Latest news with #FaronPharmaceuticals
Int'l Business Times
08-07-2025
- Business
- Int'l Business Times
Faron Pharmaceuticals To Earn Spotlight At IUIS 2025 With Its Bexmarilimab Data
In a year already marked by critical scientific milestones, Faron Pharmaceuticals is set to take center stage once again. The clinical-stage biopharmaceutical company has announced that detailed Phase II data from its BEXMAB study evaluating bexmarilimab (bex), a novel immunotherapy targeting Clever-1, has been accepted for oral presentation at the 19th International Congress of Immunology (IUIS) in Vienna, Austria, from August 17 to 22, 2025. This development is particularly significant given the current landscape of treatment for high-risk myelodysplastic syndromes (HR-MDS), a rare and aggressive group of bone marrow disorders with limited therapeutic options and poor prognoses, especially for patients who relapse or fail frontline hypomethylating agents (HMAs). Standard treatments have seen little advancement in recent decades, with response rates in the relapsed/refractory setting often below 10% and median overall survival typically less than six months. Immunotherapies targeting the tumor microenvironment, particularly macrophage-mediated immune resistance, represent a promising new frontier in hematology. Bex's ability to reprogram immunosuppressive macrophages and enhance anti-tumor immune responses marks a major shift from traditional cytotoxic approaches and has the potential to redefine the standard of care for HR-MDS and other difficult-to-treat malignancies. The company's inclusion in the oral sessions, one of the most prestigious scientific categories at IUIS, signals a rising recognition of bex's potential to change the treatment landscape for HR-MDS. This is the latest in a series of high-profile scientific endorsements for Faron, following similar honors at the American Society of Clinical Oncology (ASCO) and the International MDS Symposium earlier this year. Bex is Faron's first-in-class anti-Clever-1 monoclonal antibody designed to reprogram immunosuppressive macrophages in the bone marrow. When combined with azacitidine, a current standard-of-care hypomethylating agent, the therapy aims to overcome treatment resistance and restore the body's ability to combat cancerous cells, a vital advancement for a disease that has long been resistant to effective treatment. At IUIS 2025, Dr. Mika Kontro, MD, PhD, will deliver a presentation titled "Efficacy of Macrophage Checkpoint Clever-1 Inhibition with bexmarilimab plus Azacitidine in Myelodysplastic Syndrome: Results from the Ph1/2 BEXMAB Study." The talk will highlight both frontline HR-MDS patients and those with relapsed/refractory (r/r) disease who have failed prior HMA therapy. According to early disclosures, the data set includes impressive objective response rates and significant reductions in bone marrow blast counts, especially notable in a population where few therapeutic options remain. Acceptance into IUIS's oral presentation track is not just a ceremonial nod. It's a peer-reviewed endorsement from one of the most rigorous scientific communities in immunology. For Faron, it is another critical validation of its mission: to address treatment-resistant diseases through bold immunological strategies. "We are thrilled to see bex's data receive acceptance for oral presentation at IUIS, following similar recognition at MDS and ASCO," states Dr. Juho Jalkanen, CEO of Faron Pharmaceuticals. "This continued momentum reinforces our belief that bex holds real promise as a much-needed therapeutic option for patients with higher-risk MDS, a rare and challenging condition with few effective treatments." The past year has been pivotal for Faron. Following its positive Phase II results announced at ASCO, where bex achieved a median overall survival of 13.4 months in r/r MDS patients, more than double historical norms, the company has rapidly accelerated its development roadmap. "We're not just excited by the numbers," Dr. Juho affirms. "We're driven by what this could mean for real people living with a devastating illness. If we can offer them a longer, better-quality life, we've done something truly meaningful." With preparations underway for a registrational trial and ongoing regulatory engagement, Faron is also eyeing accelerated approval pathways. According to the company, upcoming interactions with the U.S. Food and Drug Administration will focus on confirming the new composite complete response (cCR) endpoints outlined by the IWG 2023 criteria, which link closely to survival and long-term outcomes. Though much of the spotlight is on MDS, bex is part of a larger strategy: to harness the immune system's overlooked components to address immune resistance across a range of hard-to-treat cancers. Faron's broader pipeline reflects this ambition, with additional studies underway in acute myeloid leukemia (AML) and other indications where macrophage manipulation could yield significant benefits. But for now, all eyes are on Vienna, where the company's work will once again be put to the test, and, it hopes, further cement its place among the most exciting innovators in oncology.
