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Protective Barrier Technology:
Protective Biofilm Barriers: Breakthrough Therapies Rapidly Enabled by Disruptive Medical Device Platform
Breakthrough therapies rapidly enabled by disruptive platform technology
Presented by: Eva A. Berkes, MD, Co-Founder and Co-CEO
Quorum Innovations: What We Do.
We present our technology, the Quorum Immunotherapy technology, a customized entire tumor-derived cure. We create a unique immunotherapy payload by fusing cutting-edge genetic technology with tumor cells taken from patients. Our unique bio diffusion chambers (BDCs) are then filled with this payload, which includes customized antisense oligodeoxynucleotides, and made ready for implantation.
Barrier protection is what Quorum Innovations does.
Novel disease target: impaired barriers. Environmental exposures break down protective body barriers, such as our skin and intestinal tract. Breached body barriers result in common and difficult-to-treat diseases. Quorum Innovations Biofilm Barrier Protectants are breakthrough treatments for common conditions like bacterial vaginosis (BV), chronic wounds and the orphan disease, eosinophilic esophagitis (EOE).Novel disease target: impaired barriers.
Environmental
exposures break down protective body barriers,
such as our skin and intestinal tract. Breached
body barriers result in common and difficult-to treat diseases.
Novel therapeutics: Barrier protection is what Quorum Innovations does.
Quorum Innovations is the only biotech company in the world developing novel microbiome-based therapeutics to protect and repair impaired barriers. QI Biofilm Barrier Protectants are breakthrough treatments for common conditions like bacterial vaginosis (BV), chronic wounds and the orphan disease, eosinophilic esophagitis (EOE).
Unique advantages of the Goldspire™ platform against solid tumors
Full antigenic signature capture
Quorum’s Goldspire™ platform exposes the full antigenic signature of a patient’s tumor to the immune system, providing an opportunity for a broader anti-tumor effect compared with single antigen-targeting therapies.
Broad spectrum immune activation
Quorum’s Goldspire™ platform delivers immunotherapy that is personalized to a patient’s entire unique tumor and incorporates mechanisms that stimulate both the innate and adaptive immune system. This broad-spectrum effect, when used in combination, also may enhance the effects of other immunotherapies.
No ‘off-target’ effects
Quorum’s Goldspire™ platform trains the immune system to comprehensively recognize the full antigenic signature of a patient’s unique tumor. Because the immune system ignores a patient’s own antigens, Quorum’s approach should avoid immune responses not directed to the tumor itself.
Less than 24-hour tissue processing
Quorum’s Goldspire™ platform uses a rapid tumor tissue processing technology to prepare the proprietary BDCs for implantation. By contrast, many emerging therapies targeting one or a small number of antigens require complex manufacturing procedures, such as gene editing and cell expansions, that can take several weeks.
Integrated into the ‘standard of care’
Quorum’s Goldspire™ platform can fit within the existing standard of care for patients with resectable solid tumors. Within days of tumor resection surgery, Quorum processes the tumor cells and the BDCs are then implanted in the patient and explanted 48-hours later. The patient’s immune system training begins immediately, after which they can continue with traditional standard-of-care therapies.
US Prevalence
Cost of Treatment
Recurrence Rate
Treatment Risks
Phase 3
The problem: Inadequate long-term solutions for barrier diseases
1. Current treatments are symptomatic
2. Underlying pathology – barrier dysfunction – is
not addressed
3. Diseases/symptoms recur despite treatment
4. Treatments can involve undesired exposures
(immunomodulators, hormones or antibiotics)
5. Patients and care providers are not satisfied
6. Result = areas of high therapeutic need
| US Prevalence | Cost of Treatment | Recurrence Rate | Treatment Risks |
|---|---|---|---|
| 20%-30% of women ages 14-49 | $-$$ | Up to 69% in 1 year5 | Low |
| 2% of the total population | $-$$$ | 40% in 6 months6 | Low-Mid |
| 60% of all women ages 55+ | $-$$ | Recurs if ongoing treatment is stopped | Low-Mid |
| 0.5-1 per 1,000 people | $$$$ | Recurs if ongoing treatment is stopped | Low-Mid |
The Solution: QI Biofilm Barrier Protectants
QI Biofilm Barrier Protectants resolve barrier weakness and associated disease by forming a physical protective layer.
• QI Barrier products are formulated for long-lasting protection of impaired tissues
• The proprietary QI discovery platform ensures a continuous therapeutic pipeline for barrier dysfunction diseases.
Qi Barrier Protectants … Why Now?
• Consumers and Clinicians want safe, effective treatments
• Pharma companies are investing billions of dollars to develop microbiome therapeutics
QI Barrier Protectants … Why now?
Right now, the world is ready for treatments with beneficial microbes.
Consumers/Providers
Regulatory
Insurers
Manufacturers
Investors
Media
Right now, a Medical Device development path for QI technology means huge cost and time savings.
Right now, QI technology has competitive advantage protected by its extensive IP over live bacterial therapeutics.
The Annual US Market for QI Barrier Protectants is $6 Billion
QI Barrier Protectant
Bacterial
Vaginosis
(BV)
$1B
Symptoms: vaginal
itch, foul smell,
discharge.
Complications:
premature labor and
birth, uterine
infection, STDs.
Genitourinary Syndrome of Menopause (GSM)
$1.6B
Symptoms: vaginal dryness,
itching, painful sex, urinary
urgency, painful urination,
UTIs, sexual dysfunction.
Complications: Decreased
quality of life, urosepsis,
loss of relationships and
intimacy.
