FHTX Foghorn Therapeutics Inc.
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
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FHD-286
Uveal melanoma
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Phase 1
Phase 1
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FHD-609
Synovial sarcoma
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Phase 1
Phase 1
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Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
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FHD-286
Acute myeloid leukemia (AML)
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Phase 1
Phase 1
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Phase 1 trial has been initiated.
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Latest News
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Foghorn Therapeutics Announces Dosing of First Patient in First-in-Human Clinical Program of FHD-286View Full Article Hide Full Article
- First clinical candidate of a new class of therapeutics directly targeting the chromatin regulatory system
- FHD-286 is a highly potent, selective, allosteric, oral, small molecule inhibitor of BRG1/BRM
CAMBRIDGE, Mass., May 17, 2021 (GLOBE NEWSWIRE) -- Foghorn Therapeutics Inc. (NASDAQ:FHTX), a company pioneering the discovery and development of a new class of medicines targeting genetically determined dependencies within the chromatin regulatory system, today announced that the first patient has been dosed in a first-in-human clinical trial of FHD-286 in metastatic uveal melanoma (mUM). A separate clinical study of FHD-286 in relapsed/refractory acute myelogenous leukemia (AML) is also underway.
FHD-286 is a selective inhibitor of the BAF chromatin remodeling complex ATPases BRG1 and BRM, and the first program in Foghorn's diverse pipeline of novel drug candidates targeting genetically determined dependencies within the chromatin regulatory system. FHD-286 is not only the company's first clinical stage program, the company believes it is also the first drug candidate directly targeting the chromatin regulatory system to enter clinical trials.
"Initiating our first clinical studies of FHD-286 is an important milestone for Foghorn, validating the potential of our Gene Traffic Control® platform to develop novel therapeutics and improve the lives of people with devastating diseases," said Sam Agresta M.D., M.P.H., Chief Medical Officer of Foghorn Therapeutics. "People with metastatic uveal melanoma and relapsed/refractory AML as well as MDS have limited treatment options. Based on our precise understanding of the dependencies that these cancers have on the chromatin regulatory system, we believe our dual inhibitor, FHD-286, has the potential to alter the course of disease of these people with uveal melanoma and AML as well as other diseases. In addition, we are continuing to study the effects of BRG1/BRM inhibition in other solid and hematologic tumor types for potential indication expansion in the future."
Both the FHD-286 metastatic uveal melanoma and AML (including MDS), clinical trials are first-in-human and first-in-class. Each is an open-label, monotherapy, dose-escalation study evaluating the safety, pharmacokinetics, pharmacodynamics and clinical activity of FHD-286 administered orally. To learn more about the first-in-human clinical trial of FHD-286 in metastatic uveal melanoma, please visit here.
About FHD-286
FHD-286 is a highly potent, selective, allosteric and orally available, small-molecule, enzymatic inhibitor of BRG1 and BRM, two highly similar proteins that are the ATPases, or the catalytic engines across all forms of the BAF complex, one of the key regulators of the chromatin regulatory system. In preclinical studies, FHD-286 has shown anti-tumor activity across a broad range of malignancies including both hematologic and solid tumors.
About AML
Adult acute myeloid leukemia (AML) is a cancer of the blood and bone marrow and the most common type of acute leukemia in adults. AML is a diverse disease associated with multiple genetic mutations. It is diagnosed in about 20,000 people every year in the United States.
About Uveal Melanoma
Uveal (intraocular) melanoma is a rare eye cancer that forms from cells that make melanin in the iris, ciliary body, and choroid. It is the most common eye cancer in adults. It is diagnosed in about 2,000 adults every year in the United States and occurs most often in lightly pigmented individuals with a median age of 55 years. However, it can occur in all races and at any age. UM metastasizes in approximately 50% of cases, leading to very poor prognosis.
About Foghorn Therapeutics
Foghorn® Therapeutics is discovering and developing a novel class of medicines targeting genetically determined dependencies within the chromatin regulatory system. Through its proprietary scalable Gene Traffic Control® platform, Foghorn is systematically studying, identifying and validating potential drug targets within the chromatin regulatory system. The company is developing multiple product candidates in oncology.
