Latest news with #SSc
Medscape
21-05-2025
- Health
- Medscape
Rheumatology Guideline Updates Take New Life Course Approach
MANCHESTER, England — The latest guidelines on systemic sclerosis (SSc), axial spondyloarthritis (axSpA), and systemic lupus erythematosus (SLE) from the British Society for Rheumatology (BSR) have been updated and, where appropriate, now consider the full life course of these rheumatologic diseases, experts said at BSR 2025 Annual Meeting. BSR Clinical Guidelines Program Manager Lindsay Turner told Medscape Medical News that the approach was 'really valuable because often it's hard to get evidence in a pediatric population. The updates now mean that recommendations relevant to that population are included.' BSR guidelines are generally updated every 5 years, unless evidence becomes available that warrants a 'mini update,' Turner said. But that time schedule can get stretched out over longer periods, as occurred with the SSc guideline update, as Christopher Denton, MBChB, PhD, professor of experimental rheumatology at UCL Medical School in London, England, told Medscape Medical News . 'Obviously, COVID got in the way for 2 years,' he said. 'And of course, the process itself takes at least 2 years. So I think inevitably that even if you start to do the update, it's going to be about 7-8 years.' SSc Guideline Highlights Denton, who is also head of the Centre for Rheumatology at the Royal Free Hospital, London, England, presented highlights only of the updated SSc guideline at the conference because these have already been published. Christopher Denton, MBChB, PhD One of the key recommendations he highlighted is to use nailfold capillaroscopy during the diagnosis of SSc, as this is as important as antinuclear antibody testing, taking the history, and a physical examination. Moreover, all patients diagnosed with SSc should have a baseline assessment done regardless of what treatment plan is being considered and that should include bloodwork, ECGs, echocardiograms, pulmonary function tests, and a high-resolution CT (HRCT). Discussing the HRCT recommendation, Denton said: 'I think it does reflect the importance of knowing as early as possible whether there is interstitial lung disease present and also to help you follow patients noninvasively over time.' Another 'cornerstone' of the updated guidance is being vigilant and looking out for potential complications, such as malignancy. As for treatment, 'the general recommendation, or preference, was that mycophenolate mofetil is the drug that seems to be the most effective for diffuse cutaneous disease and for interstitial lung disease and limited skin involvement,' Denton said. The guideline also tries to make it clear when autologous hematopoietic stem cell transplantation (AHSCT) may or may not be suitable based on current evidence and states that this approach must be delivered within an experienced specialized center. As such, the recommendation is that AHSCT may be considered an option for diffuse cutaneous SSc, where the benefit is felt to outweigh any risks. However, if there is severe internal organ disease, then this approach may not be appropriate and careful evaluation is required. Also, while AHSCT may be considered an option for children and young people who have severe or refractory disease, regardless of whether they have diffuse cutaneous or limited disease, it is not for adults who have later-stage diffuse cutaneous or limited disease because there is not enough evidence currently to support its use, Denton said. AxSpA Guideline Highlights As for the updated axSpA guideline on management using biologic and targeted synthetic disease-modifying antirheumatic drugs, Sizheng Steven Zhao, MBChB, PhD, clinical senior lecturer and honorary consultant in rheumatology at The University of Manchester, Manchester, England, said there were three key points. Sizheng Steven Zhao, MBChB, PhD First, be open to re-evaluating the diagnosis, Zhao said: 'Getting the diagnosis right can be challenging. Be humble. Be open with your patients about the uncertainty around diagnosis and be willing to revisit that. Re-look at the [MRI] images if treatment response doesn't make sense.' Second, 'start recording the ASDAS [Ankylosing Spondylitis Disease Activity Score],' Zhao said, in addition to recording disease activity using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). Recording the BASDAI is a requirement of the National Institute for Health and Care Excellence, but using ASDAS is 'where the future is. That's where we're moving toward,' Zhao said. He indicated that this should not be too difficult to incorporate into routine practice given that rheumatologists are already using scores such as the DAS in 28 joints for rheumatoid arthritis. Third, do not rule out using certain drug classes. 