Embed Size (px)
Citation preview
} We are a biopharmaceutical company that is developing a pipeline of novel drugs with strong intellectual property based on established API.
} Our products are subject to the 505b(2) regulatory pathway providing for a streamlined development process.
} We are seeking a strategic partner for our lead clinical stage asset 10XB-101 a novel adipolytic for body contouring.
10xBio, LLC 2
} Transformational adipolytic drug product for local fat reduction◦ Expand adipolyitc drug therapy to broader range of body areas◦ Solves existing problems related to tolerability, dosing regimen,
and cost over currently marketed Kybella in submental area.} IND Open in 12/17
� 505b(2) regulatory pathway} Proof of concept demonstrated in abdomen
� High tolerability profile with no safety issues identified� Dose dependent adipolysis demonstrated� Patient and physician suggest clinically evident adipolytic effects� Significant dosing headroom to optimize therapy
} PH 2 ready Q3 2019 for abdominal and/or submental trial(s)
} Formulation complete with 1 year stability and accelerated aging
} 3 issued U.S. patents} Top program management in place
10xBio, LLC 3
} John Dobak, M.D., Executive Chairman and Founder, is currently the CEO of DermTech. Dr. Dobak has been developing medical technology for 20 years ranging from cardiovascular devices to molecular diagnostics to pharmaceutical products. Dr. Dobak Former Founder and CEO of Lithera, Inc. that developed an injectable lipolytic drug.
} Dan Piacquadio, M.D., CEO of Therapeutics, Inc., a dermatology CRO and drug development company. Dr. Piacquadio has developed numerous products through FDA approval.
10xBio, LLC 4
10xBio, LLC 5
} Global non-invasive fat removal market estimated at $4.0BB*
} Dominated by devices} Mild effects} Multiple treatment sessions} Optimized injectable could have
much larger market than the device market◦ Ratio of injectable wrinkle treatment to
device wrinkle treatment ≈10:1
10xBio, LLC 6
0
50,000
100,000
150,000
200,000
250,000
300,000
350,000
400,000
# Pr
oced
ures
2012
2013
2014
2015
2016
2017
*Zeltiq Presentation JPM 2016, ASPS Plastic Surgery Statistics
Zeltiq Procedure Volumes
Treatment Area Potential PatientsAbdomen/Flanks 12.0 MMInner Thighs 5.0 MMOuter Thighs 4.0 MMButtocks 4.0 MMArms 4.0 MMSubmentum 3.0 MMGynecomastia 0.5 MMTOTAL POTENTIAL 36.5 MM
10xBio, LLC 7
*Zeltiq-Rabin Research Report, interview of 1,076 US men and women
Polidocanol STS DeoxycholateType Synthetic, non-ionic Synthetic, Ionic Biologic, IonicIndications Sclerotherapy Sclerotherapy Fat reductionInflammation Low Moderate HighPain Low Moderate HighSwelling Low Moderate HighTx Volume Large Moderate SmallIP Fat Tx 10xBio 10xBio Allergan
10xBio, LLC 8
5-12
• Kybella– Sodium Deoxycholate– Ionic detergent– Lyses cell membrane– Product approved May of 2015– Marketed in Europe as BelKyra– Kybella Acquired by Allergan in
2015 for $2.1 BB
10xBio, LLC 9
DeoxycholateMolecule
52000
54000
56000
58000
60000
62000
64000
Procedures
Injection AdipolysisProcedures
2016 2017
ASPS Aesthetic Procedure Volumes, 2018
} High price ◦ exceeds the cost of
submental liposuction} Pain◦ Injection likened to bee sting
} Swelling◦ can last 7-10 days
} Inflammation◦ leads to extended treatment
time of 6-9 months} Limited injection volume◦ 0.2 ml limits use in other
body area indications
10xBio, LLC 10
Injection procedure
Survey of Limitations For Kybella (ATX101) Use
Poster Presented at ASDS, 2018 Meeting
1. Cost (87%)2. Swelling (50%)3. Multiple Tx/Time to Effect
(43%)4. Downtime (33%)5. Pain/Discomfort (13%)
10xBio, LLC 11
Schlesinger, M.D.
