Immunotherapy Against Metastasis - PowerPoint Presentation

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Immunotherapy Against Metastasis

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Entering phase IIb placebo-controlled study in 2019

Safe Harbour StatementThe following presentation may include predictions, estimates or other information that might be considered forward-looking. The statements regarding the surrounding world and future circumstances in this presentation reflect RhoVac´s current thinking with respect to future events and financial performance. Prospective statements only express the assessments and assumptions the company makes at the time of the presentation. These statements are well considered, but the audience should note that, as with all prospective assessments, they are associated with risks and uncertainties.

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Utilize body’s own immune system, through T-cell activation, to fight cancer cellsRhoVac’s drug candidate, RV001, targets the protein RhoC which is documented to be overexpressed in almost all cancer cells having metastatic potential ⃰ We cooperate with the body's immune system - instead of working against it

BioStock Stockholm April 29, 2019

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⃰

Clark et al. 2000; Hakem et al. 2005; Wenandy et al. 2008; Karlsson et al. 2009; Yang et al. 2016; et al

RV001 Immunotherapy against disease progression

RhoVac has a unique immuno-oncology product: anti-metastasis for early stage of disease progression, applicable to a broad range of cancersAdjuvant Treatment of Prostate Cancer Patients with biochemical failure, Following Definitive Local TherapyProject has completed phase I/II clinical study and is now entering clinical phase IIb in placebo-controlled studyEvery year, 1.0 million (2018) new patients are diagnosed with localized prostate cancer. Following definitive local therapy 40% of these patients are expected to metastasize.Clinical development in an additional indication, in combination with a check-point inhibitor, is planned.

BioStock Stockholm April 29, 2019

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Anti-metastasis immunotherapy

Development Plan – 2019 to 2022

5Scientific Advice, EMAPre-IND Meeting, FDA

CTA Submission

PIP (Paediatric Investigation Plans)

Ongoing Research Collaboration

Immunotherapy/immune-monitoring -

University of Tübingen and Centre for Cancer Immune Therapy

Cancer stem cells –

Lund University

Start of phase IIb trial

Late Stage CMC Development

Explorative clinical trial

Completion of Phase

Ilb

Listing on

AktieTorget

(Spotlight)

Toxicological Study completed

Approval of CTA

Start of Clinical phase I/II Study

Completion of Clinical Study phase I/II

Immunological Analysis

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ManagementBioStock Stockholm April 29, 2019

6Anders Ljungqvist, MSc.Pharm, CEO, CSO & founder35+ years of experience from pharmaceutical and biotech industry

Extensive CMC, QA/GMP and project development experiencePrevious successful exit with

SurVac ApS

Anders

Månsson

,

BSc, Executive MBA, Business Development and Communication

25+ years of experience from pharmaceutical and biotech industry

Substantial track record leading major divestments, licensing and acquisitions in life science industry

Substantial management experience in portfolio management

Henrik

Stage

,

MSc, Finance, CFO

25+ years of executive experience in biotech and finance

Successful exit in 2014 with

Santaris

Pharma AS (to Roche)

10+ international deals in biotech

Clinical and Regulatory DevelopmentBioStock Stockholm April 29, 2019

7Steven Glazer, MD, Medical Director30+ years experience from pharma-, diagnostic- and biotech industry in Europe and USAExtensive clinical experience on both operational and executive levels.

Extensive experience is project development from pre-clinical to commercialization

Ann Christine Korsgaard

,

MSc. Pharm, Regulatory Affairs

20+ years of experience from pharma- and biotech industry

Extensive regulatory experience on both operational and executive levels

Extensive interaction with EMA, FDA, PMDA (Japan) and National Competent Authorities

Malene Weis,

MSc, Clinical Coordinator

20+ years of clinical experience in pharma- and biotech industry

Extensive clinical experience on both operational and executive levels

Previous clinical experience with cancer vaccine development

Andrew Stone,

MSc Medical Statistics, Biostatistician

25+ years experience from pharma- and biotech industry

20+ years experience in oncology and with interactions with both EMA and FDA

Author of a number of statistical publications and invited speaker at drug development conferences

DC capturing, absorbing and processing the antigen become “Antigen-Presenting-Cells” (APC) T-cell Activation Concept

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“APC“ interact with "naïve” T-cells which are programmed to recognize the antigen fragment and thus become to cytotoxic T-cells".

If cytotoxic T-cells meet cells that present the antigen fragment, they attack the these cells and eliminate them.

Sipuleucel-T

Docetaxel

Tumor Volume

Time (yr)

Cabazitaxel

RhoVac, 2018

Castrate resistant disease

Hormonal therapy - ADT

Recurrent disease

Non-metastatic Micro-metastasis Formation Metastatic

Castration Sensitive

Castration Resistant

CRPC

mCRPC

Chemotherapy

Targeting Cancer in Early Stage

1

st

line hormone therapy

Surgery

Radiation

2

nd

line hormone therapy

ADT

:

androgen deprivation therapy

CRPC

: castration-resistant prostate cancer

mCRPC

: metastatic castration-resistant prostate cancer

Immunotherapy

PSA rise

Localized

disease

Monitoring

After response to ADT, nearly all patients progress to CRPC within 18 to 24 months

30-50% treated with surgery or radiation experience recurrence of disease

American Cancer Society

Current Treatment Landscape In Prostate Cancer Medical, Daecher 2018

Drug management of prostate cancer, Higano, 2010

Prostate Cancer: Current Management and Future Directions,

Lynn Cancer Institute

Life expectancy drops from 100% to 30% from localised to metastatic disease.

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Prostate Cancer Progression

80% of CRPC patients develop metastasis. 46% within 2 years.

Sipuleucel-T

Docetaxel

Tumor Volume

Time (yr)

Cabazitaxel

RhoVac, 2018

Castrate resistant disease

Hormonal therapy - ADT

RV001

Non-metastatic Micro-metastasis Formation Metastatic

Castration Sensitive

Castration Resistant

Chemotherapy

Targeting Cancer in Early Stage

Xtandi

Zytiga,

Erleada

ADT

GnRH agonists

Selected Pipeline

Cabazitaxel

Xofigo, Docetaxel

Provenge

1

st

line hormone therapy

Surgery

Radiation

2

nd

line hormone therapy

* Cancer Vaccines

Immunotherapy

Active surveillance

Watchful waiting

Monitoring

Xtandi+leuprolide

ProscaVax*

Darolutamide

Xtandi+ADT

Erleada+ADT

Erleada+gnRH+

radiation

ProscaVax*

DCVAC/Pca*

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Marketed Products and Selected Pipeline

Phase I/II Clinical Trial : Study ResultsPrimary Objective, Safety and TolerabilitySafetyProportion of patients developing treatment related Grade 3, 4 or 5 toxicity in accordance with CTCAEThere were no treatment related Grade 3, 4 or 5 toxicity during the study TolerabilityGood compliance to treatment and no withdrawals due to safetyPatients only experienced mild (≤ Grade 2), reversible injection site reactionsRV001 was shown to be safe and well tolerated in patients with prostate cancer

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Phase I/II Clinical Trial : Study ResultsSecondary Objective, Immunological Response18 out of 21 patients (86%) were Confirmed Immune Responders

RV001-mediated immune response is established and the selected dose is biologically active

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Phase IIb Clinical Study – In Progress

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A Double-Blind, Placebo-Controlled Study of RV001, in Men with Biochemical Failure Following Definitive Local Therapy

(e.g. Prostatectomy, Radiotherapy)

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150 (175) patients with biochemical (PSA) recurrence following definitive local therapy will be recruited.

F

irst

-patient-in to analysis of primary end-point is estimated to 24 months

Analysis of PSA doubling time in each patient ≤12 months treatment

Primary Objective

:

To evaluate if RV001 can

reduce prostate-specific antigen (PSA) progression compared to the control group.

Time to PSA progression will be defined as the time for each patient’s PSA to double

Well defined endpoint to monitor PSA progression and also clinical practice

Secondary Endpoints

: To evaluate if RV001

can delay the time to subsequent antineoplastic therapy initiation.

Regulatory Strategy for RV001BioStock Stockholm April 29, 201914

SME Status

ITF/SME meeting

Pre-IND meeting

Ped

.

Sci.Adv

.

EMA

Sci.Adv

.

Fast track status

DK Nat.

Sci.Adv

.

Today

CTA

Subm

.

IND

RhoVac has a unique immuno-oncology product: anti-metastasis for early stage of disease progression, applicable to a broad range of cancersAdjuvant Treatment of Prostate Cancer Patients with biochemical failure, Following Definitive Local TherapyProject has completed phase I/II clinical study and is now entering clinical phase IIb in placebo-controlled studyEvery year, 1.0 million (2018) new patients are diagnosed with localized prostate cancer. Following definitive local therapy 40% of these patients are expected to metastasize.Clinical development in an additional indication, in combination with a check-point inhibitor, is planned.

BioStock Stockholm April 29, 2019

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Anti-metastasis immunotherapy

Rights Issue, pending approval at XGM 29-May-2019

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Share information

Date of listing

9 March 2016

Price at listing

8.3 SEK

Price (25-Apr-19)

32.4 SEK

Market Cap (25-Apr-19)

308 million SEK

Subscription period

:

June 5, 2019 - June 19, 2019

Subscription ratio

:

1:1

Subscription price

:

19,00 SEK per new share

Issue size

:

180,9 MSEK (before cost of issue)

The rights issue is fully secured through

subscription commitments and issue guarantees

+173%

Contact:

Anders Ljungqvist, CEO or Alexandra Ellervik, CM & PJMinfo@rhovac.com

IMMUNTHERAPY AGAINST

METASTASING CANCER

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