Agenda

• 1. Introducción

• 2. Quienes somos

• 3. Desarrollo de fármacos: Proceso

• 4. Recursos y capacidades

• 5. Desarrollo estratégico

BASIC

RESEARCH

PHARMACEUT

ICAL

INDUSTRY

APOINTECH´S RESOURCES

Infraestructures

• Laboratories: 160 m2 and 31,98 m2

• Offices: 16,65 m2 and 21 m2

• Autoclave Room

• Freezers Room

• Common laboratory

STAFF (100% Graduated)

Miguel Ángel Ávila, Agricultural Engineer. CEO

• Rubén Rosales, Biology PhD.

• Rósula García, Degree in Biology.

• Nuria Lucas, Lic. Degree in Biology and Biochemistry.

• Alba Dueñas, Degree in Biology.

1. Introducción

Investigación

Base

Apointech

Industria

Farmacéutica

2. Quiénes somos

– Empresa biotecnológica cuyo objetivo es identificar las dianas terapéuticas y conseguir tratamientos de enfermedades de base genética (Cáncer) e infectocontagiosas (Leishmania, Dengue, Malaria, Chagas)

2. Quiénes somos

• Misión: Consecución de fármacos para el tratamiento de enfermedades: – Infectocontagiosas

• Leishmaniasis • Dengue • Malaria

– De base genética

• Cancer de páncreas • Sarcoma de Ewing

– Otras aplicaciones

3. Desarrollo estándar de un fármaco

Investigación

Base

Desarrollo

Preclínico

Ensayo

Clínico

Distribución

del fármaco

I. Biotecnológica I. Farmacéutica

$150 Mill 2 Años

$50 Mill 1 Año

$250 Mill 8 Años

$400 Mill 4 Años

$850 Mill / 15 años

3. Desarrollo estándar de un fármaco

Investigación

Base

Desarrollo

Preclínico

Ensayo

Clínico

Distribución

del fármaco

I. Biotecnológica I. Farmacéutica

10.000 Compuestos 0,01%

1 Compuesto 100%

5 Compuestos 20%

250 Compuestos 4%

3. Nuestro modelo de desarrollo

Investigación

Base

Desarrollo

Preclínico

Ensayo

Clínico

Distribución

del fármaco

I. Biotecnológica I. Farmacéutica

10.000 Compuestos 0,01%

1 Compuesto 100%

5 Compuestos 20%

250 Compuestos 4%

Aumentar la tasa

de éxito Encontrar nuevas

aplicaciones

Eficacia

3. Nuestro modelo de desarrollo

Investigación

Base

Desarrollo

Preclínico

Ensayo

Clínico

Distribución

del fármaco

I. Biotecnológica I. Farmacéutica

$150 Mill 2 Años

$50 Mill 1 Año

$250 Mill 8 Años

$400 Mill 4 Años Reducir el tiempo Reducir el coste

Eficiencia

4. Recursos y Capacidades

Alianzas

Estratégicas

Infraestructura

Acuerdos de

Cooperación

Capital

Humano

4.1. Alianzas Estratégicas

• Multiplican los recursos de Apointech – Capital humano externo

– Acceso a Infraestructura

– Redes de colaboración

• Proveen de años de conocimiento en las distintas líneas de investigación

4.2 Acuerdos de Cooperación

• Proyectos conjuntos

• Prestación de servicios

• Colaboraciones de larga duración

• Sinergias en personal y equipamiento

• Formación globalizada del personal

SCIENTIFFIC EQUIPMENT

Equipment

• Cell Culture Room • 70 Human Tumor Cell Lines • Analyzer fluorescence, absorbance and luminescence. • Cryopreservation: N2, -80ºC and -20ºC freezer. • QPCR. • Centrifugue. Quality • Apointech is certified according to UNE ISO 9001:2008. • We work based on the Principles of Good Laboratory Practice (GLP) • Our staff is certified to work with experimental animals.

