BTK

Celldex Therapeutics has unveiled 52-week data from a mid-stage study of its anti-KIT drug in chronic hives, raising anticipation for ongoing registrational studies. The drug, dubbed barzolvolimab, is in a pair of Phase 3 trials in chronic spontaneous urticaria (CSU) following positive topline Phase 2 data announced in February. Some Wall Street analysts have said Celldex could challenge Novartis’ remibrutinib, which has already completed its registrational studies. Celldex’s latest results show 71% of 52 CSU patients dosed with 150 mg barzolvolimab every four weeks had a complete response, defined as no itch or hives, at 52 weeks. In the cohort of 51 patients given 300 mg every eight weeks, just over half of them had a complete response. Celldex’s Wednesday release did not mention p-values. “We believe this data set is a landmark event for the barzolvolimab program and for the treatment of CSU,” Celldex CMO Diane Young said in a statement. The candidate is being investigated in patients struggling with symptoms despite antihistamine treatment. The responses were seen regardless of patients’ prior exposure to Novartis and Genentech’s monoclonal antibody Xolair. For context, almost 56% of patients dosed twice daily with Novartis’ BTK inhibitor achieved a complete response at 52 weeks in a Phase 2b extension trial of the drug in CSU. After reporting positive long-term Phase 3 data in May, the drugmaker has said it will file remibrutinib with regulatory agencies in the second half of the year. But at 52 weeks, Celldex’s candidate has a higher incidence of neutropenia (17%) versus its earlier 16-week data (9%). Neutropenia was a big concern for investors going into the Phase 2 trial, TD Cowen analysts said in February. Celldex’s shares $CLDX were down by as much as 27% Wednesday, right after the company’s data announcement. Celldex said that neutrophil counts didn’t drop further with continued dosing in the latest Phase 2 data, and there was no link between neutropenia and infections. The Wednesday release did not mention concerns with anaphylaxis. The company said around 8% of patients in the 150 mg arm and 13% in the 300 mg arm discontinued treatment due to an adverse event. The company reported topline Phase 2 results in February that showed three doses, including the lowest dose of 75 mg, met the primary endpoint of mean change in urticaria activity score 7 (UAS7) at 12 weeks. At the time, this result was described by Cowen analysts as “superb.” The two identical Phase 3 studies of barzolvolimab in CSU, which were initiated in July, are aiming to enroll 915 patients each and will test 150 mg and 300 mg doses. Both trials are using the same primary endpoint as the Phase 2. Barzolvolimab is also in development for prurigo nodularis, atopic dermatitis and chronic inducible urticaria. Earlier this month, GlobalData analysts said barzolvolimab could achieve $874 million in US sales by 2039.

Share EADV: New data reinforce Sanofi’s innovative approach and leadership across immune-mediated skin diseases 24 abstracts for Dupixent, including 4 oral presentations, highlight impact of targeting interleukin-4 (IL4) and interleukin-13 (IL13) across atopic dermatitis (AD), prurigo nodularis (PN) and chronic spontaneous urticaria (CSU) New data show impact of Dupixent on potential for clinical remission in children as young as six years of age with moderate-to-severe AD 15 abstracts for immunology pipeline molecules, including phase 2 presentations in AD for amlitelimab, an OX40-ligand monoclonal antibody Paris, September 25, 2024. Sanofi will present 39 abstracts across approved and pipeline medicines at the 2024 European Academy of Dermatology and Venereology (EADV) medical meeting from September 25-28 in Amsterdam, the Netherlands. Presentations will include 21 abstracts for Dupixent (dupilumab) in partnership with Regeneron, highlighting the impact of targeting IL4 and IL13 across three chronic skin conditions, including disease remission data and long-term data in children with moderate-to-severe atopic dermatitis (AD), and rapid results in adults with prurigo nodularis (PN). In addition, data presentations from Sanofi’s extensive immunology pipeline include oral and poster presentations for amlitelimab, an OX40-ligand monoclonal antibody, demonstrating safety and efficacy results in moderate-to-severe AD, as well as in poster presentations for rilzabrutinib, a novel oral BTK inhibitor, showing its impact on symptoms of AD and moderate-to-severe chronic spontaneous urticaria (CSU). Dietmar Berger, M.D., Ph.D. Chief Medical Officer, Global Head of Development at Sanofi “Our data at EADV highlight the breadth of our diverse and novel approach across inflammatory dermatologic conditions, including AD, PN and CSU. Dupixent data demonstrates the potential benefit of important treatment goals such as clinical remission and the speed and durability of efficacy. We continue to evaluate Dupixent’s real-world safety profile and consistency of patient impact and satisfaction in children, adolescents, and adults with atopic dermatitis across the globe. Additionally, we are excited to share new data from our pipeline, including results for amlitelimab showing the potential to provide durable efficacy that may enable a quarterly dosing interval, with favorable safety profile.” Notable presentations include: Dupixent New results and analyses for Dupixent in children and adults with moderate-to-severe AD and adults with prurigo nodularis. Atopic dermatitis multiple poster presentations will show results in children with moderate-to-severe AD, including those from an open-label extension study on clinical remission in children aged six to 17 years of age, including after stopping treatment with Dupixent, as well as long-term efficacy and safety data for up to two years on children aged six months to five years. Additionally, real-world data in children six months to 11 years of age will show patient-reported disease severity and health-related quality of life outcomes throughout one year. an oral presentation will show real-world safety data from around the world for Dupixent in adults and adolescents with moderate-to-severe AD. Prurigo nodularis PRIME and PRIME2: an oral presentation will show new analyses on disease activity, itch, and skin clearance as early as two weeks from two pivotal clinical studies. The safety results of these studies were generally consistent with the known safety profile of Dupixent