotellic®, as well as multiple investigational agents, including MetMAb, Apo2L, anti-LILRB4, anti-CD96 and anti-CD200R1. Most recently, Dr. Jubb served as Head of Clinical Oncology and Neurology at 23andMe, where he led teams accountable for the IND filings and first-in-human clinical trials for two immune-oncology checkpoint inhibitors. Prior to 23andMe, Dr. Jubb held roles as Chief Medical Officer of Immune-Onc Therapeutics, Vice President and Head of Early Development at Achaogen and Medical Director in Oncology at Genentech. He holds MB ChB (Hons), PhD, and BSc (Hons) degrees from the University of Leeds (UK) and is a Fellow of the Royal College of Pathologists in London.

“Flare’s approach to finding and drugging transcription factors may elucidate previously unexplored and meaningful treatment possibilities for cancer patients,” said Dr. Jubb. “In just one year of discovery, the Flare team has made remarkable progress identifying genetically defined targets and promising chemical matter to develop new therapeutic candidates. I am both honored and excited to join the talented team at Flare as they continue to build a portfolio and bring potentially transformative programs into the clinic.”    

About Flare Therapeutics

Flare Therapeutics is a biotechnology company opening up a new therapeutic space with a novel approach to decipher the biology of transcription factors to develop small molecule medicines. Based on insights from the seminal work of its scientific founders, Flare’s team has uncovered ‘switch sites,’ druggable regions that are key targets for transcription factor regulation to address mutations that cause disease. Our drug discovery efforts to target switch sites has rapidly advanced, resulting in an emerging pipeline of drug programs that address well-validated transcription factors, initially focused on precision oncology with future potential in neurology, rare genetic disorders, immunology and inflammation. Flare Therapeutics was launched in 2021 and is backed by founding investor Third Rock Ventures, Boxer Capital, Nextech Invest, Casdin Capital, Invus Financial Advisors and Eventide Asset Management. For more information, please visit www.flaretx.com.

We invite you to follow us on LinkedIn and @Flaretx.


Contacts

 

Investors:

Sarah McCabe

Stern Investor Relations, Inc.

Sarah.mccabe@sternir.com


Media:

Michelle Thaler

Michelle Thaler PR, LLC

516-225-4313

MichelleThalerPR@gmail.com

 

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