A Randomized Control Trial to Compare the Euploid Rate of Blastocyst Between the PPOS (Progestin-primed Ovarian Stimulation) Protocol and the Gonadotropin-releasing Hormone (GnRH) Antagonist Protocol in Women With PCOS (Polycystic Ovary Syndrome) Undergoing PGT-A (Preimplantation Genetic Testing for Aneuploidy)

This randomized trial aims to compare the euploid rate of blastocysts between PPOS (progestin-primed ovarian stimulation) and GnRH (gonadotrophin releasing hormone) antagonist protocols in patients with PCOS (polycystic ovary syndrome) undergoing PGT-A (preimplantation genetic testing for aneuploidy). Infertile women with PCOS will be recruited for study after explanation and counseling if they fulfill the inclusion criteria and do not have the exclusion criteria. Eligible women will be randomised into one of the two groups:
Antagonist group: Women will receive antagonist once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger.
PPOS group: Women will receive oral MPA (medroxyprogesterone acetate)10mg qd from Day 3 till the day of ovulation trigger.
The primary outcome is the euploidy rate of blastocysts.

Start Date01 Dec 2024

Sponsor / Collaborator

ShangHai Ji Ai Genetics & IVF Institute

NCT06013423 / RecruitingPhase 2

Optimized Cord Blood Transplantation for the Treatment of High-Risk Hematologic Malignancies in Adults and Pediatrics

This phase II trial studies how well giving an umbilical cord blood transplant together with cyclophosphamide, fludarabine, and total-body irradiation (TBI) works in treating patients with hematologic diseases. Giving chemotherapy, such as cyclophosphamide, fludarabine and thiotepa, and TBI before a donor cord blood transplant (CBT) helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after transplant may stop this from happening in patients with high-risk hematologic diseases.

Start Date06 Jul 2024

Sponsor / Collaborator

Fred Hutchinson Cancer Center

[+1]

NCT06354179 / Not yet recruitingPhase 4IIT

Evaluation of the Benefits of Administering Immunosuppressive Drugs as Single Daily Doses Over the First Year After Liver Transplantation

World Health Organization considers non-adherence has a strong negative impact on the health of patients with chronic diseases. In transplantation, adherence to immunosuppressive drug regimens associates with late rejection and graft loss making it a critical determinant of patient outcome. The prevalence of non-adherence in transplant patients, including liver transplant patients, can be as high as 40%. Among others, life-long intake and complexity of immunosuppressive regimen make patients prone to non-adherence. For instance, non-adherence is more prevalent among patients with higher numbers of immunosuppressive drugs. One of the most commonly cited causes of non-adherence is forgetfulness and disruptions in routine, with the evening dose of twice daily regimens being the most likely to be affected6. Besides non-adherence, the constraints generated in everyday life by immunosuppression (including timely and regular drug intake) and the complexity of the immunosuppressive regimens represent a burden for the patients and are probably associated with a health-related quality of life deterioration. Therefore, long-term adherence and quality of life after liver transplantation might be improved by using a well-tolerated and easy-to-handle immunosuppressive regimen.
The immunosuppressive regimen after liver transplantation is in most cases based on different combinations of tacrolimus, mycophenolate mofetil and corticosteroids. While corticosteroids are administered once daily, tacrolimus can be administered either twice-daily (BID) as an immediate-release, or once-daily (QD) as an extended-release formulation. Among once-daily tacrolimus formulations, LCP-tacrolimus (ENVARSUS XR®) is approved for the prevention of transplant rejection in adult liver allograft recipients. It has demonstrated similar outcomes compared to immediate-release tacrolimus BID, in both kidney and liver transplantation. Mycophenolate has only been approved for BID administration, preventing from taking all immunosuppressive drugs once daily. Yet, single daily dosing would probably contribute to better adherence and quality of life in patients receiving a life-long treatment.
Although the half-life of mycophenolic acid (MPA), the active moiety of mycophenolate mofetil (MMF) is compatible with once-daily administration, no published randomized clinical study has ever evaluated the efficacy and safety of MMF administered QD.
The narrow therapeutic index and wide pharmacokinetic variability of tacrolimus and mycophenolate justify individual dose adjustment by means of therapeutic drug monitoring (TDM), in order to minimize the risk of acute rejection and the occurrence of adverse events. For tacrolimus, TDM is generally based on the trough concentration (C0) and sometimes on the area under the concentration-time curve (AUC), while for mycophenolate it should be based on the AUC of MPA. However, the dose adjustment of MMF in liver transplant patients is most of the time performed a posteriori, based on clinical signs of inefficacy of toxicity.
Limited sampling strategies with maximum a posteriori Bayesian estimation have been developed by our team for both molecules in adult liver transplant patients to estimate their AUC, which is considered the best marker of exposure for both. Therefore, tacrolimus AUC0-24h can be estimated by Bayesian estimation using samples collected before administration (C0), 8 (C8h) and 12 (C12h) hours after the administration of ENVARSUS XR®, or 1 and 3 hours after the administration of PROGRAF® and ADVAGRAF®. For mycophenolate, the MPA AUC can be estimated using samples collected 20 min, 1 and 3 hours after MMF administration, by Bayesian estimation.
Even if limited to 2 or 3 blood samples, tacrolimus TDM for ENVARSUS® requires late sampling (12h post-dose). To overcome the necessity of a longer hospital stay, microsampling devices (MSD) such as the Volumetric absorptive microsampling (VAMS®) device (Mitra®) can be used by the patients to take samples themselves, at home. Moreover, they are less invasive than venipuncture and collect low but accurate volumes of blood for analysis.
In this context, we propose a randomized controlled non-inferiority study to demonstrate that in liver transplant recipients, an immunosuppressive strategy based on single daily doses of LCP-tacrolimus (ENVARSUS XR®) and mycophenolate mofetil (CELLCEPT®) started at M6 post-transplantation is not inferior to XR-tacrolimus (ADVAGRAF®) and MMF administered BID, in terms of incidence of treatment failure (see below) at the end of the first year after transplantation, and to obtain adherence, quality of life and safety data. In order to compare solely MMF QD to MMF BID, patients on ENVARSUS XR® and MMF QD will be compared to a third group of patients receiving ENVARSUS XR® and MMF BID. A direct comparison of efficacy and safety, quality of life, adherence and exposure indices will be performed between ENVARSUS XR® and ADVAGRAF®.

