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Foundation Medicine’s tissue-based comprehensive genomic profiling test is now FDA approved to identify patients with solid tumors with RET gene fusions who may benefit from treatment with Retevmo CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Foundation Medicine Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne®CDx to be used as a companion diagnostic for Eli Lilly and Company's Retevmo (selpercatinib), which was approved by the FDA for the treatment of adult patients with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options. This announcement marks Foundation Medicine’s fifth pan-tumor approval in the U.S. for FoundationOne CDx, the only tissue test with multiple biomarkers approved as a tumor agnostic companion diagnostic in the U.S., including TMB and NTRK1/2/3. It also marks Foundation Medicine’s ninth approved companion diagnostic indication across 7 different fusion genes (ALK, ROS1, NTRK1, NTRK2, NTRK3, FGFR2, and now RET.) Using a tissue sample, FoundationOne CDx analyzes more than 300 cancer-related genes for genomic alterations in a patient’s tumor, which allows a tailored treatment approach and will determine if Retevmo is an appropriate treatment option for patients with RET gene fusions, which occur in less than two percent of solid tumors1. The test currently has over 30 companion diagnostic indications, ranging from lung, breast, prostate, colon, and other solid malignancies. “With a growing need for solutions for patients with rare fusions, high-quality companion diagnostics provide critical information to support oncologists in the development of personalized treatment plans,” said Mia Levy, MD, PhD, chief medical officer at Foundation Medicine. “With our experience successfully navigating the complexities of a pan-tumor approval, we’re proud to have another companion diagnostic for our FDA-approved tissue test that can help enable broader access to an important therapy option for RET-fusion positive solid tumors. We appreciate this meaningful collaboration with Lilly to help bring more treatment options to patients facing a cancer diagnosis.” “One of our top priorities is helping people living with lung cancer access the best treatment possible and this approval marks a milestone on the path to developing highly personalized care for them,” said GO2 for Lung Cancer President & CEO Laurie Ambrose. “We are encouraged by the expanded access and options they will receive and are confident this will positively impact the lives of people living with cancer and their loved ones.” Foundation Medicine is the global leader in companion diagnostic approvals. The company also has 60% of all U.S. companion diagnostic approvals for next generation sequencing (NGS) testing. This companion diagnostic approval is the latest in a series of collaborative efforts between Foundation Medicine and Lilly. Foundation Medicine® and FoundationOne® are registered trademarks of Foundation Medicine, Inc. Retevmo® is a registered trademark owned by or licensed to Eli Lilly and Company, its subsidiaries, or affiliates. About FoundationOne CDx FoundationOne CDx is a next-generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. FoundationOne CDx is for prescription use only and is intended as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies in accordance with their approved therapeutic product labeling. Additionally, FoundationOne CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Some patients may require a biopsy. For a full list of targeted therapies for which FoundationOne CDx is indicated as a companion diagnostic, please visit . About Foundation Medicine: Your Essential Partner in Cancer Care Foundation Medicine is a pioneer in molecular profiling for cancer, working to shape the future of clinical care and research. We collaborate with a broad range of partners across the cancer community and strive to set the standard for quality, scientific excellence, and regulatory leadership. Our deep understanding of cancer biology helps physicians make informed treatment decisions for their patients and empowers researchers to develop new medicines. Every day, we are driven to help our partners find answers and take action, enabling more people around the world to benefit from precision cancer care. For more information, please visit us on and follow us on Twitter and LinkedIn. Source: Foundation Medicine _______________________________ 1 .

