1stOncology™: Cancer Intelligence Service – Page 8660 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

aTyr Pharma Announces Expansion of Research Collaboration with The Ohio State University

On August 10, 2021 aTyr Pharma, Inc. (Nasdaq: LIFE), a clinical stage biotherapeutics company, reported that the company has expanded its research collaboration with The Ohio State University (OSU) to deepen the understanding of the immune mechanisms of sarcoid granuloma formation and identify potential biomarkers of efficacy for the company’s lead therapeutic candidate, ATYR1923, which is currently in clinical development for the treatment of pulmonary sarcoidosis (Press release, aTyr Pharma, AUG 10, 2021, View Source [SID1234586253]). The research will be conducted in the laboratory of Elliott Crouser, M.D., Professor of Pulmonology, Critical Care and Sleep Medicine at OSU. Dr. Crouser specializes in sarcoidosis research and treatment and will serve as the principal investigator.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

The collaboration, which expands upon a successful pilot proof-of-concept study, will assess the effect of ATYR1923 on sarcoid granuloma formation in vitro in blood samples taken from sarcoidosis patients. The study will focus on identifying the relevant immune mechanisms triggered in granuloma formation and analyze promising biomarkers predictive of strong granuloma formation in order to assess whether they could be used as predictive biomarkers for treatment selection or treatment response to ATYR1923.

"We look forward to working with aTyr on this important initiative to expand the current understanding of the underlying mechanisms involved in pulmonary sarcoidosis, particularly the formation of granulomas. This work has the potential to identify promising biomarkers that may be used to predict treatment response, including to ATYR1923. Current treatment options for pulmonary sarcoidosis are limited, and the ability to determine a patient population that may benefit from a potential treatment such as ATYR1923 presents the opportunity to take a much-needed step forward in managing this disease," said Dr. Crouser.

"We are very pleased to expand this research collaboration with OSU and Dr. Crouser. This collaboration will build upon the successful findings from research conducted with Dr. Crouser that were recently accepted to be presented at the upcoming European Respiratory Society International Congress in September, which demonstrate the ability of a splice variant of histidyl-tRNA synthetase, the active portion of ATYR1923, to disrupt sarcoid granuloma formation in vitro — a hallmark of this debilitating disease," said Sanjay Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. "The research generated from this collaboration may help direct us to biomarkers indicative of a population that may be sensitive to treatment with ATYR1923, which could lead to improved patient outcomes."

Sarcoidosis is an inflammatory disease characterized by the formulation of granulomas, clumps of inflammatory cells, in one or more organs of the body. Sarcoidosis in the lungs is called pulmonary sarcoidosis and occurs in more than 90% of all sarcoidosis patients. Approximately 150,000 to 200,000 Americans live with pulmonary sarcoidosis and the prognosis ranges from benign and self-limiting to chronic, debilitating disease, permanent loss of lung function and death. Current treatment options include corticosteroids and other immunosuppressive therapies, which have limited efficacy and are associated with serious side-effects when used long-term that many patients cannot tolerate.

Dr. Crouser received his medical degree from the Medical College of Ohio at Toledo, OH. He completed an internship, residency and fellowship at The Ohio State University Wexner Medical Center in Columbus, OH. He is board certified in Internal Medicine with subspecialty certifications in Pulmonary Disease and Critical Care. He is a leader in sarcoidosis research and treatment and currently serves as the Chair of the Foundation for Sarcoidosis Research’s Scientific Advisory Board. In 25 years, his laboratory has contributed to the publication of more than 100 peer-reviewed manuscripts, including the first clinical practice guidelines for sarcoidosis, which were endorsed by the American Thoracic Society in 2020. Ohio State’s Sarcoidosis Specialty Clinic was named a Center of Excellence in 2020 by the World Association of Sarcoidosis and Other Granulomatous Disorders.

