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Shareholder MeetingMarch 2nd, 2018
Mr. Rajin Ahuja
Chairman
Biomarck Pharmaceuticals, LTD
Welcome & Introduction
Biomarck Pharmaceuticals
Shareholder MeetingMarch 2, 2018
NC Biotechnology Center, Durham, NC
Agenda
Welcome and Introduction Mr. Rajin Ahuja
Board Introductions Mr. Rajin Ahuja
Board Voting Mr. Rajin Ahuja
Pre-Clinical Drug Discovery Professor Ken Adler
Clinical Development Update Dr. Brian Dickson
NSCLC
ARDS
Pediatric Cancer – expanded access Dr. Brian Dickson
Financials Mr. Mike Enright
Strategic M&A Considerations Dr. Brian Dickson
Questions and Close Dr. Brian Dickson
Board IntroductionsMr. Rajin Ahuja Chairman
Mr. Thomas Roberg Vice Chairman
Dr. Brian Dickson
Dr. Ashish Bhatia
Dr. Laura Calamos Nasir
Dr. Walker Long
Mr. Kennedy O’Herron
Mr. Craig Collard
Professor Kenneth Adler
N.C. State University
Pre Clinical Discovery Update
BIO-11006 and SYNERGY WITH CHEMOTHERAPEUTIC
AGENTS
syn·er·gyˈsinərjē/noun
noun: synergy; plural noun: synergies; noun: synergism; plural noun: synergisms1.the interaction or cooperation of two or more organizations, substances, or other agents to produce a combined effect greater than the sum of their separate effects.
BIO-11006 SHOWS SYNERGY WITH CISPLATIN IN MOUSE MODELS OF NON SMALL CELL LUNG
CANCER
Average Number of Macroscopic Metastatic Tumor Nodules in Lungs
Left lu
ng
Right lung
Left lu
ng
Right lung
Left lu
ng
Right lung
Left lu
ng
Right lung
Left lu
ng
Right lung
Left lu
ng
Right lung
Left lu
ng
Right lung
Left lu
ng
Right lung
0
1
2
3
4
5
BIO-11006 (25µM)
BIO-11006 (50µM)
BIO-11006 (100µM)
BIO-11006 (25µM) + Cisplatin
BIO-11006 (50µM) + Cisplatin
BIO-11006 (100µM) + Cisplatin
Cisplatin
Vehicle Control
a
bc d,e
f,g
h,i
j
Avg.
no. o
f met
asta
tic tu
mor
nodu
les
Vehicle Contro
l
BIO-11006 (2
5µM)
BIO-11006 (5
0µM)
BIO-11006 (1
00µM)
BIO-11006 (2
5µM) +
Cisplatin
BIO-11006 (5
0µM) +
Cisplatin
BIO-11006 (1
00µM) +
Cisplatin
Cisplatin
0
1
2
3
4
Groups
a
b
cd,e
f,g
h,i
j
Avg.
no. o
f met
asta
tic tu
mor
nodu
les
Average Number of Macroscopic Metastatic Tumor Nodules in Distal
Organs (Diaphragm, Sternum, Ribs & Mediastinum)
Aerosolized BI0-11006 : Mouse Orthotopic Lung CancerPrimary Tumor Size
(peptide treatment started on Day 26, experiment finished on Day 42)
* P < 0.05** P < 0.01
Vs untreated 42 days
Prim
ary
tum
or si
ze (m
m)
U n trea t 2
5 da y s
U n trea t 4
2 da y s
B io-1
1 0 0 6 On ly
B io-1
1 0 0 6 + C
isp lt i
n
0
1
2
3
4
**
*
TRIPLE NEGATIVE BREAST CANCER
COMBINATION OF MANS + PACLITAXEL (TAXOL) SHRINKS BREAST TUMORS IN MOUSE MODEL
• WORK PERFORMED IN COLLABORATION WITH COLLEAGUES AT UC DAVIS IN CALIFORNIA
Tumors generated by orthotopic injection of MDA-MB-468 cells into the fat pad of mouse breast. Drugs were given every three days. Tumors were measured every 3 days up to Day 21, when tumors were removed and weighed. The combination of MANS + Paclitaxel blocked tumor growth in these mice.
