bertilimumab (iCo-008) / Satellos Biosci, AstraZeneca - LARVOL DELTA

Diffuse Gastrointestinal Amyloidosis in a Patient With Multiple Myeloma (ACG 2024) - "The patient was started on daratumumab, cyclophosphamide, bortezomib, and dexamethasone...Treatment for AL amyloidosis involves autologous stem cell transplant or chemotherapy with bertilimumab, melphalan, and dexamethasone...Figure 3: Microscopic images of biopsied tissue from stomach, small intestine, and colon biopsy 3A) Duodenal biopsy showing extensive amyloid deposition in the mucosa with associated loss of crypts (H and E, original magnification x200) 3B) Congo red stained section of duodenal biopsy showing Congophilia of amyloid deposits in mucosa (Congo red stain, original magnification x100) 3C) Polarization of Congo red-stained section of duodenal biopsy showing focal apple-green birefringence (Congo red stain, original magnification x200) 3D) Antral biopsy showing extensive amyloid deposition in lamina propria with decreased density of glands (H and E, original magnification x200) 3E) Ileal biopsy showing amyloid deposition in the lamina propria (lower half..."

Clinical • Amyloidosis • Anemia • Bone Marrow Transplantation • Cardiac Amyloidosis • Cardiovascular • Colorectal Cancer • Dermatology • Endocrine Disorders • Gastrointestinal Disorder • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Oncology • Rare Diseases

Advancements in Bullous Pemphigoid Treatment: A Comprehensive Pipeline Update. (PubMed, Am J Clin Dermatol) - "Rituximab, a CD20 monoclonal antibody, depletes B-lymphocytes and has shown efficacy in severe cases. Dupilumab, targeting interleukin (IL)-4 receptor α and thus blocking IL-4 and IL-13, downregulates type 2 helper (Th2) responses and has demonstrated promising results. Targeting eosinophil-related molecules using bertilimumab and AKST4290 has yielded positive results in clinical trials. Omalizumab, an immunoglobulin (Ig) E antibody, can reduce disease severity and allows corticosteroid tapering in a number of cases. Complement inhibitors such as nomacopan and avdoralimab are being investigated. IL-17 and IL-23 inhibitors such as secukinumab and tildrakizumab have shown potential in a limited number of case reports. Neonatal Fc receptor antagonists such as efgartigimod are under investigation. Additionally, topical therapies and Janus kinase inhibitors are being explored as potential treatments for BP. These novel therapies offer promising alternatives for managing..."

Clinical • Journal • Pipeline update • Review • Bullous Pemphigoid • Dermatology • Dermatopathology • Immunology • Pruritus • IL13 • IL17A • IL23A • IL4

Autoimmune blistering diseases: Promising agents in clinical trials. (PubMed, Expert Opin Investig Drugs) - "However, except for rituximab for pemphigus vulgaris, no new drugs have been approved for the treatment of AIBDs in the last decades...Promising results were shown for a variety of new agents including nomacopan, efgartigimod, omalizumab, dupilumab, as well as chimeric autoantibody receptor T cells. Clinical translation in the field of AIBDs is highly active and we anticipate significant advances in the treatment landscape."

Journal • Review • Bullous Pemphigoid • Dermatology • Dermatopathology • Immunology • Infectious Disease • Pemphigus Vulgaris

A case of bullous pemphigoid developing under treatment with benralizumab for bronchial asthma. (PubMed, J Dermatol) - "The efficacies of benralizumab and other biologics, including bertilimumab (anti-eotaxin-1 mAb) and mepolizumab (anti-IL-5 mAb), were evaluated in several clinical trials. Also, reslizumab, an anti-IL-5 mAb, was reported as a successful treatment option in a case of BP...Additional intravenous immunoglobulin and oral azathioprine enabled the oral PSL to be tapered...To the best of our knowledge, there have been no reports of BP developing during anti-eosinophil therapy. BP may occur paradoxically via various pathways during treatment with drugs that are typically effective against BP."

Journal • Asthma • Bullous Pemphigoid • Dermatology • Dermatopathology • Immunology • Pruritus • Pulmonary Disease • Respiratory Diseases • CCL11 • IL5

"iCo merged with a tiny Satellos. Oral-Trans platform was stranded without funding. iCo-019/AMP-009 had stagnated since 2H21 and iCo-008 was licensed to Immune Pharma who's trying to exit bankruptcy. LNC is so far ahead it may not matter if iCo-019 is hypothetically better." (@EverlastDD)

iCo Therapeutics announces third quarter 2014 financial results and corporate update (PRNewswire) - P2, N=42; NCT01671956; Sponsor: Immune Pharmaceuticals; "Management continues to anticipate additional Bertilimumab (iCo-008) Phase 2 clinical data related to ulcerative colitis...iCo currently owns 654,486 shares and 123,649 warrants of Immune Pharmaceuticals [NASDAQ: IMNP] and the opportunity to earn up to  $32M in milestone payments as its partner progresses through clinical milestones."

Anticipated P2 data • Commercial • Inflammatory Bowel Disease

Immune Pharmaceuticals provides a pipeline update (GlobeNewswire) - P2, N=42; NCT01671956; “Immune recently released a new batch of bertilimumab to support its ongoing phase 2a ulcerative colitis study, which will allow a ramp-up of enrollment.  The Company continues to expect enrollment to complete in the third quarter of this year.”