About ATYR1923

aTyr is developing ATYR1923 as a potential therapeutic for patients with severe inflammatory lung diseases. ATYR1923, a fusion protein comprised of the immuno-modulatory domain of histidyl-tRNA synthetase fused to the FC region of a human antibody, is a selective modulator of neuropilin-2 that downregulates the innate and adaptive immune response in inflammatory disease states. aTyr has completed enrollment in a proof-of-concept Phase 1b/2a trial evaluating ATYR1923 in patients with pulmonary sarcoidosis. This Phase 1b/2a study is a multi-ascending dose, placebo-controlled, first-in-patient study of ATYR1923 that has been designed to evaluate the safety, tolerability, steroid sparing effect, immunogenicity and pharmacokinetic profile of multiple doses of ATYR1923. Proof-of-mechanism for ATYR1923 was established in a Phase 2 clinical trial in COVID-19 patients with severe respiratory complications, which demonstrated that ATYR1923 reduced inflammatory cytokine levels in patients consistent with preclinical models, including cytokines that are implicated in sarcoidosis and other forms of interstitial lung disease.

Turning Point Therapeutics Reports Second-Quarter Financial Results, Provides Operational Updates

On August 10, 2021 Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, reported financial results and operational updates for the second quarter ended June 30, 2021 (Press release, Turning Point Therapeutics, AUG 10, 2021, View Source [SID1234586251]).

"Our team made strong progress advancing our 4 clinical drug candidates in 5 ongoing clinical trials as well as our research programs with the first 2 development candidates targeted in the second half of 2022," said Athena Countouriotis, M.D., president and CEO. "In our clinical programs, we are pleased with ongoing enrollment in our pivotal TRIDENT-1 study of repotrectinib. In addition, we recently initiated the Phase 1 expansion cohorts in our SHIELD-1 study of TPX-0022 and just last week were granted Fast Track designation for TPX-0022 in certain gastric cancer indications. We look forward to multiple data updates from our clinical studies at medical conferences during the fourth quarter."

Second quarter and recent highlights include:

REPOTRECTINIB, ROS1/TRK Inhibitor

Enrollment of approximately 300 patients in the Phase 1 and 2 portions of the TRIDENT-1 study, including more than 50 patients in the ROS1-positive TKI-naïve advanced non-small cell lung cancer (NSCLC) patient cohort (EXP-1). Enrollment in the EXP-1 cohort is ongoing to provide continued access to new patients.

Acceptance of TRIDENT-1 clinical data for presentation at the 2021 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) in October.

Acceptance of initial clinical data from the ongoing Phase 1/2 CARE study in pediatric and young adult patients with advanced solid tumors harboring ALK, ROS1 or NTRK alterations for an oral presentation at the 53rd Congress of the International Society of Paediatric Oncology (SIOP) in October.

First patients dosed in China in the TRIDENT-1 study as part of the company’s partnership with Zai Lab to develop repotrectinib in greater China. Achievement of the milestones resulted in revenue of $5 million to Turning Point under its collaboration agreement with Zai Lab.
TPX-0022, MET/ SRC/CSF1R Inhibitor

Selection of the likely recommended Phase 2 dose (RP2D) in the ongoing Phase 1 SHIELD-1 study of TPX-0022, Turning Point’s MET, SRC and CSF1R inhibitor, and initiation of Phase 1 expansion cohorts. Subject to feedback from the U.S. Food and Drug Administration (FDA) at an end of Phase 1 meeting in the third quarter, including agreement on the RP2D, the company plans to revise the study into a potentially registrational Phase 1/2 and proceed into the Phase 2 portion.

Acceptance of SHIELD-1 clinical data for presentation at the 2021 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) in October.

Orphan Drug Designation granted by the FDA for the treatment of patients with gastric cancer, including gastroesophageal junction adenocarcinoma (GEJ).