100 Molecules

20 Molecules

5 Molecules

1 Active Molecule

DRUGS SCREENING

FULL TEST or

SUB-PANELS

IN VIVO TEST

Apointech SL offers a fast, cheap and usefull study that let you know the most effective drugs and the sensitivity of tumoral and healthy endothelium (potential antiangiogenic activity indicator)

The Full Test let you know the IC50 and GI50 of selected compounds against our full panel or against the desired tumoral cell lines.

Apointech SL enables clients to use their budgets efficiently through in vivo efficacy evaluation of potential cancer therapies in human xenograft tumor models.

Apointech´s Preclinic Evaluation Services

IN VITRO SERVICES

Molecular Screening

Apointech SL offers four different in vitro services: • Pre-screening is a fast, cheap and usefull study that let you know the most effective drugs and the sensitivity of tumoral and healthy endothelium (potential antiangiogenic activity indicator)

• The Full Test let you know the IC50 and GI50 of selected compounds against our full panel or against the desired tumoral cell lines. • Also we can perform a “Combination Study” with other drugs of clinical use. • Active ingredients identification from natural extracts.

CELL LINES

HISTOTYPE CELL LINE

Breast BT-549; HS 578T; MCF7; MDA-MB-231/ATCC; MDA-MB-468; T-47D

CNS SF-268; SF-295; SF-539; SNB-19; SNB-75; U251

Colon COLO 205; HCC-2998; HCT-116; HCT-15; HT29;

KM12; SW-620

Leukemia CCRF-CEM; HL-60(TB); K-562; MOLT-4; RPMI-8226; SR

Melanoma LOX IMVI; M14; MALME-3M; MDA-MB-435; SK-MEL-2; SK-MEL-28; SK-MEL-5; UACC-257; UACC-62

Non-Small Cell Lung

A549/ATCC; CaLu-1; EKVX; HOP-62; HOP-92; NCI-

H226; NCI-H23; NCI-H2347; NCI-H322M; NCI-H460;

NCI-H520; NCI-H522; NCI-H596; NCI-H838; SK-Mes-

1

Ovarian IGR-OV1; NCI/ADR-RES; OVCAR-3; OVCAR-4;

OVCAR-5; OVCAR-8; SK-OV-3

Pancreatic Carcinoma BxPC-3; MIA-PaCa-2; PANC-1

Prostate DU-145; PC-3

Renal 786-0; A498; ACHN; CAKI-1; RXF 393; SN12C; TK-

10; UO-31

IN VIVO SERVICES

ANIMAL MODEL FOR CANCER

Human xenograft tumor models:

Apointech SL enables clients to use their budgets efficiently through in vivo efficacy evaluation of potential cancer therapies in human xenograft tumor models. Our broad range of tumor lines ensures a wide variety of testing alternatives for your agent. Our xenograft model portfolio is evaluated on a regular basis for response to standards of care and this data is available for designing combination studies. The xenograft cancer model of choice can be used, or our scientific staff can assist in selecting the most appropriate model for your agent. Complete profiling of agents can be carried out in a variety of tumor types or in combination with the appropriate clinical agent.

IN VIVO SERVICES

PRECLINICAL TRIALS

Apointech SL is developing its capacity of perform Pharmacokinetics and

biodistribution studies: • In vivo PK (AUC, clearence) and bioavailability (i.v/p.o.) • Compound analysis in biological material (blood, tissue)

IN VIVO SERVICES

ANIMAL MODEL FOR ALZHEIMER’S DISEASE Apointech can efficiently test the efficacy of your drugs against Alzheimer’s disease (AD) using transgenic mice with human mutations that result in familial AD.

The mice used develop cellular and histological signs of AD at 1.5 months of age. At 2 months of age they show cognitive impairment. Usually, treatments start at 3 months of age, to replicate real life where treatment starts after AD has been diagnosed.