Chronic
Wounds
(CW)
$3B
Symptoms:
chronic, nonhealing wound.
Complications:
Decreased quality
of life, scarring,
sepsis, loss of limb,
mortality.
Eosinophilic Esophagitis (EOE)
$150M
Symptoms: difficulty
swallowing, acid
reflux.
Complications:
esophageal scarring,
food impaction,
perforation,
malnutrition.
Atopic Dermatitis/Skin Barrier Dysfunction (CPG)
$200M
Symptoms: itchy,
dry skin, rash.
Complications:
recurrent bacterial
infections,
decreased quality
of life.
QI Barrier Protectants: Pipeline
1
Bacterial
Vaginosis
(BV)
2
Chronic
Wounds
(CW)
3
Genitourinary Syndrome of Menopause (GSM)
4
Eosinophilic Esophagitis (EOE)
5
Atopic Dermatitis/Skin Barrier Deficiency (AD/CPG)
| Program | Indication | Funding | MOA | Pre-Clinical | CMC | Pre-Sub | Pilot Study | Efficacy Study | Rights |
|---|---|---|---|---|---|---|---|---|---|
| Qi601 | BV | Barrier | 2024 | 2025 | QI/Pharma Partner | ||||
| Qi611 | CV | DARPA | Barrier | 510k | QI | ||||
| Qi601 | GSM | Barrier | 2024 | 2025 | QI | ||||
| Qi6/Qi601 | EOE | Barrier | 2025 | 2025 | QI | ||||
| Qi601 | AD/CPG | Barrier | CPG Commercialized | QI |
Pre-Sub = FDA Pre-Submission CMC = Chemistry, Manufacturing & Controls CPG = Consumer Package Goods
First QI Product: QI BV Barrier Protectant
Clinical indication: Bacterial Vaginosis (BV)
FDA Approval of
QI BV Medical
Device:
Q2 2028
Indication: Management of symptoms of bacterial vaginosis in adults 18 years+
First QI Product: QI BV Barrier Protectant
Clinical indication: Bacterial Vaginosis (BV)
What It Is:
- Vaginal Gel
- Treatment Indication:
Bacterial Vaginosis
How It Works:
- QI Lactobacillus Biofilm Tissue Protectant adheres to and protects vaginal tissues
- Resolves tissue barrier dysfunction
- Resolves abnormal bacterial colonization in bacterial vaginosis
Why It’s Needed:
- High recurrence rate (~70%) in 1 year despite use of antibiotics
- Safer than current standard-of-care treatments
- Treats the underlying problem–vaginal barrier compromise
Financials
QI BV Barrier Protectant Estimated FDA Clearance Date : Q1 2028
Regulatory Strategy
- Medical Device: Pre-Submission (mid-2024), 510(k) clearance in early 2028
- De-Novo Application with Breakthrough Status anticipated
- Cost: ~ $0.5M
Formulation
- Novel formulation development in-house
- Outsourced to CMO in 2024 for clinical trial formulation, commercial scaling
- Cost: $1M
Medical Device Performance Testing & Manufacturing Design
- CMO final design development and verification and validation testing in preparation for commercial production; completion by 2027
- Cost: $2M
Clinical Trials
- Feasibility clinical trial design, execution and analysis; completion by 2027
- Cost: $0.5M
TOTAL: $4M
Competition BV
QI: the only biotech company developing tissue barrier device treatments
CURRENT TREATMENTS
Lupin Pharmaceuticals
Dare Biosciences
Manufacturers of generic antibiotics
secnidazole (oral)
clindamycin (vaginal gel)
metronidazole, clindamycin
DRUGS UNDER DEVELOPMENT
LUCA Biologics
Osel
Nexbiome
Ferring/Rebiotix/Mybiotix
Intralytix
L. crispatus
L. crispatus
Live bacterium
Live consortia
Phage
DEVICE UNDER DEVELOPMENT
Quorum Innovations
QI Barrier Protectant
QI ADVANTAGES:
EFFICIENCY & IP PROTECTION
Speed to market
Intellectual Property
Advanced Development Stage
Device mechanism
Global and broad, to 2040’
25 patents issued
Team
Quorum Innovations
Nicholas T. Monsul, MD.
Co-CEO & Co-Founder
Eva Berkes, MD
Co-CEO, CSO & Co-Founder
Jim Self, MBA
CBO
Chris Gardner
Director, R & D
David Whitwell, CPA, MBA
CFO
David Salinwanchik, JD
Patent Attorney/ Advisor
Ankur Ghandi
Regulatory Strategy/Product Development
Katie MacFarlane, PharmD
Market Expert / Advisor
Research, Development, and Manufacturing Overview
Play Video
Publications
Andrews, C.E. et al. “Targeted immunotherapy for glioblastoma involving whole tumor-derived autologous cells in the upfront setting after craniotomy.” Journal of Neuro-Oncology, Nov. 2023. DOI 10.1007/s11060-023-04491-4
Lee, I. et al. “Autologous cell immunotherapy (IGV-001) with IGF-1R antisense oligonucleotide in newly diagnosed glioblastoma patients.” Future Medicine, Dec. 2023. DOI 10.2217/fon-2023-0702
Perez-Olle, R. et al. “Additional Results From a Phase 1b Study of IGV-001 in Patients With Newly Diagnosed Glioblastoma” Presented at SNO 2023.
Intellectual Property
• Quorum Innovations has over 51 patents issued globally.
• 21 additional patents are pending.
• Patent term extends beyond 2040.