Fast Track Designation granted by the FDA for the treatment of patients with MET amplified advanced or metastatic gastric cancer or GEJ adenocarcinoma after prior chemotherapy.
TPX-0046, RET Inhibitor

Progress in the ongoing dose-finding portion of the Phase 1/2 SWORD-1 study, where the company continues to evaluate multiple doses and schedules to further characterize the pharmacokinetics, safety, and efficacy profile before determining the RP2D.
TPX-0131, ALK Inhibitor

Ongoing patient dosing in the Phase 1/2 FORGE-1 study of TPX-0131 in locally advanced or metastatic TKI-pretreated ALK-positive NSCLC. The study endpoints include safety and tolerability, determination of the recommended Phase 2 dose, pharmacokinetics, and any early signals of efficacy.

Publication of preclinical data in the AACR (Free AACR Whitepaper) Journal of Molecular Cancer Therapeutics showing TPX-0131 to be potent against a wide range of ALK resistant mutations, including G1202R, L1196M and multiple compound mutations.
Discovery

Advancing four internal discovery programs targeting aberrant GTPase signaling known to drive genomically defined cancers with significant unmet medical need. The most advanced programs target KRAS G12D and the p21 activated kinase, or "PAK" family. Turning Point is targeting 2 development candidates in the second half of 2022 with a goal to achieve at least one new IND per year beginning in 2023.
Second Quarter Financial Results

Revenue: Revenue of $5.2 million recognized during the quarter was driven primarily by milestones earned from Zai Lab (Shanghai) Co. Ltd. under the company’s license agreement for repotrectinib in Greater China. Revenue for the first half of 2021 totaled $30.4 million.

R&D Expenses: Research and development expenses were $44.7 million in the quarter, compared to $24.2 million in the second quarter of 2020. The $20.5 million increase was primarily driven by the year-over-year increase in investments to develop repotrectinib, TPX-0022, TPX-0046 and TPX-0131, discovery efforts and personnel expenses. R&D expenses for the first half of 2021 totaled $85.9 million.

G&A Expenses: General and administrative expenses were $17.2 million compared to $8.6 million in the second quarter of 2020, primarily related to higher personnel expenses from an increase in head count and professional services. G&A expenses for the first half of 2021 totaled $37.2 million.

Net Income/Loss: Net loss was $56.3 million compared to a net loss of $31.5 million for the second quarter of 2020. Net loss for the first half of 2021 was $91.8 million.

Cash position: Cash, cash equivalents and marketable securities at June 30, 2021 totaled approximately $1.1 billion. Net cash used during the first half of 2021 was $44.7 million. Turning Point projects its cash position funds current operations into 2024.
Upcoming Milestones
Key milestones anticipated in the second half of 2021 include:

Repotrectinib

Initiate the first cohort of a multi-arm Phase 1b/2 TRIDENT-2 combination study in patients with KRAS mutant G12D advanced solid tumors in the third quarter

Provide a clinical data update by physician assessment from multiple ROS1 and NTRK patient cohorts of the Phase 2 TRIDENT-1 study at the AACR (Free AACR Whitepaper)-NCI-EORTC conference in October

Report initial clinical data from the ongoing Phase 1/2 CARE study in pediatric and young adult patients in an oral presentation at the 53rd SIOP Congress in October
TPX-0022

Provide a clinical data update across multiple tumor types and MET genetic alterations from the Phase 1 dose finding portion of the SHIELD-1 study at the AACR (Free AACR Whitepaper)-NCI-EORTC conference in October

Initiate the Phase 2 portion of the SHIELD-1 study, pending FDA feedback, in the fourth quarter

Initiate the Phase 1b/2 SHIELD-2 study of TPX-0022 in combination with an epidermal growth factor receptor (EGFR) targeted therapy in the fourth quarter
Webcast, Conference Call, Upcoming Investor Conferences
Turning Point will webcast its Quarterly Update Conference Call today, Aug. 9 at 4:30 p.m. ET/1:30 p.m. PT. Dr. Countouriotis will host the call, which will be accessible through the "Investors" section of tptherapeutics.com or by dialing (877) 388-2118 (in the United States) or (470) 495-9489 (outside the U.S.) using conference ID 4029189. A replay will be available through the "Investors" section of www.tptherapeutics.com.