BenevolentAI is yet to give up on the drug candidate. BenevolentAI’s hopes of out-licensing its atopic dermatitis candidate this year have taken a hit. In a phase 2a trial, the topical pan-Trk inhibitor failed to improve eczema symptoms or itch, denting the prospects of the program and raising questions about the AI-enabled model that proposed the approach.  While tropomyosin receptor kinases (Trk) are best known as the targets of cancer drugs, BenevolentAI’s platform identified the receptors as mediators of itch and inflammation in atopic dermatitis, the most common form of eczema. The potential to simultaneously address the symptoms in mild to moderate atopic dermatitis with fewer side effects than existing drugs led the biotech to design Trk inhibitors.  BEN-2293, an inhibitor of TrkA, TrkB and TrkC, emerged as the lead candidate, and BenevolentAI stuck by it after a phase 1b clinical trial “demonstrated a trend towards a clinically meaningful effect,” betting that a larger, powered midphase study would validate the approach. The bet failed. The phase 2a enrolled 91 adults to use either BEN-2293 or placebo on their affected skin for 28 days. BEN-2293 proved to be safe and well tolerated, the primary endpoint of the trial, but slipped up on the secondary efficacy endpoints. The drug candidate was no better than placebo at improving the area and severity of eczema or itching. BenevolentAI had planned (PDF) to out-license the asset in the second half of the year to a pharma company focused on dermatology. The deal was one of two agreements on BenevolentAI’s road map for 2023, with the company also looking to enter into a collaboration along similar lines to its alliance with AstraZeneca.  The failure is a blow to both BEN-2293 and, by extension, the platform that identified the approach to atopic dermatitis. But BenevolentAI is yet to give up on the drug candidate, pointing to evidence that the treatment performed better in patients with a greater extent of disease at baseline to make the case for further investigation. The biotech is reviewing the data before deciding on its next steps.   While BenevolentAI’s interest in drugging Trk to treat atopic dermatitis stemmed from its AI platform, it is not the first company to try the approach. The now-defunct Creabilis hit upon the idea more than a decade ago and ran a phase 2 trial of its TrkA inhibitor in atopic dermatitis. 

LONDON, UK I April 05, 2023 I BenevolentAI ("BenevolentAI" or the "Company") (Euronext Amsterdam: BAI) announces top-line results from its Phase IIa, randomised, double-blind, placebo-controlled study of BEN-2293, a topical pan-Trk inhibitor. BEN-2293 is a selective inhibitor of the three tropomyosin-related kinases (Trk) receptors (TrkA, TrkB and TrkC) formulated to be administered topically in patients with mild-to-moderate AD. The study's primary endpoint was safety and tolerability, while secondary endpoints of the study were also specifically powered to show the fraction of patients achieving an improvement in the Eczema Area and Severity Index (EASI) and the fraction of patients achieving an improvement in the pruritus Numerical Rating Scale (NRS). In this Phase IIa study, 91 patients aged between 18-65 years with mild-to-moderate AD were randomised to receive either 1% BEN-2293 (n=49) or placebo (n=42) twice daily for 28 days on affected skin up to a maximum of 30% body surface area (BSA). BEN-2293 was shown to be safe and well-tolerated but did not demonstrate a statistically significant effect on NRS or EASI endpoints across the Intention-To-Treat (ITT) population. However, initial analysis of percentage BSA affected by AD showed an EASI treatment effect for BEN-2293 in patients with greater extent of disease at baseline, with magnitude of treatment effect growing over time (p=0.0296). This result was also observed in the Per-Protocol population (p=0.0427) with the data at 28 days showing an interaction between treatment effect and disease burden (p=0.0237) such that a significant treatment effect for BEN-2293 over placebo is expected for subjects with BSA affected of 20% or greater. This initial analysis suggests a new avenue for further clinical investigation. Dr Anne Phelan, Chief Scientific Officer at BenevolentAI, said: "BEN-2293 was found to be safe and well tolerated in this study. Although the top-line efficacy findings are not conclusive, the significant relationship of EASI efficacy with affected BSA requires further investigation and supports the hypothesis of utilising a PanTrk inhibitor in AD. We will continue to review and analyse the complete dataset in order to fully understand the outcome and the next steps.” About BenevolentAI BenevolentAI (AMS: BAI) is a leading, clinical-stage AI-enabled drug discovery and development company listed on the Euronext Amsterdam stock exchange. Through the combined capabilities of this AI platform, its scientific expertise, and wet-lab facilities, BenevolentAI is well-positioned to deliver novel drug candidates with a higher probability of clinical success than those developed using traditional methods. The Benevolent Platform™ powers the Company’s in-house drug pipeline and supports successful collaborations with AstraZeneca, as well as leading research and charitable institutions. BenevolentAI is headquartered in London, with a research facility in Cambridge (UK) and a further office in New York. SOURCE: BenevolentAI