Business Wire

Fore Biotherapeutics Presents Positive Interim Data From Phase 1/2a Trial Evaluating FORE8394 in Patients With Advanced Tumors With Activating BRAF Alterations at ESMO 2022

Share

Fore Biotherapeutics (Fore Bio), a precision oncology company dedicated to developing innovative treatments that provide a better outcome for cancer patients, announced the presentation of new data demonstrating that FORE8394, a next-generation BRAF inhibitor, provides evidence of durable anti-tumor activity and patient benefit in BRAF-mutated (V600+) cancers. Data from the ongoing Phase 1/2a study evaluating FORE8394 for the treatment of advanced solid and central nervous system (CNS) tumors with activating BRAF alterations were presented in a poster session at the European Society of Medical Oncology Congress (ESMO) taking place in Paris, France.

“I am extremely proud of the progress this team has made in advancing our next-generation, and potential best-in-class BRAF-inhibitor to address the limitations of the current standards of care and improve outcomes for patients with cancer,” said Matthew Ros, Chief Executive Officer of Fore Biotherapeutics. "These results are very encouraging and reinforce our conviction that FORE8394 has the potential to provide meaningful benefit to patients with BRAF-mutated cancers with high unmet need. We are embarking upon developing this novel treatment and are on track to initiate our global Phase 2 trial next quarter.”

As of the data cutoff date of July 31, 2022, 108 adults and children have received ≥1 dose of FORE8394 and are included in the safety population; 51 adults (≥18 years) met the criteria for the V600+ efficacy analysis; overall response rate (ORR) was 25.5% and median duration of response: 17.8 months. An additional analysis was conducted in the MAPK-inhibitor naïve subset, excluding patients with colorectal cancer (CRC) (N=21). Patients received 900-3600 mg/day of oral FORE8394 alone or with cobicistat (CYP3A4 inhibitor) to increase exposure, with the majority having been treated with total daily doses of 900-1800 mg.

Key Findings from the Ongoing Phase 1/2a Study

  • In MAPK inhibitor-naïve adult V600+ patients (N=21, excluding CRC), confirmed responses and durable benefit was seen across multiple tumor types
    • Clinical activity observed in this population includes ORR= 42.9%, clinical benefit rate ≥ 24 weeks= 71.4%, median duration of response was 17.8 months and median progression free survival (PFS) was 28.6 months
      • In patients with primary CNS tumors, 4 of 4 patients with high grade glioma and 2 of 3 patients with low grade glioma experienced a partial response (PR) ; 1 had stable disease and remains on treatment after 15+ months
      • Of 6 patients with papillary thyroid cancer, median PFS was not reached (median follow-up 5.6 years)
  • Additional responses were observed in patients with V600+ ovarian cancer where 3 of 3 patients had PR; 2 having received prior MAPK-targeted treatments
  • FORE8394 demonstrated a favorable safety profile, with long-term tolerability, across the 108 patients
    • Adverse events were transient and manageable
    • Symptomatic adverse events (AEs) were low grade (Grade 1 or 2), mild and included fatigue, nausea, diarrhea & vomiting
    • Hepatic laboratory changes were manageable with dose interruption or modification
    • No secondary cutaneous skin malignancies or acanthomas occurred
    • Only 1 participant discontinued treatment due to treatment related adverse event

"In this heterogeneous and heavily pre-treated patient population, the overall response rate and meaningful durations of response demonstrates the potential of FORE8394 to uniquely target tumors with BRAF alterations," said Stacie Shepherd, MD, PhD, Chief Medical Officer of Fore Biotherapeutics. "We're excited that the majority of gliomas demonstrated response and the prolonged benefit and tolerability experienced by some patients receiving FORE8394. Based on the strength of these findings, our Phase 2 study will further evaluate FORE8394 in patients with both solid and CNS tumors with BRAF fusions and recurrent primary CNS tumors with BRAF V600E mutations.”

“There are several limitations with first-generation BRAF inhibitors, including treatment resistance leading to disease progression and the paradoxical activation of the MAPK pathway, leading to secondary cutaneous skin cancers. In addition, these agents are inactive against class II BRAF alteration,” said Eric Sherman, MD, principal investigator and medical oncologist, Memorial Sloan Kettering Cancer Center. “These results suggest FORE8394 may provide meaningful benefit to patients, and we look forward to further exploring its potential in the upcoming Phase 2 study.”

About FORE8394

FORE8394 is an investigational, novel, small-molecule, next-generation, orally available selective inhibitor of mutated BRAF. It was designed to target a wide range of BRAF mutations while sparing wild-type forms of RAF. Preclinical studies and clinical trials have shown that its unique mechanism of action effectively inhibits not only the constitutively active BRAFV600 monomers targeted by first-generation RAF inhibitors but also disrupts constitutively active dimeric BRAF class II mutants, fusions, splice variants and others. Unlike first-generation RAF inhibitors, FORE8394 does not induce paradoxical activation of the RAF/MEK/ERK pathway. As a “paradox breaker,” FORE8394 could therefore treat acquired resistance to current RAF inhibitors and, more generally, yield improved safety and more durable efficacy than first-generation RAF inhibitors.