'Although we're blessed with three classes of drug, we only still have three classes of drug for a condition that needs many decades of treatment. Don't reflexively rule out a mechanism of action,' Zhao said. Specifically, he mentioned not ruling out the use of interleukin 17 inhibitors in a patient who had uveitis or inflammatory bowel disease (IBD). Work with ophthalmologists and gastroenterologists on a case-by-case basis to see if that drug class could still be suitable, Zhao said. Three overarching principles have been added to the guidance, which consider the goals for treatment, shared care decision-making, and the need for a multidisciplinary approach. Zhao urged his audience to read these and the full guideline, which was published in April. There were 'a lot of nuances,' put into the writing of overarching principles and the 15 recommendations, he said. The recommendations have been grouped into three broad areas: General, which covers starting, monitoring, and switching treatments; extra-musculoskeletal manifestations (EMMs), which includes uveitis, psoriasis, and IBD; and treatment strategy, which encompasses the treat-to-target approach, tapering, and treatment withdrawal. The BSR guideline is unique in its discussion of EMMs, Zhao said. This is not done in the American or European guidelines to the same extent: 'We spent that much time thinking about this because, quite frankly, all the therapies have similar efficacy across musculoskeletal features. It is the EMMs that influence which one we choose.' Zhao emphasized that physical therapy was not to be ignored and that pharmacologic treatments were there to 'enable our patients to continue physical activity, not instead of physical therapy.' SLE Guideline Highlights The updated BSR guideline for the management and treatment of SLE is just a few weeks away from publication, said Md Yuzaiful Md Yusof, MBChB, PhD, consultant rheumatologist and senior research fellow at the University of Leeds and Leeds Teaching Hospitals NHS Trust, both in Leeds, England. Md Yuzaiful Md Yusof, MBChB, PhD The updated guideline covers a much broader scope than its previous iteration, as it now includes recommendations for the management of children and adolescents, as well as adults. Literature searches were done from inception rather than from where the last guideline left off, 'particularly for the pediatric field,' Md Yusof said. Detailed guidance on the management of lupus nephritis has been included, and other new features of the guideline were the inclusion of cutaneous lupus, nonpharmacologic care, and the delivery of care, Md Yusof said. Of course, he added, 'we can't do it all,' and areas not covered were neonatal lupus, contraception and reproductive health, treatment during pregnancy and breastfeeding, complications and comorbidities, and detailed management of thrombosis and antiphospholipid syndrome. However, other national guidelines should already cover these topics. The guideline included 102 recommendations. 'I know it sounds a bit alarming, but they're quite logical and self-explanatory,' Md Yusof said. Overall, 96 of these are shown in a single infographic which is intended to act as a 'cheat code,' he added. The recommendations concern diagnosis, assessment and monitoring, management, and the delivery of care. In terms of diagnosis, timing is key, Md Yusof said. When primary care physicians have a strong suspicion of SLE, they should be looking to refer to secondary or tertiary care within 3 weeks, he said. Treat-to-target is one of the key recommendations regarding assessment and monitoring. The primary treatment goal is to meet the 2021 Definition of Remission in SLE criteria, Md Yusof said. And if that is not possible, the target should be to reach the Lupus Low Disease Activity State. As for management, there is guidance on what rheumatologists could prescribe for cutaneous disease without consulting a dermatologist, such as non-facial topical glucocorticoids and non-facial topical calcineurin inhibitors. The of use of the British Isles Lupus Assessment Group (BILAG)-2004 index and SLE Disease Activity Index 2000 to guide management choices was recommended, with the addition of Easy-BILAG, Md Yusof said. 