in its approved dermatological indications. Dermatology pipeline Data include new results and analyses for amlitelimab, an OX40-ligand monoclonal antibody, in AD, and rilzabrutinib, a novel oral BTK inhibitor, in AD and CSU. Atopic dermatitis amlitelimab: six presentations will share data for amlitelimab in moderate-to-severe AD, including an oral presentation of 68-week safety results. Additional presentations highlight a PK model that support the potential use of a quarterly dosing regimen, a post-hoc analysis showing the impact of amlitelimab on AD of the head and neck, and results from an in vitro analysis demonstrating that the anti-OX40L mechanism of amlitelimab does not deplete T cells. rilzabrutinib: a poster presentation will show the impact of rilzabrutinib on itch in adults with moderate-to-severe AD. Chronic spontaneous urticaria rilzabrutinib: three poster presentations will show the impact of rilzabrutinib on itch, hives and urticaria in adults with moderate-to-severe CSU. Hidradenitis suppurativa three poster presentations will show the impact of disease symptoms on patients with hidradenitis suppurativa and highlight the need for increased disease awareness and effective treatment options. Alopecia areata a poster presentation will show conceptual model and clinical outcome measures in alopecia areata based on the patient experience. Amlitelimab and rilzabrutinib are investigational medicines for which safety and efficacy have not been evaluated by any regulatory authority. Complete list of EADV 2024 presentations: About SanofiWe are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across the world, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Sanofi Media RelationsSandrine Guendoul | + 33 6 25 09 14 25 | sandrine.guendoul@sanofi.comEvan Berland | + 1 215 432 0234 | evan.berland@sanofi.comVictor Rouault | + 33 6 70 93 71 40 | victor.rouault@sanofi.comTimothy Gilbert | + 1 516 521 2929 | timothy.gilbert@sanofi.com Sanofi Investor RelationsThomas Kudsk Larsen |+ 44 7545 513 693 | thomas.larsen@sanofi.comAlizé Kaisserian | + 33 6 47 04 12 11 | alize.kaisserian@sanofi.comArnaud Delépine | + 33 6 73 69 36 93 |arnaud.delepine@sanofi.comFelix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.comKeita Browne | + 1 781 249 1766 | keita.browne@sanofi.comNathalie Pham | + 33 7 85 93 30 17 | nathalie.pham@sanofi.comTarik Elgoutni | + 1 617 710 3587 | tarik.elgoutni@sanofi.comThibaud Châtelet | + 33 6 80 80 89 90 | thibaud.chatelet@sanofi.com Sanofi Forward-Looking StatementsThis media update contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that pandemics or other global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2023. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. All trademarks mentioned in this press release are the property of the Sanofi group. Attachment Media Update Share By clicking “Accept All”, you agree to the storing of cookies on your device to enhance site navigation, measure site performance and show you personalized advertising. Please note your consent may be valid for other websites. You can personalize or withdraw your consent at any moment by clicking on the link "Cookies Settings". For more information on how we use cookies, including the total lifespan of cookies and the identity of third-parties intervening on our website, please consult the cookies policy, available in the site footer. When you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. This information might be about you, your preferences or your device and is mostly used to make the site work as you expect it to, to make your online experience easier by saving browsing information. The information does not usually directly identify you, but it can give you a more personalized web experience. There are two types of cookies, the first-party cookies, created by the website you visit and hosted by Sanofi, and third-party cookies, created by other websites. Because we respect your right to privacy, you can choose not to allow some types of cookies. Click on the different category headings to find out more and change our settings. For more information on the cookies, please consult the “Cookies Policy” available in the footer. These cookies are necessary for the website to function and cannot be switched off in our systems. They are only set to provide you with services you have requested, such as setting your privacy preferences, logging in or filling in forms. You can set your browser to block or alert you about these cookies, but these functions and services will not work for you and in particular, we won’t be able to save your preferences about cookies. These cookies do not store any personally identifiable information. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. They measure how often you visit our website and how you use it. They help us to know which pages are the most and least popular and see how visitors move around the site. All information these cookies collect is aggregated and therefore anonymous. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance. These cookies enable the website to provide enhanced functionality and personalization. They may be set by us or by third party providers whose services we have added to our pages. If you do not allow these cookies then some or all of these services may not function properly. These cookies may be set through our site by our advertising partners. They may be used by those companies to build a profile of your interests and show you relevant adverts on other sites. They do not store directly personal information, but are based on uniquely identifying your browser and internet device. If you do not allow these cookies, you will experience less targeted advertising. Subject to your prior consent, these cookies stored in your device by the third-parties listed below, allow us to count the number of displays of advertising content in our advertising spaces, identify these contents, the number of displays for each of them, the number of users who clicked on each content and where applicable, further actions carried out by the users on the sites linked to these advertising contents, to be able to calculate the sums due to the actors of the advertising distribution chain (communication agency, advertising management, site/distribution medium) and to establish statistics. Please note that when consenting to the use of targeting cookies, you also consent to the follow up of your navigation on other websites.