Yahoo
07-07-2025
- Business
- Yahoo
High Growth UK Tech Stocks to Watch in July 2025
The UK market has recently experienced a downturn, with the FTSE 100 and FTSE 250 indices closing lower due to weak trade data from China, highlighting ongoing challenges in global economic recovery. In this environment, identifying high growth tech stocks involves focusing on companies that demonstrate resilience and adaptability amidst fluctuating demand and supply chain disruptions. Name Revenue Growth Earnings Growth Growth Rating ENGAGE XR Holdings 22.08% 84.46% ★★★★★★ Audioboom Group 8.84% 59.33% ★★★★★☆ YouGov 3.98% 64.42% ★★★★★☆ ActiveOps 14.40% 43.34% ★★★★★☆ Oxford Biomedica 16.89% 80.47% ★★★★★☆ Trustpilot Group 14.91% 38.67% ★★★★★☆ Quantum Base Holdings 132.55% 92.87% ★★★★★☆ Windar Photonics 36.00% 48.66% ★★★★★☆ Faron Pharmaceuticals Oy 55.41% 54.99% ★★★★★☆ SRT Marine Systems 45.54% 91.35% ★★★★★★ Click here to see the full list of 43 stocks from our UK High Growth Tech and AI Stocks screener. We'll examine a selection from our screener results. Simply Wall St Growth Rating: ★★★★★☆ Overview: Faron Pharmaceuticals Oy is a clinical stage drug discovery and development company with a market cap of £240.70 million. Operations: The company focuses on drug discovery and development, operating as a clinical stage entity. Faron Pharmaceuticals Oy, a UK-based biotech firm, is making significant strides in high-growth tech through its innovative research in immunotherapy. With an expected annual revenue growth of 55.4%, Faron outpaces the UK market average of 3.6%. Despite current unprofitability, the company's earnings are forecasted to surge by approximately 55% annually over the next three years, signaling robust future prospects. Recent studies published by Faron have unveiled groundbreaking findings on Clever-1 receptors' role in cancer immunosuppression, enhancing the therapeutic potential of their lead asset bexmarilimab across various cancer treatments and potentially revolutionizing autoimmune therapies. This positions Faron not only as a key innovator but also as a potential leader in redefining effective cancer treatment paradigms. Click to explore a detailed breakdown of our findings in Faron Pharmaceuticals Oy's health report. Understand Faron Pharmaceuticals Oy's track record by examining our Past report. Simply Wall St Growth Rating: ★★★★★★ Overview: SRT Marine Systems plc, along with its subsidiaries, focuses on developing and supplying AIS-based maritime domain awareness technologies, products, and systems, with a market cap of £188.91 million. Operations: Specializing in AIS-based maritime domain awareness, SRT Marine Systems generates revenue primarily from its Marine Technology Business, which reported earnings of £11.85 million. SRT Marine Systems is distinguishing itself in the UK's high-tech sector, particularly with its recent EUR 167 million NMSS project for the Indonesian Coast Guard. This initiative underscores SRT's innovative edge by integrating AI-driven intelligence into maritime surveillance and command systems. With a projected revenue growth of 45.5% annually, SRT is outpacing the average UK market growth significantly. Moreover, earnings are expected to surge by 91.35% annually over the next three years as it moves towards profitability, highlighting its potential amid a competitive landscape. This blend of advanced technology and strong financial forecasts positions SRT to expand its influence in global maritime security solutions effectively. Click here and access our complete health analysis report to understand the dynamics of SRT Marine Systems. Assess SRT Marine Systems' past performance with our detailed historical performance reports. Simply Wall St Growth Rating: ★★★★★☆ Overview: Pinewood Technologies Group PLC is a cloud-based dealer management software provider operating in the United Kingdom, Europe, Africa, Asia, the Middle East, and internationally with a market capitalization of £459.45 million. Operations: Pinewood Technologies Group generates revenue primarily through its cloud-based dealer management software services across multiple regions, including the UK, Europe, Africa, Asia, and the Middle East. The company's market capitalization stands at approximately £459.45 million. Pinewood Technologies Group is making significant strides in the UK's tech landscape, particularly with its recent contract to integrate its Automotive Intelligence platform across approximately 350 Volkswagen and Audi dealerships in Japan. This move not only expands Pinewood's global footprint but also aligns with its strategic goals, enhancing its market position. Financially, the company is