Immutep Ltd · ASX:IMM
Immutep — Prima BioMed — Shareholder Meeting (November 2016)
27 slides from Immutep's shareholder meeting presentation, Nov 28, 2016
Slide 1: Annual General Meeting CEO Presentation
Prima BioMed Annual General Meeting CEO Presentation November 25, 2016 ASX:PRR; NASDAQ:PBMD Marc Voigt
Slide 2: Notice: Forward Looking Statements
Notice: Forward Looking Statements The purpose of the presentation is to provide an update of the business of Prima BioMed Ltd ACN 009 237 889 (ASX:PRR; NASDAQ:PBMD). These slides have been prepared as a presentation aid only and the information they contain may require further explanation and/or cl
Slide 3: 2016 Highlights
Corporate Sound financial management Sydys partnering of CVac™ Significant analyst coverage JP Morgan, ASCO, ESMO,SITC conferences 3 Patents granted 2016 Highlights Clinical First Chinese manufactured biologic dosed in Europe TACTI-mel initiated and first patients dosed – encouraging safety data AIP
Slide 4: Key Financials
Key Financials Ticker ASX: PRR; NASDAQ: PBMD Market Cap AUD $78.72M (23 Nov 16) Shares on Issue 2,071,537,809 (23 Nov 16) Options on Issue 77,378,693 Net Operating cash outflow FY 16 AUD $11.3M G&A AUD $6.98M Expenses FY 16 R&D and Intellectual Property AUD $7.06M Expenses FY16 Cash in bank AUD $18.
Slide 5: Program Update
PROGRAM UPDATE
Slide 6: Pipeline
Pipeline LAG-3 Technologies IMP321 Preclinical Phase I Phase IIa Phase IIb Metastatic Breast Cancer Proof of Concept Study in Metastatic Melanoma IMP731 Autoimmune Diseases IMP701 Cancer Autologous Dendritic Cell Therapy CVac™ Ovarian Cancer WW Prima (ex China: Eddingpharm) Phase IIb trial began Oct
Slide 7: IMP321 – one product, many applications
IMP321 – one product, many applications Chemoimmunotherapy- AIPAC I-O Combination Therapy – TACTI-mel Direct Injection—INSIGHT Cancer Vaccine Therapy – Yamaguchi/NEC
Slide 8: AIPAC- Active IMmunotherapy with PAClitaxel
AIPAC- Active IMmunotherapy with PAClitaxel Chemoimmunotherapy – adding an antigen presenting cell (APC) activator after chemotherapy treatment to boost immune responses. Encouraging scientific advice from EMA July 2015 Initiated Dec 2015 First patient dosed Feb 2016 First safety, PK and immune moni
Slide 9: IMP321 – AIPAC
IMP321 – AIPAC AIPAC trial: Active Immunotherapy PAClitaxel Phase IIb chemo-immunotherapy in metastatic breast cancer in different EU countries Arm 1, 98 patients: paclitaxel + Safety-run in, IMP321 15 (6+9) patients, 2 cohorts Arm 2, 98 patients: paclitaxel + placebo First patient in Feb. 2016 Over
Slide 10: TACTI-mel
TACTI-mel Two Active Immunotherapies in melanoma Combination therapy – combining an APC activator and a checkpoint inhibitor to kick start the immune response after removing the brake. Initiated Jan 2016 Being conducted at 6 sites in Australia First patient dosed May 2016 First safety and immune mon
Slide 11: IMP321 – TACTI-mel
IMP321 – TACTI-mel TACTI-mel trial: Two ACTive Immunotherapeutics in melanoma Phase I study in immuno-immuno combination in unresectable or metastatic melanoma in Australia up to 24 patients, 3 cohorts, IMP321 + anti-PD-1 (Keytrudaâ) max. 8 patients each First patient in May 2016 Overview Design Pha
Slide 12: Partner IMP321 trials…
Partner IMP321 trials… Yamaguchi/NEC have commenced clinical research using IMP321 as an adjuvant together with their own peptides and adjuvant in solid tumours. INSIGHT trial – German investigator sponsored trial in solid tumours testing direct intra- tumoral injection – currently waiting CA and EC
Slide 13: IMP731 Update
IMP731 Update GSK2831781, GSK’s investigational product derived from IMP731 antibody, in ongoing clinical trial in the context of autoimmune diseases To our knowledge, no other company has yet generated an antibody capable of depleting LAG-3 expressing activated T cells Up to ?64m in total upfront a