USA News Group Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, Sept. 24, 2024 /PRNewswire/ -- USA News Group – Optimism is on the rise in fight against cancer, as researchers are making progress across the field of oncology. Helping to spur on the momentum, philanthropists recently gave a historic $150 million for pancreatic cancer research to City of Hope, while Stanford experts are calling for more massive federal funding increases to cancer research. According to the latest Cancer Progress Report from the American Association for Cancer Research, the USA has seen a 33% reduction in the overall cancer death rate from 1991 to 2021. Working behind the scenes are several biotech and biopharma companies who've recently made significant developments in the field of oncology, including O ncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Nurix Therapeutics, Inc. (NASDAQ: NRIX), Incyte Corporation (NASDAQ: INCY), Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN), and Foghorn Therapeutics Inc. (NASDAQ: FHTX). Building on the impressive momentum from its BRACELET-1 breast cancer study, O ncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) continues to advance its flagship therapy, pelareorep, toward a pivotal, registration-enabling study. The recent BRACELET-1 Phase 2 trial results have generated a surge of optimism, with over half of the patients in the pelareorep arm still alive at the study's end—a remarkable achievement that underscores the potential of this innovative cancer therapy. The median overall survival (OS) for patients treated with pelareorep combined with paclitaxel has not yet been reached, with estimates suggesting a 32-month survival benefit compared to just 18 months for the control arm. This outcome, along with a 64% two-year survival rate for the pelareorep group, highlights the therapy's potential to significantly improve patient outcomes in HR+/HER2- advanced or metastatic breast cancer. "The fact that the median overall survival was not reached because more than half the patients were still alive at the end of the study is a remarkable achievement for us," said Wayne Pisano, Interim CEO and Chair of Oncolytics' Board of Directors. "It shows just how promising pelareorep treatment can be for extending the lives of breast cancer patients. This is further exemplified by the near doubling of the 2-year survival rate for patients who received pelareorep combination therapy." These promising results mirror the earlier success of the IND-213 study, which secured FDA Fast Track Designation for pelareorep in 2017. Combined, these two trials reinforce the growing belief in pelareorep's ability to make a substantial impact in oncology. Within the latest update on pelareorep's latest breast cancer study were plenty of reasons to build optimism, corroborating results of its previous randomized IND-213 breast cancer study that led to an FDA Fast Track Designation in 2017. "Taken together, the BRACELET-1 results provide compelling support for the potential of pelareorep-based combination therapy to benefit patients with advanced or metastatic HR+/HER2- breast cancer," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. "Having recently discussed with the FDA key design elements for our next breast cancer study, in combination with the strong survival data from the BRACELET-1 and IND-213 studies, we are confident in our plan to conduct a registration-enabling study to assess pelareorep-based combination therapy in patients with advanced HR+/HER2- breast cancer." As Oncolytics pushes forward, the stage is now set for the next chapter in pelareorep's journey—a registration-enabling study that could bring this promising therapy closer to becoming a vital tool in the fight against breast cancer. Clinical stage biopharma company Nurix Therapeutics, Inc. (NASDAQ: NRIX) is developing targeted protein modulation drugs designed to treat patients with cancer and inflammatory diseases. Recently, Nurix presented at the ADC & Radiopharmaceuticals Pharma & Biotech Partnering Summit in Boston, with a presentation titled Targeted Protein Degraders as Next Generation Antibody Payloads. Back in Q2 2024, Nurix also presented positive clinical data at the European Hematology Association Congress (EHA2024) supporting a potential best-in-class profile for NX-5948, its orally bioavailable degrader of Bruton's tyrosine kinase (BTK), for the treatment of chronic lymphocytic leukemia (CLL). NX-5948 demonstrated an objective response rate (ORR) of 69.2% in heavily pretreated chronic lymphocytic leukemia (CLL) patients, including in patients with Bruton's tyrosine kinase (BTK) inhibitor resistance mutations and patients with central nervous system (CNS) i "The data presented at EHA2024, reaffirm the best-in-class potential of our protein degradation platform to address the limitations of current inhibitors against challenging targets such as Bruton's tyrosine kinase," said Arthur T. Sands, M.D., Ph.D., President and CEO of Nurix. "We enter the second half of 2024 well positioned to develop our lead clinical program, NX-5948, into pivotal clinical trials in CLL in 2025 and to continue to advance our wholly owned pipeline of clinical assets, preclinical programs and strategic collaboration programs with Gilead, Sanofi and Pfizer." Recently at the ESMO 2024 Congress, Incyte Corporation (NASDAQ: INCY) gave a mini-oral presentation sharing promising results for its CDK2 inhibitor INCB123667 showing promising evidence of clinical activity in patients with advanced solid tumors, notably ovarian cancer. Of the 37 evaluable participants with platinum-resistant ovarian cancer, nine participants (24.3%) experienced an overall response (OR; 2 complete responses [CR] and 7 partial responses [PRs]). The highest OR rate of 31.3% (5 responders, including 2 CRs) was found in the 50mg BID cohort (16 evaluable participants). Additionally, a disease control rate (DCR) of 75.7% (28/37) was achieved in patients with ovarian cancer. "The early-stage clinical activity of INCB123667 represents an exciting and promising breakthrough for patients with ovarian cancer," said Pablo Cagnoni M.D., President, Head of Research and Development, Incyte. "We believe this novel CDK2 inhibitor has the potential to be a foundational treatment for platinum-resistant ovarian cancer, offering a new and differentiated treatment for patients who currently have limited treatment options. We look forward to advancing the development of INCB123667 for the treatment of patients with ovarian cancer both as a single agent and in combination." At both the ESMO 2024 Congress and IASLC 2024 World Conference on Lung Cancer (WCLC), Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) presented progress across its differentiated oncology portfolio and pipeline. Regeneron first shared five-year survival data on Libtayo (PD-1 inhibitor) first-line monotherapy in advanced non-small cell lung cancer (NSCLC) at IASLC 2024, then shared longer-term results with investigational fianlimab (LAG-3 inhibitor) plus Libtayo from initial trial in advanced melanoma showing high clinical activity, including deepening responses, per a blinded independent central review. "The breadth of our presentations at ESMO and WCLC underscore our progress in advancing treatment approaches for cancer that have the potential to be among the best in their class," said Israel Lowy, MD, PhD, Clinical Development Unit Head, Oncology, at Regeneron. "At WCLC, five-year outcomes for Libtayo monotherapy in advanced NSCLC reinforce its position as the anti-PD-1 backbone of our oncology portfolio. At ESMO, the latest two-year data for our LAG-3 inhibitor fianlimab combined with Libtayo show persistent and high clinical activity in advanced melanoma patients. As our portfolio and pipeline mature, the insights from these data are helping us advance our differentiated and novel combination approaches – all with the goal of transforming care for those living with cancer." Within its Q2 2024 financial and corporate update, Foghorn Therapeutics Inc. (NASDAQ: FHTX) stated it expects topline Phase 1 dose escalation data for its FHD-286 in combination with decitabine in relapsed and/or refractory AML patients to come in Q4 2024, and dosing of its first patient in a Phase 1 trial for FHD-909, a potential first-in-class SMARCA2 selective inhibitor for a primary target population in SMARCA4 mutated NSCLC to come in H2 2024. "We anticipate topline data from our Phase 1 combination trial with FHD-286 in patients with relapsed and/or refractory AML in the fourth quarter of 2024," said Adrian Gottschalk, President and CEO of Foghorn. "We believe FHD-286 has the potential to be a first-in-class, mutation-agnostic differentiation therapeutic. Additionally, the IND for FHD-909 cleared in May and we anticipate FHD-909 to be the first SMARCA2 selective inhibitor to enter the clinic. Dosing of the first patient in our Phase 1 trial, with primary target population in SMARCA4 mutated NSCLC, is planned for the second half of the year. We are also on track to initiate IND-enabling studies in the fourth quarter of 2024 for our Selective CBP degrader program targeting tumors harboring EP300 mutations including bladder, gastric and endometrial cancers." Article Source: USA NEWS GROUP [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment. SOURCE USA News Group WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED