Dashboard Overview

Real-time insights into Recellion ImmunoReset therapy management across your facility.

Patients in Active Treatment

Currently undergoing Recellion ImmunoReset therapy

18
Total Active Cases
2 New Enrollments

Recellion Manufacturing

mRNA CAR-T production pipeline status

3.5
Avg Production Days
All Batches On Schedule

Adverse Event Alerts

Real-time toxicity monitoring for Recellion therapy

1
Patient Under Watch
Mild CRS Symptoms

3-Month Remission Rate

Initial efficacy post-Recellion ImmunoReset infusion

92%
Overall Remission Rate
Exceeding Expectations

Treatment Journey Progress

Visual timeline of patient therapy stages for Recellion

📊 Treatment Journey Chart Placeholder

Toxicity Trend Analysis

Aggregate view of adverse event reporting for Recellion

🛡️ Adverse Event Graph Placeholder

Patient Screening & Enrollment

Streamlined assessment for refractory SLE and RA patients for Recellion ImmunoReset therapy.

5 new patient referrals in review for Recellion eligibility.

Eligibility Questionnaire

Complete assessment based on Recellion clinical criteria.

Recellion Candidates

Patients meeting initial screening criteria for Recellion ImmunoReset.

  • Patient IMX-003 (SLE)
    Age: 42 | Refractory: Yes (3 prior biologics)
    Eligible - High Priority
  • Patient IMX-009 (RA)
    Age: 55 | Refractory: Yes (4 prior biologics)
    Requires Rheumatology Review
  • Patient IMX-015 (SLE)
    Age: 38 | Refractory: Yes (2 prior biologics)
    Eligible - Standard

Therapy Logistics & Scheduling

Optimize scheduling with real-time Recellion production status and appointment management.

Recellion Production Pipeline

mRNA CAR-T manufacturing status for upcoming infusions.

Batch IMX-003: Day 2/3 (QC & Release)
Batch IMX-009: Day 1/3 (mRNA Synthesis)

Upcoming Recellion Appointments

Leukapheresis, infusion, and follow-up scheduling.

Today - May 29, 2025
• 09:00 - Patient IMX-003 Recellion Infusion
• 14:00 - Patient IMX-005 1-Month Follow-up (RA)
Tomorrow - May 30, 2025
• 10:00 - Patient IMX-009 Leukapheresis
• 15:30 - Patient IMX-012 3-Month Follow-up (SLE)
Reminder: Patient IMX-009 leukapheresis scheduled for tomorrow 10:00 AM.

Adverse Event Monitoring & Symptom Tracking

Real-time patient monitoring with early detection of CAR-T related toxicities (CRS, ICANS) for Recellion therapy.

Alert: Patient IMX-003 reported fever (38.5°C) and mild headache - possible Grade 1 CRS.

Active Monitoring Dashboard

Patients currently requiring close observation for adverse events.

  • Patient IMX-003 (SLE)
    Status: Post-Infusion Day 3
    Symptoms: Fever, Headache
    Possible Grade 1 CRS
  • Patient IMX-005 (RA)
    Status: 1-Month Post-Infusion
    Symptoms: Mild fatigue
    Stabil, Routine Monitoring

Report New Symptom

Submit real-time symptom updates for patients receiving Recellion therapy.

Clinical Insights & Analytics

Data-driven insights into Recellion ImmunoReset efficacy, safety, and patient outcomes.

Long-Term Remission Rates

Track sustained remission in SLE and RA patients post-Recellion ImmunoReset.

📊 Remission Rate Chart Placeholder

Adverse Event Trends

Analyze patterns and frequency of CAR-T related toxicities for Recellion.

🛡️ Adverse Event Graph Placeholder

Patient Reported Outcomes (PROs)

Aggregate patient quality of life and symptom burden data for Recellion patients.

📝 PROs Data Placeholder

Cost-Effectiveness Modeling

Comparative analysis of Recellion ImmunoReset vs. lifelong biologics.

💰 Cost Model Placeholder

Patient & HCP Resources

Comprehensive educational materials and support for Recellion ImmunoReset therapy.

Recellion Patient Guide

Understand your CAR-T journey, what to expect, and how to manage symptoms with Recellion.

Recellion Patient Journey Video

Healthcare Professional Training

Modules on Recellion ImmunoReset administration, toxicity management, and patient selection.

HCP Training Module Video

Frequently Asked Questions (FAQs)

Answers to common questions about Recellion ImmunoReset therapy for patients and caregivers.

  • What is mRNA CAR-T therapy?
  • How long does remission last with Recellion?
  • What are the potential side effects of Recellion?

Support Group Information

Connect with other patients and families navigating Recellion autoimmune CAR-T therapy.

  • Online Forums
  • Local Meetups
  • Patient Advocacy Contacts

Recellion: SOSTAC® Marketing Framework for ImmunoReset

Our strategic approach to launching ImmunoReset, an off-the-shelf mRNA CAR-T therapy for refractory SLE and RA in the EU market.