on a robust growth trajectory with revenues expected to grow by 25% annually and earnings by an impressive 40.2% per year. Moreover, a notable one-off loss of £2.4 million last fiscal year underscores challenges but doesn't overshadow their strong financial outlook or their commitment to innovation as evidenced by their substantial R&D investments relative to revenue. Click here to discover the nuances of Pinewood Technologies Group with our detailed analytical health report. Gain insights into Pinewood Technologies Group's historical performance by reviewing our past performance report. Explore the 43 names from our UK High Growth Tech and AI Stocks screener here. Already own these companies? Link your portfolio to Simply Wall St and get alerts on any new warning signs to your stocks. Maximize your investment potential with Simply Wall St, the comprehensive app that offers global market insights for free. Explore high-performing small cap companies that haven't yet garnered significant analyst attention. Fuel your portfolio with companies showing strong growth potential, backed by optimistic outlooks both from analysts and management. Find companies with promising cash flow potential yet trading below their fair value. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include AIM:FARN AIM:SRT and LSE:PINE. Have feedback on this article? Concerned about the content? with us directly. Alternatively, email editorial-team@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
12-06-2025
- Business
- Yahoo
Faron Pharmaceuticals presents updated Phase II data from BEXMAB Study at EHA 2025
TURKU, FI / / June 12, 2025 / Faron Pharmaceuticals (HEL:FARON)(LSE:FARN) - Strong efficacy and survival outcomes with bexmarilimab in high-risk MDS support Phase III advancement Median overall survival (mOS) of 13.4 months in r/r HR-MDS patients (n=32) treated with bexmarilimab + azacitidine; mOS of 9.3 months in TP53 mutated patients (n=13) ORR of 85% and cCR of 50% in patients with frontline MDS (n=20) Deep bone marrow responses demonstrated at all dose levels in frontline MDS and based on the safety and efficacy data of the trial, the recommended phase III bexmarilimab dose is 3 mg/kg Turku, Finland- Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company advancing next-generation immunotherapies, presents detailed phase II data from its ongoing BEXMAB study evaluating bexmarilimab in high-risk myelodysplastic syndromes (HR-MDS) as an oral presentation at the 30th European Hematology Association's (EHA) Congress, taking place in Milan from 12-15 June 2025. The presentation will be led by Dr. Mika Kontro, Associate Professor at University of Helsinki and Helsinki University Hospital Comprehensive Cancer Center, Department of Hematology, and will contain detailed results from the study of bexmarilimab, Faron's investigational anti-Clever-1 antibody, in combination with azacitidine for patients with relapsed or refractory (r/r) and frontline or treatment-naïve HR-MDS. These results expand upon those presented at ASCO 2025 and reaffirm the efficacy and safety of bexmarilimab in this difficult-to-treat population. Strong efficacy data in both r/r HR-MDS and frontline MDS, support advancement into phase III The BEXMAB study evaluated bexmarilimab (1, 3, or 6 mg/kg weekly in 28-day cycles), a first-in-class monoclonal antibody targeting the Clever-1 receptor, in combination with azacitidine, a standard-of-care hypomethylating agent (HMA). By blocking Clever-1, bexmarilimab reprograms macrophages in the bone marrow, enhancing anti-tumor immunity. With 80% of patients with r/r HR-MDS (n=32) falling in the very high/high risk category at baseline, the phase II BEXMAB data demonstrated an estimated median overall survival (mOS) of approximately 13.4 months, significantly surpassing historical outcomes of 5-6 months expected under standard of care. A mOS of 9.3 months was observed in patients with the aggressive mTP53 mutation (n=13). Five patients in the r/r HR-MDS group proceeded to stem cell transplant (SCT), the only curative option. Of the non-mTP53 mutated patients mOS has not yet been reached and 15 out of 19 patients are still alive. Dr. Mika Kontro, MD, PhD, also the principal investigator of the BEXMAB study, said, "The consistent and durable responses observed with bexmarilimab are notable in this patient population. The survival data with bexmarilimab are encouraging for r/r HR-MDS patients, who have limited treatment options after failing HMA therapy." In an updated analysis compared to the ASCO data, patients with frontline MDS (n=20; 45% with the TP53 mutation), the combination of bexmarilimab with azacitidine