Lupuzor (rigerimod) / ImmuPharma, Alora Pharma - LARVOL DELTA

ImmuPharma proves unique Mechanism of Action of P140 (Firstwordpharma Press Release) - "ImmuPharma PLC...announces a significant milestone in evidencing the unique mechanism of action ('MOA') of its P140 autoimmune technology platform...Importantly, these new discoveries announced today, in respect to the MOA of P140, highlight that: P140 has a unique MOA: The results provide direct evidence for the first time of a major key hypothesis of the unique MOA of P140; P140 is non-immunosuppressive: Unlike the most advanced therapies currently available for the treatment of autoimmune diseases, these findings indicate that P140 does not reduce or block the body's ability to mount a specific immune response; P140 is effective and safe: These findings confirm P140's potential as a safe and effective treatment for patients suffering from systemic lupus erythematosus (SLE)...These discoveries result from a new preclinical study designed by ImmuPharma Biotech's team and conducted at a world leading Laboratory in the USA."

Preclinical • Systemic Lupus Erythematosus

ImmuPharma hails oversubscribed £2.9m investment round (Proactiveinvestors) - "ImmuPharma PLC...has secured £2.91 million in new funding through an oversubscribed placing and a subscription deal with investor Lanstead Capital...The money will support further development of its P140 autoimmune technology, as well as ongoing discussions with large pharmaceutical companies about potential licensing deals....'Following on from this, we believe that 2025 will be a transformational year for ImmuPharma, with further positive news announcements within the P140 technology platform and a clear focus on securing partnering deals for all the assets across our development portfolio.'"

Financing • Lupus

HOW THERAPEUTIC PEPTIDES WORK IN AUTOIMMUNE DISEASES: P140 PEPTIDE CORRECTS FAILURES IN SECONDARY LYMPHOID ORGANS WITH AN IMPACT ON REMOTE TISSUES (AUTO 2024) - "22:103315. -Talamini L. et al., in preparation"

Asthma • Dental Disorders • Gastroenterology • Gastrointestinal Disorder • Gout • Immunology • Inflammation • Inflammatory Arthritis • Inflammatory Bowel Disease • Lupus • Oncology • Pain • Periodontitis • Pulmonary Disease • Respiratory Diseases • Rheumatology • Sjogren's Syndrome • Systemic Lupus Erythematosus

ImmuPharma says US FDA confirms date for Lupuzor meeting (Market Screener) - "ImmuPharma PLC - London-based drug discovery and development company - Notes the US Food & Drug Administration has set a date of June 7 for a type-C meeting to provide guidance on the phase 2/3 adaptive study of Lupuzor, or P140, in patients with systemic lupus erythematosus, a common type of immune disease lupus. Says this follows the announcement in late March, when it submitted a phase 2/3 clinical trial protocol to the US FDA testing the Lupuzor treatment for lupus patients."

FDA event • Immunology • Systemic Lupus Erythematosus

Immunological and translational key challenges in systemic lupus erythematosus: A symposium update. (PubMed, J Transl Autoimmun) - "Special focus was put on (i) the role played by genes, sex, TLR7, and platelets on SLE pathophysiology; (ii) autoantibodies, urinary proteins, and thrombocytopenia contribution at the time of diagnosis and during follow-up; (iii) neuropsychiatric involvement, vaccine response in the COVID-19 era, and lupus nephritis management at the clinical frontline; and (iv) therapeutic perspectives in patients with lupus nephritis and the unexpected adventure of the Lupuzor/P140 peptide. The multidisciplinary panel of experts further supports the concept that a global approach including basic sciences, translational research, clinical expertise, and therapeutic development have to be prioritized in order to better understand and then improve the management of this complex syndrome."

