X4 Pharmaceuticals’ Post

This morning MC2 Therapeutics announced positive feedback from our pre-IND meeting with the FDA concerning our phase 2 stage first-in-class oral drug candidate, MC2-32. Such interim regulatory alignment and guidance are instrumental - especially as we are pioneering uncharted territory in medical science to help people with safe and effective novel treatment paradigms. We also announced that pre-clinical studies have demonstrated that oral MC2-32 not only holds promise for our lead indication Hidradenitis Suppurativa but also for other challenging conditions like neutrophilic dermatoses and beyond skin conditions. Looking ahead, MC2 is on track to file an IND for a Phase 2b clinical trial with MC2-32 in Hidradenitis Suppurativa. We're not stopping there – we also plan to initiate a Phase 2 trial for Pyoderma Gangrenosum, a rare and painful ulcerative condition with currently no approved treatments, as part of our broader strategy to tackle additional underserved diseases with MC2-32 within Immunology and Inflammation. This progress is another testament to the exceptional dedication and skills of our MC2 Therapeutics Team - Thank you! Read the full announcement here https://lnkd.in/dtbbz3H6 #MC2Therapeutics #HealthcareInnovation #Hidradenitissuppurativa #Biotechnology #pyodermagangrenosum #Immunology #Inflammation

We are pleased to announce that we have received positive feedback from our pre-IND meeting with the FDA and are on track to file an IND in mid-2025 for a Phase 2b clinical trial in Hidradenitis Suppurativa (#HS) with MC2-32, our first-in-class oral drug candidate targeting multiple pathways involved in I&I indications.   Given MC2-32’s unique mode of action and pharmacological profile it is well positioned to address a multitude of other neutrophilic dermatoses as well as other large and rare I&I diseases which is currently being explored pre-clinically by MC2. MC2 Therapeutics is planning to explore MC2-32 in additional Phase 2 trials starting in 2025 with Pyoderma Gangrenosum (#PG), a rare skin condition causing painful ulcers, for which there is a significant unmet patient need and no approved treatments.   Read the full announcement for more on our indication expansion strategy: https://lnkd.in/dGNc39Fa   #MC2Therapeutics #Immunology #Inflammation #Biotech #Innovation #ClinicalResearch 

An very important step forward - for MC2 and for patients suffering from Hidradenitis Suppurativa. Now potentially also for patients with Pyoderma Gangrenosum.

In immunology, only one out of three physicians knows the details of the individual drug’s copay offerings. No wonder the Humira biosimilars are struggling with the affordability perception among MDs even though their copay offerings are down to $0. To learn more, see: www.thepurereport.com #immunology, #Pharma, #PatientExperience, #PatientAffordability

Explore the rapidly evolving landscape of immunology in the latest #IQVIA blog as we delve into the future #immunology, highlighting untapped opportunities in smaller immunology indications. Our author Markus Gores emphasizes that innovators must focus on patient-relevant evidence and close collaboration with #patient advocacy groups to see success. Read now for more insights: https://bit.ly/44ckues

Global Immunology Collaboration and Licensing Agreements Analysis Report 2023 with Directory of Deals Signed by the World's Leading Biopharma Companies Since 2016: DUBLIN, Nov. 17, 2023 /PRNewswire/ -- The "Immunology Collaboration and Licensing Deals 2016-2023" report has been added to ResearchAndMarkets.com's offering. Immunology Collaboration and Licensing Deals provides a comprehensive understanding and unprecedented access to the immunology...

Today, on #DayofImmunology, we want to celebrate the remarkable medical advancements in the field of immunology. 2023 marked a significant milestone for #complementtherapeutics, as the FDA has given the green light to four groundbreaking complement inhibitors to tackle various diseases. Three of these innovative inhibitors are designed to target the Complement C5 protein, while one is a pioneering oral inhibitor of Factor B. A comprehensive mini-review of all novel drugs authorized in 2023 by the FDA, EMA, and MHRA has been recently published. The first-in-class oral inhibitor of complement Factor B is included in the list. This Factor B inhibitor has been shown to lower and sustain a reduction in alternative pathway activity, as assessed by our Wieslab Functional kits. Additionally, it has also been shown to lower proteinuria and protein-to-creatinine radio in a pivotal clinical trial (NCT03373461). We are committed to advancing the field of immunology and supporting the development of complement-targeting therapies to improve patient outcomes. We look forward to seeing more therapeutics approved in the future. Read the original mini-review here: https://hubs.ly/Q02v82Fc0 #ComplementingLifeScience #AnswersinLifeScience #SvarLifeScience #ComplementResearch #ComplementBiology

Another trip to Boston? ✈ It can only be for one event - the ultimate forum for mRNA dedicated biopharma stakeholders - The mRNA-Based Therapeutics Summit USA! What's more, with Moderna's latest RSV vaccine approval, there is immense excitment as we discuss the route to successful approval with none-other than the leading regulatory bodies and key regulatory change-makers that are making history as we speak! Join Dr Peter Marks (CBER, FDA), Ka-Wai Wan (Medicines and Healthcare products Regulatory Agency), Marco Cavaleri (European Medicines Agency), Carla Vinals (Moderna), Nitisha Pyndiah, PhD (GSK), and Emily English (Cartesian Therapeutics) as they discuss the following questions: 🔹 How can we work towards successful regulatory approvals for mRNA technology as a platform to reduce the process for individual mRNA medicine applications and expedite to patients faster? 🔹 What steps can the industry take to help establish a regulatory framework around mRNA technology and combat all diseases? With 65+ key speakers and 40+ insightful case studies to share across infectious disease, oncology, rare disease and beyond, view the full program and registration details here: https://ter.li/z28m60 #mRNA #RNA #mRNATherapeutics #mRNAVaccines #WorldRNA

2024 is set to be a pivotal year for MC2 Therapeutics with significant milestones in our three Phase 2 stage clinical programs within Immunology and Inflammation. Next week in San Francisco, I am representing our dedicated MC2 Therapeutics team at the J.P. Morgan Healthcare Conference to provide an update on our progress and plans and to discuss collaborations with investors and industry partners.   Our two novel drug candidates (an oral HSP90 Inhibitor and a topical Iso-cyanate scavenger) are first-in-class with new mode of action and multiple indications potential, including Hidradenitis Suppurativa, CKD-associated Pruritus (CKD-aP) and Vulvar Lichen Sclerosus. Addressing the unmet needs of millions of patients and a testament to our commitment to pioneer novel treatment paradigms within I&I.   I look forward to engaging.   #JPM2024 #HealthcareInnovation #MC2Therapeutics #ClinicalAdvancement #Networking  

The FDA has approved AstraZeneca's Imfinzi, in combination with chemotherapy, for treating advanced or recurrent hashtag #endometrialcancer that is mismatch repair deficient. The DUO-E Phase III trial results are impressive, showing a 58% reduction in disease progression or death compared to chemotherapy alone. This marks a significant advancement in a field with limited treatment progress over the past few decades. 🌐 Key questions - What further innovations can we expect in hashtag #immunotherapy? How will this approval impact treatment standards and patient outcomes? #Innovation #CancerTreatment #FDAApproval #PatientHealth