Enrollment status • Immunology • Inflammation • Inflammatory Bowel Disease

Bertilimumab: Protection of patents until 2021/2022 (Immune Pharma) - Corporate Presentation

Patent • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation

New data supports clinical rationale for bertilimumab in ulcerative colitis (PRNewswire) - "The mice were treated with an anti-eotaxin-1 monoclonal antibody or a control antibody. Inhibition of eotaxin-1 resulted in significant amelioration of DSS-induced colitis demonstrated by statistically significant reduction in both disease activity index and body weight loss compared to controls." P2, N=90; Sponsor: Immune Pharmaceuticals; NCT01671956; Anticipated P2 topline data: early 2015.

Anticipated P2 data • Conference • Preclinical • Inflammatory Bowel Disease

Bertilimumab: Preliminary data from P2 trial (NCT01671956) for moderate-to-severe ulcerative colitis in late Q1 2019 or Q2 2019 (Immune Pharma) - Corporate Presentation

P2 data • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

Immune Pharmaceuticals provides a corporate update (GlobeNewswire) - "...An update on Immune’s manufacturing partnership with WuXi Biologics...Release of clinic-ready bertilimumab in a range of late 2019 through the second quarter of 2020....Conclusion of enrollment in the phase 2 ulcerative colitis study over the coming weeks, with preliminary results expected late in the first quarter of 2019...Decision to actively seek a partnership for bertilimumab after several near-term milestones are achieved that will enhance bertilimumab’s value."

Enrollment status • P2 data • Immunology • Inflammation • Inflammatory Bowel Disease

Immune Pharmaceuticals presents updated positive results from Phase 2 trial of bertilimumab in bullous pemphigoid (GlobeNewswire) - P2, N=10; NCT02226146; “Immune Pharmaceuticals, Inc...announced that updated data from its phase 2 study of bertilimumab in patients with moderate-to-extensive bullous pemphigoid (BP)…are being presented today at the 2018 Pre-IID Pemphigus and Pemphigoid Symposium in Orlando, FL. These updated results include complete follow-up on all subjects enrolled in the study….Intend to discuss plans for a randomized, controlled phase 2/3 study of bertilimumab in bullous pemphigoid with the FDA later this year…Expect to launch this pivotal study in 2019, using bertilimumab produced by our new manufacturing process.”

FDA event • New P2/3 trial • P2 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation

Bertilimumab: Expiry of patents between 2021 and 2022 (Immune Pharma) - Corporate Presentation

Patent • Immunology • Inflammation • Inflammatory Bowel Disease

Bertilimumab: Completion of enrollment in P2 study (NCT01671956) for ulcerative colitis by mid-2018 (Immune Pharma) - NobleCon 14 Annual Investor Conference

Enrollment status • Immunology • Inflammation • Inflammatory Bowel Disease

Bertilimumab: Patent expiry related to composition of matter and method of use in US between March 2021 and August 2022 (Immune Pharma) - Annual Report 2017: Patent expiry related to composition of matter and method of use in ex-US in March 2021; Patent expiry related to method for treating an IBD in US and ex-US in March 2034

Patent • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • Inflammatory Bowel Disease

Immune Pharmaceuticals announces acceptance of abstract at 2018 pre-IID pemphigus and pemphigoid symposium (GlobeNewswire) - “Immune Pharmaceuticals, Inc…announced today the acceptance of an abstract for a poster presentation at the 2018 Pre-IID Pemphigus and Pemphigoid Symposium: ‘A New Era of Translation and Clinical Science,’ being held May 15-16, 2018 in Orlando, FL. The poster, entitled ‘A Pilot Phase 2a Study of the Safety and Efficacy of Bertilimumab, an Anti-Eotaxin-1 Antibody, in Bullous Pemphigoid,’ detailing interim results from the Company's ongoing phase 2a trial, will be available for viewing during the poster sessions.”

P2a data

Alexion Pharmaceuticals iCo’s new partner for the development and commercialization of iCo-008 (Yahoo Finance) - “iCo Therapeutics Inc…announced today that the purchase of the assets of Immune Pharmaceuticals ('Immune'), including the sublicense of iCo-008, by Alexion Pharmaceuticals, Inc. ('Alexion') has received all requisite court approvals and the closing of the purchase transaction is expected prior to the end of Q1 2020. Alexion has assumed Immune's rights and obligations under the iCo/Immune sublicense agreement in consideration of a USD $6 million (CDN $8 million) payment in accordance with the bankruptcy proceedings of Immune."

Licensing / partnership

Safety and efficacy of bertilimumab, a human anti-eotaxin-1 monoclonal antibody, in bullous pemphigoid in a phase 2a study (SID 2019) - "Subjects with moderate-to-extensive BP received intravenous Bert 10mg/kg, 3 doses biweekly, and prednisone at a maximum initial dose of 30 mg. The PK profile of Bert supports a once every other week dosing regimen. Bertilimumab merits further study in a controlled trial of longer duration."

Clinical • P2a data

Th/Tc9 and Th/Tc17 pathways are augmented in moderate-to-extensive bullous pemphigoid patients and suppressed by bertilimumab (SID 2019) - "BP180/BP230 improvement also correlated with decreased Th/Tc2. The pathogenesis of BP may involve Th/Tc9 and Th/Tc17 cytokine activation, which are suppressed by eotaxin-1 blockade, suggesting its therapeutic potential for BP and beyond."

Clinical • IO Biomarker

iCo Therapeutics Inc. announces notice of termination of sub license for bertilimumab (iCo-008) (MENAFN news) - "iCo Therapeutics...announces that on Friday February 15, 2019 the Company delivered written notice terminating, with immediate effect, its product sublicense agreement with Immune Pharmaceuticals (IMNP: OTCQB), related to iCo-008 (Bertilimumab). Subsequent to the above noted termination, Immune Pharmaceuticals filed a voluntary petition for bankruptcy in the District of New Jersey on February 17, 2019."

Licensing / partnership