Start Date01 Jul 2024

Sponsor / Collaborator

Centre Hospitalier Universitaire de Limoges

100 Clinical Results associated with Mycophenolate Mofetil

100 Translational Medicine associated with Mycophenolate Mofetil

100 Patents (Medical) associated with Mycophenolate Mofetil

15,191

Literatures (Medical) associated with Mycophenolate Mofetil

01 Apr 2024·Journal of ethnopharmacology

Efficacy and safety of Shenqi Dihuang decoction for lupus nephritis: A systematic review and meta-analysis

Review

Author: Li, Dan ; Lai, Honghao ; Deng, Xiyuan ; Pan, Bei ; Ma, Ning ; Wang, Xiaoman ; Ge, Long ; Yang, Kehu ; Niu, Junqiang

ETHNOPHARMACOLOGICAL RELEVANCE:

Lupus Nephritis (LN) is a serious complication of systemic lupus erythematosus (SLE). However, the treatment of lupus nephritis using traditional Chinese medicine remains controversial.

AIM OF THE STUDY:

To assess the efficacy and safety of Shenqi Dihuang decoction in the treatment of LN and review the clinical guidelines.

MATERIALS AND METHODS:

Six databases (China National Knowledge Infrastructure, Wanfang, PubMed, China Biology Medicine, the Cochrane Library, and Embase) were searched from their inception to September 10, 2022, for randomized controlled trials on the treatment of lupus nephritis using Shenqi Dihuang decoction. We conducted a meta-analysis of random effects using Review Manager 5.4 and assessed the certainty of evidence using the Grading of Recommendations Assessment, Development, and Evaluation approach.

RESULTS:

A total of 15,790 citations were identified, from which 14 eligible randomized controlled trials that enrolled 1002 participants were selected for this systematic review. Low-to-moderate certainty of evidence indicated that when compared with Western medicine, Shenqi Dihuang decoction combined with Western medicine was associated with favorable effects on clinical efficacy (risk ratio (RR) = 1.25, 95% confidence interval (CI): 1.15-1.37), vascular endothelial growth factor (mean difference (MD) = -30.90, 95% CI: -40.18 to -21.63), serum level (MD = -4.81 μmol L^-1, 95% CI: -17.14 to 7.53), complement C3 (MD = -0.14 g L^-1, 95% CI: -0.23 to -0.04), erythrocyte sedimentation rate (MD = -11.87 mm h^-1, 95% CI: -22.01 to -1.73), and SLE disease activity score (MD = -3.38, 95% CI: -4.15 to -2.61), and exhibited a lower risk of infection (RR = 0.2, 95% CI: 0.05-0.90), gastrointestinal reaction (RR = 0.47, 95% CI: 0.17-1.28), and insomnia (RR = 0.29, 95% CI: 0.09-0.92).

CONCLUSIONS:

This systematic review provides a potential reference for understanding the efficacy and safety of Shenqi Dihuang decoction combined with Western medicine for treating patients with lupus nephritis. However, owing to the limited quality of the studies included in this review, lack of mycophenolate mofetil control, and high heterogeneity among the included studies, the current findings should be interpreted with caution. Therefore, the efficacy and safety of Shenqi Dihuang decoction in patients with PN still require further verification through future high-quality clinical studies.

01 Mar 2024·Transplantation

A Pilot Randomized Controlled Trial of De Novo Belatacept-based Immunosuppression After Lung Transplantation

Article

Author: Vazquez-Guillamet, Rodrigo ; Schechtman, Kenneth ; Nava, Ruben ; Goodarzi, Ahmad ; Halverson, Laura ; Puri, Varun ; Dore, Peter ; Hachem, Ramsey R ; Byers, Derek E ; Bernadt, Cory ; Kreisel, Daniel ; Youssef, J Georges ; Mitter, Brigitte ; Witt, Chad A ; Yau, Simon ; Askar, Medhat ; Gelman, Andrew E ; Huang, Howard J

Background.:

Chronic lung allograft dysfunction (CLAD) is the leading cause of death beyond the first year after lung transplantation. The development of donor-specific antibodies (DSA) is a recognized risk factor for CLAD. Based on experience in kidney transplantation, we hypothesized that belatacept, a selective T-cell costimulatory blocker, would reduce the incidence of DSA after lung transplantation, which may ameliorate the risk of CLAD.

Methods.:

We conducted a pilot randomized controlled trial (RCT) at 2 sites to assess the feasibility and inform the design of a large-scale RCT. All participants were treated with rabbit antithymocyte globulin for induction immunosuppression. Participants in the control arm were treated with tacrolimus, mycophenolate mofetil, and prednisone, and participants in the belatacept arm were treated with tacrolimus, belatacept, and prednisone through day 89 after transplant then converted to belatacept, mycophenolate mofetil, and prednisone for the remainder of year 1.

Results.:

After randomizing 27 participants, 3 in the belatacept arm died compared with none in the control arm. As a result, we stopped enrollment and treatment with belatacept, and all participants were treated with standard-of-care immunosuppression. Overall, 6 participants in the belatacept arm died compared with none in the control arm (log rank P = 0.008). We did not observe any differences in the incidence of DSA, acute cellular rejection, antibody-mediated rejection, CLAD, or infections between the 2 groups.

Conclusions.:

We conclude that the investigational regimen used in this pilot RCT is associated with increased mortality after lung transplantation.