Slide 14: IMP701 update
IMP701 update Phase I milestone received August LAG-525 derived from IMP701, in ongoing clinical trials in context of melanoma, lung and renal cancer Works by blocking LAG-3-mediated immune down-regulation (removes brake) In June 2016, Novartis amended their trial to increase enrollment from 240 to
Slide 15: CVac™
CVac™ May 2016—Sale and Licensing Agreement with Sydys to advance CVac™ Program Prima received a 9.9% equity stake in Sydys for the assets being transferred In the event of successful commercialisation of CVac, Prima could receive milestone payments and low single digit royalties on sales Provides o
Slide 16: The Market Opportunity for IMP321
The Market Opportunity for IMP321 Activator and Inhibitor
Slide 17: The I-O market is hot
The I-O market is hot The global cancer immunotherapy market is expected to reach • US$35 Billion by 2023* World-wide Q2 2016 sales for the following drugs were Yervoy® (US$241m), Opdivo® (US$840m), Keytruda® (US$314m), Tecentriq® (19m CHF) *Citi Research: Immunotherapy the beginning of the end. And
Slide 18: The LAG-3 landscape—beyond IMP321
The LAG-3 landscape—beyond IMP321 Prima together with its partners, is the global leader in developing LAG-3 related products (IMP321, IMP701 and IMP731) Increasing global R&D of LAG-3 related product candidates – we are in the right space! clinical trials pre-clinical trials Novartis (Prima’s partn
Slide 19: IP Portfolio patent families providing broad protection
IP Portfolio 12 patent families providing broad protection across all LAG-3 assets Comprises 89 pending or granted applications excluding those licensed to GSK and Novartis Protection for methods of use of IMP321 may extend to 2036 excluding SPC or term adjustments Regularly review our R&D activitie
Slide 20: Opportunity in Metastatic Breast Cancer
Opportunity in Metastatic Breast Cancer 30% of breast cancer patients have metastatic disease (at diagnosis or more frequently through recurrence)1 and 2 out of 3 are HR positive2 Metastatic breast cancer (MBC) patients have a median survival of 2-4 years3 5-year relative survival rate is approximat
Slide 21: Metastatic Breast Cancer Market
Metastatic Breast Cancer Market HER2- HR+ patient group is our primary target Potential label extension is feasible AIPAC: study in hormone receptor-positive (ER+PR+) metastatic breast carcinoma patients with IMP321 + paclitaxel Primary target patients • Global incidence of new cases of all breast c
Slide 22: Commercial Development Strategy
Commercial Development Strategy
Slide 23: Work in Progress
Work in Progress Active business development Manufacturing discussions ongoing to secure future clinical and commercial supply of IMP321 International Nonproprietary Name (INN) filed – to be announced 2017 Active research Opportunity for IMP321 approval by EMA – subject to Ph IIb positive results
Slide 24: Upcoming Milestones and Summary
UPCOMING MILESTONES AND SUMMARY
Slide 25: Upcoming Milestones
Upcoming Milestones Clinical Dec 2016: Safety-run-in results of AIPAC: immuno-monitoring data and safety data; first TACTI-mel data Q1 2017 Start of randomised phase for AIPAC Q1 2017: TACTI-mel: Dose escalation Throughout 2017: TACTI-mel results from different cohorts Mid 2017 Efficacy data from AI
Slide 26: Summary
Summary We have multiple ongoing clinical developments with several value inflection points We have strong partners with demonstrated commitment to continued development in clinical phases We have a solid cash position and sound financial management
Slide 27: Thank you!
NASDAQ: PBMD, ASX: PRR Thank you!