MOR106 / Lakefront Biotherapeutics, Novartis - LARVOL DELTA

Targeting the IL-17C-M2 macrophage axis ameliorates fibrosis in endometriosis through MAPK/ERK signaling. (PubMed, J Transl Med) - "Targeting the IL-17 C/IL-17RE axis provides a promising novel therapeutic strategy for mitigating fibrosis in endometriosis."

Journal • Endometriosis • Fibrosis • Gynecology • Immunology • Inflammation • Women's Health • IL17A • IL17C • MRC1

Epithelial-Derived IL-17C and IL-17E as Psoriatic Inflammation Amplifiers and Targets (AAD 2026) - "Selective IL-17C neutralization (e.g., MOR106) reduces inflammatory markers in preclinical and ex vivo models...IL-17RA blockade (e.g., brodalumab) downregulates IL-17A/F/C/E pathways, normalizing psoriatic gene expression... IL-17C and IL-17E, epithelial-derived cytokines, amplify psoriatic inflammation via autocrine keratinocyte and paracrine Th17/myeloid cell activation, complementing IL-17A/F in psoriatic pathology. Selective IL-17C or IL-17E (via IL-17RB) blockade, with biomarker-guided stratification, offers a rational strategy to advance therapy beyond IL-17A/F and IL-23 targets. Funding: This study was funded by LEO Pharma Ltda."

Immunology • Inflammation • Psoriasis • IL17A • IL17C • IL17RA • IL17RB • IL23A • TNFA

MOR106 alleviates inflammation in mice with atopic dermatitis by blocking the JAK2/STAT3 signaling pathway and inhibiting IL-17C-mediated Tfh cell differentiation (PubMed, Xi Bao Yu Fen Zi Mian Yi Xue Za Zhi) - "Compared with AD group, the levels of p-JAK2 and p-STAT3 protein in low-dose and high-dose MOR106 treatment groups decreased significantly. Conclusion MOR106 can reduce the inflammatory response of AD mice by blocking JAK2/STAT3 signaling pathway and inhibiting the differentiation of Tfh cells mediated by IL-17C."

Journal • Preclinical • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • ABCB1 • IFNG • IL17A • IL17C

Phase 1 and 2 Randomized Clinical Studies Determine Lack of Efficacy for Anti-IL-17C Antibody MOR106 in Moderate-Severe Atopic Dermatitis. (PubMed, J Clin Med) - P1, P2 | "Cumulatively, MOR106 demonstrated ineffectiveness for the treatment of AD, but its safety and pharmacokinetic characteristics warrant further drug development in other indications. Funding: sponsored by Galapagos NV; funded by Novartis AG."

Journal • P1 data • Atopic Dermatitis • Dermatitis • Dermatology • Dermatopathology • Immunology • Inflammation • IL17A

Galapagos reports H1 financial results with refocused pipeline and operational progress (GlobeNewswire) - "Our R&D expenditure in the first six months of 2021 amounted to €268.8 million, compared to €262.9 million for the first six months of 2020. This increase, primarily related to our filgotinib program and our Toledo program, was compensated by a decrease for ziritaxestat, the osteoarthritis (OA) program with GLPG1972, and the program in atopic dermatitis (AtD) with MOR106....We also expect additional reimbursement decisions for filgotinib in RA across a number of European countries. We are on track to complete the transition from our collaboration partner Gilead to us of the full European commercial operations for filgotinib by year-end, and we anticipate reporting on our own European sales of filgotinib starting in the second half of the year. Completion of the recruitment in the global DIVERSITY Phase 3 trial with filgotinib in Crohn’s disease by our collaboration partner Gilead is also expected later this year."

Commercial • Enrollment status • Reimbursement • Atopic Dermatitis • Crohn's disease • Dermatology • Immunology • Inflammatory Bowel Disease • Rheumatoid Arthritis • Ulcerative Colitis

MOR106: Expiry of patent related to composition-of-matter in February 2037 (Morphosys) - Annual Report 2020

Patent • Atopic Dermatitis • Dermatology

Galapagos reports first quarter 2018 results (GlobeNewswire) - "Galapagos expect to…initiate Phase 2 studies with…MOR106 (atopic dermatitis) later in 2018.”

New P2 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation

"MorphoSys and @Galapagos announced global license agreement for MOR106 with @Novartis https://t.co/o83q1xOdES $MPSYF" (,@MorphoSys)

Clinical

First in Human of Single and Multiple Doses of MOR106 (clinicaltrials.gov) - P1; N=81; Completed; Sponsor: Galapagos NV; Active, not recruiting ➔ Completed

Trial completion • Atopic Dermatitis • Biosimilar • Dermatitis • Eczema • Immunology • Inflammation

A Study to Assess Efficacy, Safety, Tolerability and PK/PD of MOR106 in Subjects With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2; N=180; Recruiting; Sponsor: Galapagos NV

New P2 trial • Atopic Dermatitis • Biosimilar • Dermatitis • Dermatology • Immunology • Inflammation

Galapagos and MorphoSys report first promising signs of clinical activity in a phase 1 study with IL-17C antibody MOR106 in atopic dermatitis patients (GlobeNewswire) - P1, N=24; NCT02739009; Sponsor: Galapagos and MorphoSys; "Galapagos and MorphoSys AG today announced Phase 1 results with their joint investigational antibody program MOR106 directed against IL-17C in patients with moderate-to-severe atopic dermatitis (AD)...Galapagos and MorphoSys intend to present the clinical data from this study with MOR106 at a future medical conference."