01 Mar 2024·Environmental research

Quantitative risk ranking of mycotoxins in milk under climate change scenarios

Article

Author: Nag, Rajat ; Cummins, Enda ; Chhaya, Rhea Sanjiv

Mycotoxins are toxic fungal metabolites that may occur in crops. Mycotoxins may carry-over into bovine milk if bovines ingest mycotoxin-contaminated feed. Due to climate change, there may be a potential increase in the prevalence and concentration of mycotoxins in crops. However, the toxicity to humans and the carry-over rate of mycotoxins from feed to milk from bovines varies considerably. This research aimed to rank emerging and existing mycotoxins under different climate change scenarios based on their occurrence in milk and their toxicity to humans. The quantitative risk ranking took a probabilistic approach, using Monte-Carlo simulation to take account of input uncertainties and variabilities. Mycotoxins were ranked based on their hazard quotient, calculated using estimated daily intake and tolerable daily intake values. Four climate change scenarios were assessed, including an Irish baseline model in addition to best-case, worst-case, and most likely scenarios, corresponding to equivalent Intergovernmental Panel on Climate Change (IPCC) scenarios. This research prioritised aflatoxin B₁, zearalenone, and T-2 and HT-2 toxin as potential human health hazards for adults and children compared to other mycotoxins under all scenarios. Relatively lower risks were found to be associated with mycophenolic acid, enniatins, and deoxynivalenol. Overall, the carry-over rate of mycotoxins, the milk consumption, and the concentration of mycotoxins in silage, maize, and wheat were found to be the most sensitive parameters (positively correlated) of this probabilistic model. Though climate change may impact mycotoxin prevalence and concentration in crops, the carry-over rate notably affects the final concentration of mycotoxin in milk to a greater extent. The results obtained in this study facilitate the identification of risk reduction measures to limit mycotoxin contamination of dairy products, considering potential climate change influences.

News (Medical) associated with Mycophenolate Mofetil

14 Jun 2024

·www.biospace.com

Cabaletta Bio Reports Positive Initial Clinical Data from Phase 1/2 RESET-Myositis™ and RESET-SLE™ Trials of CABA-201