Journal • Glomerulonephritis • Hematological Disorders • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Novel Coronavirus Disease • Psychiatry • Systemic Lupus Erythematosus • Thrombocytopenia • TLR7

Clinical trials in systemic lupus erythematosus: the dilemma-Why have phase III trials failed to confirm the promising results of phase II trials? (PubMed, Ann Rheum Dis) - "Thus, trials with many drugs against different targets, such as CD22, IL-12 and IL-23 or tyrosine kinases, have been carried out in recent years.A frustrating feature of some of the biologic drugs used to treat SLE has been the reporting of successful phase II trials followed by failures of the phase III trials.In this review, we will focus on phase II and III trials carried out with epratuzumab (anti CD22), baricitinib (Janus kinases inhibitor), rigerimod (P140 peptide) and ustekinumab (IL-12 and IL-23 inhibitor) and consider the reasons for their ultimate failure to 'make the grade'. Likewise, we will try to explain the possible reasons that can influence why good results may be obtained in phase II trials and lead to undue optimism."

Journal • P2 data • P3 data • Review • Glomerulonephritis • Immunology • Inflammation • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Rheumatology • Systemic Lupus Erythematosus • IL12A • IL23A

ImmuPharma reports 'significant' progress since restructure (London South East) - "...'Lupuzor' pharmacokinetic study was on track to deliver results in the first quarter of 2022, and to move into phase 3 after that. It also said a new proprietary synthesis of 'P140', dubbed P140/Lupuzor, had been created, giving greater intellectual property protection and cost efficiencies."

Commercial • New P3 trial • PK/PD data • Immunology • Lupus • Systemic Lupus Erythematosus

FDA approves the Lupuzor (sic) PK study (Immupharma Press Release) - “ImmuPharma…is delighted to announce that the US Food & Drug Administration ('FDA') has approved the commencement of the pharmacokinetic (‘PK’) study, as part of the new optimised international Phase 3 trial of Lupuzor™. The PK study is a Phase I study to assess the presence of Lupuzor™ in the body after administration of a single dose. The study will be carried out in a total of up to 24 healthy male subjects. Dependent on timing of patient recruitment, we anticipate that the PK study will take between 8-12 weeks to complete, from commencement.”

New P1 trial • Immunology • Lupus • Systemic Lupus Erythematosus

ImmuPharma Says FDA Agrees to Written Response for Lupus Treatment Study (Market Watch) - "ImmuPharma PLC said Thursday that the U.S. Food & Drug Administration won't require a face-to-face meeting with its partner Avion Pharmaceuticals over lupus treatment Lupuzor and will provide a written response by the end of July....Company said the FDA will review the proposed methodology of the pharmacokinetic study it requested as part of Lupuzor's international phase 3 trial."

FDA event • Lupus • Systemic Lupus Erythematosus

[VIRTUAL] Efficacy of Biological Agents for the Management of Systemic Lupus Erythematosus: A Systematic Review and Network Meta-Analysis (CRA-AHPA 2021) - "These 20 RCTs investigated the following biologics: belimumab, anifrolumab, ustekinumab, atacicept, baricitinib, blisibimod, epratuzumab, IL-2, lupuzor, PF-04236921, rontalizumab, sifalimumab, and tabalumab... The NMA identified that belimumab, anifrolumab and ustekinumab demonstrated greater response in comparison to placebo, when measured using SRI. This systematic review identified that there was heterogeneity in the outcome measures and endpoints used. In the future, the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach will be applied to rate the quality of the evidence, and to gain insight into methodological pitfalls that could have negatively altered the results of RCTs."

Retrospective data • Review • Complement-mediated Rare Disorders • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Systemic Lupus Erythematosus • IL2

"Global T-cell Surface Glycoprotein CD4 Pipeline Insights 2020: CEL-1000, Forigerimod Acetate, Ibalizumab, M-48U1, MAX-16H5, SAR-441236, TMB-360, TMB-365, & Tregalizumab - https://t.co/guyiBzPH8C https://t.co/HcqgWElC5t" (@NewsFromBW)

Clinical • CD4

Immupharma: The Life Sciences Division’s Dr Malik says shares are ’oversold’ reiterating BUY rating (Proactiveinvestors) - “ImmuPharma recently updated the market on progress within its lupus drug, Lupuzor, following guidance from the FDA as part of a Type A meeting with its licensing partner Avion Pharmaceuticals…Avion and ImmuPharma will develop and validate a bioanalytical assay in order to confirm the unique pharmacokinetic profile of Lupuzor™, known as a PK study….Strong data file ImmuPharma has shared with Avion they be enriching the patient group for the Phase III trial, targeting the most responsive lupus patients, from data taken from the first Phase III trial."