Dr. Countouriotis will also participate in a targeted oncology panel discussion at the 2021 Wedbush Pacgrow Virtual Healthcare Conference on Aug. 10 at 10:55 a.m. ET, and a "fireside chat" question-and-answer session at the 41st Annual Canaccord Genuity Growth Conference on Aug. 11 at 4 p.m. ET. Both sessions will be accessible through the "Investors" section of www.tptherapeutics.com.

Fusion Pharmaceuticals Announces Second Quarter 2021 Financial Results and Business Update

On August 10, 2021 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, reported financial results for the second quarter ended June 30, 2021 and provided an update on clinical and corporate developments (Press release, Fusion Pharmaceuticals, AUG 10, 2021, View Source [SID1234586249]).

"We are building a fully integrated radiopharmaceutical company based upon our platform, reflecting a diverse pipeline of targeted alpha therapies in development supported by manufacturing and supply chain expertise," said Chief Executive Officer John Valliant, Ph.D. "We expect to have three clinical programs employing differentiated radiopharmaceuticals underway by mid-next year. In addition to our ongoing Phase 1 study of FPI-1434, the investigational new drug application (IND) of FPI-1966 was recently cleared by the U.S. Food & Drug Administration (FDA), and we intend to submit an IND application for FPI-2059 in the first half of 2022. In parallel, we are quickly advancing programs under our partnership agreement with AstraZeneca and are planning for a combination study of FPI-1434 with KEYTRUDA (pembrolizumab)."

Dr. Valliant continued, "These programs, along with our work to build Fusion’s radiopharmaceutical manufacturing capabilities with a new facility, demonstrate the depth and versatility of our pipeline and the potential to use our expertise to create innovative treatments for a broad array of solid tumors with high unmet medical need."

Recent Highlights and Future Milestones

Corporate Updates

On July 28, Fusion announced the FDA cleared the Company’s Investigational New Drug (IND) application for FPI-1966. FPI-1966 is a targeted alpha therapy (TAT) designed to use vofatamab, a human monoclonal antibody, to target and deliver actinium-225 to tumor sites expressing fibroblast growth factor 3 (FGFR3), a protein that is overexpressed in multiple tumor types, particularly head and neck and bladder cancers. Fusion plans to initiate a Phase 1, non-randomized, open-label clinical trial in patients with solid tumors expressing FGFR3 intended to investigate safety, tolerability and pharmacokinetics and to establish the recommended Phase 2 dose. The Company anticipates initiating the Phase 1 study around the end of 2021 and reporting interim data from the first patient cohort around the end of 2022.
On June 14, Fusion announced the presentation of preliminary Phase 1 data from the single-dose portion of the study at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Virtual Annual Meeting. Results from the first three patient cohorts (n=12) demonstrated a favorable safety profile for FPI-1434. No drug-related serious adverse events and/or dose limiting toxicity were reported in administered activity up to 40kBq/kg body weight and dosimetric results were within normal organ radiation tolerability limits.
On June 14, Fusion also announced preclinical data demonstrating synergistic efficacy against olaparib-resistant colorectal and radioresistant lung cancer xenografts when combining FPI-1434 with olaparib, and preclinical data showing that treatment with FPI-1434 in combination with immune checkpoint inhibitors resulted in complete tumor eradication.
On June 2, Fusion announced that the Company entered a 15-year lease agreement with Hamilton, Ontario-based McMaster University to build a 27,000 square foot current Good Manufacturing Practice (GMP) compliant radiopharmaceutical manufacturing facility. The facility, to be built by McMaster and equipped and validated by Fusion, will be designed to support manufacturing of the Company’s growing pipeline of targeted alpha therapies (TATs).
FPI-1434 Monotherapy