'We recommend all people with mild lupus to be on hydroxychloroquine at a dose of 5 mg/kg of actual body weight per day,' he said. Glucocorticoids could be used as bridging therapy to settle disease flare but not for routine long-term maintenance. For moderate to severe disease activity, methotrexate or immunosuppression with mycophenolate mofetil, azathioprine, cyclosporin, or tacrolimus is recommended to be started early if there is no organ- or life-threatening disease. Biologics and trials are then advocated for more moderate to severe disease, where there is no renal involvement or if glucocorticoids could not be withdrawn. Trials, belimumab, rituximab, or anifrolumab are recommended for more severe disease activity. Regarding lupus nephritis, all patients should be managed jointly between rheumatology and renal services. 'Timely biopsy is really key, and also identifying poor prognostic markers from the outset,' Md Yusof said. A key message regarding glucocorticoid use is to put an end date on the prescription and 'to make sure you have a tapering plan.' Detailed advice is provided in the guideline on how to taper appropriately. The recommendation on induction treatment for lupus nephritis is the most up-to-date available, with combination therapy recommended over single-agent mycophenolate mofetil. 'Whichever combination that you use for remission induction, you carry on for the maintenance,' Md Yusof added. He concluded that the British guidelines were 'definitely more directive and also more up-to-date' than other available guidelines. Turner reported having no relevant financial relationships. Denton reported receiving research and grant funding and consultancy and speaker fees from or acting as a clinical trial investigator and serving on a steering committee for more than 20 companies. Zhao reported receiving consultancy or speaker fees from AbbVie, Alfasigma, Novartis, and UCB. He also acknowledged receiving financial support for attending conferences from Alfasigma, Eli Lilly & Company, Novartis, and UCB. Md Yusof reported acting as an advisory board member, consultant, or speaker for Alumis, Aurinia, GlaxoSmithKline, Novartis, Roche, UCB, and Vifor.
Business Wire
06-05-2025
- Business
- Business Wire
Adicet Bio Reports First Quarter 2025 Financial Results and Provides Business Updates
REDWOOD CITY, Calif. & BOSTON--(BUSINESS WIRE)--Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, today reported financial results and operational highlights for the first quarter ended March 31, 2025. 'We are approaching an exciting inflection point for our pipeline, with significant data milestones on the horizon,' said Chen Schor, President and Chief Executive Officer of Adicet Bio. 'In the second half of 2025, we expect to report preliminary Phase 1 data from our two lead programs - ADI-001 in autoimmune diseases and ADI-270 in ccRCC, with more than 6 patients with at least 3-month follow up in both programs. As we progress toward these readouts, we also look to harness the full potential of our allogeneic gamma delta 1 CAR T cell therapy platform, which we believe has key advantages over other cell types. We have identified two promising highly differentiated programs, one targeting PSMA and one follow-on program targeting autoimmune diseases with potential to become best-in-class therapies for patients fighting autoimmune diseases and cancer.' First Quarter 2025 and Recent Operational Highlights: Autoimmune diseases Enrollment open for LN and SLE patients in Phase 1 clinical trial of ADI-001 in autoimmune diseases. In April 2025, Adicet expanded enrollment in its Phase 1 trial to include patients with SLE, in addition to ongoing enrollment in LN. The Company expects to initiate enrollment for patients with systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM), stiff person syndrome (SPS) and anti-neutrophil cytoplasmic autoantibody associated vasculitis (AAV) in the Phase 1 trial in 3Q/2025. Preliminary clinical data from the trial is expected in 2H/2025, subject to study site initiation and patient enrollment. ADI-001 granted two new Fast Track Designations. In February 2025, the Food and Drug Administration (FDA) granted Fast Track Designation to ADI-001 for the treatment of refractory SLE with extrarenal involvement and for SSc. Hematologic malignancies and solid tumor indications Patient enrollment ongoing in Phase 1 trial of ADI-270 in metastatic/advanced ccRCC. Patient enrollment is underway in the Phase 1 clinical trial evaluating ADI-270 in adults with relapsed or refractory metastatic/advanced ccRCC. Adicet expects to share preliminary clinical data from the trial in 2H/2025. Oral presentation of ADI-270 data at the American Society of Gene and Cell Therapy (ASGCT) 28th Annual Meeting. Adicet will present an oral abstract highlighting strong preclinical