10xBio, LLC 12
Kybella post procedure swelling, erythema, and bruising
Small injection volume, pricing, and product packaging, limits treatment to small target areas such as submentum
or highly localized abdominal
Deoxycholate is a bioactive signaling molecule and not just a natural detergent
Deoxycholate (DCA) Stimulates IL-1B release from macrophages
} Deoxycholate receptor TGR5 activates TRPA1 and neurogenic inflammation
} Recruits neutrophils and activates neutrophils
} Upregulates inflammatory mediators- MPO, PGE2, IL-6, IL-1B
10xBio, LLC 13
Front Immunol, 2016 7:536 doi: https://dx.doi.org/10.3389%2Ffimmu.2016.00536
} 10XB-101 (polidocanol) ◦ Demonstrates improved side effects in animals and
humans with similar adipolytic effects◦ Non-ionic detergent◦ Synthetic with no known receptor interactions◦ Approved in U.S. for sclerotherapy
} Benefits◦ Higher tolerability� Less pain, swelling, inflammation◦ Larger injection volumes= expanded treatment areas◦ Shorter treatment interval◦ Broaden indications to other body areas
10xBio, LLC 14
5-12
PolidocanolMolecule(s)
} Issued Patents◦ 9,351,945, Filed 10/15, term 2035- Methods of
adipose treatment using polidocanol◦ 9,844,520, Filed 4/16, term 2035- Compositions
and formulations using polidocanol◦ 9,687,455, Filed 8/15, term 2035- Methods of
adipose treatment using sodium tetradecyl sulfate} Continuations◦ 15/810,964, filed 11/17
} PCT◦ US2016/019366
10xBio, LLC 15
Abdominoplasty, - up to 0.6 ml single injections, up to 30 injections, 30 day tissue harvest for pathology review
Post injection Images
} 3 concentrations tested} 3 volumes of injection tested} No Treatment Related AEs or
SAEs} Local Reactions: (redness,
swelling, pain, bruising)◦ Grade 0-2 (4 point scale)◦ Spontaneously resolved with no
treatment} Fat atrophy grade 1-2
documented in majority of patients
} Safety Labs WNL
10xBio, LLC 16
1 Hour Post Tx Dose 3 (high),
Volume 3 (high)
24 Hours Post TxDose 3, Volume 3Minimal Redness
and Edema
10xBio, LLC 17
Day 1, BaselinePost Injection Acute Tolerability Cohort B
Dose 2 Dose 3 VEHPain 0/2 1/2 0/4Tenderness 0/2 1/2 0/4Erythema - Grade 1 2/2 2/2 1/4Edema - Grade 1 0/2 2/2 0/4Bruising 0/2 0/2 0/4
▶ Four point scale grading (0-none, 1-mild, 2-moderate, 3-severe)
▶ Rare mild to moderate local tolerability s/p therapy
▶ All moderate local tolerability scores resolved by Day 2, all mild resolved by Day 30
▶ No bruising, burning/sting detected at any time point
▶ No safety signal detected (AEs/SAEs)
10xBio, LLC 18
Summary of All Study Visit Local Skin Reactions for Cohort B (Excluding Fat Atrophy)
Dose Concentration 0 - Absent 1 - Mild 2 - Moderate Total* n % n % n % N %
Dose 1 89 92.7 7 7.3 0 0 96 100.0 Dose 2 62 68.9 24 26.7 4 4.4 90 100.0 Vehicle 184 98.9 2 1.1 0 0 186 100.0
*Includes LSRs at Visit 2 (post injection) and Visits 3, 4, 5, 6, 7, and 8.
Summary of All Study Visit Local Skin Reactions for Cohort C (Excluding Fat Atrophy)
Dose Concentration 0 - Absent 1 - Mild 2 - Moderate Total*
n % n % n % N % Dose 1 87 90.6 7 7.3 2 2.1 96 100.0 Dose 2 67 69.8 25 26.0 4 4.2 96 100.0 Vehicle 187 97.4 5 2.6 0 0 192 100.0
*Includes LSRs at Visit 2 (post injection) and Visits 3, 4, 5, 6, 7, and 8.
10xBio, LLC 19
• Starting in week 2 and maximal by Day 28• Vehicle control grade 0 at all time points
▶ Physician reported fat atrophy in 75% of patients
▶ Patient reported fat atrophy in majority of patients
▶ Surprising result in context of extreme size of abdomens enrolled in study
Findings
75%
0%0%
20%
40%
60%
80%
100%
% Pa
tient
s w
ith F
at a
trop
hy
Fat Atrophy >/= Grade 1
Treatment Vehicle
Blinded evaluation: Composite = necrosis, inflammation, area, vasculopathy
Histopathology
Dose Composite Score
Dose 3 6.5Dose 2 5.1Dose 1 3.8Vehicle 0
10xBio, LLC 20*Cohort A analysis
} Commence Q3 2019} Single treatment, 30 injections} 3 concentrations to be tested} 3 patients per cohort
10xBio, LLC 21
Injection procedure
} Next generation adipolytic drug product} Strong potential for improved tolerability
profile and expanded usage◦ Larger treatment volumes
} 505 (b)2 with reduced development risk, time, and cost◦ Long history of API safety
} Large market opportunity
10xBio, LLC 22