Clinical • Immunology • Lupus • Systemic Lupus Erythematosus

No Conditional US Approval So Far For ImmuPharma Lupus Drug Lupuzor (Morningstar UK) - "ImmuPharma PLC on Tuesday said it has received feedback from the US Food & Drug Administration via Avion Pharmaceuticals...for auto-immune disease Lupus treatment Lupuzor....ImmuPharma and Avion said they have plans to develop and validate a bioanalytical assay to confirm the clinical pharmacology and pharmacokinetic characterisations of Lupuzor, before the phase three trial begins. Further FDA feedback specified that a special protocol assessment will not be applicable, and conditional approval of Lupuzor while the phase three trial is underway has not been confirmed at this time....Avion is planning a final guidance meeting with the FDA in the second quarter of 2021...'start of the phase three study remains on schedule for the second half of 2021...'"

FDA event • New P3 trial • Immunology • Lupus

ImmuPharma Partner To Discuss Progression Of Lupuzor Drug With US FDA (Morningstar UK) - "ImmuPharma PLC on Friday said its licencing partner for Lupuzor, Avion Pharmaceuticals LLC, has a set date for talks with...the FDA on December 4 to discuss the phase three trial of Lupuzor, a potential treatment for auto-immune disease Lupus....Avion will be asking the FDA for guidance on key aspects of the study design, clinical end points and approval process for Lupuzor as well as consideration by the FDA for the conditional approval of Lupuzor while the phase three trial is underway....ImmuPharma shares were up 18% at 12.95 pence each in London on Friday."

FDA event • Stock price • Immunology • Lupus

Update on submission to the FDA for the forthcoming international Phase 3 trial of Lupuzor in Lupus patients (Immupharma Press Release) - "ImmuPharma...announces further regulatory and operational progress for the new optimised international Phase 3 trial of Lupuzor in systemic lupus erythematosus...The FDA has offered to accept submission for a Type ‘A’ Meeting Request...Guidance to be sought by Avion on the new Phase 3 clinical trial...FDA also asked to consider a conditional approval of Lupuzor™, whilst Phase 3 trial underway...Production of new Lupuzor Phase 3 clinical trial material has been initiated."

Commercial • FDA event • NDA • Immunology • Lupus

ImmuPharma pushes ahead with drug research efforts (Proactiveinvestors) - "Signed a licensing deal with a US firm worth US$95mln in milestone payments and carried costs...we are delighted to welcome new and returning institutional and private investors as part of three successful capital raisings. This has created a robust financial position with an anticipated cash runway until the end of 2023....As we move our key asset, Lupuzor into a new international optimised Phase III trial and continue to progress our development pipeline, the investment thesis of ImmuPharma continues to strengthen."

Financing • Licensing / partnership • Immunology • Lupus

In Vivo Remodeling of Altered Autophagy-Lysosomal Pathway by a Phosphopeptide in Lupus. (PubMed, Cells) - "The phosphopeptide P140/Lupuzor, which improves the course of lupus disease in mice and patients, targets chaperone-mediated autophagy (CMA), a selective form of autophagy that is abnormally upregulated in lupus-prone MRL/lpr mice...For the first time, it is demonstrated that by occluding the intralysosome uptake of CMA substrates, a therapeutic molecule can attenuate excessive CMA activity in a pathological pro-inflammatory context and protect against hyperinflammation. This recovery effect of P140 on hyperactivated CMA is not only important for lupus therapy but potentially also for treating other (auto)inflammatory diseases, including neurologic and metabolic disorders, where CMA modulation would be highly beneficial."

Journal • Preclinical • Immunology • Inflammation • Inflammatory Arthritis • Lupus • Metabolic Disorders

ImmuPharma reports reduced losses, eyes further Lupuzor progress (Proactiveinvestors) - "Looking ahead, the firm said it is awaiting final FDA guidance prior to commencing patient recruitment for a Phase III trial of Lupuzor...For the six months ended June 30, the specialist drug discovery firm reported a pre-tax loss of £2.8mln, narrowed from a £3.3mln loss a year ago, while revenues increased to £62,207 from £11,737."