data demonstrating ADI-270's anti-tumor activity in hematologic and solid tumor models at the ASGCT Annual Meeting taking place May 13-17, 2025 in New Orleans, LA. Presented ADI-270 preclinical data at the Society for Immunotherapy of Cancer (SITC) 2025 Spring Scientific Meeting. In March 2025, Adicet presented posters covering preclinical data of ADI-270 at the SITC 2025 Spring Scientific Meeting. Corporate Update Appointed Michael Grissinger to Board of Directors. In April 2025, Adicet appointed Michael Grissinger to its Board of Directors. Mr. Grissinger brings over four decades of leadership experience in biopharmaceutical business development, strategy, and M&A to Adicet. Mr. Grissinger has an extensive track record of driving commercial success for global pharmaceutical companies, with a strong focus on immunology. He also serves on the board of directors at Aprea Therapeutics (Nasdaq: APRE) and three privately-held biotechnology companies, Envisagenics, Inc., AnaCardio AB, and NephroDI Therapeutics, Inc. Financial Results for First Quarter 2025: Research and Development (R&D) Expenses: R&D expenses were $22.8 million for the three months ended March 31, 2025, compared to $23.9 million during the same period in 2024. The decrease in R&D expenses was primarily due to a net $1.4 million decrease in expenses related to contract development manufacturing organizations and other externally conducted research and development. General and Administrative (G&A) Expenses: G&A expenses were $7.1 and 7.0 million for the three months ended March 31, 2025 and 2024, respectively. Net Loss: Net loss for the three months ended March 31, 2025 was $28.2 million, or a net loss of $0.31 per basic and diluted share, including non-cash stock-based compensation expense of $3.1 million, as compared to a net loss of $28.0 million, or a net loss of $0.35 per basic and diluted share, including non-cash stock-based compensation expense of $5.7 million during the same period in 2024. Cash Position: Cash and cash equivalents were $150.4 million as of March 31, 2025, compared to $176.3 million as of December 31, 2024. The Company expects that current cash, cash equivalents and short-term investments as of March 31, 2025, will be sufficient to fund its operating expenses into the second half of 2026. About Adicet Bio, Inc. Adicet Bio, Inc. is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer. Adicet is advancing a pipeline of 'off-the-shelf' gamma delta T cells, engineered with chimeric antigen receptors (CARs), to facilitate durable activity in patients. For more information, please visit our website at Forward-Looking Statements This press release contains 'forward-looking statements' of Adicet within the meaning of the Private Securities Litigation Reform Act of 1995 relating to the business and operations of Adicet. The words 'anticipate,' 'believe,' 'continue,' 'could,' 'estimate,' 'expect,' 'intend,' 'may,' 'plan,' 'potential,' 'predict,' 'project,' 'should,' 'target,' 'would' and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, but are not limited to, express or implied statements regarding: clinical development of Adicet's product candidates, including future plans or expectations for ADI-001 in autoimmune diseases and ADI-270 in ccRCC and the potential safety, tolerability and efficacy for the treatment of autoimmune diseases and cancer; timing and success of the Phase 1 clinical trial of ADI-001 in LN, SLE, SSc, AAV, IIM and SPS, including timing and expectations for enrollment and future data releases; timing and success of the Phase 1 clinical trial of ADI-270 in ccRCC, including expectations for future data releases; expectations regarding the presentation of preclinical data at future scientific conferences; and expectations regarding Adicet's uses of capital, expenses and financial results, including the expected cash runway. Any forward-looking statements in this press release are based on management's current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, including without limitation, the effect of global economic conditions and public health emergencies on Adicet's business and financial results, including with respect to disruptions to our preclinical and clinical studies, business operations, employee hiring and retention, and ability to raise additional capital; Adicet's ability to execute on its strategy including obtaining the requisite regulatory approvals on the expected timeline, if at all; that positive results, including interim results, from a preclinical or clinical study may not necessarily be predictive of the results of future or ongoing studies; clinical studies may fail to demonstrate adequate safety and efficacy of Adicet's product candidates, which would prevent, delay, or limit the scope of regulatory approval and commercialization; and regulatory approval processes of the U.S. Food and Drug Administration and comparable foreign regulatory authorities are lengthy, time-consuming, and inherently unpredictable; and Adicet's ability to meet production and product release expectations. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause Adicet's actual results to differ from those contained in the forward-looking statements, see the section titled 'Risk Factors' in Adicet's most recent annual report on Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in Adicet's other filings with the U.S. Securities and Exchange Commission, including its quarterly report on Form 10-Q. All information in this press release is as of the date of the release, and Adicet undertakes no duty to update this information unless required by law. ADICET BIO, INC. Consolidated Balance Sheets Information (in thousands) (Unaudited) March 31, December 31, 2025 2024 Cash, cash equivalents, and short term investments in treasury securities $ 150,439 $ 176,303 Working capital 137,116 160,744 Total assets 191,271 220,219 Accumulated deficit (526,108 ) (497,894 ) Total stockholders' equity 161,446 186,609 Expand
Yahoo
06-03-2025
- Health
- Yahoo
New Data Presented at CORA 2025 Conference Highlights Clinical Potential of Chemomab's Nebokitug in Systemic Sclerosis
Adds to Extensive Preclinical and Early Clinical Evidence that Nebokitug Interferes with Key Features of Systemic Sclerosis TEL AVIV, Israel, March 06, 2025 (GLOBE NEWSWIRE) -- Chemomab Therapeutics, Ltd. (Nasdaq: CMMB), a clinical stage biotechnology company developing innovative therapeutics for fibro-inflammatory diseases with high unmet need, today announced a new scientific presentation that further confirms the potential of nebokitug (CM-101) as a novel treatment for systemic sclerosis (SSc).1 The data will be presented at the 8th International Congress on Controversies in Rheumatology and Autoimmunity (CORA 2025) on March 8, 2025, in Venice, Italy. Systemic sclerosis is an autoimmune disease characterized by microvascular injury and extensive tissue fibrosis of the skin and internal organs. It is the most lethal of the systemic connective tissue diseases and lacks approved disease-modifying therapies. Nebokitug is a first-in-class monoclonal antibody that blocks the soluble protein CCL24, which has been shown to be a key driver of the pathways underlying fibro-inflammatory conditions such as SSc and primary sclerosing cholangitis (PSC). In extensive preclinical studies, blocking CCL24 reduced the inflammatory and fibrotic injury to the lung, skin and vasculature that are hallmarks of SSc pathology. An investigator-sponsored study showed that treatment with nebokitug induced strong and rapid reductions in inflammatory biomarkers in patients with acute lung Injury, a relevant model for the type of lung damage seen in SSc patients. 'This new data adds to the extensive body of preclinical evidence that CCL24 is a key driver of the skin, lung and vascular manifestations of this disabling condition that lacks disease-modifying therapies,' said Adi Mor, PhD, co-founder, Chief Executive Officer and Chief Scientific Officer of Chemomab. 'These results further reinforce our belief, based on multiple preclinical and patient sample studies and the positive results from our Phase 2 PSC trial, that nebokitug has substantial potential as a treatment for SSc. Chemomab has an open U.S. IND for a Phase 2 trial of nebokitug in SSc.' The new study being presented at CORA 2025 was conducted in collaboration with Dr. Alexandra Balbir-Gurman, former director of the B. Shine Rheumatology Institute at Rambam Health Care Campus, Clinical Associate Professor at the Rappaport Faculty of Medicine of the Technion-Israel Institute of Technology and a noted scleroderma researcher and clinician. The study used matching skin and serum samples from a large registry of SSc patients and data from the bleomycin-mouse model to assess nebokitug's possible effects on CCR3-expressing immune cells in SSc (CCR3 is the receptor for CCL24). Researchers analyzed CCL24's role in induced fibrosis and SSc pathogenesis and identified several peripheral immune cell populations with altered expression of CCR3, two of which are linked to SSc and its complications. These findings further underscore the role of CCL24 in SSc and strengthen the therapeutic rationale for targeting CCL24 inhibition with nebokitug as a potential