demonstrated an ORR of 85% and a cCR of 50%. In those with TP53, the ORR and cCR were 78% and 44%, respectively. In this group too, 7(35%) patients proceeded to SCT (n=5) or are in planning for transplant (n=2). Though bone marrow responses were observed across all dose levels in these patients, the 3 mg/kg appeared to be more favourable at this early stage, indicating the use of this dose for further trials. Dr. Petri Bono, Chief Medical Officer of Faron, said, "Achieving this milestone underscores our commitment to addressing the urgent needs of MDS patients. These results support ongoing positive and pivotal discussions with regulatory authorities. We are dedicated to advancing bexmarilimab through clinical development into phase III, with the goal of offering new hope to patients suffering from HR-MDS." Favourable immune activation with 3 mg/kg bexmarilimab dose According to new data to be presented at EHA, bexmarilimab showed CLEVER-1 target engagement in both blood and bone marrow across all doses with no indication of accumulation with repeated dosing. Favourable activation of both the adaptive and innate immune system indicators was seen in r/r HR-MDS and frontline MDS with 3 mg/kg bexmarilimab and azacitidine. The combination was well-tolerated in all patients with HR-MDS. The details of the oral presentation are as follows: Presentation title: Efficacy of Macrophage Checkpoint Clever-1 Inhibition with bexmarilimab plus Azacitidine in Myelodysplastic Syndrome: Results from the Ph1/2 BEXMAB Study Session: Oral presentation Presenter: Dr. Mika Kontro, MD, PhD Date and Time: 15 June 2025 11:00 - 12:15 CEST Location: Milan, Italy Abstract no: S178 Faron Pharmaceuticals remains committed to accelerating the clinical development of bexmarilimab for patients with high-risk myeloid malignancies and anticipates initiating preparations for a Phase III registrational trial in the second half of 2025, following discussions with the FDA. For more information, please contact: IR Partners, Finland(Media)Riina TuominenKare Laukkanen +358 44 313 50 553 9535 / +44 7 469 766 FINN Partners, US(Media) Alyssa Paldo +1 847 791-8085 Cairn Financial Advisers LLP(Nominated Adviser and Broker)Sandy Jamieson, Jo Turner +44 (0) 207 213 0880 Sisu Partners Oy(Certified Adviser on Nasdaq First North)Juha KarttunenJukka Järvelä +358 (0)40 555 4727+358 (0)50 553 8990 About BEXMABThe BEXMAB study is an open-label Phase I/II clinical trial investigating bexmarilimab in combination with standard of care (SoC) in the aggressive hematological malignancies of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). The primary objective is to determine the safety and tolerability of bexmarilimab in combination with SoC (azacitidine) treatment. Directly targeting Clever-1 could limit the replication capacity of cancer cells, increase antigen presentation, ignite an immune response, and allow current treatments to be more effective. Clever-1 is highly expressed in both AML and MDS and associated with therapy resistance, limited T cell activation and poor outcomes. About bexmarilimabBexmarilimab is Faron's wholly owned, investigational immunotherapy designed to overcome resistance to existing treatments and optimize clinical outcomes, by targeting myeloid cell function and igniting the immune system. Bexmarilimab binds to Clever-1, an immunosuppressive receptor found on macrophages leading to tumor growth and metastases (i.e. helps cancer evade the immune system). By targeting the Clever-1 receptor on macrophages, bexmarilimab alters the tumor microenvironment, reprogramming macrophages from an immunosuppressive (M2) state to an immunostimulatory (M1) one, upregulating interferon production and priming the immune system to attack tumors and sensitizing cancer cells to standard of care. About Faron Pharmaceuticals LtdFaron (AIM: FARN, First North: FARON) is a global, clinical-stage biopharmaceutical company, focused on tackling cancers via novel immunotherapies. Its mission is to bring the promise of immunotherapy to a broader population by uncovering novel ways to control and harness the power of the immune system. The Company's lead asset is bexmarilimab, a novel anti-Clever-1 humanized antibody, with the potential to remove immunosuppression of cancers through reprogramming myeloid cell function. Bexmarilimab is being investigated in Phase I/II clinical trials as a potential therapy for patients with hematological cancers in combination with other standard treatments. Further information is available at XXXX SOURCE: Faron Pharmaceuticals View the original press release on ACCESS Newswire Melden Sie sich an, um Ihr Portfolio aufzurufen.