Forward-Looking Statements
This press release contains "forward-looking statements" regarding the Company's clinical programs for FHD-286. Forward-looking statements include statements regarding the Company's clinical trial, product candidates and research efforts and other statements identified by words such as "could," "may," "might," "will," "likely," "anticipates," "intends," "plans," "seeks," "believes," "estimates," "expects," "continues," "projects" and similar references to future periods. Forward-looking statements are based on our current expectations and assumptions regarding capital market conditions, our business, the economy and other future conditions. Because forward-looking statements relate to the future, by their nature, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. As a result, actual results may differ materially from those contemplated by the forward-looking statements. Important factors that could cause actual results to differ materially from those in the forward-looking statements include regional, national or global political, economic, business, competitive, market and regulatory conditions, including risk regarding the timing of filing an IND for our product candidates and other factors set forth under the heading "Risk Factors" in the Company's Form 10-K. Any forward-looking statement made in this press release speaks only as of the date on which it is made.
Media Contact:
Fanny Cavalié, Foghorn Therapeutics
[email protected]Gregory Kelley, Ogilvy
[email protected]Investor Relations Contact:
Allan Reine, Foghorn Therapeutics
[email protected]Hans Vitzthum, LifeSci Advisors
617-430-7578
[email protected]
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- Received IND clearance for FHD-609, a targeted protein degrader, which is being developed for the treatment of synovial sarcoma
- Continued to advance broad therapeutic pipeline targeting the chromatin regulatory system
CAMBRIDGE, Mass., May 11, 2021 (GLOBE NEWSWIRE) -- Foghorn Therapeutics Inc. (NASDAQ:FHTX), a company pioneering the discovery and development of a new class of medicines targeting genetically determined dependencies within the chromatin regulatory system, today provided a corporate update in conjunction with its 10-Q filing for the quarter ended March 31, 2021.
"2021 has already been a year of significant progress for our clinical programs, with FHD-609 recently becoming our second drug candidate to enter the clinic," said Adrian Gottschalk, Chief Executive Officer of Foghorn Therapeutics. "FHD-609, a protein degrader targeting BRD9, is initially being evaluated as a treatment for synovial sarcoma. FHD-609 demonstrates Foghorn's capabilities to develop protein degraders."
Continued Mr. Gottschalk: "Our first program, FHD-286, is being evaluated in two separate phase I studies, one in relapsed and/or refractory AML and MDS, and a second in metastatic uveal melanoma. We look forward to generating clinical data over the next year with the first drugs to enter the clinic from our proprietary Gene Traffic Control® platform."
"Beyond these first two programs, we continue to advance multiple drug candidates targeting the chromatin regulatory system including protein degraders, enzymatic inhibitors and transcription factor disruptors."
Recent Corporate Highlights:
- Received IND clearance for FHD-609. Foghorn received FDA clearance of its IND application for FHD-609. FHD-609 is a highly potent, selective, intravenous, small molecule protein degrader of BRD9, initially being developed for the treatment of synovial sarcoma with the intention to expand into additional indications, including SMARCB1 deleted tumors.
- Received IND clearance for FHD-286. Foghorn received FDA clearance of its IND application for FHD-286 for (i) relapsed and/or refractory AML and MDS and (ii) metastatic uveal melanoma. FHD-286, is a highly potent, selective, allosteric and orally available, small-molecule, enzymatic inhibitor of BRG1 and BRM.
- Appointed Ian Smith to Board of Directors. On April 27th, 2021 Foghorn appointed Ian Smith to its Board of Directors, adding a diverse skill set spanning decades as a proven biotechnology leader.
Key Upcoming Milestones
- FHD-286 data. Foghorn expects to have initial data from its phase 1 studies of FHD-286 in metastatic uveal melanoma and relapsed/refractory AML as early as year-end 2021.
- FHD-609 data. Foghorn expects to have initial data from its phase 1 study in synovial sarcoma as early as the first half of 2022.
