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Amgen hosted an investor event focused on its rare disease portfolio Thursday, but while Mizuho analysts found details from the meeting to be "only incrementally positive," they believe obesity – where the company recently gave an early glimpse at its AMG 133 candidate – "is still the more important story for 2024."AMG 133, also known as maridebart cafraglutide, is a bispecific molecule that activates GLP-1 and inhibits GIP. Earlier this month, results from a small, early-stage study published in Nature Metabolism showed that patients given a monthly injection of the drug lost up to 14.5% of their body weight in 12 weeks. Some people kept the weight off for up to 150 days after stopping the drug.The company's presentation instead focused on a pair of rare disease therapies – Tepezza (teprotumumab) for thyroid eye disease and Krystexxa (pegloticase) for gout – that it acquired through its $27.8-billion takeout of Horizon Therapeutics, while also spotlighting some clinical-stage pipeline assets.Expanding Tepezza internationally seem important for Amgen's growth, Mizuho analysts noted. In the US, reaching patients with low clinical activity scores and developing a subcutaneous form of the drug, where a pivotal Phase III programme is set to get underway in the first half, are expected to help it grow. Outside the country, Amgen said Japan and Europe are high-priority markets, with plans to file for approval in Europe in the first half of 2024 and to launch in Japan in 2025.Plenty of room for more uptakeAccording to Barclays analysts, Amgen struck an overall positive tone by highlighting the "high level [of] addressable patients" across its rare disease portfolio. The company estimates there are about 100,000 potential patients in the US who could benefit from Tepezza, but only a small percentage of them are using it at the moment. A similar story plays out for Krystexxa; although there are over 100,000 potential patients, Amgen pegs current uptake at only around 6000.It also emphasised three other programmes it expects will be key growth drivers – the CD40 ligand antagonist dazodalibep which recently entered Phase III for Sjögren's disease; the anti-ILT7 lupus candidate daxdilimab, and the LPA1 antagonist fipaxalparant. Amgen currently has a pair of Phase II studies evaluating fipaxalparant for idiopathic pulmonary fibrosis and systemic sclerosis. A readout from the first of these studies is due in the second half.Barclays noted that the company wouldn't discuss differentiation against Bristol Myers Squibb's own LPA1 drug obexelimab, but "highlighted the unmet need and confidence in the mechanism." Obexelimab, which simultaneously binds CD19 and FcγRIIb, is currently in Phase III for IgG4-related disease. Bristol Myers Squibb acquired regional rights to the drug from Zenas BioPharma for $50 million upfront last year.

SAN DIEGO, Sept. 21, 2023 /PRNewswire/ -- Inmagene Biopharmaceuticals (Inmagene), a clinical-stage biotech company developing innovative and differentiated therapies for immunological and inflammatory diseases, today announced its partnership with Aditum Bio to create Celexor Bio (Celexor), a new biotech company focused on cell depletion of pathologic cells in autoimmune and inflammatory disorders. Celexor has been formed based on Inmagene's IMG-018, a pDC depleting antibody targeting immunoglobulin-like transcript 7 (ILT7). Celexor will obtain the exclusive global rights to develop, manufacture, and commercialize IMG-018, which will be renamed CLXR-901, in a transaction anticipated to close later this month. "We are pleased to partner with Aditum Bio, a highly innovative venture capital firm established by pharma industry leaders with deep drug development experience," said Jonathan Wang, PhD, Chief Executive Officer of Inmagene. "The formation of Celexor, based on IMG-018, has demonstrated Inmagene's strengths in discovering innovative and differentiated drug candidates." "Aditum Bio's unique incubator model enables us to accelerate the development of novel medicines, and we look forward to bringing this promising therapy to patients in need," said Joe Jimenez, Co-Founder and Managing Director of Aditum Bio. Under the terms of the agreement, Inmagene will be paid an upfront fee and is eligible to receive up to $287 million in development and sales milestone payments, as well as royalties on future product sales. In addition, Inmagene will be granted an equity stake in Celexor Bio. About IMG-018 (to be renamed CLXR-901) Created by Inmagene's proprietary QuadraTek® technology platform, IMG-018 is a monoclonal antibody that binds to the ILT7 receptor on the surface of plasmacytoid dendritic cells (pDCs) and recruits effector cells which help deplete pDCs. IMG-018/CLXR-901 has an enhanced effector function and allows for pDC depletion via the engagement of multiple cell types. These features have the potential to differentiate the ability of IMG-018/CLXR-901 to address immune disorders where ILT7 receptor and pDCs are involved. About Inmagene Biopharmaceuticals Inmagene is a global clinical-stage biotech company focused on developing novel therapeutics for immunological and inflammatory diseases. It