1. Situation Analysis (Where are we now?)

The autoimmune market, particularly for SLE and RA, presents significant unmet needs for refractory patients who fail existing therapies. Current treatments often involve lifelong biologics with high costs and varying remission rates. Recellion ImmunoReset, as a potential one-time curative mRNA CAR-T therapy, offers a unique value proposition.

  • **Market Size:** EU refractory SLE (~200,000) and RA (~600,000) patient populations.
  • **Competitive Landscape:** Direct CAR-T competitors include Allogene, Kyverna, Cabaletta Bio, Atara, and Capstan Therapeutics. Established treatments for SLE include Belimumab, Anifrolumab, Voclosporin, and Rituximab. For RA, TNF inhibitors, IL-6 targeting drugs, JAK inhibitors, Abatacept, Rituximab, and Anakinra are prevalent.
  • **Recellion's Competitive Advantages:** Off-the-shelf availability, no lymphodepletion, scalable manufacturing, and first-to-market in EU.
  • **Customer Segments:** Rheumatoid Arthritis (RA) refractory patients, Systemic Lupus Erythematosus (SLE) patients (moderate, severe), Cell therapy hospitals/centers, Health insurers and payers.

2. Objectives (Where do we want to be?)

Our primary objective is to successfully introduce Recellion ImmunoReset into the EU market, establishing it as a leading therapeutic option for refractory autoimmune diseases.

  • **Regulatory:** Achieve EMA Marketing Authorization (MA) for Recellion ImmunoReset by Q2 2029.
  • **Market Penetration (Year 1):** 25 certified CAR-T centers in 8 EU countries.
  • **Market Expansion (Year 2):** 50 certified centers in 12 EU countries.
  • **Patient Treatment (Year 1):** 200 patients (120 RA, 80 SLE).
  • **Patient Volume (Year 2):** 500 patients annually (300 RA, 200 SLE).
  • **Market Leadership (Year 2):** 10% market share in eligible population.
  • **Revenue (Year 1):** ~$12M.
  • **Revenue (Year 2):** ~$28-40M.
  • **Safety Profile:** Maintain a favorable safety profile with Grade 3+ CRS/ICANS rates below 10% in clinical trials.

3. Strategy (How do we get there?)

Our strategy centers on demonstrating superior efficacy and safety, leveraging our off-the-shelf advantage, and building strong relationships with key stakeholders.

  • **Positioning Strategy:** Position as "The First Potential Cure for Autoimmune Diseases," emphasizing a paradigm shift from chronic management to a curative treatment. Highlight visible advantages of the off-the-shelf approach.
  • **Target Market Segmentation:** Focus on refractory RA patients (failed all biologics), moderate-to-severe SLE patients (organ involvement). Tertiary autoimmune medical centers and CAR-T centers.
  • **Go-to-Market Strategy:** Take a hub-and-spoke model, starting with major academic centers. Prioritize market education, optimize patient journey, and engage payers proactively with health economics deliverables.
  • **Communication Strategy:** Differentiate against CAR-T competitors and established biologics. Emphasize Recellion's advantage and safety profile (no lymphodepletion and an off-the-shelf approach). Leverage thought leadership and digital engagement.

4. Tactics (How exactly do we get there?)

Specific actions to execute our strategy across clinical development, regulatory affairs, and market preparation.

  • **Clinical Development:** Conduct robust Phase 2/3 trials with clear endpoints for remission and safety.
  • **Regulatory Engagement:** Proactive engagement with EMA (Scientific Advice, PRIME designation) to streamline approval process.
  • **HCP Education:** Develop comprehensive training programs and digital tools (like this platform) for clinicians on patient selection, administration, and AE management. Physician Training (Year 1): 150 rheumatologists/immunologists. Physician Network (Year 2): 350 trained physicians total.
  • **Patient Advocacy:** Partner with patient organizations to raise awareness and provide support.
  • **Market Access:** Develop health economics models demonstrating long-term cost-effectiveness compared to current standards of care. Reimbursement (Year 1): Germany, France, UK approvals.
  • **Content Marketing Tactics:** Create compelling and rich content providing our team with a differentiated narrative. Develop educational content, internal/external patient journey animations and patient selection guidelines. Share data/publication in peer-review journals and medical conferences. Publish white papers on health economics and real-world evidence. Provide treatment algorithm guides for physicians.
  • **Sales & Distribution Tactics:** Deploy limited European launch (initial 8 EU countries). Engage specialized key opinion leaders. Provide patient navigation support to treatment pathways. Ensure seamless distribution through specialized pharmacy and supply chain networks.

5. Action (Who does what, when?)

Implementation plan with key responsibilities and timelines.

  • **Q2 2025:** Pre-clinical complete, ATMP & Scientific Advice.
  • **Q1 2026:** CTA via CTIS, Phase I/II read-out.
  • **Q3 2028:** MAA submission to EMA.
  • **Q2 2029:** EC decision & anticipated launch in initial EU markets.
  • **Ongoing:** Manufacturing scale-up, HCP training rollout, patient support program development.
  • **Year 1 Milestones:** CTA, GMP Setup.
  • **Year 2 Milestones:** Reimbursement, MAA.