Upcoming Events
- June 15th Investor Event. Foghorn will host its inaugural Chromatin Regulatory System Investor Event virtually on June 15th, 2021. Investors can register for the event HERE.
- Jefferies Virtual Healthcare Conference. Company presentation, June 1, 2021 at 10:00am ET.
- Goldman Sachs 42nd Annual Healthcare Conference (Virtual), June 8-10, 2021.
Financial Condition
Foghorn reported cash, cash equivalents and marketable securities of $ 160.9 million as of March 31, 2021, as compared to $185.8 million as of December 31, 2020.
About Foghorn Therapeutics
Foghorn® Therapeutics is discovering and developing a novel class of medicines targeting genetically determined dependencies within the chromatin regulatory system. Through its proprietary scalable Gene Traffic Control® platform, Foghorn is systematically studying, identifying and validating potential drug targets within the chromatin regulatory system. The company is developing multiple product candidates in oncology.
Forward-Looking Statements
This press release contains "forward-looking statements" regarding the Company's approach to treating disease. Forward-Forward-looking statements include statements regarding the Company's clinical trial, product candidates and research efforts and other statements identified by words such as "could," "may," "might," "will," "likely," "anticipates," "intends," "plans," "seeks," "believes," "estimates," "expects," "continues," "projects" and similar references to future periods. Forward-looking statements are based on our current expectations and assumptions regarding capital market conditions, our business, the economy and other future conditions. Because forward-looking statements relate to the future, by their nature, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. As a result, actual results may differ materially from those contemplated by the forward-looking statements. Important factors that could cause actual results to differ materially from those in the forward-looking statements include regional, national or global political, economic, business, competitive, market and regulatory conditions, including risk regarding the timing of filing an IND for our product candidates and other factors set forth under the heading "Risk Factors" in the Company's Form 10-K. Any forward-looking statement made in this press release speaks only as of the date on which it is made.
Media Contact:
Fanny Cavalié, Foghorn Therapeutics
[email protected]Gregory Kelley, Ogilvy
[email protected]Investor Relations Contact:
Allan Reine, Foghorn Therapeutics
[email protected]Hans Vitzthum, LifeSci Advisors
617-430-7578
[email protected] -
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CAMBRIDGE, Mass., April 28, 2021 (GLOBE NEWSWIRE) -- Foghorn Therapeutics Inc. (NASDAQ:FHTX), a company pioneering the discovery and development of a new class of medicines targeting genetically determined dependencies within the chromatin regulatory system, today announced the appointment of Ian Smith to its Board of Directors effective, April 27.
"Ian is a proven biotechnology leader with a diverse skill set, and I am excited to welcome him to our Board at this important time in the company's evolution," stated Adrian Gottschalk, Foghorn's Chief Executive Officer. "Ian has been advising the company since early 2020 on various initiatives including business development and equity financing strategies as well as company progression and development. The addition of Ian to our Board brings significant business experience and capital formation expertise to our Company."
"I believe in a precision biology approach that focuses on the cause of disease; Foghorn's focus on the chromatin regulatory system and its causal role in a broad range of serious diseases has the potential to create significant therapeutic breakthroughs," stated Mr. Smith. "I am pleased to join the Board and look forward to working with my fellow Board members, Adrian and the Foghorn leadership team."
"We welcome Ian to the Foghorn Board," stated Doug Cole, MD, Chairman of Foghorn's Board of Directors. "His experience building valuable biotech businesses will help us to deliver on the enormous potential of drugs based on chromatin dysregulation."
Mr. Smith is currently the Executive Chairperson of Viacyte, Inc. He was previously Chief Operating Officer at Vertex Pharmaceuticals, Inc. Prior to joining Vertex in 2001, Mr. Smith served as a partner in the Life Science and Technology Practice of the accounting firm Ernst & Young LLP. He also serves as Chairman of the Board of Solid Biosciences, as a board member of AavantiBio Inc., and as a Senior Advisor to Bain Capital Life Sciences.