has four clinical assets and an innovative preclinical pipeline. The company is developing its highly differentiated clinical assets, including IMG-007 (anti-OX40 mAb with extended half-life and silenced ADCC function), IMG-004 (BTKi with long half-life and pharmacodynamic duration) and IMG-008 (long-acting anti-IL-36R mAb). With its partners, Inmagene is co-developing IMG-020 (izokibep, an anti-IL-17 fusion protein), in which Inmagene owns certain global upside as well as development and commercialization rights in certain Asia regions. Further information is available at . About Aditum Bio Aditum Bio is committed to improving public health by accelerating R&D in disease areas with both large and more targeted patient populations, where medical innovation can have a significant impact. Aditum Bio focuses on mechanisms of disease, in-licenses promising drug candidates directed at such pathophysiology, and spins out individual companies dedicated to bringing each candidate through clinical trials. For more information, please visit . Media For inquiries, please contact: Anna Vardanyan [email protected] SOURCE Inmagene

DUBLIN, Ireland I January 04, 2023 I Horizon Therapeutics plc (Nasdaq: HZNP) today announced the first patient has enrolled in a Phase 2, randomized, placebo-controlled trial to evaluate its development-stage medicine daxdilimab, a potentially first-in-class, fully human monoclonal antibody targeting anti-ILT7 depletes certain dendritic cells to treat people with moderate-to-severe primary discoid lupus erythematosus (DLE). DLE is a rare, chronic, inflammatory skin condition characterized by lesions that result in scarring, irreversible hair loss and skin discoloration with no approved therapies. The localized form of primary DLE is characterized by limited cutaneous involvement of the head and scalp and usually accounts for 70 percent of primary DLE. The generalized form is characterized beyond this and includes the head-body area and usually accounts for about 30 percent of primary DLE.1 In the United States, approximately 30,000 patients with DLE are appropriate for treatment with novel therapies, including biologics.2 Primary DLE incidence rates are approximately four times higher among women compared with men and the disease has a higher prevalence among non-Latino Black and Latino populations.3 “DLE is one of the most challenging scarring skin diseases because there is no curative treatment. It causes round, inflammatory lesions that favor the scalp, face and ears and is associated with a diminished quality of life in patients,” said Benjamin Chong, M.D., associate professor, department of dermatology, University of Texas Southwestern Medical Center. “There is a tremendous unmet medical need for safe treatments for DLE. This trial will help evaluate the potential of daxdilimab to meet this need.” Horizon expects to enroll approximately 100 participants in the trial. The primary endpoint is the mean change in Cutaneous Lupus Erythematosus Disease Area and Severity Index-Activity (CLASI-A) score from baseline to Week 24. This endpoint is used to measure activity in inflammatory lupus skin disease and ranges from 0 to 70 with higher scores indicating more active and skin damaging disease.4 Key inclusion criteria include a diagnosis of moderate-to-severe DLE for more than six months prior to screening supported by a biopsy and/or a clinical feature score of ≥ 7 on the DLE Classification Criteria (DLECC) scale. This score is used to specifically validate and classify DLE across several clinical variables including atrophic scarring, disease location on the body and dyspigmentation.5 “Plasmacytoid dendritic cells, or pDCs, are reported to be abundant in DLE skin lesions while interferon levels are elevated and daxdilimab has been shown to deplete pDCs,” said Theresa Podrebarac, M.D., M.Sc., senior vice president, clinical development, Horizon. “DLE can lead to alopecia or permanent hair loss and skin dyspigmentation. Daxdilimab is also being investigated in other autoimmune conditions that are driven by high levels of interferon, including alopecia areata, dermatomyositis, lupus nephritis and systemic lupus erythematosus.” About Daxdilimab Daxdilimab is an anti-ILT7 human monoclonal antibody that depletes certain dendritic cells. Depleting these cells may interrupt the cycle of inflammation that causes tissue damage in a variety of autoimmune conditions. Horizon is also investigating daxdilimab in systemic lupus erythematosus and alopecia areata and plans to investigate it in dermatomyositis and lupus nephritis. About Horizon Horizon is a global biotechnology company focused on the discovery, development and commercialization of medicines that address critical needs for people impacted by rare, autoimmune and severe inflammatory diseases. Our pipeline is purposeful: We apply scientific expertise and courage to bring clinically meaningful therapies to patients. We believe science and compassion must work together to transform lives. For more information on how we go to incredible lengths to impact lives, visit www.horizontherapeutics.com and follow us on Twitter, LinkedIn, Instagram and Facebook. References SOURCE: Horizon Therapeutics