Immunicum Establishing a unique immuno-oncology approach by developing allogeneic, off-the-shelf, cell-based therapies - abid
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Immunicum Establishing a unique immuno-oncology approach by developing allogeneic, off-the-shelf, cell-based therapies Company Presentation November 2018
Disclaimer
This presentation contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical
facts, contained in this presentation, including statements regarding Immunicum’s view on strategy, future operations, future clinical development plans and
objectives, future financial position, future revenues, projected costs, prospects, plans and objectives of management, are forward-looking statements. The
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undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in
the forward-looking statements we make. The forward-looking statements contained in this presentation reflect Immunicum’s current views with respect to
future events, and Immunicum assumes no obligation to update any forward-looking statements except as required by applicable law. Our actual results
and/or actual events could differ materially from those anticipated in forward-looking statements for many reasons, including, without limitation, risks
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us, as presented in financial reports, press releases and in other contexts, and about the business fields and markets in which we are active, as presented
in, inter alia, scientific and other publications (although we do not assume any responsibility for information about us obtained from third parties).
2
Immunicum: corporate highlights
Immuno-Oncology: fastest growing market delivering breakthrough therapies
Ilixadencel: unique off-the-shelf cell therapy that kick-starts immune response
Phase 2 study fully enrolled; multiple studies ongoing, over 90 patients treated
Public company at Nasdaq Stockholm, announced SEK 351 M capital raise
3
Project pipeline
Product & Indication Combination Preclinical Phase I/II Phase II Phase III
Ilixadencel: an off-the-shelf cancer immune primer
Renal cell carcinoma Kinase inhibitors
Hepatocellular carcinoma Kinase inhibitors
Gastrointestinal stromal tumors Kinase inhibitors
Head and neck squamous cell carcinoma Checkpoint inhibitors
Non-small cell lung cancer Checkpoint inhibitors start enrollment 2H2018
Gastric adenocarcinoma Checkpoint inhibitors
IMM-2: allogeneic dendritic cells with adenovirus
coding for tumor antigens
IMM-3: optimized CAR-T expansion protocol
for improved anti-cancer activity
4
Ilixadencel as backbone therapy in the cancer immunity cycle:
“pushing the gas” to turn cold tumors into hot tumors for immunotherapy
4 Trafficking of CD8+ “killer” T cells to cancer tissue
Priming and activation of CD8+ T cell
3 BL 5 Infiltration of T cells into cancer tissue
immune response to neoantigens OO
LY D
MP VE
H SS
NO EL
DE
OR
TUM
Transport of neoantigens by ILIXADENCEL
2 INJECTION 6 Recognition of cancer cells by T cells
dendritic cells to lymph nodes
Release of tumor neoantigens and Killing of cancer cells
1 7
recruitment of dendritic cells
PUSH THE GAS: RELEASE THE BRAKE:
ACTIVATE THE IMMUNE SYSTEM BLOCK CANCER IMMUNE SUPPRESSION
and/or KILL CANCER CELLS
Immunicum’s ilixadencel primes and checkpoint inhibitors (Keytruda®/Opdivo®)
activates the immune system to tyrosine kinase inhibitors (sunitinib)
recognize and find cancer cells chemotherapies (gemcitabine)
5
Ilixadencel: a unique off-the-shelf immune primer
Cell based, off-the-shelf immunotherapy product
• Allogeneic cells from healthy donor leukapheresis
• GMP-production at German CMO
• Proprietary method with cocktail to create pro-inflammatory dendritic cells
not a vaccine!
Intratumoral administration
• Applicable to all injectable solid tumors
• Using the tumor as the source of neoantigens as in situ vaccination
• Off-the-shelf approach inducing an individualized response
ILIXADENCEL PRODUCTION
Healthy
1X donor
sample
100X ilixadencel
doses 50X Patients
treated
3 YEAR SHELF-LIFE
6
Ilixadencel: unique mechanism of action in the tumor
Recruits and activates the patient’s own immune cells to prime a cytotoxic Th1 response against the released neoantigens
7
Ilixadencel – RCC Phase 1/2 Study Completed
Phase 1/2 RCC: intratumoral injection in kidney of metastatic
patients results in tumor-specific CD8+ T cell in blood and tumor
RENAL CELL CARCINOMA (RCC)
S
KIDNEY
TUMOR
Normal kidney tissue surrounding
Untreated tumor area (reference) Treated tumor area Metastasis
treated tumor area
A reference slide demonstrating the A massive infiltration of cancer specific A clear absence of T cells outside of A clear increased presence of CD8+ T
amount of T cells (black dots) in a CD8+ T cells in the tumor after the tumor site (similar to a healthy cells at a distant metastasis
non-treated tumor. injection of ilixadencel. tissue) supporting that the massive demonstrates that the immune system
infiltration is tumor-specific. is also able to identify and target
cancer cells in other parts of the body.