Fusion continues to advance the multi-dose portion of its Phase 1 study evaluating FPI-1434 in patients with advanced solid tumors. The dose-finding study is enrolling patients at sites in Canada, the United States and Australia.
Fusion anticipates reporting Phase 1 multi-dose safety and imaging data, and the recommended Phase 2 dose and schedule, in the first half of 2022.
FPI-1434 Combination Therapy

Fusion has evaluated FPI-1434 in preclinical studies in combination with approved checkpoint and DNA damage response inhibitors, including PARP inhibitors, and believes the synergies observed could expand the addressable patient populations for FPI-1434 and allow for potential use in earlier lines of treatment.
Fusion anticipates the initiation of a Phase 1 combination study with FPI-1434 and KEYTRUDA (pembrolizumab) to occur six to nine months following determination of the recommended Phase 2 dose of FPI-1434 monotherapy.
FPI-2059

FPI-2059 is a small molecule radioconjugate in development as a targeted alpha therapy for various solid tumors. The molecule targets neurotensin receptor 1 (NTSR1), a promising target for cancer treatment, that is overexpressed in multiple solid tumors. FPI-2059 combines Ipsen’s IPN-1087, which Fusion acquired in 2021, with actinium-225. Fusion anticipates submitting an IND application for FPI-2059 in the first half of 2022.
Second Quarter 2021 Financial Results

Cash and Investments: As of June 30, 2021, Fusion held cash, cash equivalents and investments of $260.5 million, compared to cash, cash equivalents and investments of $299.5 million as of December 31, 2020. Fusion expects its cash, cash equivalents and investments as of June 30, 2021 will enable the Company to fund its operations through the end of 2023.
Collaboration Revenue: For the second quarter of 2021, Fusion recorded $0.5 million of revenue under the AstraZeneca collaboration agreement.
R&D Expenses: Research and development expenses for the second quarter of 2021 were $21.1 million, compared to $3.3 million for the same period in 2020. The increase was primarily related to increased platform development and research activities, clinical activities related to the ongoing Phase 1 clinical trial of FPI-1434, asset purchase agreements and preclinical research and manufacturing costs.
G&A Expenses: General and administrative expenses for the second quarter of 2021 were $6.6 million, compared to $4.0 million for the same period in 2020. The increase was primarily related to personnel related costs, including salary, benefits and stock compensation due to hiring, as well as general corporate costs, including expenses for general corporate, director and officer insurance.
Net Loss: For the second quarter of 2021, Fusion reported a net loss of $26.9 million, or $0.63 per share, compared with a net loss of $44.7 million, or $18.91 per share, for the same period in 2020. On a non-GAAP basis, excluding a change in fair value of preferred share tranche right liability and warrant liability, net loss was $7.1 million for the second quarter of 2020.
Impact of COVID-19

While Fusion is progressing the multi-dosing portion of the Phase 1 clinical trial of FPI-1434, the Company has experienced material delays in patient recruitment and enrollment as a result of continued resourcing issues related to COVID-19 at trial sites.

Moreover, there remains uncertainty relating to the trajectory of the pandemic and whether it may cause further delays in patient study recruitment. The impact of related responses and disruptions caused by the COVID-19 pandemic may result in difficulties or delays in initiating, enrolling, conducting or completing the planned and ongoing trials and the incurrence of unforeseen costs as a result of disruptions in clinical supply or preclinical study or clinical trial delays. The continued impact of COVID-19 on results will largely depend on future developments, which are highly uncertain and cannot be predicted with confidence.

Decibel Therapeutics Reports Second Quarter 2021 Financial Results and Corporate Update

On August 10, 2021 Decibel Therapeutics (Nasdaq: DBTX), a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance, reported financial results for the second quarter ended June 30, 2021 and provided a corporate update (Press release, Decibel Therapeutics, AUG 10, 2021, View Source [SID1234586248]).