MOA:SYNERGY WITH CHEMOTHERAPY
• CANCER CELLS DIVIDE MORE RAPIDLY THAN NORMAL CELLS
• CELL CYCLE: DIVIDING CELLS ARE IN A PHASE CALLED G2/M
• PLATINUM-BASED CHEMOTHERAPY (eg. CISPLATIN) PREFERENTIALLY KILLS FAST GROWING CELLS; eg. CELLS IN G2/M
• BIO-11006 KEEPS CANCER CELLS IN G2/M PHASE. THIS IS CALLED G2/M “CELL CYCLE ARREST”. THUS, IT WORKS TOGETHER WITH CISPLATIN, CARBOPLATIN, TAXOL, ETC. TO KILL CANCER CELLS AND SHRINK TUMORS
ActinCDK2pTyr15 (MARKER OF G1/S ARREST)
Histone H3 pser10 (MARKER OF G2/M ARREST)
MARCKS
siRNA
CTL
Bio-
1100
6
BIO-11006 or MARCKS siRNA induce G2/M cell cycle arrest in cancer cells
G1/S arrested
G2/M arrested
Loading control
• Platinum-based chemotherapy causes cell cycle arrest in G2 phase and accumulation of cancer cells in G2/M phase, ultimately leading to apoptosis (Cell Death).
Cell replication occurs in a series of phases, called the cell cycle. The cell cycle phases are: resting (G0; nothing is happening), G1 (or gap 1; a growth phase), S (synthesis; the replication of DNA occurs), G2 (gap 2; another growth phase), and M (mitosis; the actual division from 1 cell into 2).
Rapidly dividing cells are more likely to be in G2/M phase. The more rapidly cells are replicating, the more time they spend in G2/M phase.
METHOD OF ACTION (MOA) OF SYNERGY BETWEEN BIO-11006 AND CHEMOTHERAPEUTIC AGENTS
CELL CYCLE
MOA OF SYNERGY BETWEEN BIO-11006 AND CHEMOTHERAPEUTIC AGENTS
• CANCER CELLS DIVIDE MORE RAPIDLY THAN NORMAL CELLS
• RAPIDLY DIVIDING CELLS ARE IN G2/M PHASE MORE THAN NORMAL
• PLATINUM-BASED CHEMOTHERAPY (eg. CISPLATIN) PREFERENTIALLY KILLS FAST GROWING CELLS (eg. CELLS IN G2/M)
• BIO-11006 KEEPS CANCER CELLS IN G2/M PHASE. THIS IS CALLED G2/M “CELL CYCLE ARREST”. THUS, IT WORKS TOGETHER WITH CISPLATIN, CARBOPLATIN, TAXOL, ETC. TO KILL CANCER CELLS AND SHRINK TUMORS
CELL CYCLE
Dr. Brian Dickson
Chief Executive Officer
Biomarck Pharmaceuticals, LTD
Clinical Development Update
Clinical Development Update
ARDS
Opportunity• Unmet Need• Other Studies
Study Progress• UNC, Vanderbilt, University of Chicago• Duke, University of Pennsylvania• Enrollment• AE• Timing
Clinical Development Update
NSCLCOpportunity
• Unmet Need• Immunotherapeutics• Interaction – Potentiation
- Reduce AE
Study Progress• Regulatory• Drug Import• CRO / Cliantha• Enrollment• AE• Timing
Pediatric Cancer
(Expanded Access)
• Individual• Diffuse Intrinsic Pontine Glioma (DIPG)• Intranasal (BBB)
• Study• Sarcoma• Lung Secondary Tumors• Miami Children’s Hospital• Supplies Available• Controlled Study
• 19 year old male with synovial sarcoma and extensive lung metastases• No response to all approved treatments• Given BIO-11006 for 2 months – no effect• Severe pain, unable to walk, severely out of breath• One month life expectancy, DNR issued• Given Trabectedin as palliative therapy, 3 days after BIO-11006• Dramatic improvement (not reported before with Trabectedin alone)• Now walking, no pain or shortness of breath • CT scan confirmed significant reduction in lung metastases• Studies planned to explore if BIO-11006 potentiates chemotherapy (Taxol,
Cisplatin, Trabectedin)
Pediatric SarcomaSynergy between BIO-11006 and Trabectedin?
Strategic M&A Considerations
Reviewing All/Best Options for Shareholders
Any Action Will Require a Vote• Co-Development• Licensing• Merger/Acquisition
Bio International• Boston, MA – June 2018• Presentation• One on One Meetings• >10,000 Attendees
Press Releases• ARDS 11/2017• NSCLC 01/2018
Questions
Close