Yahoo
06-06-2025
- Business
- Yahoo
High Growth Tech Stocks To Explore In The UK June 2025
The United Kingdom's stock market has recently faced challenges, with the FTSE 100 index declining due to weak trade data from China, highlighting broader concerns about global economic recovery and its impact on UK companies closely tied to international markets. In such a fluctuating environment, identifying high-growth tech stocks that can navigate these uncertainties becomes crucial for investors seeking opportunities in the UK's dynamic technology sector. Name Revenue Growth Earnings Growth Growth Rating ENGAGE XR Holdings 22.08% 84.46% ★★★★★★ Audioboom Group 8.84% 59.33% ★★★★★☆ YouGov 3.98% 64.42% ★★★★★☆ Redcentric 5.32% 67.90% ★★★★★☆ Oxford Biomedica 16.89% 80.47% ★★★★★☆ Windar Photonics 37.17% 46.73% ★★★★★☆ Trustpilot Group 15.02% 40.20% ★★★★★☆ Quantum Base Holdings 132.55% 92.87% ★★★★★☆ Faron Pharmaceuticals Oy 55.41% 54.99% ★★★★★☆ Cordel Group 33.50% 148.58% ★★★★★☆ Click here to see the full list of 41 stocks from our UK High Growth Tech and AI Stocks screener. Underneath we present a selection of stocks filtered out by our screen. Simply Wall St Growth Rating: ★★★★★☆ Overview: Faron Pharmaceuticals Oy is a clinical stage drug discovery and development company with a market cap of £279.45 million. Operations: The company focuses on drug discovery and development, operating at the clinical stage with a market capitalization of £279.45 million. Faron Pharmaceuticals Oy, a trailblazer in the biotech landscape, recently showcased compelling phase II data at the ASCO Annual Meeting, highlighting a 56% composite CR rate with its bexmarilimab treatment in HR-MDS—significantly surpassing historical rates of 20-25% with azacitidine alone. This pivotal data paves the way for a confirmatory trial that could redefine standards for HR-MDS treatment. Moreover, Faron's strategic focus on R&D is evidenced by its robust pipeline and recent promising results published in Lancet Haematology and Scientific Reports, underscoring bexmarilimab's potential against AML and MDS. With an annualized revenue growth forecast at 55.4%, Faron is not just advancing medical science but also outpacing typical market growth rates significantly. Unlock comprehensive insights into our analysis of Faron Pharmaceuticals Oy stock in this health report. Explore historical data to track Faron Pharmaceuticals Oy's performance over time in our Past section. Simply Wall St Growth Rating: ★★★★☆☆ Overview: M&C Saatchi plc is a global advertising and marketing communications company operating across the United Kingdom, Europe, the Middle East, the Asia Pacific, and the Americas with a market cap of £213.33 million. Operations: The company generates revenue primarily through its advertising and marketing communications services across various regions, including the UK, Europe, the Middle East, Asia Pacific, and the Americas. Its financial performance is highlighted by a focus on managing costs effectively to sustain profitability. M&C Saatchi, transitioning from a challenging period with a net loss in previous years to reporting a profit of £14.73 million for 2024, illustrates resilience in the volatile advertising sector. This turnaround is marked by an earnings growth forecast of 25.2% annually, surpassing the UK market's average of 14.5%. Despite anticipated revenue contraction at -15% annually over the next three years, strategic board changes and dividend increases signal confidence in sustainable growth and governance strength. These elements suggest M&C Saatchi is navigating its recovery phase with robust measures to stabilize and potentially enhance shareholder value amidst industry shifts. Take a closer look at M&C Saatchi's potential here in our health report. Learn about M&C Saatchi's historical performance. Simply Wall St Growth Rating: ★★★★★☆ Overview: Pinewood Technologies Group PLC is a cloud-based dealer management software provider with operations in the United Kingdom, Europe, Africa, Asia, the Middle East, and other international markets; it has a market capitalization of £401.64 million. Operations: Pinewood Technologies Group focuses on providing cloud-based dealer management software across multiple regions. The company leverages its technological solutions to support automotive dealerships in streamlining their operations and enhancing customer interactions. Pinewood Technologies Group PLC, a key player in automotive software solutions, recently secured a landmark five-year contract with Volkswagen Group Japan to deploy its Pinewood Automotive Intelligence platform across approximately 350 dealerships. This strategic move not only broadens Pinewood's international footprint but also aligns with its ambitious growth targets. Financially, the company reported robust earnings for the eleven months ending December 2024, with sales reaching £31.2 million and net income