IN VIVO SERVICES

ANIMAL MODEL FOR HYPERTENSION

Cardiovascular Diseases Animal model:

Apointech SL enables you to evaluate the anti-hypertensive activity of your drugs on a well-known hypertensive rat model, spontaneously hypertensive rats (SHRs). The animal´s body weight, blood pressure, and heart rate are measured 2 h after each administration. Blood pressure and heart rate are measured by using a tail-cuff device connected to a computerized oscillometer. This noninvasive method allows repeated measurements throughout the treatment period. Body weight is assessed daily.

IN VIVO SERVICES

ANIMAL MODEL FOR DIABETES

Diabetic Disease Animal model: Apointech SL offers evaluation of test agents in models of type 1 and type 2 diabetes. Type 1 diabetes is typically modeled in streptozotocin-treated mice. The Zucker Diabetic Fatty (obese) is our genetic models of type 2 diabetes. A defect in the leptin receptor is responsible for the diabetic phenotype exhibited by ZDF rats. Procedure: Effects of test agents on blood glucose and insulin levels, along with glucose or insulin tolerance tests and assessment of plasma biomarkers (glucagon, insulin and leptin), comprise standard endpoints.

IN VIVO SERVICES

SCREENING TOXICOLOGY IN A FLY

Toxicology Studies (Drosophila melanogaster): These flies allow a rapid, quantitative and inexpensive evaluation of the toxicity of a compound. Apointech SL offers toxicology studies with Drosophila melanogaster flies. Conservation of fundamental cellular and developmental mechanisms between flies and man are extensive enough to warrant a central role for the Drosophila model in toxicological testing of today. An experiment in which a reference drug is compared with several doses of our drug under development gives a precise indication of the relative toxicity of both compounds.

EDELFOSINE

Edelfosine (ET-18-O-CH3 ; 1-octadecyl-2-O-methyl-glycero-3-phosphocholine) is a synthetic alkyl-lysophospholipid (ALP). It has antineoplasic (anti-cancer) effects. Like all ALPs, it incorporates into the cell membrane and does not target the DNA. In many tumor cells, it causes selective apoptosis, sparing healthy cells.

5. Desarrollo Estratégico

• 5.1. Desarrollo de fármacos

• 5.2. Participación en proyectos

• 5.3. Internacionalización

•

•

•

Enfermedades Infectocontagiosas

5.1. Desarrollo de fármacos

•

•

Enfermedades de base genética

• Neuroprotección • Anti-inflamación

Otras Aplicaciones

Leishmaniosis Dengue Malaria

Cancer de Páncreas

Sarcoma de Ewing

Pipeline

Fases

Fármacos

Actividad

Screening

Preclínica in

vitro

Preclínica in

vivo

Preclínica

regulatoria

Fase I Fase II Fase III Fase IV Patente

Leishmania

Humana

Leishmania

Canina

Cáncer de

Páncreas

Sarcoma de

Ewing

Dengue

Malaria

5.2. Proyectos

• Participación en PROYECTOS REGIONALES

– Proyecto en investigación Colaborativa – Plan ADELANTA, Proyecto I+D+i – Fase Pre-clínica

en Leishmaniasis • Participación en PROYECTOS NACIONALES

– INNPACTO – Ensayo Clínico GFC en Fase I – Investigación Colaborativa Aplicada en Parques

Tecnológicos – Fase Pre-clínica en Tumores sólidos y hematológicos

• Participación en PROYECTOS EUROPEOS – FP7 PANACREAS – Fase preclínica en Cancer de

Páncreas

5.3 Internacionalización

• Acuerdos para la realización de ensayos clínicos de Leishmaniasis con el gobierno Brasileño y el CIDEPRO de Colombia

• Desarrollo conjunto de fármaco contra el cáncer de páncreas con la Universidad de Bonn y Debiopharm en Alemania

• Desarrollo de fármacos huérfanos contra enfermedades infectocontagiosas con DNDi

• Participación en las principales ferias biotecnológicas Europeas – BioEUROPE, CPHI, BioSPAIN

GRACIAS POR SU ATENCIÓN

“De razones vive el Hombre pero de sueños sobrevive” Miguel de Unamuno