About Foghorn Therapeutics
Foghorn® Therapeutics is discovering and developing a novel class of medicines targeting genetically determined dependencies within the chromatin regulatory system. Through its proprietary scalable Gene Traffic Control® platform, Foghorn is systematically studying, identifying and validating potential drug targets within the chromatin regulatory system. The company is developing multiple product candidates in oncology.
Forward-Looking Statements
This press release contains "forward-looking statements" regarding the Company's approach to treating disease. Forward-Forward-looking statements include statements regarding the Company's clinical trial, product candidates and research efforts and other statements identified by words such as "could," "may," "might," "will," "likely," "anticipates," "intends," "plans," "seeks," "believes," "estimates," "expects," "continues," "projects" and similar references to future periods. Forward-looking statements are based on our current expectations and assumptions regarding capital market conditions, our business, the economy and other future conditions. Because forward-looking statements relate to the future, by their nature, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. As a result, actual results may differ materially from those contemplated by the forward-looking statements. Important factors that could cause actual results to differ materially from those in the forward-looking statements include regional, national or global political, economic, business, competitive, market and regulatory conditions, including risk regarding the timing of filing an IND for our product candidates and other factors set forth under the heading "Risk Factors" in the Company's Form 10-K. Any forward-looking statement made in this press release speaks only as of the date on which it is made.
Media Contact:
Fanny Cavalié, Foghorn Therapeutics
[email protected]Gregory Kelley, Ogilvy
[email protected]Investor Relations Contact:
Allan Reine, Foghorn Therapeutics
[email protected]Hans Vitzthun, LifeSci Advisors
617-535-7743
[email protected] -
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David Davidson, M.D. to Serve as Chief Medical and Development Officer; Hari Pujar, Ph.D. to Serve as Chief Operating Officer and Lin Guey, Ph.D. to Serve as Senior Vice President of Rare Diseases Program Strategy and Operations
Tessera Therapeutics, a biotech company pioneering Gene Writing, announced today the appointment of David Davidson, M.D. as Chief Medical and Development Officer, Hari Pujar, Ph.D. as Chief Operating Officer, and Lin Guey, Ph.D. as Senior Vice President of Rare Diseases Program Strategy and Operations. The senior appointments come just two months after the company announced over $230 million in Series B fundraising in January and will be key to advancing the company's Gene Writing platform and accelerating development of multiple therapeutic programs.
"David, Hari and Lin all bring a wealth of strategic leadership and deep expertise to Tessera at an exciting time in our growth," said Dr. Geoffrey von Maltzahn, CEO and Co-Founder of Tessera. "Together and alongside our current senior leadership team, they will be instrumental in advancing Tessera's mission to bring forth innovative and curative medicines that go beyond the limitations of current technologies."
Dr. Davidson brings over 20 years of expertise in clinical drug development focused on rare diseases and gene therapy to his new role as Tessera's Chief Medical and Development Officer. For nearly a decade, Dr. Davidson served as Chief Medical Officer of bluebird bio, where he played a critical role in advancing a broad genetic medicine pipeline across blood disorders, rare diseases and oncology, successfully leading numerous genetic medicine programs into the clinic and delivering multiple first-in-class approvals for genetic medicines in the U.S. and Europe. Prior to bluebird, Dr. Davidson led clinical research for a wide range of therapeutic programs at Genzyme and GelTex, spanning biologics, polymers, and gene therapy. He completed a fellowship in infectious diseases at the Harvard Longwood Combined ID Program, his residency training in internal medicine, and an endocrinology research fellowship at the University of Chicago Hospitals. Dr. Davidson received his M.D. from New York University and B.A. from Columbia University.
"I have been privileged to lead the clinical development of gene therapy programs from inception through approval to deliver these transformative medicines to patients with life-threatening diseases. I am excited to join the team at Tessera Therapeutics to bring innovative Gene Writing therapies into the clinic," said Dr. David Davidson. "By harnessing the power of mobile genetic elements, Tessera's Gene Writing platform is poised to realize the full potential of genetic medicine and make an unprecedented impact on human health. I am honored to help move this vision forward."