6. Control (How do we monitor performance?)

Key Performance Indicators (KPIs) and monitoring mechanisms to track progress and adjust our plan.

  • **Measurement & Monitoring:** Utilize real-time dashboard (1-3 month), surveys (physician training, patient numbers, website engagement and quarterly HCP feedback on platform and reimbursement), as well as annual medical review (includes nurses, pharmacists, and treated patients, physician satisfaction and health economic analysis).
  • **Process Review & Feedback:** Conduct weekly team standups, monthly management reviews, and quarterly business reviews. Gather physician feedback (in-clinic and surveys/boards) and patient feedback (through surveys and advocacy groups). Monitor competitive intelligence (monthly), quality, and sustainability.
  • **Outcome Metrics Summary:** Year 1: 25 centers in 8 EU countries, 150 trained physicians, 200 treated patients, 70% physician awareness, 3 reimbursement decisions. Year 2: 50 centers in 12 EU countries, 350 trained physicians, 500 treated patients, 10% market share, 2-year durability data publication. Established as standard of care, multiple indications (~100) provide annual global exposure.
  • **Clinical:** Remission rates (3-month, 6-month, 12-month), adverse event reporting (CRS, ICANS incidence), patient reported outcomes (PROs).
  • **Regulatory:** EMA approval timeline adherence, number of regulatory queries.
  • **Commercial:** Market share in target EU countries, number of certified treatment centers, patient enrollment rates.
  • **Financial:** Production costs per dose, reimbursement rates, sales revenue.
  • **Digital Platform:** User engagement (HCPs, patients), feature adoption.

Marketing Objectives: Years 1 & 2

Key goals and targets for Recellion's market penetration and expansion.

Year 1 Objectives

  • Market Penetration: 25 certified CAR-T centers in 8 EU countries
  • Physician Adoption: Train 150 rheumatologists/immunologists
  • Patient Treatment: Treat 200 patients (120 RA, 80 SLE)
  • Market Awareness: 70% awareness among target physicians
  • Reimbursement: Secure favorable decisions in Germany, France, UK

Year 2 Objectives

  • Market Expansion: 50 certified centers in 12 EU countries
  • Physician Network: Train additional 200 physicians (350 total)
  • Patient Volume: Treat 500 patients annually (300 RA, 200 SLE)
  • Market Leadership: 40% market share in eligible population
  • Evidence Generation: Publish 2-year durability data
  • Pipeline Development: Initiate Phase II studies in additional indications

Phase 2 & 3 Budget Analysis

Estimated costs for clinical trial execution, manufacturing, and regulatory affairs.

Phase 2 (100 Patients) - Estimated Cost: $16,847,000

  • Clinical Trial Execution: $12,000,000
  • Investigational Product (IP) Manufacturing: $397,000
  • Regulatory Affairs: $1,000,000
  • Quality Assurance & Control: $500,000
  • Data Management & Biostatistics: $800,000
  • Medical Monitoring & Safety Reporting: $600,000
  • Insurance & Legal: $200,000
  • Contingency (10%): $1,350,000

Phase 3 (300 Patients) - Estimated Cost: $49,791,000

  • Clinical Trial Execution: $36,000,000
  • Investigational Product (IP) Manufacturing: $1,191,000
  • Regulatory Affairs: $2,000,000
  • Quality Assurance & Control: $1,500,000
  • Data Management & Biostatistics: $2,500,000
  • Medical Monitoring & Safety Reporting: $2,000,000
  • Insurance & Legal: $600,000
  • Contingency (10%): $4,000,000

Fully-Loaded Production Cost per Patient

≈ $3,970

(Includes mRNA reagents, lipids, encapsulation, QC, fill-finish, stability study, and process development with 15% contingency)

Key Partners

Strategic collaborations essential for Recellion's success.

Academic and Clinical Research Centers

Collaborate for clinical trials, patient recruitment, and translational research in rheumatology, nephrology, and immunology.

Contract Manufacturing Organizations (CMOs)

Partner with GMP-certified facilities for scalable and compliant production of allogeneic CAR-T cell products.

Biotech and Pharma Companies

Form alliances for technology licensing, co-development, and access to CAR constructs or gene-editing platforms.

Patient Advocacy Groups

Engage with lupus and rheumatoid arthritis organizations for patient-centric development and clinical trial enrollment.

Regulatory Consultants

Collaborate with experts to manage IND, BLA, and EMA submissions and stay compliant with cell therapy regulations.

Technology Providers

Partner for viral vector production, gene-editing tools (e.g., TALEN, CRISPR), and cell expansion technologies.

Treatment Cost Comparison

Compare lifetime costs: Traditional biologics vs. Recellion's one-time CAR-T therapy

Traditional Treatment (Annual): $ × years
Recellion CAR-T (One-time): $

Treatment Process Demo

Explore the mRNA-LNP CAR-T Treatment Process step-by-step.