Laurell et al., Journal for ImmunoTherapy of Cancer 2017
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Phase 1/2 RCC: overall survival in mRCC patients more than
tripled vs historical data
Historical median OS of 14-16 months with sunitinib in newly Median OS of 48 months with ilixadencel
diagnosed mRCC patients (Heng 2009; Ko 2014; Mejean 2018) (Laurell et al., J Immunother Cancer 2017)
Still alive
Start of TKI
0 10 20 30 40 50 60 70
Time (in months) from start of ilixadencel treatment (as of January 2018)
10Phase 1/2 case report: ilixadencel followed by sunitinib
results in complete remission of brain and liver metastases
• Poor prognosis patient with multiple brain, lung and liver metastases PRIOR TO TREATMENT 6 MONTHS POST TREATMENT
• Received sunitinib due to progression after ilixadencel and surgery
• Complete response of all brain and liver metastases
• 66 months after ilixadencel treatment patient is still alive (October 2018*)
• Literature on RCC patients with brain metastases1:
Complete response of the brain
• 0% response in brain metastases to sunitinib (0/16 patients) Patient with brain metastases before
sunitinib treatment
metastases 6 months after start of
sunitinib
• 6.3 months overall survival in these 16 patients
• Potential combination synergy as sunitinib may block tumor’s defense against activated immune response
• Phase 2 study includes sunitinib for all patients after ilixadencel injections, versus sunitinib alone
* Later follow-up than included in survival graph
1) Chevreau et al., Clin Genitourin Cancer 2014
11Ilixadencel Backbone Immunotherapy for Solid Tumors in Major Indications
Ilixadencel as backbone: positioning in combination
TYROSINE KINASE INHIBITORS CHECKPOINT INHIBITORS
Kidney Liver Gastrointestinal Head and Neck Lung Gastric
(RCC) (HCC) (GIST) (HNSCC) (NSCLC) (GA/GEJ)
Phase 2 study in RCC (MERECA) fully enrolled Phase 1b/2 multi-indication study (ILIAD) now initiating
• Randomized controlled study with 88 patients in US and EU • Phase 1b study (n=21) with PD1 inhibitor pembrolizumab
• Ilixadencel followed by sunitinib, vs. sunitinib alone • Subsequent Phase 2 controlled studies per indication
• Q3 2019: top-line results • July 2018: FDA approval to allow initiation of study in US
• 2019: safety and initial dosing results expected
Phase 1/2 study in HCC completed, ongoing in GIST Preclinical Proof of Concept poster at ESMO 2018
• H2 2018: publication of HCC results expected • Synergy with checkpoint inhibitors and immune enhancers
• 2019: top-line results in GIST expected • October 2018: poster with results at ESMO conference
CONFIDENTIAL 13Capital raise of SEK 351 M with strong institutional investors in Directed Issue
and fully guaranteed Rights Issue
B A C K G R O U N D A N D R E A S O N S
S E K Directed Issue with binding subscription commitments from a number of
institutional investors, including:
178M Fourth AP-fund: SEK 38 M Gladiator: SEK 32 M
Second AP-fund: SEK 21 M Alfred Berg: SEK 20 M
Directed Issue
Nordic Cross: SEK 17 M Adrigo: SEK 10 M
Other private and institutional investors: total SEK 40 M
The capital raised is primarily intended to finance:
• extended Phase Ib/II combination study;
S E K
• investment into commercial process development and manufacturing;
173M • supportive preclinical development; and
• strengthen position in future license negotiations with major
pharmaceutical companies
Rights Issue
K E Y D A T E S
8 November: 26 November – 10 December:
EGM Subscription period
SUBSCRIPTION PRICE 21 November: 26 November – 6 December:
Record date Trading in subscription rights
SEK 8.5 Around 13 December:
Publication of outcome Rights Issue
CONFIDENTIAL 14Immunicum: corporate highlights
Unique Positioning Advanced Stage
Innovative immune primer Phase 2 fully enrolled
Off-the-shelf cell therapy Safety in 90 patients
Backbone therapy Robust manufacturing
Experienced Team Growth Opportunity
Pharma & Biotech Immuno-Oncology market
Founder as CSO SEK 351 M capital raise
CMC & Regulatory Value-inflection data in 2019
15Immunicum Establishing a unique immuno-oncology approach by developing allogeneic, off-the-shelf, cell-based therapies Thank you! ir@immunicum.com
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