SSc therapy. A 2024 peer-reviewed publication2 found strong associations between nebokitug's CCL24 target and SSc. Data from more than 200 SSc patients showed that higher CCL24 levels were linked to clinical variables associated with the most severe forms of SSc with irreversible tissue damage, including severity of skin fibrosis and calcinosis, presence of interstitial lung disease and a history of digital ulcers and synovitis. Importantly, high serum CCL24 was predictive for deterioration of pulmonary function and a higher baseline CCL24 level was associated with higher 10-year SSc-related mortality. Recent positive data from the nebokitug Phase 2 SPRING trial in patients with PSC further strengthens the rationale for assessing nebokitug in SSc. This trial was the first major clinical validation of the dual anti-inflammatory and anti-fibrotic mechanism of nebokitug. In patients with PSC, nebokitug reduced fibro-inflammatory biomarkers including the enhanced liver fibrosis (ELF) score, PRO-C3, Interleukine-6 (IL-6) and transforming growth factor beta (TGF-β), all of which are well-established indicators of SSc fibrosis and disease activity. CORA 2025 Session: 0680 - Poster Session 10: SLE, ILD and Novel Therapeutic Targets Date/Time: Saturday, March 8, 2025, 10:30 - 11:30 CETRoom: Station 02 The CORA 25 poster will also be available at the R&D section of About Nebokitug (CM-101) Nebokitug is a first-in-class dual activity monoclonal antibody that neutralizes CCL24, a soluble protein that helps drive the inflammatory and fibrotic pathways central to primary sclerosing cholangitis (PSC) and other fibro-inflammatory diseases. By inhibiting CCL24, nebokitug blocks both immune cell recruitment and fibroblast activation, thereby interrupting the self-reinforcing cycle that results in fibrosis. In clinical and preclinical studies, nebokitug has been shown to have a favorable safety profile, with the potential to treat multiple severe and life-threatening fibro-inflammatory diseases. Chemomab has reported positive results from four clinical trials of nebokitug in patients, including the Phase 2 SPRING trial in patients with PSC. This study achieved the primary safety endpoint and nebokitug-treated patients with moderate to advanced disease showed improvements on a wide range of disease-related secondary endpoints. The open label extension portion of the SPRING trial is continuing, with results expected in the first quarter of 2025. Nebokitug is also being developed for systemic sclerosis and the SSc program has an open U.S. IND. Nebokitug has received FDA and EMA Orphan Drug designations for the treatment of PSC and SSc and FDA Fast Track status for the treatment of PSC in adults. About Systemic SclerosisSystemic sclerosis (SSc), also known as scleroderma, is a rare autoimmune rheumatic disease characterized by fibrosis and inflammation of the skin, joints and internal organs, along with vascular abnormalities. It predominantly affects women and is typically diagnosed when patients are between 30 and 50 years old. It is considered the most devastating condition among systemic rheumatic diseases with severe morbidity and high mortality, with a median survival of only 10 years. There is no approved disease-modifying drug for the disease. Current estimates from the Scleroderma Foundation suggest there are approximately 100,000 SSc patients in the U.S. 1. CCL24 Expression and Impact on Immune Cell Populations in Systemic Sclerosis, R. Greenman, A. Katav, I. Vaknin, T. Snir, V. Shataylo, A. Balbir-Gurman. The 8th International Congress on Controversies in Rheumatology and Autoimmunity (CORA 2025) , March 8, 20252. Serum CCL24 as a biomarker of fibrotic and vascular disease severity in Systemic Sclerosis, E. De Lorenzis, A. Mor, R.L. Ross, S. Di Donato, R. Aricha, I. Vaknin, F. Del Galdo. Arthritis Care & Research, Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the 'safe harbor' provisions of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this press release, including statements regarding our future financial condition, results of operations, business strategy and plans, and objectives of management for future operations, as well as statements regarding industry trends, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as 'estimate,' 'intend,' 'may,' 'plan,' 'potentially,' 'will' or the negative of these terms or other similar expressions. We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things: the risk that certain acknowledgements from the End-of-Phase 2 (EOP2) meeting with the FDA in connection with PSC regulatory approval will not materialize into a pathway