Dr. Pujar, an Operating Partner at Flagship Pioneering since October 2020, will also serve as Tessera's Chief Operating Officer. Dr. Pujar brings more than 20 years of drug development, manufacturing and commercialization experience spanning AAV gene therapy, mRNA vaccines and therapeutics, and traditional vaccines and biologics. Most recently, Dr. Pujar served as Chief Technology Officer at Spark Therapeutics, a pioneer in AAV gene therapy, and Head of Technical Development and Manufacturing at Moderna, where he led mRNA and lipid nanoparticle development and manufacturing. Previously, Dr. Pujar spent 18 years at Merck & Co., developing and commercializing vaccines and biologics. Dr. Pujar received his Ph.D. in Chemical Engineering from the University of Delaware and his M.B.A. from the University of Pennsylvania.
"As medicine continues to move up the central dogma of molecular biology from proteins to mRNA to DNA, the opportunity to cure diseases will continue to expand. I'm excited to help shape Tessera Therapeutics, whose Gene Writing technology has the potential to address many of the limitations of current genetic medicine technologies," said Dr. Hari Pujar.
Dr. Guey, Tessera's Senior Vice President of Rare Diseases Program Strategy and Operations, will oversee the execution of Tessera's genetic medicine programs in Rare Diseases. Dr. Guey brings over 13 years of drug development experience in program leadership, research and nonclinical development, pharmacogenomics and epidemiology. Prior to joining Tessera, Dr. Guey served in senior leadership roles for Moderna, Xilio Therapeutics, Shire, and Pfizer. Dr. Guey received her Ph.D. in Statistics and B.S. in Mathematics from Stony Brook University.
"With its pioneering and versatile Gene Writing technology, Tessera Therapeutics is at the very forefront of genetic medicine," said Dr. Lin Guey. "I look forward to working with the Tessera team to find new ways to cure rare genetic diseases at their source."
For more information on Tessera, including how Gene Writing works, partnership opportunities, and job openings, visit www.tesseratherapeutics.com.
About Tessera Therapeutics
Tessera Therapeutics is a life sciences company pioneering Gene Writing, a new biotechnology designed to offer scientists and clinicians the ability to write small and large therapeutic messages into the genome, thereby curing diseases at their source. Gene Writing holds the potential to become a new category in genetic medicine, building upon recent breakthroughs in gene therapy and gene editing while eliminating important limitations in their reach, utilization, and efficacy. Tessera Therapeutics was founded by Flagship Pioneering, a life sciences innovation enterprise that conceives, resources, and develops first-in-category companies to transform human health and sustainability.
About Flagship Pioneering
Flagship Pioneering conceives, creates, resources, and develops first-in-category life science platform companies to transform human health and sustainability. Since its launch in 2000, the firm has, through its Flagship Labs unit, applied its unique hypothesis-driven innovation process to originate and foster more than 100 scientific ventures, resulting in over $80 billion in aggregate value. To date, Flagship has deployed over $2.3 billion in capital toward the founding and growth of its pioneering companies alongside more than $19 billion of follow-on investments from other institutions. The current Flagship ecosystem comprises 41 transformative companies, including Axcella Health (NASDAQ:AXLA), Codiak BioSciences (NASDAQ:CDAK) Denali Therapeutics (NASDAQ:DNLI), Evelo Biosciences (NASDAQ:EVLO), Foghorn Therapeutics (NASDAQ:FHTX), Indigo Ag, Kaleido Biosciences (NASDAQ:KLDO), Moderna (NASDAQ:MRNA), Rubius Therapeutics (NASDAQ:RUBY), Sana Biotechnology (NASDAQ:SANA), Seres Therapeutics (NASDAQ:MCRB), and Sigilon Therapeutics (NASDAQ:SGTX).
View source version on businesswire.com: https://www.businesswire.com/news/home/20210407005336/en/
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CAMBRIDGE, Mass., March 30, 2021 /PRNewswire/ -- Invaio Sciences, Inc., a Flagship Pioneering company focused on unlocking the potential of the planet's interdependent natural systems to solve pressing agriculture, nutrition and environmental challenges, announced today the appointment of Peleg Chevion as President and Chief Commercial Officer. Chevion, who joined the company in late 2020, will focus on accelerating the commercial activities of the company.