P1 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation

Galapagos and MorphoSys announce initiation of the IGUANA phase 2 clinical trial with MOR106 in atopic dermatitis patients (GlobeNewswire) - "Galapagos...and MorphoSys...announced today that the first patient has been screened in IGUANA, a Phase 2 study with MOR106, an investigational antibody directed against IL-17C, in atopic dermatitis patients."

Trial initiation date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation

MOR106: "MOR106 shown the first signs of clinical activity: improvement of EASI-50 at week four occurred in 83% of patients (five out of six) at the highest dose level, long-lasting effect" (Morphosys, UBS Global Healthcare Conference)

P1 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation

MorphoSys presents results for fiscal year 2017 (Morphosys Press Release) - "...plan to start a phase 2 study of MOR106 in patients with atopic dermatitis together with our partner Galapagos in the second quarter of 2018."

New P2 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation

MOR106: "MOR106 shown the first signs of clinical activity: improvement of EASI-50 at week four occurred in 83% of patients (five out of six) at the highest dose level, long-lasting effect" (Morphosys, UBS Global Healthcare Conference)

P1 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation

MOR106: Expiry of composition-of-matter patent in February 2037 (Morphosys) - Annual Report 2019

Patent

MOR106: Expiry of patents related to composition-of-matter and method of treatment in US/ex-US, EU, Australia and Canada in 2037 (Galapagos) - Annual Report 2019: Expiry of patents related to method of treatment for atopic dermatitis in 2038; Expiry of patents related to formulation and method of treatment for additional indications in 2039

Patent

A Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics (PK)/Pharmacodynamics (PD) of MOR106 in Subjects With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2; N=207; Terminated; Sponsor: Galapagos NV; Active, not recruiting ➔ Terminated; MOR106 clinical development in atopic dermatitis was stopped for futility

Clinical • Trial termination

GECKO: A Study to Test Safety and Tolerability of a Study Drug Called MOR106 Administered Concomitantly With Topical Corticosteroids, in Adult Patients With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2; N=33; Terminated; Sponsor: Galapagos NV; N=60 ➔ 33; Active, not recruiting ➔ Terminated; MOR106 clinical development in atopic dermatitis was stopped for futility

Clinical • Enrollment change • Trial termination

A Study to Test Safety, Tolerability, and the Way the Body Absorbs, Distributes, and Gets Rid of a Study Drug Called MOR106, in Healthy Subjects and in Patients With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P1; N=44; Terminated; Sponsor: Galapagos NV; N=122 ➔ 44; Active, not recruiting ➔ Terminated; MOR106 clinical development in atopic dermatitis was stopped for futility

Clinical • Enrollment change • Trial termination

A Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics (PK)/Pharmacodynamics (PD) of MOR106 in Subjects With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2; N=207; Active, not recruiting; Sponsor: Galapagos NV; Trial primary completion date: Nov 2019 ➔ Mar 2020

Clinical • Trial primary completion date

IL-17C amplifies epithelial inflammation in human psoriasis and atopic eczema. (PubMed, J Eur Acad Dermatol Venereol) - "IL-17C amplifies epithelial inflammation in Th2 and Th17 dominated skin inflammation and represents a promising target for the treatment of ISD."

Journal • CCL5 • CXCL10 • CXCL8 • VEGFA

A Study to Test Safety, Tolerability, and the Way the Body Absorbs, Distributes, and Gets Rid of a Study Drug Called MOR106, in Healthy Subjects and in Patients With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P1; N=122; Active, not recruiting; Sponsor: Galapagos NV; Recruiting ➔ Active, not recruiting; Trial completion date: Dec 2020 ➔ Mar 2020

Enrollment closed • Trial completion date

GECKO: A Study to Test Safety and Tolerability of a Study Drug Called MOR106 Administered Concomitantly With Topical Corticosteroids, in Adult Patients With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2; N=60; Active, not recruiting; Sponsor: Galapagos NV; Recruiting ➔ Active, not recruiting; Trial completion date: Jun 2020 ➔ Mar 2020

Enrollment closed • Trial completion date

A Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics (PK)/Pharmacodynamics (PD) of MOR106 in Subjects With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2; N=240; Active, not recruiting; Sponsor: Galapagos NV; Recruiting ➔ Active, not recruiting; Trial completion date: Jun 2020 ➔ Mar 2020

Enrollment closed • Trial completion date