for regulatory approval; that certain conclusions and assumptions drawn from the EOP2 meeting with the FDA discussed in the presentation will prove incorrect and adversely affect the ability for nebokitug to become an FDA fully approved therapy; the risk that the full data set from the nebokitug study or data generated in further clinical trials of nebokitug will not be consistent with the topline results of the nebokitug Phase 2 PSC trial; failure to obtain, or delays in obtaining, regulatory approvals for nebokitug in the U.S., Europe or other territories; failure to successfully commercialize nebokitug, if approved by applicable regulatory authorities, in the U.S., Europe or other territories, or to maintain U.S., European or other territory regulatory approval for nebokitug if approved; uncertainties in the degree of market acceptance of nebokitug by physicians, patients, third-party payors and others in the healthcare community; nebokitug development of unexpected safety or efficacy concerns related to nebokitug; failure to successfully conduct future clinical trials for nebokitug, including due to the Company's potential inability to enroll or retain sufficient patients to conduct and complete the trials or generate data necessary for regulatory approval, among other things; risks that the Company's clinical studies will be delayed or that serious side effects will be identified during drug development; failure of third parties on which the Company is dependent to manufacture sufficient quantities of nebokitug for commercial or clinical needs, to conduct the Company's clinical trials; changes in laws and regulations applicable to the Company's business and failure to comply with such laws and regulations; business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises; and uncertainties with respect to the Company's need and ability to access future capital; and the intensity and duration of the current war in Israel, and its impact on our operations in Israel. These risks are not exhaustive. You should carefully consider the risks and uncertainties described in the 'Risk Factors' sections of our 20-F for the year ended December 31, 2023. New risk factors emerge from time to time, and it is not possible for our management to predict all risk factors, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in, or implied by, any forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. Except as required by law, we undertake no obligation to update publicly any forward-looking statements for any reason after the date of this press release. Before you invest, you should read the documents we have filed and will file with the SEC for more complete information about us. You may get these documents for free by visiting EDGAR on the SEC website at This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities law of any such state or jurisdiction. About Chemomab Therapeutics is a clinical stage biotechnology company developing innovative therapeutics for fibro-inflammatory diseases with high unmet need. Based on the unique role of the soluble protein CCL24 in promoting fibrosis and inflammation, Chemomab developed nebokitug (CM-101), a first-in-class dual activity monoclonal antibody that neutralizes CCL24 and has demonstrated disease-modifying potential. In clinical and preclinical studies, nebokitug has been shown to have a favorable safety profile and has been generally well-tolerated, with the potential to treat multiple severe and life-threatening fibro-inflammatory diseases. Chemomab has reported positive results from four clinical trials of nebokitug in patients. Based on recent positive data from its Phase 2 SPRING trial in primary sclerosing cholangitis (PSC), the company is preparing for potential initiation of a PSC nebokitug Phase 3 trial. The design calls for a single pivotal trial based on a clinical event primary endpoint that provides a clear and streamlined pathway to potential regulatory approval. Data from the SPRING trial open label extension will be reported in the first quarter of 2025. Nebokitug has received FDA and EMA Orphan Drug and FDA Fast Track designations for the treatment of PSC. Chemomab's nebokitug program for the treatment of systemic sclerosis has an open U.S. IND. For more information, visit: Contacts: Media and Investors:Barbara LindheimConsulting Vice President, Investor & Public Relations, Strategic CommunicationsPhone: +1 in to access your portfolio
Associated Press
05-02-2025
- Business
- Associated Press
Adicet Bio Receives FDA Fast Track Designation for ADI-001 for the Treatment of Refractory Systemic Lupus Erythematosus (SLE) with Extrarenal Involvement