No CRS, ICANS, infections or serious adverse events observed in either of the first two patients through data cut-off of May 28, 2024 CABA-201 exhibited anticipated pro CAR T cell expansion and contraction with complete B cell depletion observed in both patients by day 15 post-infusion Improvements in both patients’ specific disease measures, consistent with academic experience of a similar 4-1BB CD19-CAR T, suggest emerging clinical benefit with CABA-201 while discontinuing all disease-specific therapies other than a planned steroid taper in one patient Immature, naïve B cell repopulation in first IMNM patient observed at week 8 consistent with a potential immune system reset 18 sites open and recruiting across four Phase 1/2 RESET™ trials with 5 patients enrolled as of June 12, 2024; initial clinical and translational data support continued development of CABA-201 at the current dose Company to host live investor conference call and webcast today at 8:00 a.m. ET PHILADELPHIA, June 14, 2024 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases, today reported positive initial clinical data from each of the first two patients dosed with CABA-201 in the Phase 1/2 RESET-Myositis and RESET-SLE trials. These data will be presented today at 8:15 a.m. CEST (2:15 a.m. ET) at a EULAR European Congress of Rheumatology 2024 Industry Symposia session titled “Immune Reset: The Potential of CAR T Cell Therapy to Transform the Treatment of Patients with Autoimmune Disease” in Vienna, Austria. Slides from the presentation can be found on the company’s website here. “We are encouraged by the initial safety, clinical and translational data from the RESET-Myositis and RESET-SLE trials which we believe provide important early validation regarding the potential of the selected clinical dose of CABA-201 to enable an immune system reset for patients with autoimmune diseases. By demonstrating a potentially well-tolerated safety pro with initial clinical and translational data consistent with the academic experience of a similar 4-1BB CD19-CAR T construct, we believe CABA-201 may be uniquely positioned to fulfill unmet patient needs across a broad range of autoimmune diseases,” said David J. Chang, M.D., Chief Medical Officer of Cabaletta. “With the RESET-SSc™ and RESET-MG™ trials recently opening for enrollment, an additional cohort evaluating patients with juvenile myositis incorporated into the RESET-Myositis trial and the momentum provided by the promising early clinical data, we are looking forward to accelerating clinical trial enrollment in the RESET clinical program. We continue to expect to report initial clinical data from the Phase 1/2 RESET-SSc and RESET-MG trials as well as additional data from the RESET-Myositis and RESET-SLE trials in the second half of this year.” Cabaletta designed CABA-201, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy, to deeply and transiently deplete CD19-positive B cells following a one-time infusion that may enable a reset of the immune system with the potential for durable remission without chronic therapy in patients with autoimmune diseases. Cabaletta is advancing four Phase 1/2 RESET trials evaluating CABA-201 within a total of ten cohorts with six patients in each cohort. All cohorts are evaluating the same single, weight-based dose of 1 x 106 cells/kg, following a preconditioning regimen of fludarabine and cyclophosphamide consistent with the dosing regimen used in the academic experience, without a dose escalation requirement. As of May 28, 2024, the data cut-off date, one patient treated in the immune-mediated necrotizing myopathy (IMNM) cohort in the RESET-Myositis trial had completed three months of follow-up and one patient enrolled in the systemic lupus erythematosus (SLE) non-renal cohort in the RESET-SLE trial had completed one month of follow-up. The patient with IMNM is a 33-year-old male with a two-year history of disease, positive for anti-SRP antibody and who had prior disease-specific therapy that included IVIg, rituximab, methotrexate and glucocorticoids. The patient with SLE is a 26-year-old male with a six-year history of disease, positive for anti-dsDNA antibody and who had prior disease specific therapy that included cyclophosphamide, voclosporin, belimumab, tacrolimus, mycophenolate mofetil, hydroxychloroquine and glucocorticoids. Both patients were administered a one-time infusion of CABA-201 at 1 x 106 cells/kg, following a preconditioning regimen of fludarabine and cyclophosphamide. The primary endpoint of each trial is safety and tolerability within 28 days of infusion. Secondary endpoints include translational assessments and clinical outcomes. Initial Clinical Data Summary Safety and Tolerability CABA-201 was administered during a four-day hospital stay, as currently required by the protocol, and was generally well-tolerated with no serious adverse events reported for either patient through the follow-up period. No evidence of cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) of any grade was observed for either patient through the follow-up period. Tocilizumab was not administered for either patient. No infections were observed for either patient through the follow-up period. All chronic maintenance therapy or concomitant medications were discontinued for both patients through the follow-up period, other than a planned prednisone taper for the SLE patient. Clinical and Translational Pro > Complete B cell depletion was observed within 15 days post-infusion with CABA-201 in both patients. Both patients had early, transient leukopenia, as expected with the preconditioning regimen. CAR T cell expansion associated with CABA-201 reached its peak magnitude at day 15 post-infusion in both patients and the magnitude of expansion was consistent with the academic experience with a similar 4-1BB CD19-CAR T construct. At week 12 of follow-up for the IMNM patient, the data show a decline in creatinine kinase from 617 at infusion to 308 and a total improvement score (TIS) of 30, which is consistent with the clinically meaningful improvement seen in the academic experience of a similar 4-1BB CD19-CAR T construct that also recently reported data from an IMNM patient. At week 4 of follow-up for the SLE patient, the data demonstrated an improvement in the SLEDAI-2K (systemic lupus erythematosus disease activity index) score from 26 at baseline to 10. B cell repopulation was observed in the IMNM patient at week 8 with immature, naïve B cell phenotypes as demonstrated by flow cytometry, suggesting potential immune system reset with confirmatory analyses ongoing. Investor Conference Call and Webcast Information Cabaletta will host a conference call and webcast today, June 14, 2024, at 8:00 a.m. ET to review the initial clinical data presented at the satellite symposium at the EULAR 2024 Congress and provide an update on the RESET clinical development program. A webcast of the live call can be accessed on the News and Events section of the Company’s website at . An archived replay will be available on the Company’s website. About the RESET-Myositis™ Trial The RESET-Myositis™ trial is a Phase 1/2 open-label study of CABA-201 in subjects with active idiopathic inflammatory myopathy (IIM, or myositis), including the subtypes of dermatomyositis (DM), anti-synthetase syndrome (ASyS), immune-mediated necrotizing myopathy (IMNM) and juvenile myositis (JM), each evaluated in individual cohorts. Subjects will receive a one-time infusion of CABA-201 at a dose of 1 x 106 cells/kg, following a preconditioning regimen of fludarabine and cyclophosphamide. Key inclusion criteria for the DM, ASyS and IMNM cohorts include patients between ages 18 to 75 (inclusive), evidence of active disease and disease activity despite prior or current treatment with standard of care treatments. Key exclusion criteria for the DM, ASyS and IMNM cohorts include cancer-associated myositis, significant lung or cardiac impairment, treatment with a B cell depleting agent within the prior approximately six months or treatment with a biologic agent within the prior approximately three months. About the RESET-SLE™ Trial The RESET-SLE™ trial is a Phase 1/2 open-label study of CABA-201 in subjects with systemic lupus erythematosus (SLE) and lupus nephritis (LN), each evaluated in individual cohorts. Subjects will receive a one-time infusion of CABA-201 at a dose of 1 x 106 cells/kg, following a preconditioning regimen of fludarabine and cyclophosphamide. Key inclusion criteria include patients between ages 18 to 65 (inclusive), evidence of active disease and disease activity despite prior or current treatment with standard of care treatments. Key exclusion criteria include treatment with a B cell depleting agent within the prior approximately six months or treatment with a biologic agent within the prior approximately three months. About CABA-201 CABA-201 is designed to deeply and transiently deplete CD19-positive cells following a one-time infusion, which may enable an “immune system reset” with the potential for durable remission without chronic therapy in patients with autoimmune diseases. Cabaletta is evaluating CABA-201 in multiple autoimmune conditions within five disease-specific company sponsored INDs including myositis (idiopathic inflammatory myopathy, or IIM), systemic lupus erythematosus (SLE), systemic sclerosis (SSc), generalized myasthenia gravis (gMG) and pemphigus vulgaris (PV; a sub-study to evaluate CABA-201 without preconditioning). About Cabaletta Bio Cabaletta Bio (Nasdaq: CABA) is a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies that have the potential to provide a deep and durable, perhaps curative, treatment for patients with autoimmune diseases. The CABA™ platform encompasses two strategies: the CARTA (chimeric antigen receptor T cells for autoimmunity) strategy, with CABA-201, a 4-1BB-containing fully human CD19-CAR T, as the lead product candidate being evaluated in the RESET™ (REstoring SElf-Tolerance) clinical trials in systemic lupus erythematosus, myositis, systemic sclerosis and generalized myasthenia gravis and in the RESET-PV™ sub-study within the DesCAARTes™ clinical trial in pemphigus vulgaris, along with the CAART (chimeric autoantibody receptor T cells) strategy, with multiple clinical-stage candidates, including DSG3-CAART for mucosal pemphigus vulgaris and MuSK-CAART for MuSK-associated myasthenia gravis. The expanding CABA™ platform is designed to develop potentially curative therapies that offer deep and durable responses for patients with a broad range of autoimmune diseases. Cabaletta Bio’s headquarters and labs are located in Philadelphia, PA. Forward-Looking Statements This press release contains “forward-looking statements” of Cabaletta Bio within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including without limitation, express or implied statements regarding: Cabaletta’s ability to grow its autoimmune pipeline; Cabaletta’s future plans and strategies for its CAAR T and CARTA technologies and the company’s business plans and objectives as a whole; Cabaletta’s expectations around the potential safety and therapeutic benefits of CABA-201, including its belief that CABA-201 may enable an “immune system reset” with the potential for durable remission without chronic therapy in patients with autoimmune diseases; the Company’s advancement of separate Phase 1/2 clinical trials of CABA-201 in patients with SLE, myositis, SSc and gMG and advancement of a RESET-PV sub-study within the ongoing DesCAARTes trial in PV, including the Company’s expectations for the efficiency of the trial designs and updates related to status, safety data, or otherwise and the expected timing of the related data read-outs; Cabaletta’s ability to accelerate its pipeline, develop meaningful therapies for patients and leverage its research and translational insights; the clinical significance of the initial clinical data read-out at the EULAR 2024 Congress in June 2024 for patients with myositis and SLE treated with CABA-201; Cabaletta’s additional planned initial clinical data read-outs for patients with SSc and gMG treated with CABA-201 or otherwise; Cabaletta’s advancement of the process to activate clinical trial sites and pursue patient enrollment; and Cabaletta’s planned assessment of its DesCAARTes™ and MusCAARTes™ trials. 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. These risks and uncertainties include, but are not limited to: risks related to regulatory filings and potential clearance; the risk that signs of biologic activity or persistence may not inform long-term results; Cabaletta’s ability to demonstrate sufficient evidence of safety, efficacy and tolerability in its preclinical studies and clinical trials of CABA-201; the risk that the results observed with the similarly-designed construct employed in academic publications, including due to the dosing regimen, are not indicative of the results we seek to achieve with CABA-201; risks related to clinical trial site activation, delays in enrollment generally or enrollment rates that are lower than expected; delays related to assessment of clinical trial results; risks related to unexpected safety or efficacy data observed during clinical studies; risks related to volatile market and economic conditions and public health crises; Cabaletta’s ability to retain and recognize the intended incentives conferred by Orphan Drug Designation and Fast Track Designation or other designations for its product candidates, as applicable; risks related to Cabaletta’s ability to protect and maintain its intellectual property position; risks related to fostering and maintaining successful relationships with Cabaletta’s collaboration and manufacturing partners, including in light of recent legislation; uncertainties related to the initiation and conduct of studies and other development requirements for its product candidates; the risk that any one or more of Cabaletta’s product candidates will not be successfully developed and/or commercialized; and the risk that the initial or interim results of preclinical studies or clinical studies will not be predictive of future results in connection with future studies. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause Cabaletta’s actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in Cabaletta’s most recent annual report on Form 10-K as well as discussions of potential risks, uncertainties, and other important factors in Cabaletta’s other filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Cabaletta undertakes no duty to update this information unless required by law. Contacts: Anup Marda Chief Financial Officer investors@cabalettabio.com William Gramig Precision AQ william.gramig@precisionaq.com

Clinical ResultImmunotherapyCell TherapyOrphan DrugFast Track

13 Jun 2024

·www.prnewswire.com

Antiva Biosciences Announces Formation of Scientific and Development Advisory Board

Board Consists of Distinguished Thought Leaders with Clinical Expertise Spanning Women's Health and Virology, Combined with Successful Drug Development and Commercialization Experience REDWOOD CITY, Calif., June 13, 2024 /PRNewswire/ -- Antiva Biosciences, a biopharmaceutical company developing novel, topical therapeutics for the treatment of high-risk infections and pre-cancerous lesions caused by human papilloma virus (HPV) in women, today announced the formation of a scientific and development advisory board featuring distinguished thought leaders from both academia and industry with clinical expertise spanning the fields of women's health and virology. Additionally, several inaugural members of this advisory board possess deep experience in drug discovery and development, including launch and commercialization of novel therapeutics. The newly formed scientific and development advisory board will provide Antiva with key scientific and clinical guidance to support its continued development of ABI-2280, a topical treatment for high-grade cervical intraepithelial neoplasia (HSIL, CIN 2,3) and for women with high-risk HPV infection. "We have been fortunate to establish a scientific and development advisory team comprised of distinguished scientists, clinicians and seasoned drug developers from world renowned academic institutions and industry. Their expertise will be invaluable as we work to develop ABI-2280 as the first approved drug treatment for HPV infection and pre-cancerous lesions caused by the infection," said Kristine Ball, chief executive officer of Antiva. "We will look to these thought leaders to provide strategic input and guidance into the scientific and clinical direction of our ABI-2280 program, helping us build a development path to regulatory approval where one does not yet exist." Antiva is currently enrolling patients in two phase 1/2 clinical studies of ABI-2280 for the treatment of high-grade cervical intraepithelial neoplasia (CIN 2,3) and for the treatment for high-risk HPV infection in genotypes that can lead to cancer. ABI-2280 has potent activity across all genotypes of HPV and works by blocking HPV replication and inducing apoptosis in HPV-infected cells. Antiva has leveraged its development expertise to formulate a vaginal insert of ABI-2280 that will enable self-administration at diagnosis and facilitate worldwide distribution, increasing potential impact for patients. The company's inaugural scientific and development advisory board members include: Constance A. Benson, M.D. Dr. Benson is an internationally recognized clinical and translational investigator whose current areas of research include drug development and clinical trials for a host of the most pressing needs within the virology field. She is a Professor of Medicine and Vice Chair for Education in the Division of Infectious Diseases and Global Public Health at the University of California, San Diego (UCSD), where she also serves as Co-Director of the UCSD Antiviral Research Center. In addition, she is a regulatory and product development consultant for NDA Partners, a ProPharma Company. Prior to her tenure at UCSD, Dr. Benson served on the faculties of Rush University School of Medicine and the University of Colorado School of Medicine, as well as three years of active duty in the U.S. Navy as an internist. She has mentored or co-mentored more than 100 medical students, residents, post-graduate research fellows and junior faculty engaged in infectious diseases research and has more than 300 publications to her name. J. Thomas Cox, M.D. Dr. Cox is an OB/GYN with broad-ranging expertise on human papillomavirus (HPV) and the clinical management of women with abnormal cervical cytology and HPV-induced precancer. He is Past President of the American Society for Colposcopy and Cervical Pathology (ASCCP) and previously served as Chair of the ASCCP Practice Committee, which wrote the first U.S. guidelines for the management of women with abnormal cervical cytology. He has testified before Congress twice as an expert on HPV and has served on many national committees including every Gardasil HPV vaccine data safety monitoring board since 2002 and multiple American Cancer Society expert advisory boards on HPV and gynecologic cancer. Dr. Cox has published over 90 articles and chapters on HPV and cervical disease and co-authored/co-edited the medical textbook Modern Colposcopy. In 2023 he received the ASCCP Lifetime Achievement Award. William "Bill" Lee, Ph.D. Dr. Lee has over 37 years of experience in the pharmaceutical industry. His most recent role was as executive vice president of research at Gilead Sciences, where he oversaw the company's research and preclinical programs across therapeutic areas. Earlier in his career at Gilead, Dr. Lee headed up all chemistry, manufacturing and controls (CMC) activities, including commercial manufacturing through the launch of Viread in 2001. During his 30-year tenure at Gilead, he was involved in the discovery, development and launch of 18 commercial products. Before joining Gilead, he served as head of drug delivery at California Biotechnology and prior to that, as a scientist at Syntex Research. Dr. Lee is co-inventor of Cellcept, Viread and Vemlidy (TAF). Richard Whitley, M.D. Dr. Whitley is a highly regarded expert on antiviral therapies in both pediatric and adult patients. He currently serves as the Distinguished Professor of Pediatrics, Vice Chairman for Research in the Department of Pediatrics and Co-Division Director of Pediatric Infectious Diseases at the University of Alabama at Birmingham School of Medicine. His research spans four decades, during which he has published more than 400 scientific papers on pediatric infectious disease. In 2019, Dr. Anthony Fauci appointed Dr. Whitley to chair the NIH-NIAID COVID-19 Data Safety and Monitoring Board. Today, he continues to serve as a member of the Steering Committee for the NIH Long COVID-RECOVER initiative. He was named the inaugural recipient of the Distinguished Clinical Research Scholar and Educator in Residence at the NIH Clinical Center and received the 2020 National Foundation for Infectious Diseases John P. Utz Leadership Award for his work in the field of clinical virology. Thomas C. Wright, Jr. M.D. Dr. Wright is a Professor Emeritus at Columbia University and is involved in a variety of clinical trials focusing primarily on the development of diagnostic and risk-assessment tests for cervical disease both in the U.S. and low resource settings. He previously served as the Director of the Division of Gynecologic, Perinatal, and Cytologic Pathology at Columbia University Medical Center and headed the colposcopy services at New York Presbyterian Hospital for over 15 years. He is a Past President of the American Society of Colposcopy and Cervical Pathology (ASCCP) and was the lead author of the 2001 and 2007 ASCCP Consensus Guidelines for the Management of Cytologic Abnormalities. In addition to clinical research, Dr. Wright is in active clinical practice as a gynecological pathologist at Labcorp. He has published over 250 articles and chapters on HPV and cervical disease. About HPV-Related Diseases and Cervical Cancer Human Papilloma Virus (HPV) is so common that nearly all sexually active men and women are infected with the virus at some point in their lives. Many of these are transient infections the body is capable of clearing, but this typically takes months to years. When the infections persist, they are known to drive the formation of malignancies, including cervical, anal, vulvar, penile, and head and neck cancers. The introduction of prophylactic vaccines for HPV was a major step forward in the fight against HPV-associated cancers by preventing infection by certain high-risk HPV subtypes. However, due to low adoption rates in major countries such as the US, EU, and Japan, and limited access to the vaccines in developing countries, HPV infections and the disease states driven by such infections remain a major unmet clinical need. Globally, cervical cancer is the fourth most common cancer in women and as such represents a major public health problem. According to the World Health Organization, an estimated 660,000 women were diagnosed with cervical cancer worldwide and approximately 350,000 women died from the disease in 2022. About Antiva Biosciences Antiva Biosciences, Inc. is a clinical-stage biopharmaceutical company developing novel, topical therapeutics for the treatment of diseases caused by HPV infection. The company's lead drug candidate, ABI-2280 is being developed as a topical treatment for high-grade cervical intraepithelial neoplasia (HSIL, CIN 2,3) and for women with high-risk HPV infection. For more information, please visit: . Contact Information: SOURCE Antiva Biosciences, Inc.

Executive ChangeVaccine

05 Jun 2024

·www.biospace.com

Aurinia Presents Safety and Efficacy Profile of LUPKYNIS® for People with Lupus Nephritis at European Alliance of Associations for Rheumatology (EULAR) Congress 2024

ROCKVILLE, Md. & EDMONTON, Alberta--(BUSINESS WIRE)-- Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company), today announced an oral presentation at the European Alliance of Associations for Rheumatology (EULAR) 2024 taking place in Vienna, Austria June 12-15. The data reinforces previous findings from the AURORA Clinical Program on the safety and effectiveness of LUPKYNIS® (voclosporin), a second generation calcineurin inhibitor (CNI), for the treatment of adult patients with active lupus nephritis (LN). A propensity analysis comparing the pooled AURA-LV and AURORA 1 studies to the Aspreva Lupus Management Study (ALMS) suggested that a triple immunosuppressive therapy regimen of LUPKYNIS plus lower-dose MMF and low-dose steroids (≤2 g/day) resulted in earlier and greater reductions in proteinuria, reduced cumulative steroid exposure, and demonstrated comparable rates of overall adverse events, compared to dual immunosuppressive therapy regimens combining high-dose glucocorticoids with either higher doses of MMF or cyclophosphamide. Safety and efficacy outcomes for propensity-matched patients with active LN from ALMS and AURA-LV/AURORA 1 were assessed at three and six months. Patients who received the LUPKYNIS-based regimen showed >50% reduction in steroid exposure at six months and more frequently achieved a urine protein creatinine ratio (UPCR) of <0.5 mg/mg in a faster median time as compared to the high-dose two drug regimen. These patients also achieved >50% UPCR reduction at any time point in the study significantly earlier than their propensity-matched counterparts in ALMS. These findings support guideline recommendations that LUPKYNIS plus lower-dose MMF and low-dose steroids should be considered as an initial therapy in patients with active LN. Results from this study were also recently presented at the annual European Renal Association Congress 2024. About Lupus Nephritis Lupus nephritis (LN) is a serious manifestation of systemic lupus erythematosus (SLE), a chronic and complex autoimmune disease. LN affects approximately 120,000 people in the U.S. and disproportionately affects women and people of color. People living with LN have high unmet needs and often face significant barriers to optimal care. If poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney. Medical guidelines recommend that all SLE patients receive routine LN screenings at every visit. Guidelines also note that delaying LN diagnosis has profound prognostic repercussions. Yet, research shows that approximately 50% of SLE patients are not screened for LN and 77% of people with LN go untreated. Aurinia is committed to improving health outcomes for people living with LN by educating patients and providers on the critical need for routine screening and transformative therapies that can help improve health outcomes. About LUPKYNIS LUPKYNIS (voclosporin) is the first U.S. Food and Drug Administration and European Commission approved oral medicine for the treatment of adult patients with active lupus nephritis (LN). LUPKYNIS is a second generation calcineurin inhibitor (CNI) with a dual mechanism of action, acting as an immunosuppressant through inhibition of T-cell activation and cytokine production and promoting podocyte stability in the kidney. The AURORA Clinical Program, comprised of the AURORA 1 pivotal trial and AURORA 2 extension trial, demonstrated the importance of LUPKYNIS plus standard of care to preserve kidney health in patients with active LN without reliance on chronic high-dose glucocorticoids. It is the only clinical program to include three years of LN treatment and follow-up with mycophenolate mofetil (MMF) and steroids. About Aurinia Aurinia Pharmaceuticals is a fully integrated biopharmaceutical company focused on delivering therapies to people living with autoimmune diseases with high unmet medical needs. In January 2021, the Company introduced LUPKYNIS (voclosporin), the first FDA-approved oral therapy dedicated to the treatment of adult patients with active lupus nephritis. The Company’s head office is in Edmonton, Alberta, its U.S. commercial office is in Rockville, Maryland. The Company focuses its development efforts globally. INDICATION AND IMPORTANT SAFETY INFORMATION INDICATION LUPKYNIS is indicated in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active LN. Limitations of Use: Safety and efficacy of LUPKYNIS have not been established in combination with cyclophosphamide. Use of LUPKYNIS is not recommended in this situation. IMPORTANT SAFETY INFORMATION BOXED WARNINGS: MALIGNANCIES AND SERIOUS INFECTIONS Increased risk for developing malignancies and serious infections with LUPKYNIS or other immunosuppressants that may lead to hospitalization or death. CONTRAINDICATIONS: LUPKYNIS is contraindicated in patients taking strong CYP3A4 inhibitors because of the increased risk of acute and/or chronic nephrotoxicity, and in patients who have had a serious/severe hypersensitivity reaction to LUPKYNIS or its excipients. WARNINGS AND PRECAUTIONS Lymphoma and Other Malignancies: Immunosuppressants, including LUPKYNIS, increase the risk of developing lymphomas and other malignancies, particularly of the skin. The risk appears to be related to increasing doses and duration of immunosuppression rather than to the use of any specific agent. Serious Infections: Immunosuppressants, including LUPKYNIS, increase the risk of developing bacterial, viral, fungal, and protozoal infections, including opportunistic infections. This may lead to serious, even fatal, outcomes. Nephrotoxicity: LUPKYNIS, like other calcineurin inhibitors (CNIs), may cause acute and/or chronic nephrotoxicity. The risk is increased if administered with drugs associated with nephrotoxicity. Monitor eGFR regularly. Hypertension: Hypertension is a common adverse reaction of LUPKYNIS therapy that may require antihypertensive therapy. Monitor blood pressure regularly. Neurotoxicity: LUPKYNIS, like other CNIs, may cause neurotoxicities that if severe can include posterior reversible encephalopathy syndrome, delirium, seizure, and coma; others include tremor, paresthesia, headache, and changes in mental status and/or motor and sensory functions. Monitor for neurologic symptoms. Hyperkalemia: Hyperkalemia, which may be serious and require treatment, has been reported. Concomitant use of agents associated with hyperkalemia may increase the risk for hyperkalemia. Monitor serum potassium periodically. QTc Prolongation: LUPKYNIS prolongs the QTc interval in a dose-dependent manner when dosed higher than the recommended lupus nephritis therapeutic dose. The use of LUPKYNIS in combination with other drugs that are known to prolong QTc may result in clinically significant QT prolongation. Immunizations: Avoid the use of live attenuated vaccines during treatment with LUPKYNIS. Inactivated vaccines noted to be safe for administration may not be sufficiently immunogenic during treatment with LUPKYNIS. Pure Red Cell Aplasia: Cases of pure red cell aplasia have been reported in patients treated with another CNI. If PRCA is diagnosed, consider discontinuation of LUPKYNIS. ADVERSE REACTIONS The most common adverse reactions (>3%) were glomerular filtration rate decreased, hypertension, diarrhea, headache, anemia, cough, urinary tract infection, abdominal pain upper, dyspepsia, alopecia, renal impairment, abdominal pain. Drug-Drug Interactions: Avoid co-administration of LUPKYNIS and strong CYP3A4 inhibitors or with strong or moderate CYP3A4 inducers. Co-administration of LUPKYNIS with strong CYP3A4 inhibitors is contraindicated. Reduce LUPKYNIS dosage when co-administered with moderate CYP3A4 inhibitors. Avoid use of LUPKINS with strong or moderate CYP3A4 inducers. SPECIFIC POPULATIONS Pregnancy: Avoid use of LUPKYNIS. Lactation: Consider the benefits and risks of LUPKYNIS and possible risks to the fetus when prescribing LUPKYNIS to a lactating woman. Renal Impairment: LUPKYNIS is not recommended in patients with baseline eGFR ≤45 mL/min/1.73 m2 unless benefit exceeds risk. If used in this population, reduce LUPKYNIS dose. Hepatic Impairment: For mild or moderate hepatic impairment, reduce LUPKYNIS dose. Avoid use with severe hepatic impairment. Please see Prescribing Information, including Boxed Warning, and Medication Guide for LUPKYNIS. References Dall’Era M. et al. Comparison of a Voclosporin-based, Triple Immunotherapy Regimen to High-dose Glucocorticoid-based Immunosuppressive Therapy: A Propensity Analysis of the AURA-LV plus AURORA 1 Studies and ALMS. Presented at the European Alliance of Associations for Rheumatology, 2024, Vienna, Austria. View source version on businesswire.com: Contacts Media and Investor Inquiries: Andrea Christopher Corporate Communications & Investor Relations achristopher@auriniapharma.com ir@auriniapharma.com Source: Aurinia Pharmaceuticals Inc. View this news release online at:

Clinical ResultDrug ApprovalImmunotherapyClinical Study

100 Deals associated with Mycophenolate Mofetil

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KEGG	Wiki	ATC	Drug Bank
D00752	Mycophenolate Mofetil	L04AA06	DB00688

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hematopoietic stem cell transplantation	JP	Chugai Pharmaceutical Co., Ltd.	25 Jun 2021
Lupus Nephritis	JP	Chugai Pharmaceutical Co., Ltd.	13 May 2016
Rejection of pancreas transplant	JP	Chugai Pharmaceutical Co., Ltd.	09 Feb 2005
Cardiac transplant rejection	JP	Chugai Pharmaceutical Co., Ltd.	31 Jan 2003
Liver transplant rejection	JP	Chugai Pharmaceutical Co., Ltd.	31 Jan 2003
Lung transplant rejection	JP	Chugai Pharmaceutical Co., Ltd.	31 Jan 2003
Renal transplant rejection	JP	Chugai Pharmaceutical Co., Ltd.	22 Dec 2000
Graft Rejection	US	Roche Palo Alto LLC	03 May 1995