"Our goal at Invaio is to accelerate the transition in agriculture from a chemical-based industry to a biological-based industry that addresses the needs of farmers and society, while protecting the environment," said Ignacio Martinez, Co-Founder and CEO, Invaio. "The company is now transitioning from an R&D-focused organization to a full commercial enterprise."
Martinez continued, "Peleg has already made a significant impact at Invaio since he joined the company in late 2020. He brings a very unique set of experiences, commercial leadership, and an entrepreneurial mindset perfectly suited for the next phase of the company."
Prior to joining Invaio, Chevion was President and Chief Commercial Officer of Blendhub, a global leader in food and ingredients production. Before Blendhub, Peleg worked with Lindsey Goldberg, a leading global private equity firm based in New York. Chevion also worked for seven years as a senior executive at Syngenta where he started and then led the Abiotic Stress Management indication across the spectrum of chemical, biological, genetics and digital platforms. Prior to Syngenta, Chevion spent several years leading Business Development at Crucell before the company was acquired by J&J.
Chevion began his career as an officer in the Israeli Air Force, and later held diverse roles in the Israeli startup ecosystem. Chevion graduated from the IDF Computer Academy. He received an L.L.B from Tel Aviv University, an MBA from INSEAD and is a licensed attorney in Israel.
"Since joining Invaio last year, I have been impressed by the breakthrough platform technologies we are developing, our integrated solutions approach and the commercial traction of the company," said Peleg Chevion, President and Chief Commercial Officer, Invaio. "We are curing diseases like Greening in Citrus and Xylella in Olives, significantly reducing the use of chemicals with our precision delivery systems, and discovering biological products with consistent performance using proprietary Artificial Intelligence and Machine Learning technologies"
Chevion continues, "We are laser focused on developing unique solutions for our partner growers and other stakeholders in three segments: perennials, row crops and vegetable crops. We see the opportunity and have a sense of urgency to deliver."
About Invaio Sciences:
Invaio Sciences is a multi-platform technology company that unlocks the potential of the planet's interdependent systems to address pressing agricultural, nutritional, and environmental challenges. Founded by Flagship Pioneering in 2018, Invaio leverages discoveries from diverse fields including human therapeutics, agriculture, environmental science, and advanced manufacturing. The company's deep understanding of the physiology of insects, plants and trees, together with its novel integrated solutions approach, promises to refine agricultural practices and reduce the need for pesticides globally. Invaio Sciences is dedicated to developing solutions that are mindful of beneficial insects, bad for pests, and safer for us all. For more information, please visit www.invaio.comAbout Flagship Pioneering:
Flagship Pioneering conceives, creates, resources, and develops first-in-category life science platform companies to transform human health and sustainability. Since its launch in 2000, the firm has, through its Flagship Labs unit, applied its unique hypothesis-driven innovation process to originate and foster more than 100 scientific ventures, resulting in over $80 billion in aggregate value. To date, Flagship has deployed over $2.3 billion in capital toward the founding and growth of its pioneering companies alongside more than $19 billion of follow-on investments from other institutions. The current Flagship ecosystem comprises 41 transformative companies, including Axcella Health (NASDAQ:AXLA), Codiak BioSciences (NASDAQ:CDAK) Denali Therapeutics (NASDAQ:DNLI), Evelo Biosciences (NASDAQ:EVLO), Foghorn Therapeutics (NASDAQ:FHTX), Indigo Ag, Inari Agriculture, Kaleido Biosciences (NASDAQ:KLDO), Moderna (NASDAQ:MRNA), Rubius Therapeutics (NASDAQ:RUBY), Sana Biotechnology (NASDAQ:SANA), Seres Therapeutics (NASDAQ:MCRB), and Sigilon Therapeutics (NASDAQ:SGTX).
View original content to download multimedia:http://www.prnewswire.com/news-releases/invaio-sciences-strengthens-leadership-team-with-appointment-of-peleg-chevion-as-president-and-chief-commercial-officer-301258544.htmlSOURCE Invaio Sciences