"The second quarter of 2021 has been a time of continued progress across the business as we gear up for meaningful milestones expected in 2022. We have several 2022 catalysts slated for our pipeline programs, including advancing our DB-OTO program into clinical development and the planned interim analysis from our human Phase 1b clinical trial of DB-020 for cisplatin-induced hearing loss," said Laurence Reid, Ph.D., Chief Executive Officer of Decibel. "We were pleased to welcome Dr. William H. Carson as Chairman of the Board of Directors and also announced several significant appointments to our Scientific Advisory Board, further bolstering our team of academic and industry experts. We look forward to working with these world-class experts as we work to pursue our goal of delivering novel therapies to patients with hearing loss and balance disorders."

Company Highlights:

Appointed New Chairman of Board of Directors: In June 2021, Decibel announced the appointment of William H. Carson, M.D., as Chairman of the Board of Directors.
Expanded Scientific Advisory Board: In May 2021, Decibel announced the appointment of several leading experts in gene therapy, cochlear development and molecular genetics to its Scientific Advisory Board (SAB). Appointees included Connie Cepko, Ph.D., Guangping Gao, Ph.D., Matthew Kelley, Ph.D., Glenn Pierce, M.D., Ph.D. and Dinah Sah, Ph.D.
Pipeline Progress

Gene Therapies for Congenital, Monogenic Hearing Loss

On Track to Achieve DB-OTO Key Milestones in 2022: Decibel expects to submit an investigational new drug application (IND) with the U.S. Food and Drug Administration (FDA) and/or a Clinical Trial Application (CTA) in Europe for DB-OTO and initiate a Phase 1/2 clinical trial of DB-OTO for pediatric patients with congenital hearing loss due to an otoferlin deficiency in 2022.
Preclinical Pipeline Continues to Progress: Decibel expects to announce the program target for its AAV.104 discovery program in patients with autosomal recessive hearing disorders in 2021.
Gene Therapies for Hair Cell Regeneration

On Track to Announce AAV.201 Program Target: Decibel continues to advance AAV.201, its gene therapy program for regeneration of hair cells in the vestibule for the treatment of bilateral vestibulopathy (BVP). Decibel plans to announce the program target for AAV.201 in 2022.
Otoprotection Therapeutic

On Track to Report Interim Results from Phase 1b Proof-of-Concept Trial of DB-020 for the Treatment of Cisplatin-Induced Hearing Loss: Decibel expects to report interim results from the ongoing Phase 1b clinical trial of DB-020 in patients with cisplatin-induced hearing loss in the first half of 2022.
Second Quarter 2021 Financial Results:

Cash Position: As of June 30, 2021, cash, cash equivalents and available-for-sale securities were $184.6 million, compared to $54.3 million as of December 31, 2020. The increase in cash, cash equivalents and available-for-sale securities was due to receipt of the proceeds from the issuance and sale of our Series D convertible preferred stock and from our initial public offering (IPO) in the first quarter of 2021.
Research and Development Expenses: Research and development expenses were $6.8 million for the second quarter of 2021, compared to $5.3 million for the second quarter of 2020. The increase in research and development expenses for the second quarter of 2021 was driven primarily by an increase in manufacturing costs related to toxicology studies of DB-OTO.
General and Administrative Expenses: General and administrative expenses were $4.9 million for the second quarter of 2021, compared to $2.6 million for the same period in 2020. The increase in general and administrative expenses for the second quarter of 2021 was primarily attributable to increases in professional fees, personnel costs and directors’ and officers’ insurance costs incurred as a result of becoming a public company.
Financial Guidance:

Based on its current operating and development plans, Decibel believes that its existing cash, cash equivalents and available-for-sale securities will fund its pipeline programs and operating expenses into 2024.

Foghorn Therapeutics Provides Second Quarter 2021 Corporate Update

On August 10, 2021 Foghorn Therapeutics Inc. (Nasdaq: FHTX), a clinical stage biotechnology company pioneering a new class of medicines that modulate gene expression through selectively targeting the chromatin regulatory system, reported a corporate update in conjunction with the Company’s From 10-Q filing for the quarter ended June 30, 2021 (Press release, Foghorn Therapeutics, AUG 10, 2021, View Source [SID1234586247]). With an initial focus in oncology, Foghorn’s Gene Traffic Control Platform and resulting broad pipeline has the potential to transform the lives of people suffering from a wide spectrum of diseases.

"We continue to make solid progress advancing our two first-in-class clinical programs to emerge from our proprietary Gene Traffic Control Platform," said Adrian Gottschalk, President and Chief Executive Officer. "We anticipate having initial phase I data of FHD-286, our selective, oral inhibitor of BRG1/BRM in metastatic uveal melanoma and relapsed or refractory AML and myelodysplastic syndromes (MDS), as early as the fourth quarter of 2021, and phase I data of FHD-609, our first protein degrader clinical candidate, for the treatment of synovial sarcoma as early as the first half of 2022."

Continued Mr. Gottschalk, "Beyond these two clinical programs, we continue to expand our robust pipeline of precision therapeutic candidates targeting different aspects of the chromatin regulatory system, including our protein degrader programs and platform, including FHD-609, our BRM-selective degrader, ARID1B protein degrader and other undisclosed programs."

Recent Corporate Highlights:

Dosed First Patient with FHD-286. In May 2021, Foghorn announced the dosing of the first patient in its first-in-human clinical trial of FHD-286, an inhibitor of BRG1/BRM, in metastatic uveal melanoma and relapsed or refractory AML and MDS, areas of high unmet medical need. This is Foghorn’s first drug candidate to enter the clinic and the first of a new class of therapeutics directly targeting the chromatin regulatory system. To learn more about these studies please visit ClinicalTrials.gov. (Link here for metastatic uveal melanoma and here for AML and MDS)
Received investigational new drug application (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. Sites for the phase 1 study have been initiated and are currently screening patients. To learn more about this study, please visit ClinicalTrials.gov.
BRM Selective Inhibitor Program Advanced to Lead Optimization. Data presented during Foghorn’s 2021 Research & Development Webinar demonstrated robust tumor growth inhibition with the Company’s BRM-selective inhibitor. The program has advanced into lead optimization with an IND planned for 2022.
Participation at AACR (Free AACR Whitepaper) 2021. In April 2021, Foghorn presented a poster titled "Discovery of novel BAF inhibitors for the treatment of transcription factor-driven cancers" (Link to poster here) and chaired a panel at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021. Key highlights of the data presented included a novel series of compounds discovered and developed by Foghorn that potently and selectively inhibit the ATPase components of the BAF complex, BRG1 and BRM. These preclinical data provided the foundation for first-in-human studies of BAF ATPase inhibition as a novel therapeutic to treat uveal melanoma.
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. The addition of Ian to the Board brings significant business development and capital formation expertise to Foghorn.
Held First Research and Development Day Webinar. On June 15th, 2021, Foghorn held its inaugural Research and Development Day Webinar showcasing presentations from key opinion leaders and the Foghorn management team highlighting the biological importance of the chromatin regulatory system in gene expression and human disease and its broad applicability in precision oncology. The replay can be accessed here.
Key Upcoming Milestones:

FHD-286 data. Foghorn expects initial data from the Company’s phase 1 studies of FHD-286 in both metastatic uveal melanoma and relapsed/refractory AML and MDS as early as the fourth quarter of 2021.
FHD-609 data. Foghorn expects initial data from the Company’s phase 1 study in synovial sarcoma as early as the first half of 2022.
Upcoming Events

The Wedbush PacGrow Healthcare Virtual Conference, panel discussion, "Bullseye – Targeted Oncology Part 2," Wednesday, August 11 at 10:20 a.m. ET. The webcast can be accessed here.
The Morgan Stanley Global Healthcare Conference, September 13-15, 2021.
Financial Condition

Foghorn reported cash, cash equivalents and marketable securities of $141.3 million as of June 30, 2021, as compared to $160.9 million as of March 31, 2021, and $185.8 million as of December 31, 2020.