About Fore Biotherapeutics

Fore Bio is a precision oncology company dedicated to developing innovative treatments that provide a better outcome for cancer patients. Its lead asset FORE8394 is a Class I/II BRAF inhibitor with demonstrated clinical safety and early efficacy signals in an ongoing Phase 1/2a clinical trial. Leveraging a proprietary functional genomics platform that can screen a wide range of known mutations for cancer-driving genes, the Fore R&D team is optimizing drug development by identifying existing compounds with known clinical profiles and a clear path through clinical development to advance new medicines for patients without treatment options. For more information, please visit www.fore.bio or follow us on Twitter and LinkedIn.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

Investors and Media:
Argot Partners
212.600.1902 | ForeBio@argotpartners.com

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Seoul Semiconductor Participates in the World’s Biggest Lighting Expo Held in Germany to Showcase its High-Efficiency & Performance LED Lighting Systems30.9.2022 10:00:00 CEST | Press release

Seoul Semiconductor Co., Ltd. (KOSDAQ: 046890), a globally recognized optical semiconductor manufacturer, takes part in ‘Light + Building 2022’ held in Frankfurt, Germany, from October 2 to 6, 2022 to unveil its high-efficiency and high-performance LED lighting solutions. This lighting festival is one of the world’s largest lighting expos attended by more than 200,000 visitors from 55 nations in the world. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220930005011/en/ [Photo] Seoul Semiconductor’s Booth for ‘Light + Building 2022’ (Photo: Business Wire) Seoul Semiconductor is expected to showcase differentiated lighting systems including ‘WICOP technology-based high-efficiency lighting solutions’ and ‘SunLike technology for reproducing natural light.’ WICOP high-efficiency lighting systems are mid- and high-power solutions that are mainly applied to landscape & horticulture lighting and street lamps. They outperform existin

Turkey is Calling Europe for Flight Trainings30.9.2022 09:30:00 CEST | Press release

Alfa Holding’s Aviation Services, Turkey’s rapidly growing private aviation services company, has met with leaders from European capitals to promote Turkey as a leading European flight training hub. Turkish civil aviation has received significant investment in recent years, developing into an important center for Europe in terms of civil aviation training. Turkey’s climate conditions and its first-rate, state-of-the-art equipped airports mean Turkey is vying with other countries to become a top aviation training hub in addition to offering other aviation-related businesses. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220930005023/en/ Turkey is calling Europe for flight trainings (Photo: Business Wire) Alfa Aviation Services Chairman of the Board Mehmet Fatih Pakır, at his recent visit to France engaged in bilateral meetings with industry peers, commenting, “We are planning to cooperate with the European civil aviation aut

Enlighted Ushers in New Era of Smart Building IoT Data and Space Intelligence30.9.2022 09:01:00 CEST | Press release

Today Enlighted, a leading proptech company, released a curated portfolio of smart IoT building solutions to create customer value and further enable sustainable enterprises across industries and geographies. According to analyst firm Verdantix1, 75% of firms will use IoT data for space utilization monitoring. The solutions announced today, part of Siemens' open business platform Xcelerator, elevate the use of IoT building data to a new level of functionality for leaders seeking to improve productivity of their operations and to reach carbon neutrality. “We anticipate our new solutions and alignment with Siemens Xcelerator business platform will enable our customers to leverage their building’s IoT and activity data to vastly improve processes and decisions around the interactions of people and their spaces,” said Stefan Schwab, CEO, Enlighted. “Additionally, we will help them further transform their real estate portfolios with a focus on long-term sustainability to meet ESG goals.” Sp

L&T Technology Services Joins Hands with Qualcomm to Provide Solutions for the Global 5G Private Network Industry30.9.2022 09:00:00 CEST | Press release

L&T Technology Services Limited (BSE: 540115, NSE: LTTS), a leading global pure-play engineering services company, today announced that it is collaborating with Qualcomm Technologies, Inc. to deploy end-to-end solutions for the global 5G Private Network Industry utilizing their combined core expertise in the Hi-Tech & Telecommunication domain. LTTS and Qualcomm Technologies will bring together core competencies in telecommunication solutions and services for the benefit of end-customers in the manufacturing and warehousing/logistics sector. As the demand for a connected world continues to grow rapidly, LTTS engineers are leveraging LTTS’ chip-to-cloud expertise to unleash the power of 5G and transform global manufacturing and supply chain processes. Qualcomm Technologies, an industry leader in 5G globally, is accelerating the expansion of 5G connectivity, and its end-to-end domain expertise is enabling the growth of the broader technology ecosystem spanning 5G Private Network RAN, devi

TRAWELL CO S.P.A. Confirms That Consumer Spending Is Strong in Airports Worldwide30.9.2022 08:05:00 CEST | Press release

The Board of Directors ofTraWell Co S.p.A. (Euronext Growth Italia, ticker: TWL), which met yesterday afternoon, approved the consolidated half-yearly financial report as of 30 June 2022, which shows that passengers’ spending in airports is very strong. The group registered the following results for H1 2022: REVENUES of € 10.9 million, an increase of € 3.7 million (+ 52%); EBITDA equal to + € 2.0 million, up by € 2.2 million; NET PROFIT equal to + € 2.0 million, an increase of € 2.6 million. The revenues of 10.9 million euros (+ 52%) show a strong improvement of the spending environment compared to 2021. The analysis of Group’s revenues by geographical area confirms an ideal international diversification in H1 2022, with America as the first market of the Group with approximately 50% of revenues, Europe with 28% as the second market and Asia with approximately 22% of revenues. Rudolph Gentile, President and CEO of the TraWell Group: "Demand is high, and the industry is rebounding as pa