at £5.7 million. These figures underscore a significant upward trajectory in both revenue and earnings, projected to grow annually by 25% and 42.2%, respectively—outpacing the UK market averages significantly. This performance is particularly noteworthy given the context of their recent large one-off loss of £2.4M, highlighting their resilience and potential for sustained growth despite past volatility. Dive into the specifics of Pinewood Technologies Group here with our thorough health report. Review our historical performance report to gain insights into Pinewood Technologies Group's's past performance. Discover the full array of 41 UK High Growth Tech and AI Stocks right here. Are you invested in these stocks already? Keep abreast of every twist and turn by setting up a portfolio with Simply Wall St, where we make it simple for investors like you to stay informed and proactive. Take control of your financial future using Simply Wall St, offering free, in-depth knowledge of international markets to every investor. Explore high-performing small cap companies that haven't yet garnered significant analyst attention. Fuel your portfolio with companies showing strong growth potential, backed by optimistic outlooks both from analysts and management. Find companies with promising cash flow potential yet trading below their fair value. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include AIM:FARN AIM:SAA and LSE:PINE. Have feedback on this article? Concerned about the content? with us directly. Alternatively, email editorial-team@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Entrepreneur
02-06-2025
- Business
- Entrepreneur
Paradigm Shift in MDS Treatment: Faron Pharmaceuticals Unveils Landmark Phase II Trial Data at ASCO 2025
The ability to not only extend life but also improve quality of life by reducing transfusion needs and infection rates is what sets this treatment apart You're reading Entrepreneur United Kingdom, an international franchise of Entrepreneur Media. In a field long hindered by stagnation, Faron Pharmaceuticals may have just turned a critical corner in the fight against high-risk myelodysplastic syndromes (HR-MDS). The Finnish clinical-stage biopharmaceutical company unveiled highly promising results from its Phase II BEXMAB trial at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. The updated data, presented during a Rapid Oral Abstract Session by Dr. Naval Daver of MD Anderson Cancer Center, revealed that Faron's investigational immunotherapy, bexmarilimab (bex), when combined with the standard-of-care drug azacitidine, achieved a median overall survival (mOS) of 13.4 months in patients with relapsed/refractory (r/r) MDS, which is more than double the typical 5-6 months expected under current treatments. "These are patients who historically have had virtually no effective options after standard HMA therapies fail," said Dr. Juho Jalkanen, CEO of Faron Pharmaceuticals. "To see such meaningful survival and response rates gives us real hope that we're on the path to a true therapeutic breakthrough." The study reported an objective response rate (ORR) of 63% in r/r MDS patients (n=32) and an even higher ORR of 72% in treatment-naïve, frontline HR-MDS patients (n=18). Moreover, 56% experienced a complete (100%) reduction. Under the recently updated 2023 International Working Group (IWG) criteria, the composite complete response (cCR) rate was 56%, more than double the typical 25% response seen with azacitidine alone. Bex is a first-in-class monoclonal antibody targeting the Clever-1 receptor, a key mediator in immune suppression within the tumor microenvironment. By blocking Clever-1, the drug reprograms macrophages in the bone marrow, enabling them to mount a more effective anti-tumor immune response. "The ability to not only extend life but also improve quality of life by reducing transfusion needs and infection rates is what sets this treatment apart," confirmed Dr. Juho. "This is especially critical for a patient population that is often elderly and frail." Indeed, the therapy has demonstrated a favorable safety profile. No new safety concerns were reported, and the treatment was well-tolerated even among patients with severe anemia and recurrent infections. The impressive data from the BEXMAB study supports Faron's plan to move forward with a registrational Phase III trial comparing bex + azacitidine versus placebo + azacitidine in frontline HR-MDS. Discussions with the FDA are scheduled for an upcoming end-of-Phase II meeting. "Given the strong correlation between cCR and survival under the new IWG 2023 guidelines, we believe this could form the basis for accelerated approval," Dr. Juho stated. As the oncology community digests the implications of this data, one thing is clear: Faron Pharmaceuticals has taken a bold step forward in its mission to reshape cancer treatment through immune reprogramming.