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Uveitis	Phase 3	US	National Eye Institute	01 Aug 2013
Uveitis	Phase 3	AU	National Eye Institute	01 Aug 2013
Uveitis	Phase 3	IN	National Eye Institute	01 Aug 2013
Uveitis	Phase 3	MX	National Eye Institute	01 Aug 2013
Uveitis	Phase 3	SA	National Eye Institute	01 Aug 2013
Coronary Disease	Phase 3	CA	Hoffmann-La Roche, Inc.	01 Oct 2010
Graft vs Host Disease	Phase 3	US	National Cancer Institute	01 Jun 2009
Hodgkin's Lymphoma	Phase 3	US	National Cancer Institute	01 Jun 2009
Non-Hodgkin Lymphoma	Phase 3	US	National Cancer Institute	01 Jun 2009
Cystitis, Interstitial	Phase 3	US	National Institute of Diabetes & Digestive & Kidney Diseases	01 Mar 2007

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


FDA_CDER Manual	Not Applicable	Renal transplant rejection	491	MYCOPHENOLATE MOFETIL 2 g/day (Europe Study)	imbgusiwok(cokgmjgtar) = imdlyuowvv zbfcrtqfdc (giiarzypys ) View more	Positive	01 May 2024
				MYCOPHENOLATE MOFETIL 3 g/day (Europe Study)	imbgusiwok(cokgmjgtar) = hyrhcqixel zbfcrtqfdc (giiarzypys ) View more
FDA_CDER Manual	Not Applicable	Renal transplant rejection	503	Mycophenolate Mofetil 2g/day (Europe/Canada/ Australia Study)	pwettzxbjs(xxoqpvjfnh) = utcpfgcayk ichqjjtdto (zahhuuqweu ) View more	Positive	01 May 2024
				Mycophenolate Mofetil 3g/day (Europe/Canada/ Australia Study)	pwettzxbjs(xxoqpvjfnh) = lsenbfeglw ichqjjtdto (zahhuuqweu ) View more
FDA_CDER Manual	Not Applicable	Cardiac transplant rejection	650	MYCOPHENOLATE MOFETIL (ITT)	mlnfdlbxrb(ugbpjehlqg) = ymjxolwtie wlmmgccouz (aehtfxvyno ) View more	Positive	01 May 2024
				MYCOPHENOLATE MOFETIL (Treated Patients)	mlnfdlbxrb(ugbpjehlqg) = ebropvsxws wlmmgccouz (aehtfxvyno ) View more
FDA_CDER Manual	Not Applicable	Liver transplant rejection	565	MYCOPHENOLATE MOFETIL	kizrezflyv(isntfdxlgx) = auuwbojerc irzjsczaig (nyzozbduyr ) View more	Positive	01 May 2024
FDA_CDER Manual	Not Applicable	Renal transplant rejection	499	Mycophenolate Mofetil 2g/day (USA Study)	fflhyxajir(fybatrgnrb) = tiitzlyyjm uhsozyeabx (ueahgcfpgo ) View more	Positive	01 May 2024
				Mycophenolate Mofetil 3g/day (USA Study)	fflhyxajir(fybatrgnrb) = zuiuhabgcc uhsozyeabx (ueahgcfpgo ) View more
NCT02251821 (CTgov)	Phase 2	Primary Myelofibrosis	61	Umbilical Cord Blood Transplantation+Fludarabine Phosphate+Busulfan+CYCLOPHOSPHAMIDE+Melphalan+Tacrolimus+Ruxolitinib+mycophenolate mofetil+Methotrexate	frwvfxibxh(bmckipzemj) = dawvgtyyfn wexdsjzsvx (hxekapsyrg, xpqwjgisvc - wihuwrqzdz) View more	-	05 Mar 2024
NCT02441803 (CTgov)	Phase 2	Acute Myeloid Leukemia	11	Stem Cell Infusion+Clofarabine+Fludarabine+Busulfan+Decitabine+cytarabine+Idarubicin (Matched Sibling Donor Group)	ipuzzfsdaj(fdotutdsuz) = reeybnjgrs dbzcudllrl (goayrnhsns, qtlovdynxy - kmzfevvhvq) View more	-	17 Jan 2024
				Stem Cell Infusion+Clofarabine+Fludarabine+Busulfan+Cyclophosphamide+Decitabine+Tacrolimus+mycophenolate mofetil+cytarabine+Idarubicin (Haploidentical Donor Group)	ipuzzfsdaj(fdotutdsuz) = qexpzokqhr dbzcudllrl (goayrnhsns, qgqsgwffjg - umleiqjegt) View more
NCT03959241 (BMT CTN 1703/1801, CTgov)	Phase 3	Philadelphia chromosome positive chronic myelogenous leukemia \| acute leukemia \| Myelodysplastic Syndromes ... View more	431	Tacrolimus/Methotrexate+Tacrolimus+Methotrexate	hpgnriuupr(djnktqjewv) = ovtujfabfd pkbxhuaznt (psfpgfzjju, rfvnkwwsst - hpoiwscfsp) View more	-	12 Jan 2024
NCT01850108 (CTgov)	Not Applicable	Anemia, Sickle Cell	26	Bone marrow transplantation+Mesna+Fludarabine+Thymoglobulin+Sirolimus+Mycophenolate mofetil (MMF)+Cyclophosphamide (CTX)	slhmyedsmo(wlumqpvnzp) = wlaysldufx fphowbrpwi (oneongciur, ffmtogvinr - kberphtmem) View more	-	10 Jan 2024
ASH2023	Not Applicable	Chronic graft-versus-host disease	1,040	PTCy/Tac	rznqzngndg(xzitbicbnk) = rjfmrznkoz xswrxbfilz (lihsfxuszk, 34 - 45)	-	09 Dec 2023
				PTCy/Tac + MMF	rznqzngndg(xzitbicbnk) = xznecxlyph xswrxbfilz (lihsfxuszk, 14 - 29)

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