Commercial • Immunology • Lupus

ImmuPharma updates on US FDA Special Protocol Assessment submission for Lupuzor's Phase III trial (Proactiveinvestors) - "In a brief statement, the...company said that, in discussions, Avion Pharmaceuticals, its licensing partner for Lupuzor, has confirmed that, whilst the review period by the FDA for an SPA request is normally up to 45 days - which has now passed - Avion has as yet not received a response from the regulator and as such the file is still in the review queue, due to the current workload at the FDA."

Special Protocol Assessment • Immunology • Lupus

ImmuPharma raises £6.5mln to invest in pipeline of up-and-coming drugs (Proactiveinvestors) - "ImmuPharma...said it has raised £6.5mln via an oversubscribed share placing with the cash earmarked to develop the group's drug pipeline....Lead drug Lupuzor is licensed to Avion Pharmaceuticals in the US, which is funding the final-stage clinical assessment of the lupus treatment."

Commercial • Immunology • Lupus

IN BRIEF: ImmuPharma Partner Avion Submits Request To FDA For Lupuzor (Morningstar UK) - "ImmuPharma's licensing partner, Avion Pharmaceuticals, submitted a special protocol assessment request to the US Food & Drug Administration. ImmuPharma said the review period for such an assessment request was up to 45 days."

FDA event • Immunology • Lupus • Systemic Lupus Erythematosus

ImmuPharma attracts first funding from US healthcare specialists (Proactiveinvestors) - "ImmuPharma PLC...the AIM-listed drug development group, has arranged funding of up to US$6.3mln through two specialist US healthcare investors...including Lupuzor and the partnership with Avion Pharmaceuticals, as we prepare for the start of a new international optimised Phase III trial, in lupus patients...Its lead program is Lupuzor, which is in Phase III trials for the treatment of lupus and might have therapeutic benefit for other autoimmune diseases."

Financing • Lupus

[VIRTUAL] CHAPERONE-MEDIATED AUTOPHAGY IN NORMAL AND ACUTE MYELOID LEUKEMIA GRANULOCYTIC DIFFERENTIATION (EHA 2020) - "To reinforce the data, we took advantage of a CMA targeting therapy, currently in clinical trial to treat systemic lupus erythematosus (SLE), P140/Lupuzor®...Conclusion Altogether, we demonstrated that reduction of CMA activity is necessary for efficient granulocytic differentiation of hematopoietic cells. Therefore, CMA activity may impede AML differentiation and thus participate in maintaining an immature AML phenotype."

Acute Myelogenous Leukemia • Alzheimer's Disease • CNS Disorders • Gene Therapies • Hematological Disorders • Hematological Malignancies • Immunology • Leukemia • Lupus • Movement Disorders • Oncology • Ophthalmology • Parkinson's Disease • Systemic Lupus Erythematosus • CD34 • CSF3 • HSP90AA1 • ITGAM

Completion of Lupuzor pivotal phase III study and initiation of follow up study (Immupharma Press Release) - "ImmuPharma...is pleased to confirm that the ongoing 52-week, randomised, double-blinded, Phase III clinical trial of Lupuzor...is now complete, following the last patient having attended their final assessment. Final patient data from the trial are being collated and entered into the database...top line results remain on track to be reported by the end of Q1 2018...ImmuPharma is initiating a 'follow-up' study permitting eligible patients from the completed Phase III study, to receive Lupuzor...for a further six months in an open-label scheme."

P3 data: top line • Trial completion • Trial initiation date • Immunology • Lupus

Update on Lupuzor pivotal phase III study – full analysis of patient recruitment (Immupharma Press Release) - P3, N=200; NCT02504645; Sponsor: ImmuPharma; "ImmuPharma...is pleased to provide further details of patient participation following confirmation (as announced on 22 December 2016) that the Company had successfully completed, on target, patient recruitment into its pivotal 52-week Phase III clinical trial of Lupuzor...Top line results are estimated to be reported in Q1 2018."

Anticipated P3 data: top line • Enrollment closed • Immunology • Lupus