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

Media Alert: Prosimo to Exhibit at the Gartner® IOCS Conference 2022 and Present the Power of Single Architecture for Simplifying Multicloud Networking6.12.2022 17:24:00 CET | Press release

Prosimo, the Application Experience Infrastructure company, is demonstrating (Booth #511) its full-stack solution for simplifying multi-cloud networking at Gartner IT Infrastructure Operations & Cloud Strategies conference, taking place December 6-8th in Las Vegas. The company plans to present a customer case example of the advantages of using a single network infrastructure for its cloud computing services. The Gartner Market Guide for Multicloud Networking Software encourages I&O leaders responsible for cloud and edge infrastructure to “prefer the native capabilities of the cloud providers when starting out, and avoid forklifting data center networking designs and vendors in the public cloud, because this will lead to integration and cost inefficiencies.”1 And to “invest in MCNS when a consistent set of broader, “full-stack” Level 3 through Level 7 networking and network security capabilities (e.g., routing, DNS, CDN, WAF, firewall, and observability) via a single management platform

Fortius Metals Raises Seed Round of $2M from AM Ventures to Bring Advanced Metal 3D Printing to the Aerospace Industry6.12.2022 17:00:00 CET | Press release

Fortius Metals, Inc., an innovative metal 3D printing company, has announced today that it has closed on a priced seed financing round with AM Ventures. The $2M round will be used to scale manufacturing capacity, grow the company and accelerate its go-to-market strategy. Fortius Metals is a large format additive manufacturing company that specializes in advanced materials to help customers develop solutions previously not possible with robotic 3D printing. Fortius Metals’ patented technology will enable welding and 3D wire fabrication using high performance metal alloys to meet the exacting demands of aerospace customers and robotic welding fabricators. AM Ventures, the foremost venture capital firm for the additive manufacturing sector, focuses solely on startups built around industrial-grade 3D printing offerings, including hardware, software, materials, and applications. AM Ventures’ portfolio includes an elite group of 17 companies engaged in 3D printing, out of over 2,400 start-up

SonarSource Posts Record Growth with its Clean Code Solution in 20226.12.2022 17:00:00 CET | Press release

SonarSource, the leading provider of Clean Code solution, today announced record growth in developer and enterprise customer adoption. With a 43% growth in its user base, SonarSource supports more than 400,000 organizations and seven million users. The Sonar solution leads the industry with total analyzed code – which now tops more than half a trillion lines of code for organizations across the world. By adding 5,000 paying customers in 11 months, Sonar now supports 21,000 enterprise customers including over 75% of Fortune 100 and nearly half of Fortune 500 companies. Much of this progress transpired on the heels of the Company closing a $412 million funding round, which brought its valuation to $4.7 billion. SonarSource’s massive momentum is driven by the recognition from enterprises everywhere that Clean Code is an organizational imperative for long-term competitiveness and market success. A Rapid Pace of Innovation With a laser focus on empowering developers to deliver Clean Code, S

Large crowds come together in Sharjah to celebrate the UAE’s 51 st National Day6.12.2022 16:02:00 CET | Press release

Sharjah's celebrations of the 51st UAE National Day were concluded which attracted an audience of multiple nationalities, both residents and foreign visitors, over a period of 10 days to participate in a range of activities. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20221206005624/en/ Part of the National Day activities in Sharjah (Photo: AETOSWire) From November 24 to December 3, 2022, Sharjah's cities and major tourist and cultural destinations including Al Majaz Amphitheater, Sharjah National Park, Maliha Public Park, Dibba Al Hisn, Khorfakkan Amphitheater, to Wadi Al Helo and various areas of Kalba, and parks and residential areas in Al Bataeh, various areas of Al Madam, Al Dhaid Fort, to the Heritage Village in Al Hamriyah, hosted celebrations to commemorate the achievements of the nation on the 51st National Day. His Excellency Khaled Jassim Al Midfa, Chairman of Sharjah National Day Celebrations Committee, commende

Ledger Launches Ledger Stax, Designed by Tony Fadell6.12.2022 16:00:00 CET | Press release

Ledger, the world leader in critical digital asset security, has teamed up with Tony Fadell, builder of the iPod1, to bring clarity and confidence to owning digital value. Ledger Stax™ is a usable way for you to take control of cryptocurrency and digital collectibles. It’s built on uncompromisingly secure architecture, and introduces a unique form designed for unprecedented accessibility and interactivity. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20221206005695/en/ Ledger Launches Ledger Stax, Designed by Tony Fadell (Photo: Business Wire) Ledger Stax has a new E Ink2 display, which covers the front and curves around the spine—you can view complete transaction details at a glance. E Ink is always viewable: your favorite art appears on the Ledger Stax screen, even when it is off. It also provides unmatched energy efficiency, so the battery can last for weeks or even months on one battery charge. “With the Ledger Nano™ ser