REDWOOD CITY, Calif. & BOSTON--(BUSINESS WIRE)--Feb 5, 2025-- Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to ADI-001 for the potential treatment of adult patients with refractory systemic lupus erythematosus (SLE) with extrarenal involvement. Fast Track Designation is a process designed to facilitate development and expedite the review of drugs intended to treat serious conditions and fill an unmet medical need. About ADI-001 ADI-001 is an investigational allogeneic gamma delta chimeric antigen receptor (CAR) T cell therapy targeting CD20 for the treatment of autoimmune diseases. ADI-001 was granted Fast Track Designation by the FDA for the treatment of relapsed/refractory class III or class IV lupus nephritis (LN), and SLE with extrarenal involvement. The Company is advancing ADI-001 across six autoimmune indications. Patient enrollment is ongoing in the Phase 1 study evaluating ADI-001 for the treatment of LN. Patient enrollment in SLE, systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM, or myositis), and stiff person syndrome (SPS) is expected to be initiated in the first quarter of 2025. Initiation of enrollment in anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (AAV) is expected in the second half of 2025. In the Phase 1 GLEAN trial, ADI-001 was shown to target B-cells via an anti-CD20 CAR and demonstrated robust exposure and complete CD19+ B-cell depletion both in peripheral blood and secondary lymphoid tissue. About Adicet Bio, Inc. Adicet Bio, Inc. is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer. Adicet is advancing a pipeline of 'off-the-shelf' gamma delta T cells, engineered with chimeric antigen receptors (CARs), to facilitate durable activity in patients. For more information, please visit our website at Forward-Looking Statements This press release contains 'forward-looking statements' of Adicet within the meaning of the Private Securities Litigation Reform Act of 1995 relating to the business and operations of Adicet. The words 'anticipate,' 'believe,' 'continue,' 'could,' 'estimate,' 'expect,' 'intend,' 'may,' 'plan,' 'potential,' 'predict,' 'project,' 'should,' 'target,' 'would' and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, but are not limited to, express or implied statements regarding the initiation of patient enrollment for the Phase 1 trial of ADI-001 in SLE, SSc, IIM, SPS and ANCA AAV and potential benefits resulting from the Fast Track Designation. Any forward-looking statements in this press release are based on management's current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, including without limitation, the effect of global geopolitical conflicts and economic conditions on Adicet's business and financial results, including with respect to disruptions to Adicet's preclinical and clinical studies, business operations, employee hiring and retention, and ability to raise additional capital; Adicet's ability to execute on its strategy including obtaining the requisite regulatory approvals on the expected timeline, if at all; that positive results, including interim results, from a preclinical or clinical study may not necessarily be predictive of the results of future or ongoing studies; clinical studies may fail to demonstrate adequate safety and efficacy of Adicet's product candidates, which would prevent, delay, or limit the scope of regulatory approval and commercialization; and regulatory approval processes of the FDA and comparable foreign regulatory authorities are lengthy, time-consuming, and inherently unpredictable; and Adicet's ability to meet production and product release expectations. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause Adicet's actual results to differ from those contained in the forward-looking statements, see the section entitled 'Risk Factors' in Adicet's most recent annual report on Form 10-K and periodic and current reports on Form 10-Q and Form 8-K filed with the U.S. Securities and Exchange Commission (SEC), as well as discussions of potential risks, uncertainties, and other important factors in Adicet's other filings with the SEC. All information in this press release is as of the date of the release, and Adicet undertakes no duty to update this information unless required by law. CONTACT: Adicet Bio, Inc. Investor and Media ContactsInvestors: Anne Bowdidge [email protected] Mohite Precision AQ 212-362-1200 [email protected]: Kerry Beth Daly [email protected] INDUSTRY KEYWORD: ONCOLOGY HEALTH FDA STEM CELLS GENETICS PHARMACEUTICAL BIOTECHNOLOGY SOURCE: Adicet Bio, Inc. 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